JOINT TUBERCULOSIS AND HIV PROGRAMMING INFORMATION NOTE

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JOINT TUBERCULOSIS AND HIV PROGRAMMING INFORMATION NOTE April 2014 This document has been prepared by the Global Fund Interagency Working Group on TB/HIV. Member organizations of the Working Group include the Global Fund, PEPFAR, the Stop TB Partnership, UNAIDS, UNICEF and the WHO. It is intended to support countries and other applicants in the preparation of a single concept note for tuberculosis and HIV under the Global Fund s new funding model.

Contents 1. Purpose and Rationale... 1 1.1 Purpose... 1 1.2 Rationale... 2 2. Joint TB and HIV Programming... 3 2.1 Harmonization of policy and program management... 5 2.2 Alignment of critical components of the health system... 5 2.3 Integrated TB and HIV service delivery... 7 2.4 Community systems strengthening... 7 2.5 Human rights, gender equity and key populations engagement... 7 3. Process and steps in joint TB and HIV programming and development of single concept note... 8 3.1 Mechanisms for TB and HIV program coordination...8 3.2 National strategic plans...8 3.3 Epidemiological analysis... 9 3.4 Program reviews... 9 3.5 Gap analysis... 9 3.6 Concept note writing... 9 4. Suggested roles and responsibilities for joint TB and HIV programming... 10 4.1 National TB and HIV program managers and stakeholders... 10 4.2 Country Coordinating Mechanisms (CCMs)... 10 4.3 Technical agencies and partners... 11 5. Key references and recommended further information...11 Annexes Annex 1: List of 38 high TB/HIV burden countries to which the Global Fund board decision regarding single concept note submission applies...13 Annex 2: Ten Frequently Asked Questions on the Global Fund board decision regarding single concept note submission... 15 Annex 3: Interventions that have high impact (HIV, TB and TB/HIV activities)... 19 Figures Figure 1: Schematic framework of TB and HIV programming... 3 Box 1: Principles of joint TB and HIV programming... 4

1. Purpose and Rationale 1.1 Purpose HIV is the strongest risk factor for tuberculosis (TB), and TB is a leading cause of death for people living with HIV. Yet, HIV-related TB is preventable and curable, and the deleterious effects of TB on HIV can be mitigated. The Board of the Global Fund, the Technical Review Panel (TRP), and the Secretariat Grant Approvals Committee have expressed concerns about the limited coverage of collaborative TB/HIV activities within grants of the Global Fund, and called for measures for improvement. Results indicate that there has been insufficient inclusion of collaborative TB/HIV activities in TB and HIV grants and this limits the impact of the programs on the burden of disease in people living with HIV and TB. The global commitment, as expressed in the Global Plan to Stop TB 1 and the 2011 UN High Level Political Declaration on HIV/AIDS is to reduce HIV-related TB deaths by 50percent by 2015, compared to 2004 23. Efforts to strengthen TB and HIV collaboration need to be stepped up if the global target is to be met. In light of this continued challenge, the Global Fund Board decided in October 2013 4 that countries with high burden of co-infection with TB and HIV 5 shall submit a single concept note that presents integrated and joint programming of the two diseases. Development of such single TB and HIV concept notes should be supported through the country dialogue process. The purpose of this information note is to describe processes and steps to be considered by Global Fund stakeholders at national and global levels as they work to achieve a joint TB and HIV programming approach. It is particularly intended to assist high burden countries (see Annex 1), in developing a single TB and HIV concept note in line with the Global Fund Board decision indicated above and in the context of the Global Fund s new funding model. The information note is also useful for all other countries applying for TB and HIV funding, to ensure the development of robust collaborative TB/HIV activities in their grants. It is important to note that the single concept note presents the prioritized, high impact interventions and activities under both the TB and HIV program (including collaborative TB/HIV activities; see Annex 2) and a detailed description how these two programs will work jointly to address the burden of co-infection with TB and HIV. Countries preparing a TB and HIV single concept note are strongly encouraged to consider addressing common health system-related constraints, which limit the successful implementation of TB and HIV programs and other cross-cutting areas for joint TB and HIV programming (see below and figure 1). It is useful to refer to other relevant Global Fund information notes particularly 1 http://www.stoptb.org/global/plan/ 2 http://www.unaids.org/en/media/unaids/contentassets/documents/document/2011/06/20110610_un_a- RES-65-277_en.pdf 3 United Nations General Assembly Resolution 65/277 Political Declaration on HIV/AIDS: Intensifying our efforts to eliminate HIV/AIDS. New York, United Nations, 2011. 4 The Global Fund. Global Fund Strategy, Investment, and Impact Committee (2013). Decisions and Recommendations to the Board; GF/30/11: GF/SIIC09/05: Implementing TB-HIV Collaboration Services. 5 World Health Organization. Global Tuberculosis Report 2013. WHO, Geneva, Switzerland; 2013. Available from: http://www.who.int/tb/publications/global_report/en/ 1 P a g e

those related to HIV, TB and health systems strengthening, technical guidance notes published by technical partners 6 (see list of key references and recommended further information at the end of this information note) and the ten frequently asked questions regarding the respective Global Fund Board decision (Annex 2). For further information related to the Board decision point on the single TB and HIV concept note, readers are encouraged to send a message to hivtechrequest@theglobalfund.org. 1.2 Rationale HIV-associated TB remains a major public health concern. At the end of 2012 TB contributed to 20 percent of 1.6 million AIDS deaths and HIV contributed to 25 percent of the 1.3 million TB deaths. The vast majority (90 percent) of these estimated cases and deaths are in the African and South-East Asian regions 7. Antiretroviral therapy (ART) prevents TB and results from a meta-analysis indicate that HIV treatment reduces an individual s risk of developing TB by 65 percent irrespective of CD4 cell count 8. Further scale up of ART globally will reduce the new TB cases among people living with HIV. ART coverage among people living with HIV and with TB in 2012 was 57 percent, despite the WHO recommendation that all HIV positive people with TB should receive it 1. A new molecular rapid TB test (Xpert MTB/RIF) substantially increases the speed and quality of TB diagnosis among people living with HIV. Integrated TB and HIV service delivery has been shown to increase the chances of TB patients to receive ART by 60 percent, and to shorten the initiation time by 72 days, and to reduce mortality by almost 40 percent 9. The progress in implementation of TB/HIV collaborative activities has varied substantially among countries. Analysis conducted among the top ten countries accounting for 71 percent of the estimated global burden of HIV-associated TB in 2012 identified the following key challenges: Slow and conservative uptake of evidence-based global TB and HIV policies by national policy makers (e.g. timely provision of ART for TB patients living with HIV, isoniazid preventive therapy (IPT)). Insufficient planning and resources to quickly roll out national policies and evidence based practices once developed (e.g. resource needs for nationwide training, supplies such as antiretroviral drugs (ARVs), IPT and HIV test kits). Logistical and administrative challenges to program scale-up (e.g. parallel drug supply systems). Mismatch between TB and HIV prevention, treatment and care services (e.g. increased access and coverage of HIV testing for TB patients and minimal access to ART and other interventions). 6 http://www.theglobalfund.org/en/fundingmodel/support/infonotes/ 7 World Health Organization. Global Tuberculosis Report 2013. WHO, Geneva, Switzerland; 2013. Available from: http://www.who.int/tb/publications/global_report/en/ 8 Suthar et al. Antiretroviral therapy for prevention of tuberculosis in adults with HIV: a systematic review and meta-analysis. PLoS Med. 2012;9(7):e1001270. doi: 10.1371 9 World Health Organisation. Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection. Recommendations for a public health approach (Chapter 9). WHO, Geneva, Switzerland; 2013. Available from: http://www.who.int/hiv/pub/guidelines/arv2013/download/en/ 2 P a g e

Non-harmonized, non-standardized and duplicative TB and HIV monitoring and evaluation systems. Intensive collaboration, coordination, and regular communication between TB and HIV programs and stakeholders will be critical to overcome these constraints, promote synergies and gain efficiencies for better TB and HIV health outcomes. 2. Joint TB and HIV Programming The purpose of joint TB and HIV programming is to maximize the impact of Global Fund and other investments for better health outcomes. It allows for better targeting of resources and harmonization of efforts, including for cross-cutting areas such as health and community systems strengthening to scale up TB and HIV services and to increase their effectiveness and efficiency, quality and sustainability. Joint TB and HIV programming also entails synergized management of the programs. Joint TB and HIV programming takes a broader view of the entirety of the TB and HIV programs. It identifies opportunities for aligning plans, optimizing support systems and integrating services. This, in turn, results in stronger collaborative TB/HIV activities, as well as a number of other benefits beyond the two diseases. Figure 1 shows a schematic representation of the joint HIV and TB programming. Figure 1. Schematic framework of TB and HIV programming Country-led dialogue and related decision-making by TB and HIV stakeholders, including civil society organizations and affected communities, firmly built on the principles of human rights, are essential for joint TB and HIV programming. Understanding the national context, including the epidemiology of TB and HIV, characteristics of community systems, the 3 P a g e

organizational structure and building blocks of the health system, and the recognition of critical enablers, will help to determine the scope of and areas for joint planning. Emphasis should be on gaining efficiency from synergized program management and consistent collaboration and coordination of TB and HIV services (e.g. through joint planning, joint budgeting, supervision and monitoring). This might entail undergoing adjustments in the management of the TB and HIV programs. The principles of joint programming are summarized in box 1 below. At the same time, it should be ensured that program areas that are outlined in global and national strategies pertaining specifically to a TB and an HIV program are adequately included in the concept note; i.e. based on disease epidemiology, national priorities and the extent of the program response. Annex 3 provides an overview of high impact HIV and TB strategies and interventions, as well as TB/HIV collaborative activities. For example, under the TB component, the concept note might outline how strategies for prevention, diagnosis and treatment of MDR-TB and TB prevention activities are addressed in key populations, such as prisoners or miners. Under the HIV component, the concept note could describe strategies for implementing the key basic program activities for gaining control of the epidemic, as defined by UNAIDS 10, such as high impact prevention, including voluntary medical male circumcision and comprehensive programming for key populations, rapidly scaling up quality provision of antiretroviral drugs, and the four prongs for the elimination of mother-to-child transmission of HIV. Box 1. Principles of joint TB and HIV programming Country context determines the scope of joint programming: It has to be recognized that there is no one-size-fits-all approach. The epidemiology of TB and HIV, maturity and capacity of programs, diverse health infrastructures and management, as well as client needs should determine the scope and critical areas of joint programming with a flexible approach. Phased implementation with no disruption of functions and activities: The main purpose of joint programming is to improve the performance of program activities. Therefore, it is important the implementation of key actions of joint programming should be phased to prevent disruption of ongoing activities and functions. Maximizing resources: Efficiencies can be gained at several levels of the programs, from planning and coordination to service delivery. This reduces duplication and targets resources to achieve maximum impact. This will also contribute to an increasingly sustainable program response. Delivery of integrated TB and HIV services: One goal of joint TB and HIV programming is to provide comprehensive services at the point of care, including with other priority health services, at the same place and time. 10 UNAIDS. Investing for results. Results for people. A people-centred investment tool towards ending AIDS. UNAIDS. Geneva; 2012. Available from: http://www.unaids.org/en/media/unaids/contentassets/documents/unaidspublication/2012/jc2359_investing -for-results_en.pdf 4 P a g e

The following describes critical areas for joint TB and HIV programming. 2.1 Harmonization of policy and program management Critical to effective joint HIV and TB programming is the harmonization of evidence-based national policies and program guidance, based on internationally accepted policies and guidelines, and the synergized management of the TB and HIV programs that ensure efficient execution of the policies and guidelines. 2.1.1 Conducive policy and program environment Increased efficiency between TB and HIV programs need to be sought through harmonization and coordination of national guidelines, tools and processes. This is a critical step to provide integrated TB and HIV care and services at health facility and community levels. The lack of critical and up-to-date policies and program guidance, or the presence of obsolete or inconsistent TB and HIV policies, hampers national progress. This needs to be addressed through country dialogue involving equally represented TB and HIV stakeholders, including civil society organizations and affected communities. 2.1.2 Program management for execution of policies and joint plans Countries need to ensure that organizational structures are adequate to promote the execution of joint TB and HIV programming. Where they are not, these structures may need to be reviewed. Intensive in-country dialogue and consultations, including all TB and HIV stakeholders, are needed in defining the scope and type of mechanisms to ensure synergy in TB and HIV program management at all levels. In order to avoid disruptions in TB and HIV program activities and wastage in resources, caution needs to be exercised. A suitably phased approach should be adopted, based on the local context considerations, while planning and implementing the agreed mechanisms. 2.2 Alignment of critical components of the health system Joint TB and HIV programming should involve alignment in the critical components (subsystems) of the health system described below, depending on the national context and the outcome of country dialogue and consultation. The scope and extent of alignment of these subsystems for TB and HIV and, if applicable, with other priority health programs, should be guided by the gain in efficiencies and its impact in overall program performance. One goal should be to ensure the delivery of integrated TB and HIV services, including other health services at the same place and time. For further information on the subsystems, please refer to the information note on health systems strengthening 11. Critical components of the health system that can be considered for alignment as part of the joint TB and HIV programming are described below. 11 The Global Fund. Information note on Health Systems Strengthening for Global Fund Applicants. Geneva, Switzerland; March 2014. Available from: http://www.theglobalfund.org/en/fundingmodel/support/infonotes/ 5 P a g e

2.2.1 Health information system Effective monitoring and evaluation of TB and HIV services with standardized indicators and data-capturing formats, harmonized with the national health management information system, are required. This will also enable effective measurement and assessment of performance and impact. Synergies can be sought in boosting and improving existing TB and/or HIV systems, integrating existing and compatible systems and in promoting the use of technologies and electronic systems. Countries which have date systems for TB and HIV case reporting need to find mechanisms to link them, such as through the use of unique patient identifiers. As patients on antiretroviral therapy require lifelong treatment, investing in electronic and longitudinal data systems and patient medical records for TB and HIV will become increasingly important. 2.2.2 Laboratory and diagnostic services Promoting a common integrated platform for TB and HIV laboratory and diagnostic services, including the inclusion of other priority health programs, is a critical area of joint TB and HIV programming. Emphasis should be placed on joint laboratory planning that is aligned with existing national laboratory strategic plans, and harmonized forecasting of supplies based on epidemiology and national priority programs and services. 2.2.3 Procurement and supply chain management Alignment in the procurement and supply chain management for TB, HIV and other services will ensure uninterrupted, efficient and transparent purchase, storage and distribution of medicines, consumables and other products that are necessary for effective delivery of integrated TB and HIV services. Strengthening existing procurement and supply chain management systems, including for laboratory services, will be a critical area for joint TB and HIV programming to seek synergies and efficiencies. 2.2.4 Health workforce Efficiencies can be gained by promoting training and retaining activities to develop skilled and competent health workforce, including community workers that can provide integrated TB and HIV services. Promoting task shifting of critical services (e.g. ART initiation or MDR- TB management) to non-physician health workers (e.g. clinical officers, nurses) would help in promoting synergies. Similarly, it will be useful to consider developing a systematic approach of engagement for private, for-profit care providers, faith-based and civil society service providers. Many of these have excellent community outreach mechanisms for client follow-up, enabling the provision of quality integrated TB and HIV services in line with national policies, based on the local context. 2.2.5 Financing Joint TB and HIV planning should ensure activities which contribute to the adequate and equitable availability of financial resources for the management and delivery of integrated TB and HIV services at all levels. Decisions in financial planning and allocation should 6 P a g e

ensure that there is effective dialogue between TB and HIV stakeholders and other relevant bodies. Vertical donor resources can pose a challenge for national planning processes, and ideally all available financial resources (national, donor, other) should be included in discussions about funding needs and resource allocation. 2.3 Integrated TB and HIV service delivery The provision of integrated TB and HIV services at the same place and time is critical for ensuring quality of services that reduce the financial and opportunity costs on people requiring services. In addition, it promotes efficient and effective use of program resources, and should be considered as a minimum requirement of joint TB and HIV programming. Integrated service delivery should be promoted using existing platforms of primary health care services including the inclusion of other priority health programs depending on national and local context. For example, existing facilities and resources of decentralized TB services can serve as a platform to expand access to clinical services and provide critical HIV treatment and prevention services, not only for HIV-positive TB patients, but also to others living with HIV or at risk of HIV. Similarly efficiencies can be gained through harmonizing and placing diagnostic and laboratory services for TB and HIV in the same place. Integrating TB and HIV services to maternal neonatal and child health (MNCH) services to address the needs of women and children is an important consideration for joint TB and HIV programming. Attention should be given to strengthening and prioritizing infection control measures, particularly to prevent the transmission of TB in health care facilities. TB infection control measures include coordination of activities beyond TB and HIV programs that need to be considered during joint programming. All administrative, environmental and personal measures to cut the transmission of TB in health care facilities need to be prioritized as part of joint TB and HIV programming. 2.4 Community systems strengthening Community system strengthening should be an essential component of joint TB and HIV programming and particularly focusing on the delivery of integrated community based TB and HIV services along or integrated with other priority program services, such as MNCH. Community-based organizations often have the comparative advantage of knowledge and understanding of the local context and have more flexibility in adapting to local situations. Community systems also tend to have more capacity to function in difficult-to-reach, remote areas and conflict zones, which offers a unique opportunity for increased efficiency and maximized synergy between relevant programs. 2.5 Human rights, gender equity and key populations engagement The vulnerable groups most affected by TB and HIV often overlap, and addressing discrimination, stigmatization or marginalization in these groups can immensely contribute to better health outcomes. Systematic identification of key population groups that are affected by both TB and HIV, and developing in collaboration with them specifically tailored services on the basis of human rights and gender equity principles, should be considered as 7 P a g e

part of joint TB and HIV programming. Ensuring meaningful engagement of representatives of key populations in the planning, design and implementation of these services is very critical for success and impact for better health outcomes. 3. Process and steps in joint TB and HIV programming and development of single concept note While introducing changes based on the joint TB and HIV programming described above, according to country context, it is important to note that: (a) some of the recommended changes are appropriate and can be implemented in the short term; (b) some changes are appropriate and will require a longer time period for full implementation; and (c) some changes are not appropriate due to the specific country context. During the planning phase of single concept note preparation, consensus should be reached on the understanding and implications of the changes proposed under joint TB and HIV programming, in the context of the three scenarios described above. The following are processes and activities that those designing the TB and HIV programs and other stakeholders should consider during the planning and preparation of a single TB and HIV concept note. 3.1 Mechanisms for TB and HIV program coordination Joint TB and HIV programming will entail the two programs developing or expanding on mechanisms for routine coordination which go beyond the focus on collaborative TB/HIV activities to broader program collaboration on TB and HIV. Such governance mechanisms could be established at the Ministry of Health, National AIDS and TB Councils or the Country Coordinating Mechanism (CCM), based on the context of the country. They could also be at a technical level involving technical working groups on various common issues. Mechanism for ongoing coordination should also exist at other levels, depending on the context of the country (e.g. regional or state level). Through these mechanisms, the two programs should endeavor to jointly plan, implement, review progress and identify common challenges and solutions, including joint technical assistance needs. It is important that there is equal and meaningful representation of TB and HIV stakeholders in these coordination bodies, including civil society organizations and key populations. 3.2 National strategic plans A country s funding request should be based on a robust, fully costed and prioritized national TB and HIV strategic plans, developed through inclusive and multi-stakeholder efforts. These strategies should be consistent with the national health strategy and be implemented in the context of the wider national health sector response. Efforts need to be made to achieve greater harmonization between TB and HIV national strategic plans, especially with 8 P a g e

respect to situation analysis, goals and targets, approaches to service delivery and planning cycles. The advantage of having one national TB and HIV strategic plan should be weighed and the decision should be based on inclusive country dialogue and the national policy and program context. In the absence of a joint TB and HIV strategic plan, each plan should incorporate critical items that enforce synergies between the two programs, including collaborative TB/HIV activities. 3.3 Epidemiological analysis Epidemiological situations and profiles for TB and HIV should be regularly updated to guide planning, implementation and investment decisions. They should include, for each disease, description of recent trends (including changing incidence, prevalence and mortality), the drivers of the epidemic, the type of epidemic, and the population groups that are most affected. Updating epidemiological profiles should go with identification of data gaps and assessment of data systems for the two diseases. Opportunities to address common challenges in availability of data should be identified, such as data exchange and consistency, and common investments). 3.4 Program reviews In situations where program reviews are being planned, efforts for conducting them jointly between the TB and HIV programs should be made. Where this is not possible, critical areas of joint TB and HIV planning described above and collaborative TB/HIV activities should be a mandatory part of each disease program review or the health sector reviews with participation from both disease programs. Where program reviews are not planned in time for the application due to the national cycle, epidemiological and impact analysis should be conducted to inform national disease strategic plan development, the investment case and the concept note. 3.5 Gap analysis Program reviews would normally identify areas of strengths and weaknesses in the performance of TB and HIV programs and offer recommendations for improvement. The gap analysis is a process of quantifying the difference between the current and desired states. It includes defining shortfalls in coverage of services, achievement of targets, access to services by specific populations, capacity of the health system and enabling environment. The gaps identified should be costed and matched with available funds (financial gap analysis). 3.6 Concept note writing The single TB and HIV concept note is the mechanism to request financing from the Global Fund for the two diseases for countries with high burden of co-infection with TB and HIV. The concept note should be based on sound national strategies for TB and HIV. It should also utilize information from current epidemiological analyses, program reviews and gap analysis to develop a compelling case for funding to significantly improve health outcomes and impact of TB and HIV programs. 9 P a g e

The concept note includes the following: Country context: describes current epidemiological status, health system capacity, critical enablers and program achievements. Funding landscape additionality, sustainability: outlines the current and anticipated funding landscape of the programs over the proposed grant duration. Funding request: prioritizes its funding needs to the Global Fund through its selection of appropriate modules. Implementation arrangements and risk assessment: defines implementation capacity and risk mitigation measures to program delivery. In developing the single TB and HIV concept note, ensure that: processes are clearly defined for joint TB and HIV programming and effective mechanisms established for intense collaboration between TB and HIV programs and stakeholders throughout the development of the single concept note; all the necessary information is available for both TB and HIV, including epidemiological data, service coverage, national policies, strategies and financial data; and technical support required is clearly defined and that sources of support are identified. 4. Suggested roles and responsibilities for joint TB and HIV programming 4.1 National TB and HIV program managers and stakeholders Establish or strengthen national coordinating bodies between TB and HIV programs and stakeholders and define terms of reference based on national context in order to promote joint TB and HIV programming and the delivery of integrated TB and HIV services. Particular emphasis needs to be placed on joint planning, budgeting, supervision and effective communication at all levels. The community as a critical national stakeholder for both TB and HIV, as well as faith-based organizations and the private sector, should be active players throughout. Assess the national TB and HIV policy and program environment including progress, challenges, opportunities and context-specific solutions and targets through joint program reviews or gap analysis. Harmonize national TB and HIV policies and program guidance with evidence-based, internationally accepted policies and guidelines. 10 P a g e

Promote task shifting and explore locally responsive and acceptable decentralized models of HIV and TB service provision. Enhance cross-training on identification, prevention, and treatment of both diseases among health providers at all levels, including at the community. 4.2 Country Coordinating Mechanisms (CCMs) Establish and integrate mechanisms into the work of the CCM, such as structural adjustments and changes that guarantee effective coordination and intense collaboration between TB and HIV programs and stakeholders. This could include enhancing representation of chair(s) of TB and HIV coordinating bodies into the CCM. Monitor the development and submission of a single TB and HIV concept note within the new funding model process to promote efficient and effective use of resources and synergies in the management and implementation of TB and HIV programs. Define, harmonize and coordinate technical support needs for joint TB and HIV programming and implementation. 4.3 Technical agencies and partners Promote joint TB and HIV programming in the development of national strategic plans, implementation, program reviews and in costing for the country s full expression of demand. Provide joint technical assistance and support to national TB and HIV programs to address and close gaps in systematic and technical areas that are part of the joint TB and HIV work. 5. Key references and recommended further information This first part of this section provides a list of publications that are specific to TB and HIV joint programming and/or collaborative TB/HIV activities. For those program areas that are outlined in global and national strategies pertaining specifically to a TB and an HIV program and that may be included, as appropriate, in the concept note, readers are encouraged to refer to the publications listed under Global Fund information notes and investment guidance, in the latter part of this section. Guidance on TB/HIV, including Monitoring and Evaluation 11 P a g e

World Health Organization. WHO policy on collaborative TB/HIV activities: guidelines for national programmes and other stakeholders. WHO, Geneva; 2012. Available from: www.who.int/tb/publications/2012/tb_hiv_policy_9789241503006/en UNAIDS/ World Health Organization. UNAIDS/WHO resource kit for high impact programming. Technical Brief for Development of Global Fund Concept Notes. TB and HIV Collaborative Activities. Guidance note. UNAIDS/WHO, Geneva; 2014 (forthcoming). Available from: http://www.unaids.org/en/ourwork/programmebranch/countryimpactsustainability department/globalfinancingpartnercoordinationdivision/ World Health Organization. Guidelines for intensified tuberculosis case-finding and isoniazid preventive therapy for people living with HIV in resource-constrained settings. WHO, Geneva; 2011. Available from: www.who.int/tb/challenges/hiv/icf_iptguidelines/en/index.html World Health Organization. Guide to monitoring and evaluation for collaborative TB/HIV activities: 2014 revision. WHO, Geneva; 2014. Available from: http://www.who.int/tb/publications/en/ Global Fund information notes and investment guidance The Global Fund. Global Fund Strategic Investment Guidance and Information Notes. TB Strategic Investment Information Note. Geneva; February 2014. Available from: http://www.theglobalfund.org/en/fundingmodel/support/infonotes/ The Global Fund. Global Fund Strategic Investment Guidance and Information Notes. Strategic Investments for HIV programs. Geneva; March 2013 (update expected in May 2014). Available from: http://www.theglobalfund.org/en/fundingmodel/support/infonotes/ The Global Fund. Global Fund Strategic Investment Guidance and Information Notes. Information Note on Community Systems Strengthening. Geneva; March 2014. Available from: http://www.theglobalfund.org/en/fundingmodel/support/infonotes/ The Global Fund. Global Fund Strategic Investment Guidance and Information Notes. Guidance on Health Systems Strengthening for Global Fund Applicants. Geneva; March 2014. Available from: http://www.theglobalfund.org/en/fundingmodel/support/infonotes/ The Global Fund. Global Fund Strategic Investment Guidance and Information Notes. Information Note on Human Rights for HIV, TB, Malaria and HSS Grants. Geneva; February 2014. Available from: http://www.theglobalfund.org/en/fundingmodel/support/infonotes/ The Global Fund. Global Fund Strategic Investment Guidance and Information Notes. Information Note on Addressing women, girls, and gender equality. Geneva; March 2012. Available from: http://www.theglobalfund.org/en/fundingmodel/support/infonotes/ 12 P a g e

Annex 1: List of 38 high TB/HIV burden countries to which the Global Fund Board decision regarding the single concept note for TB and HIV applies 12 High TB/HIV Burden Countries Estimated TB/HIV incidence, 2012 HIV Positive Rate South Africa 330,000 65% India 130,000 5.40% Mozambique 83,000 58% Zimbabwe 55,000 70% Nigeria 46,000 23% Kenya 45,000 39% Uganda 35,000 50% Zambia 35,000 54% United Republic of Tanzania 32,000 39% Ethiopia 23,000 10% Cameroon 19,000 37% Myanmar 19,000 27% Democratic Republic of the Congo 16,000 16% Malawi 16,000 59% Swaziland 13,000 77% Thailand 12,000 13% Lesotho 9,900 75% Viet Nam 9,300 7% 12 This list is based on data from the World Health Organization, 2013 13 P a g e

High TB/HIV Burden Countries Estimated TB/HIV incidence, 2012 HIV Positive Rate Côte d'ivoire 8,000 27% Indonesia 7,500 28% Namibia 7,300 47% Angola 5,500 9.60% Central African Republic 5,300 39% Botswana 5,100 63% Ukraine 4,800 14% Haiti 4,300 20% Sudan 4,300 7.50% Chad 4,100 20% Sierra Leone 3,900 12% Congo 3,600 33% Rwanda 2,900 26% Ghana 2,800 24% Cambodia 2,700 4.40% Burundi 2,500 19% Burkina Faso 1,600 15% Mali 1,200 28% Togo 1,200 24% Djibouti 540 10% 14 P a g e

Annex 2: Ten Frequently Asked Questions on The Global Fund Board Decision Of A Single Concept Note Submission For Joint HIV And TB Programming 13 1. What is the Global Fund Board decision? Countries with high co-infection rates of TB and HIV will have to submit a single concept note that presents integrated and joint programming for the two diseases, unless the Secretariat determines that extraordinary circumstances warrant separate concept note submissions; and The Secretariat and partners should facilitate the development of such TB and HIV concept notes through the country dialogue process to present integrated programs to the Board for approval. 2. What is the aim of the decision of the Global Fund Board on submission of a single concept note for TB and HIV? The aim is to maximize the impact of Global Fund investments to make an even greater contribution towards the vision of a world free of the burden of HIV and tuberculosis. Enhanced joint HIV and TB programming will allow to better target resources, to scale-up services and to increase their effectiveness and efficiency, quality and sustainability. Completing a single concept note for TB and HIV entails systematic and ongoing country level dialogue between TB and HIV programs and stakeholders prioritizing the alignment of planning and strategic investments, including for cross-cutting areas like HSS and CSS. 3. What was the impetus behind the Global Fund Board s decision? The Board of the Global Fund provided suggestions in the past on how to improve the programmatic response to the diseases, which has not yielded the expected results. Separate programming and lack of adequate and systematic dialogue between the two programs continued. As a result, patients do not benefit from the services they need. For example, by the end of 2012 TB contributed to 20% of 1.6 million AIDS deaths HIV caused 25% of 1.3 million TB deaths Only 57% of TB patients received ART, the most powerful intervention for preventing HIV and TB illness, death and transmission; this is despite the recommended 100% coverage. The evidence base for the WHO-recommended collaborative TB/HIV activities is compelling. While some progress is being demonstrated, acceleration for joint programming is urgent. In addition, TB/HIV services need to be considered as critical components of quality care for TB and HIV. 4. Which countries should submit a single TB and HIV concept note? 13 This document was prepared by the HIV and TB interagency working group, a sub-group of the Global Fund Joint Disease Committee for HIV and TB. It is available from: http://www.theglobalfund.org/en/fundingmodel/ 15 P a g e

The decision primarily applies to the 41 countries which WHO considers as the TB/HIV priority countries that have the highest estimated number of people living with HIV who develop TB. These countries represent 92% of the global burden of HIV- associated TB in 2012.. An exact list of the countries among these 41 that will be eligible for funding for HIV and TB under the new funding model can be found in the Annex of this document.. The Global Fund Secretariat, along with technical partners of respective countries, will work closely with the CCM to help ensure a single concept note is submitted for the two diseases. Other countries (particularly countries with concentrated and increasing HIV epidemics e.g. in Central Asia and Eastern Europe) are also encouraged to consider joint planning and concept note submission. At a minimum, other countries which plan to request funding for HIV and TB should include TB/HIV collaborative activities in their concept notes, in line with the instructions provided in the NFM tools and guidance materials. 5. What is the process to develop a single concept note? Concept note development is embedded in the country dialogue in which stakeholders from TB and HIV programs should participate. The steps that are identified for concept note development under the new funding model are also applicable for the development of single TB and HIV concept note. This includes epidemiological and impact assessment, program reviews, development or update of national strategic plans, and gap analysis. Applying strategic investment thinking throughout the concept note development process is critical to target investments on the interventions and populations where they will have maximum impact. During all these steps meaningful engagement and voice of key affected populations and civil society organizations equally representing TB and HIV should be ensured. The concept note will also include cross-cutting activities such as HSS, CSS, program management, monitoring & evaluation and human rights, which offer great opportunities for identifying synergies between the TB and HIV programs. The single concept note template and instructions for completion will be available at the beginning of 2014 on the Global Fund new funding model website: http://www.theglobalfund.org/en/about/grantmanagement/fundingmodel/ 6. What does this decision mean to TB and HIV program reviews as part of the new funding model? In high TB/HIV burden countries HIV and TB program reviews should be aligned and conducted jointly. In cases where these cannot be conducted jointly, TB/HIV collaboration should be a mandatory part of each disease program review or the health sector reviews with participation from both disease programs. The timing of the submission of the joint TB and HIV concept notes should be aligned such that recommendations from the two program reviews are available and can be addressed in the concept note to the Global Fund. Where program reviews are not planned in time for application due to the national cycle, epidemiological and impact analysis should be conducted to inform NSP development, investment case and concept notes. 16 P a g e

7. What does this decision mean to national strategic plans as part of the new funding model? There may be advantages to working towards alignment of national strategic plans for TB and HIV in terms of strategies and timeframes. For example, both programs would have the most up-to-date data and analysis to draw upon when developing a single concept note. The Global Fund Secretariat will assess how best to support development of a single concept note that builds on national planning processes. Where the quality of a national strategic plan is considered low or not up-to-date the anticipated application to the Global Fund could be used by countries to identify opportunities for a more focused and effective use of the resources available for HIV and TB. The country could engage in a process to update their strategy and/or to align the HIV and TB national strategic plans. Comprehensive, investment-oriented and coordinated strategies will provide a solid basis for application to the Global Fund. 8. What does the single concept note mean for management of HIV and TB programs? With regards to the requested submission of a single concept note for HIV and TB, the Global Fund will follow a similar approach to how it manages its broader grant portfolio recognizing that there is not a one- size fits all and country context is essential. In this, the single TB and HIV concept note is intended to stimulate a country-led dialogue and related decision making leading to an optimization of HIV and TB programming, service delivery and health outcomes achieved. This might also entail structural adjustments, where needed. The Global Fund recognizes that the situation might be different for each country that is submitting a single concept note. Countries will therefore determine their own scope and areas of joint programming depending on their local context including the epidemiology of TB and HIV. 9. What does this decision mean to the technical support my country receives? Technical support can be given to help countries make stronger linkages across the disease programs. Coordinating technical support in relation to Global Fund processes is the overall responsibility of the Country Coordinating Mechanisms. In-country technical partners and stakeholders are expected to coordinate in support of the Country Coordinating Mechanisms and harmonize their approach to supporting joint concept note development. The following mechanisms can be accessed in addition to technical support from domestic sources, in-country technical partners and bilateral donors: a. For preparation of concept notes Except for writing of concept notes: - Use of existing technical support budgets from Global Fund grants. - Alternatively, CCMs can utilize up to US$150,000 of existing grants (in the manner of a non-material reprogramming) towards strengthening of national strategic plans or strategic investment planning including for example: epi- analysis, NSP strengthening/ development, costing, etc. For writing of concept notes it is recommended to reach out to technical partners. 17 P a g e

b. Throughout program implementation Technical partners will be available to support countries in relevant stages during program implementation. A number of mechanisms for technical assistance during grant implementation exist through which countries can access technical support providers. More details will be available on the Global Fund website or through the e-mail address, both of which are provided in section 10 below. 10. Where can I obtain additional information? A letter from the Chair of the Global Fund Board was sent to the ministers of health of countries to which this decision applies. At the beginning of 2014 the Global Fund Secretariat is publishing on its website (http://www.theglobalfund.org/en/about/grantmanagement/fundingmodel/) guidelines and tools for the new funding model, which take into consideration the Board decision on the single TB and HIV concept note. Send an e-mail to hivtechrequest@theglobalfund.org or contact your Fund Portfolio Manager These Frequently Asked Questions will also be disseminated by WHO, UNAIDS, Stop TB Partnership and PEPFAR to all in-country partners to ensure coordination and understanding. Annex 3 A. Basic HIV interventions that have high impact 14 Basic programs that have high impact, directly impact on reducing HIV transmission and on keeping people alive and healthy and productive. They are evidence based and evidence informed interventions which include: Antiretroviral therapy for people living with HIV (including for preventing HIV transmission), HIV-testing and treating opportunistic infections. Prevention of mother-to-child transmission of HIV (PMTCT) using ARVs or ART.6 Behavior change programs, including for people engaging in casual sex, and young people and condom promotion. Male circumcision (in countries with high HIV prevalence and low coverage rates of circumcision practiced for religious or cultural reasons). HIV testing and counselling, with linkage to HIV services, including ART. Integrated prevention and treatment focusing on key populations: in many epidemics the key populations at higher risk of HIV infection are people who inject drugs, sex workers, men who 14 For more detail refer to strategic investment guidance in HIV; available from: http://www.theglobalfund.org/en/fundingmodel/support/infonotes/ 18 P a g e

have sex with men and transgender people. Other vulnerable populations may be important in specific settings (including adolescent girls, orphans, people in prisons and migrants). B. Components of the Stop TB Strategy and implementation approaches 15 1. Pursue high-quality DOTS expansion and enhancement a. Secure political commitment, with adequate and sustained financing b. Ensure early case detection, and diagnosis through quality-assured bacteriology c. Provide standardized treatment with supervision, and patient support d. Ensure effective drug supply and management e. Monitor and evaluate performance and impact 2. Address TB/HIV, MDR-TB and the needs of poor and vulnerable populations a. Scale up collaborative TB/HIV activities b. Scale up prevention and management of multidrug-resistant TB (MDR-TB) c. Address the needs of TB contacts, and of poor and vulnerable populations 3. Contribute to health system strengthening a. Help improve health policies, human resource development, financing, supplies, service delivery and information b. Strengthen infection control in health services, and other congregate settings and households c. Upgrade laboratory networks, and implement the Practical Approach to Lung Health (PAL) d. Adapt successful approaches from other fields and sectors, and foster action on the social determinants of health 4. Engage all care providers a. Involve all public, voluntary, corporate and private providers through Public Private Mix (PPM) approaches b. Promote use of International Standards for Tuberculosis Care (ISTC) 5. Empower people with TB, and communities a. Pursue advocacy, communication and social mobilization b. Foster community participation in TB care, prevention and health promotion c. Promote use of the Patients Charter for Tuberculosis Care 6. Enable and promote research a. Conduct program-based operational research b. Advocate for and participate in research to develop new diagnostics, drugs and vaccines 15 For more detail refer to the TB strategic investment framework; available from: http://www.theglobalfund.org/en/fundingmodel/support/infonotes/ 19 P a g e

C. Collaborative TB/HIV activities 16 A. Establish and strengthen the mechanisms for delivering integrated TB and HIV services A.1 Set up and strengthen a coordinating body for collaborative TB/HIV activities functional at all levels A.2. Determine HIV prevalence among TB patients and TB prevalence among people living with HIV A.3. Carry out joint TB/HIV planning to integrate the delivery of TB and HIV services A.4. Monitor and evaluate collaborative TB/HIV activities B. Reduce the burden of TB in people living with HIV and initiate early antiretroviral therapy (the Three I s for HIV/TB) B.1. Intensify TB case-finding and ensure high quality anti-tuberculosis treatment B.2. Initiate TB prevention with Isoniazid preventive therapy and early antiretroviral therapy B.3. Ensure control of TB Infection in health-care facilities and congregate settings C. Reduce the burden of HIV in patients with presumptive and diagnosed TB C.1. Provide HIV testing and counselling to patients with presumptive and diagnosed TB C.2. Provide HIV prevention interventions for patients with presumptive and diagnosed TB C.3. Provide co-trimoxazole preventive therapy for TB patients living with HIV C.4. Ensure HIV prevention interventions, treatment and care for TB patients living with HIV C.5. Provide antiretroviral therapy for TB patients living with HIV 16 World Health Organization. WHO policy on collaborative TB/HIV activities: guidelines for national programmes and other stakeholders. WHO, Geneva; 2012. Available from: www.who.int/tb/publications/2012/tb_hiv_policy_9789241503006/en 20 P a g e