Part III
Looking to the Future



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PEPFAR Implementation: Progress and Promise Part III Looking to the Future

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PEPFAR Implementation: Progress and Promise 8 Toward Sustainability Summary of Key Findings In less than 2 years and under challenging circumstances, the U.S. Global AIDS Initiative has made progress toward meeting the 5-year targets of PEPFAR and has established a foundation for achieving the broader, longer-term goals of the Leadership Act. The continuing challenge for the U.S. Global AIDS Initiative is to simultaneously maintain the urgency and intensity that have allowed it to support a substantial expansion of HIV/AIDS services in a relatively short time while also placing greater emphasis on long-term strategic planning and increasing the attention and resources directed to capacity building for sustainability. Whether one is considering activities and programs within PEPFAR’s categories of prevention, treatment, care or orphans and other vulnerable children—and often because of such categorization—similar challenges are evident. These include a need to improve the status of women and girls, the importance of capitalizing on opportunities for synergy by improving the integration of programs, the near exhaustion of existing capacity, and myriad questions that need to be addressed through evaluation and operations research. Despite the expanded availability of HIV/AIDS services supported by PEPFAR, the HIV/AIDS pandemic continues to devastate many countries and requires continued U.S. commitment.

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PEPFAR Implementation: Progress and Promise Recommendations Discussed in This Chapter Recommendation 8-1: The U.S. Global AIDS Coordinator should continue to focus on planning for the next decade of the U.S. Global AIDS Initiative, taking full advantage of the knowledge gained from the early years of PEPFAR about the focus countries’ epidemics and how best to address them. The next strategy should squarely address the needs and challenges involved in supporting sustainable country HIV/AIDS programs, thereby transitioning from a focus on emergency relief. Recommendation 8-2: The U.S. Global AIDS Initiative should continue to increase its focus on the factors that put women at greater risk of HIV/AIDS and to support improvements in the legal, economic, educational, and social status of women and girls. Recommendation 8-3: To meet existing targets for prevention, treatment, and care, the U.S. Global AIDS Initiative should increase the support available to expand workforce capacity in heavily affected countries. These efforts should include education of new health care workers in addition to AIDS-related training for existing health care workers. Such support should be planned in conjunction with other donors to ensure that comparative advantages are maximized and be provided in the context of national human resource strategies that include relevant stakeholders, such as the ministries of health, labor, and education; other ministries; employers; regulatory bodies; professional associations; training institutions; and consumers. Recommendation 8-4: The U.S. Global AIDS Initiative should increase its contribution to the global evidence base for HIV/AIDS interventions by better capitalizing on the opportunity PEPFAR represents to learn about and share what works. The U.S. Global AIDS Coordinator should further emphasize the importance of and provide additional support for operations research and program evaluation in particular—not as the primary aim but as an integral component of programs. All programs should include robust monitoring and evaluation that factors into decisions about whether and in what manner the programs are to continue. The initiative should maintain its appropriate openness to new and innovative approaches and programs, but unproven programs in particular should be required to have an evaluation component to determine their effectiveness.

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PEPFAR Implementation: Progress and Promise 8 Toward Sustainability This chapter examines the President’s Emergency Plan for AIDS Relief (PEPFAR) as a whole and focuses on themes that emerge across all four PEPFAR categories. The focus is on identifying improvements that would support the U.S. Global AIDS Initiative in making further progress toward its 5-year targets and the ultimate goal of the Leadership Act—U.S. leadership in addressing and controlling the HIV/AIDS pandemic. COMMON THEMES PEPFAR Has Supported Expanded Availability of HIV/AIDS Services In the 15 focus countries, the U.S. Global AIDS Initiative has, as intended, supported HIV/AIDS activities and programs on a national scale, and the Office of the Global AIDS Coordinator (OGAC) reports substantial early progress toward its targets. In roughly 2 years, OGAC reports that PEPFAR has supported antiretroviral therapy (ART) for more than 800,000 adults and children; HIV testing and counseling for nearly 19 million people; services to prevent mother-to-child transmission of HIV to more than 6 million women, including preventive antiretroviral medications (ARVs) for more than half a million women found to be HIV-positive (estimated by OGAC to have resulted in the prevention of HIV infection in more than 100,000 infants); public education campaigns, school curricula, and other types of information and education community outreach that are estimated to have reached more than 140 million adults and children; care and support

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PEPFAR Implementation: Progress and Promise services for approximately 4.5 million adults, orphans, and other vulnerable children; training in HIV/AIDS care and support services for well over a million people, including physicians, nurses, clinical officers, pharmacists, laboratory workers, epidemiologists, community workers, teachers, midwives, birth attendants, and traditional healers; and expansion and strengthening of clinical laboratories, supply chain management systems, blood supply systems, safe medical practices, and monitoring and evaluation systems (OGAC, 2005a, 2006a, 2007). Although data are not yet available with which to determine the quality or impact of these services, the Committee believes this substantial expansion of services represents inroads into the HIV/AIDS epidemics in the focus countries. Although data are not yet available to determine the quality or impact of these services, the Committee believes that this substantial expansion of services represents significant inroads into the HIV/AIDS epidemics in the focus countries. Transition from Emergency to Sustainability Is Critical for Success In 2003, when the U.S. Congress passed the landmark Leadership Act, it was widely recognized that the HIV/AIDS pandemic in developing countries had reached crisis proportions and had to be addressed urgently. According to the Leadership Act: Congress recognizes that the alarming spread of HIV/AIDS in countries in sub-Saharan Africa, the Caribbean, and other developing countries is a major global health, national security, development, and humanitarian crisis. (p. 728) A previous Institute of Medicine (IOM) committee that examined the issues surrounding scale-up of ART at the start of PEPFAR urged that “ART scale-up in resource-constrained settings worldwide must proceed immediately.” The committee detailed the challenges involved, but stated: Recognizing these challenges, there remains an urgency to provide ART as rapidly as is feasible in order to extend the duration of as many lives as possible and reverse the course of social collapse in many countries heavily afflicted by HIV/AIDS. (IOM, 2005, p. 3) In keeping with global consensus, congressional mandate, and expert opinion, OGAC characterized its strategy as an “emergency plan” and has implemented PEPFAR accordingly. A study by the Center for Strategic and International Studies issued shortly after publication of the PEPFAR strategy asserted that the ultimate success of PEPFAR would be judged in large part by the speed of its response; highlighted several “impressive, early, and accelerated steps taken to create and begin PEPFAR”; and made many recommendations for enhancing the capacity of the U.S. Global AIDS Coordinator (the Coordinator) to continue to implement the initiative rapidly and effectively (Nieburg et al., 2004, p. 3).

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PEPFAR Implementation: Progress and Promise Hallmarks of PEPFAR have been its continued sense of urgency and the rapidity with which it has supported the implementation of programs and delivery of services—not only ART, but across the spectrum of HIV/AIDS care and support. As discussed in the preceding chapters, the speed with which PEPFAR has been implemented has drawn both praise and criticism and has had both positive and negative consequences. Awareness of the 5-year life of the Leadership Act and the characterization of the strategy as a “Plan for Emergency Relief” has generated anxiety that the United States does not plan to be involved in the fight against HIV/AIDS for the long haul, as will be necessary to allow countries to develop sustainable programs. During the Committee’s visits to the focus countries, it heard expressions of both deep appreciation and gratitude for U.S. leadership and generosity, and profound concern about whether and for how long the United States would sustain its commitment. Many of the people with whom the Committee met—officials of the host country governments, people working in community-based organizations of all varieties, people working in clinical facilities of all types, and people from all walks of life living with HIV/AIDS and its consequences—pointed to their organization, their facility, their personnel, their equipment, their supplies, or simply themselves and said they were there thanks to U.S. support. At the same time, however, they were already worried about what would happen after 5 years and asking: Could the country sustain these programs without continued support? What would happen to the people who were on ART? What about all the people waiting for programs to expand so they could be accommodated? Should people even start ART if there is a chance they would have to stop? The understanding of the HIV/AIDS pandemic as an exceptional kind of long-term crisis requiring both an urgent as well as a sustained and sustainable response, and the thinking that the key to sustainability is country ownership and leadership and that the harmonization imperative is central to supporting countries all developed in concert (UN, 2003a,b; UNAIDS, 2004; Jooma, 2005). The Leadership Act highlighted the challenge of expanding “interventions from a pilot program basis to a national basis in a coherent and sustainable manner” (p. 714). The same IOM committee that urged the provision of ART as rapidly as feasible also made several recommendations for ensuring the sustainability of such initiatives (IOM, 2005). The same analysts from the Center for Strategic and International Studies who praised the urgency of PEPFAR’s action also asserted that its ultimate success would be judged not only by the speed of its responses, but also by their sustainability (Nieburg et al., 2004). Increasingly, the approach advocated for addressing the HIV/AIDS crisis eschews the dichotomy between emergency relief and long-term development and favors instead a blending of “developmental relief” and “emergency development,” while underscoring the importance of working within the framework of harmonization to

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PEPFAR Implementation: Progress and Promise promote country ownership and leadership for sustainability (UN, 2003a,b; UNAIDS, 2004, Jooma, 2005; Ooms, 2006). According to the United Nations: Both developmental relief—humanitarian assistance that contributes to sustainable development—and emergency development—urgent and accelerated assistance to aid nations in overcoming the long-term negative impact of AIDS, must be put into practice. Like traditional humanitarian assistance, the response must move quickly and draw on international human resources to complement in-country capacity; and like traditional development assistance, it must focus on capacity building, improving existing structures and sustainability. (2003b, p. 27) Although PEPFAR is characterized as a plan for emergency relief, the Coordinator has also characterized harmonization as its central tenet and described “building capacity for sustainable, effective, and widespread HIV/AIDS responses” as one of the cornerstones of the PEPFAR strategy (OGAC, 2004, p. 4). From the outset, PEPFAR has sought to strengthen and expand the capacity of the focus countries to develop national HIV/AIDS programs and provide services. PEPFAR has provided substantial funding and technical assistance for many activities intended to be of lasting benefit—supporting focus country governments in the development of national plans and monitoring and evaluation systems; improving existing and building new facilities; developing curricula for and training a wide variety of health workers; strengthening and expanding laboratory, blood supply, and medical waste management systems; improving and expanding supply chains; and strengthening existing and fostering new community-based organizations (OGAC, 2005a,b, 2006a). PEPFAR’s second annual report to Congress is titled Action Today: A Foundation for Tomorrow and evidences a continued commitment to harmonization and an increased emphasis on sustainability (OGAC, 2006a). Recommendation 8-1: The continuing challenge for the U.S. Global AIDS Initiative is to simultaneously maintain the urgency and intensity that have allowed it to support a substantial expansion of HIV/AIDS services in a relatively short time while also placing greater emphasis on long-term strategic planning and increasing the attention and resources directed to capacity building for sustainability. The U.S. Global AIDS Coordinator should continue to focus on planning for the next decade of the U.S. Global AIDS Initiative, taking full advantage of the knowledge gained from the early years of PEPFAR about the focus countries’ epidemics and how best to address them. The next strategy should squarely address the needs and challenges involved in supporting sustainable country HIV/AIDS programs, thereby transitioning from a focus on emergency relief.

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PEPFAR Implementation: Progress and Promise The Committee’s recommendations for improvement are premised on the assumption that Congress will reauthorize the U.S. Global AIDS Initiative and are directed toward helping PEPFAR continue the transition from emergency response to sustainability, and thus to make further progress toward both its 5-year performance targets and the ultimate goal of the Leadership Act. None of the issues raised by the Committee or its recommendations for enabling PEPFAR to progress more effectively should be construed as a lack of general support for the U.S. Global AIDS Initiative or its authorizing legislation. Increasing Focus on Status of Women and Girls Is Key to Sustainability The Leadership Act calls for a focus on women and girls and articulates the need to address their particular vulnerability if the response to the HIV/AIDS pandemic is to succeed. Specifically, the act requires that the PEPFAR strategy provide the following: A description of the specific strategies developed to meet the unique needs of women, including the empowerment of women in interpersonal situations, young people and children, including those orphaned by HIV/AIDS and those who are victims of the sex trade, rape, sexual abuse, assault, and exploitation. A description of the specific strategies developed to encourage men to be responsible in their sexual behavior, child rearing and to respect women including the reduction of sexual violence and coercion. A description of the specific strategies developed to increase women’s access to employment opportunities, income, productive resources, and microfinance programs. (p. 719) The PEPFAR strategy is responsive to these mandates, and OGAC reports that PEPFAR is currently supporting numerous programs and services directed at reducing the risks faced by women and girls (see Table 8-1). Country Teams have categorized PEPFAR-supported activities according to whether they are focused in any of five areas: (1) increasing gender equity, (2) addressing male norms, (3) reducing violence and sexual coercion, (4) increasing income generation for both women and girls, and (5) ensuring legal protection and property rights (OGAC, 2004). However, no information is yet available with which to determine either the individual or collective impact of these activities on the status of and risks to women and girls. To the extent possible with data collection systems that do not always identify the sex of the person receiving services, PEPFAR has been able to demonstrate that women and girls are receiving PEPFAR-supported prevention, treatment, and care services in proportions equal to or greater than

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PEPFAR Implementation: Progress and Promise TABLE 8-1 Summary of PEPFAR Activities Responsive to Legislative Imperatives Concerning Women and Girls Legislative Imperative Number of Related Activities Identified as Responsive to Imperative in Fiscal Year 2006 Country Operational Plans Increase gender equity 460 Address male norms and behavior 348 Reduce violence and coercion 243 Increase women’s and girls’ access to income and productive resources 97 Increase women’s legal rights 80 SOURCE: OGAC, 2006h. men and boys.1 Table 8-2 summarizes the access of women and girls to PEPFAR-supported services. Although it was formed relatively late,2 OGAC has established a Technical Working Group on Gender. Its purpose is to support focus country programs in implementing “evidence-based, gendered approaches” in order to meet legislative requirements and PEPFAR goals (see Box 8-1). In June 2006, the Coordinator hosted a “Gender Consultation” and committed to acting on the recommendations developed as a result. The Committee urges the Coordinator to keep this commitment and implement the recommendations expeditiously. Recommendation 8-2: Most of the factors that contribute to the increased vulnerability of women and girls to HIV/AIDS cannot be readily addressed in the short term. The Leadership Act appropriately views these factors as priorities on the agenda for the fight against HIV/AIDS. In the transition from emergency response to sustainability, these factors will require increased emphasis and support, and the U.S. Global AIDS Initiative will need to keep gender issues at the core of its efforts. The U.S. Global AIDS Initiative should continue to increase its focus on the factors that put women at greater risk of HIV/AIDS and to support improvements in the legal, economic, educational, and social status of women and girls. 1 For sites that PEPFAR supports directly, disaggregation of data by sex is possible, and the sex of more than 90 percent of clients is known. Disaggregation by sex of data on activities that PEPFAR supports indirectly is possible when enabled by national data collection systems. 2 The Technical Working Group on Gender was established in September 2005, later than most of the other groups.

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PEPFAR Implementation: Progress and Promise TABLE 8-2 Summary of Access to PEPFAR-Supported Services for Women and Girls PEPFAR Category Service Access to Services Prevention Prevention of mother-to-child transmission Accessed by women during 6 million pregnancies Treatment Antiretroviral treatment Women 61% of recipients Care Voluntary counseling and testing Women 70% of people served* Orphans and Other Vulnerable Children Services for orphans and other vulnerable children Girls 51% of children receiving services *Includes voluntary counseling and testing provided as part of services to prevent mother-to-child transmission. SOURCE: OGAC, 2006h, 2007. BOX 8-1 Objectives of the Gender Technical Working Group At the country level: Provide targeted technical assistance to country programs to ensure that they meet PEPFAR legislative requirements related to gender issues. Assist country programs in designing and implementing evidence-based approaches and best practices addressing gender issues. Assess the progress of all country programs in addressing gender issues, and strengthen their capacity to monitor and report on this progress. Conduct technical reviews of country program plans and strategies to help ensure that gender-related legislative requirements are being addressed and that best practices for addressing gender issues are being incorporated into programs. At the central level: Provide technical guidance to other Technical Working Groups to promote integration of gender-sensitive approaches into their programmatic guidance and oversight. Provide program and policy guidance and support OGAC in responding to PEPFAR legislative requirements and requests related to gender issues, women, and girls. Organize forums (globally and regionally) to exchange technical information on gender issues and promote networking. Identify areas for and facilitate development of targeted evaluations for program improvement. SOURCE: OGAC, 2006d.

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PEPFAR Implementation: Progress and Promise of a full range of integrated HIV/AIDS services. The availability of each of the continuum’s activities—prevention, treatment, and care—strengthens and reinforces the effect of each intervention” (OGAC, 2004, p. 17). The importance of networks, linkages, and referrals—to “integrate medical and non-medical services to care for the whole person and the family at the community level” (Dybul, 2005)—is emphasized throughout PEPFAR’s strategy and guidance documents (OGAC, 2004, 2006d,e), as well as supporting materials for the Country Teams provided by the Technical Working Groups (OGAC, 2006d,e). Improving integration is the subject of a number of PEPFAR’s current targeted evaluations and a priority for future ones. Although PEPFAR’s annual and other reports have highlighted some successes with integration (OGAC, 2005a, 2006a), OGAC is not systematically evaluating whether it is succeeding at supporting integrated programs and services. Thus the Committee was unable to determine whether the initiative has improved in the area of integration overall. During its visits to the focus countries, the Committee observed several positive examples of integration among PEPFAR-supported programs—of systems for referral from counseling and testing programs to ART programs, of linkages between ART services and home-based care services, and of integration of HIV and tuberculosis testing and treatment. But the Committee also observed many missed opportunities for improving the comprehensiveness and effectiveness of services through better integration—for example, between programs aimed at prevention of mother-to-child transmission and infant feeding programs; between counseling and testing services and further counseling services, ART, and other treatment; between counseling and testing and clinics addressing sexually transmitted infections and reproductive health; between HIV and tuberculosis testing and treatment services; among multisectoral services for orphans and other vulnerable children; and between HIV/AIDS and food aid programs. Faith-based organizations play an important role in the fight against HIV/AIDS and have a broad reach into communities in all the focus countries (WHO, 2004c; GHC, 2005; EPN, 2006). PEPFAR is partnering with a wide range of such organizations (OGAC, 2005d). However, the Committee is concerned that exemptions for faith-based organizations could contribute to a lack of comprehensive services available at the community level and of routine integration of prevention into all programs. Specifically, the Leadership Act underscores the importance of involving faith-based organizations in the initiative and states that “[a]n organization that is otherwise eligible to receive assistance … to prevent, treat, or monitor HIV/AIDS shall not be required, as a condition of receiving the assistance, to endorse or utilize a multisectoral approach to combating HIV/AIDS, or to endorse, utilize, or participate in a prevention method or treatment program to which the

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PEPFAR Implementation: Progress and Promise organization has a religious or moral objection” (p. 733). In practical terms, this means that organizations with a religious or moral objection are exempt from having to promote and provide condoms, even when doing so is necessary to address the needs of the population with which they are working. For example a faith-based organization with an objection to condoms could be operating a counseling and testing program, ART program, or prevention program and not be providing information about condoms or condoms themselves. During its country visits, the Committee was told by some faith-based organization partners that when individual clients requested access to or information about condoms, they were referred to a service outlet that could give them what they wanted, and that this process would ensure that all individuals who needed condoms would get them. During the country visits, however, the Committee heard concerns about the extent to which these referrals were routine and consistent. Conversely, the Committee did not observe or hear about organizations that had sought an exemption from providing abstinence/be faithful information and programming. It is critical that prevention succeed, and thus PEPFAR needs to have strong mechanisms for ensuring that all proven prevention interventions are available where needed. Even as defined by PEPFAR, nearly everyone is a high-risk person in a generalized epidemic with high prevalence; thus most people need information about and access to all preventive methods, including condoms. PEPFAR’s own definition highlights the need to ensure at a minimum that faith-based organizations that do not themselves provide proven interventions are consistently facilitating access to those interventions elsewhere. Ideally, PEPFAR would actively link these faith-based organizations with partners that would provide these interventions and ensure that such linkages were successfully addressing all prevention needs of their clients. Increased Knowledge About What Works Against the AIDS Pandemic Is Needed Because of its magnitude and reach, the U.S. Global AIDS Initiative represents a golden opportunity to learn about what works best in addressing the pandemic. The Leadership Act emphasizes the importance of both basic and applied research, and requires that research be an integral part of PEPFAR. In addition, because of the many gaps in the knowledge base for addressing HIV/AIDS, the initiative has an obligation to “learn by doing” (IOM, 2005). In doing so, the initiative can help the global community learn not only about what approaches are cost-effective for preventing infection and caring for people affected by HIV/AIDS and its consequences, but also about how to scale up effective programs, how to implement programs in

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PEPFAR Implementation: Progress and Promise a manner that builds capacity and strengthens health systems overall, how best to manage such global initiatives, and how to work most effectively within the framework of harmonization to empower countries to own and lead the fight against their HIV/AIDS epidemics. Functioning as a Learning Organization Beginning with its strategy, PEPFAR has been committed to learning, and the program has displayed many of the characteristics of a successful learning organization. The PEPFAR strategy envisioned OGAC as a “small organization focused on leadership, coordination, learning, and oversight” that would “strive to remain flexible and innovative in its approaches” (OGAC, 2004, p. 67). The Committee has seen many examples of OGAC’s success in realizing this vision and encourages OGAC to continue in this vein. Chapter 3 provides greater detail about the evolution of OGAC and its management practices. The Committee was also impressed by the energy, commitment, creativity, and agility of the Country Teams and is concerned about whether they are adequately supported to sustain these qualities. At the time of the Committee’s visits to the focus countries, rapid scale-up of activities had to be managed largely with existing staff. Heavy demands for plans and reports from OGAC, other agencies, and Congress, as well as the imperative to coordinate with numerous entities both within the U.S. government and in the country at large, were creating a tremendous strain on the Country Teams. Although the Country Teams indicated that the situation had improved somewhat since the program’s inception and that OGAC’s management was continuing to evolve, the possibility of stagnation or “burnout” or of insufficient resources for oversight to maintain quality continues to be of concern. Improvements in and regularization of planning and reporting requirements, increased resources for the coordination function—including the recently identified best practice of a PEPFAR Country Team coordinator—and increased technical support for Country Teams are all promising developments. The Committee encourages OGAC to continuously solicit input from and be fully responsive to the Country Teams and to increasingly have the program directed from the field upward, particularly as the Country Teams continue to gain knowledge and understanding of effective implementation. Of particular concern are two frustrations the Country Teams commonly expressed to the Committee: that heavy demands from OGAC reduce the time available to spend with implementing partners in supporting and overseeing their programs, and that inflexibility in central policies reduces their ability to tailor programming to the specific needs of the country and thus to be as harmonized with country strategies and plans as is appropriate.

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PEPFAR Implementation: Progress and Promise Currently OGAC does not formally evaluate or provide systematic information about its performance on critical aspects of program management such as coordination, both internally and externally; harmonization; communications; transparency; comprehensive and integrated programming; continuous improvement; and contributions to the evidence base. The initiative would benefit from fuller and more formal evaluation of these aspects. Such evaluations would need to incorporate the concepts of “downward accountability” and “horizontal accountability,” thus including solicitation of feedback from program participants at all levels—partners, other donors, host country governments, and particularly people in the focus countries. Research The PEPFAR strategy commits to building the evidence base on what works against HIV/AIDS and fostering innovation (OGAC, 2004), and the initiative is indeed helping to expand knowledge about the implementation of HIV/AIDS programs and services in resource-constrained countries. The U.S. Global AIDS Initiative supports global AIDS research through several entities: the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), the U.S. Agency for International Development (USAID), and OGAC. NIH and CDC support basic, clinical, social science, translational, and clinical operations research on therapeutic and preventive regimens, microbicides, and vaccines (NIH, 2005). USAID supports applied and operations research focused on addressing the needs for program implementation in resource-limited countries. USAID’s HIV/AIDS research agenda includes studies of ART, prevention of mother-to-child transmission, ABC (abstinence/be faithful/use condoms), male circumcision, injection safety, nutrition, psychosocial issues for orphans and other vulnerable children, microbicides, and vaccines. Although significant, these NIH, CDC, and USAID research activities generally are not funded through PEPFAR or controlled by the Coordinator, and thus were not a focus of the Committee’s work. Instead, the Committee focused on the research OGAC controls and supports directly. OGAC is currently supporting about $22 million worth of targeted evaluations, primarily in the focus countries, to support the programs and policies of the initiative. These evaluations cover a wide range of topics as summarized in Table 8-3. Although OGAC has not yet articulated an overall strategy for research, it recently issued a “Blueprint for Public Health Evaluations in PEPFAR.” The blueprint describes the underlying strategy for a broadened conception of targeted evaluations and outlines a new management structure for such evaluations, including roles and responsibilities and the process for the review and approval of evaluation proposals (OGAC, 2006i). As part of the

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PEPFAR Implementation: Progress and Promise TABLE 8-3 Summary of PEPFAR Targeted Evaluations   Number of Targeted Evaluationsa Total Budget by Program Areab Abstinence/Be Faithful 5 4,025,000 Condoms and Other Prevention 1 275,000 Prevention of Mother-to-Child Transmission 14 4,945,000 HIV/AIDS Treatment/Antiretroviral Drugs 2 1,200,000 HIV/AIDS Treatment/ART Services 15 4,140,000 Palliative Care/Basic Health Care and Support 4 1,812,000 Orphans and Other Vulnerable Children 6 4,175,000 Counseling and Testing 3 620,000 Palliative Care for Tuberculosis and HIV 6 376,000 Strategic Information 8 1,247,000 Total 64 $22,815,000 aOGAC documents list two targeted evaluations with no information on the program area, budget, or agency. bThere is no budget information for 12 of the 64 evaluations. materials provided to support the development of annual country operational plans, OGAC has also given the Country Teams a list of priorities for targeted evaluations (OGAC, 2006d,e). The list is extensive and includes priorities for prevention, treatment, and care and other cross-cutting issues, such as gender and orphans and other vulnerable children. Additional research needs are a common theme across the chapters on PEPFAR’s prevention, treatment, care, and orphans and other vulnerable children categories. The Committee encourages OGAC to target (or continue to target) evaluations to the following issues: Evaluation of prevention programs is especially important for two reasons. First, although there is good evidence and general agreement that behavior changes—including those represented by ABC—are effective in reducing the spread of HIV/AIDS, there is less evidence and agreement about the effectiveness of specific approaches and programs for changing behavior. Second, PEPFAR’s target of preventing 7 million new infections by 2010 will be measured at the country level using modeling techniques that reflect the state of the art and have been developed in conjunction with global health partners such as the Joint United Nations Programme on HIV/AIDS (UNAIDS). PEPFAR’s approach and estimates will thus be consistent with other global estimates, and the estimates will also be made jointly with the Global Fund. Because these will be country-level estimates, however, it will not be possible to learn from them which approaches and programs have had the greatest and most cost-effective impact on preventing infections. Hence there is a particular need for evaluation of prevention programs at the program level.

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PEPFAR Implementation: Progress and Promise There are still more questions than answers about how best to provide ART under conditions like those found in the PEPFAR focus countries. The International Epidemiologic Databases to Evaluate AIDS Consortium, which is supported by U.S. Global AIDS Initiative funds, provides a rich resource for exploring these questions in clinical research settings. PEPFAR support for operations research in all ART programs would serve to expand the global knowledge base for addressing critical questions, including how to provide high-quality, cost-effective ART; how to scale up ART to the national level; and how to sustain ART and avoid the development of widespread resistance. In particular, focused analysis is required to address logistical and process obstacles that have arisen as a result of the rapid emergency scale-up, including treatment of children, nutritional support, how to optimize care delivery, resistance monitoring, adherence, down referral, sources of treatment failure, and optimal approaches to the treatment of HIV/AIDS and tuberculosis in children. Evaluation of care programs is particularly important for appropriate decision making about the scaling up of programs that are truly effective in terms of both desired outcome and costs. Currently, little is known about how care services are affecting the health status and quality of life of people living with and affected by HIV/AIDS or their communities. Focused analysis of the following topics could improve the provision of care services and their ultimate impact: Optimal approaches to providing family-centered, community-based care services that are well-linked to PEPFAR’s network model. Understanding and reducing stigma and discrimination through culturally appropriate and culturally specific interventions. The appropriate use of volunteers and familial caregivers for complex and long-term caregiving tasks as part of PEPFAR’s home-based care services, including examination of factors that contribute to burnout and fatigue, appropriate training for the skills needed, potential types of compensation, and programmatic contributions that can bolster the physical and mental health of these caregivers. Optimal approaches for integrating care services with prevention and treatment to create a continuum of services that can best meet the needs of families and communities. Little is known about the effectiveness and impact of programs for orphans and other vulnerable children. The global community has only recently defined the basic package of services that should be provided to these children, and there is much to learn about the relative effectiveness of the specific strategies and programs for providing those services (UNAIDS and UNICEF, 2004). Unlike its prevention target, PEPFAR’s target for providing

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PEPFAR Implementation: Progress and Promise care to 10 million people affected by HIV/AIDS is measured very early in the process and in terms of individual people. At this point, the care target counts the number of people who receive services. Eventually, as with prevention, it will be necessary to know about the impact of those services on the health status and social well-being of a country’s population of children. Thus it will be critical to have program-level information about the relative effectiveness of programs for children. To promote quality and sustainability, all programs need to be supported in managing their own quality assurance and quality improvement processes. Initially, PEPFAR’s emphasis was on supporting programs in having data systems to allow for self-assessment. Like other donors that have demanded attribution of results, PEPFAR has too often created parallel data collection and reporting systems that have burdened program sites and not necessarily given them the ability to use the data for their own quality assurance and improvement purposes. PEPFAR can address this need by continuing to provide strong support for the development of country monitoring and evaluation systems and participating fully in the Third One of harmonization—one national monitoring and evaluation system. In addition, PEPFAR has supported some quality improvement projects using a model originally developed by USAID (USAID, 2006). OGAC is currently seeking to expand its quality improvement activities, including increasing the number of quality improvement projects and providing related training to all headquarters staff. Recommendation 8-4: The U.S. Global AIDS Initiative should increase its contribution to the global evidence base for HIV/AIDS interventions by better capitalizing on the opportunity PEPFAR represents to learn about and share what works. The U.S. Global AIDS Coordinator should further emphasize the importance of and provide additional support for operations research and program evaluation in particular—not as the primary aim but as an integral component of programs. All programs should include robust monitoring and evaluation that factors into decisions about whether and in what manner the programs are to continue. The initiative should maintain its appropriate openness to new and innovative approaches and programs, but unproven programs in particular should be required to have an evaluation component to determine their effectiveness. Dissemination Sharing of knowledge and outside scrutiny are essential to expanding the knowledge base. Creation of the PEPFAR ExtraNet and broadening of participation in PEPFAR’s annual meeting (see Chapter 3) are promising

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PEPFAR Implementation: Progress and Promise developments. The initiative will need to continue to expand its avenues for sharing knowledge gained through the implementation of PEPFAR. Measuring Success Key to understanding what works against the HIV/AIDS pandemic is to learn whether PEPFAR has succeeded—that is, to understand the outcomes and impact of the effort. Although it would be premature to judge success in these terms at this time, OGAC is supporting the structures and processes necessary to evaluate the outcomes and impact of PEPFAR. OGAC’s outcome and impact indicators were developed as part of the global effort to harmonize monitoring and evaluation efforts, and thus are referenced to and largely consistent with those of other organizations such as Global Fund, UNAIDS, UNICEF, and WHO (OGAC, 2004, 2005c; WHO et al., 2004). Further efforts to harmonize monitoring and evaluation are ongoing, and PEPFAR’s continued commitment and active participation will be required if they are to be successful (GIST, 2006). To measure what really matters—reductions in disability, disease, and death from HIV/AIDS; increases in the capacity of partner countries to sustain and expand HIV/AIDS programs without setbacks in other aspects of their public health systems; and improvements in the lives of the people living in these countries—the United States and other donors will be heavily dependent on the capabilities of the partner countries. To understand whether these ultimate goals are being achieved and what contributions the U.S. Global AIDS Initiative is making to their achievement, it will be necessary to study national trends, such as rates of new HIV and other infections; rates of survival from HIV/AIDS and other diseases; child survival, development, and well-being; and the general health status of the population and key subpopulations. Particularly within the agreed framework of harmonization, the data and analyses necessary to study these trends will have to come primarily from the partner countries themselves (UN, 2003a,b; UNAIDS, 2004; OGAC, 2005b). Thus the United States, in conjunction with other donors, will need to continue to place priority on helping to strengthen the monitoring and evaluation systems of the partner countries. CONCLUSION The Committee found that the U.S. Global AIDS Initiative has made a strong start, is progressing toward its 5-year targets, and is increasingly well positioned to support countries in controlling their epidemics. At the same time, however, PEPFAR has not yet reached the half-way mark for any of its targets, each focus country still faces an enormous challenge in

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PEPFAR Implementation: Progress and Promise controlling its epidemic, and the HIV/AIDS pandemic continues to grow. The Joint United Nations Programme on HIV/AIDS has estimated that more than 4 million people worldwide became newly infected with HIV in 2006, and unless prevention efforts are highly successful, millions more will become infected every year (UNAIDS, 2006). Of the nearly 7 million people in low- and middle-income countries now estimated to need ART or to face an early death, fewer than one-quarter are receiving the therapy (WHO, 2006), and millions more of those already infected with HIV will eventually need it. Fewer than 1 in 10 pregnant women infected with HIV in low- and middle-income countries are benefiting from ARVs to prevent transmission to their babies, and at most 12 percent of the children born to these women who require ART are receiving it (WHO, 2006). With ART and appropriate care, AIDS is a chronic disease—it can be managed but not cured—and people receiving ART will need to be on it for the rest of their lives. Only a fraction of the legions of devastated families and orphaned children are currently receiving the support services they need, and the number of children orphaned by AIDS globally is projected to exceed 20 million by 2010 (UNICEF, 2006). The Committee believes that continued commitment by the United States, along with all other donors, to supporting the fight against the HIV/AIDS pandemic will be required until countries have developed sustainable programs, and that continued U.S. leadership is necessary to prevent complacency and battle fatigue and to bring the virus under control. In sustaining this commitment and this leadership, the United States will continue to answer the call from the global community: AIDS is exceptional and the response to AIDS must be equally exceptional. It requires ongoing leadership on both the national and international levels. Twenty-five years into the epidemic, the global response to AIDS must be transformed from an episodic, crisis-management approach to a strategic response that recognizes the need for long-term commitment and capacity-building, using evidence-informed strategies that address the structural drivers of the epidemic. (UNAIDS, 2006, p. 17) REFERENCES Chankova, S. 2006. Evidence-based planning of human resources for health: Examples from sub-Saharan Africa. Global Health Council Presentation, October 2006. Bethesda, MD: Abt Associates, Inc. Dybul, M. 2005 (May 24). Integrated prevention, treatment and care: Network systems. Presentation at the PEPFAR Second Annual Field Meeting, Addis Ababa, Ethiopia. EPN (Ecumenical Pharmaceutical Network). 2006. Annual report, 2005. Kenya: EPN Publications. GHC (Global Health Council). 2005. Faith in action: Examining the role of faith-based organizations in addressing HIV/AIDS: A multi-country, key informant survey. Washington, DC: GHC.

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PEPFAR Implementation: Progress and Promise Gilks, C. F., S. Crowley, R. Ekpini, S. Gove, J. Perriens, Y. Souteyrand, D. Sutherland, M. Vitoria, T. Guerma, and K. De Cock. 2006. The WHO public-health approach to antiretroviral treatment against HIV in resource-limited settings. The Lancet 368(9534):505–510. GIST (Global Implementation Support Team). 2006. Fact sheet: The Global Implementation Support Team: Coordinating UN action and provision of technical support for accelerating HIV/AIDS responses in countries. http://data.unaids.org/pub/BrochurePamphlet/2006/2006_gist_en.pdf (accessed January 12, 2007). Harries, A. D., E. J. Shouten, and E. Libamba. 2006. Scaling up antiretroviral therapy in resource-poor settings. The Lancet 367:1870–1872. Huber, S. C. 2006. Empowering communities to address their health challenges. Global Health Council Presentation, October 2006. Boston, MA: Management Sciences for Health. IOM (Institute of Medicine). 2005. Scaling up treatment for the global AIDS pandemic: Challenges and opportunities. Washington, DC: The National Academies Press. Jooma, M. B. 2005. Southern Africa assessment: Food security and HIV/AIDS. African Security Review 14(1). Kober, K., and W. Van Damme. 2004. Scaling up access to antiretroviral treatment in southern Africa: Who will do the job? The Lancet 364(9428):103–107. Nieburg, P., J. Kates, and J. S. Morrison. 2004. Enhancing the rapid response capacity of the U.S. global AIDS coordinator: Lessons from other U.S. emergency responses. A report of the CSIS HIV/AIDS Task Force in collaboration with the Kaiser Family Foundation. Washington, DC: Center for Strategic and International Studies. NIH (National Institutes of Health). 2005. FY 2005 international project listing. Rockville, MD: NIH. OGAC (Office of the U.S. Global AIDS Coordinator). 2004. The President’s Emergency Plan for AIDS Relief: U.S. five-year global HIV/AIDS strategy. Washington, DC: OGAC. OGAC. 2005a. PEPFAR first annual report to Congress. Washington, DC: OGAC. OGAC. 2005b. The President’s Emergency Plan for AIDS Relief: Defining U.S. support for national strategies (PowerPoint Presentation, July 2005). Washington, DC: OGAC. OGAC. 2005c. The President’s Emergency Plan for AIDS Relief: Indicators, reporting requirements, and guidelines for focus countries (revised for FY2006 reporting). Washington, DC: OGAC. OGAC. 2005d. PEPFAR: Community and faith-based organizations. Report to Congress mandated by report 108-599, accompanying H.R. 4818. Washington, DC: U.S. Department of State. OGAC. 2006a. PEPFAR second annual report to Congress. Washington, DC: OGAC. OGAC. 2006b. PEPFAR report on food and nutrition for people living with HIV/AIDS. Washington, DC: OGAC. OGAC. 2006c. PEPFAR report on work force capacity and HIV/AIDS. Washington, DC: OGAC. OGAC. 2006d. PEPFAR: Technical considerations for the FY2007 Country Operational Plans. Washington, DC: OGAC. OGAC. 2006e. PEPFAR FY2007 COP resource guide. Washington, DC: OGAC. OGAC. 2006f. Report on education: The President’s Emergency Plan for AIDS Relief. Washington, DC: OGAC. OGAC. 2006g. Report on refugees and internally displaced persons: The President’s Emergency Plan for AIDS Relief. Washington, DC: OGAC. OGAC. 2006h. The President’s Emergency Plan for AIDS Relief report on gender-based violence and HIV/AIDS. Washington, DC: OGAC. OGAC. 2006i. A blueprint for public health e valuations in the President’s Emergency Plan for AIDS Relief. Washington, DC: OGAC. OGAC. 2007. PEPFAR third annual report to Congress. Washington, DC: OGAC

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