a

GAO

United States General Accounting Office

Report to the Chairman, Subcommittee 

on Foreign Operations, Export Financing, 

and Related Programs, Committee on 

Appropriations, House of 

Representatives

July 2004 GLOBAL HEALTH

U.S. AIDS Coordinator 

Addressing Some Key 

Challenges to 

Expanding Treatment, 

but Others Remain

GAO-04-784
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 (see figure). These challenges were also 

highlighted by numerous experts GAO interviewed and in documents GAO 

reviewed.

Major Challenges to Expanding ARV Treatment in Resource-poor Settings 

a

GAO asked all 28 respondents specific questions about coordination; respondents raised the other four challenges when answering

open-ended questions. 

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. 

The President’s Emergency Plan for 

AIDS Relief (PEPFAR), announced 

January 2003, aims to provide 2 

million people with antiretroviral 

(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. 

GAO recommends that the Secretary 

of State direct the U.S. Global AIDS 

Coordinator to monitor agencies’ 

efforts to coordinate with host 

governments and other stakeholders; 

work with the USAID Administrator 

and HHS Secretary to resolve 

contracting capacity constraints and 

any negative effects from agency 

differences on procurement, foreign 

taxation of U.S. assistance, and 

auditing of non-U.S. grantees; specify 

the activities that PEPFAR can 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 

underlying economic and policy 

factors creating the crisis in human 

resources for health care. State, HHS, 

and USAID concurred with the 

report’s conclusion and said work is 

underway to address the majority of 

challenges and issues raised. 

www.gao.gov/cgi-bin/getrpt?GAO-04-784.

To view the full report, including the scope 

and methodology, click on the link above. 

For more information, contact David Gootnick 

at (202) 512-3149 or gootnickd@gao.gov. 

Highlights of GAO-04-784 a report to the 

Chairman, Subcommittee on Foreign 

Operations, Export Financing, and Related 

Programs, House Committee on 

Appropriations 

July 2004

GLOBAL HEALTH 

U.S. AIDS Coordinator Addressing Some 

Key Challenges to Expanding Treatment, 

but Others Remain 
Page i GAO-04-784 Global Health

Contents

Letter 1

Results in Brief 2

Background 5

U.S. Government Faces Five Major Challenges to Expanding ARV 

Treatment in Resource-poor Settings 14

Coordinator’s Office Has Taken Steps to Address Challenges, but 

Continued Effort Is Needed 32

Conclusions 45

Recommendations for Executive Action 46

Agency Comments and Our Evaluation 46

Appendixes

Appendix I: Objectives, Scope, and Methodology 48

Appendix II: Structured Interview Questions 51

Appendix III: U.S. and International HIV/AIDS Funding 58

Appendix IV: The Structure of the Office of the U.S. Global AIDS 

Coordinator 61

Appendix V: PEPFAR Obligations as of March 31, 2004 63

Appendix VI: Detailed Analysis of Challenges Identified in Structured 

Interviews 65

Appendix VII: Analysis of Difficulty of Coordination 70

Appendix VIII: Joint Comments from the Department of State, HHS, and 

USAID 73

Appendix IX: GAO Contact and Staff Acknowledgments 79

GAO Contact 79

Staff Acknowledgments 79

Tables Table 1: Guidance Issued by the Office of the U.S. Global AIDS 

Coordinator to Field Staff on ARV Procurement and 

PEPFAR Deadlines 37

Table 2: Difficulty Coordinating with Various Groups as Reported 

by Respondents 71

Table 3: Difficulty Coordinating on Various Issues as Reported by 

Respondents 72
Contents

Page ii GAO-04-784 Global Health

Figures Figure 1: Progress toward PEPFAR Goals: Percentages Receiving 

Treatment in Focus Countries as of February 2004 8

Figure 2: Recent International and U.S. Milestones in Efforts to 

Combat AIDS Worldwide 10

Figure 3: U.S. Agencies Involved in PEPFAR 12

Figure 4: Major Challenges to Expanding ARV Treatment in 

Resource-poor Settings 15

Figure 5: U.S. HIV/AIDS Funding in the 14 PEPFAR Focus 

Countries, Fiscal Years 2003 and 2004 58

Figure 6: World Bank, Global Fund, HHS/CDC, and USAID HIV/

AIDS Funding in the PEPFAR Focus Countries 59

Figure 7: Office of the U.S. Global AIDS Coordinator Organization 

Chart 61

Figure 8: Coordination Challenges Identified by Respondents 65

Figure 9: U.S. Policy Constraints Identified by Respondents 66

Figure 10: Host Country Human Resource Challenges Identified by 

Respondents 67

Figure 11: Host Government Constraints Identified by 

Respondents 68

Figure 12: Infrastructure and Logistics Challenges Identified by 

Respondents 69
Contents

Page iii GAO-04-784 Global Health

Abbreviations

AIDS acquired immune deficiency syndrome

ARV antiretroviral 

ARVs antiretroviral medications

CDC Centers for Disease Control and Prevention

FDA U.S. Food and Drug Administration

FDC fixed-dose combination

HHS Department of Health and Human Services

HIV human immunodeficiency virus (that causes AIDS)

ICH International Conference on Harmonization

MSF Médecins sans Frontières (French NGO Doctors Without 

Borders) 

NIH National Institutes of Health 

NGO nongovernmental organization

PEPFAR the President’s Emergency Plan for AIDS Relief

PMTCT prevention of mother to child transmission

TB tuberculosis 

UN United Nations

UNAIDS Joint United Nations Program on HIV/AIDS

USAID U.S. Agency for International Development

WHO World Health Organization

This is a work of the U.S. government and is not subject to copyright protection in the 

United States. It may be reproduced and distributed in its entirety without further 

permission from GAO. However, because this work may contain copyrighted images or 

other material, permission from the copyright holder may be necessary if you wish to 

reproduce this material separately.
Page 1 GAO-04-784 Global Health

United States General Accounting Office

Washington, D.C. 20548

A

July 12, 2004 Letr

The Honorable Jim Kolbe 

Chairman, Subcommittee on Foreign Operations, 

Export Financing, and Related Programs

Committee on Appropriations

House of Representatives 

Dear Mr. Chairman: 

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),1

 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.2

 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 

1

P.L. 108-25.

2

The President’s announcement targeted 14 countries: Botswana, Côte d’Ivoire, Ethiopia, 

Guyana, Haiti, Kenya, Mozambique, Namibia, Nigeria, Rwanda, South Africa, Tanzania, 

Uganda, and Zambia; the President announced a 15th country, Vietnam, on June 23, 2004. In 

addition to these focus countries, the Coordinator’s Office will oversee HIV/AIDS activities 

in 96 other countries.
Page 2 GAO-04-784 Global Health

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).3

 We 

coded the responses to our open-ended interview questions using a set of 

analytical categories we developed.4

 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.) 

Results in Brief U.S. government agencies face five major challenges in expanding ARV 

treatment in resource-poor settings: (1) difficulties coordinating with 

others involved in providing treatment, (2) U.S. government policy 

constraints, (3) shortages of qualified health workers in host countries,

3

In the two countries where there is no USAID mission (Botswana and Côte d’Ivoire), we 

interviewed the official in charge of USAID’s Southern Africa Regional HIV/AIDS program 

and the head of health issues for USAID’s Western Africa Regional Office, respectively.

4

These staff spoke with us with the understanding that individual respondents and the 

countries where they serve would not be named in our report. The challenges identified 

include those experienced by U.S. officials during an earlier program that used ARV drugs to 

prevent HIV transmission from mothers to infants.
Page 3 GAO-04-784 Global Health

(4) host government limitations, and (5) weak infrastructure. Specifically, 

our analysis of the structured interviews and other documentation revealed 

the following:

• Nearly all agency field staff cited problems coordinating with non-U.S. 

groups, and slightly fewer cited problems coordinating with other U.S. 

government entities. Limited coordination has led to duplicate efforts, 

confusion regarding standards, and heavy administrative burdens. 

• Field staff lacked clear guidelines for procuring ARV drugs, which made 

it difficult to plan treatment programs, possibly inhibiting the agencies’ 

ability to support country HIV/AIDS treatment programs. Also, 

inadequate contracting capacity in the field may create delays in 

obtaining medical supplies and executing agreements with 

implementing organizations. Further, differences among agencies 

regarding procurement, foreign taxation of U.S. assistance, and auditing 

of non-U.S. grantees may inhibit the agencies’ joint efforts to expand 

ARV treatment. 

• Recipient countries faced critical shortages of qualified health workers, 

including doctors, nurses, and administrators, needed to expand ARV 

treatment. 

• In some host governments, limited political commitment to addressing 

HIV/AIDS, poor delineation of roles and responsibilities, and slow 

decision-making processes hamper efforts to expand treatment. 

• Many countries have weak systems for monitoring and evaluating health 

care programs; inadequate systems for managing drug supplies; poor 

linkages among programs providing HIV/AIDS services; and 

deteriorating physical infrastructure, including labs, clinics, and roads 

needed to access rural areas. 

Although the Office of the U.S. Global AIDS Coordinator has begun to 

address challenges in all areas, some challenges require additional effort, 

longer-term solutions, and the support of others involved in providing ARV 

treatment. Specifically: 

• Coordination. The Coordinator’s Office has created mechanisms for 

enhancing coordination within the U.S. government and acknowledged 

the importance of collaborating with others. However, it is too soon to 

tell whether these mechanisms will be effective in resolving the 
Page 4 GAO-04-784 Global Health

coordination challenges field staff identified, and the PEPFAR strategy 

does not state whether the mechanisms will be monitored. 

• U.S. government policy constraints. Agencies are exploring ways to 

enhance contracting capacity in the field and address differences 

regarding procurement, foreign taxation of U.S. assistance, and auditing 

of non-U.S. grantees. While the Coordinator’s Office did provide 

guidance to U.S. field staff on ARV procurement, this guidance did not 

address key issues—such as specifying activities PEPFAR can support 

in countries that use ARV drugs not approved for purchase by the 

Coordinator’s Office—which may affect the U.S. government’s ability to 

rapidly expand treatment. 

• Shortages of qualified health workers. To address these shortages, the 

Coordinator’s Office is focusing on short-term activities, such as 

providing training and technical assistance through paid workers and 

volunteers from the United States and other countries. However, U.S. 

government officials said the use of international volunteers for some 

activities is not cost effective. The Coordinator’s Office is also 

developing longer-term interventions, such as increasing health 

workers’ compensation, and is discussing with other donors ways to 

implement these efforts. The Coordinator characterized the human 

resource shortage as one of the most important challenges to addressing 

HIV/AIDS.

• Host government constraints. The Coordinator has directed U.S. 

ambassadors and their missions to encourage host countries’ 

commitment to fight HIV/AIDS by engaging heads of state, reaching out 

to community and religious leaders, and conducting mass media 

campaigns. The Coordinator’s Office has not begun to work with host 

governments and other groups involved in AIDS treatment to address 

other, systemic constraints outside its authority, such as poor 

delineation of roles among host government bodies or slow decisionmaking processes. 

• Weak infrastructure. The Coordinator has assigned a team of experts to 

assess the collection and analysis of data used to monitor and evaluate 

treatment and work with other groups to synchronize data reporting 

systems. The Coordinator is also taking steps to better manage drug 

supplies. However, some field staff expressed differing views on 

implementing a model called for in the U.S. Leadership Act and 

proposed in the PEFFAR strategy to improve health care infrastructure 
Page 5 GAO-04-784 Global Health

and treatment referrals. While the office is working to upgrade labs, it 

has not addressed other physical impediments such as lack of space at 

health facilities. The strategy does not address additional physical 

impediments, such as poor roads, that are outside its direct authority.

To improve the U.S. Global AIDS Coordinator’s ability to address key 

challenges to expanding AIDS treatment in PEPFAR focus countries, we 

are recommending that the Secretary of State direct the Coordinator to (1) 

monitor implementing agencies’ efforts to coordinate PEPFAR activities 

with host governments and other stakeholders involved in ARV treatment; 

(2) work with the Administrator of USAID and the Secretary of HHS to 

resolve contracting capacity constraints and any negative effects from 

agency differences on procurement, foreign taxation of U.S. assistance, and 

auditing of non-U.S. grantees; (3) 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 (4) work with 

national governments and international partners to address the underlying 

economic and policy factors creating the crisis in human resources for 

health care. 

In providing written comments on a draft of this report, State, HHS, and 

USAID concurred with the report’s overall conclusion that while the 

agencies have addressed a number of key challenges in providing services, 

other challenges remain for the medium and long term (see app. VIII for a 

reprint of their comments). Although the agencies did not specifically 

comment on GAO’s recommendations, they said work is underway to 

address the majority of challenges and issues raised. They also provided 

technical comments that we have incorporated where appropriate.

Background 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 resourcepoor 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.
Page 6 GAO-04-784 Global Health

AIDS Takes Heavy Toll, 

Particularly in Africa

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 HIVinfected 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. 

Recent Advances Allow 

HIV/AIDS Treatment in 

Resource-poor Settings

Propelled by recent advances in ARV treatment, PEPFAR is the first U.S. 

program to seek to dramatically expand HIV/AIDS treatment in resourcepoor 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 manufacturers5

have combined three drugs in one pill—known as fixed-dose combinations, 

or FDCs6

—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

5

There is one brand-name FDC that combines three drugs in one pill; however, HHS 

treatment guidelines do not recommend this drug combination because it is ineffective.

6

Fixed-dose combinations of ARV drugs are single pills that contain more than one ARV 

medication. Reducing the number of pills that must be taken at any one time is intended to 

simplify the regimen and thus promote adherence and decrease the risk of resistance. 
Page 7 GAO-04-784 Global Health

approved by a “stringent regulatory authority,”7 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.8

 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 

20029

 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 

7

In guidelines to field staff, the Coordinator’s Office defines stringent regulatory authority as 

a drug regulatory body that closely resembles the HHS/FDA in standards utilized in its 

operations. The Coordinator’s Office considers as stringent regulatory authorities regulatory 

agencies in countries that participate in the International Conference on Harmonization 

(ICH). The ICH is an agreement between the European Union, Japan, and the United States 

to harmonize regulatory requirements for the testing, application, and approval of 

pharmaceutical medications; it is a joint initiative between government regulators and 

industry manufacturers. The Coordinator’s Office also considers Canada’s drug regulatory 

body to be a stringent regulatory authority and states that other countries may be 

considered on a case-by-case basis to have a stringent regulatory body if the countries have 

implemented ICH guidelines and resemble the HHS/FDA in operation. 

8

According to technical comments on a draft of this report that were submitted jointly by 

the Coordinator’s Office, HHS, and USAID, patents and/or exclusivity protect most of these 

brand-name drugs in the United States and overseas. 

9

The Global Fund is a multilateral, non-profit, public-private mechanism to rapidly disburse 

grants to augment existing spending on the prevention and treatment of HIV/AIDS, 

tuberculosis, and malaria while maintaining sufficient oversight of financial transactions 

and program effectiveness. See U.S. General Accounting Office, Global Health: Global 

Fund to Fight AIDS, TB and Malaria Has Advanced in Key Areas, but Difficult 

Challenges Remain, GAO-03-601 (Washington, D.C.: May 7, 2003).
Page 8 GAO-04-784 Global Health

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. 

Figure 1: Progress toward PEPFAR Goals: Percentages Receiving Treatment in Focus Countries as of February 2004

South Africa

Tanzania

Zambia

Namibia

Ethiopia

Mozambique

Kenya

Nigeria

Rwanda

Côte d'Ivoire

Haiti

Guyana

Uganda

Botswana

Focus country Goal Percentage of goal

47.88

0 5 10 15 20 25 30 35 40 45 50

33.33

13.94

5.48

5.22

4.28

4.00

4.00

2.24

1.74

0.93

0.93

0.29

2.14

33,000

60,000

1,800

25,000

77,000

50,000

350,000

250,000

110,000

210,000

23,000

120,000

150,000

500,000

Source: GAO analysis based on information from the Office of the U.S. Global AIDS Coordinator and the Futures Group International; 

HHS/CDC provided data on patients receiving ARV treatment in Ethiopia that was used to obtain the percentage of treatment goal 

for that country.
Page 9 GAO-04-784 Global Health

PEPFAR Builds on Earlier 

U.S. Efforts to Combat 

HIV/AIDS Globally

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.10 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.) 

10Intrapartum and Neo-Natal Single Dose Nevirapine Compared with Zivovudine for 

Prevention of Mother-to-Child Transmission of HIV-1 in Kampala, Uganda: HIVNET 012 

Randomized Trials, The Lancet, September 4, 1999. 
Page 10 GAO-04-784 Global Health

Figure 2: Recent International and U.S. Milestones in Efforts to Combat AIDS Worldwide

a

P.L. 108-7, Consolidated Appropriations Resolution, 2003.

b

P.L. 108-199, Consolidated Appropriations Act, 2004. 

International

U.S.

Source: GAO.

President 

announced 

PMTCT 

Initiative

President 

announced 

PEPFAR

WHO released 

formal plan for 

getting 3 million 

people on ARV 

treatment by the 

end of 2005

Senate confirmed U.S. 

Global AIDS Coordinator 

• Congress 

appropriated 

funds for 

PEPFARb

• The U.S. Global 

AIDS Coordinator 

obligated first 

tranche of funds

• USAID and HHS/CDC 

disbursed first tranche of 

funds under the PMTCT 

Initiative

• President signed U.S. 

Leadership Act 

authorizing PEPFAR

Congress 

appropriated 

funds for 

PMTCT 

Initiativea

Global Fund 

launched

1/02 6/02 1/03 2/03 5/03 10/03 1/04 12/03
Page 11 GAO-04-784 Global Health

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.11 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.) 

11These HHS agencies, together with the HHS/CDC, received money through PEPFAR in 

fiscal year 2004. Other HHS agencies, such as the Food and Drug Administration, the 

Administration for Children and Families, the Indian Health Service, the Office of the 

Assistant Secretary for Planning and Evaluation, and other institutes of the National 

Institutes of Health, have not received PEPFAR funds but are providing planning and other 

input to PEPFAR.
Page 12 GAO-04-784 Global Health

Figure 3: U.S. Agencies Involved in PEPFAR 

Office of the U.S. Global 

AIDS Coordinator

The Coordinator's Office is 

responsible for the oversight and 

coordination of all U.S. 

government resources and 

activities for combating HIV/AIDS 

internationally.

State Department

USAID

The State Department, 

where the U.S. Global AIDS 

Coordinator is based, raises 

HIV/AIDS issues through 

diplomatic channels and 

public relations campaigns.

HHS provides clinicians, 

epidemiologists, public health 

advisors, and other medical 

experts who work directly with 

foreign governments, health 

institutions, and other entities; is 

involved in HIV/AIDS research; 

and has experience expanding 

HIV/AIDS and other health 

services in resource-poor settings 

in the United States.

USAID has a 

network of overseas 

missions with personnel 

trained in procurement 

and managing foreign 

grantees; it works 

primarily with NGOs.

HHS

Other agencies involved in PEPFAR:

Department 

of Commerce

Department 

of Labor

Peace

Corps

Department 

of Defense

Source: GAO, with information from the Office of the U.S. Global AIDS Coordinator; USAID; HHS; and the Departments of Commerce, 

Defense, and Labor; and the Peace Corps.
Page 13 GAO-04-784 Global Health

Global AIDS Coordinator’s 

Office Established, 

Implements Funding 

Mechanisms 

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;12 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

12Budget officials in the Coordinator’s Office said that only those funds already appropriated 

to agencies were obligated by this target date. After Congress appropriated funds for 

PEPFAR on January 23, 2004, agencies obligated the remaining track 1 and 1.5 funds, 

according to officials in the Coordinator’s office, HHS, and USAID. 
Page 14 GAO-04-784 Global Health

ministries of health (and/or national AIDS control programs).13 (See app. V 

for additional information on initial obligations.)

U.S. Government Faces 

Five Major Challenges 

to Expanding ARV 

Treatment in Resourcepoor Settings 

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.)

13According to the Federal Grant and Cooperative Agreement Act of 1977, 31 U.S.C. 6301-

6308, procurement contracts are used to acquire goods or services “for the direct benefit or 

use of the United States Government”; grant agreements are used to transfer funds to a 

recipient “to carry out a public purpose of support or stimulation authorized by a law of the 

United States” in which “substantial involvement is not expected” by the U.S. agency 

providing the grant; and cooperative agreements are similar to grant agreements except that 

“substantial involvement is expected between the agency and the recipient.” 
Page 15 GAO-04-784 Global Health

Figure 4: Major Challenges to Expanding ARV Treatment in Resource-poor Settings

a

We asked all 28 respondents specific questions about coordination; respondents raised the other four 

challenges when answering open-ended questions. See app. I for a more detailed description of how 

we identified these five main challenges. 

U.S. Government Faces 

Challenges Coordinating 

ARV Treatment Programs 

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. 

Almost All Field Staff Cited 

Difficulty Coordinating with 

Non-U.S. Groups

Twenty-seven of 28 respondents cited challenges coordinating with nonU.S. government groups, particularly with host governments and 

multilateral organizations. 

0

5

10

15

20

25

30

Number of respondents

Source: GAO.

Coordination 

challengesa U.S. policy constraints

Insufficient host 

country human 

resources

Host government 

 constraints

Poor 

infrastructure 

and logistics

25

28

23

19

16
Page 16 GAO-04-784 Global Health

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). 
Page 17 GAO-04-784 Global Health

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.14 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. 

Field Staff Cited Challenges 

Coordinating with Headquarters 

and Other U.S. Agency Field 

Offices 

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 

14This may be due to the fact that the 3-by-5 campaign is the largest and most recent 

international ARV treatment initiative.
Page 18 GAO-04-784 Global Health

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; 
Page 19 GAO-04-784 Global Health

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. 

U.S. Policy Constraints 

Limit Agencies’ Ability to 

Rapidly Expand Treatment 

Programs 

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. 

Unclear Guidance on ARV 

Procurement Complicates 

PEPFAR’s Ability to Support 

Country Treatment Programs 

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 

Fund15 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,16 will present a challenge as more governments purchase 

generic FDCs to boost adherence. An HHS/CDC official in the same 

15The United States is one of the largest contributors to the Global Fund, and the U.S. 

Secretary of Health and Human Services currently chairs the Fund.

16These requirements may be waived if, among other factors, information is available to 

attest to the safety, efficacy, and quality of the product or if the product meets the standards 

of the HHS/FDA or other controlling U.S. authority.
Page 20 GAO-04-784 Global Health

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. 

Field Staff Concerned That 

Current Contracting Capacity Is 

Insufficient to Manage PEPFAR 

Funds 

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 Initiative17 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. 

17The communication included input from USAID and HHS/CDC field staff in 13 of the 14 

PEPFAR focus countries as well as U.S.-based officials from these and other agencies.
Page 21 GAO-04-784 Global Health

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 PEPFAR18 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 

18According to procurement officers at HHS/CDC headquarters, embassies can write 

contracts for up to $250,000; contract agreements typically cover a longer period of time and 

more complex transactions than purchase orders.
Page 22 GAO-04-784 Global Health

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. 

Differing Laws and Regulations 

May Inhibit Agencies’ Joint 

Efforts to Expand Treatment 

Programs 

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.19 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. 

19For example, according to a USAID legal official, for USAID and its grantees, the agency’s 

source, origin, and nationality rules implement provisions of the Foreign Assistance Act of 

1961, as amended, and other statutory provisions generally requiring the purchase of U.S. 

goods, regardless of whether the goods are purchased or used overseas. HHS/CDC, on the 

other hand, does not have similar agency regulations or implementing procedures other 

than those stated in the Buy American Act (U.S.C. 10a-10d). However, this act applies to 

supplies acquired for use in the United States. Since PEPFAR supplies will be used outside 

the United States, HHS/CDC has stated that the Buy American Act would not apply to its 

PEPFAR grantees who acquire supplies for use overseas. 
Page 23 GAO-04-784 Global Health

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.20 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, 

20For example, taxation would include value added taxes and customs duties. In addition, 

under the legislation, the Secretary of State “shall expeditiously seek to negotiate 

amendments to existing bilateral agreements as necessary to conform with this 

requirement.”
Page 24 GAO-04-784 Global Health

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).21 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. 

Insufficient Host Country 

Human Resources Hinder 

ARV Treatment Expansion 

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.

21The HHS/CDC audit requirements also state that the U.S.-based firm conducting the audit 

has international branches and current licensure/authority in the country where the audit is 

being conducted.
Page 25 GAO-04-784 Global Health

U.S. and Multilateral Sources 

Cited Host Country Worker 

Shortages 

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 

Health22 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,23 and a separate WHO paper stated that shortages of human 

resources are a major constraint to expanding HIV/AIDS treatment and 

care.24 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.25 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.

22These organizations are USAID contractors working overseas.

23WHO and World Bank, High-Level Forum on the Health Millennium Development Goals: 

Improving Health Workforce Performance, Issues for Discussion, Session 4 (Geneva, 

Switzerland: 2003).

24WHO, Workshop on Human Resources and Service Delivery Aspects of Scaling Up ARV 

Treatment in Resource-limited Settings: A Preliminary Discussion Paper (draft, October 

2003).

25Christoph Kurowski, Kaspar Wyss, Salim Abdulla, N’Diekhor Yémadji, and Anne Mills, 

Human Resources for Health: Requirements and Availability in the Context of Scaling 

Up Priority Interventions in Low Income Countries: Case Studies from Tanzania and 

Chad, January 2003. The purpose of the study was to explore the role and importance of 

human resources for the expansion of health services in low-income countries. The study 

was conducted under the auspices of the London School of Hygiene and Tropical Medicine, 

Health Economics and Financing Programme.
Page 26 GAO-04-784 Global Health

The country’s president cited human resource constraints as one of the 

major challenges to introducing ARV treatment in Botswana.26 

Inadequate Training of Workers 

Hinders ARV Treatment Expansion

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, lowquality nursing and medical training schools inhibit the countries’ ability to 

produce qualified providers.27 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 USAIDfunded report stated that donors traditionally have focused more on shortterm rather than longer-term interventions such as helping to develop and 

improve medical, nursing, and other technical schools. 

High Turnover Exacerbates 

Shortages

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 

26In remarks before a Center for Strategic and International Studies forum on “Botswana’s 

Strategy to Combat HIV/AIDS: Lessons for Africa, and President Bush’s Emergency Plan for 

AIDS Relief,” November 12, 2003, Washington, D.C.

27USAID, Academy for Educational Development, Support for Analysis and Research in 

Africa (SARA), Jenny Huddort, Oscar F. Picazo, and Sambe Duale, The Health Sector 

Human Resource Crisis in Africa: An Issues Paper (Washington, D.C.: 2003). 
Page 27 GAO-04-784 Global Health

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.28 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 onequarter to two-thirds of health care professionals interviewed in some 

African countries expressed an intention to emigrate to other countries.29 

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.30

National Policies and 

Regulations Limit Use and Hiring 

of Doctors 

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 

28Ibid. Another USAID-funded report, on the Zambian HIV/AIDS workforce, cited an average 

annual salary for a doctor in Zambia of $7,525 in the public sector, $9,240 at an NGO, and 

$17,050 in the private sector (see USAID, Initiatives, Inc., and University Research Co. LLC, 

Jenny Hoddart, Rebecca Furth, Dr. Joyce Lyons, HIV/AIDS Workforce Study (Washington, 

D.C.: 2003)).

29WHO, Recruitment of Health Workers from the Developing World: Report by the 

Secretariat (Geneva, Switzerland: 2004).

30WHO, The World Health Report 2004: Changing History (Geneva, Switzerland: 2004).
Page 28 GAO-04-784 Global Health

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. 

Host Government 

Constraints Inhibit 

Expansion of ARV 

Treatment 

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. 

Limited Political Commitment 

Hampers Treatment Expansion

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.

Poor Delineation of Roles 

Impedes Expansion Efforts

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 
Page 29 GAO-04-784 Global Health

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. 

Slow Decision-Making Processes 

Delay Rapid Expansion

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.

Weak Infrastructure Hinders 

Expansion of Treatment 

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. 

Information Infrastructure Is 

Weak 

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 
Page 30 GAO-04-784 Global Health

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.31 

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 collected32 but less consensus regarding 

how the data should be collected and reported. 

Systems for Managing Drug 

Supply Are Inadequate

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. 

Poor Program and System 

Linkages Inhibit Treatment 

Expansion

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 

31WHO and World Bank, High-Level Forum on The Health Millennium Development Goals, 

Monitoring the Health MDGS, Issues for Discussion: Session 3 (2003).

32For example, the data collected for treatment programs include the number of treatment 

facilities or programs and the number of people being treated. (See pp. 43-44 for a more 

detailed discussion of these indicators.) 
Page 31 GAO-04-784 Global Health

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. 

Physical Infrastructure, 

Including Health Care Facilities, 

Is Insufficient 

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 USAIDHHS/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 
Page 32 GAO-04-784 Global Health

countries in the bottom third.33 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. 

Coordinator’s Office 

Has Taken Steps to 

Address Challenges, 

but Continued Effort Is 

Needed 

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. 

33WHO, World Health Report 2000 Health Systems: Improving Performance (Geneva, 

Switzerland: 2000), annex table 10.
Page 33 GAO-04-784 Global Health

Coordinator’s Office 

Attempting to Enhance 

Coordination, but Too Early 

to Judge Effectiveness

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.34 

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 

34In many countries, such structures have been set up to facilitate the development and 

implementation of Global Fund and World Bank programs. The structures have had varying 

degrees of success.
Page 34 GAO-04-784 Global Health

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.

Agencies Exploring 

Solutions to Some U.S. 

Government Constraints, 

but ARV Procurement 

Problems Remain 

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. 

PEPFAR Agencies Exploring 

Options to Enhance Contracting 

Capacity and Address Differing 

Agency Laws, Regulations, and 

Requirements

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 
Page 35 GAO-04-784 Global Health

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.

Global AIDS Coordinator 

Provided Guidance to Field on 

ARV Procurement, but Problems 

Remain 

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.
Page 36 GAO-04-784 Global Health

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.35 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.36 

35The Coordinator’s Office, together with WHO, UNAIDS, and regulatory agencies from 23 

countries, held a conference in Gaborone, Botswana, on March 29-30, 2004, to specify 

principles to be applied when considering the use of FDCs. 

36Neither the technical nor official comments on a draft of this report that were submitted 

jointly by the State Department, HHS, and USAID address whether the process supercedes 

the Coordinator’s previously stated policy of purchasing only drugs approved by stringent 

regulatory authorities that include bodies other than the HHS/FDA. 
Page 37 GAO-04-784 Global Health

Table 1: Guidance Issued by the Office of the U.S. Global AIDS Coordinator to Field Staff on ARV Procurement and PEPFAR 

Deadlines 

Note: The Coordinator’s Office emailed this guidance to all field staff. 

a

According to WHO, under this process, evaluators from both industrialized and developing countries 

assess a manufacturer’s data on its product’s safety, efficacy, and quality, as well as the manufacturing 

processes and facilities. Through this process, WHO has found some generic ARV drugs acceptable, 

in principle, for U.N. agencies to procure. 

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

Date Event Details

November 25, 

2003

Guidance for 

completing track 2 

plans 

• Stated that “Each mission must adhere to U.S. government policy in procuring ARV drugs and 

other medicines.” 

• Stated that “Separate guidance is available on current U.S. government policy.” 

• Did not state what U.S. government policy is or where separate guidance on current policy 

could be found. 

• Did not note that (as discussed earlier in this report) the agencies implementing PEPFAR have 

different standards for procuring items to be used abroad. 

December 16, 

2003

Responses to 

questions on ARV 

procurement and 

other issues

• Stated “no” in response to a question asking if a proposed procurement mechanism under 

PEFAR would allow for the purchase of generics. 

• Stated that “specific guidance will be provided separately” in response to a question asking if 

there is a definitive PEPFAR policy on the procurement of generic drugs.

• Stated that a WHO prequalification process for drugs does not constitute approval by a 

stringent regulatory authority.a

January 19, 

2004

Deadline for obligating funds under tracks 1 and 1.5

January 30, 

2004

Updated guidance 

for completing track 

2 plans

No change from November 25, 2003, guidance regarding ARV procurement.

February 20, 

2004

Responses to 

questions on ARV 

procurement and 

other issues

• Stated that certain FDCs cannot be used “until there has been a demonstration that these 

drugs are safe and effective.” 

• Stated that the U.S. government is working with international regulators to resolve safety and 

efficacy issues and that a complete question-and-answer sheet on ARV procurement is being 

prepared. 

February 23, 

2004

PEPFAR strategy 

issued

Leaves open the possibility that PEPFAR agencies could in the future procure certain FDCs or 

other generics.

March 24, 2004 Responses to 

questions on ARV 

procurement 

• Provided a definition of “stringent regulatory authority.”

• Provided a statement of USAID’s procurement regulations, specifying requirements related to 

source and origin, safety and efficacy, and patents.

• Provided the anticipated timeframe for publishing requests for proposals for procurement and 

quality assurance (second quarter of 2004) and awarding contracts (by the end of 2004).

March 31, 2004 Deadline for submitting track 2 plans
Page 38 GAO-04-784 Global Health

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. 
Page 39 GAO-04-784 Global Health

Coordinator’s Office 

Focusing on Short- and 

Long-term Interventions to 

Alleviate Shortage of Health 

Workers 

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 interventions37 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. 

Coordinator’s Office Proposed 

Several Short-term Solutions; 

U.S. Field Staff Have Raised 

Concerns over Use of 

International Volunteers 

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.38 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 

37The Coordinator’s Office defines short-term interventions as those that generally take less 

than a year to implement, and long-term interventions as those spanning PEPFAR’s 5-year 

time frame and beyond. 

38The Coordinator’s Office expects to make an award by September 30, 2004, in response to 

a request for applications for twinning activities, according to technical comments on a 

draft of this report that were submitted jointly by the Coordinator’s Office, HHS, and USAID. 

Multiple missions had visited or were in the process of visiting countries to provide 

technical assistance for human capacity development. 
Page 40 GAO-04-784 Global Health

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. 

PEPFAR Strategy Identifies 

Longer-term Interventions 

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 healthcare 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 
Page 41 GAO-04-784 Global Health

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. 

Coordinator’s Office 

Focuses on Enhancing 

Leadership and Political 

Commitment 

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.39 It calls for using public-private partnerships at local, 

39For example, many people who think they may be infected are too ashamed and afraid to 

be tested for the disease, fearing social isolation, rejection, or violence.
Page 42 GAO-04-784 Global Health

national, regional, and international levels to strengthen global and incountry 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 faithbased 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.

Coordinator’s Office Aims to 

Strengthen Infrastructure 

for Information and Drug 

Supply; Some Field Staff 

Had Differing Views on 

Implementing Proposed 

Health Care Model 

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. 
Page 43 GAO-04-784 Global Health

Coordinator’s Office Attempting 

to Improve Data Collection and 

Reporting

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. 
Page 44 GAO-04-784 Global Health

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.

PEPFAR Strategy Has Identified 

Short-term Actions for Managing 

the Drug Supply 

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.

PEPFAR Proposes “Network 

Model” to Address Basic Health 

Infrastructure; Some Field Staff 

Had Differing Views on 

Implementing this Model 

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. 
Page 45 GAO-04-784 Global Health

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. 

Certain Physical Impediments 

Are Not Addressed 

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.

Conclusions 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 
Page 46 GAO-04-784 Global Health

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. 

Recommendations for 

Executive Action 

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. 

Agency Comments and 

Our Evaluation 

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 
Page 47 GAO-04-784 Global Health

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.

Sincerely yours,

David Gootnick, Director

International Affairs and Trade
Page 48 GAO-04-784 Global Health

Appendix I

Objectives, Scope, and Methodology ApApenednxidexiIs

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.1

 

Methodology for Identifying 

Challenges to Expanding 

ARV Treatment

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.2

 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 

1

The President announced a 15th country, Vietnam, on June 23, 2004. 

2

These staff spoke with us with the understanding that individual respondents and the 

countries where they serve would not be named in our report. The challenges identified 

include those experienced by U.S. officials during an earlier program that used ARV drugs to 

prevent HIV transmission from mothers to infants.
Appendix I

Objectives, Scope, and Methodology 

Page 49 GAO-04-784 Global Health

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 questions3

 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-toone 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.4

 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 

3

The key questions were 6.d, 6.e, 9, 10.b, 12.a, 12.b, 12.c, 13.a, 13.b, 13.c, 14.b, and 16.

4

We do not provide the number of responses here; individual respondents often provided 

several responses that fell into the same subcategory.
Appendix I

Objectives, Scope, and Methodology 

Page 50 GAO-04-784 Global Health

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.

Methodology for Assessing 

the U.S. Response

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);5

 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. 

5

The Office of the U.S. Global AIDS Coordinator prepared this report in collaboration with 

the Departments of State (including the U.S. Agency for International Development), 

Defense, Commerce, Labor, Health and Human Services (including the Centers for Disease 

Control and Prevention, the Food and Drug Administration, the Health Resources and 

Services Administration, the National Institutes of Health, and the Office of Global Health 

Affairs); and the Peace Corps.
Page 51 GAO-04-784 Global Health

Appendix II

Structured Interview Questions ApendxiI

Introduction 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.

COUNTRY

Respondent’s(s’)

• name(s)

• titles(s)

• email(s)

• phone number(s) 

Respondent’s(s) agency

Date of interview

Name(s) of interviewer(s)
Appendix II

Structured Interview Questions

Page 52 GAO-04-784 Global Health

Background 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.

ARV treatment PMTCT Plus

PMTCT (over 

last 12 months)

PMTCT (total, 

to date)

1. We are interested in the PMTCT, PMTCT Plus, and 

other ARV programs. Which of these programs does 

your mission/field office support? 

2.a. Approximately how many people are currently 

receiving these services in your country? 

2.b. Please indicate whether the numbers in the PMTCT 

Plus column are included in the ARV treatment 

column. 

Yes

no

2.c. Please provide the name of the document(s) you used 

to obtain the data for each of these services.

2.d. Please indicate if the available data are inadequate to 

answer the question for any of these services.

3.a. Of the number in 2.a., how many are being supported 

by U.S. government programs? 

3.b. Please provide the name of the document(s) you used 

to obtain the data for each of these services.

3.c. Please indicate if the available data are inadequate to 

answer the question for any of these services.

4.a. Over the next 6-12 months, how many people in your 

country do you realistically expect to start treatment? 

4.b. Please provide the name of the document(s) you used 

to obtain the data for each of these services.

4.c. Please indicate if the available data are inadequate to 

answer the question for any of these services.

5.a. Of the number in 4.a., how many will be supported by 

U.S. government programs? 

5.b. Please provide the name of the document(s) you used 

to obtain the data for each of these services.

5.c. Please indicate if the available data are inadequate to 

answer the question for any of these services.
Appendix II

Structured Interview Questions

Page 53 GAO-04-784 Global Health

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.

Voluntary counseling and testing

Rapid testing

Targeting of at-risk groups

Safe motherhood programs

Mother/child health programs

Family planning assistance

Education programs

Community outreach

Short course zidovudine (AZT)

Single dose nevirapine

Continuous ARV treatment

Treatment for partners

Treatment of opportunistic infections

TB diagnosis and treatment

Diagnosis and treatment of STIs

Lab support

Palliative care

Surveillance

Monitoring and evaluation

Training (of doctors, nurses, healthcare workers and administrators)

Other (please describe)
Appendix II

Structured Interview Questions

Page 54 GAO-04-784 Global Health

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?

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?

Coordinating with other 

USG agencies

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 

hiring/contracting of services

ARV drugs 

other drugs (for opportunistic infections)

diagnostics (e.g., test kits, including rapid test kits)

lab equipment and commodities (e.g., reagents)

vehicles

computers or other office equipment

other (please specify)
Appendix II

Structured Interview Questions

Page 55 GAO-04-784 Global Health

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. 

Coordination with non-U.S. 

organizations (host 

government, multilateral 

and nongovernmental 

organizations, other 

bilateral donors)

10.a. How does your mission/field office interface with the host 

government in your country on the programs listed in 6.a.? The 

procurement activities listed in 6.b.?

10.b. What are the key challenges your mission/field office has faced in 

working with the host government? Please provide examples of the 

consequences of these challenges. 

11.a. With what other non-U.S. organizations does your mission/field office 

currently coordinate on the programs listed in 6.a.? The procurement 

activities listed in 6.c.? 

11.b. Through what mechanisms? Are there any established mechanisms to 

ensure coordination? 

12.a. Please describe the key challenges your mission/field office has faced 

coordinating with non-U.S. organizations on VCT, PMTCT, PMTCT Plus, 

and/or other ARV treatment. Please provide examples of the consequences 

of these challenges. 
Appendix II

Structured Interview Questions

Page 56 GAO-04-784 Global Health

12.b. Based on your experience at your current post, please rate the extent 

to which you experience difficulties coordinating with the following 

partners:

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 functionrelated coordination challenges that may arise among stakeholders in a 

given country:

• harmonization of treatment protocols

• harmonization of procurement policies

• 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 

Very great 

extent

Great 

extent

Moderate 

extent

Some or little 

extent No extent

No basis to 

judge

Coordinating with other U.S. agencies

Coordinating with host government

Coordinating with multilateral organizations 

(World Bank, Global Fund, UN 

organizations)

Coordination with other bilateral donors

Coordinating with NGOs and/or the private 

sector
Appendix II

Structured Interview Questions

Page 57 GAO-04-784 Global Health

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? 

Very great 

extent

Great 

extent

Moderate 

extent

Some or little 

extent No extent

No basis to 

judge

Harmonization of treatment 

protocols

Harmonization of procurement 

policies

Harmonization of monitoring and 

evaluation indicators (i.e., the 

data collected)

Harmonization of data collection 

methods

Harmonization of data reporting 

requirements

Coordinating provision of 

feedback to those who administer 

services and/or collect data
Page 58 GAO-04-784 Global Health

Appendix III

U.S. and International HIV/AIDS Funding ApendxiI

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.

Figure 5: U.S. HIV/AIDS Funding in the 14 PEPFAR Focus Countries, Fiscal Years 2003 and 2004

Note: This information is provided solely for background purposes; therefore, we did not assess the 

reliability of these data.

a

These figures represent USAID and HHS/CDC combined spending limits for HIV/AIDS 

activities in each of the countries in fiscal year 2003. Other U.S. agencies, including the 

Departments of Agriculture, Defense, Labor, and State, allocated additional, smaller 

amounts of funds for HIV/AIDS activities in fiscal year 2003 that may have been spent in the 

PEPFAR focus countries. The National Institutes of Health obligated a total of $78 million in 

0

10

20

30

40

50

60

70

80

90

100

Uganda

Kenya

South Africa

Zambia

Nigeria

Tanzania

Ethiopia

Rwanda

Mozambique

Namibia

Haiti

Botswana

Côte d'Ivoire

Guyana

Source: GAO analysis based on data from USAID, HHS/CDC, and the Office of the U.S. Global AIDS Coordinator.

Funding (in millions of dollars)

Fiscal year 2003 spending limitsa

Fiscal year 2004 planned allocationsb
Appendix III

U.S. and International HIV/AIDS Funding

Page 59 GAO-04-784 Global Health

fiscal year 2003 to the 14 countries for HIV/AIDS research, and estimated fiscal year 2004 

obligations to the 14 countries at $86 million.

b

These figures represent planned allocations determined by the Office of the U.S. Global 

AIDS Coordinator for each of the 14 countries for fiscal year 2004. The allocations include 

funds from USAID, HHS, and the Coordinator's Office and will be used by USAID, HHS, the 

Department of Defense, State Department, and the Peace Corps to carry out PEPFAR 

activities.

Figure 6: World Bank, Global Fund, HHS/CDC, and USAID HIV/AIDS Funding in the PEPFAR Focus Countries

Note: This information is provided solely for background purposes; therefore, we did not assess the 

reliability of these data.

Source: GAO analysis based on data from the World Bank, the Global Fund, HHS/CDC, USAID, and the 

Office of the U.S. Global AIDS Coordinator.

0 40 60 80 100 120 140 160 180 200 20

Guyana

Botswana

Namibia

Haiti

Rwanda

Côte d'Ivoire

South Africa

Mozambique

Zambia

Tanzania

Kenya

Ethiopia

Nigeria

Uganda

Funding (in millions of dollars)

USAID Fiscal year 2003 obligationsc

HHS/CDC Fiscal year 2003 obligationsc

Global Fund 2-year approved funding amountsb

World Bank multi year obligationsa
Appendix III

U.S. and International HIV/AIDS Funding

Page 60 GAO-04-784 Global Health

a

World Bank projects in the PEPFAR countries are for approximately 5-year periods. Three projects 

began in 2001, one project began in 2002, four projects began in 2003, and one is scheduled to begin 

in 2004. As of December 2003, 16 percent of the total funds obligated had been disbursed. Obligations 

refer to the total amount committed for the duration of the project in that country. Disbursed amounts 

refer to the amount of funds withdrawn by the country from the World Bank.

b

The Global Fund figures are 2-year approved funding amounts. The Fund approved most of these 

amounts in 2003, two in 2002, and three in 2004. As of April 2004, there were a total of 32 HIV/AIDSrelated grants for the 14 countries, 7 of which had not yet been signed. Seventeen percent of the total 

grant funds approved had been disbursed.

c

Obligations are binding agreements that will result in immediate or future outlays. Other U.S. 

agencies, including the Departments of Agriculture, Defense, Labor, and State, may have obligated 

additional, smaller amounts of funds to the PEPFAR countries for HIV/AIDS-related activities. 

HHS/NIH obligated a total of $78 million to the 14 countries for HIV/AIDS research in fiscal year 2003. 
Page 61 GAO-04-784 Global Health

Appendix IV

The Structure of the Office of the U.S. Global 

AIDS Coordinator ApendxiIV

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). 

Figure 7: Office of the U.S. Global AIDS Coordinator Organization Chart

Note: in addition to the areas shown here, the Coordinator’s Office also includes staff focused on 

strategic policy and planning, issue support and analysis, several administrative assistants, and 6 

unallocated FTEs.

a

FTE = full-time-equivalent position, equal to one person working full time, two people working half 

time, and so on.

• Management Services—provides administrative support to the office, 

including human resources, information management, and operational 

budget.

U.S. Global AIDS 

Coordinator

Deputy Coordinator 

and Chief 

Medical Officer 

Deputy 

Coordinator 

Director of 

Management 

Services 

Source: GAO, based on information provided by the Office of the U.S. Global AIDS Coordinator on April 14, 2004.

Director of Training 

and Human 

Resources

Director of 

Diplomatic Liaison

Director of 

Program Services

Director of 

Government

Relations

Director of 

Budget and 

Appropriations

Director of Monitoring, 

Evaluation and 

Strategic Information

Director of 

Communications

Deputy Chief 

Medical Officer

3 FTEsa 6 FTEs 4 FTEs who liaise with the 

Global Fund and other 

diplomatic contacts, and 2 

detailees who liaise with 

the Department of Labor 

and the Department of 

Commerce/private sector.

4 FTEs 8 FTEs working 

with each of the 

focus countries

5 FTEs 3 FTEs 3 FTEs
Appendix IV

The Structure of the Office of the U.S. Global 

AIDS Coordinator 

Page 62 GAO-04-784 Global Health

• 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. 
Page 63 GAO-04-784 Global Health

Appendix V

PEPFAR Obligations as of March 31, 2004 ApendxiV

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, 2004.1

 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 million2

in five areas: (1) modifying behavior by encouraging abstinence and 

faithfulness ($4.9 million obligated by USAID);3 (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 

1

This information is provided solely for background purposes; therefore, we did not assess 

the reliability of these data. 

2

Track 1 also provided $1 million to HHS and USAID for strategic information activities, 

including gathering and assessing data for monitoring and evaluating PEPFAR. 

3

According to a budget official in the Coordinator’s Office, most of the transferred funds 

were obligated through contracts or grant agreements with organizations that deliver 

services.
Appendix V

PEPFAR Obligations as of March 31, 2004 

Page 64 GAO-04-784 Global Health

their efforts. As of May 31, 2004, the Coordinator’s Office had approved 14 

countries’ operational plans totaling $589,401,340. 
Page 65 GAO-04-784 Global Health

Appendix VI

Detailed Analysis of Challenges Identified in 

Structured Interviews ApendxiVI

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. 

Figure 8: Coordination Challenges Identified by Respondents

Note: All 28 respondents identified coordination challenges. As noted on pp. 14 and 15, 27 

respondents reported challenges coordinating with non-U.S. government groups as a whole (including 

host governments, among all stakeholders, and with other stakeholders) and 24 reported challenges 

coordinating with other U.S. agencies in the field and/or headquarters. 

a

The majority of responses falling into this category referred to harmonization of policies and activities 

among all or most groups involved in HIV/AIDS program expansion. 

b

Other stakeholders include multilateral organizations, bilateral organizations, NGOs, and the private 

sector.
Appendix VI

Detailed Analysis of Challenges Identified in 

Structured Interviews 

Page 66 GAO-04-784 Global Health

Figure 9: U.S. Policy Constraints Identified by Respondents 

Note: Twenty-five respondents identified challenges regarding U.S. policy constraints. In addition to 

the five constraints shown, two or fewer respondents cited the following constraints: agencies have 

different auditing requirements for non-U.S. grantees; PEPFAR needs to invest in building sustainable 

capacity to address HIV/AIDS rather than investing in short-term projects; and PEPFAR’s focus is less 

well defined than that of the PMTCT Initiative.

a

These issues include conforming to spending percentages in the PEPFAR authorizing legislation; 

HHS and USAID operating under different laws and regulations; and whether PEPFAR resources can 

be channeled through U.N. agencies. 

0

5

10

15

20

25

30

Number of respondents

Source: GAO.

Lack of 

guidance on 

other issuesa

Poor 

synchronization 

of program 

planning with 

U.S. budget 

cycles

Inadequate 

contracting 

capacity in 

the field

Lack of clear 

guidance for 

procuring ARV 

drugs

U.S. human 

resource 

issues

4

5 5

13

21
Appendix VI

Detailed Analysis of Challenges Identified in 

Structured Interviews 

Page 67 GAO-04-784 Global Health

Figure 10: Host Country Human Resource Challenges Identified by Respondents

Note: Twenty-three respondents identified challenges regarding host country human resources. In 

addition to the three challenges shown, two or fewer respondents cited the following challenges: lack 

of staff motivation, host government policies regarding the use and hiring of doctors, and difficult 

personalities. 

0

5

10

15

20

25

30

Number of respondents

Source: GAO.

Staff are not 

properly trained

Not enough 

staff

High staff 

turnover

14

7

18
Appendix VI

Detailed Analysis of Challenges Identified in 

Structured Interviews 

Page 68 GAO-04-784 Global Health

Figure 11: Host Government Constraints Identified by Respondents

Note: Nineteen respondents identified challenges regarding host government constraints.

0

5

10

15

20

25

30

Number of respondents

Source: GAO.

Political 

unrest

Poor delineation Corruption

of roles among 

government 

bodies 

responsible for 

addressing 

HIV/AIDS

Lack of 

political 

commitment/ 

leadership

Host government 

slow to build 

consensus/ make 

decisions

44 4

7

11
Appendix VI

Detailed Analysis of Challenges Identified in 

Structured Interviews 

Page 69 GAO-04-784 Global Health

Figure 12: Infrastructure and Logistics Challenges Identified by Respondents

Note: Sixteen respondents identified challenges regarding infrastructure and logistics. 

0

5

10

15

20

25

30

Number of respondents

Source: GAO.

Inadequate 

facilities

Poor drug 

management 

and delivery 

systems

Weak systems 

for monitoring 

and evaluating 

programs 

Poor linkages 

among 

programs

8

6

5

8
Page 70 GAO-04-784 Global Health

Appendix VII

Analysis of Difficulty of Coordination ApendxiVI

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. 
Appendix VII

Analysis of Difficulty of Coordination 

Page 71 GAO-04-784 Global Health

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:a

Table 2: Difficulty Coordinating with Various Groups as Reported by Respondents

Source: GAO. 

a

Twenty-seven of the 28 respondents answered this question. 

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. 

Very Great 

Extent Great Extent 

Moderate 

Extent 

Some or 

Little Extent No Extent 

No Basis to 

Judge 

Moderate or 

Greater

Extent

Coordination with other 

U.S. agencies 1 - 1 17 8 - 2 

Coordination with host 

government - - 15 9 2 1 15 

Coordination with 

multilateral 

organizations (World 

Bank, Global Fund, UN 

organizations) - - 13 11 2 1 13 

Coordination with other 

bilateral organizations - - 3 18 4 2 3 

Coordination with 

NGOs and/or the 

private sector - - 4 16 6 1 4 
Appendix VII

Analysis of Difficulty of Coordination 

Page 72 GAO-04-784 Global Health

Question 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:a

Table 3: Difficulty Coordinating on Various Issues as Reported by Respondents 

Source: GAO.

a

Twenty-six of the 28 respondents answered this question. 

Very Great 

Extent

(1)

Great Extent

(2)

Moderate 

Extent

(3)

Some or 

Little Extent 

(4)

No Extent 

(5)

No Basis 

to Judge 

(6)

Moderate or 

greater

Harmonization of 

treatment protocols 1 2 5 5 10 3 8 

Harmonization of 

procurement policies 1 5 9 3 3 5 15 

Harmonization of 

monitoring and 

evaluation indicators 

(i.e., the data collected) 2 1 7 13 3 - 10 

Harmonization of data 

collection methods 2 - 11 10 3 - 13 

Harmonization of data 

reporting requirements 4 3 8 9 2 - 15 

Coordinating provision of 

feedback to those who 

administer services andor collect data 3 3 10 8 1 1 16 
Page 73 GAO-04-784 Global Health

Appendix VIII

Joint Comments from the Department of 

State, HHS, and USAID ApendxiVI
Appendix VIII

Joint Comments from the Department of 

State, HHS, and USAID

Page 74 GAO-04-784 Global Health
Appendix VIII

Joint Comments from the Department of 

State, HHS, and USAID

Page 75 GAO-04-784 Global Health
Appendix VIII

Joint Comments from the Department of 

State, HHS, and USAID

Page 76 GAO-04-784 Global Health
Appendix VIII

Joint Comments from the Department of 

State, HHS, and USAID

Page 77 GAO-04-784 Global Health
Appendix VIII

Joint Comments from the Department of 

State, HHS, and USAID

Page 78 GAO-04-784 Global Health
Page 79 GAO-04-784 Global Health

Appendix IX

GAO Contact and Staff Acknowledgments ApendxiIX

GAO Contact Cheryl Goodman, (202) 512-6571

Staff 

Acknowledgments 

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. 

(320205)
GAO’s Mission The General Accounting Office, the audit, evaluation and investigative arm 

of Congress, exists to support Congress in meeting its constitutional 

responsibilities and to help improve the performance and accountability of 

the federal government for the American people. GAO examines the use of 

public funds; evaluates federal programs and policies; and provides 

analyses, recommendations, and other assistance to help Congress make 

informed oversight, policy, and funding decisions. GAO’s commitment to 

good government is reflected in its core values of accountability, integrity, 

and reliability.

Obtaining Copies of 

GAO Reports and 

Testimony

The fastest and easiest way to obtain copies of GAO documents at no cost 

is through GAO’s Web site (www.gao.gov). Each weekday, GAO posts 

newly released reports, testimony, and correspondence on its Web site. To 

have GAO e-mail you a list of newly posted products every afternoon, go to 

www.gao.gov and select “Subscribe to Updates.”

Order by Mail or Phone The first copy of each printed report is free. Additional copies are $2 each. 

A check or money order should be made out to the Superintendent of 

Documents. GAO also accepts VISA and Mastercard. Orders for 100 or 

more copies mailed to a single address are discounted 25 percent. Orders 

should be sent to:

U.S. General Accounting Office

441 G Street NW, Room LM

Washington, D.C. 20548

To order by Phone: Voice: (202) 512-6000 

TDD: (202) 512-2537 

Fax: (202) 512-6061

To Report Fraud, 

Waste, and Abuse in 

Federal Programs

Contact:

Web site: www.gao.gov/fraudnet/fraudnet.htm

E-mail: fraudnet@gao.gov

Automated answering system: (800) 424-5454 or (202) 512-7470

Congressional 

Relations

Gloria Jarmon, Managing Director, JarmonG@gao.gov (202) 512-4400

U.S. General Accounting Office, 441 G Street NW, Room 7125 

Washington, D.C. 20548

Public Affairs Jeff Nelligan, Managing Director, NelliganJ@gao.gov (202) 512-4800

U.S. General Accounting Office, 441 G Street NW, Room 7149 

Washington, D.C. 20548
United States

General Accounting Office

Washington, D.C. 20548-0001

Official Business

Penalty for Private Use $300

Address Service Requested

Presorted Standard

Postage & Fees Paid

GAO

Permit No. GI00