Aids Fonds funding for programmes to prevent HIV drug resistance

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1 funding for programmes to prevent HIV drug resistance Call for proposals July 2012 Page 1 van 10 Documentnumber /JKA/RAP

2 Universal Access Lifting barriers to universal access is an important multiyear strategic objective of the. Under this objective, the international policy for 2012 includes a call for proposals, focussed on treatment as prevention and/or the prevention of HIV drug resistance. 1 At the 2011 High Level Meeting on AIDS, UN Member States adopted a Political Declaration on AIDS, providing a roadmap towards achieving the vision of zero new HIV infections, zero discrimination and zero AIDS-related deaths. Through this declaration UN Member States promised to deliver antiretroviral therapy to 15 million people by 2015, eliminate new HIV infections in children, achieve a 50% reduction in new HIV infections among adults, reduce transmission of HIV among people who inject drugs by 50% and reduce TB deaths in people living with HIV also by half. 2 According to UNAIDS estimates, around 14 million people are in need of antiretroviral treatment based on CD4 counts below 350. At the end of 2011, only 6.6 million people were receiving these life-saving medicines. For every person placed on treatment, 2.5 people are still becoming infected every year, amounting to approximately 2.7 million new infections in Scale-up of a combination of effective prevention interventions therefore remains urgent, and antiretroviral treatment will play a central role. Unfortunately, the rapid scale up of antiretroviral treatment often results in a compromised monitoring of the quality of these programs. 1 Advise international funding 2011 and 2012, internal memo Page 2 van 10

3 Increasing use of antiretrovirals The number of people judged to be in need of antiretroviral therapy in 2011 will almost double as a result of recent World Health Organization recommendations on the use of antiretroviral drugs to prevent HIV transmission. These recommendations follow on last year s release of the results of the HPTN 052 study, which showed that early antiretroviral therapy for the HIV-positive partner reduced the risk of HIV transmission by 96% in serodiscordant partnerships. Similarly, evidence from KwaZulu-Natal demonstrates that, at the population level, antiretroviral therapy is already having an impact. Every 1% increase in antiretroviral coverage among adults in rural communities between 2004 and 2011 was associated with a 1.7% reduction in the risk of HIV acquisition. This means that global HIV incidence could be reduced if greater progress towards universal access to antiretroviral treatment can be achieved. The new WHO guidelines 3 recommend that in couples who are serodiscordant where one partner is living with HIV and the other not antiretroviral therapy is offered to the person living with HIV to prevent his or her partner from becoming infected with the virus. These guidelines are the newest example of a treatment as prevention approach, a term used to describe HIV prevention methods that use antiretroviral treatment to decrease the chance of HIV transmission. Thirteen countries already make recommendations for serodiscordant couples on the use of antiretrovirals for prevention of HIV transmission, including several African countries with a high burden of HIV infection. Together with recommendations for antiretroviral therapy for all TB patients diagnosed with HIV, and all pregnant women irrespective of CD4 counts, the impact of the new guidance is to add around six million people to the number in need of antiretroviral treatment in low- and middle-income countries, adding up to almost 13 million people. In addition to this, antiretroviral treatment will increasingly be used by HIV negative people after the iprex, TDF2 and CAPRISA studies provided evidence that pre-exposure prophylactic use of antiretrovirals (PrEP) can reduce the risk of acquiring HIV. So, more and more people who have never felt the consequences of HIV-related diseases will start using antiretrovirals. Either because they are using those drugs prophylactic, or because they start antiretroviral treatment shortly after infection. This means that we may have to reconsider choices for medicines in first-line regions and methods to improve adherence. 3 Page 3 van 10

4 HIV drug resistance HIV drug resistance refers to the ability of the virus to withstand the effects of a given antiretroviral drug to prevent its replication. Drug resistant virus will continue to replicate in the presence of the drug to which it has become resistant. As ART continues to expand, the emergence of some drug resistance is inevitable. It is related to the total number of people on treatment and to the number of years antiretroviral treatment has been rolled out. Insufficient knowledge among patients and health workers, insufficient health care infrastructure from which to deliver HIV treatment, the cost of antiretrovirals and the complexities of supply chain management, the lack of support required to optimize adherence and inadequate patient monitoring mechanisms are among the many factors leading to treatment failure and eventually drug resistance. If patients develop HIV drug resistance to their first-line regimen, they stop responding to it effectively. In order to stay healthy, they need to receive a second-line regimen. In 2010, in low- and middle-income countries, second-line treatment regimens were on average at least six times more expensive than firstline treatment. Keeping drug resistance at bay is therefore a key strategy to the success and sustainability of HIV treatment programmes. 4 HIV drug resistance will undermine the investments made in the global expansion of HIV treatment programs in resource-limited settings, risking a reversal of the gains made in the response to HIV. To assess clinical and programmatic factors associated with HIV drug resistance, the World Health Organization has developed a set of so called early warning indicators. These indicators are currently monitored by over 50 countries by abstracting data routinely recorded in clinical records 5. The prevention of HIV drug resistance is associated with: Patient care: appropriate prescribing and patient monitoring Patient behaviour: adherence Clinic/program management: efforts to reduce treatment interruptions, follow up, retention on first-line ART, procurement and supply management of antiretroviral drugs. The LAASER program The LAASER program, coordinated by, set out in 2006 to strengthen and improve the quality and durability of HIV/AIDS treatment in Africa and Asia. The program has generated new evidence to better inform HIVDR programs in the future. Numerous reports on LAASER program outcomes and affiliated projects are being published in scientific journals 6, showing that: 4 5 Diane E. Bennett et al. HIV Drug Resistance Early Warning Indicators in Cohorts of Individuals Starting Antiretroviral Therapy Between 2004 and 2009: World Health Organization Global Report From 50 Countries Clin Infect Dis. (2012) 54 (suppl 4): S280-S LAASER brochure: HIV drug resistance in Africa and Asia, achievements of the LAASER program Page 4 van 10

5 6% of recently infected patients in Asia have evidence of HIV drug resistance at the time they start ART, putting them at risk of early treatment failure. Alarming numbers of African patients are on suboptimal first-line regimens because 1 in 20 HIV-positive had clinically important resistance mutations against minimally one of the prescribed drugs. HIV drug resistance is on the rise, particularly in East Africa, with an overall 38% increase of relative risk for each additional year elapsing since ART rollout. Primary HIV drug resistance in Ugandan cities is now already 12%. This is probably due to the earlier start of ART roll-out in Uganda. Half of the African patients who switched to second-line treatment switched unnecessarily, resulting in increased treatment costs and loss of drug options. Additionally, late detection of treatment failure in other patients resulted in more extensive HIV drug resistance, which will impair the effectiveness of second-line regimens. Based on these findings, the LAASER program has put forward a number of recommendations for future programming. The long-term success of treatment can be achieved through investment in resistance monitoring today. A growing concern among HIV drug resistance experts is the general absence of routine viral load monitoring in Africa. As a consequence, either premature and inaccurate diagnoses of treatment failure, or delayed diagnoses, leading to development of higher levels of HIVDR, may result. Current HIV drug resistance testing is expensive and technically challenging, making it unfeasible for many resource-limited settings. A more cost-effective approach for the monitoring of HIV drug resistance is therefore required. Communities of key populations, including people living with HIV, face many challenges and it may be difficult to prioritize issues like resistance. HIV drug resistance will become even less of an advocacy priority unless its importance is constantly upheld by policy makers. Enhanced and more focused advocacy work is needed to address the emergence and impact of HIV drug resistance. Specific advocacy should be conducted to ensure that price reductions on secondline treatment for adults and children are continued and strengthened in order to ensure access to these life-saving medicines. National ART programs that were rapidly scaled-up in the context of relatively weak health systems risk the development of HIV drug resistance due to inadequate program retention and adherence support at the patient and clinic levels. National ART programs should allocate ~0.5%-1% of budgets to monitor HIV drug resistance prevention efforts and their outcomes. Based on the LAASER recommendations we have formulated this call for proposals, to prevent and adequately address HIV drug resistance. As a private and non governmental organization supports important but underfunded niches. For this call, seeks proposals on innovative initiatives, especially activities that are linked to programs where antiretrovirals are used to prevent transmission or acquisition of HIV. Activities should have a leverage effect beyond the particular programme. Page 5 van 10

6 Call for proposals on HIV drug resistance Scope The scope of this call includes the full range of activities that can prevent and adequately address HIV drug resistance for participating patients. All interventions have to contribute to the quality of care of the patients involved. This call is particularly meant for innovative approaches. Interventions could be, but are not limited to, viral load monitoring, targeted resistance monitoring, adherence counselling and support, focused advocacy on the importance of HIV drug resistance or providing medicines with a lower risk of resistance. Activities can be part of programs in which antiretrovirals are used to prevent the transmission (earlier start of treatment) or acquisition (pre-exposure prophylaxis) of HIV. Aim and objectives To support programmes that implement activities to prevent and adequately address HIV drug resistance in participating individuals. o To support the introduction of improved regimens, avoidance of stockouts, and better procurement and supply management. o To support better patient monitoring, including the use of viral load and resistance testing. o To support the understanding of treatment options, access and stay in care, and adherence to treatment. Especially for people living with HIV who are asymptomatic To generate results that can be transferred beyond the context in which the programme takes place. To involve communities in creating a favourable environment for preventing and addressing HIV drug resistance Monitoring and Evaluation Close monitoring of the quality of treatment programmes and gathering evidence on how to prevent HIV drug resistance is hardly done. Therefore, each program under this call should start with developing hypotheses on the proposed interventions followed-up by close monitoring and evaluation during and after the activities. The format for the activity plan and budget includes indicators for outcome and output (appendix). If proposals are rewarded with a grant, the proposal will become the basis for further monitoring, Annual financial statements and information on progress are required. explicitly values information with regard to the outcome of the activities, which means that applicants commit to reporting about this after the grant period has ended (since this is often the moment wherein outcome can be observed). Projects that receive support as part of a specific call will be evaluated in coherence with the other projects that receive a grant under the same call. Eligibility criteria for proposals 1. Applications have to be submitted before the deadline of 1 September 2012, 9 am CET. 2. Programmes should take place in one of the following countries: South Page 6 van 10

7 Africa, Kenya, Zambia, Zimbabwe, Malawi, Thailand, Brazil, Botswana, Rwanda, Namibia or Lesotho 7 3. Programmes should focus on approaches to prevent and adequately address HIV drug resistance 4. Programmes should be primarily aimed at improving the quality of care for the target group 5. The activities are grounded in a context analysis. 6. Applicants should use the specific format provided in appendix I for their application. The application should be in English and the form has to be submitted in Microsoft Word to 7. Applicants should use the specific format provided in appendix II to describe objectives, outcomes, indicators, activities and the budget. The framework has to be submitted in Microsoft Excel to Eligibility criteria for applicants 1. Funding will only be applied to registered organisations and not to individuals. 2. Applicants must be non-profit and non-governmental organisations. 3. Organisations should provide their latest annual narrative and financial report together with the application 4. Organisations must have strong management and the capacity to formulate a proposal, to carry out the proposed activities and to effectively manage award funds Budget For each programme a maximum budget of is available for the duration of three years (maximum of per year). The total available budget is In the situation of a high number of proposals of excellent quality and the availability of funds, additional budget can be added in January This selection is based on the WHO progress report 2011, page 98 and includes the low- and middle income countries with the highest number of people receiving antiretroviral therapy and an estimated antiretroviral therapy coverage of 50%. Page 7 van 10

8 Procedures Publication NGO s from the selected countries are asked to submit a proposal through this call. NGO s are reached via global networks and partners of. The call is published on the website and will be actively distributed at the International Aids Conference in Washington. Language All communication will be in English. Quality review Proposals that are submitted before the deadline of 1 September, 2012, will be checked on the above mentioned eligibility criteria for proposals and applicants. Proposals that fulfil these criteria will be reviewed by experts in the field. The submitting organizations receive the anonymous reviews and are given the opportunity to write a rebuttal. Based on the reviews and the rebuttals, an external commission will give its advice to the Board of. The Board will make a final decision. Evaluation criteria The reviewers will assess all eligible proposals on the following evaluation criteria: Overall quality of the proposal Capacity to monitor outcome indicators Relevance of the programme and potential impact for the target group in the specific context Potential of sharing (and implementing) the results with other stakeholders Feasibility of the programme and its positive impact on the general health system, for example through partnerships Budget in comparison to the proposed activities Sustainability: links with other stakeholders and other sources of funding Innovativeness of the proposed activities Programmes where a broad range of interventions will be combined to increase the potential impact will have an asset. Apart from these criteria, aims for a diverse portfolio which means that programmes of comparable quality may be assessed differently in order to cover different subjects, different target groups and different regions within one call. Page 8 van 10

9 Timeline 1 September :00 am CET - Deadline for submitting proposals 26 September 2012 Proposals reviewed by experts, anonymous reviews sent to submitting organization 3 October :00 am CET - Deadline for rebuttal by submitting organization 31 October 2012 Advice of the external advisory committee based on reviews and rebuttals 1 December 2012 Decision by the board of, acknowledgements immediately afterwards 1 April 2013 Deadline for start of the programme (all programmes must start within four months after the decision of the Board) Page 9 van 10

10 Appendix I application form Appendix II activity framework and budget Page 10 van 10

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