Technology Solutions for Global Health
Technology Solutions for Global Health May 2011 In the developing world, the difference between sickness and health for millions of babies and mothers can be as simple as a sterile needle and syringe, a reliable refrigerator for storing vaccines, or a diagnostic test at point of care. In reality, needles are not easily sterilized; refrigerators are expensive, require fuel, or are difficult for rural health workers to maintain; and laboratories where urine and blood are analyzed for infectious disease often are found only in major cities. For the past 30 years, PATH has managed multiple projects focused on technology solutions to health needs. Working in many developing countries, PATH improves health by assessing needs and developing affordable and appropriate health, nutrition, and reproductive health technologies to solve them. Activities are carried out through effective partnerships with public-sector agencies (i.e., the World Health Organization) and privatesector companies. Involving the commercial sector improves the chances of developing low-cost, widely available, sustainable products. Technologies range from simple products which can be manufactured by small, local industries to highly sophisticated technologies produced with state-of-the-art industrial processes and materials. PATH s areas of expertise include: Needs assessment Technology design and development Technology assessment and evaluation Technology transfer Local introduction, training and advancement of new technologies Technology-related technical assistance Commercialization and business development To improve the safety and effectiveness of immunization services, PATH works on vaccine delivery devices and cold chain technologies. A vaccine heat-exposure indicator has been advanced and methods of stabilizing vaccines are being investigated. Injection devices include autodisable syringes with features which prevent reuse; a prefill, single-dose syringe with an attached needle; and a needle-free injector. Technologies to deal with medical waste especially used needles and syringes are being developed and advanced, as are various refrigeration technologies to keep vaccines and pharmaceuticals cool throughout the distribution channels. To improve maternal health and child health, low-cost technologies designed for use by low-literate health workers include a home birth kit, a portable scale to screen for low birthweight, and safe injection delivery devices for antibiotics for neonatal infections and for treatment of mothers with postpartum hemorrhage. To improve reproductive health, new versions of diaphragms and female barriers are being designed and developed to protect women against HIV/ AIDS, sexually transmitted diseases, and pregnancy. Work on effective delivery systems for microbicides is also a focus. In the area of nutrition, PATH is working on a method of food fortification and low-cost ways of improving surveillance of vitamin A deficiency and other micronutrients among populations. To improve diagnosis of major diseases, easyto-use, low-cost test kits for tuberculosis, diarrheal diseases, fevers (including malaria), sexually transmitted infections, and cervical cancer for use at the point of care are being developed and advanced. For treatment of HIV/AIDS patients, low-cost methods of monitoring disease status are underway. More than 30 health technologies are currently at some point of development and another 20 are already commercialized and available on the market. Suggestions for new technologies are welcome. PATH s work in this area is supported by a wide variety of funders including the United States Agency for International Development under the HealthTech program, the Bill & Melinda Gates Foundation, UNICEF, and others. Not included in this booklet are descriptions of PATHs work on vaccine development and advancement. For further information, please contact: info@path.org
Technology Solutions Portfolio at PATH Technologies being developed and advanced at PATH address needs for: Immunization and Safe Injection Maternal and Child Health Reproductive Health Nutrition Diagnostics for Infectious Diseases Safe Water
Immunization and Safe Injection
Technology Solutions for Global Health April May 2012 2010 Vaccines in the Uniject TM Injection System The World Health Organization (WHO) estimates that in some countries the percentage of injections given with syringes or needles reused without sterilization is as high as 70 percent. At the same time, the use of multidose vials often leads to 50 percent of vaccine being wasted or children being turned away due to reluctance to open a vial for just one child. Two decades ago, prefilled syringes were too costly for use in developingcountry public-sector health programs, and no prefilled syringe on the market offered an autodisable feature. In collaboration with the United States Agency for International Development, WHO, and many others, PATH developed a compact prefilled autodisable injection system known as the Uniject TM injection system, initially for use with vaccines. Uniject simplifies the act of giving an injection, makes the unsafe reuse of the syringe impossible, and reduces the burden on logistics systems by making medicament, needle, and syringe available at the same place and time. It eliminates the wastage commonly associated with multidose vials. Today, Uniject is licensed to BD, the world s largest manufacturer of injection equipment, for commercial production and distribution. BD sells the empty Uniject to pharmacuetical and vaccine producers, who then fill their products into it and sell the finished, prefilled drug or vaccine in Uniject to both public health programs and private-sector health channels. Today, BD produces Uniject in Singapore with a fully automated, highvolume production line and markets them globally to pharmaceutical companies. WHO has prequalified PT BioFarma s tetanus toxoid (TT) and hepatitis B vaccines in Uniject. Crucell, a major multinational vaccine producer, has announced plans to make its liquid pentavalent (DTP-HepB-HIB) vaccine available in Uniject with initial launch anticipated in 2013. At least one Indian vaccine producer markets its hepatitis B vaccine in Uniject. Operational research to assess the potential of incorporating TT in Uniject into immunization programs was conducted in Afghanistan, Ghana, and Mali in 2003. Hepatitis B vaccine in Uniject has been used nationwide in Indonesia for birth dose immunization since 2005 and is in use in the private sector in India. Uniject is a trademark of BD. Compact prefilled autodisable injection device filled with vaccine. With Uniject anybody can inject the vaccine. An illiterate midwife who s never been trained in medicine or birthing can do an absolutely perfect job. Dr. Francois Gasse, UNICEF, Reuter s Health, July 2002. Uniject and the associated equipment for filling and packaging are available to vaccine and pharmaceutical companies from BD Pharmaceutical Systems, New Jersey, USA Roderick Hausser, Tel: (201) 847-5185, Fax: (201) 847-4869. Hepatitis B vaccine and tetanus toxoid are available from manufacturers in India and Indonesia. For more information regarding this project, contact Steve Brooke at sbrooke@path.org. Funding for this project has been provided by the United States Agency for International Development under PATH s HealthTech program. UNICEF/HQ020263/Giacomo Pirozzi
Technology Solutions for Global Health May 2011 SoloShot Although sterile, disposable syringes and needles offer the best protection against transmission of bloodborne diseases, they are often reused in the developing world. Each year, more than 12 billion injections are administered worldwide; in the past in developing countries 50 percent of injections were estimated to be unsafe. A primary source of transmission of disease has been the reuse of contaminated needles and syringes. To be completely safe, single-use injection devices must be designed to automatically and irrevocably inactivate after a single cycle of filling and injection. The World Health Organization/Expanded Programme on Immunization (WHO/EPI) called for the design of such devices in 1987. In response to WHO s call, PATH designed one of the first feasible approaches to nonreusable syringes for immunizations: an autodisable (AD) syringe with a fixed needle that automatically locks after a single injection. When the syringe is filled to the preset 0.5-ml level, the plunger stops and cannot be pulled back further. After the vaccine is injected, the plunger automatically locks so that the syringe and needle cannot be reused. Known as the SoloShot syringe, this technology was licensed to and is now manufactured and marketed by BD, one of the world s leading syringe manufacturers. Third-party field validations of the device in Pakistan in the early 1990s demonstrated the acceptability and usability of the design. PATH also has assisted several other manufacturers of AD syringes to ensure a wide variety of products are available and to facilitate the lower pricing that accompanies increased competition and production volume. Since commercial introduction in 1992, 6 billion vaccinations have been delivered using SoloShot syringes by public health programs in more than 40 developing and emerging countries. United Nations Children s Fund which has already distributed hundreds of millions of AD syringes to EPI programs now provides only AD syringes to countries requesting disposable syringes, many of which are SoloShot syringes. BD continues to supply the syringes to national and international public health agencies at low cost. In fact, the syringe was one used in the recent PATH- and WHO-sponsored meningitis vaccine campaign in West Africa where millions of people were immunized. The price of AD syringes is dropping rapidly and is currently within two cents of the price of disposable syringes. PATH is also assisting USAID-supported family planning agencies with the introduction of a 1-ml AD syringe to be bundled with injectable contraceptives. AD syringes are now routinely used in immunization programs throughout the world. They can be used safely by vaccinators regardless of past experience or training. The devices are quicker to use than a conventional syringe and are preferred over a conventional syringe by vaccinators due to the speed and ease with which a correct vaccine dose can be drawn. An autodisable, single-use syringe. The autodisable syringe, which is now widely available at low cost, presents the lowest risk of person-toperson transmission of bloodborne pathogens. WHO-UNICEF-UNFPA Joint Statement, 2003. This technology has been licensed and is available from BD Pharmaceutical Systems, New Jersey, USA, Michael Garrison michael_garrison@bd.com. Funding for this project has been provided by the United States Agency for International Development under PATH s HealthTech program. SoloShot is a trademark of BD.
Technology Solutions for Global Health May 2009 2010 Technologies for Immunization Safety Each year, more than 16 billion injections are administered worldwide. In some regions, 17 to 75 percent are estimated to be with reused, unsterilized injection equipment. It is estimated that unsafe reuse causes 20 million hepatitis B infections, 2 million hepatitis C infections, and 260,000 HIV infections annually. In addition, needlestick injury is estimated to cause 40 percent of hepatitis B, 40 percent of hepatitis C, and 2.5 percent of HIV/ AIDS infection among the estimated 35 million health workers worldwide. Immunization programs have been proactive in introducing technologies and practices for injection safety, notably with autodisable syringes, sharps disposal boxes, and needle-removal systems. Opportunities remain to further increase immunization safety by reducing the use of sharps and improving safety of other steps of vaccination. As new vaccines such as Haemophilus influenzae type b, human papillomavirus, pneumococcal, and rotavirus vaccines are rolled out in developing countries, children may be subjected to an increased number of injections. It is critical that immunization systems maintain a focus on safety to ensure that these children reap the maximum health benefits with minimal associated risks. There are a number of technologies available to improve injection safety in developing-country settings. Retractable-needle syringes have been used in industrialized countries for many years, but their relatively high cost has limited introduction in low-resource countries. As technology and market development lead to less-expensive options in this category, the value assessment is changing, and opportunities are growing for developingcountry use. Needle removers separate the needle from the syringe immediately after giving an injection, containing the dangerous sharp waste in a small container for safe disposal. Syringe melters compact syringe waste volume, trap and disinfect needles, and facilitate recycling. Safety boxes, currently imported from Europe or Asia, may be able to be manufactured in Africa or other low-resource settings using innovative coatings and materials to meet international quality standards. PATH has been a leader in developing, identifying, and promoting appropriate solutions for safe injections and waste management. In 2008 PATH published a resource page on the web on the subject of medical waste, available at http://www.path.org/projects/health_care_waste_resources.php. In 2009 the World Health Organization (WHO) published product specifications and a test protocol for needle cutters as part of their Performance, Quality, and Safety program. This established a standard for WHO prequalification which then facilitates procurement of quality devices by the United Nations Children s Fund and other international and national organizations. Needles and sharps waste are dangerous to the community. Recognizing the importance of needleremoval to improve the safety of sharps waste management, it is recommended that the process of assessment and introduction be accelerated in African countries. GAVI/Implementation task force workshop on the management of biomedical waste, Senegal, 2003. For more information regarding this project, contact Joanie Robertson at jrobertson@path.org. Funding for this project has been provided by the United States Agency for International Development under PATH s HealthTech program and from the Bill & Melinda Gates Foundation. Robert Maletta
Technology Solutions for Global Health May 2012 Vaccine Vial Monitors Vaccines require careful storage and transport to the point of use to avoid harmful heat exposure. In the past, there was no way to detect whether individual vials had been exposed to heat, so national immunization programs adopted conservative guidelines for vaccine handling and disposal of vaccines when heat exposure was suspected. In 1985, PATH launched a search for suitable technologies that could indicate exposure to heat. An appropriate technology used for the food industry was discovered; PATH worked with the manufacturer to adapt it for vaccines, resulting in a product known as the vaccine vial monitor (VVM). VVMs are small, circular indicators, printed directly on vial labels or adhered to the tops of vials. The inner square is chemically active and changes color irreversibly from light to dark with exposure to heat over time. By comparing the color of the inner square to the reference color, a health worker can determine whether the vaccine has been exposed to heat. Important decisions on whether to use or discard vaccine and which vials should be used first are now clear due to the VVM. VVMs can be manufactured for a variety of heat-exposure specifications suitable for use with any vaccine, including BCG, diphtheria, hepatitis B, Hib, HPV, measles, oral polio, pertussis, pneumococcal, rabies, rubella, tetanus, and yellow fever vaccines. Since introduction in 1996, VVMs have helped to ensure that only potent vaccine is used to immunize children and to extend the reach of services thus raising coverage. The presence of VVMs made it possible for the World Health Organization (WHO) to implement the multi-dose vial policy that allows health workers to use opened vials of some liquid vaccines for more than one day. This has markedly reduced vaccine wastage, saving millions of dollars in immunization programs throughout the world. VVMs are also used to help manage and improve vaccine distribution. VVMs are manufactured by TEMPTIME Corporation in New Jersey under the product name HEATmarker * and are sold to vaccine producers throughout the world. WHO requires that all vaccine purchased through the United Nations Children s Fund (UNICEF) be labeled with VVMs. A WHO/UNICEF joint policy statement urges all vaccine self-procuring countries, donor agencies, and international organizations to include VVMs among the minimum requirements for vaccine purchase agreements and donations. Since their introduction in 1996, over 3 billion VVMs have been used on vaccine vials. WHO and UNICEF estimate that the use of VVMs is saving the global health community at least US$5 million per year. * HEATmarker is a trademark of TEMPTIME Corporation. Labels on vaccine products to indicate heat exposure. Used properly, this [vaccine vial monitors] can be a miracle tool to reduce wastage and prevent the use of heat damaged stock. Umit Kartoglu, WHO Department of Vaccine and Biologicals. GAVI Immunization Focus, July 2003. For more information on HEATmarker VVMs, contact TEMPTIME Corporation 116 American Road Morris Plains, NJ 07950, USA Tel: (973) 984-6000 Fax: (973) 984-1520 website www.temptimecorp.com e-mail tedp@temptimecorp.com. For more information regarding this project, contact Debra Kristensen at dkriste@path.org. Funding for this project has been provided by the United States Agency for International Development under PATH s HealthTech program.
Technology Solutions for Global Health May 2012 Mucosal Immunization Technologies AIDS, tuberculosis, acute respiratory-tract infections, and diarrheal diseases account for millions of deaths annually worldwide. All are caused by pathogens that enter the body via the mucosa, tissue linings found in the oral cavity and the reproductive and gastrointestinal tracts. Vaccines administered directly to the mucosa can trigger key antibodies and preferentially activate specific cells. Yet, mucosal vaccines face significant barriers to success due to in situ dilution and dispersion, interference from inert food and dust particles, enzymatic degradation, and low ph in the stomach. These and other factors can limit the ability of the vaccine to reach its target immune cells, resulting in a suboptimal immune response. To more effectively protect people from pathogens that enter the body via the mucosa, new technological approaches are needed. PATH recently developed a mucosal immunization technology platform viable in two formats that builds on several proven formulation, adjuvant, and delivery technologies that enable the efficient sublingual administration of subunit vaccines. The first format is a liquid solution at room temperature that transforms into a gel upon contact, enabling it to adhere to mucosal surfaces. Its gel matrix also protects the vaccine antigen from degradation caused by salivary enzymes. The second is a fast-dissolving tablet (FDT) that disintegrates instantly in a small amount of saliva. The FDT can also be reconstituted in diluents or a buffer and then is administered orally with a liquid dropper. As each format is needle-free, the technology platform also promises to improve the safety of vaccination. PATH recently demonstrated the thermoresponsive properties of the technology platform and its enhanced permeability of the epithelium barrier. Tests also revealed tolerability by cultured epithelium cells. In animal models, the gel format demonstrated desirable gelation, spreading, and retention (>20 minutes) on the sublingual mucosa, maximizing the proportion of antigen gaining access to target cells. Tetanus toxoid vaccine gel elicited a high level of relevant antibodies in serum and in the secretions of the oral cavity and the gastrointestinal and reproductive tracts of mice. PATH has applied the FDT format to a candidate enterotoxigenic E. Coli vaccine, producing a lead formulation that is stable at 12 months under refrigeration. Next steps include developing a formulation that is stable at room temperature for four weeks in a glass vial and then adapting it into a tablet. Additional assessments are under way as PATH continues to research the two formats as value-added product presentations for human and veterinary vaccines. Novel methods to induce mucosal immunity. The best defense against these predominantly mucosal pathogens would be vaccines, preferably mucosal vaccines capable of inducing both systemic and mucosal immunity. van Ginkel F, Nguyen H, McGhee J. Vaccines for mucosal immunity to combat emerging infectious diseases. Emerging Infectious Diseases. 2000;6(2):123 132. For more information regarding this project, contact Dexiang Chen at dchen@path.org. Support for this project has been provided through funding from private foundations and individual donors to the Health Innovation Portfolio at PATH and the Bill & Melinda Gates Foundation. PATH/Scott Areman
Technology Solutions for Global Health February May 2009 2010 Cold Chain Technologies Effective vaccine distribution and storage are critical to achieving immunization coverage and impact. As new and more expensive vaccines become available, greater capacity is needed in the cold chain to accommodate the new vaccines, and the loss of vaccine due to heat or freeze damage is becoming less tolerable due to greater financial risk. Innovative cold chain technologies can help improve the reliability of vaccine distribution, reduce unnecessary wastage of valuable vaccines, and help strengthen the overall immunization system. PATH is working to advance technologies that improve the cold chain; for example, smart refrigerators that keep vaccines cold without freezing, and lower-cost solar refrigerators without batteries that provide affordable refrigeration for more health clinics as well as facilitate immunization services in remote settings. PATH is also working on software solutions to update the management systems that underlie the cold chain infrastructure. A new tool is being developed for tracking countrywide inventories of cold chain equipment and improving the ability of managers to plan over multiple years to accommodate new vaccines. In 2008, PATH and the United Nations Children s Fund introduced the cold chain equipment management software (CCEM) version 1. Workshops were conducted in Seattle and Panama to train immunization managers and global experts. Version 2 is expected by mid-year 2009. PATH is working to advance solar refrigerators that do not require traditional batteries for energy storage. Direct-drive solar refrigerators and new long-life batteries developed for the hybrid automobile market hold the promise of reducing operating costs while expanding the reach of vaccine refrigeration. In 2009 we will likely see the World Health Organization (WHO) prequalify the first device in the direct-drive class. PATH is assisting WHO in the development of new specifications for refrigerators and cold chain monitoring equipment that will encourage manufacturers to create innovative products that fit developing-country needs. PATH continues to work on global policy that will help countries adopt new technologies and practices to preserve vaccine in the cold chain. For example, we are working with WHO to add specifications under their product qualification system that will allow new technologies, such as transport containers with new cooling technologies. We are also helping the global community study the possibility of removing some heat-stable vaccines from the cold chain in some locations. Appropriate and innovative technologies for vaccine cold chain. Vaccines are sensitive to heat and freezing and must be kept at the correct temperature from the time they are manufactured until they are used. Immunization in Practice. A Practical Resource Guide for Health Workers. WHO, 2004. For more information regarding this project, contact Joanie Robertson at jrobertson@path.org. Funding for this project has been provided by the United States Agency for International Development under PATH s HealthTech program and from the Bill & Melinda Gates Foundation. PATH/Carib Nelson Mail: PO Box 900922, Seattle, WA 98109, USA Location: 2201 Westlake Ave, Suite 200, Seattle, WA 98121, USA
Technology Solutions for Global Health April May 2012 2010 An Improved Passive Vaccine Carrier Evidence from the field indicates that when vaccines are transported from health centers to remote populations, temperatures inside vaccine carriers are often maintained with frozen ice packs, putting the vaccines at risk of freezing. Many of the common vaccines containing aluminum adjuvants are sensitive to freezing, including those that are more costly such as human papillomavirus, pneumococcal, liquid rotavirus, and cholera vaccines. If frozen, these vaccines lose their potency, leaving those vaccinated at risk of disease, costing lives, damaging the reputation of vaccination programs, and wasting valuable health dollars. In spite of documented evidence of vaccine freezing, current World Health Organization (WHO) Performance, Quality and Safety (PQS) specifications for passive vaccine carriers do not require the demonstration of freeze prevention. To protect vaccines from being exposed to freezing temperature conditions, WHO policy recommends the use of cool water packs. Alternatively, if ice packs are used, they must be conditioned or allowed to warm from -20 C to +0 C. Conditioning is not an exact science, and experiments have documented the freezing of vaccines even when they are stored in a cold box with conditioned ice packs. PATH is proposing to address the problem of vaccine freezing at the periphery of the health system by incorporating an inner vaccine box made of engineered phase-change material (EPCM) into vaccine carriers. When used with non-conditioned ice packs, the EPCM vaccine box will protect vaccines stored within the carrier from exposure to temperatures below 0 C, preventing the freezing of vaccines. Other primary advantages of the proposed modified vaccine carrier design are longer holdover time than cool water packs, adaptability to existing vaccine carriers, low training burden, and low cost compared to other freeze-prevention carrier designs. Vaccine carriers retrofitted with the EPCM liner and filled with frozen ice packs have been tested at various ambient temperatures, successfully demonstrating freeze protection. Temperatures have dropped below 0 C for up to 19 hours in the same carriers but without the EPCM liner. To understand the performance of the improved vaccine carrier design in a field setting, preliminary data on prototype designs will be gathered in Vietnam in 2012. Temperature loggers will be placed inside and outside the vaccine carriers to monitor internal and ambient temperatures during transport. In addition to collecting information on current vaccine outreach practices and frequency of freezing in the use of passive vaccine carriers, feedback on the improved vaccine carrier design, ease of use, and holdover time will also be collected. Laboratory data and potential manufacturing approaches are being discussed with several manufacturers of low-cost, PQS-prequalified vaccine carriers to determine their interest in modifying their products with an EPCM liner. Vaccine carrier containing phasechange material liner. Vaccines are sensitive to heat and freezing and must be kept at the correct temperature from the time they are manufactured until they are used. Immunization in Practice. A Practical Resource Guide for Health Workers. Geneva: WHO; 2004. For more information regarding this project, contact Nancy Muller at nmuller@path.org. Funding for this project has been provided by the United States Agency for International Development under PATH s HealthTech program, from private foundations and individual donors to the Health Innovation Portfolio at PATH, and from the Bill & Melinda Gates Foundation through a Grand Challenges Exploration grant. PATH/Shawn McGuire
Technology Solutions for Global Health September May 2011 2010 Assessing Retrofit Solutions to Improve Domestic Refrigerator Performance for Vaccine Storage The World Health Organization (WHO) advises against storing vaccines in refrigerators that do not meet WHO Performance, Quality and Safety (PQS) performance standards. However, many clinics, including most of those in Australia, Canada, Europe, and the United States, continue to store vaccines, often valued in the thousands of dollars, in untested domestic refrigerators because they are cheaper and easier to purchase. These domestic refrigerators pose a significant threat to a clinic s valuable vaccines. PATH seeks to identify a set of low-cost technological modifications to domestic refrigerators with the potential to prevent the economic loss and unnecessary health risks from compromised vaccine storage conditions. The team is investigating simple and affordable technological modifications that will provide improved temperature control in domestic refrigerators. These modifications include the following components: Continuous temperature monitoring of refrigerator temperatures. We believe that this is likely to become a minimum standard for all vaccine storage points because products such as the FridgeTag TM are increasingly promoted by WHO and the United Nations Children s Fund in an effort to increase the visibility of true vaccine storage and transport conditions. Automatic thermostat control. Refrigerator performance with an aftermarket thermostat control device that is easy to install and will respond quickly to an accurate measurement of the vaccine compartment temperature has the potential to compensate for the substandard mechanical thermostat in most domestic refrigerators. Small circulating fan. The addition of a small, low-power, circulating fan, similar to those used in computers, has the potential to greatly improve the homogeneity of temperature in all areas of the vaccine compartment. Phase-change material (PCM). Commercial PCM will be evaluated as an alternative to water. We will evaulate PCM materials in both a coolant brick format, placed at the bottom of the refrigerator to increase the holdover time, as well as an internal six-sided protective box that creates a safe micro-environment within the refrigerator for vaccine storage. PATH has identified potential retrofit solutions, including the results of laboratory testing of domestic refrigerators funded by the Centers for Disease Control and Prevention and conducted by the National Institute of Standards and Technology. A technical evaluation will determine the potential of these retrofit solutions to improve performance of domestic refrigerators to meet the WHO PQS standards for compression refrigerators. The team will share this information in a technical report and market analysis by the close of project in December 2012. A domestic refrigerator holding $4,687 worth of rotavirus vaccine. Domestic refrigerators are designed for food storage and not for the requirements of vaccine storage. Precautions and fridge modifications are needed in order to store vaccines. Public Health Agency of Canada, National Vaccine Storage and Handling Guidelines for Immunization Providers (2007). For more information regarding this project, contact Sophie Newland at snewland@path.org Funding for this project has provided through funding from private foundations and individual donors to the Health Innovation Portfolio at PATH. UNICEF
Technology Solutions for Global Health September May 2011 2010 Cold Chain Equipment Manager As governments and donors invest in new, higher-cost vaccines, there is mounting pressure for countries to demonstrate supply chain preparedness extending to the point of vaccine delivery at the health facility. Yet, in the frequent absence of an up-to-date cold chain equipment inventory, national Expanded Programme on Immunization (EPI) managers, the World Health Organization (WHO), the United Nations Children s Fund, and donors have poor visibility of cold chain capacity below the regional level. Consequently, procurement plans cannot prioritize the districts or provinces with the greatest need for new equipment, inform repair services, or optimize new equipment selection in response to a facility s energy availability or storage capacity needs. Recognizing the urgent need for countries to inventory and better manage supply chain equipment such as refrigerators, cold rooms, and cold boxes, PATH developed a software tool called Cold Chain Equipment Manager (CCEM). The tool can help vaccination programs manage equipment requirements down to the facility level, forecast equipment needs for different scenarios, and generate procurement lists according to national policies. CCEM differs from other available equipment management tools because, in addition to the usual data management, analysis, and reporting functions of a conventional inventory tool, it allows countries to view the cost and logistical implications of potential programmatic changes through what if scenarios such as procedural changes or the introduction of a new vaccine. Five countries Kenya, Malawi, Nicaragua, Uganda, and Zimbabwe have successfully implemented cold chain inventories in CCEM 2, generating equipment plans in advance of new vaccine introduction. When Uganda piloted the first version of CCEM in 2007, public health managers found they could introduce human papillomavirus vaccine without buying new refrigerators. They also saw that the primary storage issues were going to be at the national and provincial levels and were able to transition resources to those levels to accommodate the increased burden. Since then, the CCEM tool has been a useful reference bank for information about cold chain inventory and status as it can quickly calculate storage capacities, shortages, and surpluses. In 2009, Uganda was able to present the Japan International Cooperation Agency (JICA) with an evidence-based investment case for cold chain equipment in preparation for the introduction of pneumococcal vaccine. As a result Uganda received JICA funds for much needed equipment. Today, they are using CCEM to plan for the introduction of the rotavirus vaccine in 2013. In the future, PATH hopes to support EPI teams in Ethiopia, Mozambique, and Swaziland to implement cold chain inventories with CCEM for analysis and equipment planning. We also plan to deploy a web-based version of CCEM as an integrated component to other web-based applications maintained by the information technology departments of the ministries of health. Cold Chain Equipment Manager training in Nairobi, Kenya. An ideal supply chain is one that ensures that the limits of science are not constrained by the limits of systems. Dr. Orin Levine, Johns Hopkins Bloomberg School of Public Health excerpt from http://www.path.org/ projects/project-optimize.php. CCEM 2 is available for free download at www.path.org and www.technet21.org. For more information regarding this project, contact Sophie Newland at snewland@path.org Funding for this project has been provided by the United States Agency for International Development under PATH s HealthTech program. PATH/Joe Little
Technology Solutions for Global Health May 2012 Vaccine Stabilization Maintaining cold chains to store and transport vaccine is a challenging task in many developing countries. The potential for heat to damage vaccines is highest in areas where power outages or gas shortages prevent refrigerators from operating or where vaccine must be transported over long distances to reach remote populations. Vaccines containing an aluminum adjuvant are also sensitive to freezing. Accidental freezing can occur when vaccines are placed too close to the walls of ice-lined refrigerators, the evaporator in certain refrigerators, or the frozen ice packs inside insulated transport carriers. Inadvertent exposure of vaccines to damaging temperatures has been well documented in both developed and developing countries. When health workers suspect a vaccine is temperature damaged, the vaccine is often discarded at great cost to the immunization program. When temperature damage goes unnoticed, children may receive ineffective vaccine. Thermostable vaccines will improve the effectiveness and efficiency of immunizations by preventing temperature damage to vaccines, reducing vaccine wastage, and decreasing logistical and equipment requirements as well as the costs of vaccine transportation and storage, especially at the periphery of the cold chain. Thermostable vaccines will also facilitate coverage gains by enabling vaccine delivery in remote areas beyond the reach of the existing cold chain. Additional benefits, such as improved vaccine safety and superior product formats, are also possible depending on the stabilization methods used. PATH is researching several methods to improve the thermostability of vaccines of importance to developing countries such as vaccines for measles, hepatitis B, diphtheria-tetanus-pertussis (DTP), Haemophilus influenzae type B (Hib), Shigella, enterotoxigenic Escherichia coli, meningococcal, rotavirus and pandemic influenza. Research is being conducted in collaboration with vaccine producers, vaccine development projects, technology companies, laboratories, and universities. Achievements include: Development of a method to protect vaccines containing an aluminum adjuvant from freeze damage and advancing its application to pentavalent (DTP-hepatitis B-Hib) vaccine through formulation development, analytical method development, preclinical work, laboratory-scale production, and stability studies. PATH s vaccine freeze-protection technology is in the public domain so that vaccine manufacturers worldwide can use the approach. Identification of a technology to improve the heat stability of hepatitis B and Hib vaccines and demonstration of its compatibility with the above method to obtain a heat- and freeze-protected hepatitis B vaccine product. Marked improvements in the stability of hepatitis B and meningococcal A vaccines through reformulation involving glass-forming sugars plus other excipients and processing via spray drying. Thermostable vaccines improve vaccine effectiveness and ease logistics....heat-stable vaccines and combination formulations can simplify and improve drug and vaccine delivery while expanding the reach of modern medicine to millions more who could benefit. Daar AS, Thorsteinsdóttir H, Martin DK, et al. Top 10 biotechnologies for improving health in developing countries. Nature Genetics. 2002;32:37. For more information regarding this project, please visit our web site at http://www.path.org/projects/ vaccine-stabilization.php or contact Debra Kristensen at dkriste@path.org. Funding for this project has been provided by the Bill & Melinda Gates Foundation. Ümit Kartoglu
Technology Solutions for Global Health May 2012 Disposable-Syringe Jet Injection According to the World Health Organization (WHO), 16 billion injections are given each year, yet in developing countries at least 50 percent of injections given are unsafe. 1 Reuse of contaminated needles and syringes, needlestick injuries among health workers, and threats to the community from improperly disposed of and potentially contaminated needles and syringes are serious health risks, possibly spreading infection and diseases such as HIV and hepatitis. Jet injectors deliver vaccines and medicines without using needles; instead, jet injectors generate a pressurized liquid stream that pushes through the skin and delivers injections into the tissue. First introduced in the 1940s, early-model jet injectors were used to give millions of injections even helping to eradicate smallpox. More recently, disposable-syringe jet injectors (DSJIs) have been developed to prevent cross-contamination between patients. This technology is currently the only available needlefree technology that can be used to deliver all injectable vaccines used in developing-country immunization programs, at all depths of delivery (intradermal, subcutaneous, and intramuscular). It also requires no change in vaccine formulation and can be filled from multi-dose and single-dose vials at the point of use. PATH has worked with several developers on their respective DSJI technologies to advance designs that are affordable and adapted for routine immunization in low-infrastructure settings. In addition, PATH is exploring ways in which this technology could facilitate new vaccination strategies. For example, intradermal delivery offers the potential advantage of effective immunization with smaller doses, allowing for reduced costs of each vaccination and increased coverage for vaccines that are in short supply due to high cost or limited production capacity. PATH has identified potential benefits of using DSJIs for this type of vaccination. PATH is working with multiple device developers and global stakeholders, assisting with design, regulatory advances, economic analysis, and clinical research. PATH has conducted user assessments of device prototypes in the field (Brazil, China, and India) and suggested design adjustments based on user feedback. PATH helped to formalize a WHO Performance, Quality, and Safety specification and verification pathway for DSJI technology. Also PATH recently completed a clinical study where DSJIs were compared with traditional needles and syringes in delivering measles-mumps-rubella vaccine. PATH plans to continue to explore acceptability and sustainability of DSJIs, especially in terms of intradermal delivery in developing-country immunization programs. 1 Simonsen L, Kane A, Lloyd J, Zaffran M, Kane M. Unsafe injections in the developing world and transmission of bloodborne pathogens: a review. Bulletin of the World Health Organization. 1999;77:789 800. Needle-free immunization with a disposable-syringe jet injector. Needle-free delivery systems offer an answer to the problem of sharps in the vaccination programs. That is why WHO is so interested in this technology. In addition, the intradermal administration of fractional doses of IPV [inactivated polio vaccine] could make this vaccine affordable for developing country use. Dr. Roland Sutter of the World Health Organization and the Global Polio Eradication Initiative. For more information regarding this project, contact Darin Zehrung at dzehrung@path.org. Funding for this project has been provided by the United States Agency for International Development and the Bill & Melinda Gates Foundation. PATH/Patrick McKern
Technology Solutions for Global Health May 2012 2010 Reconstitution Technologies Many obstacles must be overcome before a vaccine can be safely delivered to a child in a developing country. Delays in transit and uneven temperatures can spoil the vaccine. Some vaccines require reconstitution mixing dry components with wet diluents which can also cause challenges. Irregular supply chains can separate dried vaccines from their respective diluents. Even if everything arrives on time, together, and at the right temperature, poor lighting and outdated training can prevent a health worker from effectively administering the vaccine. In addition, the needles used to reconstitute vaccines represent a risk of transmitting infection and causing disease if used and disposed of improperly. All these contribute to inappropriate reconstitution and administration of vaccines scenarios that have been connected to deaths and injuries around the world. For reconstitution of critical vaccines to become safer and more economical, the process of reconstitution must be simple and must eliminate the adverse events and wastage that can occur with improper reconstitution. Technologies that keep a dried vaccine and its diluent together ensuring that both are at the same temperature, are not separated, and have a simplified mixing process of the two parts offer many advantages over current systems. Single-dose, prefilled reconstitution devices (SPRDs) can address these, representing a means of eliminating reconstitution errors, reducing supply wastage, and reducing the impact on the medical waste disposal system. Selective and strategic introduction of vaccines through low-cost SPRDs can reduce adverse events and wastage while improving vaccine effectiveness. PATH examined a variety of SPRDs to see if they were suitable for use in developing countries. Five devices were evaluated by health workers in Andhra Pradesh, India. Results were favorable: users felt they could deliver injections with more safety and less wastage with SPRDs. They also provided extensive input on the design and use of the devices. PATH continues to advocate for and support the development of low-cost SPRDs for use with spray-dried or lyophilized vaccines. PATH is also conducting additional research to assess how specific features of integrated reconstitution devices for vaccine delivery impact stakeholders all along the value chain. Our goal is to enable selective and strategic introduction of vaccines in a low-cost SPRD format to reduce mortality and morbidity associated with reconstitution-related adverse events. We facilitate interactions among users, device developers, vaccine manufacturers, and experts in research. At every point we aim to ensure that the technology is safe, affordable, and sustainable. A simple, economical process for reconstitution of vaccines. Single-dose, prefilled reconstitution devices (SPRDs) can make reconstitution of critical vaccines safer and more economical. SPRDs can help eliminate adverse events or wastage that can occur with improper reconstitution, which also reduces impact on the medical waste disposal system. For more information regarding this project, contact Darin Zehrung at dzehrung@path.org. Support for this project was provided through funding from private foundations and individual donors to the Health Innovation Portfolio at PATH. Scott Areman
Technology Solutions for Global Health April May 2012 2010 Intradermal Adapter Rabies vaccine is expensive and often in short supply approximately 20,000 people die of rabies each year in India, often because they were unable to access treatment. For rabies vaccine, the same or better protection can be achieved by delivering smaller amounts of vaccine intradermally (into the top layer of the skin), sparing valuable doses and stretching supplies to provide for more patients. Intradermal (ID) regimens for rabies vaccine have been adopted in many regions, protecting people who have been exposed to rabid animals, while saving costs and vaccine. This approach is not yet universal, despite clear benefits, due in part to the difficulty of giving an ID injection correctly. The Mantoux technique, which uses a traditional needle and syringe for ID delivery, has historically been recognized as a difficult and inconsistently used technique. In many countries, only certain health care workers are able to perform ID injections, such as for rabies vaccine and Bacillus Calmette- Guérin or BCG, a vaccine given intradermally at birth to prevent tuberculosis. Smaller ID doses of other vaccines could also be effective. Such dose sparing could be particularly meaningful to immunization programs in low- and middle-income countries, as they could potentially reduce the amount of vaccine needed per patient, thereby cutting costs and overcoming vaccine shortages. However, concerns regarding the difficulty and a lack of reliability of conventional ID injections limit research in this field and introduction of this technique into immunization programs. The PATH intradermal adapter makes ID injections easier. It facilitates the procedure by standardizing injection depth and angle. It is anticipated that the ID adapter would expand the pool of health care workers capable of performing the procedure. This would have a particularly high impact in remote or underserved communities with more limited access to health care specialists. In partnership with SID Technologies of Newtown, Pennsylvania, PATH developed the ID adapter from the initial concept through manufacturing of clinic-ready devices. We modified and tested successive design prototypes, incorporating feedback from health care workers in the United States and India. Performance of the current model has been proven in preclinical testing, and will be demonstrated in a clinical trial with saline and ultrasound imaging in the United States in 2011. The ID adapter will then be used in a clinical trial with rabies vaccine in 2012. The intradermal adapter fits over a conventional needle and syringe. The use of reliable ID delivery devices for rabies vaccination and for other vaccines and drugs can have application in areas where health care workers are not used to, or confident with, ID delivery by the Mantoux technique. Recommendation of the World Health Organization/Bill & Melinda Gates Foundation Consultation, Annecy, France, October 7 9, 2009. For more information regarding this project, contact Darin Zehrung at dzehrung@path.org. Support for this project was provided through funding from private foundations and individual donors to the Health Innovation Portfolio at PATH. PATH/Emily Griswold
Technology Solutions for Global Health April May 2012 2010 Microneedle Patches Some vaccines are too expensive for developing-country immunization programs. Others are subject to shortages or imperfect distribution systems. Any one of these factors can prevent people from accessing the vaccines that they need. PATH is exploring ways to bridge the gap. A potential solution for some vaccines is intradermal (ID) delivery. The skin is an active player in the human immune system, particularly the shallow, upper layers. Delivering vaccines directly to these tissues can be very effective. Research shows that reduced-dosage of vaccine delivered intradermally can achieve the same results as an intramuscular or subcutaneous injection. ID delivery does so using up to 80 percent less vaccine helping to optimize the capacity of the cold chain, lower the cost of each dose, and enable immunization programs to stretch their vaccine supplies across more patients. This approach is not yet universal despite clear benefits. This is due, in part, to the difficulty of giving an ID injection correctly. The Mantoux technique, which uses a traditional needle and syringe for ID delivery, can be difficult to learn and impractical to use in many settings. Concerns regarding the difficulty and a lack of reliability of conventional ID injections limit research in this field and introduction of this technique into immunization programs. Microneedles are a diverse field of delivery technologies designed to access the intradermal cells. Some microneedle patches consist of tiny needles coated with vaccine, while others use the skin s moisture to dissolve the vaccine into the intradermal layer. Hollow microneedles are a different type of device, using miniature needles attached to a regular syringe. Preclinical studies show great promise for these technologies, particularly with influenza and herpes simplex virus vaccines. Easy to use and intuitive, these devices could simultaneously make intradermal delivery easier and more effective. Building on earlier work under the Health Innovation Portfolio where we tested herpes simplex virus, malaria, and hepatitis B vaccines with microneedles PATH formed a collaboration with the Georgia Institute of Technology (Georgia Tech) and Emory University. This project aims to create a microneedle patch that allows people to self-administer influenza vaccine. PATH will evaluate the technology from a variety of angles, including medical, economic, social, and regulatory, and PATH will assist Georgia Tech in developing a strategy to address any issues. The team will also carry out a cost-effectiveness analysis to quantify the potential cost implications of a self-administered vaccine. Our work will assess the feasibility of this novel approach and help plan for the introduction of microneedles into clinical practice more effectively. One example of a microneedle patch. If we can make it easier for people to be vaccinated and improve the effectiveness of the vaccine, we could significantly reduce the number of deaths caused every year by influenza. Dr. Mark Prausnitz, Georgia Institute of Technology. For more information regarding this project, contact Darin Zehrung at dzehrung@path.org. Support for this project was provided through funding from private foundations and individual donors to the Health Innovation Portfolio at PATH, and from National Institute of Biomedical Imaging and Bioengineering. Scott Areman
Technology Solutions for Global Health October May 2011 2010 Intranasal Delivery Devices Intranasal and pulmonary delivery devices deliver vaccines or medications directly to the nasal cavity or lungs, where they can be absorbed directly by the appropriate tissues. Studies have demonstrated that vaccines against some pathogens can be more efficacious when delivered by the intranasal or pulmonary route, particularly if these are the routes of infection. In addition, many drugs may be delivered by intranasal and pulmonary routes. Advantages of these routes of delivery include targeting the drug to the site of infection or disease, rapid absorption into the blood stream, and easier, needle-free delivery. In high-income countries, intranasal and pulmonary devices are used for influenza vaccine as well as treatment of noncommunicable pulmonary diseases such as asthma. These routes of delivery may also be suitable for critical developing-country health needs, including measles and tuberculosis vaccines, novel vaccine technologies such as DNA or viral vector vaccines, and drugs for respiratory infections such as tuberculosis or pneumonia. For these applications, the delivery approach has the potential to enable increased access, improved safety over needle injections, and reduced treatment costs. However, existing delivery technologies are often focused on high-income country markets, and do not necessarily address the needs of developing countries such as cost, safety, and ease of use. The development of intranasal or pulmonary delivery drugs and vaccines important to public health is ongoing. In addition to improved efficacy, wider use of these delivery routes could have added benefits including the potential for delivery by a broader range of health care workers and a reduction in the use of sharps. Identification of and access to the delivery device designs that better meet developing-country public health requirements, such as cost and safety, would facilitate the introduction of new therapies. Optimizing the design and manufacture of delivery devices to ensure the production of reliable, low-cost, and appropriate devices for future vaccine and drug applications would also help to address the needs of developing countries. PATH recently conducted an analysis of intranasal delivery technologies for use with live attenuated influenza vaccine. A variety of types of intranasal delivery devices were evaluated, including liquid drops and sprays, dry powders, prefilled and user-filled devices, single-use and multiuse devices, and separate and integrated reconstitution technologies. The results were used to inform manufacturers of new, low-cost influenza vaccines intended for developing-country use, of the delivery device options currently available and the important considerations for selecting or developing a delivery technology for use with their vaccines. PATH also continues to explore the landscape of aerosol and pulmonary delivery technologies and potential applications for public health. Evaluation of a nasal spray device. Inhalational administration of substances is necessary for treatment of asthma and chronic lung disease, and has been evaluated for delivery of other molecules. There is a need for development of affordable and standardized devices for administration... World Health Organization (WHO). The Selection and Use of Essential Medicines. Report of the WHO Expert Committee, 2009. Geneva: WHO; 2009. Available at: http://www.who. int/medicines/publications/ TRS958_2010.pdf For more information regarding this project, contact Darin Zehrung at dzehrung@path.org. Support for this project was provided through funding from the Bill & Melinda Gates Foundation. PATH/Gene Saxon
Technology Solutions for Global Health April May 2012 2010 SmartConnect In many developing countries, health care is delivered in rural areas at health posts or dispensaries that are at significant distance from higherlevel facilities. Due to their rural locations, the infrastructure connecting these facilities is often poor, they may only be accessible via small roads or tracks, and some are off the electrical grid or at the periphery of cell phone service. These facilities have many communication needs with the health service, including filing incidence reports on diseases, receiving results of diagnostics tests as well as general administrative information. In addition, there is a need to provide automatic monitoring of equipment including vaccine refrigerators and test equipment. Increasing the reliability and speed of this communication permits health workers to spend more time with patients and allows new services to be offered. In collaboration with Inveneo, a San Francisco-based social enterprise, PATH has developed SmartConnect, a communication device for peripheral health facilities. The idea behind SmartConnect is to focus on a facility-based communication appliance (such as a point-of-sale terminal). Advantages of a facility-based device include being able to tie the device to existing infrastructure, improved physical security and reliability, and a user interface that is adapted to specific communication tasks. The device was designed to use cellular network for communication where data is encoded into short message service (SMS) messages. SMS is the lowest common denominator for data communication and can be cost-effective, provided that the amount of data being sent is small. The messages are sent between the device and a server connected to the internet. The server is a bridge between the device and the health system, forwarding messages by either email or SMS and making results visible on a web-accessible dashboard. The core SmartConnect device consists of a microprocessor, a cell phone radio, digital input output peripherals, and an external antenna. Inveneo developed hardware and software prototypes of SmartConnect based on requirements developed by PATH. Initial communication applications for the device included monitoring the vaccine cold chain, reporting surveillance data, and tracking stock levels. The team conducted an initial field trial in Nicaragua in collaboration with PATH s Nicaragua office and a technology assessment in Vietnam in collaboration with Project Optimize. The initial version of SmartConnect has provided important information on communication needs of health facilities and how they can be supported with a communication appliance. Future versions of SmartConnect are likely to adopt the Android platform as the underlying hardware. SmartConnect version 2. During visits to remote health posts, PATH s SmartConnect team learned that it often takes many hours of travel by foot, horse, or bus to reach the nearest town. As a result, health workers face long delays in picking up diagnostic test results and submitting reports. Additionally, problems such as running out of supplies or trouble with equipment, often go unreported. For more information regarding this project, contact Richard Anderson at randerson@path.org. Support for this project was provided through funding from private foundations and individual donors to the Health Innovation Portfolio at PATH. PATH/Patrick McKern
Technology Solutions for Global Health April May 2012 2010 Technologies for Oral Delivery of Vaccines Vaccines against some pathogens can be more efficacious when delivered by the oral route, particularly if these are the routes of infection. By adopting a route for vaccine delivery that mimics the natural infection, the appropriate immune tissue is targeted, which could be beneficial for a protective immune response. Vaccines and medications that are suitable for this route of delivery include oral poliovirus vaccine, rotavirus vaccine, and some nutritional supplements. There are many devices that can deliver drugs and vaccines orally, some are not appropriate for developing countries, while others are only suitable under particular circumstances. Some vaccines have large dose sizes, which preclude certain types of devices; these bulky containers can easily overburden a packed cold chain. While many technologies could be repurposed for vaccines, some were developed with high-income countries in mind and require manufacturing processes beyond the reach of developingcountry vaccine manufacturers. Finally, even the most streamlined, userfriendly design will do little good if it is too costly for immunization programs in low-resource settings. A major benefit to oral delivery is the ease of administration. Health workers with minimal training can safely immunize the community s children. It also means one less shot for a baby and one less needle for disposal. While there are many options that could do this job, finding the right technology for a particular situation can be a challenge. The device has to fit the drug s format, be inexpensive to manufacture and purchase, and ideally should also integrate seamlessly in to the logistics system and be suitable for outreach to remote areas. One size does not fit all, but careful planning can make access to and delivery of immunizations easier and more effective. Connecting device developers to vaccine manufacturers and enabling these partnerships through a long development process calls for creative and synergistic approaches. PATH specializes in exploring the landscape of available technologies, identifying and developing solutions, and helping countries articulate their needs so that manufacturers can offer products that best fit a program s unique situation. For example, PATH recently conducted an analysis and user assessment of oral delivery technologies for use with rotavirus vaccine. A variety of types of devices were evaluated, including liquid droppers and tubes, modified syringes, prefilled and user-filled devices, single- and multiuse devices, and separate and integrated reconstitution technologies. The results were used to inform manufacturers developing new, low-cost rotavirus vaccines intended for use in low-resource countries. PATH continues to explore the landscape of oral delivery technologies and potential applications for public health. We work to ensure that the presentation and packaging of vaccines and medications is appropriate, sustainable, and enables the best coverage and efficacy possible. Oral delivery of polio vaccine in Bangladesh. A major benefit to oral delivery is the ease of administration. For more information regarding this project, contact Darin Zehrung at dzehrung@path.org. Support for this project was provided through funding from the Bill & Melinda Gates Foundation. M. Dorgabekova
Technology Solutions for Global Health March May 2010 2012 Spring Infusor Pump for Anitibiotic Treatment of Osteomyelitis Osteomyelitis (inflammation of the bone) is a common and serious problem in developing countries that largely affects children and young adults. 1 Treatment of acute osteomyelitis (early infection) consists of longterm administration of antibiotics and can cure the infection. 2 However, in low-resource settings treatment for acute osteomyelitis is often not accessed and can progress to chronic osteomyelitis. Treatment for chronic osteomeyelitis involves complex surgery and can result in morbidity, such as loss of a limb. 3 Enabling delivery of antibiotics in the home could increase access to early treatment, lessen the burden on the paitent s family as well as the health system, and result in improved health outcomes and patient quality of life. PATH is assessing the value of using a simple, affordable spring infusor pump that would allow long-term outpatient administration of antibiotics for the treatment of osteomylitis. Unlike the traditional intravenous (IV) bag and pole set up, patients using this device do not need to be immobile and can continue with daily activities. PATH has identified the Go Medical Industries (Subiaco, Australia) Springfusor, an infusor pump designed to be wellsuited for use in low-resource settings, as a potential solution. This device is small, portable, and easy-to-use. It enables a patient to receive continuous or intermittent parenteral IV therapy in their home rather than require longterm hospitalization. The device does not require batteries or electricity and is powered by a spring. The product has United States Food and Drug Administration approval and European CE Mark and is currently used in developed countries for pain control and muscle relaxation drugs. PATH is working to understand the context of use in Rwanda and the potential value of the technology, including gathering direct stakeholder input. In addition, PATH is also determining how a product could be made sustainably available for purchase by the public sector. PATH s efforts are complemented by a planned field trial using the Springfusor for early treatment of osteomyelitis that will be conducted by the People s Survival Alliance later this year. PATH is collaborating with the People s Survival Alliance to coordinate activities and to jointly develop an evidence base for use of the technology, which includes clinical, technical, and market information. 1. Acute septic arthritis and osteomyelitis in children an African perspective page. The Ptolemy Project website. Available at: http://www.ptolemy.ca/members/archives/2010/osteomyelitis/index. html. Accessed March 7, 2012. 2. Solagberu BA. New classification of osteomyeltits for developing countries. East Africa Medical Journal. 2003;80(7):373 378. 3. Stanley CM, Rutherford GW, Morshed S, et al. Estimating the healthcare burden of osteomyelitis in Uganda. Transactions of the Royal Society of Tropical Medicine and Hygiene. 2010;104(2):139 142. Portable IV carrying case designed in Rwanda and Springfusor pumps....osteomyelitis disproportionately affects the young, and is a burden on both clinical and surgical services. To decrease this burden in populations with limited resources, improved diagnosis and more timely treatment of acute osteomyelitis is needed. Stanley CM, Rutherford GW, Morshed S, et al. Estimating the healthcare burden of osteomyelitis in Uganda. Transactions of the Royal Society of Tropical Medicine and Hygiene. 2010;104(2):139 142. For more information regarding this project, contact Paul LaBarre at plabarre@path.org. Support for this project was provided by the United States Agency for International Development and through funding from private foundations and individual donors to the Health Innovation Portfolio at PATH. PATH/Mike Eisenstein
Maternal and Child Health
Technology Solutions for Global Health May 2010 BIRTHweigh III Low birth weight is a well-known indicator of risk for newborn babies and is a major cause of infant mortality and morbidity in the developing world. Each year, millions of infants in developing countries are born underweight. Most babies are delivered outside of health facilities by nonliterate traditional birth attendants (TBAs) who may need appropriate tools to identify low birth weight newborns and follow up with appropriate care immediately. May 2012 In the mid-1980s PATH conducted a needs assessment of TBAs in several African countries, which resulted in the concept of an easy-to-use, yes/no indicator of low birth weight that could be used by relatively untrained midwives and TBAs. BIRTHweigh I, developed and field-tested by PATH in several countries, was subsequently adopted for use in Indonesia. The device allowed nonliterate birth attendants to identify low birth weight newborns (<2,500 grams) and then follow up with special care. BIRTHweigh I was designed for low-resource, in-country production; local economic development; and regional distribution. United Nations Children s Fund (UNICEF) currently distributes a similar scale under the brand name BebeWey. BIRTHweigh II, developed in the early 1990s, is a revised version designed for modern manufacturing methods and features a tactile as well as a visual indication of birth weight. This model performed successfully when included in a comparative evaluation of BIRTHweigh I, II, and BebeWey in Egypt. Nonetheless, interest among manufacturing and programmatic partners became scarce and project development was suspended. More recently, PATH designed the BIRTHweigh III to meet the need for correctly dosing newborns with gentamicin to prevent serious bacterial infections. Using the same technological platform as the second scale, this scale permits nonliterate birth attendants and community health workers to categorize newborns into three different weight categories (normal birth weight: 2,500 grams; low birth weight: 2,000 2,499 grams; very low birth weight: <2,000 grams). Prototypes of BIRTHweigh III were built and field tested in collaboration with the Saving Newborn Lives Project in both Nepal and India in 2004. Results from both of these studies concluded that the BIRTHweigh III scale classified infants into weight categories with a high degree of consistency and accuracy and that the scale is extremely practical and useful for resourcepoor settings, especially those with low levels of literacy. Even though the BIRTHweigh III scale is not yet commercially available, PATH continues to receive requests from programs in low-resource settings interested in using it. In 2006, PATH produced a report detailing feasible commercialization options to ensure availability and access of the BIRTHweigh III scale. PATH is making the report available to manufacturers interested in commercialization opportunities. Hand-held, portable, plastic, spring scale for measuring low birth weight. The scale will be very useful in settings where community health workers are dealing with decisions about identifying low birth weight newborns. For more information regarding this project, contact Patricia Coffey at pcoffey@path.org. Funding for this project has been provided by the United States Agency for International Development under PATH s HealthTech program and by Save the Children.
Technology Solutions for Global Health February January 2008 2010 Delivery Kit High rates of maternal and perinatal mortality in developing countries indicate a crucial need for new and innovative interventions for pregnancy and neonatal care. In developing countries most women have no access to maternity services due to distance, cost, and local customs; many give birth alone. High rates of neonatal and maternal tetanus and sepsis indicate a need for education and materials focused on clean birth practices. The basic delivery kit is an inexpensive, simple kit designed to help create a clean birthing environment, particularly for home births. The contents of the delivery kit include a clean razor blade, cord ties, a small bar of soap, a plastic delivery sheet, and pictorial instructions. The delivery kit is designed for use by skilled birth attendants, family members, and women who give birth unassisted in the home. Community health workers and traditional birth attendants are oriented to the kits so they can either provide it as part of their birth delivery services or encourage families to purchase the kit for home deliveries. The kits are also designed to be sold through retail distribution outlets. In 1994, PATH assisted a women s health small business in Nepal to design, develop, and market a locally appropriate kit. With the approval of the Ministry of Health (MOH) in Nepal, that kit is now being sold and used throughout the country. More than one million kits have been sold since 1994. Qualitative and quantitative evaluations have demonstrated its acceptability and effectiveness. To further demonstrate the health effects of kit use, PATH conducted the first cross-sectional study of single-use delivery kits in Africa. This major quantitative evaluation of the kit s impact on preventing cord infection and puerperal sepsis in Tanzania was carried out in collaboration with the National Institute for Medical Research and the MOH. A total of 3,262 women were enrolled in the study, which was completed in late 2004. Results show that the kit has significant impact in reducing rates of infection. Newborns of mothers who used the clean delivery kit were about 13 times less likely to develop cord infection than infants whose mothers did not use the kit. Women who used the kit were about 3 times less likely to develop puerperal sepsis than women who did not use the kit. The study results suggest that making clean delivery kits available through government health clinics, markets, private pharmacies, or other commercial channels could likely help reduce rates of infection. PATH continues to seek opportunities to promote the use of clean delivery kits and integrate their use into larger maternal and child health programming around the world. A manual describing how to set up a local production project is available from PATH. Inexpensive, simple, delivery kit for use in home births. A recent PATH study in Tanzania demonstrates that clean delivery kits are an appropriate and acceptable technology that reduces rates of maternal and neonatal infection. For use within Nepal, kits can be ordered from Maternal and Child Health Products Pvt., Ltd., Purano, Baneshwor, P.O.B. 7136, Kathmandu, Nepal, Tel: 977-1-475-418, Fax: 977-1-410-375, email at mch@ecomail.com.np. To purchase delivery kits from UNFPA, contact Procurement Services, Midtermolen 3, 2100 Copenhagen, Denmark, email Ann Janssens at janssens@unfpa.org. For more information regarding this project, contact Siri Wood at swood@path.org. Funding for this project has been provided by the United States Agency for International Development under PATH s HealthTech program. Mail: PO Box 900922, Seattle, WA 98109, USA Location: 2201 Westlake Ave, Suite 200, Seattle, WA 98121, USA
Technology Solutions for Global Health May 2012 2010 Neonatal Resuscitator Birth asphyxia when a baby does not breathe at birth accounts for about 23 percent of the estimated 4 million neonatal deaths that occur annually. Approximately 904,000 newborns die every year due to intrapartumrelated hypoxic events including intrapartum-related neonatal deaths and intrapartum stillbirths, and 99 percent of these deaths occur in low- and middle-income countries. Babies suffering from intrapartum-related events often do not breathe immediately at birth. Of the approximately 10 million babies who do not breathe immediately at birth, about 6 million require basic neonatal resuscitation. Sixty million home- or community-based births occur every year, but most do not have access to resuscitation resources. To address birth asphyxia, appropriate technology and neonatal resuscitation training should be available to all skilled birth attendants and to communitylevel health workers where skilled attendants are not available. According to the World Health Organization, basic newborn resuscitation requires a bag and a mask resuscitator for ventilation, a mucus extractor for suctioning, a source of warmth for thermal protection, and a clock. Neonatal resuscitation devices are also available in a tube-and-mask design. Recently, Laerdal Medical, a world-class manufacturer of resuscitation equipment, developed a low-cost, high-quality suite of neonatal resuscitation technologies for low-resource settings. Laerdal Medical collaborated with the American Academy of Pediatrics to develop a comprehensive set of training materials to teach evidence-based resuscitation skills in low-resource settings the Helping Babies Breathe (HBB) Global Development Alliance (GDA). The HBB materials are bringing neonatal resuscitation skills and equipment to low-resource settings through a global development alliance. PATH s focus is to enhance availability of appropriate devices in low-resource settings, particularly Asia and Africa. Initially, we conducted a web-based survey to determine experts practices and preferences related to neonatal resuscitators in developing countries, published an inventory of all neonatal resuscitation devices available worldwide, and conducted an evaluation of reusable, silicone bag-and-mask devices that cost less than US$30 each. We also conducted a situation analysis of essential newborn care in selected states in India and market assessment studies in two regions (Southern Africa and West Africa). These studies provide baseline information regarding availability, affordability, and use of products. Currently, PATH participates in the HBB GDA by providing assistance to strengthen logistics systems and create/increase demand for newborn resuscitation equipment and training. Specifically, we are conducting an independent, third-party evaluation of new designs of neonatal resuscitators and/or component pieces (i.e., face/device interface) as part of the HBB GDA to reduce neonatal mortality by improving newborn resuscitation. An evaluation of manual bulb suction devices was implemented in 2011 and evaluation of new simplified resuscitator design is ongoing. Neonatal resuscitator for use by birth attendants. Neonatal resuscitation is positively associated with lower newborn mortality, both asphyxiarelated and all neonatal mortality. From March 2008 consultation Newborn Resuscitation: Strategies for Settings from the District Hospital to the Community in Washington, DC. For more information regarding this project, contact Patricia Coffey at pcoffey@path.org. Funding for this project has been provided by the United States Agency for International Development under PATH s HealthTech program, Atlantic Philanthropies under the Maternal and Neonatal Technology Initiative, and through funding from private foundations and individual donors to the Health Innovation Portfolio at PATH. PATH/Patrick McKern
Technology Solutions for Global Health May 2010 2012 Chlorhexidine for Umbilical Cord Care Omphalitis, an infection of the umbilical stump, is a common cause of morbidity and mortality in neonates in the developing world. Over 4 million neonatal deaths occur annually, of which 36 percent are attributed to neonatal infections. In some areas, this rate can be as high as 50 percent. Recent community-based randomized trials in rural areas in Bangladesh, Nepal, and Pakistan have shown that applying 4% chlorhexidine solution (CHX) to the umbilical cord stump prevents infection and saves newborn lives. These trials and concurrent research support cord cleansing with CHX as an efficacious, acceptable, feasible, and cost-effective newborn care intervention. CHX cord cleansing reduces the risk of death before 28 days by up to 23 percent and eliminates two-thirds to three-quarters of serious umbilical infections. Such findings suggest, for example, that widespread practice of CHX cord cleansing could prevent more than 200,000 newborn deaths each year in South Asia. CHX can be delivered through existing health services and initiatives such as antenatal and obstetric care and other essential newborn care activities. It can also be provided at a large scale through retail outlets, including pharmacies, public facility- and community-based providers, and community health workers who have contact with women planning to give birth at home. Initially, PATH developed product specifications and transferred them to a Bangladeshi pharmaceutical company capable of manufacturing quality CHX at a reasonable cost. In parallel, we collaborated with a local market research firm to conduct a product attribute study that evaluated the preferences of potential users and service providers for containers and applicators. Study results were conveyed to the pharmaceutical company to develop a locally available CHX product. We assessed the demand for CHX at multiple price points in two districts in Bangladesh using the contingent valuation method. PATH collaborated with the Projahnmo Study Group on operations research on training, behavior change, advocacy development, and distribution and also conducted stakeholder surveys to assess country readiness for product introduction. At the global level, PATH submitted a successful application to the World Health Organization Essential Medicines List to include 4% CHX for umbilical cord care. In 2011, PATH convened a meeting to disseminate findings from randomized controlled trials to policymakers in the south Asia region, and conducted a manufacturer search for suitable industry partners in India. Currently, PATH is coordinating and supporting global rollout of CHX including its integration into global programs. A newborn treated with 4% chlorhexidine. We believe that the use of 4% chlorhexidine for topical cord antisepsis represents an important intervention with the potential for substantial effect on public health. Mullany LC, Darmstadt G, Khantry SK, et al. Topical application of chlorhexidine to the umbilical cord for prevention of omphalitis and neonatal mortality in southern Nepal: a community-based, clusterrandomised trial. The Lancet. 2006;367:910 918. For more information regarding this project, contact Patricia Coffey at pcoffey@path.org. Funding for this project has been provided by the United States Agency for International Development under PATH s HealthTech program. PATH/Mutsumi Metzler
Technology Solutions for Global Health May 2012 2010 Gentamicin in Uniject The World Health Organization estimates that at least four million neonatal deaths (death during the first 28 days of life) occur around the world every year. Newborn infections are responsible for approximately one-third of these deaths. Case-fatality rates for severe bacterial infections are high in part due to not administering or delaying the administration of necessary antibiotics (including gentamicin). Treating infants in rural areas, where infrastructure is limited and where community health workers provide many essential services, presents a special challenge. To achieve maximum impact on neonatal sepsis rates, it is important that newborns with these infections receive immediate treatment. Gentamicin in a prefilled syringe such as the Uniject * injection system (gent-uniject) can help ensure immediate delivery of lifesaving antibiotics in communities and peripheral health care settings. An accurate, premeasured dose is given in a nonreusable, sterile device (with minimal preparation and waste) when the signs of a neonatal infection are first detected. Community health workers can be trained to use gent-uniject and a complementary antibiotic to extend accessibility and facilitate administration. The dose of gentamicin for neonates has traditionally been based on body weight. Since the Uniject injection system delivers a fixed dose, PATH collaborated in a study that identified safe and therapeutic fixed-dosing intervals. Based on those data, two fixed doses of gent-uniject were developed for neonates in three common weight ranges. Instituto BiologicoArgentino (Biol), an Argentine pharmaceutical manufacturer, and PATH produced a clinical trial lot that was used in the first field evaluation of gent-uniject, which was conducted by PATH and John Snow International in Nepal in 2009. In the study, female community health volunteers and government health staff in five villages administered gent-uniject to newborns with possible severe bacterial infections. Study results indicate that use of gent-uniject, in combination with oral cotrimoxazole and an appropriate scale, is feasible and acceptable when delivered by female community health volunteers of various ages and literacy. In June 2010, PATH presented a rapid assessment of value at a United States Agency for International Development expert consultation on future programmatic opportunities for gent-uniject. In response, PATH reviewed the range of possible product options to deliver antibiotics to treat neonatal sepsis in the community. Results showed that gent-uniject was a favorable way to package gentamicin to simplify delivery and expand access to treatment. Currently, PATH is seeking opportunities to assess coverage and cost-effectiveness of gent-uniject when used in community-based programming at the country level. *Uniject is a trademark of BD. Prefilled, single-use injection device filled with gentamicin....to further simplify the parenteral administration of gentamicin, the use of disposable syringes pre-filled with gentamicin, or a single-use simple Uniject device should be tested. Bang AT, Bang RA, Baitule SB, et al. Effect of home-based neonatal care and management of sepsis on neonatal mortality: Field trial in rural India. The Lancet. 1999;354:1955 1961. Uniject injection systems and the associated equipment for filling and packaging are available to vaccine and pharmaceutical companies from BD Pharmaceutical Systems, New Jersey, USA, Roderick Hausser, Tel: (201) 847-5185, Fax: (201) 847-4869. For more information regarding this project, contact Patricia Coffey at pcoffey@path.org. Funding for this project has been provided by the United States Agency for International Development under PATH s HealthTech program. Penny Dawson
Technology Solutions for Global Health May April 2010 2012 Oxytocin in Uniject Obstetric hemorrhage is estimated to cause 25 percent of all maternal deaths and is the leading direct cause of maternal mortality worldwide. Postpartum hemorrhage (PPH) is generally considered to account for the majority of cases of obstetric hemorrhage, occurs in over 10 percent of all births, and is associated with a 1 percent case fatality rate. It is a particular problem in low-resource settings where home deliveries of infants are prevalent. The short response time required in the event of hemorrhage makes referral and transport to a health care facility impractical in most cases. The percentage of maternal deaths due to PPH has been reported as 34 percent in Africa, 31 percent in Asia, and 21 percent in Latin America and the Caribbean, while only 13 percent of maternal deaths in developed countries are due to PPH. The use of oxytocin for active management of the third stage of labor can significantly reduce the incidence of postpartum hemorrhage. The World Health Organization recommends use of a 10-IU dose of oxytocin given intramuscularly. To facilitate the recommended use of oxytocin in developing countries, particularly in peripheral health settings and in home deliveries (attended by a person with midwifery skills), a prefilled, easy-to-use, injection-ready dose of oxytocin would be ideal. The Uniject TM * injection system is a compact, prefilled, autodisable syringe that offers delivery of the life-saving benefits of oxytocin to women in peripheral health care settings and homes. This easy-to-use, injection-ready format ensures an accurate dose in a nonreusable, sterile device with minimal preparation and minimum waste. These benefits can improve the ability of midwives and village health workers to administer oxytocin outside of health care facilities and in emergency situations or remote locations. Oxytocin can stand moderate heat exposure for some time, but substantial heat exposure reduces potency. Therefore, a time-temperature indicator can be included on the product package to help ensure that medication given to a woman is potent while allowing more flexibility for field transport and storage of oxytocin in Uniject. Instituto Biológico Argentino, an Argentine pharmaceutical manufacturer, has obtained regulatory approval in nine Latin American countries. Gland Pharma, an Indian pharmaceutical manufacturer, has obtained regulatory approval in India. Additional regulatory approvals are planned or pending in a number of other countries. Oxytocin in Uniject can be available for pilotlevel use from these manufacturers on a limited basis. A summary of research that has been conducted to date with oxytocin in Uniject is available at: http://www.path.org/publications/files/ts_oiu_res_ sum_1998-2011.pdf. A resource page for countries and programs interested in using oxytocin in Uniject is available at: http://www.path.org/projects/unijectoxytocin-resources.php. *Uniject is a trademark of BD. Compact prefilled, autodisable injection device filled with oxytocin. Uniject [with oxytocin] was well tolerated and offers an alternative for oxytocin administration. Strand RT, et al. Postpartum hemorrhage: A prospective, comparative study in Angola using a new disposable device for oxytocin administration. Acta Obstetricia et Gynecologica Scandinavica. 2005;84:260 265. Uniject injection systems and the associated equipment for filling and packaging are available to vaccine and pharmaceutical companies from BD Pharmaceutical Systems New Jersey, USA Roderick Hausser Tel: (201) 847-5185 Fax: (201) 847-4869 For more information regarding this project, contact Steve Brooke at sbrooke@path.org. Funding for this project has been provided by the United States Agency for International Development under PATH s HealthTech program. PATH/Glenn Austin
Technology Solutions for Global Health May 2010 Packaging Solutions for Nevirapine Clinical trials have shown single-dose nevirapine (NVP) to be a low-cost, efficacious therapy for prevention of mother-to-child transmission (PMTCT) of HIV-1. The single-dose therapy includes a 200-mg NVP tablet taken by the mother at the onset of labor and 0.6 ml of NVP oral suspension (NVP syrup) given to the infant within 72 hours of birth. Achieving widespread use of NVP for infants in developing countries has been challenging because of the high prevalence of births outside the health care system, the required timing for the dose, and the limited reach of antenatal care and PMTCT services. Programs have begun giving the NVP tablets to HIV-positive pregnant women during antenatal visits to take home so they can have the tablet readily available. Fewer programs have been providing the infant dose of NVP syrup to take home, due in part to the lack of a simple, robust, and tamper-evident single-dose package. Improving single-dose packaging of NVP syrup for PMTCT programs is the primary objective of a public-private partnership among United States Agency for International Development, Boehringer Ingelheim (BI) (manufacturer of Viramune * brand NVP), and PATH. PATH has identified and evaluated the function and acceptability of numerous single-dose packaging candidates. BI has tested the physical compatibility of the candidates with their NVP syrup. USAID has provided funding as well as guidance on field needs. The result was a simple yet elegant solution that has been successfully piloted and introduced in Kenya. PMTCT clinics are provided with supplies of two components 1-ml Exacta-Med dispensers (an oral-dosing syringe) and self-sealing foil laminate pouches designed by PATH to surround and protect the dispenser once the nurse fills it with the infant dose of NVP syrup. The pouch is also labeled with pictorial and expiry information that reminds the woman of proper use if she gives birth outside the health care system. PATH worked with the Elizabeth Glaser Pediatric AIDS Foundation, Family Health International, and the National HIV/AIDS and the Sexually Transmitted Disease Control Program of Kenya to evaluate the pouch and dispenser approach in PMTCT programs in Kenya. A pilot introduction was completed in July 2006. Results indicated high acceptability among health workers and HIV-positive mothers and confirmed the value of the approach. Country-wide introduction of the NVP infant-dose pouch is underway in Kenya. BI now makes the pouches available at no cost through its PMTCT Donations Program. PATH has developed a set of resources to support organizations considering introduction of the NVP infant-dose pouch which can be downloaded from PATH s website at http://www.path.org/projects/nevirapine_pouch_resources.php. *Viramune is a registered trademark of Boehringer Ingelheim. Exacta-Med is a registered trademark of Baxa Corporation. Nevirapine packaging developed by PATH. Many babies will benefit it will make a difference. Emily, Nurse at Vihiga District Hospital in Kenya. The NVP infant-dose pouch is currently available to qualifying programs at no cost through the PMTCT Donations Program along with the Exacta-Med Dispenser, manufactured by Baxa Ltd. For more information on how to receive the pouch, dispensers, and nevirapine, visit www.pmtctdonations.org. For information regarding this project, contact Adriane Berman at aberman@path.org. Funding for this project has been provided by the United States Agency for International Development under PATH s HealthTech program and the Sapling Foundation. PATH/Patrick McKern
Technology Solutions for Global Health April May 2012 2010 Non-Pneumatic Antishock Garment Postpartum hemorrhage (PPH) continues to be the single most common cause of maternal morbidity and mortality, accounting for approximately 25 percent of maternal deaths globally. Over 90 percent of these deaths occur in developing countries where the infrastructure and training at primary care facilities are not sufficient to handle obstetric emergencies. If not treated immediately, PPH can cause irreparable damage to vital organs or death from hypovolemic shock. In severe cases, when the administration of uterotonic drugs does not stop the bleeding, the need for access to an obstetric care facility with blood transfusion and surgical capabilities is critical. For women suffering from uncontrollable PPH, a method to control the bleeding, reverse the shock, and stabilize the patient for safe transport to a comprehensive obstetric care facility could be lifesaving. One method to manage PPH is the use of a non-pneumatic antishock garment (NASG). The NASG is a lightweight neoprene garment that resembles the bottom half of a wet suit. It is made up of five segments that close tightly with Velcro. The NASG applies pressure to the lower body and abdomen, thereby stabilizing vital signs and resolving hypovolemic shock. When fitted correctly, the reusable NASG forces blood to the essential organs heart, lungs, and brain and allows the woman to be transported to an obstetric care facility. Unfortunately, the NASG is not readily available in most low-resource settings. Despite recent reductions in price, distribution remains a challenge. Once the NASG is affordable, available, and accessible and health care workers are sufficiently trained, the NASG could play an important role in reducing mortality and morbidity among women that experience PPH. In order for the NASG to achieve widespread impact, it must be available at affordable prices and at consistently high quality. PATH has tested sample devices from multiple manufacturers to characterize their performance, quality, and durability before and after rigorous washing. We have also drafted quality performance standards and specifications. Additionally, PATH has negotiated affordable, high-quality manufacturing of the NASG in China and India. We are currently initiating global regulatory, procurement, and access strategies that will ensure available, affordable, and accessible distribution of the NASG in low-resource settings. Non-pneumatic antishock garment. In our research, women who appeared clinically dead, with no blood pressure and no palpable pulse, were resuscitated and kept alive for up to two days [using the NASG] while waiting for blood transfusions. Suellen Miller, CNM, PhD, international maternal health expert and director of the Safe Motherhood Programs of the University of California, San Francisco Women s Global Health Imperative. For more information regarding this project, contact Paul LaBarre at plabarre@path.org. Support for this project was provided through funding from private foundations and individual donors to the Health Innovation Portfolio at PATH, the United States Agency for International Development through PATH s HealthTech program, and from the John D. and Catherine T. MacArthur Foundation. PATH/Jered Singleton
Technology Solutions for Global Health May 2010 Cryotherapy for Cervical Cancer Prevention April 2012 Cervical cancer affects an estimated 490,000 women worldwide each year and leads to more than 270,000 deaths. About 85 percent of women who die from cervical cancer reside in developing countries. Cervical cancer can be prevented if precancerous lesions are identified early and treated promptly. Cryotherapy, a freezing treatment, is recognized as the most cost-effective and feasible approach to treating precancerous cervical lesions in these settings. It can also be used in a single visit screen-and-treat approach in primary care settings, an approach which has been demonstrated to increase rates of follow-up. Widespread availability of cryotherapy in developingcountry settings is an essential component of an effective screening and treatment approach to cervical cancer prevention in these settings where it is needed most. Cryotherapy uses a refrigerant gas to destroy abnormal cells. An important aspect of making cryotherapy readily available in developing-country settings is the ability to use carbon dioxide (CO 2 ), the least expensive and most accessible type of gas, as the refrigerant. Recent bench testing of a range of cryotherapy devices has demonstrated that clogging or blockage of the device, previously thought to be associated with use of CO 2, may only affect certain devices, suggesting that with an appropriate device, CO 2 could be used effectively. One of the devices reaching unexpectedly warm temperatures in our bench testing was the LL100, (manufactured by Wallach Surgical Devices), the most commonly used equipment in low-resource settings. PATH shared these findings with representatives from Wallach Surgical Devices, and on September 19, 2009, Wallach took action. They issued a recall for the LL100 sold for use with CO 2. The recall covers equipment that goes back 15 years and affects about 2,500 devices in use worldwide. The integration of temperature-monitoring equipment into an upcoming clinical evaluation of cryotherapy will allow for assessment of the correlation between tip temperatures achieved and depth of necrosis information critically needed in understanding whether CO 2 can be successfully used as the refrigerant gas for cryotherapy. Cryotherapy device. For more information regarding this project, contact Jenny Winkler at jwinkler@path.org. Support for this project was provided through funding from private foundations and individual donors to the Health Innovation Portfolio. PATH/Jered Singleton
Technology Solutions for Global Health May April 2010 2012 Mobile Midwife Platform In many regions of the world, there is a shortage of health care providers who have the skill and ability to collect and act on information required for care. Areas such as sub-saharan Africa and South Asia suffer from a virtual absence of highly-skilled health care providers. For instance, the doctor-to-population ratio in rural India is 0.33 doctors per 1,000 people. As a result, there is an inverse relationship between access to skilled care at birth and maternal and newborn mortality; the lower the attendance by a skilled birth attendant, the higher the risk of death or complications. Leveraging the abilities of all available caregivers helps to maximize human resources and lessen capacity constraints. By providing a tool that offers point-of-care guidance in accordance to local adaptations of global best practices, lesser-skilled providers can be empowered to act on critical health information and improve the services they deliver, reduce delays, and improve access to appropriate care. The Mobile Midwife Platform (MMP) runs on a mobile device (phone or tablet) and is designed to improve postnatal maternal and newborn care by minimally trained health care providers in rural clinic- and home-based settings. The MMP increases accessibility to standards of care, backed by global best practices, to populations with limited options. The tool provides midwives with localized guidance on clinical decisions, patient record management, and instructional support. These components enable timely and improved health care service delivery, improved patient education, and real-time data transmission and aggregation for field-based consultation, organizational research, and process improvement. PATH has partnered with Action, Research, and Training in Health (ARTH) and the University of Washington (UW) Department of Computer Science and Engineering. ARTH is a nongovernmental agency operating in Udaipur, India. They developed training materials and care protocols for ARTH midwives who provide clinic- and home-based care to approximately 50,000 people in the region. Leveraging the Open Data Kit software tools developed by UW, graduate students are adapting the software to meet the specific health needs and use scenarios of midwives and mothers. The project commenced in November 2010. After intensive collaborative design and requirements gathering, the team initiated a pilot introduction in India with ARTH nurse midwives. The two-month study will test the appropriateness and usability of the device as well as evaluate provider compliance with postnatal care protocols and treatment. The study will also evaluate the impact of the device on the length and distribution of time spent with the patient, and the capability of the device to be used as an educational tool for patients. The pilot study will involve two of ARTH s clinics in rural Rajasthan, seven ARTH-trained midwives and physicians, and more than 200 home-based visits. Upon the successful completion of the study, the project team expects to broaden the application of the MMP to include antenatal care and to extend the program to government-employed midwives in the region. Nurse midwives training on the Mobile Midwife Platform. Around the world, countless lives are lost due to insufficient access to quality health information. The availability of accurate, timely, and analyzed data is directly relevant to the quality of an individual s health and the health care system in general, the delivery of individual care, and the understanding and management of overall health systems. Ranck J. Health Information and Health Care: The Role of Technology in Unlocking Data and Wellness A Discussion Paper. Washington, DC: United Nations Foundation and Vodafone Foundation Technology Partnership; 2011. For more information regarding this project, contact Noah Perin at nperin@path.org. Support for this project was provided through funding from private foundations and individual donors to the Health Innovation Portfolio. University of Washington/Carl Hartung,
Technology Solutions for Global Health May April 2010 2012 Developing an Affordable Sanitary Pad Girls as well as women in the developing world suffer from lack of adequate solutions to manage menstruation. Imported pads are prohibitively expensive for low-income families. Research conducted in Uganda indicates that about 90 percent of urban poor women and girls cannot afford off-the-shelf sanitary pads and instead improvise with materials such as grass, leaves, old newspapers, and pieces of cloth. These materials, however, have been linked to certain reproductive tract infections. They also have limited absorbency and make it difficult for girls to participate in school during their periods. The United Nations Children s Fund estimates that 1 in 10 school-age African girls either skips school during menstruation or drops out entirely because of lack of menstrual hygiene solutions. Numerous studies have confirmed that educating girls is associated with significant development and health benefits to the girls, their families, and society. These benefits include protecting girls from HIV/AIDS, abuse, and exploitation; reducing subsequent child and maternal mortality; improving child nutrition and health; decreasing fertility rates; enhancing women s domestic role and their political participation; and improving economic productivity. PATH s solution is to develop and advance low-cost menstrual management options for girls and women in low-resource settings. Our finding from focus group discussions and literature reviews indicate that girls and women are interested in disposable products that offer better absorbency and have a cheaper price tag than available options. There are also reusable options (cloth pads and menstrual cups) that can last for several years. These approaches require a higher up-front cost, access to clean water and soap, and thorough drying resources that are not always available in poor communities. We are currently exploring a hybrid concept (i.e., a combination of a reusable, fluidresistant sleeve with a disposable, absorbent core) to address the growing challenge of disposing of plastic-lined pads and to reduce the cost. This hybrid option could also offer girls and women the flexibility of using a variety of absorbent materials that are available to them. We completed an initial prototype of a hybrid pad based on pad testing that we conducted and targeted product specifications that we identified in early 2011. In the fall of 2011, PATH conducted focus group discussions with women and girls in Cambodia for input on various prototype designs of the hybrid pad. While women did not actually use the prototypes, their feedback on the design, materials, and preferences will help to further define the product specifications; we are now synthesizing the results of those discussions. PATH will also gather focus group feedback from South African and Indian women on perceived acceptability of these pads through a project on menstrual management and sanitation systems. We hope to understand what women like and dislike about the hybrid sanitary pad design, the availability of appropriate waterproof fabrics, and the potential effect the pads may have on sanitation systems in India and South Africa. Prototype design of a reusable hybrid pad with a disposable liner. The Kasiisi Project Girls Support Program in Uganda found a 30% decrease in absenteeism and an improvement in grades when sanitary pads and underwear were provided to primary school girls. http://www.globalgiving.com/ pfil/2700/affordable_sanitary_ Pads.pdf For more information regarding this project, contact Nancy Muller at nmuller@path.org. Support for this project was provided through funding from private foundations and individual donors to the Health Innovation Portfolio. PATH
Technology Solutions for Global Health May 2010 2012 NIFTY Infant Feeding Cup Infants with a high risk of breastfeeding difficulties include preterm infants, those with cleft palates, and neonates whose mothers die of birth-related causes. Preterm infants often require short-term supplemental feeds while they transition to exclusive breastfeeding. Infants with cleft palates and motherless infants require a long-term viable feeding option. Feeding tools in high-resource settings such as nasogastric tubes, bottles, and breast pumps are impractical, unhygienic, and unsafe in settings that lack clean water and electricity. For these reasons, the World Health Organization and the United Nations Children s Fund recommend hand expression of breast milk and the use of a small cup to feed newborns with feeding difficulties. Generic cups available in low-resource settings (e.g., coffee mug or medicine cup) have wide rims relative to an infant s mouth, which impedes efficient feeding. Suboptimal pacing of a feeding decreases intake, and wide rims increase spilling of hand-expressed breast milk. Repeated over multiple feeds, a feeding pattern of insufficient caloric intake results in longer feeding times, reduced endurance, compromised nutritional status, and increased susceptibility to infection and death. The difference between adequate and inadequate intake can be small, for example, as little as two teaspoons per feed for a 33-week 1,800 g preterm infant. This minute addition can translate into substantial growth, development, and strength even over a short period of a few days. PATH and our partners are working to develop an appropriate cup design for delivering this small but critical increase in intake. The NIFTY TM cup is a prototype technology designed to be simple to use, easy to clean, inexpensive, and efficient in the delivery of expressed breast milk (or formula) to infants unable to breastfeed. The cup has an extended reservoir off the cup lip that is similar in size to a neonate s mouth and a delivery channel to the reservoir with minimal grooves that is designed to optimize feeding efficiency. A novel and key feature of this product is that it combines two functions the ability to capture hand-expressed breast milk directly into the cup and to feed an infant with the expressed mother s milk. In collaboration with our partners the University of Washington, Seattle Children s Hospital Craniofacial Center, and Komfo Anokye Teaching Hospital in Kumasi, Ghana we conducted an inventory of infant cup feeding options, defined NIFTY TM cup product specifications, and created a prototype based on those specifications. We developed simple pictorial instructions to demonstrate correct use to target populations of caregivers, midwives, community health workers, and other health care providers. In the near term, we will assess the feasibility and acceptability of our prototype in relation to hand expression of breast milk and current infant feeding practices. A comprehensive business plan is being developed to identify key stakeholders, current procurement practices, targeted value propositions, revenue/cost models, and supply chain opportunities and obstacles in low-resource settings where infant cup feeding is recommended and practiced. The NIFTY TM cup. Cup feeding is recommended as a feeding method for sick and low birth weight infants by WHO and UNICEF. World Health Organization (WHO). Optimal Feeding of Low Birth Weight Infants. Geneva: WHO; 2006. For more information regarding this project, contact Patricia Coffey at pcoffey@path.org. Funding for this project has been provided by the United States Agency for International Development under PATH s HealthTech program and by Seattle Children s Hospital Craniofacial Center. PATH
Technology Solutions for Global Health October May 2010 2011 Balloon Tamponade Postpartum hemorrhage (PPH) in developing countries continues to be the single most common cause of maternal morbidity and mortality, accounting for approximately 25 percent of maternal deaths globally. Fourteen million cases of PPH occur each year. Deaths and serious complications resulting from PPH can be attributed largely to the lack of available emergency obstetrical interventions, inadequate referral systems, and the delivery of substandard care. The consequences of PPH are devastating to families and costly for health systems. The risk of death is greatest for women who are anemic or have other underlying health problems and therefore are less able to deal with blood loss. Most cases of PPH can be treated if the bleeding is controlled and managed immediately. A balloon tamponade is a minimally invasive obstetric intervention that can effectively treat and manage severe postpartum bleeding. When inserted into the uterus and slowly filled with saline water, it exerts pressure on the uterus until the bleeding stops. It works rapidly and effectively, reducing the need for risky surgical interventions and blood transfusions. It also serves a critical role in reducing blood loss until the woman can be transported to a facility that can provide surgical management and other treatment options. The World Health Organization, the International Federation of Gynecology and Obstetrics, and the International Confederation of Midwives recognize balloon tamponades as a method that could have significant impact in the management of intractable PPH. This device is widely used in developed countries; however, commercially available devices are prohibitively expensive for developing-country maternal health programs. PATH s solution is to develop and advance a lower-cost balloon tamponade that could be used by trained health workers in low-resource settings. A lower-cost device would allow for wider access to and use of this intervention with the potential to significantly impact the mortality and morbidity rates of women suffering from PPH. In collaboration with researchers, design companies, device manufacturers, maternal health projects, and stakeholders, PATH is currently planning work to develop, test, and introduce a low-cost balloon tamponade in low-resource settings. Initially PATH conducted a situational analysis to determine current practices using tamponades for PPH in developing and developed countries. Expert opinions were sought, and a literature review was conducted to understand the key issues around use of the tamponade and the practice of using readily available supplies, such as condoms and catheters, to assemble tamponade devices at the point of care. Results from these studies provided information on user patterns, cost issues, availability, and acceptability and will guide the design and development of a lower-cost solution. Currently PATH is a member of a PPH task force and is working closely with professional organizations and global health partners to advance the balloon tamponade for the management and treatment of PPH. Photo goes here A condom catheter balloon tamponade. The tamponade... could be particularly effective in reducing the maternal mortality rates of low-resource countries, as it can be performed in small centers with minimal facilities. WHO considers that this intervention can be highly effective; it should be rigorously evaluated as a priority. World Health Organization consulting group, 2008. For more information regarding this project, contact Elizabeth Abu-Haydar at eabuhaydar@path.org. Support for this project is provided through funding from private foundations and individual donors to the Health Innovation Portfolio at PATH and by the United States Agency for International Development (USAID) under a Development Innovation Ventures grant. PATH/Erica Jacoby
Technology Solutions for Global Health May 2010 2012 Digital Public Health Platform According to World Health Organization estimates, newborns who die within their first 28 days of life account for nearly 40 percent of all deaths of children under age five. In low-resource settings, simple interventions such as birth preparedness, hygienic delivery, thermal care, and immediate breastfeeding could prevent the majority of these deaths. For these best practices to be adopted, household-level behavior change must be promoted. Traditional behavior change communication (BCC) programs that design messaging through the development of written materials, media campaigns, or traditional-format videos have sought a global improvement of health outcomes. Recent technology advances could improve the breadth and depth of BCC on health impacts. Customized educational videos can now be developed at the community level and shown using low-cost video projectors and cell phones. This novel globally informed, locally developed approach balances community perspectives with scientific evidence. Building on established principles of BCC and incorporating them into affordable new technologies, PATH developed the Digital Public Health (DPH) platform which leverages a local-to-global approach with community-led, culturally appropriate video to demonstrate globally informed health interventions to health care workers and patients during household visits and community gatherings. PATH is working with the University of Washington and local nongovernmental organizations (NGOs) in India to integrate video-based maternal and child health education into existing community health systems to augment current health efforts with the DPH platform. Modeled after a local NGO s successful program for improved agriculture practices in India, DPH video content is created, filmed, and reviewed in the community, bolstering local engagement, empowerment, and participation. By customizing videos that combine scientific evidence and visual demonstrations with local customs, dialects, and input, a wide spectrum of health topics can be messaged in response to health issues and behaviors. In 2012, PATH will conduct a one-year pilot project to implement the DPH approach in more than 20 rural villages in India as part of PATH s Sure Start maternal and child health project. Community members will develop video content for women to watch and discuss in mothers groups that emphasizes practices known to improve maternal and child health. We will assess the process of video creation and community mediation as a method of improving maternal and infant survival in resource-poor settings, develop a strategy for the evaluation of project outcomes, and create a scalability plan for other regions. The adaptability, community engagement, and effectiveness of the DPH model will facilitate the integration of this approach into a wide range of health programs. Preliminary results from work in Rajasthan, India, found that midwives using the DPH platform felt that they provided more complete information, better engaged the mother s support network, and improved their credibility and authority in the eyes of their patients. New mother viewing a video on the Digital Public Health platform. I enjoy showing the video. When I talk to the villagers they don t understand, but by showing the video they understand. Midwife from Rajasthan, India during initial user testing. For more information regarding this project, contact Richard Anderson at randerson@path.org. Support for this project is provided through funding from private foundations and individual donors to the Health Innovation Portfolio at PATH the National Science Foundation, and the University of Washington. University of Washington/Brittany Fiore-Silfvast
Technology Solutions for Global Health May 2010 2012 Noninvasive Technology for Anemia Detection Globally, anemia continues to be a serious problem with far-reaching consequences for health as well as social and economic development. It is estimated that iron-deficiency anemia affects 42 percent of children under age 5 and 53 percent of children from 5 to 14 years of age. The majority of the 56 million pregnant women and 468 million non-pregnant women worldwide affected by anemia live in sub-saharan Africa and Southeast Asia. Anemia places women at risk for poor pregnancy outcomes including increased risk of maternal and perinatal mortality and morbidity, preterm births, and low birth weight. Anemia in children is associated with impaired cognitive performance, motor development, and language development. Effective screening programs for anemia have been hampered by the lack of a simple, safe, accurate, affordable hemoglobin (Hb) testing tool. Commonly used methods to screen for anemia require a blood draw, placing patients and health workers at risk of infection from contact with blood and sharps. PATH is advancing an accurate, noninvasive anemia screening device that could be used in low-resource settings at the point of care by minimally trained health workers. A noninvasive device that can be shown to be reliable, robust, and affordable would reduce the risk of infection for patients and health workers, eliminate the need for reusable supplies and the disposal of hazardous waste, and reduce costs. Another anticipated advantage of this technology is that Hb readings are displayed on a screen in less than a minute. This could provide evidence to support important immediate treatment for children and pregnant women. We are collaborating with two companies that have developed devices based on reflectance spectroscopy technology, the ToucHb device developed by Biosense (Mumbai, India), and the US Food and Drug Administration-approved Pronto7 device developed by Masimo Corporation (Irvine, CA). These devices are noninvasive, provide quantitative measurements, are portable, and simple to use. PATH conducted an extensive literature review of the current scientific methods for noninvasively measuring Hb. Based on this research, user assessments of promising devices were carried out in India and Ghana to evaluate their acceptability and identify possible challenges to their integration within ongoing maternal health services. Public-sector market assessments were conducted in India, Kenya, and Uganda to identify market development approaches that would support the accelerated introduction of noninvasive screening devices into existing antenatal and child health programs in developing countries. Findings show that devices need to be accurate, affordable, and support existing anemia prevention strategies. PATH will be validating the accuracy and the appropriateness of the devices and working closely with our private-sector partners to increase the availability of these devices in low-resource settings. Noninvasive anemia device. The World Health Organization has ranked iron-deficiency anemia as the third leading cause of disability adjusted life years lost for females from 15 to 44 years of age. De Benoist B, McLean E, Egli I, Cogswell M, eds. WHO and CDC Worldwide Prevalence of Anaemia 1993 2005. Geneva: World Health Organization; 2008. For more information regarding this project, contact Elizabeth Abu-Haydar at eabuhaydar@path.org. Support for this project is provided through funding from private foundations and individual donors to the Health Innovation Portfolio at PATH and by the United States Agency for International Development under PATH s HealthTech program. PATH/Patrick McKern
Technology Solutions for Global Health May 2010 2012 Safety Management System for Human Milk Banks Breast milk is considered a pillar of child survival; it has unique immunological and nutritional properties that help infants get a healthy start in life. Infants who receive breast milk are less likely to become seriously ill or die from infections compared to infants who do not receive breast milk. This is especially true of vulnerable infants in developing countries who may face continual exposure to pathogens through unsafe water or unhygienic conditions. The World Health Organization has asked countries to promote the safe use of donor milk, when the mother s own milk is unavailable, through human milk banks (HMBs) for infants who are preterm, low birth weight, malnourished, born to HIV-positive mothers, or orphaned. Safe donor milk processing includes collection, pasteurization, and frozen storage. Currently, many low-resource health care facilities do not have access to HMB systems, as commercial-grade pasteurizers are not affordable. Alternately, flash heating is a safe and affordable method of breast milk pasteurization. This method is being piloted in a small HMB in South Africa, but challenges exist in accurately monitoring proper time and temperature requirementst in order for milk to achieve safe pasteurization. To address the challenge of ensuring safe pasteurization in homes and resource-limited health care facilities, PATH is advancing a safety management system based on a platform called FoneAstra. This system leverages mobile phones to precisely monitor flash-heat pasteurization of donor breast milk. FoneAstra components include a mobile phone, a USB cable and bridge, a glass jar, and a temperature sensor probe. These are paired with simple pasteurization equipment: a freezer, a pot, and a heat source. We worked closely with the University of Washington s departments of Computer Science and Engineering and Human Centered Design and Engineering to develop a novel USB bridge that connects the phone and temperature probe. FoneAstra software gives simple audio and visual instructions for safe pasteurization and transmits the data wirelessly to a server for reports and review. These quality assurances can boost acceptance of donor milk by demonstrating that pasteurization of breast milk in resource-limited settings can be done safely a critical step toward expanding HMB adoption. PATH is managing a one-year pilot study of the FoneAstra in collaboration with the Human Milk Banking Association of South Africa. We will conduct a field test to evaluate the use of FoneAstra as a low-cost HMB system compared to routine flash-heat or more expensive commercial pasteurizing systems. We will also conduct a cost analysis to guide scalability of HMB systems in South Africa. User assessments will be performed with milk bank staff to validate that they can correctly operate the system. If shown to be appropriate and effective, we anticipate that this technology will also be adapted for other health purposes, such as monitoring vaccine refrigerator temperatures. The FoneAstra safety management system. To investigate, as a risk-reduction strategy the safe use of donor milk through human milk banks for vulnerable infants, in particular premature, low-birth-weight and immunocompromised infants, and to promote appropriate hygienic measures for storage, conservation, and use of human milk WHO s call to countries concerning donor milk for vulnerable infants. World Health Assembly, May 24, 2008. For more information regarding this project, contact Kiersten Israel-Ballard at kisrael-ballard@path.org. Support for this project is provided through funding from private foundations and individual donors to the Health Innovation Portfolio at PATH, the University of Washington, and the Bill & Melinda Gates Foundation through the Grand Challenges Explorations initiative. PATH/Patrick McKern
Reproductive Health
Technology Solutions for Global Health May 2010 Injectable Contraceptives in the Uniject TM Injection System May 2010 The World Health Organization (WHO) estimates that annually the reuse of injection devices may cause 20 million infections with hepatitis B virus, 2 million infections with hepatitis C virus, and 250,000 infections with HIV worldwide. International development and family planning agencies have been seeking feasible and affordable methods to reduce unsafe injection practices that could lead to the spread of bloodborne diseases. This is true for vaccines and medicines as well as injectable contraceptives that are becoming increasingly popular around the globe as women search for safe, highly effective, reversible methods of contraception that do not require compliance with a daily regimen. Depot medroxyprogesterone acetate (DMPA, also known as Depoprovera) is administered by injection once every three months, making it highly convenient. While provision of sterile needles and syringes with every dose of contraceptive is the current standard, the risk of reuse still exists. Autodisable (AD) syringes prevent reuse, but like disposable syringes they can be diverted to other uses during the distribution process. With guidance from WHO and a multitude of other collaborators, PATH developed an AD, prefilled syringe known as the Uniject * device. Today, the Uniject device, which is licensed to BD, prevents reuse, simplifies matching of syringes and supplies, ensures dose accuracy, and is simple to use in both clinic and community settings. Use of the Uniject device as a means of helping to increase safe community access to injectable contraceptives in developing countries has been a long-term goal at PATH, the United States Agency for International Development (USAID), and other international agencies. BD has invested significant funds to develop large-scale manufacturing operations so it can supply empty Uniject devices to pharmaceutical companies in large quantities at reasonable prices. Pfizer is currently proceeding with a European Medicines Agency submission of depo-subq provera 104 in the Uniject device (depo-subq in Uniject) for regulatory approval. PATH is playing an increasingly large role in both global and country-level introduction planning for depo-subq in Uniject and is coordinating planning activities of a range of external stakeholders on behalf of USAID. Activities by PATH and external partners are building the evidence base and country-level preparedness for eventual product introduction and scale-up. These activities include an acceptability study in Malawi, as well as demand modeling, logistics research, and detailed introduction planning for five countries: Kenya, Malawi, Pakistan, Rwanda, and Senegal. Prefilled, single-use injection device filled with injectable contraceptives. The Uniject device has gone all the way from the drawing board to realization. Craig Stephens, Judge for Tech Museum Award given to PATH for Uniject in 2003. Uniject devices and the associated equipment for filling and packaging are available to vaccine and pharmaceutical companies from BD Pharmaceutical Systems New Jersey, USA Roderick Hausser Tel: (201) 847-5185 Fax: (201) 847-4869 For more information regarding this project, contact Steve Brooke at sbrooke@path.org. Funding for this project has been provided by the United States Agency for International Development under PATH s HealthTech program. *Uniject is a registered trademark of BD.
Technology Solutions for Global Health May 2012 2010 SILCS Diaphragm Access to family planning has helped millions of women plan and space births and subsequently has improved health outcomes. Despite these successes, an estimated 215 million women worldwide who want to avoid pregnancy lack access to modern contraceptives. This resulted in approximately 86 million unintended pregnancies globally in 2008. An estimated 385,000 women die every year from complications associated with pregnancy and childbirth with unsafe abortion accounting for a high percentage of maternal deaths. Almost all these deaths are preventable. In addition, women represent more than 50 percent of people living with AIDS. Sexually transmitted infections (STIs), excluding HIV/AIDS, are the second most significant cause of loss of health in women, especially young women. Women want and need more femaleinitiated methods that can protect against pregnancy and STIs. Diaphragms could help meet this need, but some characteristics of traditional diaphragms limit their use and acceptability. PATH responded to the call for simple-to-use, female barrier protection by developing the SILCS Diaphragm, a single-size, reusable device with a contoured rim that fits most women with improved comfort. Design and development of the SILCS Diaphragm began in 1994, and user-centered evaluations of over 200 prototype designs resulted in refined performance and features. PATH used stakeholder assessments to ensure that comfort, ease of handling, and acceptability were built into the product. As a result, the SILCS Diaphragm directly addresses user and programmatic needs which will lead to improved access and acceptability. Acceptability studies among naïve users in South Africa and Thailand found that women were able to learn to use the device easily and that women and men found it acceptable during use. In a comparative crossover study of the SILCS Diaphragm with a traditional diaphragm in the Dominican Republic, 19 of 20 women reported preferring the SILCS Diaphragm after short-term use. Where regulatory authority and clinical practice allow, the single-size device could be provided over the counter or outside the clinic-based system. The SILCS Diaphragm design was patented in 1998; a second patent on spring modifications was filed and has been granted in several countries. PATH licensed the technology to Kessel GmbH of Germany in 2010 for commercialization. PATH s research partner and regulatory sponsor, CONRAD, completed clinical validation of contraceptive effectiveness in 2011. Kessel and PATH are working on applications for regulatory approval in Europe and in the United States. While Kessel introduces the product through existing distribution channels in developed and middle-income countries, PATH is undertaking health systems assessments in Africa (South Africa and Uganda) and India to develop strategies to introduce this new diaphragm in developing country markets. In addition, PATH is evaluating the SILCS Diaphragm as a delivery system for microbicide gel and as a controlledrelease device. The SILCS Diaphragm, an intravaginal barrier contraceptive. A significant advantage [of the SILCS Diaphragm] for resource-poor settings is that it is a reusable method that women can control with little dependence on the health care system. W. Holmes editorial in Sexual Health, May 2010. For more information regarding this project, contact Maggie Kilbourne-Brook at mkilbou@path.org. Funding for this project has been provided by the United States Agency for International Development through CONRAD and PATH s HealthTech program, the Bill & Melinda Gates Foundation, and other donors. PATH/Mike Wang
Technology Solutions for Global Health May 2012 Woman s Condom According to World Health Organization (WHO) estimates, 448 million new infections of curable sexually transmitted infections occur each year. In 2009, an estimated 2.6 million people became newly infected with HIV, with heterosexual contact as one of the primary modes of transmission. Women represent slightly more than half of the 34 million people living with HIV worldwide and 60 percent of this population is in sub-saharan Africa. In addition, approximately 86 million unintended pregnancies occurred globally in 2008. Complications associated with pregnancy and childbirth claim the lives of an estimated 358,000 women each year, and unsafe abortion accounts for a high percentage of maternal deaths. Many women lack power over sexual decisions; they are not in a position to ask their partners to abstain from sex with others or to use male condoms. An estimated 215 million women wish to delay or space their pregnancies but do not have access to modern contraceptives. A female condom can protect against sexually transmitted infections, including HIV, as well as pregnancy. Experience with currently marketed female condoms has shown that women and men are interested in and will use these barrier devices if they are acceptable and easy to use. With user input from several countries, PATH designed the Woman s Condom to be more acceptable to use for both partners. Couples evaluated prototypes and offered design suggestions to improve acceptability, thus making it more likely that the barrier will be used consistently and properly. The Woman s Condom is comfortable and easy to use. Its unique design features enable easy insertion, secure fit during use, good sensation, and easy removal. In 2008, PATH transferred production of the Woman s Condom to the Dahua Medical Apparatus Company (Dahua) in Shanghai, China. Results from a contraceptive effectiveness trial currently being conducted by the Eunice Shriver National Institute of Child Health and Development (NICHD), with CONRAD acting as the regulatory sponsor, will be used to apply for US Food and Drug Administration clearance in 2014. The Woman s Condom was granted CE Mark approval in December 2010, which certifies the device meets consumer safety standards and can be marketed in countries in the European Union. In addition, the Shanghai Food and Drug Administration granted approval to market the Woman s Condom in China in 2011. It is currently under review by the WHO/United Nations Population Fund Technical Review Committee; the committee s approval could lead to bulk public-sector purchase by United Nations agencies. We received funding in January 2011 from the Netherlands Ministry of Foreign Affairs to support the Protection Options for Women (POW) product development partnership. The POW partners (CONRAD, Dahua, NICHD, and PATH) are increasing protection options, verifying safety and efficacy, and developing markets for the Woman s Condom. Initial introduction activities are being conducted in China and South Africa. A next-generation female condom. The participants rated the Woman s Condom better than two [other products] in terms of appearance, ease of use and overall fit, and better than [another product] in terms of feel. Joanis C, Beksinska M, Hart C, et al. Three new female condoms: which do South-African women prefer? Contraception. 2011:83;248 254. For more information regarding this project, contact Patricia Coffey at pcoffey@path.org. Funding for this project has been provided by the United States Agency for International Development under the CONRAD program and the PATH HealthTech program, the Bill & Melinda Gates Foundation, the Netherlands Ministry of Foreign Affairs, Universal Access to Female Condoms, the Lemelson Foundation, William and Flora Hewlett Foundation, and others. PATH/Glenn Austin
Technology Solutions for Global Health April May 2012 2010 Microbicide Delivery Device In the midst of the growing AIDS pandemic, microbicides could provide urgently needed options for women and men seeking protection from HIV and other sexually transmitted infections. With numerous microbicide products in preclinical or clinical trials, most research has focused on the safety and effectiveness of candidate products, with much less research targeted on devices for delivering these products. Microbicide delivery devices will be critical in ensuring safe and effective use of microbicide products. The device impacts the product s overall safety (relationship with product purity and stability, avoidance of local trauma associated with insertion or use), efficacy (consistent delivery of the required amount of product in the intended location), and acceptability (comfort, ease of use, disposability). PATH s goal is to ensure that safe, acceptable, and appropriate delivery devices are available for introduction and use with microbicides in low-resource settings. Since 2003, PATH has conducted a wide range of activities to inform and advance the development of new microbicide delivery methods including stakeholder research, clinical and acceptability research, bench testing, commercialization activities, regulatory work, and product development. In collaboration with microbicide sponsors, researchers, device manufacturers, design companies, and universities, PATH is currently advancing several novel microbicide delivery methods to help reduce cost, ensure microbicide efficacy, and increase user acceptability. Methods include: A user-filled paper applicator that is low cost, easily disposed of, and prevents over-filling makes it an important option for microbicide gel delivery in low-resource settings. We evaluated the applicator with Tenofovir 1% gel and are working with key stakeholders in South Africa and elsewhere to advance its use as a delivery option for Tenofovir gel. SILCS Diaphragm as a controlled-release microbicide delivery system. We have completed feasibility and proof-of-concept testing for the controlled-release microbicide delivery system. This combination of barrier method and slow-release microbicide could enable prevention of both pregnancy and disease. We are currently looking for additional funding to continue next steps in this development effort. SILCS Diaphragm as a reusable delivery system for micobicide gel. We are continuing to build evidence of feasibility, safety, and acceptability. Two studies were recently completed: (1) a feasibility study using MRI to compare gel retention and distribution in the vagina with the SILCS Diaphragm (single-sided and double-sided gel delivery) to a gel delivered by a vaginal applicator, and (2) ease of use and acceptability when couples used these three gel application scenarios during intercourse. CONRAD is planning studies to evaluate the safety and efficacy of the SILCS Diaphragm with Tenofovir gel as a dual-protection device. Microbicide in a tube with applicator. Devices used to deliver microbicide products must be acceptable, affordable, and appropriate for women and men around the world to ensure optimum access and use of microbicides. For more information regarding this project, contact Jessica Cohen at jcohen@path.org. Funding for this project has been provided from private foundations and individual donors to the Health Innovation Portfolio at PATH, by the United States Agency for International Development under PATH s HealthTech program, and from the Foundation for AIDS Research. PATH/Jesse Schubert
Nutrition
Technology Solutions for Global Health April 2012 Retinol Binding Protein Enzyme Immunoassay (RBP-EIA) For almost 50 years, researchers have known that administering oral doses of vitamin A could prevent the consequences of severe vitamin A deficiency (VAD) including blindness and death. Analysis of over 150,000 children between the ages of six months and five years from several countries in which VAD is a concern indicate that almost one-quarter of early childhood deaths, especially related to diarrhea and measles, could be prevented by vitamin A (retinol) supplementation. Public health planners and researchers need easier, less expensive ways to assess the extent of VAD among populations to inform public policies and promote well-targeted supplementation programs. Strategies for controlling VAD aim to provide adequate intake through dietary improvement, fortification, and supplementation. To identify the optimal mix of strategies and to monitor progress, reliable information on the magnitude and distribution of VAD in populations is needed. The current tools to do so are expensive and require external assistance; simpler, lessexpensive, field-appropriate tools are needed. RBP has been shown to be a surrogate indicator for retinol, an accepted indicator of vitamin A status. The RBP-EIA was developed by PATH as an easy way to detect and quantify RBP using human plasma or serum. The test is rapid; results are available within 40 minutes. It can be read on a standard or portable EIA reader, and the results are calculated based on values from calibrator control sera provided with the kit. The RBP-EIA has been designed to produce data rapidly; to reduce reliance on costly, centralized laboratory facilities; and to provide an effective tool for field monitoring of VAD in at-risk populations. Laboratory validation has shown a strong correlation between the results obtained by the RBP-EIA and retinol, as determined by high-performance liquid chromatography (HPLC), when serum is used. The RBP-EIA has also demonstrated a strong correlation to HPLC using samples collected from a population of children at risk of VAD. The RBP-EIA predicted a VAD prevalence of 20.2 percent, while the use of HPLC determined the prevalence to be 20.4 percent. A 2004 field evaluation conducted in Thailand demonstrated that RBP is a good surrogate of retinol in both venous and capillary blood samples to estimate VAD in preschool children. Results from experiments using dried blood spots as a sample for the RBP-EIA demonstrated a positive correlation. PATH successfully licensed its RBP-EIA technology to Scimedx, a US diagnostic device manufacturer, for introduction to commercial markets. As of 2011, over 700 test kits had been distributed to support the assessment of nearly 30,000 samples through the Demographic Health Surveys in Uganda, Tanzania, and other academic research institutions. Scimedx continues to support RBP-EIA availability as part of their commercial strategy to stock and supply test kits for orders requiring relatively small quantities for specialized use in diagnostic or surveillance activities. Simple, less-expensive test for vitamin A deficiency. The potential for local assessment of vitamin A serum concentrations through RBP determination is promising. This would bring an accurate and simple vitamin A assessment methodology into the toolbox of local public health workers. Tanumihardjo SA, Blaner WS, Jiang T. Dried blood spot retinol and retinol-binding protein concentrations using enzyme immunoassay as surrogates of serum retinol concentrations. MOST Technical Report, June 2002. Tests can be ordered from Caryn Shapiro, Scimedx, New Jersey, cshapiro@scimedix.com. For more information regarding this project, contact Ralph Schneideman at rschneideman@path.org. Funding for this project has been provided by the United States Agency for International Development under PATH s HealthTech program.
Technology Solutions for Global Health May 2012 Ultra Rice Technology Billions of people suffer from micronutrient malnutrition, a factor that substantially contributes to the global burden of disease, affects the development of young children, and dramatically reduces the productivity of entire populations. PATH s Ultra Rice technology is a culturally appropriate and cost-effective micronutrient delivery system that packs vitamins and minerals, including iron, zinc, thiamin, and folic acid, into extruded rice grains made from rice flour. Grains fortified using the Ultra Rice technology resemble traditional rice in size, shape, and color. When blended with milled rice, typically at a 1:100 ratio, the resulting fortified rice is nearly identical to traditional rice in smell, taste, and texture. Since the micronutrients are inside the grains, they are less vulnerable to nutrient loss during preparation and cooking. PATH s Ultra Rice project is focused on expanding its evidence base, developing markets, and broadening adoption of fortified rice. Market development In India, PATH transferred the Ultra Rice technology to Usher Agro, a large rice miller, which will soon produce grains for both public- and private-sector distribution channels. Building on earlier introduction efforts, PATH is working with state governments to expand the distribution of fortified rice within India s public-sector food programs, including the Public Distribution System, which provides subsidized commodities to families below the poverty line. In Brazil, PATH transferred the Ultra Rice technology to Urbano Agroindustrial, one of the largest rice millers in the country. Urbano will be working with PATH and GAIN to launch a fortified rice pilot introduction through commercial retailers, accompanied by a social marketing campaign to enhance demand for the product. PATH has also established a technical center of excellence at the Federal University of Viçosa to facilitate future transfers of the Ultra Rice technology and strengthen the supply chain. In Burundi, PATH, in partnership with World Vision, is distributing fortified rice through a school meal program supported by the World Food Programme (WFP). PATH aims to improve the micronutrient status of children served by the program and generate further operational and biological impact data, which will expand the evidence base for the Ultra Rice technology and build the case for its inclusion on the approved commodity lists of the US Government and the WFP. Affordability It costs less than US$1.00 per child per school year to integrate fortified grains made with the Ultra Rice technology into rice-based lunches, delivering one-third to one-half the recommended daily intake of iron, folic acid, zinc, and thiamin in one serving of rice. Ultra Rice is a registered US trademark of Bon Dente International, Inc. Ultra Rice is an innovative technology to address micronutrient deficiency. Research highlights Fortified rice was more effective than iron drop supplements at improving the iron status of children aged 6 to 24 months in a southwest region of Brazil. School children aged 5 to 12 years consuming fortified rice in India had a significant increase in iron stores, as well as a significant reduction in the incidence of morbidities compared to a control group. The prevalence of anemia among women in Mexico consuming fortified rice decreased by 80 percent, resulting in a significant decrease relative to a control group. For more information regarding this project, contact Dipika Matthias at dmatthais@path.org. Funding for this project has been provided by the Bill & Melinda Gates Foundation, the United States Department of Agriculture, and the Abbott Fund. PATH/Satvir Malhotra
Diagnostics for Infectious Diseases
Technology Solutions for Global Health May 2009 HIV Dipstick The spread of HIV by parenteral infection via blood or blood products has been largely eliminated in the developed world through the routine screening of blood. However, blood supplies may still not be routinely screened in developing countries, where the current cost of test kits and equipment is prohibitively high or where access to appropriate tests is low. In addition, there are continual needs for low-cost, highly accurate HIV tests to supplement available diagnostic-test algorithms for research purposes and for field surveillance and epidemiology. In the early 1990s, PATH developed a rapid, inexpensive method for detection of antibodies to HIV-1 and HIV-2. The HIV dipstick was developed with the primary goal of providing an accurate, simple, HIV screening method for small- to medium-sized blood banks in developing countries. The cost per test from manufacturers was initially lower than the cost of other commercially available rapid tests. The assay takes approximately 20 minutes to perform and requires no special equipment. The affordability and ease of use of the HIV dipstick make it suitable for low-volume HIV testing where more sophisticated, automated methods are neither cost-effective nor appropriate. The HIV dipstick is currently being used in blood banks and public health laboratories for diagnosis of HIV and also as a screening tool in HIV surveillance studies. A study by the World Health Organization (WHO) in Burkina Faso demonstrated that using the HIV dipstick in combination with another commercial test is an accurate and cost-effective method of serodiagnosis of HIV. The HIV dipstick test was evaluated in the laboratory as well as under field conditions using over 10,000 serum samples, and has consistently demonstrated a sensitivity of over 99%, while retaining a specificity of 98% or more. An independent evaluation by WHO of the HIV-1 version of the test was completed in 1990. The dipstick was subsequently optimized for combined detection of HIV-1 and HIV-2 in 1992, and has now been evaluated in 17 different countries. PATH transferred the technology for production to local firms in Argentina, India, Indonesia, and Thailand. Kits from these producers were evaluated by WHO s Global Programme on AIDS in 1995 and 1998 and received high marks for accuracy, ease of use, and suitability. HIV tests from three of the manufacturers were added to the WHO/UNICEF bulk procurement list for HIV tests in 1997. Since the initial technology transfers, total sales of the HIV dipstick to both public- and private-sector buyers have exceeded 19 million tests. In 2004, the licensees worked together to reengineer and upgrade the product. One major outcome of the development of the technology was the lowering of the cost and increased availability of rapid HIV tests from multiple companies, resulting in much more affordable HIV testing throughout the developing world. First low-cost, rapid HIV-1 and HIV-2 test on the market. The availability of the dipstick and other quick, easy tests has enabled countries in the South to develop effective, on-site diagnostic testing procedures and provide same-day results. From the International Development Research Centre website. For more information regarding this product, contact Joachim Oehler, The Concept Foundation, 111 Paholyothin Road, Thailand Science Park, Klong 1, Klong Luang, Pathumthani 1212, Thailand, Tel: 662-564-8021, Fax: 662-564-8024, joehler@conceptfoundation.org. Funding for this project has been provided by the International Development Research Centre of Canada, the Rockefeller Foundation, and by the United States Agency for International Development under PATH s HealthTech program.
Technology Solutions for Global Health April 2012 Non-Instrumented Isothermal Nucleic Acid Amplification Device Many infectious diseases that affect global health are most accurately diagnosed through nucleic acid amplification and detection. However, existing nucleic acid amplification tests are too expensive and complex for most low-resource settings. The small numbers of centralized laboratories that exist in developing countries tend to be in urban areas and primarily cater to the affluent. In contrast, rural area health care facilities commonly have only basic equipment, and health workers have had limited training and possess little ability to maintain equipment and handle reagents. Reliable electric power is a common infrastructure shortfall. To address this, PATH has been leading development of technologies that facilitate electricity-free, instrument-free nucleic acid amplification. The development of the prototype non-instrumented nucleic acid amplification (NINA) heating device represents the first example of using an exothermic chemical reaction and engineered phase-change material in a nucleic acid amplification test. In the NINA heater, we use the exothermic reaction of calcium oxide (CaO, or quicklime) and water to generate the necessary heat. PATH has demonstrated the use of this configuration to stabilize a heat mixture within a narrow temperature range (65 C ± 0.5 C) suitable for several isothermal amplification strategies. NINA heater prototypes have been used to demonstrate proof of principle by amplifying genomic malaria DNA, HIV-1 DNA, and Ralstonia solanacearum (agricultural pathogen) DNA using loop-mediated amplification. 1 Additionally, PATH has received feedback from potential users in low-resource setting clinics in India, Kenya, and Zambia. PATH plans to assess the performance of NINA with a variety of infectiousdisease pathogens and isothermal amplification strategies. Next-generation prototypes will incorporate feedback from our field studies by increasing the number of sample wells and by improving ease of use around activation and miniaturization. We are actively seeking manufacturing partners to help optimize the design for manufacturing scalability as well as partners with novel isothermal amplification strategies and relevant infectious disease primers. We are also working on non-instrumented solutions such as simple sample preparation and naked-eye detection that will, together with NINA, help build a fully functional, electricity-free, molecular diagnostic kit. PATH recently initiated an National Institutes of Health-funded collaboration with the US Centers for Disease Control and Prevention that merges scientific and engineering capabilities to adapt the NINA platform into a point-of-care HIV test. The NINA device could potentially enable diagnosis of acute HIV-1 infection and/or infant HIV that would have gone undetected by existing point-of-care rapid HIV tests currently in use in low-resource settings. 1 LaBarre P, Hawkins KR, Gerlach J, et al. A simple, inexpensive device for nucleic acid amplification without electricity toward instrument-free molecular diagnostics in low-resource settings. Plos One. May 2011;6(5):1 8. A prototype NINA device is demonstrated in a Kenyan clinic. The non-instrumented isothermal nucleic acid amplification device can enable highly accurate diagnosis at the periphery where there is no access to electricity. For more information regarding this product, contact Paul LaBarre at plabarre@path.org. Funding for this project has been provided from private foundations and individual donors to the Health Innovation Portfolio at PATH and the National Institutes of Health. Lisa Stroux
Technology Solutions for Global Health May 2012 Chagas Immunochromatographic Strip Test Chagas disease (American trypanosomiasis), caused by the parasite Trypanosoma cruzi, is one of the most significant neglected diseases in the developing world. It is found throughout Latin America and is primarily transmitted by insects native to this region. Untreated chronic Chagas disease can lead to serious cardiac and digestive complications, resulting in loss of productivity and ultimately death. An estimated 10 million people are infected with T. cruzi worldwide, and more than 25 million are at risk of being infected every year according to the World Health Organization. Adding to the burden, the highest incidence of Chagas disease is found in poor and rural settings, where a tremendous diversity of parasite reservoirs and vectors combine with inadequate housing conditions to greatly facilitate disease transmission. As such, Chagas disease dramatically and disproportionally impacts the poorest and most disadvantaged populations. The use of two or more diagnostic tests is currently recommended for confirmation of infection. However, the diagnostic tests most commonly used enzyme-linked immunosorbent assays (ELISA) and immunohemaggulination assays (IHA) require well-equipped laboratories, skilled technicians, and/or refrigeration, making it difficult for these tests to be used in low-resource settings. The Chagas Immunochromatographic Strip (ICS) Test has the potential to become an effective and appropriate tool for detection of Chagas disease because ICS tests offer many advantages for use in low-resource settings. They provide test results quickly and require neither sophisticated laboratories nor extensive training. The successful use of ICS tests by trained community health workers is widely recognized as evidenced by the use of ICS tests in HIV and malaria clinical management throughout resource-poor communities around the globe. PATH has conducted an evaluation of the Chagas ICS Test in our laboratory using 375 previously characterized clinical specimens from a Chagas endemic region. These analyses showed that the Chagas ICS Test had a sensitivity of 99.5% and specificity of 96.8%. The results to date are promising, and we will soon begin a field evaluation of test performance with whole blood specimens. Simultaneously, we are working to establish partners who will manufacture and distribute the Chagas ICS Test at a price lower than other point-of-care tests. Prototype Chagas ICS Test, positive (right) and negative (left) results. The need for an an affordable, accurate Chagas diagnostic has been reiterated by every Chagas regional initiative. To address this need PATH is developing a rapid test for Chagas disease that combines a well-accepted and inexpensive format ICS test, with a T. cruzi antigen that is proprietary to a private company in Argentina. For more information regarding this project, contact Cori Barfield at cbarfield@path.org. Funding for this project has been provided from private foundations and individual donors to the Health Innovation Portfolio at PATH. PATH/Rebecca Barney
Technology Solutions for Global Health September 2011 Advancing a New Diagnostic Test for Onchocerciasis in Africa Onchocerciasis, or river blindness, is a major cause of preventable blindness around the world. Caused by parasitic worms transmitted to humans through the bite of the blackfly, onchocerciasis typically affects poor, rural communities near fast-flowing streams and rivers. An estimated 180 million people are at risk for the disease, and 37 million people are infected. Most of the disease burden is in Africa, where affected individuals experience intense itching, severe skin disfiguration, and with years of repeated exposure permanent blindness. In addition to its health effects, the disease leads to massive economic losses when productive agricultural lands are abandoned for fear of infection. Programs to control blackflies with insecticides and mass treatment of affected communities with Ivermectin have succeeded in reducing the disease burden. As efforts move from disease control to elimination, better diagnostic tools will be needed, especially for monitoring post-control areas for signs of reinfection and for detecting cases in low-prevalence areas. PATH is developing a new diagnostic test that can be used to support programs as they move to the disease elimination phase. PATH will develop and make available a rapid test for onchocerciasis that is based on the detection of antibodies to a parasite antigen. A similar test has been shown to be useful in the past but is no longer commercially available. The new test will address limitations of existing diagnostic tools in use. Anticipated advantages over methods currently in use include point-of-care use, low cost, rapid results, minimal training requirements, the need for only a finger prick to collect blood samples for analysis, and the ability to detect early infections. We have finished a landscape analysis of potential manufacturers, and early prototypes are expected to be available for third-party evaluations by spring of 2012. Ov16 rapid test prototypes. During these past 15 years, most of the efforts have been geared towards the control of onchocerciasis as a major public health problem affecting millions of persons among the poorest. Now, scientific evidence has demonstrated the feasibility of onchocerciasis elimination, thus opening a window of hope for the future. Dr. Paul-Samson Lusamba- Dikassa, Director, African Programme for Onchocerciasis Control (APOC), from 15 Years of APOC, Unique Global Public- Private Partnership For more information regarding this project, contact Tala V. de los Santos at tdelossantos@path.org. PATH/Allison Golden Funding for this project has been provided by the Bill & Melinda Gates Foundation.
Technology Solutions for Global Health May April 2010 2012 Rapid Tests for Cervical Cancer Cervical cancer is a preventable disease that strikes an estimated 470,000 women each year and kills more than 270,000 of them. While the industrialized world has made good progress in preventing the disease, about 85 percent of cervical cancer deaths occur in developing countries where it is a leading cause of cancer mortality among women. The lack of effective cervical cancer screening and treatment programs in poorer countries, including lack of accurate, easy-to-use, and affordable screening tests that provide rapid results, is the main cause of inequity. In 2003, PATH began assessing the scientific and economic feasibility of providing new screening tests for the types of human papillomavirus (HPV) that cause most cervical cancers. PATH entered into collaborations with private-sector partners QIAGEN Inc. (formerly Digene Corporation) and Arbor Vita Corporation to develop two different rapid tests that would be safe, accurate, affordable, simple, and acceptable to women in low-resource settings. If development of such tests is successful, women would then have highly sensitive alternatives to Pap smear testing and would be able to get test results more quickly. If rapid-results testing revealed that a woman is infected with a high-risk type of HPV, she could receive medical management on the same day, which would greatly reduce her risk of developing cervical cancer. By 2008, while PATH continued to advance a rapid HPV strip test with Arbor Vita, PATH and QIAGEN had jointly developed an HPV DNA molecular test, called carehpv. This test processes dozens of samples in approximately 2.5 hours. The test was evaluated in Shanxi, China, where 2,500 rural women were screened using vaginal and cervical samples, and it yielded good results. PATH is currently conducting demonstration projects with carehpv within public-sector facilities in India, Nicaragua, and Uganda. The results from these projects will be used to inform ministries of heath and other key stakeholders about the feasibility, effectiveness, and acceptability of carehpv. A prototype of Arbor Vita s AVC AVantage HPV E6 test was completed, and it is being evaluated in China to determine its performance. The results from both the demonstration projects and field testing will become available by the end of 2012. In addition, in order to facilitate the establishment of health services that are ready to incorporate the new tests, PATH is working closely with Jhpiego and the Peruvian Cancer Institute to establish regional centers to train service providers in triage and treatment techniques necessary for follow-up with HPV-positive women. PATH and Jhpiego also are collaborating closely with regional and global health organizations in order to mobilize support from international and developing-countrybased champions of alternative screening and treatment technologies. Lab technician working with the carehpv test, Shanxi, China. Safe, simple, accurate, and affordable biochemical screening tests for cervical cancer may be the breakthrough needed to reduce suffering due to cervical cancer in low-resource settings. For more information regarding this project contact start@path.org. Funding for this project has been provided by the Bill & Melinda Gates Foundation and by the National Institute of Allergy and Infectious Diseases. CICAM
Technology Solutions for Global Health May April 2012 2010 Simple and Affordable Testing for Multidrug-Resistant Tuberculosis Tuberculosis (TB), a bacterial disease caused by Mycobacterium tuberculosis, is a major health problem in developing countries and is re-emerging as a major health threat in the developed world. High prevalence in some developing countries is associated with HIV infection and AIDS. World Health Organization (WHO) statistics indicate there are 14 million cases of active TB worldwide, and approximately 9.4 million new cases occur each year. TB results in the highest mortality rate of any infectious disease in the world and approximately 1.7 million deaths annually. TB is a highly contagious disease that can be difficult to identify and diagnose accurately. Since it is curable with a course of antibiotic therapy, early diagnosis and treatment can curtail the spread of the disease within the general population. Some progress has been made in introducing new tools to achieve early diagnosis. However, early diagnosis of TB at the peripheral level remains a significant challenge since existing methods have low sensitivity (sputum smear), take a long time to produce results (solid culture), or are very expensive (automated liquid culture methods and automated nucleic acid amplification tests). The microscopic observation drug susceptibility (MODS) test was first described by the TB working group at the Universidad Peruana Cayetano Heredia (UPCH), Lima, Peru. This is an accurate, rapid, and inexpensive liquid culture-based method for determining TB positivity and resistance to first-line antibiotic therapies (isoniazid and rifampicin). It employs a simple, inexpensive tissue culture plate and commonly available culture media to provide results with a rapid turnaround from specimen collection to results dissemination (usually within seven days). The original platform has been validated in five countries with extremely high sensitivity and specificity. UPCH contacted PATH and asked for assistance in making the test easier and safer to use. PATH collaborated with Hardy Diagnostics (CA) to develop the TB MODS Test Kit. This kit includes everything that researchers and laboratory technicians need to perform the MODS test while providing test standardization and convenience to users. Additionally, it includes a PATHdesigned silicone-based protective sealing lid for the culture plate to prevent cross contamination between samples and increase biosafety. WHO endorsed the UPCH-designed MODS test in 2010. The TB MODS Test Kit has received a CE Mark and is for sale in European countries. With Hardy Diagnostics commitment, the TB MODS Test Kit can be provided at low cost to low-resource countries. PATH is now taking steps to introduce the TB MODS Test Kit in those countries. PATH is also undertaking a field evaluation of the kit in Peru to generate performance data as well as a landscape analysis in countries where PATH has offices in order to gauge the level of interest in the MODS test and the TB MODS Test Kit. Hardy Diagnostics TB MODS Test Kit. Under these conditions, MODS and NRA [nitrate reductase assay] are recommended for direct testing of sputum specimens. Together with CRI [colorimetric redox indicat]methods, MODS and NRA are also recommended for indirect DST [drug susceptibility test] of M. tuberculosis isolates grown in conventional culture. WHO Policy Statement Noncommercial culture and drug-susceptibility testing methods for screening patients at risk for multidrug-resistant tuberculosis. For more information regarding this project, contact David Boyle at dboyle@path.org or Mutsumi Metzler at mmetzler@path.org. Funding for this project has been provided by the United States Agency for International Development under PATH s HealthTech program and from the Bill & Melinda Gates Foundation. Hardy Diagnostics
Technology Solutions for Global Health May 2009 Rapid Strip Test for Malaria Despite intensive public health efforts, more than 300 million new cases of malaria occur each year, resulting in more than a million deaths worldwide. Microscopy is still the standard method for diagnosis in many parts of the developing world, but it is time consuming, labor intensive, and can only be performed by expert microscopists in specialty clinics or higher levels of the health care system. It is impractical whenever large numbers of samples must be examined. An alternative test method was urgently needed for the rapid and accurate identification of falciparum malaria infection in smaller clinics and rural hospitals. The malaria immunochromatographic strip (ICS) test developed by PATH under HealthTech utilizes relatively inexpensive, off-the-shelf components and is formatted to identify Plasmodium falciparum in whole blood. A test can be completed in less than 20 minutes using a single drop of finger-stick blood. It can be performed and the results interpreted by technicians with minimal training. The strips are stable for months at ambient temperatures when appropriately sealed in foil pouches, and built-in procedural controls indicate whether each strip performs correctly. The malaria ICS test has been evaluated in the laboratory as well as under field conditions in the developing world in collaboration with the Centers for Disease Control and Prevention and USAID in Peru and Malawi. The evaluations demonstrated a sensitivity of over 96%, and a specificity of 93% or more. Ease-of-use studies have also concluded that the test is extremely easy to interpret. PATH then licensed the manufacturing know-how to two companies, one in Germany and one in India. Reported sales of the test by spring 2005 were 300,000 tests. PATH has also provided technical assistance to two other commercial manufacturers for development of their own falciparum malaria ICS tests; sales have been in the range of 40,000,000 worldwide. The simple, rapid ICS technologies allow testing for falciparum malaria in rural or small clinics or hospitals in the developing world so that accurate results can be returned the same day, allowing effective patient follow-up and prescription of appropriate therapeutic drugs. This is especially important since WHO now recommends artemisinin combined therapy, a relatively expensive treatment, because the falciparum malaria organism is resistant to chloroquine. Epidemiological surveillance teams can also use the test to gather baseline data or to assess the effect of public health interventions. The tests can supplement or confirm infection in conjunction with microscopic diagnosis of malaria at central reference facilities. In lowervolume blood banks or transfusion centers, the test can be used to rapidly test donated blood before storage and subsequent transfusion. A rapid, easy-to-read, low-cost test for malaria. A study of the PATHdeveloped rapid test for malaria diagnosis found that in areas where microscopy expertise is lacking and laboratory capacity limited, the rapid test is considered useful. Parkes R, et al. Comparison of a nested polymerase chain reaction restriction fragment length polymorphism method, the PATH antigen detection method, and microscopy for the detection and identification of malaria parasites. Canadian Journal of Microbiology. 2001;47(10):903 907. The test has been transferred to companies in Germany and India and is available from: Human GmbH, Tel: 49-6122-9988-275, Fax: 49-6122-9988-100 or Span Diagnostics, Tel: 91-261-8677211, Fax: 91-261-8679319. Funding for this project has been provided by the United States Agency for International Development under PATH s HealthTech program.
Safe Water
Technology Solutions for Global Health May April 2010 2012 Safe Water: A Market-Based Approach Safe drinking water is essential to good health. However, in resource-poor settings, water often comes from unsafe sources and carries deadly pathogens. The World Health Organization estimates that 1.1 billion people lack access to improved water supplies, and 1.8 million people nearly 5,000 children a day die each year from preventable diarrheal diseases; many of these deaths are attributed to unsafe water. Various products exist today to treat and safely store water. Yet, according to international experts, less than 1 percent of those without access to improved water supplies are being reached with current efforts to promote household water treatment and storage (HWTS). Clearly, the scale of the problem is far beyond what current efforts can handle. Commercial markets supply low-income consumers in the developing world with household goods such as soap, food items, and basic commodities. PATH understands that HWTS products can be successfully marketed and sold to these consumers in a similar way for positive health outcomes. Market-based solutions offer a number of potential advantages. In general, the private sector is more nimble and innovative, has greater resources, is more responsive to consumer preferences, and has the potential for sustainability and scalability without ongoing subsidies. Through the Safe Water Project, PATH has worked to catalyze and facilitate new partnerships and approaches to selling HWTS products to low-income consumers. Partners can now take these initiatives to scale independent of PATH and the marketplace will make them sustainable. These established market products and infrastructure are ready to be used in a coordinated manner by nongovernmental organizations and the public sector to cost-effectively provide products to the poorest of the poor, ultimately leading to a greater overall impact on health. Four user-driven PATH-improved products are being carried forward by private-sector partners, including two water treatment elements and two HWTS gravity-fed devices. One improved HWTS device is already being sold in Cambodia. Several successes based on our market-based distribution models are ready to be scaled in Cambodia and India and to be replicated in new countries. PATH also continues to refine tools to support our distribution partners around sales recruiting and training, active monitoring, and encouragement of sound enterprise operating principles. The Safe Water Project activities, funded by the Bill & Melinda Gates Foundation, are wrapping up and the results of this five-year learning initiative will be disseminated throughout 2012. PATH and our partners are moving forward with the most successful of our product, distribution, financing, sales and operational approaches and seeking funding for replication in new settings. PATH is actively cultivating public-sector partnerships to complement the role of the private sector in meeting the universal need for safe drinking water. A household water and safe storage device developed with and for low-income families. Through the Safe Water Project, PATH has worked to catalyze and facilitate new partnerships and approaches to selling household water treatment and safe storage products to low-income consumers. For more information regarding this project, contact Glenn Austin at gaustin@path.org. Funding for this project is provided by the Bill & Melinda Gates Foundation. Hydrologic
Technology Solutions for Global Health September May 2010 2011 PATH s Prototype Water Filter for Household Water Treatment The World Health Organization estimates 1.8 million people, including nearly 4,000 children a day, die each year from preventable diarrheal diseases; many of these deaths are attributed to unsafe water. Various products exist today to treat and safely store water. Yet, according to international experts, less than one percent of the 1.1 billion people without access to improved water supplies are being reached with current efforts to promote household water treatment and storage (HWTS). Too few people have access to simple water treatment solutions that could save lives. In collaboration with outdoor equipment manufacturer Cascade Designs, Inc. (CDI) and India-based design consultant Quicksand, PATH worked to design a prototype HWTS device specifically for the developing-world consumer. Proper assembly and use of the device can be figured out without prior knowledge or experience with water treatment products or practices. The size, shape, and physical appearance of the device are both appropriate and appealing. It meets the water consumption needs of low-income households, and it is a device that consumers aspire to have in their home. There is no chemical smell or taste in the treated water, and the cleaning of the device a common practice in the developing world for household goods can be done effectively with hands and fingers. All of these factors for which we designed the prototype were learned through two major initiatives completed by PATH s Safe Water Project: an extended user study that examined how low-income households in rural and semi-urban areas of Andhra Pradesh, India, used and misused a variety of HWTS products, and the development of design guidelines for HWTS products for developing-world consumers. The prototype is PATH s physical application of the HWTS design guidelines. Many of the insights from these two initiatives are also being used to inform marketing strategies for low-income households who have little experience with HWTS products or water treatment in general. After a small fabrication run of these preproduction prototypes, 15 prototypes were field tested in Andhra Pradesh, India during a three-month study to better understand its application in a developing-world setting. By testing this preproduction prototype in low-income households, we were able to validate the HWTS design guidelines. PATH has finalized agreements with three Chinese manufacturers to develop, produce, and sell their own gravity-fed HWTS devices to low-income households. The new devices will follow general design guidelines and lessons learned from the prototype device. Each manufacturer will interpret the reference design style based on its own market knowledge, thus differentiating the products and creating competition between product lines. The prototype device was designed for low-income households. PATH has licensed the prototype design to three Chinese manufacturers to create and sell their own household water treatment and storage devices. For more information regarding this project, contact Glenn Austin at gaustin@path.org. Funding for this project is provided by the Bill & Melinda Gates Foundation. PATH/Glenn Austin
Technology Solutions for Global Health May 2010 Chlorine Test Strips September 2011 The World Health Organization estimates 1.8 million people, including nearly 4,000 children a day, die each year from preventable diarrheal diseases; many of these deaths are attributed to unsafe water. Various products exist today to treat and safely store water. Yet, according to international experts, less than 1 percent of the 1.1 billion people without access to improved water supplies are being reached with current efforts to promote household water treatment and storage (HWTS). Too few people have access to simple water treatment solutions that could save lives. PATH and Cascade Designs, Inc. from Seattle, WA, partnered with the maker of rapid and accurate tests for various chemical solutions, Precision Laboratories from Arizona, to refine a simple test strip that enables accurate chlorine dosing of treated water. Accurate dosing of chlorine to treat water balances the need for residual safety with optimal taste and odor even at various water temperatures and ph levels. With the presence of commonly found natural water contaminants, this test strip produces highly precise and accurate results. The chlorine test strip from Precision Laboratories allows PATH to address the market need for a low-cost, appropriate, and easy-to-use chlorine indicator to help others ensure that water is safer for those most in need. PATH worked with Precision Laboratories to customize instructions on the label with three illustrated steps designed to convey accurate use of the product to illiterate and nonnative English speakers: (1) dip the strip in water, (2) move back and forth for five seconds, (3) read the result. The indicator pad color shows whether chlorine is below, within, or above the target range of 0.2 ppm to 2.0 ppm. Precision Laboratories has guaranteed a five-year supply of the customlabeled product, as well as preferential pricing for PATH and other organizations that manage implementation of chlorine-based interventions for treatment of drinking water in low-resource settings. Each bottle of 100 test strips costs just US$3.50 or US$0.035 per test. The test is accurate to 0.01 ppm with a residual chlorine detection range of 0 ppm to 5 ppm. PATH helped design the Precision test strip to meet the needs of users in low-income settings. PATH is looking for additional opportunities for the test strips, as they could be useful for monitoring community-scale chlorinebased treatment or conducting field research of chlorine-based treatment interventions, whether at the community or household level. The test strip is available through Precision Laboratories. A simple, easy-to-read test strip for testing for accurate levels of chlorine. The chlorine test strip from Precision Laboratories allows PATH to address the market need for a low-cost, appropriate, and easy-to-use chlorine indicator to help others ensure that water is safe for those most in need. For more information regarding the Precision test strip product, contact Precision Laboratories at preclab@aol.com. For more information regarding this project, contact Jesse Schubert at ChlorineTest@path.org. Funding for this project is provided by the Laird Norton Family Foundation.
Technology Solutions for Global Health September May 2010 2011 Smart Electrochlorinator 200 Safe drinking water is essential to good health, but in developing nations, water often comes from unsafe and inconvenient sources. The World Health Organization reports that 880 million people worldwide rely on unimproved water sources for their drinking water (e.g., surface water such as lakes, rivers, and dams, or from unprotected dug wells or springs). In rural areas around the globe, eight out of ten people are without access to improved drinking water. PATH has been investigating ways to increase access to safe water at the community level, and chlorine has been shown to be one effective treatment method. In collaboration with Cascade Designs, Inc. (CDI), Seattle,WA, PATH worked to develop a prototype of a portable, battery-powered, easy-to-use device that creates a concentrated chlorine solution using salt, water, and a power source (in this case, a car battery). Iterations of the electrochlorination prototype yielded the Smart Electrochlorinator 200, or SE200. A little larger than a soda can, the SE200 operates using a single push button. Two white lights indicate the device is working and reinforce with users and observers the creation of the chlorine solution. A purple light indicates whether or not enough salt is in the solution, and a red light indicates whether the battery needs to be charged. A seven-minute run cycle produces enough chlorine to treat up to 200 liters of water. The SE200 also has the flexibility to allow a user to easily measure smaller doses to accommodate a variety of water container sizes. The smart circuitry in the device measures changes in water chemistry to deliver consistent concentrations of chlorine for accurate dosing without complex monitoring or calculations. The device and its components are portable and easy to set up at most water sources including water trucks, boreholes, and dug wells. Since chlorine is available on demand, there is no need to store or transport the chemical and no risk of chemical degradation over time. PATH s community water projects have helped PATH and CDI to optimize the product for the developing world. Field trials have tested the device in multiple settings and have explored multiple uses for the device. In Ghana, Mali, Niger, and Zimbabwe the device was used by nongovernmental organizations and community water committees to offer treated water at minimum costs. Small business kiosks that sell treated water have tested the SE200 in Guinea, India, Kenya, Mali, and Tanzania. The device has been used to aid a water business franchise in Nairobi, Kenya. Schools and community centers have used the device for water treatment in Nepal. In Thailand, a joint US/Thai military operation tested the device for humanitarian assistance and disaster relief. Additional activities are under way to finalize the commercialization of the SE200, aid in scaling up the device, and expand its use to more locations, ultimately increasing the access of safe water to families with the greatest needs. The SE200 produces enough chlorine to treat up to 200 liters of water. Water and sanitation is one of the primary drivers of public health... Once we can secure access to clean water a huge battle against all kinds of diseases will be won. Dr. Lee Jong-wook, Director-General, World Health Organization For more information regarding this project, contact info@path.org. Funding for this project is provided by the Laird Norton Family Foundation, the Lemelson Foundation, PATH s Fund for Health Technologies, and the Washington Global Health Technology Competitiveness Program. PATH
Technology Solutions for Global Health May April 2010 2012 New Design of the Ceramic Water Pot A drink of clean, safe water is nearly always within reach in the industrialized world, but a billion people across the globe struggle for access to this basic commodity. In resource-poor countries, families often rely on unimproved surface water and, as a consequence, suffer from waterborne diseases. According to the United Nations Children s Fund, 44 percent of the rural population in Cambodia does not have access to a clean water source. Nearly one-tenth of child deaths for those under age five in Cambodia can be attributed to waterborne illnesses. Ceramic water filters are one of a number of products for household water treatment which have been in use since ancient times. Ceramic water pots (CWPs) consist of a ceramic filter and accompanying receptacle for the filtered water. The typical ceramic filter holds eight to ten liters of water and is suspended inside a plastic receptacle. The receptacle is fitted with a tap and a lid; users pour water into the filter, wait for the water to flow through the filter into the receptacle, and dispense filtered water from the tap. CWPs are used throughout Africa, Asia, and Latin America. While CWPs are effective at water treatment, scale-up and sustainability via market forces have been limited by factors including durability, production quality, product aesthetics, and distribution. PATH s Safe Water Project and CWP manufacturer Hydrologic are working with the Seattle firm CAD-Based Solutions to redesign the external portions of Hydrologic s Tunsai CWP for the Cambodian market. The ceramic pot will remain the same, but changes in appearance of the receptacle and other exterior components have been proposed to make the CWP more desirable and to encourage sales. In development for over a year, the Super Tunsai has been aesthetically redesigned to align with Cambodian consumer preferences. It remains a simple device that produces clean water in a reasonable amount of time but it is more attractive than the original Tunsai, easier to ship and store, and priced for the low- to middle-income consumer. PATH recently completed a pilot project in Cambodia, combining sales of the Super Tunsai with a microfinance loan. The results were compelling: increased uptake from 6 percent to 43 percent among microfinance institution clients, over 80 percent sustained use, and 100 percent loan repayment. An additional measurement showed that 21 percent of the general population in the pilot area had purchased the new product. The project was profitable for the pilot partners, and they intend to expand this model to more locations in Cambodia. PATH is looking for funding to replicate this pilot in other countries and also to design a new lower-cost version of the CWP container to reach even poorer families. The Super Tunsai, launched in Cambodia in early 2011. Give users choices, and make the options not only functional, but also attractive and appealing. Enable users by providing solutions that are convenient, accessible and affordable Tom Clasen, London School of Hygiene and Tropical Medicine For more information regarding this project, contact Pat Lennon at plennon@path.org. Funding for this project is provided by the Bill & Melinda Gates Foundation. PATH
Technology Solutions for Global Health May 2010 May 2012 Sanitation: A Strategic Approach According to the United Nations Children s Fund, more than 2.5 billion people live without access to improved sanitation. People without access to safe water and basic sanitation facilities are exposed to fecal contamination and are put in contact with harmful viruses, bacteria, and parasites that can lead to serious infections and diseases such as diarrhea, cholera, typhoid, and hepatitis A. This exposure results in the deaths of more than 4,000 children every day. Sanitation practices such as open defecation have serious health consequences and have been linked to reduced school attendance especially for female students with dramatic effects on personal development. Despite the ongoing efforts of many governmental and nongovernmental stakeholders, large gaps in access to sanitation remain, resulting in this continuing health burden concentrated in low-income communities. PATH s sanitation strategy addresses access and sustainability in four key areas: market approaches, technology and products, financing, and an overall sanitation framework focused on end users. Sustainable sanitation solutions begin with a thorough understanding of the sanitation value chain and an in-depth assessment of gaps involved in the delivery of sanitation products and services at the household- or community-toilet level. PATH is adapting effective technologies into products that are well-suited for consumers who need affordable, appropriate products and enterprising providers who need sustainable business models. Also, PATH is working to enable suppliers with loans to improve their ability to expand delivery of sanitation products and services to low-income households. These loans provide working capital and allow providers to build inventory and purchase capital equipment. However, a user-centered focus requires looking beyond markets, technology, and financing as discrete elements of development. We created a framework of domains that represents the roles and spheres of influence at all levels of the decision-making process and considers critical social, cultural, financial, legal, and power relationships in order to understand the complexities and interactions of these domains. With this framework we aim to increase demand for and acceptance of improved sanitation solutions. PATH has a number of ongoing projects addressing key gaps in sanitation provision and uptake, including financing, demand generation, gender issues, business and service delivery models, and product design with special focus on platform technologies for both household and community systems. In Cambodia and India we are developing financing mechanisms for enterprises and consumers, and we are working to understand the product and service delivery networks in Kenya, Tanzania, and Uganda. Additionally, we are evaluating the impact of menstrual hygiene products on sanitation systems in both India and South Africa and the effect those impacts have on women and girls. Key outputs from these activities will include reports, case studies, new product designs, and recommendations to policy leaders. We are currently seeking funds to build on these activities. A new business model for sanitation in Nairobi. The world is still far from meeting the Millennium Development Goal (MDG) target for sanitation and is unlikely to do so by 2015. Only 63% of the world now has improved sanitation access, a figure projected to increase only to 67% by 2015, well below the 75% aim in the MDGs. United Nations Children s Fund and World Health Organization. Millennium Development Goal drinking water target met. March 6, 2012. Available at: http://www.who. int/mediacentre/news/releases/2012/ drinking_water_20120306/en/index. html. For more informationregarding this project, contact Glenn Austin at gaustin@path.org. Funding for this project has been provided by International Finance Corporation, Water and Sanitation Program, University of Maryland, International Development Enterprises, The Laird Norton Family Foundation, and Sanergy. PATH