1

Background

The U.S. government supports global HIV programs through an initiative known as the President’s Emergency Plan for AIDS Relief (PEPFAR). This report presents the results of an Institute of Medicine (IOM) evaluation of PEPFAR. The U.S. Congress mandated that the IOM conduct a study that includes “an assessment of the performance of United States-assisted global HIV/AIDS programs” and “an evaluation of the impact on health of prevention, treatment, and care efforts that are supported by United States funding.”1 The complete statement of task for this evaluation, derived from the legislative mandate, can be found in Appendix A.

This report is organized into four principal parts. Part I provides an introduction to the report through this chapter, which provides background on PEPFAR and through Chapter 2, which describes the scope and approach for the evaluation. Part II describes how PEPFAR is organized and managed, and the investments made through PEPFAR over time. Part III describes the effects of PEPFAR-supported activities in its major programmatic areas, including the aspects of the program that are directly specified in the legislative mandate for this evaluation: Prevention, Care and Treatment, Children and Adolescents, Gender, and Health Systems Strengthening. For pragmatic reasons the different program areas are discussed in separate chapters. However, each chapter also recognizes the inherent re-

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1 Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008 P.L. 110-293 110th Cong., 2nd sess. (July 30, 2008) at img101(c), 22 U.S.C. 7611(c)(1)(i) and (ii).



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1 Background The U.S. government supports global HIV programs through an initia- tive known as the President’s Emergency Plan for AIDS Relief (PEPFAR). This report presents the results of an Institute of Medicine (IOM) evalu- ation of PEPFAR. The U.S. Congress mandated that the IOM conduct a study that includes “an assessment of the performance of United States- assisted global HIV/AIDS programs” and “an evaluation of the impact on health of prevention, treatment, and care efforts that are supported by United States funding.”1 The complete statement of task for this evaluation, derived from the legislative mandate, can be found in Appendix A. This report is organized into four principal parts. Part I provides an introduction to the report through this chapter, which provides background on PEPFAR and through Chapter 2, which describes the scope and ap- proach for the evaluation. Part II describes how PEPFAR is organized and managed, and the investments made through PEPFAR over time. Part III describes the effects of PEPFAR-supported activities in its major program- matic areas, including the aspects of the program that are directly specified in the legislative mandate for this evaluation: Prevention, Care and Treat- ment, Children and Adolescents, Gender, and Health Systems Strengthen- ing. For pragmatic reasons the different program areas are discussed in separate chapters. However, each chapter also recognizes the inherent re- 1  Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008 P.L. 110-293 110th Cong., 2nd sess. (July 30, 2008) at §101(c), 22 U.S.C. 7611(c)(1)(i) and (ii). 19

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20 EVALUATION OF PEPFAR latedness of these program areas in a continuum of services. Part IV places these major programmatic areas in the context of a discussion of key issues that are not explicitly stated in the legislative mandate for the evaluation but that are integral to the committee’s consideration of the future of U.S. government (USG) involvement in the global response to HIV/AIDS. Here, there is particular emphasis on the evolution of PEPFAR to support sustain- able, evidence-informed management of HIV and AIDS in partner coun- tries. The Summary, preceding this chapter, synthesizes the major messages of this report, in particular highlighting key issues that cut across chapters; captures the overall achievements and challenges of PEPFAR; and presents together in one place the recommendations of the committee. GLOBAL BURDEN OF HIV The first documentation of what became known as acquired immune deficiency syndrome (AIDS) was in 1981, and several years later the cause of the disease was discovered to be a virus, now called human immunode- ficiency virus (HIV) (Barre-Sinoussi et al., 2004; CDC, 1981, 1982; Levy et al., 1984; Popovic et al., 1984). Since then, the pandemic nature of the virus has been recognized, and the effort to control its spread has become a leading global health priority (UNAIDS, 2012). In 2011, an estimated 34 million people were living with HIV and about 2.5 million people became newly infected with the virus. Of those newly infected, 330,000 were children. Worldwide, the estimated annual number of new HIV infections peaked in 1997. While the number of new infections has declined steadily, the number of people living with HIV has continued to rise, in part because of increased access to antiretroviral therapy (ART) treatment and declines in the number of deaths due to AIDS- related causes. Nonetheless, despite the increased availability of treatment, HIV/AIDS is still a major cause of death across the world. In 2011, AIDS led to the deaths of an estimated 1.7 million people (UNAIDS, 2012). Although HIV continues to affect all regions of the world, the greatest burden of HIV falls on sub-Saharan Africa, which is home to 69 percent of people living with HIV and, in 2011, had the highest number of new HIV infections. Asia is the second most affected region because of the large size of its population, with nearly 5 million people living with HIV in South, South-East, and East Asia combined; the Caribbean follows sub-Saharan Africa in prevalence of HIV in adults (UNAIDS, 2012). The impact of HIV is felt at all levels within countries—it shortens life expectancy, changes population demographics, and overloads health and social systems. The epidemic has had a drastic socioeconomic effect on countries that are already under-resourced and has required significant

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BACKGROUND 21 political and financial commitment from both the national governments of affected countries and the international community (OGAC, 2009a). HISTORY OF U.S. INVESTMENT TO RESPOND TO GLOBAL HIV/AIDS The USG first began addressing HIV in low-income countries in the 1980s. HIV/AIDS funding through the U.S. Agency for International Devel- opment (USAID) grew from $1.1 million in fiscal year (FY) 1986 to $510 million in FY 2002 (USAID, 2009). The United States was already a leading donor of HIV/AIDS assistance in the world in the late 1990s, accounting for an estimated 49 percent of total contributions in 1998 (Alagiri, 2001). In 1999, the Clinton Administration initiated the Leadership and Invest- ment in Fighting an Epidemic initiative to support a $100 million funding increase directed to prevention, care and treatment, and capacity and infra- structure development (USAID et al., 1999). Continuing the trend, in 2002 President Bush launched a $500 million program to reduce mother-to-child transmission, called the International Mother and Child HIV Prevention Initiative. This program aimed to reach up to 1 million women each year in 12 African countries, the Caribbean region, and 2 focus Caribbean coun- tries, focusing on increasing the availability of services, including antiret- roviral drugs, for prevention of mother-to-child transmission and building health care delivery systems. The activities in this program were managed by various USG agencies such as USAID and the U.S. Centers for Disease Control and Prevention (CDC) (Shaffer et al., 2004; White House, 2002). The United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act of 2003 In his 2003 State of the Union address, President Bush asked the U.S. Congress to authorize $15 billion over 5 years to address the urgent and severe crisis of HIV/AIDS globally (Bush, 2003). Congress authorized this initiative just a few months later through the United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act of 2003 (henceforth, the Leadership Act).2 It became the largest investment that any donor had made for combating a single disease (Donnelly, 2012; OGAC, 2009a). The authorizing legislation clearly articulated the urgent need to scale up and rapidly implement HIV services and interventions for prevention, care, and treatment in countries most affected by the HIV pandemic.3 Even 2  United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act of 2003, P.L. 108-25, 108th Cong., 1st sess. (May 27, 2003). 3  Ibid.

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22 EVALUATION OF PEPFAR with the sense of urgency and the focus on scale up of services, the autho- rizing legislation also recognized the need for sustainability, acknowledging the challenge of expanding programs and activities that had already been initiated in a “coherent and sustainable manner”4 and emphasizing, for example, the importance of supporting mechanisms to ensure a sustainable supply of quality ARTs and other medicines5 and promoting the sustain- ability of activities to prevent mother-to-child transmission of HIV and provide medical care and support services to HIV positive parents and their children.6 The Leadership Act also emphasized programs that specifically address the vulnerabilities of women and children, the development and strengthening of health care systems and human resources, and the necessity of periodic monitoring and evaluation (M&E).7 The legislation stipulated that an effective distribution of funds would be 55 percent for treatment, 15 percent for palliative care, 20 percent for prevention, and 10 percent for orphans and vulnerable children.8 It further specified the following budgetary allocation requirements: • “not less than 55 percent . . . shall be expended for therapeutic medical care” for those with HIV, of which “at least 75 percent should be expended for the purchase and distribution of antiretro- viral pharmaceuticals and at least 25 percent should be expended for related care”;9 • “not less than 33 percent” of funds allocated for prevention “shall be expended for abstinence-until-marriage” programs;10,11 and • “not less than 10 percent . . . shall be expended for assistance for orphans and vulnerable children affected by HIV/AIDS.”12 PEPFAR’s goals, budgetary allocations, and targets are summarized later in this chapter in Table 1-2. The authorizing legislation also imposed the restrictions that “no funds made available to carry out this Act, or any amendment made by this Act, may be used to promote or advocate the legalization or practice of prostitu- 4  Ibid., §2(16). 5  Ibid., §301(a), 22 U.S.C. 2151 §104A(d)(5)(C). 6  Ibid., §315(b). 7  Ibid., §301(a), 22 U.S.C. 2151 §104A(d). 8  Ibid., §402(b)(1-4). 9  Ibid., §403(a). 10  Ibid., §403(a). 11 “Abstinence-until-marriage” programs were later referred to using the term “abstinence and be faithful” or “AB.” USG-supported HIV prevention programs are discussed in depth in Chapter 5. 12  Supra, note 2 at §403(b).

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BACKGROUND 23 tion or sex trafficking”13 nor “to provide assistance to any group or organi- zation that does not have a policy explicitly opposing prostitution and sex trafficking.”14 The authorizing legislation also noted that nothing in this restriction should “be construed to preclude the provision to individuals of palliative care, treatment, or post-exposure pharmaceutical prophylaxis, and necessary pharmaceuticals and commodities, including test kits, con- doms, and, when proven effective, microbicides.”15 The history of these budgetary requirements and of the funding restrictions on implementation of programs are discussed in subsequent chapters of this report. The Leadership Act described the essential elements for program imple- mentation. It mandated that (1) the President institute a comprehensive and integrated 5-year strategy to control HIV/AIDS globally by focusing on prevention, care, and treatment; (2) priorities be assigned to pertinent executive branches; (3) agencies improve coordination and cooperation; (4) resources be used to accomplish the projected goals; and (5) resources be coordinated with relevant assistance from multilateral organizations, for- eign country governments, international organizations, and governmental and nongovernmental organizations. The legislation also created the position of the U.S. Global AIDS Coor- dinator (the Coordinator), which sits within the U.S. Department of State (DoS) and holds the rank of ambassador.16 The President, with the advice and approval of the Senate, appoints the Coordinator, who then is ac- countable for overseeing and coordinating all U.S. resources and programs used to combat HIV/AIDS globally.17 The first Coordinator was Ambas- sador Randall Tobias (2003–2006). Ambassador Mark R. Dybul followed (2006–2009), and the current Coordinator is Ambassador Eric Goosby. The President’s Emergency Plan for AIDS Relief: First Five-Year Strategy The first U.S. Five-Year Global HIV/AIDS Strategy, instituted in re- sponse to the legislation’s mandate, was titled “The U.S. President’s Emer- gency Plan for AIDS Relief” (OGAC, 2004). This generated the acronym PEPFAR, which has become the common name for the program.18 As 13  Supra, note 2 at §301(e). 14  Supra, note 2 at §301(f). 15  Supra, note 2 at §301(e). 16  Supra, note 2 at §102(a) 22 U.S.C. 265(a)(2)(f)(1). 17  Supra, note 2 at §102(a) 22 U.S.C. 265(a)(2)(f)(1) and §102(a) 22 U.S.C. 265(a)(2)(f) (2)(B)(i). 18  Hereinafter in this report, the program across its entire history will be referred to as PEPFAR. When a distinction is made between phases of the program, the program during the years covered in the first legislation and Five-Year Strategy (2004–2008) will be referred to as PEPFAR I, while the program during the years since the reauthorization legislation and second Five-Year Strategy (2009–2013) will be referred to as PEPFAR II.

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24 EVALUATION OF PEPFAR described previously, the initiation of PEPFAR did not represent a zero baseline for USG investment in global HIV programs—rather, it was a ma- jor scale-up and expansion of programs with an articulated central mission and reorganization with a new coordinating mechanism, as detailed in the Five-Year Strategy. The organizational infrastructure used to implement PEPFAR is described in detail in Chapters 3 and 4. The Five-Year Strategy laid out three overarching goals to guide pro- gram development: (1) to promote strong leadership at all levels to combat HIV/AIDS; (2) to utilize best practices within bilateral HIV/AIDS preven- tion, care, and treatment programs, in harmony with the policies and goals of national HIV/AIDS strategies employed by partner governments; and (3) to work with multilateral organizations, partner governments, and other partners to ensure coordination at all levels, to apply best practices, to adhere to sound management practices, and to harmonize M&E between partners to ensure efficiency and effectiveness. The initial strategy also specified several principles to guide these goals, including respond urgently to the HIV/AIDS crisis; seek novel approaches; devise ways in which to measure goals and ensure accountability; develop and implement programs that align with the objectives of partner countries; integrate prevention, care, and treatment programs; and build and strengthen national capacity. The strategy also laid out the following specific targets for PEPFAR: prevent 7 million new HIV infections by 2010, provide treatment with antiretrovi- ral (ARV) drugs to 2 million people living with HIV, and provide care for 10 million people living with and affected by HIV/AIDS (including orphans and vulnerable children) (OGAC, 2004). As described in the Five-Year Strategy, the initiation of PEPFAR in- cluded significant new resources, $9 billion of the $15 billion budget au- thorized in the Leadership Act, as intense bilateral investment focused on programs in the same countries targeted in the International Mother and Child HIV Prevention Initiative; together the burden of HIV in these coun- tries accounted for more than 50 percent of the global HIV burden (OGAC, 2004; White House, 2002). These were countries with limited resources and infrastructure with which to address the epidemic. They became known, with the addition of Vietnam, as the “focus countries.”19 The Five-Year Strategy also described a pledge of $1 billion over 5 years to the Global Fund to Fight AIDS, Tuberculosis, and Malaria and the plan to devote $5 19  The 15 focus countries are Republic of Botswana, the Republic of Côte d’Ivoire, the Federal Democratic Republic of Ethiopia, the Cooperative Republic of Guyana, the Republic of Haiti, the Republic of Kenya, the Republic of Mozambique, the Republic of Namibia, the Federal Republic of Nigeria, the Republic of Rwanda, the Republic of South Africa, the United Republic of Tanzania, the Republic of Uganda, the Socialist Republic of Vietnam, and the Republic of Zambia. These countries are named in the Leadership Act, with the exception of Vietnam, which was added later.

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BACKGROUND 25 billion over 5 years to existing bilateral efforts to support HIV/AIDS, tu- berculosis, and malaria programs and research. The Five-Year Strategy em- phasized renewed commitment and consolidation of policy and leadership for all bilateral USG HIV/AIDS programs, encompassing programs through USAID, the Department of Health and Human Services, the Department of Defense, the Department of Labor, and the Peace Corps in more than 100 countries in diverse geographical regions (Table 1-1), as well as DoS public diplomacy and small-scale HIV/AIDS prevention programs in many countries (OGAC, 2004). IOM Prior Evaluation of PEPFAR: PEPFAR Implementation: Progress and Promise Three years after the initiation of PEPFAR, the IOM released the report of an evaluation of its implementation, a study that was mandated by the Leadership Act.20 The IOM convened an independent committee of experts, three subcommittees, and several consultants to design and conduct the study, and provided Congress with a report in 2007 for use as it considered reauthorization of the program (IOM, 2007). The IOM evaluation focused on PEPFAR implementation in the 15 focus countries and was primarily a process evaluation. The evaluation did not cover the contributions of the United States to the Global Fund to Fight AIDS, Tuberculosis, and Malaria (Global Fund) (IOM, 2005). The first IOM evaluation centered on the idea of “harmonization” and focused on PEPFAR’s contribution to capacity building in partner countries to address HIV/AIDS (IOM, 2007). The evaluation was based in part on the “Three Ones” principles that UNAIDS, host countries, donor countries, and international organizations endorsed as guiding principles of harmoni- zation, recognizing the need for maximum coordination to target the prior- ity needs of countries, to use resources efficiently, and to avoid duplication of effort. According to these principles, countries are encouraged to have one agreed upon HIV/AIDS Action Framework, one National HIV/AIDS Coordinating Authority, and one HIV/AIDS country-level M&E system in order to strengthen the country-level response to HIV/AIDS (UNAIDS, 2004a,b). The evaluation employed a wide range of methods, including six meet- ings for information gathering and deliberations; reviews of scientific and other literature as well as PEPFAR documents; and discussions with a range of stakeholders, including PEPFAR staff, in-country implementation partners, and other donors and stakeholders. The committee also analyzed budget and program performance data from PEPFAR I. Between October 20  Supra, note 2 at §101(c)(1).

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26 EVALUATION OF PEPFAR TABLE 1-1 PEPFAR HIV/AIDS Programs in 2004 Region/Country USAID HHS DoD DoL Peace Corps Sub-Saharan Africa  1 Angola B B B  2 Benin B B B V  3 Botswana R B B B V  4 Burkina Faso R B V  5 Burundi R B  6 Cameroon R B V  7 Cape Verde R  8 Chad R B V  9 Congo, D.R. of B B B 10 Côte d’Ivoire R B 11 Djibouti R 12 Eritrea B B 13 Ethiopia B B B B 14 Gabon B V 15 Gambia, The R 16 Ghana B B B V 17 Guinea Bissau R 18 Kenya B B B B V 19 Lesotho R B B V 20 Liberia R 21 Madagascar B B V 22 Malawi B B B B V 23 Mali B B V 24 Mauritania B 25 Mozambique B B B B V 26 Namibia B B B B V 27 Niger R V 28 Nigeria B B B B 29 Rwanda B B 30 Senegal B B B V 31 Sierra Leone R B 32 Somalia R 33 South Africa B B B B V 34 Sudan R 35 Swaziland R B B V 36 Tanzania B B B B V 37 Togo R B B V 38 Uganda B B B B V 39 Zambia B B B B V 40 Zimbabwe B B B B

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BACKGROUND 27 TABLE 1-1 Continued Region/Country USAID HHS DoD DoL Peace Corps Asia and Near East 41 Bangladesh B 42 Burma R 43 Cambodia B B B B 44 China R B 45 East Timor R 46 Egypt B B 47 India B B B B 48 Indonesia B B B 49 Jordan B 50 Laos R B 51 Nepal B B V 52 Papua New Guinea R 53 Philippines B 54 Thailand R B B 55 Vietnam R B B B 56 West Bank/Gaza B Europe and Eurasia 57 Albania B V 58 Armenia B 59 Azerbaijan B 60 Belarus B 61 Bosnia R 62 Bulgaria R 63 Croatia R 64 Estonia R 65 Georgia B B 66 Kazakhstan B B V 67 Kosovo B 68 Kyrgyzstan R B 69 Latvia R 70 Lithuania R 71 Macedonia R 72 Moldova B 73 Romania B B B V 74 Russia B B 75 Serbia R 76 Tajikistan R B 77 Turkmenistan R V 78 Ukraine B B B V continued

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28 EVALUATION OF PEPFAR TABLE 1-1 Continued Region/Country USAID HHS DoD DoL Peace Corps 79 Uzbekistan R B V Latin America and the Caribbean 80 Antigua & Barbuda R V 81 Argentina B 82 Bahamas B 83 Barbados R 84 Belize R B B V 85 Bolivia B B V 86 Brazil B B B 87 Chile B 88 Colombia B 89 Costa Rica B B 90 Dominica R V 91 Dominican Republic B B B V 92 Ecuador B V 93 El Salvador B V 94 Grenada V 95 Guatemala B V 96 Guyana B B B V 97 Haiti B B B V 98 Honduras B B B V 99 Jamaica B B V 100 Mexico B 101 Nicaragua B V 102 Panama R B V 103 Paraguay B V 104 Peru B B B V 105 St. Lucia R V 106 St. Kitts and Nevis R V St. Vincent & 107 R V Grenadines 108 Suriname R V 109 Trinidad and Tobago R B 110 Uruguay B 111 Venezuela B NOTE: B = Bilateral program; R = regional program; V = volunteers. DoD = U.S. Department of Defense; DoL = Department of Labor; HHS = U.S. Department of Health and Human Services; USAID = U.S. Agency for International Development. The 14 focus countries named in the original authorizing legislation are italicized. SOURCE: Appendix F from PEPFAR’s First Five-Year Strategy (OGAC, 2004).

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BACKGROUND 29 2005 and February 2006, the committee visited 13 of the 15 focus countries to directly observe implementation activities. The committee was not able to visit Côte d’Ivoire or Haiti because of security concerns, but it did hold conference calls with country teams and implementing partners in these countries. The committee synthesized the observations, findings, and con- clusions that emerged as common across the country visits and triangulated these syntheses with information from other documents and interviews in order to make conclusions about significant components of PEPFAR I implementation (IOM, 2007). The first IOM evaluation concluded that PEPFAR had made good strides toward meeting its performance targets in the first 2 years and that it had laid a foundation for reaching the longer-term goals of the Leadership Act. The committee also recognized PEPFAR’s contribution to the research, communication, dissemination, and global evidence base of HIV/AIDS information. The evaluation emphasized the need for PEPFAR to transi- tion from an emergency response to a program that fosters the sustain- ability that will be needed to achieve long-term goals while still expanding HIV/AIDS services, and it noted that PEPFAR had significantly improved capacity-building efforts to support this transition (IOM, 2007). The 2007 IOM evaluation’s recommendations can be summarized in the following main messages. PEPFAR should (1) address long-term factors by expanding prevention strategies including for key populations, improv- ing the status of women and girls, and strengthening workforce capacity; (2) develop a strategy to institutionalize its role as a learning organization and to expand the knowledge base by conducting and publishing research; (3) harmonize its policies and activities with international and national stakeholders, particularly for strategic planning and monitoring and evalu- ation; (4) remove budget allocation requirements, which the evaluation report concluded had limited PEPFAR’s ability to tailor its activities to the specific needs of each country and to coordinate with national plans; (5) es- tablish performance targets for the care of orphans and vulnerable children; and (6) expand, improve, and integrate services using evidence-based strate- gies and supporting adequate availability of ARVs, the use of local capacity, and provision of community-based, family-centered services (IOM, 2007). Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008 The U.S. Congress passed the Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008 (the Lantos-Hyde Act of 2008) on July 30,

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30 EVALUATION OF PEPFAR 2008.21 This reauthorization legislation extended the USG’s commitment to global HIV/AIDS programs for another 5 years, from 2009 to 2013 (PEPFAR II)22 and provided continuity of support in the core program areas that had been initiated by PEPFAR I. The legislation authorized up to $39 billion for PEPFAR bilateral HIV/AIDS programs as well as U.S. contribu- tions to the Global Fund.23 The major contrast in the reauthorization from the original legislation was a focus on a transition to activities and goals that would use different tools and processes for the USG to contribute to a more independent and sustainable response in and by partner countries to their HIV epidemics. The act called for a new 5-year global strategy to expand efforts in the program areas supported by PEPFAR; provide capacity-building assistance to countries; ensure the role of civil society in the response; and identify appropriate criteria, methods, and measures to encourage transparency and benchmarks for success for framework agree- ments with partner countries for sustainability and accountability.24 The Lantos-Hyde Act of 2008 set performance targets that included the prevention of 12 million new infections worldwide (no proportional goal was stated for women or children), the provision of care for 12 million people living with or affected by HIV/AIDS including 5 million orphans and other children made vulnerable by HIV/AIDS, and the training and retention of 140,000 new health care workers. The reauthorization legisla- tion also established the goal of supporting the provision of ART to people with HIV/AIDS, beyond the initial goal of 2 million under the Leadership Act of 2003, and set new programmatic requirements, many of which were related to prevention activities.25 In addition, it removed almost all of the highly specific fiscal bench- marks that were instituted in the original legislation. The benchmarks remaining were a preservation of the earmark to use 10 percent of funding for orphans and vulnerable children26 and a revision to now require that more than half of the funds be spent on ART and other care and treat- ment services.27 For prevention, the Lantos-Hyde Act of 2008 required the Coordinator to establish a balanced HIV sexual transmission prevention strategy to govern expenditures for prevention activities in countries with 21  Supra, note 1. 22  In this report the program across its entire history is referred to as PEPFAR. When a dis- tinction is made between phases of the program, the program during the years covered in the first legislation and the first Five-Year Strategy (2004–2008) is referred to as PEPFAR I, while the program during the years since the reauthorization legislation and the second Five-Year Strategy (2009–2013) is referred to as PEPFAR II. 23  Supra, note 1 at §401(a) and §302(f) and §303(b). 24  Supra, note 1 at §101(a). 25  Supra, note 1 at §101(a). 26  Supra, note 1 at §402 and §403(2), 22 U.S.C. 7673(b). 27  Supra, note 1 at §403(3), 22 U.S.C. 7673(c).

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BACKGROUND 31 generalized epidemics. This “balanced funding” directive replaced the 20 percent earmark for prevention, which included one-third earmarked for abstinence programs, from the original 2003 legislation. Instead of iden- tifying a specific requirement for the distribution of funds for prevention of sexual transmission, programs in countries with generalized epidem- ics are now required to provide a compelling explanation, justified by the Coordinator, if less than 50 percent of prevention funding is directed toward activities promoting (a) abstinence, (b) delay of sexual debut, (c) monogamy, (d) fidelity, and (e) partner reduction. These programs are to be “implemented and funded in a meaningful and equitable way . . . based on objective epidemiological evidence as to the source of infections and in consultation with the government of each host country involved in HIV/ AIDS prevention activities.”28 Second PEPFAR Five-Year Strategy In December 2009, Ambassador Goosby released a new legislatively required PEPFAR Five-Year Strategy, which included the targets written into the reauthorization legislation, but specified that the treatment target should provide direct support for more than 4 million people (OGAC, 2009a). Unlike the legislation, this Five-Year Strategy extended the time- frame of these performance targets through FY 2014, rather than FY 2013 (OGAC, 2009a). The new strategic plan established the future direction of PEPFAR II and, based on the areas of emphasis in the reauthorization legis- lation, identified the need to “(1) transition from an emergency response to promotion of sustainable country programs; (2) strengthen partner govern- ment capacity to lead the response to this epidemic and other health needs; (3) expand prevention, care, and treatment in concentrated and generalized epidemics; (4) integrate and coordinate HIV/AIDS programs with broader global health and development programs to maximize impact on health systems; [and] (5) invest in innovation and operations research to evaluate impact, improve service delivery, and maximize outcomes” (OGAC, 2009a, p. 14). The evolution of PEPFAR’s goals, budgetary allocations, and targets over time is summarized in Table 1-2. Changes in PEPFAR Since the Lantos-Hyde Act and the Second Five-Year Strategy Since the reauthorization of PEPFAR, as the implementation of the sec- ond Five-Year Strategy has progressed, some additional key developments 28  Supra, note 1 at §403(1), 22 U.S.C. 7673(a).

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32 EVALUATION OF PEPFAR TABLE 1-2 Summary of PEPFAR’s Goals, Budgetary Requirements, and Targets Goals from PEPFAR Five-Year Strategies PEPFAR I PEPFAR II 1. Encourage bold leadership at every level to fight 1. Transition from an emergency HIV/AIDS response to promotion of 2. Apply best practices within bilateral HIV/AIDS sustainable country programs prevention, treatment, and care programs, in 2. Strengthen partner government concert with the objectives and policies of host capacity to lead the response governments’ national HIV/AIDS strategies to the HIV epidemic and other 3. Encourage partners, including multilateral health demands organizations and other host governments, to 3. Expand prevention, care, and coordinate at all levels to strengthen response treatment in both concentrated efforts, to embrace best practices, to adhere and generalized epidemics to principles of sound management, and to 4. Integrate and coordinate HIV/ harmonize monitoring and evaluation efforts to AIDS programs with broader ensure the most effective and efficient use of global health and development resources programs to maximize impact on health systems 5. Invest in innovation and operations research to evaluate impact, improve service delivery, and maximize outcomes PEPFAR Budgetary Allocation Requirements Authorizing Legislationa Reauthorization Legislationb 2003 2008 Therapeutic medical care: Not less than 55 percent, Care and Treatment: More than 50 of which at least 75 percent for the purchase and percent for antiretroviral treatment distribution of antiretrovirals and at least 25 percent for HIV/AIDS; clinical monitoring for related care of HIV-seropositive people not in need of antiretroviral treatment; care for associated opportunistic infections; nutrition and food support for people living with HIV/ AIDS; and other essential HIV/ AIDS-related medical care for people living with HIV/AIDS Palliative care: 15 percent Prevention: 20 percent, of which not less than 33 Prevention: Balanced funding for percent for abstinence-until-marriage programs prevention activities for sexual transmission of HIV/AIDS, based on objective epidemiological evidence and in consultation with the governments of partner countries involved in HIV/AIDS prevention activities. For countries with a generalized epidemic, justification is required if less than 50 percent of this funding is allocated for promoting abstinence, delay of sexual debut, monogamy, fidelity, and partner reductionc Orphans and vulnerable children: Not less than 10 Orphans and vulnerable children: percent Not less than 10 percent

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BACKGROUND 33 TABLE 1-2 Continued PEPFAR Targets Lantos-Hyde Leadership Acta Reauthorization Presidential and First Five- Actb Second PEPFAR Declaration, World Year Strategy (Through Five-Year Strategy AIDS Day, 2011 (FY 2004–2008) FY 2013) (Through FY 2014) (Through 2013) Treatment for 2 Treatment for at Treatment for more than 4 Treatment for 6 million least 3 million million million Prevention of Prevention of Prevention of more than 12 7 million new 12 million new million new infections infections infections Reduce the rate 80 percent access 80 percent coverage of of maternal- to counseling, testing for pregnant women; to-child testing, and 85 percent coverage of transmission by treatment to antiretroviral prophylaxis, and 20 percent by prevent the treatment as indicated, for 2005 and 50 transmission of HIV-positive pregnant women; percent by 2010 HIV from mother 480,000 babies of HIV-positive to child mothers born HIV-negative 65 percent coverage of early infant diagnosis and 80 percent coverage of testing for older children of HIV-positive mothers Provision Provision of care Provision of care to more than of care to to 12 million, 12 million, including 5 million 10 million, including 5 orphans and vulnerable children including million orphans orphans and and vulnerable vulnerable children children Care and treatment services to children with HIV in proportion to their percentage within the HIV-infected population Training and Training and retention of more retention of than 140,000 new health care 140,000 new workers health care workers continued

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34 EVALUATION OF PEPFAR TABLE 1-2 Continued Ensure that in countries with a major PEPFAR investment (greater than $5 million), the partner government leads efforts to evaluate and define needs and roles in the national response Ensure that every partner country with a Partnership Framework will change policies to address larger structural conditions, such as gender- based violence, stigma, or low male partner involvement that contribute to the epidemic a  United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act of 2003, P.L. 108-25, 108th Cong., 1st sess. (May 27, 2003). b  Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008, P.L. 110-293, 110th Cong., 2nd sess. (July 30, 2008). c New prevention technologies or modalities (e.g., male circumcision) are not included when calculating this funding breakdown. SOURCES: Obama, 2011; OGAC, 2004, 2009a. have taken place. The number of partner countries in which the intensity of PEPFAR implementation warrants management through the annual Coun- try Operational Plan (COP) process has expanded from the original 15 focus countries. In 2009, when the scope of this evaluation was established, an additional 16 countries were preparing COPs for a total of 31 countries; by FY 2011, this had increased to 33. There are also 3 regions for which one COP is submitted for operations in multiple countries (GAO, 2011). Several new initiatives have been instituted that are targeted at aims articulated in the reauthorization legislation and the second Five-Year Strat- egy. As part of the effort to meet the goals of training a new health care workforce, PEPFAR established the Medical Education Partnership Initia- tive and the Nursing Education Partnership Initiative (described further in Chapter 9) (Palen et al., 2012). In addition, a New Partners Initiative was launched to encourage a greater emphasis on capacity building for partner organizations in partner countries (described further in Chapter 10) (USAID OIG, 2007). In addition, new scientific evidence has emerged that has affected or will affect decisions about the programs supported and implemented through PEPFAR, for example, in areas such as voluntary male circumcision and the use of antiretrovirals as prevention in serodiscordant couples. There have also been newly articulated commitments and goals. Build- ing on the evolving implementation of PEPFAR and the evolving evidence base, Secretary Clinton articulated PEPFAR’s commitment to the goal of

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BACKGROUND 35 achieving an “AIDS-free generation” by focusing on combination preven- tion, the prevention benefit of ART, voluntary medical male circumcision, and ending the transmission of HIV from mothers to children (Clinton, 2012). Furthermore, in December 2011, on World AIDS Day, President Obama announced the expansion of the treatment target to providing treat- ment to 6 million people by the end of 2013 (Obama, 2011). At the meeting of the International AIDS Society in July 2012, PEPFAR announced several new investments, including $80 million to support in- novative approaches to ensure treatment for HIV-positive pregnant women; $40 million to support voluntary medical male circumcision in South Af- rica; $15 million for implementation research to identify the specific inter- ventions that are most effective for reaching key populations; $20 million for a challenge fund to support country-led expansion of services for their key populations; and $2 million to bolster civil society efforts to address key populations (Clinton, 2012). In November 2012, PEPFAR released a “blueprint” that is intended to provide “a road map that clearly outlines PEPFAR’s contribution to achiev- ing an AIDS-free generation,” which it defines as a generation in which “virtually no children are born with the virus. As these children become teenagers and adults, they are at far lower risk of becoming infected than they would be today thanks to a wide range of prevention tools, and if they do acquire HIV, they have access to treatment that helps prevent them from developing AIDS and passing the virus on to others” (OGAC, 2012, p. 4). The blueprint emphasizes the principles of scaling up services, sharing responsibility among the full range of stakeholders in the HIV response, focusing on women and girls to increase gender equality in HIV services, ending stigma and discrimination that contribute to the HIV epidemic, and adapting to and adopting new science and evidence for both effec- tive implementation of interventions and capturing cost-saving efficiencies (OGAC, 2012). In addition to these PEPFAR-specific developments since the reautho- rization legislation, in May 2009 the Obama administration announced a new 6-year Global Health Initiative (GHI) as an approach to global health investments that are coordinated, integrated, and results-driven (GHI, 2012a; White House, 2009). The GHI’s initial consultation docu- ment described how it would incorporate PEPFAR’s strategic cumulative goals within a comprehensive U.S. global health policy (DoS, 2010), and PEPFAR’s second Five-Year Strategy indicated how PEPFAR can help lever- age current USG investments in global health as a part of the GHI (OGAC, 2009b). Initially, a new GHI office, with an Executive Director, was created at the Department of State to coordinate efforts among the three agencies that oversee most U.S. global health programs, USAID, CDC, and OGAC. In July 2012, this office was closed, with the three core agencies to con-

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36 EVALUATION OF PEPFAR tinue a collaborative leadership structure directed by the ongoing mandate to ensure implementation of GHI principles in the field. At the same time, a new Office of Global Health Diplomacy was created at the DoS with a shift away from the coordination function of the original GHI office to a mandate of advancing GHI priorities and policies as a component of U.S. foreign relations (GHI, 2012b; Kaiser Family Foundation, 2012). In De- cember 2012, the current U.S. Global AIDS Coordinator, Ambassador Eric Goosby, was named to also lead the Office of Global Health Diplomacy (Goosby, 2012; McNeil, 2012). Finally, it is also important to note that in addition to bilateral HIV programs in partner countries, the scope of the U.S. response to global HIV/ AIDS has also included major investments in funding to the Global Fund and in support for basic research related to HIV, primarily through the U.S. National Institutes of Health. REFERENCES Alagiri, P., Collins, C., Summers, T., Morin, S., Coates, T. 2001. Global spending on HIV/ AIDS: Tracking public and private investments in AIDS prevention, care, and research. Washington, DC: Kaiser Family Foundations. Barre-Sinoussi, F., J. C. Chermann, F. Rey, M. T. Nugeyre, S. Chamaret, J. Gruest, C. Dauguet, C. Axler-Blin, F. Vezinet-Brun, C. Rouzioux, W. Rozenbaum, and L. Montagnier. 2004. Isolation of a T-lymphotropic retrovirus from a patient at risk for acquired immune de- ficiency syndrome (AIDS). 1983. Revista de Investigacion Clinica; Organo del Hospital de Enfermedades de la Nutricion 56(2):126-129. Bush, G. W. 2003. State of the Union address. http://georgewbush-whitehouse.archives.gov/ news/releases/2003/01/20030128-19.html (accessed June 8, 2010). CDC (U.S. Centers for Disease Control and Prevention). 1981. Pneumocystis pneumonia—Los Angeles. Morbidity and Mortality Weekly Report 30(21):1-3. CDC. 1982. Update on acquired immune deficiency syndrome (AIDS)—United States. Morbid- ity and Mortality Weekly Report 31(37):507-508, 513-504. Clinton, H. 2012. Remarks at the 2012 International AIDS Conference. http://www.state.gov/ secretary/rm/2012/07/195355.htm (accessed March 19, 2013). Donnelly, J. 2012. U.S. reveals nearly $1.5 billion in unspent AIDS money. http://www. globalpost.com/dispatch/news/health/us-reveals-nearly-15-billion-unspent-aids-money (accessed August 17, 2012). DoS (U.S. Department of State). 2010. Implementation of the Global Health Initiative: Con- sultation document. Washington, DC: DoS. GAO (U.S. Government Accountability Office). 2011. President’s Emergency Plan for AIDS Relief program planning and reporting: Report to congressional committees. Washington, DC: GAO. GHI (Global Health Initiative). 2012a. About the GHI. http://www.ghi.gov/about/index.htm (accessed December 12, 2012). GHI. 2012b. Global Health Initiative next steps—A joint message. http://www.ghi.gov/ newsroom/blogs/2012/194472.htm (accessed February 4, 2013). Goosby, E. 2012. Strengthening global health by elevating diplomacy. http://blogs.state. gov/index.php/site/entry/strengthening_global_health_by_elevating_diplomacy (accessed February 4, 2013).

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BACKGROUND 37 IOM (Institute of Medicine). 2005. Plan for a short-term evaluation of PEPFAR implementa- tion: Letter report 1. Washington, DC: The National Academies Press. IOM. 2007. PEPFAR implementation: Progress and promise. Washington, DC: The National Academies Press. Kaiser Family Foundation. 2012. Raising the profile of diplomacy in the U.S. global health response: A backgrounder on global health diplomacy. Washington, DC: Kaiser Family Foundation. Levy, J. A., A. D. Hoffman, S. M. Kramer, J. A. Landis, J. M. Shimabukuro, and L. S. Oshiro. 1984. Isolation of lymphocytopathic retroviruses from San Francisco patients with AIDS. Science 225(4664):840-842. McNeil, Jr., D. 2012. New office in U.S. to fight AIDS. The New York Times, December 15, A7. Obama, B. 2011. Remarks by the president on World AIDS Day. Washington, DC. OGAC (Office of the Global AIDS Coordinator). 2004. The President’s Emergency Plan for AIDS Relief: U.S. five year global HIV/AIDS strategy. Washington, DC: OGAC. OGAC. 2009a. The U.S. President’s Emergency Plan for AIDS Relief: Five-year strategy. Washington, DC: OGAC. OGAC. 2009b. The U.S. President’s Emergency Plan for AIDS Relief: Five-year strategy. An- nex: PEPFAR’s contribution to the Global Health Initiative. Washington, DC: OGAC. OGAC. 2012. PEPFAR blueprint: Creating an AIDS-free generation. Washington, DC: OGAC. Palen, J., W. El-Sadr, A. Phoya, R. Imtiaz, R. Einterz, E. Quain, J. Blandford, P. Bouey, and A. Lion. 2012. PEPFAR, health system strengthening, and promoting sustainability and country ownership. Journal of Acquired Immune Deficiency Syndromes 60(Suppl 3):S113-S119. Popovic, M., M. G. Sarngadharan, E. Read, and R. C. Gallo. 1984. Detection, isolation, and continuous production of cytopathic retroviruses (HTLV-III) from patients with AIDS and pre-AIDS. Science 224(4648):497-500. Shaffer, N., M. S. McConnell, O. Bolu, D. Mbori-Ngacha, T. L. Creek, R. Ntumy, and L. Mazhani. 2004. Prevention of mother-to-child HIV transmission internationally. Emerg- ing Infectious Disease 10(11):2. UNAIDS (Joint United Nations Programme on HIV/AIDS). 2004a. Consultation on harmoni- zation of international AIDS funding, end-of-meeting agreement, Washington consula- tion of April 25, 2004. Geneva: UNAIDS. UNAIDS. 2004b. “Three Ones” key principles. Conference paper 1, Washington consultation of April 4, 2004. Geneva: UNAIDS. UNAIDS. 2012. UNAIDS report on the global AIDS epidemic 2012. Geneva: UNAIDS. USAID (U.S. Agency for International Development). 2009. USAID’s HIV/AIDS annual budget. http://transition.usaid.gov/our_work/global_health/aids/Funding/FactSheets/hiv_ budget.html (accessed March 19, 2013). USAID, HHS (U.S. Department of Health and Human Services), and DoD (U.S. Department of Defense). 1999. Leadership and Investment in Fighting an Epidemic (LIFE): Proposed joint operating plan of the U.S. Agency for International Development, the U.S. Depart- ment of Health and Human Services, and the U.S. Department of Defense. Washington, DC: USAID. USAID OIG (Office of Inspector General). 2007. Audit of USAID’s New Partners Initiative created under the President’s Emergency Plan for AIDS Relief. Washington, DC: USAID. White House. 2002. Fact sheet: President Bush’s International Mother and Child HIV Pre- vention Initiative. http://georgewbush-whitehouse.archives.gov/news/releases/2002/06/ 20020619-1.html (accessed January 28, 2013). White House. 2009. Statement by the president on Global Health Initiative. http://www. whitehouse.gov/the_press_office/Statement-by-the-President-on-Global-Health-Initiative (accessed March 19, 2013).

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