Global Health: U.S. AIDS Coordinator Addressing Some Key Challenges to Expanding Treatment but Others Remain
Published: 2004-07-12T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: The President's Emergency Plan for AIDS Relief (PEPFAR), announced January 2003, aims to provide 2 million people with anti-retroviral (ARV) treatment in 14 of the world's most severely affected countries. In May 2003 legislation established the position of the U.S. Global AIDS Coordinator in the State Department. GAO was asked to (1) identify major challenges to U.S. efforts to expand ARV treatment in resource-poor settings and (2) assess the Global AIDS Coordinator's response to these challenges.
section_title: What GAO Found
paragraphs: GAO interviewed 28 field staff from the U.S. Agency for International Development (USAID) and the Department of Health and Human Services (HHS), who most frequently cited the following five challenges to implementing and expanding ARV treatment in resource-poor settings: (1) coordination difficulties among both U.S. and non-U.S. entities; (2) U.S. government policy constraints; (3) shortages of qualified host country health workers; (4) host government constraints; and (5) weak infrastructure, including data collection and reporting systems and drug supply systems. These challenges were also highlighted by numerous experts GAO interviewed and in documents GAO reviewed. Although the Global AIDS Coordinator's Office has begun to address these challenges, resolving some challenges requires additional effort, longer-term solutions, and the support of others involved in providing ARV treatment. First, the Office has taken steps to improve U.S. coordination and acknowledged the need to collaborate with others, but it is too soon to tell whether these efforts will be effective. Second, to address policy constraints, U.S. agencies are working to enhance contracting capacity in the field and resolve differences on procurement, foreign taxation of U.S. assistance, and auditing of non-U.S. grantees. However, the Office's guidance did not address key issues related to the use of PEPFAR funds to buy certain ARV drugs. Third, the Office has proposed short-term solutions to the health worker shortage, such as using U.S. and other international volunteers for training and technical assistance; however, agency field officials said that using such volunteers is not cost effective. The Office is discussing with other donors certain longer-term interventions. Fourth, the Office has taken steps to encourage host countries' commitment to fight HIV/AIDS, but it is not addressing systemic challenges outside its authority, such as poor delineation of roles among government bodies. Finally, the Office is taking steps to improve data collection and reporting and better manage drug supplies.

section_title: Letter
paragraphs: In January 2003, the President announced an unprecedented 5-year  initiative to combat the global HIV/AIDS pandemic. The President’s  Emergency Plan for AIDS Relief (PEPFAR), as authorized through the U.S.  Leadership Against HIV/AIDS, TB and Malaria Act of 2003 (the U.S.  Leadership Act), nearly triples the U.S. financial commitment to  addressing the disease and targets $9 billion in new funding to dramatically  expand prevention, treatment, and care efforts in 14 of the world’s most  severely affected countries. The administration’s strategy establishes the  goal of supplying antiretroviral (ARV) treatment to 2 million HIV-infected  people, preventing 7 million new HIV infections, and providing care to 10  million people infected or affected by HIV/AIDS, including orphans. The  strategy also seeks to streamline the U.S. approach to global HIV/AIDS  treatment by coordinating and deploying U.S. agencies and resources  through a single entity, the Office of the U.S. Global AIDS Coordinator (the  Coordinator’s Office), created in January 2004, within the Department of  State. The U.S. Agency for International Development (USAID) and the  Department of Health and Human Services (HHS) are primarily responsible  for implementing PEPFAR overseas.
Whereas previous U.S. programs focused mainly on preventing HIV/AIDS,  PEPFAR proposes that the U.S. government commit significantly greater  resources to providing treatment for those infected by the virus. In this  context, you requested that we (1) identify major challenges to U.S. efforts  to expand ARV treatment in resource-poor settings and (2) assess the U.S.  Global AIDS Coordinator’s response to these challenges.
To identify challenges to U.S. efforts to expand ARV treatment, we  conducted 28 structured telephone interviews in December 2003 and  January 2004 with key staff from USAID and HHS’ Centers for Disease  Control and Prevention (HHS/CDC) in the 14 targeted countries (we  conducted one USAID and one HHS/CDC interview in each country). We  coded the responses to our open-ended interview questions using a set of  analytical categories we developed. We also reviewed numerous  documents analyzing treatment programs from U.S. government agencies,  U.N. organizations, and nongovernmental organizations (NGO), including  reports by medical experts and practitioners. We also interviewed U.S.- based officials from USAID and HHS; representatives from multilateral  organizations, including the World Health Organization (WHO), the Joint  United Nations Program on HIV/AIDS (UNAIDS), the World Bank, and the  Global Fund to Fight AIDS, TB, and Malaria (Global Fund); and medical  experts experienced in treating people with HIV/AIDS in resource-poor  settings. To assess the U.S. Global AIDS Coordinator’s approach to  coordinating the U.S. response to these challenges, we reviewed the  February 2004 PEPFAR 5-year strategy, administration guidance, and  information on the emerging structure and initial activities of the  Coordinator’s Office. We also interviewed officials from the Coordinator’s  Office, USAID, and HHS. We conducted our work from July 2003 through  May 2004, in accordance with generally accepted government auditing  standards. (See app. I for further details of our scope and methodology and  app. II for our structured interview questions.)
subsections: section_title: Background
paragraphs: About 40 million people globally were living with HIV/AIDS as of December  2003, most of them in sub-Saharan Africa; few have access to treatment.  Propelled by recent advances in ARV treatment, PEPFAR is the first U.S.  program to seek to dramatically expand HIV/AIDS treatment in resource- poor settings. PEPFAR builds on U.S. bilateral efforts begun in June 2002 to  prevent mother-to-child transmission of HIV during pregnancy, labor and  delivery, and breastfeeding. In May 2003, P.L. 108-25 established the  position of the U.S. Global AIDS Coordinator to lead the U.S. response to  HIV/AIDS abroad; the Senate confirmed the Coordinator in October 2003.  The office received its initial appropriation in January 2004.
subsections: section_title: AIDS Takes Heavy Toll, Particularly in Africa
paragraphs: About two-thirds of those infected with HIV live in sub-Saharan Africa.  More than 50 percent of all HIV infections in the world, and nearly 70  percent of HIV infections in Africa and the Caribbean, occur in the 14  PEPFAR countries. According to WHO, less than 7 percent of the HIV- infected people in need of ARV drugs were receiving them at the end of  2003. UNAIDS reports that about 3 million people died from AIDS in 2003,  the vast majority of them in sub-Saharan Africa. The disease has decimated  the ranks of parents, health-care workers, teachers, and other productive  members of society in the region, severely straining national economies  and contributing to political instability.
section_title: Recent Advances Allow HIV/AIDS Treatment in Resource-poor Settings
paragraphs: Propelled by recent advances in ARV treatment, PEPFAR is the first U.S.  program to seek to dramatically expand HIV/AIDS treatment in resource- poor settings. In the 1990s, medical experts found that new forms of  treatment, involving a combination of three drugs, were effective in  suppressing the virus and thus slowing progression to illness and death.  According to medical experts, data from Brazil, Uganda, and Haiti showed  that patients in resource-poor settings adhere well to this complex drug  regimen. Adherence to ARV treatment is important: if patients do not take  the drugs properly or consistently, the virus in their bodies may become  resistant to the drugs and the drugs will cease to be effective. The  treatment must continue for life.
Since 2000, the price of ARV drugs has dropped considerably, from a high  of more than $10,000 per person per year to a few hundred dollars or less  per person annually, owing in part to the increased availability of generic  ARV drugs and public pressure. In addition, some generic manufacturers  have combined three drugs in one pill—known as fixed-dose combinations,  or FDCs—thereby reducing the number of pills that patients must take at  one time. While major multilateral and other donors allow recipients of  their funding to purchase these FDCs, the Office of the U.S. Global AIDS  Coordinator currently funds only the purchase of drugs that have been approved by a “stringent regulatory authority,” citing concerns about the  quality of drugs that have not demonstrated safety and efficacy to such an  authority. Presently, only brand-name drugs meet this standard. As a  result, the Coordinator’s Office does not now fund the purchase of generic  ARV drugs, including FDCs. However, on May 16, 2004, the HHS Secretary  announced an expedited process for reviewing data submitted to the  HHS/Food and Drug Administration (HHS/FDA) on the safety, efficacy, and  quality of generic and other ARV drugs, including FDCs, intended for use  under PEPFAR.
To date, only more developed countries have offered ARV treatment on a  massive scale. The planned expansion of treatment to millions of people in  developing countries under PEPFAR coincides with international efforts to  increase the availability of treatment to HIV-infected people in poor  countries. These efforts include the launch of the Global Fund in January  2002 and a campaign by WHO, announced in 2003 on December 1 (World  AIDS Day), to provide access to ARV treatment to 3 million people by the  end of 2005, commonly referred to as the “3 by 5” campaign. (See app. III  for more information on global, including U.S., HIV/AIDS funding.)   PEPFAR’s goal is to initiate ARV treatment for nearly 2 million people in the  14 targeted countries by 2008. As of February 2004, a total of 78,921 people,  or about 4 percent of that goal, were receiving ARV treatment in these  countries (see fig. 1). On April 25, 2004, to synchronize international  efforts, the Global AIDS Coordinator and his counterparts from UNAIDS,  the World Bank, the Global Fund, and other bilateral donors voiced their  support for an international agreement to abide by the following principles:  (1) that there be one agreed-upon framework for coordinating HIV/AIDS  activities among all donors and other partners in each recipient country;  (2) that each recipient country have one national AIDS coordinating  authority; and (3) that each recipient country have one system for  monitoring and evaluating AIDS programs.
section_title: PEPFAR Builds on Earlier U.S. Efforts to Combat HIV/AIDS Globally
paragraphs: PEPFAR builds on U.S. bilateral efforts begun in June 2002 under another  presidential initiative that focused on preventing mother-to-child  transmission (PMTCT) of HIV during pregnancy, labor and delivery, and  breastfeeding. This $500 million initiative, formally known as the  International Mother and Child HIV Prevention Initiative, and more  commonly referred to as the PMTCT Initiative, focused on the same 14  countries as PEPFAR. According to administration officials, the countries  were selected based on the severity of their HIV/AIDS burden, the extent to  which they have a substantial U.S. government presence, the effectiveness  of their leadership, and foreign policy considerations. The initiative focuses  on treatment and care for HIV-infected pregnant women and provides a  short course of ARV treatment that has been shown to be 50 percent  effective in lowering the risk of transmission of the virus in breast-feeding  mothers. With the establishment of the Coordinator’s Office, PMTCT  Initiative funding and activities were included in PEPFAR.  (See fig. 2 for a  timeline of international and U.S. efforts to combat HIV/AIDS worldwide.)
The agencies primarily responsible for implementing PEPFAR are the State  Department, where the U.S. Global AIDS Coordinator is based and reports  directly to the Secretary of State; USAID; and the Department of Health and  Human Services (HHS). The Coordinator plays an overall coordinating role,  and the State Department raises HIV/AIDS issues through diplomatic  channels and public relations campaigns. USAID maintains overseas  missions in 12 of the 14 PEPFAR focus countries, with personnel trained in  procurement and managing grants to foreign entities; it works with NGOs  and other entities. HHS’s overseas presence is focused on providing  technical assistance and is more recently initiated. HHS/CDC provides  clinicians, epidemiologists, and other medical experts who generally work  directly with foreign governments, health institutions, and other entities.  Within HHS, PEPFAR also draws on expertise from the National Institutes  of Health/National Institute of Allergy and Infectious Diseases, which is  involved in HIV/AIDS research in PEPFAR focus countries; the Health  Resources and Services Administration, which has experience expanding  HIV/AIDS and other health services in resource-poor settings in the United  States and is providing some assistance in several PEPFAR focus countries;  and the Office of the Secretary/Office of Global Health Affairs, which plays  a coordinating role on HIV/AIDS within HHS. Other agencies involved in  PEPFAR are the Department of Defense, which works on HIV/AIDS issues  with foreign militaries, helps construct health facilities, and conducts some  research and program activities in PEPFAR focus countries; the Peace  Corps; and the Departments of Labor and Commerce, which are involved in  HIV/AIDS-related activities in the workplace and with the private sector,  respectively. (See fig. 3.)
section_title: Global AIDS Coordinator’s Office Established, Implements Funding Mechanisms
paragraphs: In May 2003, the U.S. Leadership Act established the position of the U.S.  Global AIDS Coordinator “to operate internationally to carry out  prevention, care, treatment, support, capacity development, and other  activities for combating HIV/AIDS;” the Senate confirmed the Coordinator  in October 2003. (See app. IV for detailed information on the structure of  this office.)  The Coordinator has been granted authority to transfer and  allocate the funds appropriated to his office among the U.S. agencies  implementing PEPFAR in the 14 focus countries and additional bilateral  HIV/AIDS programs in other countries. The U.S. Leadership Act authorizing  PEPFAR states that not less than 55 percent of the amount appropriated  pursuant to section 401 of the act is to be spent on treatment and that at  least three-quarters of that amount should be spent on the purchase and  distribution of ARV drugs for fiscal years 2006 through 2008. Of the  remaining 45 percent, 20 percent should be spent on prevention, 15 percent  on palliative care, and 10 percent on orphans and other vulnerable children.
Congress appropriated $488 million for the Coordinator’s Office in fiscal  year 2004, and the President requested $1.45 billion for fiscal year 2005. The  office was formally established in January 2004. It created three  mechanisms, or funding “tracks,” to allocate money: track 1, track 1.5, and  track 2. Tracks 1 and 1.5 are one-time mechanisms that rapidly allocated  funds to expand ongoing activities through Washington, D.C.-based  multicountry awards and locally based country-specific awards,  respectively. Track 2 serves as an annual operational plan for each country.  A portion of the funds for tracks 1 and 1.5 were obligated by a target date of  January 20, 2004 and the remainder were obligated by mid-February  following congressional notification; budgets for track 2 were submitted  to the Coordinator’s Office for review on March 31, 2004, and approved on a  rolling basis through early May. Pending congressional review, the  Coordinator’s Office expects that agencies will have begun to obligate  these funds by the end of June. PEPFAR activities are generally executed  through procurement contracts or through grant agreements or  cooperative agreements with implementing entities such as NGOs and ministries of health (and/or national AIDS control programs).  (See app. V  for additional information on initial obligations.)
section_title: U.S. Government Faces Five Major Challenges to Expanding ARV Treatment in Resource- poor Settings
paragraphs: In our structured interviews, we identified the following major challenges  to U.S. government agencies in expanding ARV treatment in resource-poor  settings:  (1) difficulties coordinating with other groups involved in  combating HIV/AIDS; (2) U.S. government policy constraints; (3) shortages  of qualified health workers; (4) host government constraints; and (5) weak  infrastructure (see fig. 4). These challenges were also highlighted by  numerous government and nongovernment experts whom we interviewed  and in documents we reviewed. (See app. VI for additional analysis of these  challenges.)
subsections: section_title: U.S. Government Faces Challenges Coordinating ARV Treatment Programs
paragraphs: All of the field staff we interviewed in the 14 PEPFAR countries identified  problems coordinating with other groups. Nearly all cited problems  coordinating with non-U.S. government groups, and slightly fewer cited  problems coordinating with other U.S. government entities. Consequences  of the coordination problems cited by field staff include duplicate efforts,  confusion over standards, and heavy administrative burdens.
subsections: section_title: Almost All Field Staff Cited Difficulty Coordinating with Non-U.S. Groups
paragraphs: Twenty-seven of 28 respondents cited challenges coordinating with non- U.S. government groups, particularly with host governments and  multilateral organizations.
Just over three quarters (22 of 28) of the field staff we interviewed provided  examples of challenges to coordination between the U.S. government and  the host governments in the PEPFAR focus countries. One of the most  commonly cited challenges dealt with host governments’ perceptions. Field  staff said that host government officials are often skeptical of donors’  intentions and may question the commitment of donors and the  sustainability of new treatment programs, especially when they think that  donors are promoting programs that run counter to their national  strategies. Similarly, an NGO official working with the host government in  one of the 14 PEPFAR focus countries reported that when initial funding  plans were created, U.S. field staff for the country ignored existing  government and NGO programs. The official said that the plans for this  country also did not incorporate any funding for training, which was a  stated government priority. In addition, consulting the host government  only after funding applications were completed has increased government  officials’ skepticism regarding U.S. intentions and programs in this country,  according to U.S. field staff. Field staff also noted that it is difficult to  coordinate with host governments owing to the governments’ limited  human resource capacity. In addition, staff are often hindered by the  governments’ slow bureaucratic practices and lack of understanding of  U.S. and other donors’ programs and policies. Field staff commented that  all of these problems, paired with expedited PEPFAR timelines and  consequently compressed consultation time, could increase the challenges  faced by the United States in persuading host governments to support  PEPFAR plans for expanded treatment.  Field staff generally reported the  most difficulty coordinating with host governments and multilateral  organizations (see app. VII).
Sixteen of 28 field staff identified coordination challenges with multilateral  organizations (such as the World Bank, the Global Fund, WHO, and other  U.N. organizations), with many citing perception issues. Because of the  influx of PEPFAR funding, the United States will significantly increase its  financial investment in treatment programs, potentially causing other  donors to see themselves as overshadowed. Staff noted that before the  United States instituted the PMTCT Initiative, UNICEF was the main  implementer of these programs. According to field staff we interviewed,  when the United States expanded its own programs, UNICEF and other  donors felt “steamrolled” by programs that were quickly put in place by the  United States with little input from the donor community. Some U.S. staff  said that PEPFAR is replicating this unilateral approach. According to  these staff, the perception that the United States acts unilaterally is  compounded by the fact that, unlike many other donors, U.S. agencies are  not allowed to contribute money to other donors’ programs or to pooled  host government funding “baskets” for the health and other sectors. The  staff noted that some donors therefore indicated that the United States is  willing to create duplicative programs. Staff frequently cited the need for  the United States to work with the WHO as both the PEPFAR program and  WHO’s 3-by-5 campaign begin. Staff said that such coordination is needed  to minimize overlapping efforts, confusion over standards, and the  administrative burden on host governments and other donors.
Finally, while some staff noted that they have not had enough time to  coordinate efforts, many said that all stakeholders need to harmonize  specific aspects of treatment programs—including treatment guidelines,  training schedules and materials, technical approaches, educational and  media campaigns, procurement policies, hiring and payment policies, and  the collection and reporting of data. The staff indicated that without  harmonization, unnecessary duplication and confusion could occur as  treatment programs are expanded.
section_title: Field Staff Cited Challenges Coordinating with Headquarters and Other U.S. Agency Field Offices
paragraphs: Twenty-four of 28 respondents cited challenges in coordinating with other  U.S. government agencies, their agency’s headquarters, or the  Coordinator’s Office in Washington, D.C. Twenty-two of the field staff we  interviewed told us that they face challenges coordinating with  headquarters, and 15 of 28 said that they face challenges coordinating with  other U.S. government agencies in the field. These challenges were also  cited in documents field staff prepared for the Global AIDS Coordinator.
Field staff reported that headquarters did not coordinate with them early in  the process of developing activities for the PMTCT Initiative and PEPFAR.  For example, they expressed concern that headquarters announced  intended programs without first notifying staff in the field or giving them  the opportunity to discuss the PMTCT Initiative and PEPFAR programs  with host governments. Field staff stated that government officials in these  countries often regarded such announcements as statements of  commitment rather than intention, resulting in overly optimistic  expectations of the amounts of funding they might receive from the United  States. Also, headquarters’ limited coordination with field staff has made it  more difficult for U.S. officials in-country to work with host governments,  increasing these governments’ perception that the United States is  imposing programs on them rather than seeking their commitment or  concurrence, which could impede U.S. efforts to expand ARV treatment.
In addition, when discussing coordination problems between the field and  headquarters, most field staff said that they were burdened by  administrative requirements, during both the PMTCT Initiative and the  initial stages of the PEPFAR planning. For example, eight respondents  stated that they rushed to complete multiple reporting requirements that  were often unclear or redundant. This point was also made in several  written communications from the field to the Coordinator’s Office. Three  respondents stated that at the same time they were trying to work with  their agency counterparts in the field to complete integrated reporting  requests from the Coordinator’s Office, they were asked by headquarters to  prepare duplicative, agency-specific reports, which further compounded  their burden. Five respondents indicated that the time spent responding to  these requests within the period allotted has directly limited their ability to  implement treatment programs.
Just over half (15 of 28) field staff also identified coordination challenges  among agencies in the field. Most staff that raised interagency issues cited  challenges arising from the different agencies’ roles—for example,  HHS/CDC has traditionally provided technical assistance directly to foreign  governments through cooperative agreements, while USAID has focused  on development, primarily by managing grant agreements implemented by  NGOs. Staff further stated that as the programs become more coordinated,  challenges could arise from agencies’ differing administrative procedures.  For example, agencies may have different procurement or hiring policies;  agencies entering a program area may find themselves competing with  another agency previously dominant in that area; and field staff busy with  administrative tasks and program implementation may find little time to  communicate with their field counterparts.
section_title: U.S. Policy Constraints Limit Agencies’ Ability to Rapidly Expand Treatment Programs
paragraphs: Twenty-five of the 28 structured interview respondents identified U.S.  policy constraints as a challenge that could limit the ability of the agencies  implementing PEPFAR to rapidly expand treatment programs. In  particular, unclear guidance on whether U.S. agencies can purchase  generic ARV drugs, including FDCs, makes it difficult for the PEPFAR  agencies to plan support for national treatment programs, some of which  use these drugs. In addition, field staff raised concerns that their current  contracting capacity will not be sufficient to manage the large influx of  funds expected under PEPFAR. Further, differing laws governing the funds  appropriated to these agencies—affecting procurement standards and  foreign taxation of U.S. assistance—and varying grant requirements used  by the agencies may challenge their joint efforts to expand ARV treatment  programs.
subsections: section_title: Unclear Guidance on ARV Procurement Complicates PEPFAR’s Ability to Support Country Treatment Programs
paragraphs: Twenty-one respondents indicated that they had not received adequate  guidance on the procurement of ARV drugs, which makes it difficult for the  U.S. missions to plan their support of country programs. At least four of the  national programs in the PEPFAR focus countries are currently purchasing  generic ARV drugs with their own funds or with funds from the Global  Fund or other sources, and other countries are considering purchasing  them. In addition, in other PEPFAR countries, NGOs such as Médecins sans  Frontières (Doctors Without Borders) are also purchasing generic ARV  drugs. Given this situation, and the fact that USAID and HHS/CDC have  different procurement standards, one USAID official in Africa stated that  adhering to the agency’s current standards, which generally require that  USAID-financed pharmaceuticals be produced in and shipped from the  United States, will present a challenge as more governments purchase  generic FDCs to boost adherence. An HHS/CDC official in the same  country stated that the host government is buying these drugs with Global  Fund money and training doctors and pharmacists to support this regimen.  He said that it would complicate the country’s ability to expand treatment if  the United States is not able to support such a regimen.
In addition, in communications to the Global AIDS Coordinator in mid- to  late-2003, U.S. government officials in several PEPFAR focus countries  requested guidance regarding local procurement of ARV drugs. A  September 18, 2003, communication from Ethiopia observed that several  local companies are poised to produce generic ARV drugs, and an October  8, 2003, communication from Uganda stated that generic drugs are  available at much lower prices than brand-name drugs. The Uganda  communication also stated that procurement of nonlocal goods or services  (e.g., U.S. brand-name ARV drugs) to implement PEPFAR will undermine  PEPFAR’s goal of enhancing local capacity to fight HIV/AIDS.
section_title: Field Staff Concerned That Current Contracting Capacity Is Insufficient to Manage PEPFAR Funds
paragraphs: Almost half (13 of 28) of the structured interview respondents, primarily  from HHS/CDC, stated that contracting capacity in the field is a problem.  According to documents submitted to the Coordinator’s Office, U.S.  government field staff in four countries expressed the need for increased  contracting capacity to process procurement of goods and services, such  as medical equipment, and increased capacity to award and administer  contracts, grant agreements, and cooperative agreements with  implementing organizations to allow rapid expansion of treatment under  PEPFAR. Further, a June 2003 communication summarizing lessons  learned from the PMTCT Initiative stated that HHS/CDC, which uses the  embassy contracting system, has experienced considerable delays, funding  level ceilings, and other difficulties in processing contractual transactions.  HHS/CDC uses the embassy contracting system because it does not have  contract officers in the field. The communication stated that these  difficulties raise concerns that the embassy system will not be able to  handle the number of contracts and inflow of funds needed to expand  treatment under PEPFAR.
Two HHS/CDC respondents cited embassy spending limits as a problem.  One HHS/CDC respondent explained that the embassy in his country can  process purchase orders for up to $100,000 but that orders exceeding that  amount require additional consultation in Washington, a process that can  take 4 to 6 months. He added that the $100,000 ceiling will be reached  quickly under PEPFAR and that the embassy procurement system is  designed for buying items like furniture rather than evaluating, awarding,  and managing long-term contracts or grant agreements with implementing  partners. Another HHS/CDC respondent stated that it takes time to  familiarize embassy personnel with the specifications for certain medical  equipment related to ARV treatment. Moreover, he stated that if the  equipment is specialized, it may have only one supplier, causing additional  delays for the embassy to justify sole sourcing. When questioned about  these examples, HHS/CDC contract officers at headquarters stated that a  time frame of several months is not unusual and that the process could take  just as long regardless of whether it went through the embassy, HHS/CDC  headquarters, or an HHS/CDC field office.
Although HHS/CDC field staff articulated more concerns regarding  inadequate contracting capacity in the field, the PMTCT Initiative summary  stated that the current number of USAID contract officers in the field will  be insufficient to facilitate the number of contracts and large amount of  funds needed to meet PEPFAR treatment goals. Another communication,  dated December 5, 2003, spoke of “an urgent plea for greater contracting  officer support,” and a third communication, dated October 16, 2003, cited  “a desperate need for contracting agents in-country.” In addition, a USAID  respondent in one country and HHS/CDC respondents in three countries  stated that more staff in general are needed in the field to expand treatment  under PEPFAR.
The PMTCT Initiative summary and a communication from Botswana to  the Coordinator’s Office offered several suggestions for addressing the  problem. These suggestions included changing the contracting system or  increasing the number of contract officers in the field and strengthening  USAID regional contracting offices with additional personnel and capacity  to travel to countries in their region. The PMTCT Initiative summary also  recommended that HHS/CDC and its parent agency, HHS, work with the  Department of State to review current contracting mechanisms and  develop strategies that will allow for greater flexibility and capacity to  program PEPFAR funds. According to technical comments on a draft of  this report that were submitted jointly by the Coordinator’s Office, HHS,  and USAID, the funding requests required of field staff for track 1.5 (rapid  allocation of funds to expand ongoing activities) and track 2 (annual  operational plans) specifically asked what additional contracting support  field staff would need, and some posts have been allotted staffing positions  to help fill these gaps.
section_title: Differing Laws and Regulations May Inhibit Agencies’ Joint Efforts to Expand Treatment Programs
paragraphs: The agencies implementing PEPFAR are subject to varying laws and  regulations regarding procurement and foreign taxation of U.S. government  assistance, as well as differing grant requirements for audits of grantees.  These differences may cause confusion among NGOs—particularly if they  are not U.S. organizations—receiving grants from several agencies to  implement PEPFAR.
Agencies Have Different Procurement and Taxation Rules  USAID and HHS agencies, such as HHS/CDC and the National Institutes of  Health (HHS/NIH), may require their grantees to use different procurement  standards owing to the agencies’ different appropriations legislation and  operating procedures. In South Africa, for example, according to USAID  officials in that country, the mission obligated all of its money for drug  procurement under PEPFAR track 1.5 through the HHS/NIH; that agency’s  funds are governed by less restrictive rules for overseas procurement, and  HHS/NIH was therefore able to allocate the money quickly to meet a  January 2004 deadline. In a January 2004 communication submitted to the  Coordinator, officials in that country raised questions regarding the  application of different procurement rules. Interview respondents in two  other African countries also raised these questions.
Similarly, the South African communication to the Coordinator raised  questions concerning the application of rules on foreign taxation  restrictions. Section 506 of the Foreign Operations, Export Financing and  Related Programs Appropriation Act for 2004 (the 2004 Foreign Operations  Appropriations Act) prohibits funds appropriated by the act to be used to  provide assistance for a foreign country under a new bilateral assistance  agreement unless the agreement exempts the assistance from taxation. In  addition, the provision states that when a host country assesses taxes on  U.S. assistance provided under the act, an amount equal to 200 percent of  the total assessment shall be withheld from the fiscal year 2005  appropriations for assistance to that country.  Since this restriction applies  only to funds appropriated under the 2004 Foreign Operations  Appropriations Act, it does not affect funds appropriated to HHS agencies  in their own appropriations acts. According to the communication from the  field and interviews we conducted with the procurement and legal officials  who contributed to it, there could be confusion among agencies and grant  recipients over managing funds provided under different appropriations  laws, since some of the funds are subject to the taxation provision and  some are not.
In addition, there was initial confusion over what restrictions would apply  to money appropriated to the Coordinator’s Office and transferred to HHS  agencies. Since funding for the Coordinator’s Office was appropriated  under the 2004 Foreign Operations Appropriations Act, certain restrictions  apply to these funds, including the taxation provisions discussed above and  procurement restrictions in the Foreign Assistance Act of 1961. Officials  from the Coordinator’s Office told us that they recently determined that  funds transferred to agencies from that office would still be subject to their  original appropriations restrictions. In contrast, funds appropriated  directly to HHS for PEPFAR-related activities are not subject to these  restrictions. We spoke with the authors of the South African  communication and an HHS/CDC grantee, who raised concerns over  managing funds that may be subject to differing restrictions. They stated  that grantees could be confused by differing sets of rules. The grantee, a  U.S. organization, also noted that non-U.S. grantees often lack the  resources to ascertain what these rules require. According to HHS officials,  the Coordinator’s intention is to set one policy for all U.S. government  agencies implementing PEPFAR.
Agency Requirements for Auditing Grantees Vary  Agencies have varying grant requirements regarding the auditing of foreign  recipients of U.S. funds, possibly complicating the agencies’ oversight of  organizations implementing PEPFAR. Office of Management and Budget  circular A-133 provides uniform auditing standards applicable to all U.S.  government agencies with respect to grants awarded to U.S. entities.  However, it does not apply to non-U.S. entities that receive funds directly  as grant recipients or indirectly as subrecipients. U.S. government officials  expect that many such entities will implement PEPFAR. USAID officials  noted that their agency requires that any local (i.e., non-U.S.) grantee  spending more than $500,000 in U.S. government funds per year be audited  annually, for example, by a preapproved local audit firm in accordance with  U.S. government auditing standards. HHS/CDC’s audit requirements for  non-U.S. grantees differ from USAID’s in that audits must be performed by  a U.S.-based firm (which, according to USAID audit officials, could be  expensive). HHS/CDC’s audit requirements for non-U.S. grantees also  state that audits must be performed according to international accounting  standards or standards approved by HHS/CDC. The January  communication from South Africa requested that these differences be  worked out quickly so that field staff can incorporate appropriate language  and cost implications in grant agreements currently being negotiated with  organizations that will be implementing PEPFAR.
section_title: Insufficient Host Country Human Resources Hinder ARV Treatment Expansion
paragraphs: Insufficient host country human resources critically challenge U.S. efforts  to implement and expand AIDS treatment, according to agency officials in  23 of our structured interviews as well as key documents we reviewed.  Inadequate training; high staff turnover, due in part to low compensation;  and national policies and regulations limiting the use and hiring of doctors  all contribute to human resource constraints in the PEPFAR countries.
subsections: section_title: U.S. and Multilateral Sources Cited Host Country Worker Shortages
paragraphs: U.S. field staff in 18 of 28 structured interviews identified shortages of  trained host country personnel, including doctors, nurses, and  administrators, as a major limitation to U.S. efforts to expand ARV  treatment. In addition, three officials working with the Coordinator’s Office  identified the human resource shortage as a critical issue that could impede  the success of PEPFAR. Further, an assessment of four AIDS treatment  sites in Kenya by Family Health International and Management Sciences for  Health found that all sites were operating at half the recommended  staffing levels. Multilateral and bilateral organizations have also reported  on health personnel shortages. A joint World Bank–WHO paper stated that  in many poor countries, the number of health workers is grossly  insufficient for the widespread implementation of a minimum of lifesaving  interventions, and a separate WHO paper stated that shortages of human  resources are a major constraint to expanding HIV/AIDS treatment and  care. For example, the size of the health workforce in Tanzania must  triple by 2015 to deliver health care, including HIV/AIDS treatment, to the  majority of the population, according to a report funded by the United  Kingdom Department for International Development. While accurate data  are difficult to obtain, WHO data indicate wide variances in the numbers of  doctors and nurses in the 14 countries. Even in Botswana, one of the 14  countries reporting the highest number of doctors per capita, field staff  reported a shortage of trained doctors who can provide ARV treatment.
The country’s president cited human resource constraints as one of the  major challenges to introducing ARV treatment in Botswana.
section_title: Inadequate Training of Workers Hinders ARV Treatment Expansion
paragraphs: Half of the field staff we interviewed said that in the countries where they  work, insufficient numbers of personnel are adequately trained to facilitate  expansion of ARV treatment. According to a USAID-funded paper, low- quality nursing and medical training schools inhibit the countries’ ability to  produce qualified providers. In addition, an HHS/CDC official in one  African country cited lack of public health training as a key challenge to  expanding AIDS treatment in that country. A Coordinator’s Office official  and UNAIDS officials stated that limited human capacity inhibits the ability  of PEPFAR countries to monitor and evaluate ARV treatment, and an  advisor to a national AIDS program in another African country stated that  staff at the national drug procurement center are not properly trained and  that as a result, the center has experienced shortages of health supplies.
Moreover, donor efforts to improve the skills of health workers through  training are not well coordinated, according to USAID and HHS/CDC  officials in the field. Lack of coordination results in duplicative training  materials or different messages, according to an HHS and WHO official  respectively. Further, the World Bank–WHO paper notes that payment of  high per diems by donors to ensure attendance at workshops and seminars  distracts managers and staff from their work.  In addition, the USAID- funded report stated that donors traditionally have focused more on short- term rather than longer-term interventions such as helping to develop and  improve medical, nursing, and other technical schools.
subsections: section_title: High Turnover Exacerbates Shortages
paragraphs: According to agency field staff and multilateral and other U.S. sources, high  turnover of health services personnel is a significant factor contributing to  the shortage of health workers in PEPFAR countries, hindering the delivery  and expansion of ARV treatment. Seven respondents cited high staff  turnover as a challenge, and of these seven, four cited low public sector pay  as a factor leading to turnover. Written documents from field staff also  stated that low public sector pay contributes to turnover. For example, the  USAID-HHS/CDC Fiscal Year 2004 PMTCT Initiative Implementation Plan  for Rwanda stated that rapid turnover of personnel, due to noncompetitive  public sector salaries, “burnout,” and the loss of trained health-care  workers from the public sector, affects the health ministry’s ability to  advance programs. Further, the document anticipated that personnel issues  will constitute a major challenge to expanding ARV treatment in that  country. A USAID-funded study reported that, in some cases, health care  providers leave the public sector to earn higher salaries in the private  sector or with NGOs. Similarly, the President of Botswana said that the  country’s national ARV program lost skilled health and other workers to  NGOs and development partners, who pay higher salaries than the  government. Three U.S. field staff we spoke with emphasized the need for  donors to coordinate on common policies regarding salaries for health  workers. Likewise, a World Bank expert and a WHO official suggested that  donors should develop policies to supplement salaries for public health  workers to help alleviate the shortages.
Worker emigration and death from AIDS among health workers also  contribute to staff shortages. World Bank and WHO reports noted that low  pay and poor working conditions contribute to the migration of skilled  health workers from resource-poor countries. WHO reported that one- quarter to two-thirds of health care professionals interviewed in some  African countries expressed an intention to emigrate to other countries.   The report identified lack of training and career opportunities, poor pay  and working conditions, and political conflicts and wars as the main  factors leading to emigration. In addition, according to a May 2004 WHO  report, AIDS deaths have dramatically increased among the health  workforce throughout the developing world.
section_title: National Policies and Regulations Limit Use and Hiring of Doctors
paragraphs: Host governments’ national policies and regulations regarding the use and  hiring of doctors limit the number of health services personnel available to  provide ARV treatment. For example, U.S. government officials in one  country said that a policy requiring that only doctors treat AIDS patients  represented the greatest obstacle to expanding treatment. Documentation  on the national ARV program in that country recommended devolving  responsibility to lower level staff, but mentioned that labor issues could  hinder this. In another country, according to a U.S. official, hiring doctors  in the public sector can take 6 months to a year.
section_title: Host Government Constraints Inhibit Expansion of ARV Treatment
paragraphs: Rapid expansion of treatment has been impeded by host government  constraints, including, in some countries, limited political commitment to  combating HIV/AIDS, poor delineation of roles among government bodies  responsible for addressing HIV/AIDS, and slow decision-making processes,  according to 19 of the structured interview respondents and written  communications to the Coordinator’s Office from the field.
subsections: section_title: Limited Political Commitment Hampers Treatment Expansion
paragraphs: Eleven of the 28 respondents cited lack of political commitment to address  HIV/AIDS as a major challenge. According to U.S. officials working in one  country, despite proclamations at the highest levels that HIV/AIDS  constitutes an emergency, it is not treated as such. They noted that they  have great difficulty getting a response from the government, which tends  to be slow and bureaucratic, and that the health ministry has never been  powerful or well funded. Similarly, USAID officials in another country said  that although there are strong leaders at the health ministry’s HIV/AIDS and  TB division, weak leadership at higher levels in the ministry has made it  difficult to advance programs. A joint U.S. government communication,  dated September 18, 2003, from a third country stressed the urgent need for  high-level political commitment to assure that ministries provide sufficient  oversight and staff for effective programming. Conversely, staff in a fourth  country stated that political will to address HIV/AIDS has been  demonstrated by the central government but not at the local level, where  much of the program implementation will occur.
section_title: Poor Delineation of Roles Impedes Expansion Efforts
paragraphs: A quarter of the respondents (7 of 28) cited institutional constraints, such  as poor delineation of roles between government bodies responsible for  addressing HIV/AIDS, as an impediment to expanding treatment. For  example, a U.S. official in one country said that the lack of a clear  distinction and definition of roles and responsibilities within the ministry of  health and weak management structure constrained his efforts to  implement the PMTCT Initiative. A U.S. official in another country reported  difficulty working with the host government because several different  government entities have responsibility for HIV/AIDS, with no clear  reporting hierarchy. Further, HHS/CDC officials in a third country voiced  concern about friction between the health minister and the AIDS minister  regarding the control of money from the World Bank. The HHS/CDC  officials are concerned that the disagreement might result in two separate  coordinating mechanisms, causing duplication of efforts.
section_title: Slow Decision-Making Processes Delay Rapid Expansion
paragraphs: Four respondents from our structured interviews cited host governments’  slow decision-making processes as a key challenge to rapidly expanding  ARV treatment. For example, according to a U.S. government official in one  country, extensive consultation and discussion delayed programmatic and  management decisions, slowing implementation of the PMTCT Initiative.  Similarly, HHS/CDC officials in another country said that country’s  tradition of consensus-based decision-making requires a great deal of  consultation and thus inhibits the country’s ability to quickly address  situations such as the AIDS epidemic. According to the officials, this  slowness was the major challenge in implementing the PMTCT Initiative in  that country. However, the officials also stated that consensus-based  decision-making reduces opportunities for corruption, a problem reported  by U.S. officials in four countries as a challenge to implementing programs.  An HHS/CDC official in a third country reported that decision making is  slow because several levels of officials have to approve even routine  decisions.
section_title: Weak Infrastructure Hinders Expansion of Treatment
paragraphs: HHS/CDC and USAID field staff in 16 of 28 structured interviews cited  weak infrastructure in host countries as an impediment to implementing  and expanding ARV treatment. Specifically, they noted weak systems for  gathering information needed to monitor and evaluate programs;  inadequate systems for managing the drug supply; poor linkages among  HIV/AIDS programs and between these programs and basic health care  infrastructure; and insufficient physical infrastructure, including health  facilities, roads, and water supply.
subsections: section_title: Information Infrastructure Is Weak
paragraphs: In 8 of the 28 structured interviews, HHS/CDC and USAID field staff stated  that the infrastructure needed for monitoring and evaluating treatment  programs is weak. For example, field staff in one country stated that the  national AIDS control program’s indicators and data collection methods are  not sufficient to identify populations infected with HIV, and staff in a  second country said that that inadequate feedback to those who administer  services or collect data hampers the improvement of programs. Staff from  this country also stated that agencies’ differing methods of reporting  activities make determining data accuracy difficult. In addition, U.S. agency  documents from PEPFAR countries indicated the need for better data  collection tools, feedback of analysis and data to district and community  facilities, behavior change to increase the value placed on data, and  monitoring of the impact of programs as AIDS treatment expands.
A joint WHO–World Bank paper also emphasized the need to improve  health information systems at local, national and international levels.   Moreover, half or more of the structured interview respondents indicated  that they experienced moderate or greater difficulties in harmonizing data  collection methods and reporting requirements with other stakeholders  involved in AIDS treatment (see app. VII). According to officials from the  U.S. government, WHO, and UNAIDS, there is general international  consensus on what data should be collected but less consensus regarding  how the data should be collected and reported.
section_title: Systems for Managing Drug Supply Are Inadequate
paragraphs: Eight of 28 interview respondents said that the infrastructure needed to  manage and deliver drug supplies in their countries is inadequate,  complicating efforts to expand ARV treatment. Respondents in several  countries commented on, among other things, the difficulty of maintaining  a reliable supply of drugs and basic health commodities; a lack of  infrastructure for distributing and storing drugs and other commodities and  the absence of a sound commodity management information system; and a  protracted ARV shortage that could lead to drug resistance in thousands of  affected patients. In one country, fear of being penalized has kept the  government’s agency for procuring drugs and related items from sharing  information on drug shortages, thereby exacerbating the problem and  inhibiting efforts to address it, according to an advisor to the national AIDS  program.
section_title: Poor Program and System Linkages Inhibit Treatment Expansion
paragraphs: According to six interview respondents and written communications to the  Coordinator’s Office from five countries, poor linkages among programs  providing HIV/AIDS services inhibit the expansion of these services. For  example, U.S. officials in one country stated that the mechanism for  referring patients from sites where they receive counseling and testing to  sites where they can receive treatment needs to be improved. In addition,  U.S. officials in three other countries stressed the need to link PMTCT and  ARV treatment programs to other health services required by patients and  their families, such as nutrition and family planning.
Poor linkages between donor-supported HIV/AIDS programs and basic  health systems may also impair the ability of these systems to continue  ARV treatment once donor support is discontinued. According to an expert  directing two HIV/AIDS projects in four African countries, unless ARV  treatment is linked to investments in sustainable health systems, HIV/AIDS  programs can draw resources away from, and thus harm, the overall health  sector in recipient countries. For example, U.S. officials in one African  country stated that PEPFAR activities could decrease the number of staff,  quality of facilities, and availability of drugs for basic health services that  are not specifically focused on combating HIV/AIDS.
section_title: Physical Infrastructure, Including Health Care Facilities, Is Insufficient
paragraphs: According to our interviews and the documents we reviewed, deteriorated  physical infrastructure also constitutes a challenge to expanding ARV  treatment programs. Many of the hospitals, clinics, and laboratories in the  PEPFAR focus countries—some of which have experienced years of civil  strife—are ill equipped to handle expansion of ARV treatment. For  example, U.S. officials working in one country said that inadequate health  care facilities, including lack of laboratories, hamper the monitoring of  ARV treatment.  According to a U.S. government communication from  Ethiopia dated September 18, 2003, facilities must be refurbished and  equipment installed, among other needs, to support the implementation of  ARV treatment. A November 4, 2003 summary of a joint U.S. agency  discussion in Kenya stated that most health facilities targeted for  involvement in treatment activities have physical infrastructure needs that  should be addressed, including needs for testing and counseling space,  electricity, clean water, air conditioning in pharmacy storerooms to  maintain drug quality, and improved laboratory space. Further, the USAID- HHS/CDC Fiscal Year 2004 PMTCT Initiative Implementation Plan for  Uganda stated that there is inadequate space for program staff and  equipment at the ministry of health and for HIV counseling and testing in  prenatal clinics.
Multilateral and nongovernmental organizations have also identified weak  health care infrastructure as an impediment to expanding ARV treatment.  For example, when WHO ranked the overall health system performance of  its 191 member states in 2000, it ranked all 14 of the PEPFAR focus  countries in the bottom third. In many of these countries, up to one-half of  the population lacks access to basic health care and many health facilities  lack basic commodities, such as syringes, as well as laboratories and safe  drug storage facilities. In addition, limited infrastructure, including roads, a  clean water supply, and electricity, presents barriers to expanding ARV  treatment. For example, field staff from one country said that deteriorated  roads and other basic physical infrastructure pose a major challenge to  delivering clinical and diagnostic services.
section_title: Coordinator’s Office Has Taken Steps to Address Challenges, but Continued Effort Is Needed
paragraphs: The Office of the U.S. Global AIDS Coordinator has acknowledged each of  the five challenges to expanding ARV treatment programs and has taken  certain steps to address them, but some of these challenges require  additional effort, longer-term solutions, and the support of others involved  in providing ARV treatment.  First, the Coordinator’s Office has devised  means to improve coordination among U.S. agencies and with host  governments and other organizations; however, it is too soon to tell  whether they will be effective and the PEPFAR strategy does not state  whether the means will be monitored. Second, U.S. agencies are exploring  ways to address some U.S. government constraints, but the Coordinator’s  Office guidance on ARV procurement leaves key problems unresolved.  Third, the Coordinator’s Office proposed short-term assistance to address  health worker shortages, including the use of paid workers and volunteers  from the United States and other countries, and the PEPFAR strategy  proposes several longer-term interventions. However, U.S. officials said  that using international volunteers for the short-term activities is not cost  effective. Fourth, although the Coordinator’s Office has called for stronger  commitment by host governments, it has not addressed other, systemic  constraints outside its direct authority. Finally, the Coordinator’s Office is  taking steps to strengthen systems for monitoring and evaluating progress  toward PEPFAR treatment goals and is seeking to involve the private  sector in improving the management and supply of drugs. However, some  field staff had differing views on implementing a “network model”  proposed in the strategy for improving basic health care infrastructure and  facilitating treatment referrals. In addition, the Coordinator’s Office has not  addressed physical impediments such as lack of space for counseling and  testing.
subsections: section_title: Coordinator’s Office Attempting to Enhance Coordination, but Too Early to Judge Effectiveness
paragraphs: The Office of the U.S. Global AIDS Coordinator has acknowledged the  importance of coordinating with national governments and other groups  and has created mechanisms, such as HIV/AIDS teams led by the  ambassador in each country, to enhance U.S. government coordination in  the field and with the host government. However, it is too soon to tell  whether these mechanisms will resolve the coordination challenges  identified by field staff, and the PEPFAR strategy does not state whether  the mechanisms will be monitored.
Recognizing that providing ARV treatment requires a sustained,  collaborative effort from international, national, and local organizations,  the PEPFAR strategy outlined an approach to leverage the strengths of  each entity while building local capacity. According to the strategy, the  Coordinator is expected to maximize U.S. technical assistance, training,  and research experience when expanding treatment programs, while  working with other stakeholders to leverage strengths and fill program  gaps. In tandem with the host governments in the 14 PEPFAR focus  countries, the Coordinator is also expected to encourage the development  of a single in-country structure to facilitate coordination among donors, the  host government, NGOs, and other stakeholders.
The increased coordination may also facilitate efforts to harmonize  proposal, reporting, surveillance, management, and evaluation procedures  to ensure that programs are comparable and complimentary and to  decrease the burden on host organizations and governments. The strategy  specifies that the Coordinator’s Office will work with technically expert  partners, such as WHO, to determine the best treatment options and ensure  that there are sound management strategies in place to support them.  Finally, the Coordinator will encourage stakeholders to work through local  partners and promote programs that support the countries’ national  strategies.
In addition, the Coordinator has worked to establish relationships with  international counterparts, meeting with the leadership of WHO, UNAIDS,  the World Bank, and the Global Fund. The Coordinator, together with the  HHS Secretary, also led a delegation of representatives from the  administration, the Congress, WHO, UNAIDS, the Global Fund, and  numerous private entities and NGOs to meet with leaders and view ARV  treatment and other HIV/AIDS-related programs in four African nations in  December 2003.
To ensure that U.S. efforts in the field are coordinated, and to enhance  relationships with the host government, the Coordinator has directed that  an HIV/AIDS team, led by the Ambassador, be set up in each country. These  teams may also have an official designated by the Ambassador to serve as  the day-to-day liaison. The teams are generally comprised of  representatives of each of the agencies working on HIV/AIDS-related  projects in a given country. According to the field staff we interviewed,  these teams have already been set up in most countries, and some  countries had already established HIV/AIDS teams that will now focus on  PEPFAR. Also, to improve coordination between headquarters and the  field, the Coordinator’s Office sought input from field staff by requesting  written documents and by conducting an intensive series of meetings with  field staff over a 2-week period in November 2003. However, it is too soon  to tell whether these mechanisms will be effective in resolving the  coordination challenges field staff identified.
section_title: Agencies Exploring Solutions to Some U.S. Government Constraints, but ARV Procurement Problems Remain
paragraphs: The Office of the U.S. Global AIDS Coordinator, together with the agencies  implementing PEPFAR, is exploring options for addressing U.S.  government constraints involving (1) contracting capacity in the field; (2)  differing laws and regulations governing funds appropriated to  implementing agencies, in particular, USAID and HHS/CDC, with respect to  procurement and foreign taxation of goods purchased with U.S. assistance;  and (3) differing agency requirements for auditing non-U.S. grantees. In  addition, the Coordinator’s Office has provided guidance to the field on  ARV procurement. However, this guidance leaves key issues unresolved.
subsections: section_title: PEPFAR Agencies Exploring Options to Enhance Contracting Capacity and Address Differing Agency Laws, Regulations, and Requirements
paragraphs: The Coordinator’s Office and PEPFAR agencies are exploring ways to  enhance contracting capacity in the field and to address differing laws,  regulations, and audit requirements that may affect their joint efforts to  expand ARV treatment programs. While no specific options have been  proposed to date, the Coordinator’s Office has directed USAID to develop a  request for proposals to design and implement a mechanism for procuring,  distributing, and managing the supply of drugs and other items. All  PEPFAR agencies and possibly other, non-U.S., stakeholders would use this  mechanism as well. As a joint mechanism, it may address some of the  contracting capacity needs raised by field staff, as well as the differing  agency regulations pertaining to procurement. Guidelines on procurement  released by the Coordinator’s Office on March 24, 2004, note that U.S.  agencies involved in PEPFAR have different limitations on their ability to  procure goods and services from outside the United States and that the  office is reviewing options for addressing this issue. The guidelines state  that the office will provide additional guidance in the future, although no  specific time frame is given.
Regarding foreign taxation of goods bought with U.S. assistance, the  PEPFAR strategy states that tariffs and duties on pharmaceuticals are  “barriers” that can increase the cost of drugs in developing countries and  “work at cross purposes” with initiatives to improve access to medicines.  According to officials from the Coordinator’s Office, legal experts from the  State Department and other PEPFAR agencies are discussing how to  address differing agency appropriations laws regarding this issue. In  addition, audit officials from USAID and HHS are discussing how to  address differing agency requirements for auditing non-U.S. grantees.
section_title: Global AIDS Coordinator Provided Guidance to Field on ARV Procurement, but Problems Remain
paragraphs: The Coordinator’s Office provided guidance to U.S. field staff on ARV  procurement, but this guidance did not resolve the following issues  regarding the use of PEPFAR funds to purchase these drugs:  (1) The policy  of the Coordinator’s Office on procuring ARVs may change in the future.   (2) The Coordinator’s Office does not define how PEPFAR activities and  funding can support host country treatment sites that do use generics.   (3) In at least one country, the office’s current ARV procurement policy  conflicts with PEPFAR’s stated principle of providing assistance in a  manner consistent with host country plans and policies.
Coordinator’s Office Provided Guidance on ARV Procurement The Coordinator’s Office issued guidance to field staff on ARV procurement  over a 5-month period (November 2003–March 2004) in an ad hoc,  question-and-answer format in response to inquiries from the field (see  table 1). This guidance was issued before, during, and after our structured  interviews. According to officials from the Coordinator’s Office, they also  addressed questions from field staff during 2 weeks of intensive meetings  in Washington, D.C., in November 2003 and during visits to the PEPFAR  focus countries over the next several months.  However, the Coordinator’s  Office provided the most detailed guidance more than 2 months after a  January 19, 2004, deadline for obligating initial funds and just one week  before field staff in each country were required to submit their operational  plans for fiscal year 2004.
As noted previously, the Coordinator’s current policy is to fund only the  purchase of drugs that have been approved by entities it defines as  stringent regulatory authorities, citing concerns about safety and efficacy.  The Coordinator’s Office convened a meeting with international regulators  in March 2004 to develop principles for evaluating the safety and efficacy of  FDCs. In addition, it has directed HHS/CDC to develop a request for  proposals to assure the quality of drugs and other products procured with  PEPFAR funds. On May 16, 2004, the HHS Secretary announced an  expedited process for reviewing data submitted to the HHS/FDA on the  safety, efficacy, and quality of generic and other ARV drugs, including  FDCs, intended for use under PEPFAR.   Drugs approved under this  process can then be purchased with PEPFAR funds provided that  international patent agreements and local government policies allow their  purchase, according to the Coordinator’s Office, HHS, and USAID.
Guidance from Coordinator’s Office Does Not Resolve All Issues The ARV procurement guidance provided by the Coordinator’s Office did  not resolve all issues regarding the use of PEPFAR funds to purchase these drugs. While the guidance clearly stated that no PEPFAR funds could be  used to purchase drugs that have not been approved by entities the office  defines as stringent regulatory authorities, the PEPFAR strategy leaves  open the possibility that funds could in the future be used to procure  generic ARV drugs, including FDCs, provided they meet safety and efficacy  standards agreed to by the office. Moreover, the strategy endorses the  selection of products such as FDCs, which combine several active  ingredients. An April 8, 2004, press release from HHS elaborates that  combination therapies, including FDCs, are considered by many to be  essential to treating diseases like HIV/AIDS as well as to limiting the  development of drug resistance. The press release states that, among other  advantages, FDCs simplify dosing, which could result in better patient  adherence to therapy.
In addition, the ARV procurement guidance issued by the Coordinator’s  Office does not define how PEPFAR activities and funding can support host  country treatment sites that do use generics. The March 24, 2004, guidance  acknowledged that many countries’ treatment guidelines include FDCs and  other drugs that have not been approved by stringent regulatory  authorities. PEPFAR funds therefore cannot be used to purchase these  products or build logistical systems that support only these products but  can be used to “provide other support” to treatment sites that use them.
Further, in at least one country, the office’s current policy, which in effect  does not allow the purchase of generics, conflicts with PEPFAR’s stated  principle of providing assistance in a manner consistent with host country  plans and policies. An inquiry from Kenya cited by the Coordinator’s Office  in its February 20, 2004, response states that the country’s first line  treatment, at both government and faith-based or private sector facilities,  relies on FDCs “for reasons of economics, pill burden, and other factors.”   The inquiry urgently requested clarification from the Coordinator’s Office,  stating that a decision on whether FDCs and other generics can be  purchased will profoundly affect the extent to which the Kenya mission  “must develop parallel rather than integrated systems” and the level of  resources needed to reach treatment targets under PEPFAR. Other major  donors such as the Global Fund—to which the United States is one of the  largest contributors and for which the HHS Secretary currently serves as  the Chairman of the Board—allow their funds to be used for purchasing  generic ARV drugs, including FDCs.
section_title: Coordinator’s Office Focusing on Short- and Long-term Interventions to Alleviate Shortage of Health Workers
paragraphs: The Coordinator’s Office will focus on both short- and long-term  interventions to address host country human resource shortages, which it  has identified as a critical limitation to implementing its treatment goals. In  the short term, the office will focus on rapidly expanding and mobilizing  health care personnel through interventions that include the use of paid  workers, international volunteers, training, and technical assistance to  meet treatment goals under PEPFAR. However, in June 2003, U.S.  government officials documented their concerns about the use of  international volunteers for some of these activities. The PEPFAR strategy  also identified longer-term interventions that should be considered by  host governments and other donors, and the Coordinator’s Office is  initiating discussions with these groups to explore options for  implementing longer-term interventions.
subsections: section_title: Coordinator’s Office Proposed Several Short-term Solutions; U.S. Field Staff Have Raised Concerns over Use of International Volunteers
paragraphs: The Coordinator’s Office will respond to immediate needs to increase  manpower through several short-term interventions, including the use of  international volunteer health professionals, but field staff expressed  concern that this intervention will generate other problems. In addition to  using volunteers, U.S. efforts will focus on training existing providers in  case management for ARV treatment and providing technical assistance  through arrangements that include “twinning”—pairing health facilities in  the PEPFAR focus countries with organizations in the United States and  other countries—to provide training and technical assistance, according to  the PEPFAR strategy. The Coordinator’s Office will also support host  country efforts to depend less on the scarce supply of skilled health  workers by extending responsibility for patient treatment to nurses,  counselors, and health volunteers, as well as exploring options to involve  traditional healers, birth attendants, and family members in treatment and  care. The Coordinator characterized the human resource shortage as the  second most important issue after political leadership in addressing  HIV/AIDS. Accordingly, Coordinator’s Office officials stated that all  contracts and contract renewals include language on developing local  human resource capacity.
However, USAID and HHS/CDC field officials informed the Coordinator’s  Office of potential problems associated with using international volunteers  to address health worker shortages and training. Specifically, the use of  such volunteers for short overseas tours creates heavy administrative  burdens, may not be sustainable over the long term, and is not cost  effective, according to a June 2003 communication summarizing lessons  learned from the PMTCT Initiative. The communication recommended that  tours be for a minimum of one year. In addition, regarding twinning, a  USAID official in one country stated that the ministry of health raised  concerns over the time involved in training international volunteers and  that twinning will not address issues such as attracting and enrolling nurses  who will stay in the country, particularly in rural areas. Despite its attention  to training and technical assistance, the strategy does not discuss the  extent to which the Coordinator’s Office will collaborate with other donors  on training to minimize duplicative sessions and workplace disruptions  when staff attend training.
section_title: PEPFAR Strategy Identifies Longer-term Interventions
paragraphs: The PEPFAR strategy outlines longer-term interventions to stem the critical  human resource shortage in the 14 countries, emphasizing actions that host  governments can take on their own or in discussion with other donors.  These include increasing the quality and number of graduates from medical  and related professional schools, improving retention of the health sector  workforce through salary increases and other incentives, and establishing  bilateral and international agreements to resolve salary differentials. The  June 2003 communication emphasized the need for guidance on the extent  to which U.S. agencies will supplement the salaries of government health- care workers in PEPFAR focus countries in order to retain qualified  employees and implement activities under PEPFAR.
According to an official in the Coordinator’s Office, the office is developing  a policy statement on the use of PEPFAR resources for salaries. This  official stated that the Coordinator’s Office plans to work with other  donors, including the World Bank, to support long-term interventions such  as supplementing salaries and building and strengthening professional  schools. The Coordinator’s Office is engaged in frequent meetings with the  3-by-5 team at WHO and has met with officials at the World Bank and  UNAIDS to discuss a coordinated approach to human capacity  development. An interagency group formed under the PMTCT Initiative is  also contributing to these efforts. According to an expert at the World  Bank, donors should help finance host countries’ efforts to address human  resource issues. Because PEPFAR will play a central role in its focus  countries, a WHO official stated that other donors will look to the United  States to address long-term interventions to issues faced by host country  governments. An October 2003 document from U.S. field staff in one  African country also raised the importance of U.S. government support for  salaries for government workers in the national health system, adding that  the national government cannot afford to pay for significant numbers of  new staff.
section_title: Coordinator’s Office Focuses on Enhancing Leadership and Political Commitment
paragraphs: The Coordinator’s Office called on U.S. officials, including ambassadors, to  advocate for bold leadership to fight HIV/AIDS and identified mechanisms  for fostering political commitment and reaching out to all groups involved  in combating the disease in recipient countries.  The Coordinator’s Office  has not begun to work with other stakeholders to address other, more  systemic host government constraints that U.S. field staff identified.
Recognizing that containment of HIV/AIDS requires bold leadership and  political commitment, the PEPFAR strategy calls for high-level officials in  Washington and American ambassadors abroad to encourage commitment  from heads of state and other government leaders. The strategy emphasizes  that American embassy staff must be informed and engaged on the issue of  HIV/AIDS in their host countries and asks them to raise the issue in host  government forums. On November 26, 2003, the Global AIDS Coordinator  sent a communication to embassies in the PEPFAR focus countries that  summarized points for building support at the country level. For example,  the communication requested that all chiefs of mission brief host  government leaders on PEPFAR in order to build their support for the  program and establish a process whereby U.S. field staff, along with host  government officials and other stakeholders, can rapidly begin to design  and implement PEPFAR. However, these efforts were hindered by the fast  pace of PEPFAR, which, as previously discussed, made it difficult for field  staff to consult with host governments.
The PEPFAR strategy looks to a broad range of community leaders and  private institutions to generate leadership and fight the stigma associated  with HIV/AIDS. It calls for using public-private partnerships at local,  national, regional, and international levels to strengthen global and in- country responses to HIV/AIDS. For example, the strategy states that the  United States will engage community leaders such as mayors, tribal  authorities, elders, and traditional healers to promote correct and  consistent information about the epidemic and to combat stigma and  harmful cultural practices. In addition, it commits to working with faith- based leaders and joint national and international business and labor  coalitions to facilitate efforts to improve and expand programs in the  workplace and take advantage of marketing, communications, and  logistical skills to improve the reach and effectiveness of AIDS programs.  The strategy also calls on U.S. officials to advocate for a greater global  response through multilateral forums such as UNAIDS, international  conferences, and participation in the Global Fund.
Neither the PEPFAR strategy nor the Coordinator’s Office addresses other  host government constraints raised by our interview respondents,  including the poor delineation of roles between government bodies  responsible for combating HIV/AIDS and slow decision-making processes,  that are outside the Coordinator’s control and will take additional time to  resolve.
section_title: Coordinator’s Office Aims to Strengthen Infrastructure for Information and Drug Supply; Some Field Staff Had Differing Views on Implementing Proposed Health Care Model
paragraphs: The Coordinator’s Office has taken several steps to improve the  infrastructure needed to support expansion of ARV treatment; however,  some field staff expressed differing views on implementing a proposed  tiered system of health care. In response to the PEPFAR strategy’s  emphasis on results-driven interventions, the Coordinator’s Office is  working to strengthen systems to monitor and evaluate progress toward  treatment goals. In addition, the Coordinator’s Office seeks to improve  countries’ abilities to manage the drug supply in the short run by, among  other things, calling on the private sector to help with distribution. The new  procurement mechanism (see p. 34) is also meant to address these issues.  Consistent with the U.S. Leadership Act authorizing PEPFAR, the strategy  proposes the use of a “network model” of health care facilities to provide a  high volume and level of services in central medical centers and more basic  services in outlying areas to enhance access to ARV treatment. However,  some field staff expressed differing views on this model. Neither the  strategy nor the Coordinator’s Office addresses certain physical  infrastructure impediments raised in documents submitted to the  Coordinator or by our interview respondents.
subsections: section_title: Coordinator’s Office Attempting to Improve Data Collection and Reporting
paragraphs: To support the effective gathering and reporting of information to monitor  and evaluate progress toward PEPFAR goals, the Coordinator’s Office will  support training to improve and expand recipient countries’ surveillance  and laboratory capacity. The office will provide assistance to countries for  improved information gathering and reporting to measure progress in  reaching program goals. These indicators measure the numbers of facilities  supported, practicing professionals and community workers trained, and  clients reached. The Coordinator’s Office worked with officials from HHS,  the U.S. Census Bureau, USAID, other U.S. agencies, UNAIDS, WHO, and  the Global Fund, to assess new data needs and minimize duplicative data  collection. The Coordinator’s Office developed HIV/AIDS-specific coding  categories to gather information for a number of activities, including (1)  preventing HIV transmission from mothers to babies, (2) other HIV  prevention activities, (3) treatment, (4) care, and (5) assessing laboratory  infrastructure needs. For example, to gather information for ARV  treatment, the Coordinator’s Office developed a facility checklist to assess  delivery of treatment, including eligibility criteria for patients, clinical  monitoring and lab tests offered, standard operating procedures and  protocols, and record keeping.
The Coordinator’s Office is working with the Global Fund and other  organizations to synchronize systems for monitoring and evaluating  HIV/AIDS programs. According to the office, U.S. officials have met with  officials from UNAIDS, the World Bank, the Global Fund, and WHO to  discuss developing common indicators and guidelines for paper-based or  electronic tracking. To assist U.S. field staff in planning and monitoring  treatment programs and report on PEPFAR progress, the office has  established the following indicators for monitoring and evaluating ARV  treatment:  the number of facilities, programs, or both, including a separate  breakout of the number of faith-based facilities or programs; the number of  clients served; the number of new clients served; the number of clients  continuously receiving treatment and related services for more than 12  months; and the number of people trained. To measure progress toward the  overall PEPFAR goal of providing ARV treatment to 2 million people by the  end of 2008, field staff in each of the focus countries will report  semiannually to the Coordinator’s Office on the number of people receiving  ARV drugs through PEPFAR.
According to the Coordinator’s Office, data will be collected and stored in  an electronic repository that is expected to be operational in September  2004. Twice a year, U.S. field staff will electronically transmit data  measuring the progress of PEPFAR activities to the Coordinator’s Office.
According to the office officials, the office will put the information in a  database that field staff and multilateral organization can access.
Because fully equipped laboratories are necessary for monitoring ARV  treatment to limit the development of resistant strains of the virus, the  Coordinator’s Office will fund assessments of existing laboratory  infrastructure and will fund upgrades of laboratories, as needed. In  addition, the Coordinator’s Office will support the development,  adaptation, and translation of training materials for specimen collection,  storage, shipment, testing, and record keeping.
section_title: PEPFAR Strategy Has Identified Short-term Actions for Managing the Drug Supply
paragraphs: The PEPFAR strategy recognizes that the sharp increase in the volume of  products to be provided under the program and from other sources such as  the Global Fund may challenge existing national supply systems.  Accordingly, as noted on p. 34, the Coordinator’s Office is developing a  request for proposals to design and implement a joint procurement  mechanism to better manage the supply of drugs and other products. The  strategy calls for training personnel in health logistics systems and  supporting efforts to minimize drug diversion, counterfeiting and waste. It  also states that the United States will collaborate with other donors to  minimize distribution gaps. To accomplish its objectives in the short run,  the Coordinator’s Office will call on the private sector to perform some  logistics functions, such as building up distribution and information  management systems and improving storage conditions. For example,  PEPFAR agencies will provide technical assistance and fund training to  strengthen procurement and distribution systems. By increasing the  number of people trained in procurement and distribution, PEPFAR seeks  to improve local capacity to negotiate, purchase, manage, and supply  goods. However, the implementation of this objective may face the same  human resource constraints noted previously, due to the limited number of  available workers.
section_title: PEPFAR Proposes “Network Model” to Address Basic Health Infrastructure; Some Field Staff Had Differing Views on Implementing this Model
paragraphs: Consistent with the U.S. Leadership Act authorizing PEPFAR, the PEPFAR  strategy proposes a tiered model for providing treatment; however, some  field staff expressed differing views on implementing this model.  According to the strategy, this “network model” integrates prevention,  treatment, and care activities through a layered system of central facilities  that support satellite centers and mobile units to reach the most rural  areas. It comprises central medical facilities, regional and district-level  facilities, and community clinics.
A September 18, 2003 communication to the Coordinator from U.S. field  staff in Ethiopia stated that the model is appropriate in that country, and  that current HHS/CDC and USAID planning for PEPFAR in Ethiopia uses  the model. In addition, an October 28, 2003 communication from  Mozambique stated that the country has developed an integrated health  network with levels of supervision and referral that correspond to the  model. However, field staff in Uganda, the country often cited by U.S.  government headquarters officials as having a successful model, stated in a  written communication to the Coordinator dated October 8, 2003, that the  model is not fully operational in Uganda owing to the same host country  constraints that many resource-poor countries face. According to the  communication, weak or nonexistent infrastructure, limited human and  financial resources, and poor training constrain the model at all levels.
section_title: Certain Physical Impediments Are Not Addressed
paragraphs: Although the PEPFAR strategy acknowledges that many of the affected  countries lack the necessary health infrastructure needed for effective  HIV/AIDS treatment, it does not address certain physical impediments  raised by U.S. government field staff, such as inadequate space for HIV  counseling and testing in prenatal clinics and other medical facilities. While  the strategy recognizes that lack of basic amenities such as clean water is a  barrier to successful treatment, it does not discuss how to address this  issue. In addition, it does not discuss the impact of deteriorating roads,  which affect the delivery of drugs and other commodities. Clean water,  passable roads, and other basic infrastructure are outside the direct  authority of the Coordinator’s Office.
section_title: Conclusions
paragraphs: The Office of the U.S. Global AIDS Coordinator faces five key challenges as  it leads U.S. efforts to significantly expand ARV treatment in the 14  PEPFAR focus countries. Certain key challenges, such as the shortage of  trained health workers, limited commitment of some host governments,  and weak infrastructure require long-term solutions and the support of host  governments, donors, and other organizations providing ARV treatment.  Other challenges are within the control of the U.S. government, and the  Coordinator’s Office has begun to (1) take steps to facilitate host  government participation in planning PEPFAR activities and (2) explore  ways to enhance U.S. contracting capacity in the field and address differing  laws, regulations, and requirements applicable to the agencies  implementing PEPFAR. In addition, HHS, with the support of the  Coordinator’s Office, recently announced an expedited review process for  generic and other ARV drugs, including FDCs, which could be procured  with PEPFAR funds. However, the Coordinator’s Office has not specified  the activities that PEPFAR can fund and support in national treatment  programs that use ARV drugs not approved for purchase by the office.  Given the importance of these challenges to expanding ARV treatment, it is  critical that the Coordinator’s Office ensure that the issues reach full and  timely resolution.
section_title: Recommendations for Executive Action
paragraphs: To improve the U.S. Global AIDS Coordinator’s ability to address  challenges in expanding AIDS treatment in PEPFAR focus countries, we  recommend that the Secretary of State direct the Coordinator to  monitor implementing agencies’ efforts to coordinate PEPFAR activities  with stakeholders involved in ARV treatment, including taking adequate  steps to actively solicit the input of host government officials and  respond to their input;  collaborate with the Administrator of USAID and the Secretary of HHS  to address contracting capacity constraints in the field and resolve any  negative effects resulting from the differing laws governing the funds  appropriated to these agencies in the areas of procurement and foreign  taxation of U.S. assistance, as well as differing requirements for auditing  non-U.S. grantees;  specify the activities that PEPFAR can fund and support in national  treatment programs that use ARV drugs not approved for purchase by  the Coordinator’s Office; and   work with national governments and international partners to address  the underlying economic and policy factors creating the crisis in human  resources for health care.
section_title: Agency Comments and Our Evaluation
paragraphs: The State Department, HHS, and USAID provided combined written  comments on a draft of this report (see app. VIII for a reprint of their  comments). The agencies concurred with the report’s overall conclusion  that while they have addressed a number of key challenges in providing  services, other challenges remain for the medium and long term. The  agencies did not specifically comment on GAO’s recommendations;  however, they noted that program efforts and activities have progressed  beyond what the report describes, and work is underway to address the  majority of challenges and issues raised. Some of these efforts reflect our  recommendations. The agencies also provided technical comments that we  have incorporated as appropriate. Our draft report contained the first 3  recommendations. We added the fourth recommendation in light of  additional information State, HHS, and USAID provided when they  commented on a draft of this report. This information reemphasized the  need for these agencies to engage in efforts to address the critical shortage  of health workers in recipient countries.
We are sending copies of this report to the U.S. Global AIDS Coordinator,  the Secretary of HHS, the Administrator of USAID, and interested  congressional committees. Copies of this report will also be made available  to other interested parties on request. In addition, this report will be made  available at no charge on the GAO web site at http://www.gao.gov.
If you or your staff have any questions about this report, please contact me  at (202) 512-3149. Other GAO contacts and staff acknowledgments are  listed in appendix IX.
section_title: Objectives, Scope, and Methodology
paragraphs: The Chairman of the Subcommittee on Foreign Operations, Export  Financing, and Related Programs of the House Committee on  Appropriations asked us to (1) identify major challenges to U.S. efforts to  expand antiretroviral (ARV) treatment in resource-poor settings and (2)  assess the U.S. Global AIDS Coordinator’s response to these challenges.  Our work focused on the 14 countries targeted under the President’s  Emergency Plan for AIDS Relief (PEPFAR): Botswana, Côte d’Ivoire,  Ethiopia, Guyana, Haiti, Kenya, Mozambique, Namibia, Nigeria, Rwanda,  South Africa, Tanzania, Uganda, and Zambia.
subsections: section_title: Methodology for Identifying Challenges to Expanding ARV Treatment
paragraphs: To identify challenges to U.S. efforts to expand ARV treatment, we  conducted 28 structured telephone interviews in December 2003 and  January 2004 with key staff from the U.S. Agency for International  Development (USAID) and the Department of Health and Human Services’  Centers for Disease Control and Prevention (HHS/CDC) responsible for  implementing HIV/AIDS programs in the 14 targeted countries. To ensure  balance, we conducted one USAID and one HHS/CDC interview in each  country. We coded the responses to our open-ended interview questions  using a set of internally developed analytical categories.
Our structured interview document contained 16 questions on the  implementation and expansion of HIV/AIDS treatment programs, including  program activities and coordination and management challenges (see app.  II). To develop the questions and further assess challenges, we reviewed  numerous documents analyzing treatment programs from U.S. government  agencies, U.N. organizations, and nongovernmental organizations (NGO),  including reports by medical experts and practitioners. We also  interviewed U.S.-based officials from USAID and HHS; representatives  from multilateral organizations, including the World Health Organization  (WHO), the United Nations Joint Program on HIV/AIDS (UNAIDS), the  World Bank, and the Global Fund to Fight AIDS, TB, and Malaria (Global  Fund); and medical experts experienced in treating people with HIV/AIDS  in resource-poor settings. We traveled to Geneva, Switzerland, to meet with  WHO, Global Fund, and UNAIDS representatives, and to Paris, France, to  meet with program experts from Médecins sans Frontières (Doctors  Without Borders), an NGO providing ARV and other AIDS treatment in  resource-poor countries. Most of the structured interview questions were  open ended; two were closed ended (see app. II for a list of the questions).  Experts reviewed initial versions of our open- and close-ended questions  and four of our initial respondents pretested the questions. We refined our  questions based on their input.
To summarize the open-ended responses, we systematically coded a set of  key questions on challenges to coordination and program expansion from  our structured interviews. We grouped the responses into five major  challenge categories. As in any exercise of this type, the categories  developed can vary when produced by different analysts. To address this,  two GAO analysts reviewed the responses to the key questions from five  interviews and independently proposed categories, separately identifying  major challenges and then agreeing on a common set of challenges. They  independently analyzed and differentiated responses into subcategories  within each major challenge area and then agreed on a common set of  subcategories. We refined these subcategories during the coding exercise  that followed. Interview responses falling into a specific subcategory often  derived from a variety of questions in our analysis; there was not a one-to- one correspondence between questions and categories.
We then analyzed applicable statements from each of the 28 interviews and  placed them into one or more of the resulting subcategories. Four GAO  analysts each examined 7 of the 28 interviews. One analyst made some  adjustments in placements to ensure consistency in coding and then  compiled the resulting placements into a single master document. The  analyst then summarized and tallied the number of respondents providing  information in each subcategory.  Two GAO analysts then independently  reviewed the interview analysis document. All disagreements regarding the  placement of responses into subcategories were discussed and reconciled.  Figure 4 presents the numbers of respondents citing challenges in each of  the five major categories, and figures 8 through 12 present the breakout of  each major challenge into subcategories. These figures show subcategories  containing information from 3 or more respondents; we also cite in  footnotes other information provided by only 1 or 2 respondents.
We explicitly prompted respondents with questions on coordination issues.  We identified the other four major challenges during our analysis of the  responses to the coded questions. As a result, the number of respondents  providing information on coordination challenges is higher than the  number providing information on the other four challenges.
We conducted a separate analysis of the two closed-ended questions, which  asked respondents to rank the degree of difficulty coordinating with  various groups (question 12.b), and coordinating with all parties on specific  activities (question 13.b). (See app. VII.)
Finally, to expand on the structured interviews, we reviewed relevant U.S.  laws, regulations, and policies governing procurement, contracting,  taxation, and auditing; documents that field representatives prepared for  the Coordinator’s Office; and documents from multilateral organizations  and NGOs. We also interviewed U.S.-based officials from the Coordinator’s  Office, USAID, and HHS.
section_title: Methodology for Assessing the U.S. Response
paragraphs: To assess the Global AIDS Coordinator’s response to these challenges, we  reviewed The President's Emergency Plan for AIDS Relief: U.S. Five Year  Global HIV/AIDS Strategy (February 2004); administration guidance,  including several communications to the field on ARV procurement; and  information on the emerging structure and initial activities of the  Coordinator’s Office. We also interviewed officials from the Coordinator’s  Office, USAID, and HHS.
We conducted our work from July 2003 through May 2004, in accordance  with generally accepted government auditing standards.
section_title: Structured Interview Questions
subsections: section_title: Introduction
paragraphs: The following questions are to assist the U.S. General Accounting Office to  gather information on how USAID missions and HHS/CDC field offices  coordinate the implementation and scale up of ARV treatment programs in  the field.  Specifically, we are looking to understand how your agency  coordinates with other U.S. government agencies and other key  stakeholders (multilateral, other bilateral, host government,  nongovernmental) to identify the challenges to these coordination efforts,  and to obtain lessons learned that can inform the President’s Emergency  Plan for AIDS Relief.
section_title: Background
paragraphs: For questions 2-5, please refer to appropriate documents. Where asked,  please indicate the name of the document(s) you used to answer these  questions. last 12 months) to date)
We are interested in the PMTCT, PMTCT Plus, and  other ARV programs.  Which of these programs does  your mission/field office support?
Approximately how many people are currently  receiving these services in your country?
Please indicate whether the numbers in the PMTCT  Plus column are included in the ARV treatment  column.
Please provide the name of the document(s) you used  to obtain the data for each of these services.
Please indicate if the available data are inadequate to  answer the question for any of these services.
Of the number in 2.a., how many are being supported  by U.S. government programs?
Please provide the name of the document(s) you used  to obtain the data for each of these services.
Please indicate if the available data are inadequate to  answer the question for any of these services.
Over the next 6-12 months, how many people in your  country do you realistically expect to start treatment?
Please provide the name of the document(s) you used  to obtain the data for each of these services.
Please indicate if the available data are inadequate to  answer the question for any of these services.
Of the number in 4.a., how many will be supported by  U.S. government programs?
Please provide the name of the document(s) you used  to obtain the data for each of these services.
Please indicate if the available data are inadequate to  answer the question for any of these services.
6.a. Please look at the list of program activities related to PMTCT, PMTCT  Plus, and ARV treatment that we sent to you.  In which of these program  activities is your mission/field office involved?  Indicate which of these  activities are directly funded by your mission/field office.
Training (of doctors, nurses, healthcare workers and administrators)
6.b. I’m going to read out a list of items and services related to ARV  treatment.  Does your mission/field office procure any of them? diagnostics (e.g., test kits, including rapid test kits) lab equipment and commodities (e.g., reagents)
6.c. What types of program activities (listed in 6.a.) and procurement  activities (just discussed) is your mission/field office best suited to  perform?  6.d. With which of these activities do you face the greatest challenges to  implementation? 6.e. What do you see as a feasible solution to these challenges?   7. How do you program resources according to congressional earmarks?   Given the earmarks in the authorizing legislation for the President’s  Emergency Plan for AIDS Relief (55% for treatment, of which 75% is to be  spent on ARV drugs), do you have to make major changes in your programs  to accommodate these earmarks?
section_title: Coordinating with other USG agencies
paragraphs: 8.a. Has a point of contact for the President’s Emergency Plan for AIDS  Relief been designated in your country?  If so, is this contact at the U.S.  Embassy?  If not, at which agency? 8.b. What other U.S. government agencies does your mission/field office  work or coordinate with on VCT, PMTCT, PMTCT Plus, and/or other ARV  treatment programs?  Please identify the program activities that these  agencies perform.  8.c. How does your mission/field office currently coordinate with these  agencies?  (Please tell us about all formal and informal coordination  mechanisms, such as regular meetings, procedures for information sharing,  MOUs, TORs, informal contacts, etc.) 8.d. Are there any plans to change the method of coordination? 9. Please describe the key challenges your mission/field office has faced  coordinating with other U.S. agencies on VCT, PMTCT, PMTCT Plus, and/or  other ARV treatment.  Please provide examples of the consequences of  these challenges.
section_title: Coordination with non-U.S. organizations (host government, multilateral and nongovernmental organizations, other bilateral donors)
paragraphs: Coordinating with multilateral organizations  (World Bank, Global Fund, UN  organizations)
12.c. If you have not already addressed this issue in question 12.a., with  which type of partner do you experience the most coordination challenges?   Please explain. 13.a. Based on our research to date, we have identified certain function- related coordination challenges that may arise among stakeholders in a  given country:  harmonization of monitoring and evaluation indicators  harmonization of data collection methods  harmonization of data reporting requirements   harmonization of feedback to those who administer services and/or  collect data  Are there any other functional areas that you think raise or may raise  significant coordination challenges? 13.b. Based on your experience at your current post, please rate the extent  to which you experience difficulties coordinating with other partners in the  following areas: 13.c. If you have not already addressed this issue in question 12.a. or 13.a.,  with which area do you experience the most coordination challenges?   Please explain. 14.a. What activities did your mission/field office initiate with funding from  the PMTCT Initiative?   14.b. What were the key challenges you faced on the PMTCT Initiative and  what were the lessons learned that can inform the implementation of  PEPFAR?   15. Could you please tell us about a successful ARV treatment program in  the country where you serve?  What factors contribute to its success?   Could you please provide contacts (phone, email address) with whom we  can follow up, if necessary?  16. What changes—if any—would you suggest be made to facilitate  interagency and international coordination in scaling up ARV treatment?
section_title: U.S. and International HIV/AIDS Funding
paragraphs: With the advent of PEPFAR, U.S. proposed funding for HIV/AIDS-related  activities in the 14 focus countries increased substantially, as shown in  figure 5.
section_title: The Structure of the Office of the U.S. Global AIDS Coordinator
paragraphs: The Office of the U.S. Global AIDS Coordinator was organized to manage  U.S. policies and programs to combat the global AIDS epidemic and to  support administrative, communications, and diplomatic efforts. To  accomplish this mission, the office has eight specialized units (see fig. 7).
Management Services—provides administrative support to the office,  including human resources, information management, and operational  budget.
Communications—plans and implements all communications support  for PEPFAR activities while promoting the involvement of public and  private organizations.
Diplomatic Liaison—prepares strategic plans, conducts activities to  promote international involvement, and coordinates international  response on HIV/AIDS by working with non-U.S. stakeholders.
Training and Human Resources—oversees human capacity and  development activities and develops, implements, and monitors training  programs.
Program Services—develops and monitors the 14 countries’ PEPFAR  implementation plans and provides technical and clinical support to the  focus countries and for all other activities conducted by the Global AIDS  Coordinator.
Monitoring, Evaluation, and Strategic Information—evaluates progress  toward PEPFAR goals and the impact of PEPFAR activities; works with  the international community to harmonize information collection and  serves as the liaison to both the research community and the research  and information divisions of implementing agencies.
Government Relations—responds to congressional requests for  information, communicates policy to the Congress, and prepares  congressional reports and compliance documents.
Budget and Appropriations—develops the annual program budget for  the Coordinator’s Office and serves as the liaison to the White House,  administrative departments and agencies, and the field on program  budget issues, including disbursement, tracking, and reporting.
As of June 25, 2004, 69 percent of the positions shown in figure 7 were  staffed. Positions within the Coordinator’s Office are filled with a  combination of permanent hires and individuals on reimbursable and  nonreimbursable detail from other sections of the State Department or  other agencies.
section_title: PEPFAR Obligations as of March 31, 2004
paragraphs: The Office of the U.S. Global AIDS Coordinator reported that, together with  USAID and HHS, it had obligated a total of $346.9 million in PEPFAR funds  as of March 31, 2004. These funds were obligated by means of tracks 1 and  1.5 through many awards to implementing entities in the 14 focus countries  for activities related to HIV/AIDS treatment, prevention, and care, as  follows.
Track 1 provided rapid funding to organizations such as U.S.-based  NGOs that can respond quickly in more than one country. As of March  31, 2004, the Coordinator’s Office had awarded a total of $114.7 million  in five areas: (1) modifying behavior by encouraging abstinence and  faithfulness ($4.9 million obligated by USAID); (2) providing care for  AIDS orphans and vulnerable children ($4.7 million obligated by  USAID); (3) providing ARV therapy for those infected with HIV ($92  million obligated by HHS); and (4) preventing HIV transmission through  safe medical injection ($13.1 million obligated by USAID and HHS).
Track 1.5 provided rapid funding to programs run by organizations in  individual countries. USAID and HHS obligated a total of $232 million  under track 1.5 for all 14 countries combined as of March 31, 2004. Like  track 1 funding, this funding was to continue and expand ongoing  activities. When allocating funding under track 1.5, U.S. missions were  encouraged to consider programs that build on the PMTCT Initiative, in  particular those that expand treatment to cover mothers and their  partners.
Track 2 provides funding for each country’s first annual operational plan.  The Coordinator will assess annual funding levels in consultation with the  U.S. agencies and Chiefs of Mission in each country and release funds after  approving each country’s plan. According to guidance provided by the  Coordinator’s Office, these assessments are meant to ensure that U.S.  agencies in each country are leveraging their strengths and coordinating  their efforts. As of May 31, 2004, the Coordinator’s Office had approved 14  countries’ operational plans totaling $589,401,340.
section_title: Detailed Analysis of Challenges Identified in Structured Interviews
paragraphs: Figures 8 through 12 provide more information on the challenges that 28  respondents in the field identified during the structured interviews. To  generate these figures, we separately analyzed responses in each of the five  main challenge categories and placed them in specific subcategories within  each challenge category. We then tallied the number of respondents in each  of the subcategories to generate figures 8 through 12. Many respondents  reported challenges in more than one category or subcategory.
section_title: Analysis of Difficulty of Coordination
paragraphs: Our structured interview analysis contained two closed-ended questions  that asked respondents to rank the difficulty of (1) coordinating with  various groups and (2) coordinating with all parties on specific activities  (see questions 12.b and 13.b in app. II).
When asked to rank the difficulty of coordinating with various groups, 15  respondents indicated that they experienced at least moderate difficulty  coordinating with the host government in the country where they serve,  and 13 reported the same level of difficulty coordinating with multilateral  entities, such as the World Bank and U.N. organizations (see table 2). By  comparison, only 2 respondents stated they had at least moderate difficulty  coordinating with other U.S. government entities. The majority of  respondents reported only a minimal degree of difficulty (“some or little  extent” or “no extent”) coordinating with other bilateral donors, NGOs, and  the private sector. Respondents said that the difficulty coordinating with  nongovernmental and private organizations was that they are so numerous  and not all are known.
Question 12.b:  Based on your experience at your current post, please rate  the extent to which you experience difficulties coordinating with the  following partners:  Regarding coordination on specific activities, 16 respondents reported  moderate or greater difficulty coordinating provision of feedback to those  who administer services or collect data, and 15 reported a similar degree of  difficulty in coordinating procurement policies and data reporting  requirements (see table 3). Half of the 26 respondents who answered this  question reported moderate or greater difficulty coordinating data  collection methods. The majority reported little or no difficulty  coordinating treatment protocols or data to be collected.
section_title: Joint Comments from the Department of State, HHS, and USAID
section_title: GAO Contact and Staff Acknowledgments
subsections: section_title: GAO Contact
section_title: Staff Acknowledgments
paragraphs: In addition to the person named above, Kate Blumenreich, Martin de  Alteriis, David Dornisch, Kay Halpern, Reid Lowe, Rebecca L. Medina, Mary  Moutsos, and Tom Zingale made key contributions to this report.
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