3

PEPFAR Organization and Implementation

This chapter describes the organization and management of the President’s Emergency Plan for AIDS Relief (PEPFAR) and places the role of PEPFAR and the implementation of PEPFAR-supported programs in the broader contexts of the HIV epidemic in partner countries and of the policy environment at the domestic, partner country, and global levels.

As described in Chapter 1, PEPFAR focuses primarily on activities that facilitate the delivery of HIV prevention, care, and treatment services to beneficiaries in partner countries. These activities include directly supporting service provision as well as supporting activities that promote or facilitate the delivery of services, such as strengthening health care and other systems, building capacity, providing technical assistance, and engaging with governments and other stakeholders to encourage a policy environment that supports an effective response to HIV (OGAC, 2004, 2009b).1,2 To support these activities, PEPFAR operates through a coordination, management, and implementation structure that follows a whole-of-government approach involving multiple U.S. government (USG) agencies. In a manner that inextricably links PEPFAR to foreign relations and health diplomacy, central coordination is based in the Department of State through

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1 United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act of 2003, P. L. 108-25, 108th Cong., 1st sess. (May 27, 2003).

2 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).



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3 PEPFAR Organization and Implementation This chapter describes the organization and management of the Presi- dent’s Emergency Plan for AIDS Relief (PEPFAR) and places the role of PEPFAR and the implementation of PEPFAR-supported programs in the broader contexts of the HIV epidemic in partner countries and of the policy environment at the domestic, partner country, and global levels. As described in Chapter 1, PEPFAR focuses primarily on activities that facilitate the delivery of HIV prevention, care, and treatment services to beneficiaries in partner countries. These activities include directly support- ing service provision as well as supporting activities that promote or facili- tate the delivery of services, such as strengthening health care and other systems, building capacity, providing technical assistance, and engaging with governments and other stakeholders to encourage a policy environ- ment that supports an effective response to HIV (OGAC, 2004, 2009b).1,2 To support these activities, PEPFAR operates through a coordina- tion, management, and implementation structure that follows a whole-of- government approach involving multiple U.S. government (USG) agencies. In a manner that inextricably links PEPFAR to foreign relations and health diplomacy, central coordination is based in the Department of State through 1  United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act of 2003, P. L. 108-25, 108th Cong., 1st sess. (May 27, 2003). 2  Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tu- berculosis, and Malaria Reauthorization Act of 2008, P.L. 110-293, 110th Cong., 2nd sess. (July 30, 2008). 65

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66 EVALUATION OF PEPFAR the Office of the U.S. Global AIDS Coordinator (OGAC), while in partner countries PEPFAR is housed in U.S. diplomatic missions under the over- sight of the U.S. ambassador to the country. From this home base in the Department of State, the implementation of PEPFAR involves multiple USG agencies that oversee and manage PEPFAR-supported programs at both headquarters level and in partner countries (IOM, 2007; PEPFAR, 2012). PEPFAR also engages implementing partners, which may be based in the United States, in partner countries, or in other countries (IOM, 2007). Fig- ure 3-1 shows a schematic overview of how PEPFAR is implemented, from congressional appropriations through service delivery to beneficiaries. The sections that follow describe the core components and levels of PEPFAR’s organization and implementation. This chapter is complemented by a more detailed discussion in Chapter 4 of the flow of PEPFAR funding through the levels described in Figure 3-1. This chapter focuses on organization and implementation within and among the levels of PEPFAR. Chapter 11 pro- vides an in-depth discussion of PEPFAR’s knowledge management, includ- ing systems for monitoring, evaluation, research, and information transfer. ORGANIZATION OF PEPFAR AT THE CENTRAL/HEADQUARTERS LEVEL Office of the U.S. Global AIDS Coordinator The formal organizational unit for PEPFAR is OGAC at the Depart- ment of State. OGAC is overseen by the Coordinator, an appointed posi- tion at the level of ambassador who reports directly to the U.S. Secretary of State. OGAC serves as the administrative office for PEPFAR and directs and coordinates activities at both the headquarters level in Washington, DC, and at the country level, where PEPFAR operates under the additional oversight of the U.S. ambassador of the country. OGAC staff members, including detailees from other USG agencies, coordinate administrative, financial, and programmatic implementation, oversight, and guidance. OGAC also has country support team leaders who serve as the princi- pal point of contact and liaison to in-country PEPFAR mission teams (IOM, 2007; PEPFAR, 2013a). The organizational structure of OGAC has changed over time; the current structure at the time of this evaluation is shown in Figure 3-2. In addition, the Coordinator and other OGAC staff represent the United States on global bodies responding to the HIV/AIDS pandemic and participate with multinational organizations, including the Joint United Nations Programme on HIV and AIDS (UNAIDS), the Global Fund, the World Health Organization (WHO), and the United Nations Children’s Fund (UNICEF), on a range of aspects of the global HIV response, such as

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PEPFAR ORGANIZATION AND IMPLEMENTATION 67 Congress Congress appropriates funding for PEPFAR to OGAC and other USG agencies. OGAC provides oversight HHS/CDC and guidance and OGAC coordinates administrative, financial, and programmatic USAID implementation. Peace DOD DOL Corps USG agency headquarters and PEPFAR interagency mission teams oversee USG Agency HQ/PEPFAR Mission Team implementation of PEPFAR-supported activities. Some activities are implemented by mission team staff. Prime Partners Programs and services are implemented through a variety of prime partners and sub-partners from the public and private sectors. Beneficiaries Sub-Partners Beneficiaries vary depending on the type of Beneficiaries activity supported. FIGURE 3-1 PEPFAR overall organization and implementation. CDC = U.S. Centers for Disease Control and Prevention; DoD = U.S. Department of Defense; DoL = Department of Labor; HHS = U.S. Department of Health and Human Services; HQ = headquarters; OGAC = Office of the U.S. Global AIDS Coordinator; USAID = U.S. Agency for International Development; USG = U.S. government. SOURCE: Developed by the IOM after document review and consultations with OGAC.

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68 Principal U.S. U S Global AIDS Deputy Coordinator Coordinator Director of Special Special Inter- Assistant Assistant departmental Coordination Special Advisor for Global Legal Advisor Senior Advisor Health Partnerships Deputy Deputy Deputy Chief Senior Advisor Coordinator for Coordinator for Coordinator for p Operations for Policy Polic Strategic Private Pri ate Sector External E ternal Officer Information Engagement Relations Chief Director of Medical Director of Director of Director of Directory of Director of Sustainability Executive Officer and Congres- Director of Multilateral Management Country Technical and Director Director of sional Public Affairs Diplomacy and Budget Support Leadership Integration Research Relations and Science FIGURE 3-2 Organizational structure of OGAC (last updated November 14, 2011). SOURCE: PEPFAR, 2011.

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PEPFAR ORGANIZATION AND IMPLEMENTATION 69 developing normative technical guidelines and conferring with other donors and institutions with respect to global priorities and harmonizing elements of the global response (IOM, 2007; PEPFAR, 2013b). U.S. Government Implementing Agencies Although coordinated through OGAC, PEPFAR is implemented through a number of USG agencies.3 At the headquarters levels, the leaders of these agencies are involved in overseeing the implementation of PEPFAR programs through their respective agencies (IOM, 2007; PEPFAR, 2012). They also participate in a number of coordination bodies and mechanisms, as described in the section that follows. The various agencies and depart- ments involved in the USG response to the global HIV/AIDS include the following: • The Department of State houses OGAC and provides its infra- structure, including information technology, human resources, and accounting. In partner countries, Department of State chiefs of mission provide overall leadership for interagency HIV/AIDS teams and engage in discussions of policy with partner country leaders. In addition, the Department of State’s PEPFAR Small Grants Pro- grams make funds available to ambassadors to support local proj- ects, which typically involve local communities, nongovernmental organizations (NGOs), and municipalities. Through its embassies, the Department of State also implements diplomatic initiatives and other HIV/AIDS programs and uses public diplomacy tools to support local communications and engagement with PEPFAR (PEPFAR, 2012). • The U.S. Agency for International Development (USAID) supports the implementation of PEPFAR programs with a direct in-country presence in 50 countries as well as through 7 regional programs. USAID’s foreign service officers, physicians, epidemiologists, and public health advisors work with governments, NGOs, and the private sector to provide training, technical assistance, and com- modities for HIV-related prevention, treatment, and care. USAID also supports multi-sectoral responses to HIV/AIDS that address impact of the epidemic outside the health sector. USAID supports programs in areas such as agriculture, education, democracy, and 3  In general when this report refers to activities that are carried out by OGAC or actions that are recommended to be taken by OGAC, the activities and actions should be understood to be carried out by the USG implementing agencies through PEPFAR’s interagency mechanisms, coordinated by OGAC.

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70 EVALUATION OF PEPFAR trade, which have a shared objective of reducing the impact of HIV/ AIDS on nations, communities, families, and individuals. USAID also supports the New Partners Initiative (NPI) for building the capacity of community-level organizations and contributing to the long-term local ownership of HIV/AIDS responses. In addition, USAID supports a number of international partnerships (such as the International AIDS Vaccine Initiative and UNAIDS). Finally, USAID supports the targeted research, development, and dissemi- nation of new technologies as well as packaging and distribution mechanisms for antiretrovirals (ARVs) through the Supply Chain Management System (PEPFAR, 2012). • The Department of Health and Human Services (HHS) implements PEPFAR prevention, treatment, and care programs in developing countries and conducts or supports HIV/AIDS research. HHS con- tributes to the implementation of PEPFAR through several agen- cies, coordinated by the Office of Global Affairs (PEPFAR, 2012). o The Division of Global HIV/AIDS (DGHA) at the U.S. Centers  for Disease Control and Prevention (CDC) provides technical assistance to 75 countries through its country and regional of- fices, with approximately 380 staff members at headquarters and 1,300 overseas (more than 1,000 of them locally employed nationals), including physicians, epidemiologists, public health advisors, behavioral scientists, and laboratory scientists. These staff members provide technical assistance and direct support to strengthen and build sustainable laboratory, epidemiology, sur- veillance, and health information systems; expand high-quality HIV service delivery and transition these services to local own- ership; implement evidence-based HIV prevention programs; and conduct research on program impact and cost-effectiveness. DGHA is also able to coordinate with other HHS global health programs, such as global disease detection, public health train- ing, and prevention and control of other infectious diseases, as well as with domestic HIV/AIDS prevention programs in the United States (PEPFAR, 2012).  o The National Institutes of Health (NIH) is the lead federal  agency for biomedical research on AIDS. Through an inter- national research and training portfolio that includes work in more than 90 countries, NIH supports basic science research as well as clinical and behavioral research into HIV and its associ- ated opportunistic infections, co-infections, and malignancies (PEPFAR, 2012). o The Health Resources and Services Administration (HRSA)  Global HIV/AIDS Program implements the rapid rollout of

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PEPFAR ORGANIZATION AND IMPLEMENTATION 71 ARVs and other clinical services, training and technical assis- tance, and nursing leadership development. HRSA supports education and training in more than 25 countries for thousands of health care workers and provides HIV quality-improvement models and software in order to improve the quality of care in PEPFAR countries (PEPFAR, 2012). o The Food and Drug Administration (FDA) ensures the avail-  ability of effective and safe ARVs. To increase the options for low-cost, high-quality HIV/AIDS therapies available for pur- chase under PEPFAR, FDA has used focused engagement with companies and priority assessments to approve single-entity, fixed-dose combination, and co-packaged versions of previously approved ARVs, most of which are still protected in the United States by patent and/or exclusivity (PEPFAR, 2012). o The Substance Abuse and Mental Health Services Administra-  tion (SAMHSA) applies technical expertise and program experi- ence in substance abuse and dependence prevention, treatment, and recovery to PEPFAR’s programs, with an emphasis on the use of medication-assisted treatment as an HIV prevention in- tervention (PEPFAR, 2012). • The Department of Defense (DoD) supports HIV/AIDS prevention, treatment, and care; strategic information; infrastructure develop- ment and support; human capacity development; and program and policy development in host militaries and civilian communities of 73 countries around the world. These activities are implemented through direct military-to-military assistance, support to nongov- ernmental organizations and universities, and collaboration with other USG agencies. The executive agent for global HIV/AIDS pre- vention, care, and treatment for foreign militaries is the DoD HIV/ AIDS Prevention Program (DHAPP), based at the Naval Health Research Center (NHRC) in San Diego, California. DHAPP ad- ministers funding, conducts training, provides technical assistance, and oversees the contributions to PEPFAR of a variety of DoD organizations (PEPFAR, 2012). • The Peace Corps uses PEPFAR resources to extend its contribution to HIV-related work in countries with Peace Corps posts through- out the world, using volunteers who have language and cultural training and who live in the communities where they work. PEPFAR supports the Peace Corps to enhance HIV/AIDS programming and in-country training; field additional Peace Corps volunteers specifi- cally in support of PEPFAR goals; and provide targeted support for community-initiated projects. The Peace Corps provides long-term capacity development support, including management and pro-

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72 EVALUATION OF PEPFAR grammatic expertise, to nongovernmental, community-based, and faith-based organizations, with particular emphasis on ensuring that community-initiated projects and programs provide holistic support to people living with and affected by HIV/AIDS (PEPFAR, 2012). • The Department of Labor implements PEPFAR workplace-targeted projects that focus on prevention and on reducing stigma and discrimination related to HIV/AIDS through workplace educa- tion, protective HIV/AIDS workplace policies, and engagement and capacity building with employer associations, governments, and trade unions. The Department of Labor also contributes to an international technical assistance program focusing on child labor targeting HIV-affected children (PEPFAR, 2012). • The Department of Commerce provides in-kind support to PEPFAR through its engagement with companies, industry organizations, and multilateral organizations aimed at fostering private-sector involvement in HIV interventions and public–private partnerships. The U.S. Census Bureau, within the Department of Commerce, is another important PEPFAR partner, which assists with data management and analysis, survey support, estimating infections averted, and supporting the mapping of country-level activities (PEPFAR, 2012). OGAC Headquarters-Level Interagency Coordinating and Guidance Mechanisms Interagency advisory bodies and processes support OGAC’s coordi- nation and the implementation of PEPFAR by sharing information and contributing to decision making for programmatic activities. For example, USG agency program directors make up the group of deputy principals who give policy and programmatic guidance to political appointees in the agency principals groups as well as to the AIDS Coordinator. Input also comes from the country support teams that liaison with and share information from the country and region implementing teams. OGAC also coordinates interagency technical working groups (TWGs) that focus on specific service areas and topics (IOM, 2007).4 4  OGAC operates the following TWGs (by program area): Prevention of Sexual Transmis- sion in the General Population (Including Youth); Prevention of HIV in Persons Engaged in High-Risk Behaviors; Medical Transmission; Counseling and Testing; Prevention with Posi- tives Taskforce; Male Circumcision Taskforce; Care and Treatment Steering Committee; Adult Treatment; PMTCT/Pediatric AIDS; Tuberculosis (TB) and HIV/AIDS; Care and Support; Orphans and Vulnerable Children; Community/Faith Based Organizations, Food, Nutrition, and HIV/AIDS; Gender; Public–Private Partnerships; Health Systems Strengthening; Human Resources for Health; Laboratory; Finance and Economics; Strategic Information Steering

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PEPFAR ORGANIZATION AND IMPLEMENTATION 73 One of the functions of the interagency coordination and advisory mechanisms is to develop and communicate operational guidance, technical considerations, and programmatic guidance to PEPFAR mission teams and implementing partners (IOM, 2007). Some overall aspects of the guidance process are discussed here, while the content of the guidance in specific program areas, including the timing and extent of changes over time, are discussed in the relevant chapters in this report. In many technical areas related to HIV programs, PEPFAR does not issue programmatic guidance of its own, but instead defers to the norma- tive guidance of other authoritative technical bodies when it is available, primarily from the World Health Organization (NCV-7-USG; NCV-10-USG; NCV-13-ML).5 Guidance for the implementation of such normative international guid- ance is often covered in PEPFAR’s operational guidance or technical con- siderations. In other areas of the HIV response, PEPFAR issues its own programmatic guidance, for example, when there are programmatic needs not comprehensively addressed by existing normative guidance or when there are legislative directives and USG policies that may not align with international standards (PEPFAR, 2013c). The number and frequency of guidance documents issued varies by programmatic area, and in some areas PEPFAR’s programmatic guidance has changed substantially since the be- ginning of the program. The use of evidence and the threshold for evidence required to instigate a change in guidance also seems to have varied by programmatic area. Guidance is discussed in more depth for each PEPFAR program area in the subsequent chapters of this report. Interviewees at both headquarters and at the country level described several challenges related to central guidance from OGAC. One is a lack of clarity concerning such things as appropriate service packages, allowable activities, and efforts in emerging areas of program emphasis, such as coun- try ownership, capacity building, health systems strengthening, and tran- sitioning to new models of implementation (396-ES; 272-ES; 196-ES; 331-ES). Another challenge noted by interviewees is the timeliness of guidance. The guidance Committee; Monitoring and Evaluation; Surveillance and Survey; Health Management In- formation Systems. Staff from USG agencies, USG-funded partners, and non-USG-funded partners may participate in each TWG (OGAC, 2012). 5  For citations of interview data: Country Visit Exit Synthesis Key: Country # + ES Country Visit Interview Citation Key: Country # + Interview # + Organization Type Non-Country Visit Interview Citation Key: “NCV” + Interview # + Organization Type Organization Types: United States: USG = U.S. Government; USNGO = U.S. Nongovernmental Organization; USPS = U.S. Private Sector; USACA = U.S. Academia; Partner Country: PCGOV = Partner Country Government; PCNGO = Partner Country NGO; PCPS = Partner Country Private Sector; PCACA = Partner Country Academia; Other: CCM = Country Coordinating Mechanism; ML = Multilateral Organization; OBL = Other (non-U.S. and non-Partner Coun- try) Bilateral; OGOV = Other Government; ONGO = Other Country NGO.

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74 EVALUATION OF PEPFAR document on prevention of sexual transmission was one notable example cited as having suffered from a lengthy delay in moving from OGAC headquarters to the field (166-26-USG; 587-23-USG; 166-26-USG). One reason noted for the slow or delayed issuance of guidance was the iterative process for generating, reviewing, and approving the guidance, which usually requires information gathering, discussion, and agreement among multiple USG agencies and technical working groups. While this may ensure thorough vetting, it can also result in a lengthy period to go from the headquarters process to dissemination and implementation at the country level (NCV-11-USG; NCV-17-USG; NCV-18-USG; 587-23-USG; 166-26-USG; 587-23-USG; 166-26-USG). Another challenge that interviewees noted was that guidance sometimes takes a “one-size-fits-all” approach that does not fit all country programs, whether because of limited applicability to special circumstances in smaller, more narrowly focused country programs or because of limited room for adaptation to local culture and standards. Interviewees expressed a desire for more balance in guid- ance, as well as in the implementation of programs, between what is driven by USG headquarters and what is driven by the mission team in a country through its planning and coordination with partner country stakeholders (272-ES; 196-ES; 396-ES; 542-ES; 461-ES; 636-ES; 331-ES). ORGANIZATION OF PEPFAR AT THE COUNTRY LEVEL PEPFAR country programs that submit a Country Operational Plan (COP) to OGAC typically have an interagency U.S. mission team made up of representatives of all implementing departments and agencies working in the country (see Figure 3-3 for an illustration of a mission team). U.S. ambassadors or chiefs of mission are the leaders of interagency PEPFAR teams, ultimately responsible for ensuring that policies and programs are coordinated at the highest levels, accounting for all plans and reports sub- mitted to OGAC, and engaging with partner-country leadership. Mission teams coordinate all of the program activities in the country and are almost all anchored by a country coordinator. The members of the mission teams work with implementing partners, other international organizations and donors, and partner country governments and nongovernmental entities to implement programs and services, develop partnerships, participate in co- ordination and planning processes, and support policies that contribute to an effective response to HIV and ensure that more attention and resources are put toward HIV/AIDS. Mission team staff members also participate in joint planning committees or working groups organized by the partner country government or by multilateral organizations. In addition members of the interagency mission team also work with the Global Fund’s local committee, known as the Country Coordinating Mechanism, to improve implementation of Global Fund grants programs and to facilitate coordina-

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PEPFAR ORGANIZATION AND IMPLEMENTATION 75 Ambassador Deputy Chief of Mission Health Attaché Public Affairs Officer USAID Mission Director HHS/CDC Chief of Party DoD Representative Peace Corps Country Director Global Fund Liaison PEPFAR Coordinator Strategic Information Liason Adult PMTCT/ Gender TWG Prevention Care and Treatment Pediatric AIDS OVC TWG or Gender TWG Support TWG TWG TWG Advisor FIGURE 3-3 Example structure of PEPFAR mission team. NOTE: The structure of each team will vary by country. Different TWGs are present in different countries; this figure includes an illustrative example. CDC = U.S. Centers for Disease Control and Prevention; DoD = U.S. Department of Defense; HHS = U.S. Department of Health and Human Services; OVC = orphans and vulner- able children; PMTCT = prevention of mother-to-child transmission; TWG = technical working group; USAID = U.S. Agency for International Development. SOURCE: Adapted from IOM and NRC, 2010, OGAC, 2009a, and information gathered from mission teams on country visits (November 2010–February 2012). tion between the Global Fund and USG programs (240-2-USG; 331-3-USG; 587-2-USG; 196-6-USG; 196-26-USG; 636-3-USG; 116-4-USG; 166-4-USG; 166-31-USG; 272-2-USG; 935-2-USG; 461-4-USG; 542-3- (IOM, 2007; IOM and NRC, 2010; USG; 396-2-USG; 396-39-USG; 934-2-USG; NCV-20-USG) USG, 2011). Although some PEPFAR-supported activities are implemented directly by members of the mission team, most PEPFAR-supported programs and services within countries are implemented by a variety of different partners, including international and partner country nongovernmental organiza- tions, academic institutions, partner country governments, private-sector entities, civil society organizations, and faith-based organizations. Most of the activities that PEPFAR supports and implements in partner countries are determined by and contracted through the in-country mission teams, although some programs and initiatives are funded and managed at the central, headquarters level. Chapter 4 describes in more detail the different ways in which programs are funded and implemented. Activities are expected to aim toward performance targets and goals in areas such as prevention, care, treatment, monitoring and evaluation, Partnership Framework development, capacity building, and health systems strengthening (the process for setting program targets is discussed further in Chapter 11, Knowledge Management) (OGAC, 2004, 2009b). Specific activities supported and implemented by PEPFAR will be described and

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80 EVALUATION OF PEPFAR BOX 3-1 Examples of Vulnerable Populations Identified from Country Visit Interview Data • Women •  hildren (in general as well as specifically infants exposed to HIV C through maternal transmission; orphans; HIV-positive children; chil- dren with disabilities; immigrant children; street children; youth and adolescents, especially out-of-school youth; and young women en- gaged in intergenerational sex, including marital relationships) • Serodiscordant couples •  eople with multiple concurrent partners, including people engaged P in polygamy • Sex workers and their clients • Men who have sex with men • People who inject drugs and their sexual partners • Prisoners • Trafficked people • Internally displaced people • Uniformed personnel (police and military) • Taxi drivers • Truckers and people near trucking routes • Transient workers •  embers of isolated workforces, such as miners, loggers, and M fishermen • People living in remote or otherwise hard-to-reach areas • Minority ethnic groups, especially those with language barriers • People living in poverty or who are socioeconomically disadvantaged • Elderly • Health care workers •  eople living in certain high-prevalence areas within a country (rural, P urban, high-prevalence sub-national regions) • People living with HIV SOURCE: (240-ES; 331-ES; 587-ES; 196-ES; 636-ES; 116-ES; 166-ES; 272-ES; 935-ES; 461-ES; 542-ES; 396-ES; 934-ES). who engage in sex work. Women and children as well as serodiscordant couples and people with multiple concurrent sexual partners were also commonly identified as vulnerable. Many interviewees also characterized populations as vulnerable because of such factors as life-stage, geographical region, socioeconomic status, occupation, and ability to access services. In

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PEPFAR ORGANIZATION AND IMPLEMENTATION 81 many cases, interviewees described those most vulnerable and most in need of services simply as those who were already HIV-positive (240-ES; 331-ES; 587-ES; 196-ES; 636-ES; 116-ES; 166-ES; 272-ES; 935-ES; 461-ES; 542-ES; 396-ES; 934-ES). This wide range of identified needs and perspectives on vulnerability can pose a challenge in trying to plan strategically for a response to HIV that is prioritized according to the drivers of the epidemic and the popula- tions most in need of services. An overarching challenge described by inter- viewees was the need to allocate limited resources among a range of types of identified needs and available services. Indeed, in some cases there was a lack of alignment and at times contention among stakeholders about how to target and prioritize the response (240-ES; 587-ES; 461-ES; 331-ES; 166-ES; 196-ES; 935-ES). Another commonly expressed challenge was a lack of data on population size, baseline HIV prevalence and other factors for specific populations that are vulnerable or at elevated risk, which made it difficult to fully understand the epidemic and the performance of the ongoing response and therefore to have a well-informed process for setting priorities (166-5-USG; 396-24-USNGO; 240-9- USG; 331-7-PCNGO; 396-37-USNGO; 396-39-USG; 636-6-USG; 166-19-PCGOV; 116-15-USNGO; 461-ES) . In some cases it was noted by U.S. mission team members, civil society groups, and stakeholders within partner country governments that achieving a shift in priorities can require a great deal of evidence and effort, especially if there are social, political, policy, or cultural barriers to implementing certain intervention approaches or focusing on certain marginalized populations. Examples of such barriers perceived by interviewees included a lack of government commitment to specific populations or programs, restrictive or punitive national policies, governmental resistance to acknowledging some populations at elevated risk as part of their epidemic, and the criminaliza- tion of some behaviors or practices associated with these populations (240-ES; 396-ES; 461-ES; 166-ES; 270-ES; 240-ES; 542-ES; 331-ES; 935-ES). Interviewees in many countries credited PEPFAR for playing a facilita- tive role in acknowledging, addressing, and including in the country’s HIV response the needs of populations that are vulnerable or at elevated risk, in particular through PEPFAR’s support for the generation and use of epi- demiological data, surveys, and special studies to better understand and respond to the specific drivers of epidemics (396-6-PCGOV; 934-24-PCGOV; 196-1-USG; 196- 8-ML; 196-10-PCGOV; 196-11-USNGO; 196-13-OGOV; 116-1-USG; 116-4-USG; 166-4-USG; 240-9-USG; 240-12-USG; 272-13-USG; 331-3-USG; 331-10-PCGOV; 331-14-USG; 331-15-USG; 331-24-PCGOV; 587-9-USG; 636-1-USG; 934-21- . This support for USG; 461-1-USG; 396-1920-USG; 396-53-USNGO; 272-22-USG; 272-25-USG; 166-23-USG) generating data and encouraging its use to inform planning for the response is discussed further in Chapter 9 in the section on information systems in partner countries and in Chapter 11 on PEPFAR’s knowledge management efforts. In addition to supporting the generation of data, PEPFAR has both field- and headquarters-level efforts to review COPs to ensure that PEPFAR’s

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82 EVALUATION OF PEPFAR planned prevention and other programmatic activities align with the avail- able epidemiological data in that country and to promulgate a response that addresses the specific drivers of the epidemics (Ryan, 2010). At the same time PEPFAR also has the articulated goal of working to better harmonize its efforts with national priorities and the national response.7 These two goals are sometimes in conflict. For example, even where epidemiological data exist or had been produced through PEPFAR support, PEPFAR and partner countries sometimes experienced conflict about the translation of epidemiological data and other information about the response into aligned program priorities. In undertaking targeted prevention efforts, PEPFAR and partner country stakeholders, particularly partner country govern- ments, disagreed in some cases about the populations to be targeted. While PEPFAR might have put forth the need to address specific populations at elevated risk, some partner country stakeholders preferred instead to focus on, for example, the general population or on children and youth (542-9-PCGOV; 587-ES; 166-5-USG; 240-8-USG; 331-18-USNGO; 587-7-PCGOV; 587-12-USG). PEPFAR’s role in the process of aligning its contribution to the HIV response with partner country government priorities and with the available evidence on the HIV epidemic in partner countries is a critical topic that is also discussed in the following section and in more depth throughout this report where it intersects with specific aspects of PEPFAR-supported efforts. PEPFAR IMPLEMENTATION AND THE POLICY ENVIRONMENT Since its creation, PEPFAR has operated in the context of domestic, global, and partner country policy environments, each of which intro- duces factors that can either facilitate or constrain PEPFAR’s priorities and actions as well as the effectiveness of its efforts. Thus, in addition to attempting to implement well-established practices and interventions and to incorporate scientific advances, PEPFAR has also had to navigate diverse political pressures while developing its priorities, guidance, and program- ming. Within the United States, PEPFAR’s efforts must contend with pres- sures coming from the U.S. Congress, advocacy groups, the media, and the general public. The United States’ domestic policy environment influences what PEPFAR is authorized to undertake or address for the U.S. response to global HIV as well as how PEPFAR-supported programs and activities are implemented. In addition, PEPFAR is influenced by its inherent role as a part of the diplomatic and foreign relations mission of the United States. Finally, PEPFAR must also navigate its relationship with global bodies, other donors, and, as discussed in the preceding section, the governments 7  Supra, note 2.

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PEPFAR ORGANIZATION AND IMPLEMENTATION 83 and other stakeholders in the countries where it works. Situated within this larger political environment, PEPFAR has played a key role at the global level and within countries in influencing HIV policy. This section is a brief overview that synthesizes some key general aspects of PEPFAR’s relation- ship with and role in the policy environment; this overview is linked to the committee’s assessment of specific policy issues that intersect with specific programmatic areas, which are discussed in more depth in the pertinent chapters of the report. There are several related but distinct ways that PEPFAR interacts with policy formulation and implementation. One is the development of PEPFAR’s own guidance to set general policy and programmatic direction for PEPFAR’s activities within partner countries, alluded to earlier in this chapter (PEPFAR, 2013c). This affects how PEPFAR money will be spent and what aspects of the HIV response will be prioritized, and often the effects are not limited to PEPFAR-supported activities but also influence activities that are supported through other resources (IOM, 2007). The other two primary pathways are through PEPFAR’s relationship with the policy context in partner countries and PEPFAR’s relationship with the broader global policy environment. PEPFAR Implementation and the Policy Environment in Partner Countries In the partner countries where PEPFAR is implemented, the countries’ policies affect every aspect of program implementation, from how preven- tion, treatment, and care services can be provided to the infrastructure and functioning of health and other systems that contribute to the HIV response as well as the broader policy and legal environment. As such, partner country policies are inextricably linked with PEPFAR’s efforts to address the HIV epidemic and with the program implementation decisions that PEPFAR makes in different contexts. When well aligned, the local policy environment can enhance PEPFAR’s ability to achieve its goals and contribute to an effective HIV response in the partner country, but in some cases it can be constraining; this was exemplified by one interviewee who stated that ‘political issues with the government have slowed down the progress of PEPFAR’ (636-16-USG). Beyond adapting to operate and implement programs within the re- alities of the local policy environment, PEPFAR also works to inform or influence policy change in partner countries. Such efforts have included providing technical support to work toward the development and imple- mentation of HIV-related laws and policies within countries as well as of other laws that affect the response to HIV. Examples include contributing to national guidelines and policies for HIV-related services and commodi- ties, the adoption of specific HIV-related laws, the training of government

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84 EVALUATION OF PEPFAR officials on HIV-related issues, and changing the legal environment for those made vulnerable by HIV, including addressing issues such as work- place discrimination, inheritance rights, legal protection, and criminaliza- tion of behaviors and activities that affect some populations at elevated risk (196-10-PCGOV; 196-11-USNGO; 396-8-PCNGO; 396-21-USG; 396-23-USG; 272-11-PCNGO; 272-12-USNGO; 272-13-USG; 272-22-USG; 542-8-USNGO; 331-18-USNGO; 461-13-USACA; 461-14-USG; 461-18-USG; 636-9-USACA; 240-2-USG; 240-3-USG; 240-12-USG; 240-19-USACA; 240-24-USG; 587-13-USG; 587-14-PCGOV; 587-17-PCNGO; 116-13-PCNGO; 116-18-PCNGO; 935-10-USG; 166-17-USG; 166-19-PCGOV; 166-23-USG; 166-27-PCNGO) . In ad- dition to specific activities aimed at policy development or policy changes, the direct engagement of PEPFAR and its implementing partners with part- ner country stakeholders, including civil society and national and subna- tional governments, has also been an avenue for PEPFAR to both respond to and influence partner country policies that affect the HIV epidemic and the response (396-23-USG; 396-44-PCGOV; 331-18-USNGO; 116-2-USG; 116-13-PCNGO; 116-18-PCNGO; 240-19-USACA; 587-5-PCGOV; 272-12-USNGO; 166-23-USG; 542-2-USG; 542-6-ML; 542-13-USG). These efforts have been occurring and evolving since the inception of PEPFAR, and the second Five-Year Strategy emphasized policy goals to address structural factors related to the HIV epidemic with implementation in part through the Partnership Framework process (OGAC, 2009b,c). Policy-related ac- tivities have not always been consistently codified as part of the portfolio of PEPFAR-supported activities and country program planning processes. However, by 2012 policy development and alignment was offered as one of the selection of potential implementation activities in PEPFAR’s guidance in nearly every program area (OGAC, 2011). As described previously, another major contribution to informing or influencing policy in partner countries has been PEPFAR’s support for data collection efforts to better understand the epidemic and to inform partner country planning and policies. PEPFAR Implementation and the Global Policy Environment Although the committee was not mandated to examine the role of PEPFAR in global HIV policy and this study was not designed to carry out a comprehensive assessment in this area, this topic emerged from the planning and data collection during the evaluation as an important aspect of PEPFAR operations and implementation that intersects with the effects of PEPFAR’s programmatic contribution to the HIV response. Therefore, a broad synthesis of perspectives on PEPFAR’s influence in the arena of global HIV is presented here, drawn from interviews conducted with individuals across a diverse range of stakeholders in the global HIV response, includ- ing advocates, representatives of bilateral and multilateral organizations involved in the AIDS response, and PEPFAR staff. PEPFAR contributes to the global policy arena in various aspects of the global HIV response, such as developing normative technical guidelines

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PEPFAR ORGANIZATION AND IMPLEMENTATION 85 and conferring with other donors and institutions with respect to global priorities and harmonizing elements of the global response, including par- ticipating in the global dialog about politically sensitive issues such as the intersections of HIV with drug use, sex work, and human rights (NCV-7-USG; NCV-10-USG; NCV-13-ML; NCV-11-USG; NCV-20-USG; NCV-21-ML; NCV-14-ML; NCV-22-USNGO; NCV-24-USNGO; NCV-32-OBL). At the global level, PEPFAR has the potential to have an outsized influence on the global HIV policy agenda because of its immense resources in both funding and personnel. PEPFAR was identified by interviewees as a central force in the global HIV/AIDS response and some interviewees acknowledged that there was the potential for PEPFAR to be a dominating force. However, they noted that this had generally not happened in their engagement and interactions with PEPFAR leadership and staff and also recognized the challenges in policy engagement faced by those responsible for implementing PEPFAR at all levels, given the complex political and policy environment and range of influences under which PEPFAR oper- ates (NCV-16-USG; NCV-27-ML; NCV-32-OBL). Despite some challenges described further below, overall interviewees referred to the importance of PEPFAR’s pres- ence in the global policy community and saw it as fundamentally changing global HIV programming in predominantly positive ways (NCV-13-ML; NCV-14-ML; NCV-16-USG; NCV-22-USNGO; NCV-23-USNGO; NCV-24-USNGO; NCV-25-USNGO; NCV-29-ML). An overarching theme that emerged across stakeholders was that of PEPFAR’s leadership, and interviewees offered several examples of ways in which PEPFAR has positively influenced the global HIV agenda. One example was the way that PEPFAR pushed from the beginning to prioritize high-burden countries; another was PEPFAR’s demonstration that it was feasible to scale up HIV treatment and other services in these countries (NCV-13-ML; NCV-16-USG; NCV-13-ML; NCV-28-ML). Another example was PEPFAR’s role as a driver for the implementation and scale-up of interventions based on existing and emerging evidence in some program areas, such as prevention of mother-to-child transmission, programs for orphans and vulnerable children, male circumcision, and the recent momentum for the call for an AIDS-free generation (NCV-13-ML; NCV-16-USG; NCV-27-ML; NCV-28-ML; NCV-29-ML). In addi- tion to the use of evidence to inform programming, several interviewees also identified PEPFAR’s focus on the monitoring and evaluation of its programs as an important contribution to the global HIV response (NCV-13-ML; NCV-14-ML; NCV-25-USNGO; NCV-32-OBL), something that was echoed at the country level (NCV- 5-USACA; 461-14-USG; 272-15-PCNGO; 240-8-USG; 636-18-ONGO; 396-55-USG; 331-14-USG; 116-23-USPS; 166-23- . As one interviewee said: USG; 272-22-USG; 461-18-USG) “I think that the constant insistence on accountability and evalu- ation programs, I think that’s something, particularly since the advent of PEPFAR, and also before, actually, that the U.S. was

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86 EVALUATION OF PEPFAR always pushing for, which I think that was a very good thing.” (NCV-14-ML) The principle of supporting the use of program monitoring and other evidence was nonetheless accompanied by considerable challenges in prac- tice; this topic is discussed in depth by program area throughout this report and more comprehensively in Chapter 11 on PEPFAR’s knowledge management. Although PEPFAR’s engagement in the global policy arena was overall seen as positive, interviewees identified specific PEPFAR policies and fund- ing limitations as challenges in achieving a coordinated and well-aligned global response to HIV. These included some challenges that were noted as having improved over time, including, for example, working toward improved harmonization of indicators and shifting to a less restrictive resource allocation for prevention to allow country programs to match evidence-based programming to the epidemic more appropriately (NCV-11-USG; NCV-3-USG; NCV-7-USG; NCV-21-ML; NCV-10-USG; NCV-17-USG). They also included some ongo- ing challenges, especially related to supporting evidence-based prevention programming for the prevention of sexual transmission and for targeted in- terventions for people who inject drugs and people who engage in sex work (NCV-22-USNGO; NCV-24-USNGO; NCV-32-OBL). All of these challenges will be discussed in more depth in the relevant subsequent chapters of the report. Concerning the process of coordination with other stakeholders in the global response, multiple interviewees provided examples of PEPFAR’s constructive participation with multinational organizations, including UNAIDS, the Global Fund, and UNICEF (NCV-13-ML; NCV-14-ML; NCV-21-ML; NCV-22- USNGO), and several interviewees noted that these relationships had expanded over the course of PEPFAR’s implementation (NCV-13-ML; NCV-14-ML; NCV-21-ML). For example, one interviewee stated that trying to coordinate with multiple USG organizations simultaneously had been a challenge but that the intro- duction of PEPFAR had effectively addressed this (NCV-14-ML). Interviewees also noted the participation of PEPFAR officials in the UNAIDS Programme Coordinating Board as an example of commitment to international collabo- ration, particularly because the highest levels of PEPFAR leadership were increasingly engaged (NCV-13-ML; NCV-14-ML; NCV-16-USG). Interviewees described challenges in PEPFAR’s coordination and work with the Global Fund, in- cluding a lack of discussion about strategic planning (NCV-21-ML; NCV-25-USNGO) and a failure to identify synergies between the two programs (NCV-22-USNGO), and several interviewees suggested that PEPFAR’s support for bolstering the Global Fund could be stronger (NCV-14-ML; NCV-16-USG). However, the recent introduction of a Geneva-based PEPFAR liaison to the Global Fund was identified as having a positive effect on dialogue between the two programs (NCV-21-ML; NCV-20-USG).

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PEPFAR ORGANIZATION AND IMPLEMENTATION 87 PEPFAR and other global stakeholders intersect not only at the level of global policy dialog but also at the country level, where they are all contributing as a community of external donors to the national response to HIV. At this level of interaction, several interviewees noted mixed success in collaboration within partner countries between PEPFAR pro- grams and other stakeholders, including UNAIDS, the Global Fund, the World Health Organization, and other bilateral donors (NCV-13-ML; NCV-14-ML; NCV-21-ML; NCV-23-USNGO; NCV-32-OBL). Some interviewees attributed this to the perception that PEPFAR country activities and strategic planning remain siloed (NCV-13-ML; NCV-23-USNGO), whereas others said that the large number of PEPFAR staff and implementing partners inevitably introduce difficul- ties in the logistics of coordination, regardless of the program’s intent (NCV-14-ML; NCV-32-OBL). The coordination between PEPFAR and other global stakeholders at the country level is discussed in more depth in the chapters on funding (Chapter 4), health systems (Chapter 9), sustainability of the response (Chapter 10), and data collection, data use, and data sharing (Chapter 11). SUMMATION PEPFAR is large, multifaceted, and complex, supporting a wide range of activities that are carried out by many different partners in a diverse group of countries. PEPFAR-supported programs operate alongside programs sup- ported through other external and partner country funding sources, other funders that share the same ultimate aim as PEPFAR. In addition, health outcomes are also influenced by cultural, societal, geographical, and politi- cal factors and influences that vary by country and are not within the con- trol of PEPFAR-supported programs. As PEPFAR increasingly emphasizes country ownership and alignment with national plans, the extent to which the USG directly influences all levels of priority setting, decision making, and implementation can be quite limited. As discussed in depth in the description of the evaluation approach in Chapter 2, the committee endeavored to conduct a rigorous evaluation of PEPFAR that took into account the complexities of implementation in order to develop a credible assessment of the contribution of PEPFAR to changes in health outcomes and health impact within the landscape of other funding sources, other HIV programs, and other factors that affect health. REFERENCES GAO (U.S. Government Accountability Office). 2009. Foreign aid reform: Comprehensive strategy, interagency coordination, and operational improvements would bolster current efforts. Washington, DC: GAO.

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88 EVALUATION OF PEPFAR Gouws, E., K. A. Stanecki, R. Lyerla, and P. D. Ghys. 2008. The epidemiology of HIV infec- tion among young people aged 15-24 years in southern Africa. AIDS 22(Suppl 4):S5-S16. IOM (Institute of Medicine). 2007. PEPFAR implementation: Progress and promise. Wash- ington, DC: The National Academies Press. IOM and NRC (National Research Council). 2010. Strategic approach to the evaluation of programs implemented under the Tom Lantos and Henry J. Hyde U.S. Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008. Washing- ton, DC: The National Academies Press. 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. 2009a. Email communication between OGAC staff and IOM: “List of TWGs and country reams organization.” Washington, DC: OGAC. OGAC. 2009b. The U.S. President’s Emergency Plan for AIDS Relief: Five-year strategy. Washington, DC: OGAC. OGAC. 2009c. Guidance for PEPFAR partnership frameworks and partnership framework implementation plans. Version 2.0. Washington, DC: OGAC. OGAC. 2011. The President’s Emergency Plan for AIDS Relief: FY2012 country operational plan guidance technical considerations. Washington, DC: OGAC. OGAC. 2012. PEPFAR technical working group co-chairs. Washington, DC: OGAC. OIG (Office of Inspector General). 2008. Review of the office of the U.S. Global AIDS co- ordinator. Washington, DC: U.S. Department of State and the Broadcasting Board of Governors. OIG. 2009. The exercise of chief of mission authority in managing the President’s Emergency Plan for AIDS Relief overseas. Washington, DC: U.S. Department of State and the Broadcasting Board of Governors. OIG. 2010. Review of the President’s Emergency Plan for AIDS Relief (PEPFAR) at select embassies overseas. Washington, DC: U.S. Department of State and the Broadcasting Board of Governors. PEPFAR (President’s Emergency Plan for AIDS Relief). 2011. Organizational chart of the office of the U.S. Global AIDS coordinator. http://www.pepfar.gov/documents/ organization/177361.pdf (accessed September 1, 2012). PEPFAR. 2012. Implementing agencies. http://www.pepfar.gov/about/agencies/index.htm (ac- cessed November 13, 2012). PEPFAR. 2013a. About OGAC. http://www.pepfar.gov/about/ogac/index.htm (accessed May 20, 2013). PEPFAR. 2013b. Partnerships—multilateral cooperation. http://www.pepfar.gov/partnerships/ coop/index.htm (accessed May 20, 2013). PEPFAR. 2013c. Reports—guidance. http://www.pepfar.gov/reports/guidance/index.htm (ac- cessed May 20, 2013). Ryan, C. A. 2010. Evaluation of PEPFAR prevention programs. Paper read at Public Informa- tion Gathering Session: Committee on Planning the Evaluation of PEPFAR, January 7, 2010, Washington, DC. Simonds, R. J., Carrino, C. A., Moloney-Kitts, M. 2012. Lessons from the President’s Emer- gency Plan for AIDS Relief: From quick ramp-up to the role of strategic partnership. Health Affairs 31(7):1397-1405. UNAIDS (Joint United Nations Programme on HIV/AIDS). 2007. Practical guidelines for intensifying HIV prevention: Towards a universal approach. Geneva: UNAIDS. UNAIDS. 2012. Report on the global AIDS epidemic. Geneva: UNAIDS. USAID (U.S. Agency for International Development). 2009. Guidance on the Definition and use of the Global Health and Child Survival Account. Washington, DC: USAID.

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PEPFAR ORGANIZATION AND IMPLEMENTATION 89 USG (U.S. Government). 2011. U.S. Government-funded technical support to recipients of grants from the Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund) (accessed November 17, 2012). USG. 2012. Interagency paper on country ownership. Washington, DC: Global Health Initiative.

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