United States Department of State

U.S. INTERNATIONAL

RESPONSE TO

HIV/AIDS

1999
On the Cover:

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1. In this Tanzanian primary school, about 30 percent of the children are orphaned by AIDS. For some 

of them, the lunch provided at the school is their only meal of the day.

Photo:L. Gubb, World Health Organization Photo 

2.HIV/AIDS researcher in Thailand

Photo:Family Health International

3.Down-to-earth messages about condom availability and usage made Project Action's condom 

vending campaign in Portland, Oregon highly successful.

Photo: Mark Hooper

4.Nepali women wait to see a doctor on a Saturday afternoon at the reproductive helath 

outreach clinic organized by the Family Planning Association of Nepal and the local non-

governmental organization, General Welfare Pratisthan, in the village of Malekhu.

Photo:Mary O'Grady, Family Health International

5.Peer education training for young people in Romania.

Photo:Population Services International

6.To induce people to change longstanding behavior, unusual and dramatic communications are 

often needed. A camel rider promote Population Services International products.

Photo:Population Services International/Burkina Faso

7.Rapt attention at a lecture in Mexico city. “Women want to be able to make informed decisions 

about the methods of birth control in addition to condoms for sexually transmitted diseases 

prevention.”

8.An HIV/AIDS prevention campaign in Portland, Oregon drives home the fundamental message, 

“Don't even THINK about sex without a condom.” 

Photo:Population Services International/US Programs

9.Nurses in Thailand attending a workshop on AIDS prevention. Health care and social support 

for people withAIDS should be administered within th general health services.

Photo:World Health Organization Photo

10.Uganda, Kampala-Nakasero Blood Bank screening the samples collected by AIC.

Photo:Family Health International

DEPARTMENT OF STATE PUBLICATION 10589

Bureaus of Oceans and International Environmental and Science Affairs

Emerging Infectious Diseases and HIV/AIDS Program

Released March 1999
U.S

INTERNATIONAL

RESPONSE TO

HIV/AIDS

1999

Contents

Contents....................................................................................................................iii

Executive Summary ....................................................................................................v

Introduction: World AIDS Situation............................................................................ vii

Assessment of U.S. Interests ...................................................................................... 1

Assessment of 1995 Strategy ..................................................................................... 4

Issue Overview ........................................................................................................ 10

Agency Strategies..................................................................................................... 17

Office of National AIDS Policy .............................................................................. 17

U.S. Department of State..................................................................................... 18

U.S. Agency for International Development .......................................................... 21

U.S. Information Agency...................................................................................... 33

U.S. Peace Corps ................................................................................................ 34

U.S. Department of Health and Human Services................................................... 35

National Institutes of Health ........................................................................... 35

Centers for Disease Control and Prevention .................................................... 41

Food and Drug Administration........................................................................ 43

U.S. Department of Commerce ............................................................................ 45

U.S. Department of Defense ................................................................................ 47

National Intelligence Council ............................................................................... 49

Role of Pharmaceutical Industry ............................................................................... 50

Role of International Non-governmental Organizations .............................................. 55

Role of International Organizations........................................................................... 60

Conclusion .............................................................................................................. 64

Appendices

Appendix A

U.S. Government Contact List for HIV/AIDS Issues.......................................... 65

Appendix B

List of Acronyms ............................................................................................ 68

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vi

Executive Summary

The 1999 U.S. International Response to HIV/AIDS (human immunodeficiency virus/acquired immune deficiency syndrome) is part of a continuing effort by the U.S. Government to

create positive change in the international fight against HIV/AIDS. It will be used to foster

political commitment and to develop international partnerships. It also provides a framework

of effective programs and strategies that can serve as a model of government policy and

resource investments to more effectively meet the challenges posed by the global HIV/AIDS

pandemic.

The 1999 report examines the present world AIDS situation and assesses the U.S. foreign

policy interests presented by the HIV/AIDS pandemic. It then reviews the objectives and

accomplishments of the 1995 U.S. International Strategy on HIV/AIDS, and identifies the HIV/

AIDS challenges confronting the United States and other members of the international community. The report includes agency strategies that identify specific objectives to effectively

address HIV/AIDS issues. The programs, policies, and activities represent commitments by

each agency and have been adopted at the highest level of agency authority. To underscore

the global battle against HIV/AIDS, the report also identifies the respective roles of the pharmaceutical industry, international non-governmental organizations, and international organizations.

The 1999 report, like the 1995 report, is the product of an interagency effort. Participating

agencies include the Office of National AIDS Policy, the U.S. Department of State, the U.S.

Agency for International Development, the U.S. Information Agency, the U.S. Peace Corps, the

U.S. Department of Health and Human Services (National Institutes of Health, Centers for

Disease Control and Prevention, and the Food and Drug Administration), the U.S. Department

of Commerce, the U.S. Department of Defense, the National Intelligence Council, and the U.S.

Department of Justice.

The goals of the 1999 U.S. International Response to HIV/AIDS are to:

• Raise awareness of the issue of international HIV/AIDS;

• Raise the level of priority accorded to stemming the spread of HIV/AIDS by all governments;

• Promote collaboration between governments, international organizations, and the private sector in developing international partnerships to leverage investments of capital

and expertise into sustainable programs to fight HIV/AIDS;

• Encourage and support the efforts of UNAIDS and other international organizations;

• Promote respect of human rights for those afflicted with HIV/AIDS; and

• Highlight the special and growing needs of women and children infected with HIV/AIDS.

The target audience of the report includes governments of both developing and developed

nations, international organizations, non-governmental organizations, industry, and the public at large. The 1999 report should not be viewed as a funding directory or as a manual for

eradicating the HIV/AIDS epidemic. Rather, it is a compilation of government policies, programs, and priorities to further coordinate and share our collective expertise. Through successful, responsible partnerships at home and abroad, the global community can realize the

benefits of the lessons learned and accomplish greater goals.

No member of the global community can afford, either in terms of human suffering or

development and economic costs, to ignore the impending devastation that has already be-
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gun to ravage national economies, security, and social infrastructure. It threatens the very

fabric of society, regardless of race, economic means, or spiritual belief. HIV/AIDS has hit

hardest those least able to meet its economic costs and those in their most productive stage

of life.

The dynamic global environment, where people change addresses and transportation routes,

and exchange goods and services over vast distances, links all nations in this battle. We must

approach the solutions to our collective dilemma in a universal and collaborative way. Only

then can we bring to bear the most fervent action and the most specialized resources we each

have to offer. We look forward to each nation making a political commitment at the highest

levels and bringing sustainable commitments to see this fight through to its successful conclusion.

This report will be used as a foreign policy tool to foster political commitment by other

governments and to assist U.S. efforts in establishing or strengthening international partnerships to address the pressing challenge of HIV/AIDS. We will disseminate and discuss U.S.

Government programs and activities and encourage leaders to establish or strengthen national plans against HIV/AIDS, and expand the broad range of relevant activities - including

education for prevention, improved access to treatment, and strengthened research efforts to

develop new tools against HIV/AIDS. And finally, we will continue to work with international

organizations, governments, non-governmental organizations, industry, and others in the private sector to reduce human suffering, mitigate the impact that HIV/AIDS is having around the

globe, and to work towards the day when HIV/AIDS is eradicated.
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toll from HIV/AIDS is projected to increase exponentially in the years to come.

HIV/AIDS is a global problem touching virtually

every country and every family around the world. It

does not recognize boundaries of nationality, gender, age, occupation or sexual preference. Globally,

1 in every 100 adults 15 to 49 years of age is HIVinfected; at least 80 percent of these infections are

due to heterosexual transmission.

Regional Assessment

HIV/AIDS is resident in humans in every region

of the globe, from sub-Saharan Africa to Asia and

the Pacific, the Americas, Eastern and Western Europe, to the Middle East (figure 1). However, HIV

infections are concentrated largely in countries least

Introduction: World AIDS Situation

A Rapidly Expanding Epidemic

Dire predictions from the 1980s have become

the reality of the 1990s. HIV/AIDS is insinuating

itself into communities previously little troubled by

the epidemic and is strengthening its grip on areas

where AIDS is already the leading cause of death in

adults. The cumulative number of those infected

has more than tripled from the 10 million infections estimated in 1990. UNAIDS and the World

Health Organization estimate that more than 33

million people are infected with HIV and that 16,000

new infections are acquired every day. Worldwide,

an estimated 13.9 million people have lost their

lives to the disease - 2.5 million in 1998 alone.

Given the current rate of infection as well as the

sheer number of those already infected and the

limited availability of state of the art care, the death

Figure 1. Estimated Number of Adults and Children Living With HIV/AIDS as of End of 1998.

Source: UNAIDS data, 1998

North America

890,000

Caribbean

330,000

Latin America

1.4 Million

Western Europe

500,000

North Africa &

Middle East

210,000

Sub-Saharan

Africa

22.5 Million

Eastern Europe

& Central Asia

270,000 East Asia

& Pacific

560,000

South &

South-East Asia

6.7 Million

Australia

& New Zealand

12,000

Total: 33.4 Million
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able to afford the care for infected people. In fact,

more than 95 percent of people with HIV live in the

developing world. It is estimated that by the year

2020 HIV will be responsible for 37 percent of all

adult deaths from infectious diseases in the developing world.

HIV/AIDS is now threatening development gains

that local and donor governments, citizens, nongovernmental organizations, and international agencies have worked for decades to achieve. In many

sub-Saharan African countries, AIDS has increased

infant mortality and reduced life expectancy to levels not seen since the 1960s. Infant and child mortality rates are expected to double and even triple

early in the next century. By the year 2010, life

expectancy in some sub-Saharan countries could

decrease by 30 years or more. AIDS is doubling,

or even tripling, death rates among young adults in

countries in southern Africa. In Botswana and Zimbabwe, prevalence among young adults has reached

*** Probability of a child dying before age 5, per 1,000 live births.

Source: United States Bureau of the Census, World Population Profile 1998, Population Division,

International Program Center, Washington DC, 1998.

 Demographic Indicators for 2010, With and Without AIDS

Country Child Mortality*** Life Expectancy

2010 2010

with AIDS without with AIDS without

Botswana 119.5 38.3 37.8 66.3

Burkina Faso 144.7 108.7 45.6 60.7

Burundi 128.6 90.9 45.3 60.8

Cameroon 108.3 78.0 49.8 63.2

Côte d’Ivoire 120.9 84.2 46.7 61.8

Ethiopia 183.4 136.7 38.6 54.7

Kenya 105.2 45.4 43.7 69.2

Lesotho 121.9 70.7 44.7 65.9

Malawi 202.6 136.0 34.8 56.8

Namibia 118.8 37.5 38.9 70.1

Nigeria 112.7 68.2 46.3 64.9

Rwanda 166.4 105.5 37.6 59.2

South Africa 99.5 48.5 48.0 68.2

Swaziland 152.2 77.5 37.1 63.2

Tanzania 131.3 95.8 46.1 60.7

Uganda 120.6 92.2 47.6 59.5

Democratic Republic

of Congo 116.2 97.3 51.9 59.8

Zambia 160.7 96.9 37.8 60.1

Zimbabwe 115.6 31.8 38.8 69.5

Brazil 31.4 20.6 67.7 75.5

Haiti 129.1 119.0 54.4 58.8

Honduras 55.2 29.3 59.7 73.4

Burma 80.3 70.1 58.8 62.8

Cambodia 133.9 123.9 52.8 56.7

Thailand 25.0 21.2 72.9 75.1
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25 percent—one person in four, a historic new high.

In South Africa, it is estimated that 3 million people

are now living with HIV, and 700,000 were infected

in 1997 alone. Deputy President Mbeki, speaking

for President Mandela, has stated that South African economic growth could slow by 1 percent a

year because of AIDS.

Globally, the number of children under 15 who

have lived with or are living with HIV/AIDS since

the start of the epidemic in the late 1970s has

reached approximately 3.8 million—2.7 million of

whom have already died. Nearly 600,000 children

were infected with HIV in 1998; most were infected

before or during birth or through breastfeeding by

HIV-infected mothers. From the beginning of the

epidemic until the start of 1998, some 8.2 million

children around the world lost their mothers to AIDS.

In 1997, it is estimated that HIV/AIDS orphaned

1.6 million children. At present, 90 percent of the

orphans live in sub-Saharan Africa.

An important trend of the 1990s has been the

beginning of a shift of the global AIDS problem from

Africa to Asia, which will soon have more new HIV

infections than any other region of the world. The

recent spread of the HIV epidemic in Asia and the

Pacific has been swift. Since 1994, almost every

country in Asia and the Pacific region has seen HIV

prevalence rates increase by more than 100 percent. Nearly 7.2 million people in the region are

now believed to be living with HIV. In years to come,

that number may grow dramatically. India and

China, the two most populous countries on earth,

have experienced exponential growth. India, with

a population of over 900 million, had 3–5 million

people infected in just the last 3 years, making it

currently the nation with the greatest number of

HIV/AIDS-infected individuals. China, the world’s

most populous nation, will need to act quickly and

effectively to avoid following a similar course.

In some countries—such as Indonesia and the

Philippines—HIV has remained at roughly the same

low levels for a number of years. The situation in

Latin America is mixed, with prevalence rising rapidly in Mexico, Brazil and Guyana. In other countries, as in many industrialized nations, infection

rates have stabilized or are falling. The level of damage sustained by developing nations varies with the

maturity of the epidemic and the response of national authorities and local communities to the

threat of its spread throughout the population.

In Eastern Europe, though the absolute numbers are lower, many countries have experienced a

doubling or tripling of their infections since 1994.

Before 1995, the incidence of HIV/AIDS in the

former Soviet Union and Eastern Europe was negligible. However, in 1996, 8,000 new HIV cases were

reported. The bulk of the spread has been in injecting drug users and the sex partners of injecting

drug users (IDU), which may provide a bridge for

the virus into the general population. In Russia

2,223 cases of HIV were reported in the first

6 months of 1997, and by the year 2000, without

appropriate interventions to eliminate illegal injection drug use and to curb high-risk behaviors, as

many as 1 million Russians could be infected with

HIV.

The long lag time between HIV infection, development of AIDS symptoms, and death—which is

4–5 years in developing countries and 10 years, on

average, in industrialized countries—helps explain

why most countries have yet to see the damage

the epidemic can do to their social and economic

fabric.
1

Assessment of U.S. Interests

In the face of HIV/AIDS, the U.S. Government

aims to reduce human suffering and stem further

disease transmission. The U.S. has a critical leadership role to play in assisting the global effort to

address the growing threat of HIV/AIDS. We must

continue to take a leadership role in mitigating the

devastating individual and social impacts of the disease. Focusing our considerable technical and human resources on this pandemic confirms our national ethos to help those in need. Fulfilling this

trust, however, is also in the interest of U.S. citizens. This pandemic is the silent enemy of economic growth, national well-being, and stability

around the globe. Further, our collective hopes of

new markets, foreign investment and stable democracies could be threatened by the unbridled spread

of HIV. The recent outbreaks in Russia and the

Ukraine are sobering reminders that this danger applies worldwide.

The number of AIDS cases worldwide will continue to rise in the next millennium and will increasingly undermine other projects intended to foster

key U.S. policy goals, including democratization,

economic development, conflict resolution and

peacekeeping, and the promotion of individual and

political rights. The AIDS pandemic will overwhelm

underfunded and inadequate health delivery systems in much of the developing world and could

undo hard-won health, social, and economic gains

by nations around the world and represent a significant increase in government costs.

HIV/AIDS is not simply about mustering resources, technological know-how, and collective will

to manage and eventually halt the spread of disease. The political and economic reverberations

of HIV/AIDS demand a far broader response. Its

increased incidence among military populations, its

impact on the debates about both North-South issues and gender equity, and its challenges to principles of human rights are all inextricable elements

of policy development and implementation.

Security and Political Concerns

Although not an issue of strategic security in the

classic sense, the growing prevalence of HIV/AIDS

internationally and its pervasive impact must reshape U.S. thinking about definitions of security

and about U.S. leadership in a changing world. The

security implications are due to the fact that the

increase in HIV-infected military personnel is gradually weakening the capacity of militaries to defend

their nations and maintain civil order, to provide

qualified personnel for peacekeeping, and to have

access to a healthy conscription pool.

The high HIV/AIDS infection rates in military personnel of many countries, including officers as well

as enlisted personnel, will result in national security threats as military command structures are diminished and depleted by the disease. A 1998

UNAIDS report entitled “AIDS and the Military” states

that military HIV infection rates in Zimbabwe and

Cameroon are three to four times higher than in

the civilian population. A strong correlation found

between rank and prevalence rates indicated that

as the disease progresses, militaries will suffer from

debilitated leadership and an inability to meet military needs and commitments.

HIV/AIDS has potential implications for political

stability. In many instances, the spread of HIV/

AIDS is part of a crippling cycle affecting leadership and governance. Civil strife, refugee flows,

urbanization, and poverty all play a role in creating

conditions conducive to the rapid spread of HIV.

When economies and governments fail, or are

chronically enfeebled, health systems falter rapidly.

This leaves populations more prone to illness and

at greater risk of economic decline. As an example,

political instability and disease have reinforced each

other in Rwanda and the countries of the former

Soviet Union.

Industrialized countries are not immune to the

destabilizing effects of HIV infections. HIV blood

test scandals have resulted in national outcries.

Special considerations for the needs of HIV-infected

persons (e.g., anti-discrimination, compensation,

funding of care) also have been socially divisive

issues.
2

Social and Economic Impacts

Like the spread of the disease, the economic

impact of HIV/AIDS is pervasive and devastating.

A 1993 study by DRI/McGraw estimated that by the

year 2000, the direct (medical) and indirect (loss

of labor force and family impact) costs of the disease will exceed $500 billion. Severely affected

countries will experience large impacts on their

health sector and on the poor. According to the

World Bank, AIDS will affect the health sector in

two ways: by increasing demand and by reducing

the supply of a given quality of care at a given price.

In the case of an HIV/AIDS epidemic, the number

of patients that will overwhelm healthcare systems

will lead to an increase in total national expenditure on healthcare, both in absolute terms and as

a proportion of national product. The net effect

will be to increase the price and reduce the availability of healthcare for everyone, which will tend

to affect the poor the most. Governments, therefore, will confront trade-offs along at least three dimensions: treating AIDS versus preventing HIV infection; treating AIDS versus treating other illnesses;

and spending for health versus spending for other

objectives.

Regionally, a severe HIV/AIDS epidemic will tend

to worsen poverty and increase inequality because

low-income households will be more adversely affected by an HIV/AIDS-related illness and death. Decisions made at the household level to reallocate

resources (such as time, labor, housing, and land)

to meet costs related to the disease may alter the

distribution of income in society and create new

groups of poverty. Because HIV is predominantly

transmitted sexually, AIDS afflicts many people in

their 20s, 30s, and 40s—their most economically

productive as well as child-bearing years.

One important way in which AIDS is likely to exacerbate poverty and inequality is the increase in

the number of children who lose one or both parents. Embattled populations are becoming progressively less productive and are burdened with increasing numbers of children orphaned by AIDS.

As a result, development in these countries is adversely affected, and they will require increased

economic and medical assistance from the community of developed nations. The problems posed

by HIV/AIDS will generate additional pressure on

North-South transfers of resources, cooperation,

and bilateral relations.

Impact on the Workplace

Most prevalent among adults in their years of

greatest productivity, the economic well-being, particularly of developing nations, will be drastically

affected by the presence and spread of HIV/AIDS

in the country. AIDS affects the workplace, both

because of reduced productivity and because HIVrelated illnesses can cause increased absenteeism

among employees and increased employee costs.

Employee turnover related to the disease requires

increased training and recruitment costs.

 The loss of so many working-age adults to illness and death undermines previous achievements

in extending life expectancy and increases the burden placed upon the gamut of government and

social systems: the education system, healthcare

systems, business and industry, communities, and

families. Already the HIV/AIDS epidemic is taking a

toll on educational systems. Children are being

forced to leave school to care for ailing parents who

themselves have fallen prey to the disease. When

orphaned, children usually abandon school in more

immediate need of a livelihood as a means of selfsupport. That livelihood all too often becomes commercial sex work, selling themselves to survive or

to support their remaining siblings or other extended family. This situation, already worsened by

the growing international financial crises in Asia,

Russia and Latin America, portends an even greater

likelihood of increased transmission of HIV/AIDS

and other sexually transmitted infections (STI).

The pool of uneducated and undereducated

people due to HIV/AIDS-related causes further

threatens to undermine critical economic and business investment. Critical to attracting investment,

is a stable, well-educated, and healthy labor pool

for production of goods for domestic and international commercial markets. Increased turnover of

employees, additional training, and other employeerelated expenses could raise the costs of doing business and discourage international investment critical to stabilizing regional and national economies.

This could also mean a reduction in taxes and production-related revenues generated as part of a

healthy economic climate. At the same time, increased healthcare needs and associated costs for

treating HIV/AIDS victims strain national healthcare

budgets.
3

Poorly trained and educated girls and women,

with few opportunities for employment in the business sector, may resort to or be sold into prostitution by impoverished family members in an effort

to cover family expenses in times of economic hardship. Not only does this lead to a further undermining of the roles and status of women, but also

leads to the increased transmission of HIV/AIDS,

and an exacerbation of the poverty/HIV/AIDS cycle

of suffering. With fewer healthy people and accelerated infection rates, there will be fewer persons

available to support the growing numbers requiring care. They will likely look to the formal

healthcare system, in whatever state it may exist,

for care and support. And the ever-growing numbers of sick and dying will severely burden inadequate healthcare infrastructures and heighten fear

and intolerance, which could lead to an increase in

human rights violations.

Healthcare Costs

Of all the economic and social costs incurred

by HIV/AIDS, healthcare costs are the most easily

quantifiable. The World Bank estimates that in the

average country, the annual treatment cost of AIDS

is about 2.7 times GNP per capita. Spending on

AIDS treatment increases with GNP; and, on average, treating an AIDS patient for 1 year costs about

the same as educating 10 primary school students

for 1 year. The simulated impact of a severe AIDS

epidemic on healthcare expenditures, illustrated

below, predicts that if India maintains its current

level of healthcare subsidies, a severe AIDS epidemic would increase government healthcare expenditure by about $2 billion per year by 2010. If

subsidies are increased to the 50 percent level, the

same epidemic would increase annual government

health expenditures by an additional $30 billion

(figure 2).

Figure 2. Simulated Impact of a Severe AIDS Epidemic on Health Expenditures, India, 1990–2010.

Source: Ellis, Alam, and Gupta, 1997 (authors’ calculations) Government Health Expenditure (billions of 1996 dollars)

Year
4

Assessment of 1995 Strategy

The July 1995 U.S. International Strategy on HIV/

AIDS was structured around three broad categories

of goals:

• Prevent new HIV infections;

• Reduce personal and social impact; and

• Mobilize and unify national and international

efforts.

The following is a brief review of the progress

made on these goals since that time. This review

does not constitute an exhaustive analysis of the

activities of each agency; rather, it is simply intended

to highlight areas of success and identify areas

where more action might be taken.

Prevent New HIV Infections

Under the heading of preventing new HIV infections, the 1995 Strategy laid out several points for

action:

• Implement diplomatic initiatives to promote

more active involvement on HIV/AIDS issues

by national governments;

• Develop behavioral prevention strategies;

• Augment research;

• Safeguard the blood supply;

• Provide access to health services and technologies; and

• Address the adverse impact of poverty and

other factors on prevention efforts.

Implement Diplomatic Initiatives

on HIV/AIDS Issues by National

Governments

As a result of the 1995 U.S. International Strategy on HIV/AIDS, the Department of State, in conjunction with other agencies, has taken numerous

diplomatic initiatives to promote more active involvement on HIV/AIDS by national governments.

For example, the Department initiated senior staff

briefings and high-level directives to engage host

government counterparts; placed the issue of HIV/

AIDS on multilateral agendas; promoted positions

at the Fourth World Conference on Women; placed

HIV/AIDS on the G–7 agenda of Finance and Foreign Ministers in 1996 in Lyon; supported the G–8

agreement to work more closely on an AIDS vaccine, made at the Denver Summit and reconfirmed

at subsequent summits; and supported consensus

on HIV/AIDS-related Human Rights Commission

Resolutions.

On December 1, 1998, at President Clinton’s

World AIDS Day event, Secretary of State Madeleine

Albright issued a statement to highlight the foreign

policy implications of HIV/AIDS and initiate activity

on a U.S. diplomatic initiative on HIV/AIDS. The

1998 statement builds on the Secretary of State’s

1997 World AIDS Day statement, in which she called

on nations, private institutions, local and international business, communities, and families to intensify the fight to curb the HIV/AIDS epidemic. In

addition, U.S. ambassadors and other embassy representatives were instructed to meet with host country counterparts to brief them on the U.S. International Strategy on HIV/AIDS and to encourage leaders to expand HIV/AIDS prevention and mitigation

programs.

The U.S. Agency for International Development

(USAID) has been successful in identifying effective prevention strategies and, through USAID missions and U.S. embassies, publicized successes to

government and community health workers so that

they could be duplicated elsewhere. Dissemination

activities have included producing training curricula;

convening workshops; distributing “lessons

learned” documentation (electronic, hard copy, CDROM, etc.); and most importantly, incorporating

these best practices into all USAID-assisted programs.

Develop Behavioral Prevention

Strategies

USAID and the Department of Health and Human Services (DHHS), primarily through the National

Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC), have supported
5

an ongoing portfolio of behavioral research to identify and monitor risk behaviors and their psychosocial and environmental determinants. CDC scientists have also completed and are disseminating

information from several large, multi-site intervention trials evaluating one-on-one-, small-group-, and

community-level behavioral intervention strategies.

Approximately six trials evaluating interventions for

young gay and bisexual men, young men about to

be released from prison, serodiscordant couples

(i.e., HIV status is not the same), and HIV-infected

persons are now in the formative or implementation phase. Continual research also includes HIV

risks to postpartum women and perception and behaviors that influence acceptance of HIV counseling and testing. Finally, CDC established an ongoing database of HIV intervention research literature

to facilitate ready identification of scientifically credible intervention models for HIV prevention programs to use.

NIH supports a range of behavioral research

through a number of its component institutes and

centers. These studies have demonstrated the

important interaction of biological, psychological,

and social factors that contribute to HIV prevention, transmission, and disease progression among

individuals and population groups. Findings from

these studies have significantly contributed to the

understanding of human behaviors that affect HIV

transmission risk and to the development of successful interventions to encourage sustained behavior change.

In the past 5 years, USAID, through work with

host country governments and community groups,

has provided behavior change services for over 22

million men, women, and youth, helping them to

reduce their risk of HIV infection. To accomplish

this task, USAID has trained over 180,000 new dedicated counselors and educators. In addition, with

partner organizations, the clinical management of

sexually transmitted diseases (STD) has been improved in more than 22 countries as a significant

way to reduce the efficiency of HIV sexual transmission.

Building on this investment in behavioral research, the USAID-funded AIDS Control and Prevention Project (AIDSCAP) supported over 250 studies

ranging from an intervention trial to define costeffective approaches to HIV/AIDS education for

vocational students in Sao Paulo, Brazil, to a collaborative, AIDSCAP/UNAIDS/WHO multi-site efficacy study of the impact of personal risk reduction

counseling and HIV testing on sexual-risk behavior.

AIDSCAP also built new tools for behavioral research

related to HIV and sexually transmitted infections

(STI) and adapted rapid ethnographic assessment

procedures to the STI field. The resulting Targeted

Intervention Research (TIR) manual was tested and

applied in nine countries in Africa and Southeast

Asia. It was used to develop a locally meaningful

health education message and to enable developing-country researchers/providers to improve doctor-patient communication by using local language

and concepts in STI screening and case management.

USAID’s Women and AIDS Research Program, a

cooperative agreement with the International Center for Research on Women (ICRW), supported 17

small behavioral studies on the perceptions and

experiences of women and girls around sexuality,

HIV/AIDS, and risk reduction. This research has

resulted in a dramatic increase in the quality and

quantity of knowledge regarding the behavioral, sociocultural, and economic factors that influence

women’s vulnerability to HIV infection throughout

the world. It has brought to the forefront the need

to incorporate women and a gender perspective into

HIV prevention programs; has built local non-governmental organization (NGO) and government capacity to deal with gender issues, and in the second phase of the project, has turned the research

findings into eight HIV/AIDS interventions, focusing on the special needs and circumstances of

women.

USAID’s social and behavioral research at the

macro level has developed and applied epidemiological and economic projections for HIV/AIDS to

improve policymaking. In the Dominican Republic, policy research involving epidemiological models and projections stimulated the President to sign

into law legislation to enhance HIV/AIDS prevention efforts. In Brazil, a study of the economic losses

associated with high consumer prices for condoms

was used successfully by local advocates to convince the Federal Government to reduce taxes on

condoms. In South Africa, support for research on

the social and economic impact of HIV/AIDS has

provided crucial data for policy dialogue concerning the need for private and public investment in

HIV/AIDS prevention and care. USAID-funded

projects have established formative behavioral research as a prerequisite of technically sound intervention development. Thus, most of our future interventions will contain data collection components
6

that enrich the knowledge base for understanding

HIV risk behavior and opportunities for prevention

and care.

Finally, behavioral research is one of the core

mandates of Horizons, USAID’s new global leadership and operations research project managed by

the Global Bureau’s HIV/AIDS division. Through

mechanisms under USAID’s HIV/AIDS strategic objective, USAID is initiating intervention research on

a range of behavioral topics, including improving

risk reduction interventions for women and girls;

promoting effective STI care-seeking behavior by

men as well as women; supporting culturally appropriate counseling and testing; strengthening

community mobilization and empowerment for HIV

prevention, care, and support; improving methods

for personal HIV risk assessment; and understanding the economic and societal pressures that increase sexual risk behavior.

Augment Research

The results of research provide the foundation

on which interventions are developed. Based on

such research, the U.S. Government has made large

strides toward improving intervention strategies

such as new approaches to stem mother-to-child

transmission and new behavioral interventions. To

this end, it is notable that the results of studies

supported by NIH and CDC in the U.S. and by USAID

in Thailand highlight the dramatic success of antiretroviral therapy (AZT) in reducing the risk of perinatal transmission.

NIH has strengthened its overall program on HIV/

AIDS since 1995 (for a complete description, see

NIH section, page 35). Through many of its Institutes and Centers, a robust research and research

training program is ongoing. NIH works with a range

of national and international partners, including

UNAIDS, WHO, other U.S. Government agencies,

and industry to advance the research mission on

HIV/AIDS. NIH continues to work with international

partners to garner support for the G–8 AIDS vaccine effort.

NIH is supporting additional intervention studies in countries, including Malawi, Zambia, South

Africa, Zimbabwe, Uganda, Ethiopia and Thailand.

These studies address questions about the use of

STD treatment and microbicides in reducing sexual

transmission and about breastfeeding and the use

of antiretroviral drugs to reduce mother-to-child

transmission in international settings.

CDC emphasizes the eradication of perinatal HIV

transmission in the U.S. through research, training,

and pilot projects. CDC is actively involved in ongoing research on using AZT in pregnant women to

prevent perinatal HIV transmission. In 1995 NIH

pledged to place a high priority on following up initial studies on methods to prevent HIV transmission from mother to fetus, including AZT and micronutrient treatment (vitamin A) during pregnancy,

and on further defining the context of their use.

The Department of Defense continued in its cooperation with other countries in the quest for the

identification of an HIV/AIDS vaccine and the identification of “best practice” for the treatment of HIV/

AIDS. Further, the Department of Commerce,

U.S. Patent and Trademark Office, developed a

homepage that provides a searchable database with

the full-text and images of patents related to AIDS

research.

Safeguard Blood Supply

The Food and Drug Administration (FDA) has

worked with manufacturers to facilitate the development of new testing methodologies and other

approaches to assure the safety of the blood supply. FDA is also collaborating with international

organizations such as the World Health Organization (WHO) to harmonize biological standards on

blood safety and is actively involved in training others in their specialty. Additionally, USAID and NIH,

primarily through the National Heart, Lung and Blood

Institute (NHLBI), have directly supported improvements in health care infrastructure and research

on relevant diagnostics by providing advocacy and

leadership in the area of blood safety, including

the development of assays for detection of HIV, and

in development of universal precautions.

Provide Access to Health Services

and Technologies

Toward the goal of providing greater access to

health services and technologies, USAID is supporting female condom distribution and market research

in over 15 countries. The USAID Population, Health

and Nutrition (PHN) Center has developed a global

research agenda for determining the net public

health value of providing the female condom

through public- and private-sector outlets. In addition, USAID supports several grants for specific
7

areas of research, including female-controlled topical spermicides and microbicides, the economic

impact of HIV/AIDS, inexpensive STD diagnostics,

and novel testing and counseling strategies.

FDA has worked with manufacturers to facilitate

the rapid development of new agents to prevent

and treat HIV-related conditions and medical devices to prevent transmission, through streamlining the FDA review and drug approval process for

HIV/AIDS therapies. FDA has approved 12 drugs

as antiretroviral agents used to treat the virus and

25 drugs for the treatment of opportunistic infections related to HIV.

Address the Adverse Impact of Poverty

and Other Factors on Prevention Efforts

In 1996, USAID redesigned its HIV/AIDS strategic objective to better reflect the experience gained

to date in prevention activities and to respond more

effectively to the growing and changing worldwide

epidemic. Representatives of host governments,

international development organizations, NGOs, the

private sector, affected communities, people living

with HIV/AIDS (PLWHA), and USAID Mission and Regional Bureau staff participated in a series of activities resulting in recommendations to expand the

scope of USAID’s response to the epidemic.

The revised Strategic Objective (SO) states: “to

increase the use of improved, effective and sustainable responses to reduce HIV transmission and

to mitigate the impact of the HIV/AIDS epidemic.”

This new strategy is based on the need for continued and expanded efforts to prevent HIV transmission and a new focus on mitigating the disease’s

impact on people and their communities, while

more closely studying its social, economic, and

policy impacts.

Included in the revised strategy is a directive to

“develop and promote approaches that address key

contextual constraints and opportunities for prevention and care interventions.” HIV/AIDS prevention and management efforts are often hampered

by the policies, norms, and financial constraints

under which they operate. USAID will work with

the Department of State and other agencies to address these environmental constraints and effectively communicate the economic, social, and

health costs of HIV/AIDS to key policymakers; promoting the elimination of barriers that inhibit the

flow of HIV/AIDS prevention and management information and services to youth, women, people

living with HIV/AIDS and other vulnerable groups;

developing and promoting effective strategies for

providing basic care and support services for

PLWHA; and supporting initiatives to dedicate increased resources for HIV/AIDS prevention and

management.

Reduce Personal and Social

Impact

The 1995 Strategy called for a greater consideration of the problems HIV/AIDS poses that go beyond the medical and health implications. The strategy stipulated that in order to mitigate the impact

of HIV/AIDS on the individual and society, the following broader issues must be taken into account:

• Providing care and support;

• Guaranteeing human rights;

• Protecting politico-military structures at risk;

and

• Placing HIV/AIDS on the sustainable development agenda.

Provide Care and Support

In an effort to provide greater care and support,

USAID was active in advocating a strategy of “prevention to care,” which included improving access

to counseling and testing, reducing stigma, improving psychosocial and basic medical support for HIVpositive persons, and implementing selected interventions for survivors. USAID and NIH have studies

underway to find ways to limit progression of HIV

disease in infected children and to increase childhood survival in developing countries, particularly

Africa and Asia.

Providing care and support to those living with

HIV/AIDS reaches beyond the health sector. As

such, increased attention has been given to the

social and economic impacts of HIV/AIDS. The

USAID Regional Missions support a range of studies on the social, economic, and community impacts of HIV/AIDS in Africa, Asia, and Latin America,

ranging from studies on the social and economic

impacts of HIV/AIDS in Southern Africa to studies

of collaboration between traditional and biomedi-
8

cal healers in managing HIV/AIDS in Zambia and

Senegal. At the request of the Office of the Vice

President, the National Intelligence Council (NIC)

Office of Transnational Issues recently published a

study assessing the social and economic impact of

AIDS in the sub-Saharan Africa region.

Guarantee Human Rights

In the area of human rights, the Department of

State and other U.S. Government representatives

implemented diplomatic initiatives to promote and

safeguard protection under the law for persons living with HIV/AIDS with regard to access to

healthcare, employment, education, travel, housing, and social welfare in all appropriate fora. The

U.S. Government supported consensus on the UN

Commission on Human Rights’ biennial resolution

“The Protection of Human Rights in the Context of

the Human Immunodeficiency Virus (HIV) and Acquired Immune Deficiency Syndrome (AIDS).” The

resolution sets out guidelines states may follow in

dealing with the health crisis and human toll of AIDS

and HIV. The resolution also asks the Secretary

General to solicit input from countries, specialized

agencies, and related governmental and non-governmental organizations in order to provide a

progress report to the Commission on follow-up.

The next session of the Commission at which the

HIV/AIDS resolution will be considered will take

place in March 1999. In addition, the Department

of State continues to include HIV/AIDS-related discrimination and human rights abuses in regular

embassy reporting.

Protect Politico-Military Structures

The Department of Defense furthered its efforts

to protect politico-military structures at risk by continuing to conduct military-to-military educational

programs on HIV/AIDS, which are expected to contribute to changes in high-risk behavior and an overall decrease in rates of infection in foreign militaries. Additionally, the National Intelligence Council

prepared a national estimate on the impact of HIV/

AIDS on military establishments. USAID also

funded, through AIDSCAP, a global initiative called

the Civil-Military Alliance on HIV/AIDS to provide

network collaboration and information sharing opportunities among civilian and military populations

in Africa, Asia, Latin America, the Caribbean, and

Eastern and central Europe.

Place HIV/AIDS on the Sustainable

Development Agenda

The Department of State is directly responsible

for placing health and HIV/AIDS on the international

agenda as elements of sustainable development.

Health—including a discussion of HIV/AIDS—continues to be a part of the USAID programs for development assistance. The Department of State also

placed HIV/AIDS on the G–7 agenda of Finance and

Foreign Ministers in 1996 in Lyon and supported

the G–8 agreement to work more closely on an AIDS

vaccine or vaccines, made at subsequent summits.

These efforts culminated in increased collaboration

and President Clinton’s call for an HIV/AIDS vaccine by 2007.

Mobilize and Unify National and

International Efforts

The 1995 International Strategy called for increased collaboration and unification of U.S. Government HIV/AIDS prevention and mitigation efforts

and stated that “strengthened collaboration within

and among countries is an essential component to

improving efforts to combat global HIV/AIDS.”

In this vein, the Department of State has actively

forged international partnerships to promote HIV/

AIDS prevention. In particular, at the Fourth World

Conference on Women, the Department of State

successfully promoted major tenets of the 1995

International Strategy on HIV/AIDS. U.S. positions

in support of the strategy were adopted at the Beijing

conference. In addition, the Department of State,

USAID, the Office of National AIDS Policy (ONAP)

and others continue to work with UNAIDS and other

international organizations with the goal of unifying international efforts to mitigate and prevent HIV/

AIDS.

Through public diplomacy, the U.S. Information

Agency (USIA) continues to share with foreign publics key policies and a variety of American federal

and local government and non-governmental organizational activities that contribute to HIV awareness, prevention, and treatment programs in the

United States and abroad. An example of USIA efforts is the campaign mounted to bring attention to

the December 1, 1997 World AIDS Day issue of AIDS

orphans.
9

Since 1995, the Office of National AIDS Policy

has taken further steps toward unifying national efforts. Representatives from Department of State,

USAID, ONAP Director’s Office, the Department of

Health and Human Services (DHHS), and others

worked together collaboratively and met several

times to develop a National AIDS Strategy. In addition, the Office of National AIDS Policy coordinates

the Interdepartmental Task Force on HIV/AIDS,

aimed at developing a coordinated response to the

steps laid out in the National AIDS Strategy. ONAP

also coordinates the federal response to World AIDS

Day, and as a member of the President’s Domestic

Policy Council, provides ongoing input into the development of the annual federal budget request.

Areas for Continued or Future Action

• Strengthening political commitment by governments to more actively address HIV/AIDS and

its impacts;

• Strengthening public health infrastructures;

• Making AIDS treatment more accessible and

affordable;

• Addressing the adverse impact of poverty and

other factors on prevention efforts;

• Protecting human rights; and

• Improving collaboration and donor coordination through sharing both technical and financial resources.
10

Issue Overview

A U.S. Government Interagency Working Group

on International HIV/AIDS agreed to the following

issues as those most relevant for action through

agency programs. They are HIV transmission prevention, vaccine research, and mitigation of the

impact of HIV/AIDS. Within these larger issues are

several other issues of importance, including treatment equity, behavioral research/behavioral change

intervention, AIDS-orphaned children, women and

health, microbicide development, and donor coordination. This section provides an overview of these

issues.

Effective Interventions

Antiretroviral Drugs

New breakthroughs in the development of

multidrug therapies and antiretrovirals used to reduce the perinatal transmission of the disease from

mother to fetus or newborn are providing a larger

arsenal of weapons with which to fight the HIV/AIDS

epidemic. Potent new combinations of antiretroviral

drugs have reduced viral load in patients and have

proven to be one of the major scientific advances

in 1996. However, the relative short-term success

of potent three-drug combinations, due to the development of drug resistance and the extreme costs

and difficulty in the treatment regimen, undermines

the long-term prospects for continued success and

their widespread availability beyond the developed

world.

While drug therapies may extend and improve

the quality of life for HIV/AIDS patients, they are

not a cure for the HIV/AIDS virus and are not available to all who need them. Nor have they been

proven successful for everyone and often cause

severe negative side effects. The costs of

antiretroviral therapy range from U.S. $10,000 to

U.S. $15,000 per person per year and require an

established public health infrastructure that can assure compliance with a continuous, comprehensive,

and vigorous treatment regimen, making the treatments impractical and unwise for much of the developing world.

In addition to cost, drug-resistant strains of HIV

emerge if an individual’s viral replication is not completely suppressed by antiretroviral treatment or

compliance with the treatment regime. As a result,

viral load increases and disease progression may

occur. The misconception that antiretroviral therapy

is a cure may work against prevention of transmission if individuals believe they are no longer contagious and continue high-risk behavior. And although

antiretrovirals can prevent mother-to-child transmission of the disease, they provide no protection to

the mother. The potential emergence of drug-resistant strains combined with the emergence of

mutated strains of the virus, and the need for more

widespread availability of prevention and treatment

measures, demand that all efforts for vaccine research and transmission prevention be redoubled

immediately.

HIV Transmission Prevention

HIV transmission can be reduced and the socioeconomic impacts of HIV/AIDS alleviated with effective development and implementation of improved policies, strategies, and coordinated HIV

prevention programs, underpinned by strong commitment and involvement from national, state, provincial, and local governments.

Now, as more accurate numbers are tabulated

to show the presence and rate of infection, it is

evident that the fight to end HIV/AIDS will be long

and will require the sustained partnerships of all

affected. HIV/AIDS is a multisectoral problem that

can be solved only with interventions comprised of

well-planned sustainable programs, which address

legal, social, and economic inequities as well as a

new array of problems unique to HIV/AIDS. The

effort requires the collaborative expertise of international organizations, governments, industry, and

non-governmental organizations.

There exists no single, standardized set of interventions in HIV/AIDS prevention programming. Specific regional strategies must include an appropriate mix of programs proven to be effective for the

vulnerable populations being addressed. Taken into

account must be the available resources and local

risk behaviors and approaches that would be tailored to cultural attitudes and belief systems.

Preventing sexual transmission requires comprehensive and persuasive education to convince

people to change deeply ingrained sexual behav-
11

iors and gender and power relations, a difficult and

complex task that can challenge cultural, religious,

and personal beliefs. But prevention works.

There is good evidence that HIV infection rates

are stabilizing or decreasing in places where focused

and sustained prevention programs have engendered significantly safer behavior. This is not just

the case in industrialized countries in Europe and

the Americas. It is true around the world. For example, surveillance testing in urban areas of Uganda

over the past 5 years reveals a 40 percent drop in

HIV prevalence among pregnant women. This decline in HIV infection is particularly striking in young

women and is associated with delayed first sexual

intercourse, increased condom use, and fewer

sexual partners.

In Thailand, annual surveys of young men

showed both substantial reductions in risk behavior and decreases in HIV infection levels. Between

1991 and 1995, visits to sex workers reported by

these men were cut by almost one-half; and those

who reported not using a condom on the last visit

dropped from nearly 40 percent in 1991 to slightly

over 5 percent in 1995. As a result, HIV prevalence among this group has decreased from 8 percent in 1992 to less than 3 percent in 1997. The

first signs of an HIV turnaround are also being seen

among young people in northern Tanzania. In

areas with active prevention programs, prevalence

in young women fell by 60 percent over a period of

6 years.

Other methods of preventing HIV transmission

also may have an important impact on slowing the

pandemic. For example, NIH-sponsored researchers are developing and testing topical microbicides,

substances that a woman could use in her vagina

before sex to prevent the transmission of HIV and

other sexually transmitted diseases. USAID,

UNAIDS, and others also have facilitated more widespread use in Africa of the female condom. These

interventions may help women to protect themselves in situations where they are unable to avoid

sex with partners who are HIV-infected or are unable to persuade their partners to use a condom.

However, to prevent HIV transmission it is no

longer sufficient to focus solely on sexual transmission as the only route of HIV infection. While

heterosexual and male-to-male sexual contact are

the primary means of transmission, there are many

other routes which, if ignored, will continue to raise

transmission rates, resulting in further spread of

the deadly virus (figure 3).

Injection drug use, for example, is another prevalent mode of HIV transmission. In many countries,

Figure 3. HIV and Injecting Drug Use (IDU), 1997.

Source: WHO Programme on Substance Abuse
12

drug injection accounts for more HIV infections than

sexual transmission. According to UNAIDS, threequarters of cases recorded in Malaysia, Vietnam,

southwest China, northeast India, and Myanmar are

among injecting drug users. In Western Europe, if

one counts infections passed on to the sex partners and infants of drug users, drug injection accounts for 44 percent of AIDS cases. In the southern cone countries of Latin America it accounts for

nearly a third. In Eastern Europe the picture is even

more alarming. Some 87 percent of HIV infections

in Belarus, for example, are among drug injectors.

In the Russian Federation, most infections were

spread sexually until 1995, and injection drug use

was virtually unheard of. However, in 1996 and

1997 confirmed infections in drug users accounted

for four out of every five newly-diagnosed infections.

Researchers have shown that several approaches

to HIV prevention can reduce the number of new

infections when properly executed, including: education and behavior modification; the social marketing and provision of condoms; treatment of other

sexually transmitted diseases; drug abuse treatment

(for example, methadone maintenance for injection drug users); and the use of antiretroviral drugs

to interrupt the transmission of virus from mother

to infant.

Integration of the use of proper procedures for

blood safety and universal infection control is effective in reducing blood-borne HIV transmission

in health programs. Developing and applying intervention strategies, within existing health programs,

to decrease transmission by other routes, such as

perinatal and by blood, is absolutely integral to the

decrease of HIV transmission rates.

The case of mother-to-child transmission is estimated to be the source of 5–10 percent of the total

of new HIV infections in many developing countries, with almost 600,000 children infected in

1998. Compounding the situation is the fact that

over 1.5 million HIV-infected women become pregnant each year. The majority of these pregnancies

are in Africa and Asia.

A recent USAID-funded clinical trial conducted

by the Centers for Disease Control and Prevention

with the Thailand Ministry of Health found that HIV

transmission from mother to child could be reduced

by 50 percent by giving the drug AZT to mothers

during the last 4 weeks of pregnancy and during

labor and delivery. Trials show that antiretroviral

pills given to pregnant women during the last week

prior to and during labor, combined with safe alternatives to replace breastfeeding, cut overall vertical transmission of HIV to 9 percent. This compares with the norm in developing countries of up

to 35 percent.

While preventing HIV transmission is necessary

to curb the ever-growing epidemic, countering the

increasing rates of opportunistic infections is also

essential. HIV-related increases will occur in the

progression of dormant tuberculosis (TB) infection

to infectious TB diseases in individuals infected with

both diseases. People whose immune defenses

are weakened by HIV infection are more vulnerable

to microbes, including the bacillus that causes TB.

The resulting infections are responsible for the recurring illnesses which in their late stages are called

AIDS, and which ultimately lead to death. According to UNAIDS, about 30 percent of all AIDS deaths

result directly from TB. The World Bank estimates

that between directly causing AIDS deaths and indirectly facilitating the spread of TB, HIV will be

responsible for up to half of all adult deaths from

infectious disease in the year 2020 (see figure 4).

Programs to address other STIs, which exacerbate or are exacerbated by HIV/AIDS, must be

implemented along with more comprehensive, accurate, and inexpensive diagnostic testing and counseling. In Tanzania, the “Mwanza study” showed

that using simple, realistic syndromic management

to treat sexually transmitted infections within a study

population reduced the number of new infections

by an impressive 42 percent.

Prevention of and reduction in transmission rates

are key to slowing the HIV/AIDS epidemic; however,

it is important to note that should HIV transmission

cease tomorrow, the continual impact of AIDS cases

following the natural course of HIV will remain great

for many years to come. Therefore, tailored combinations of programs designed to mitigate the

devastation wreaked by HIV/AIDS, as well as prevention of transmission, are needed for an effective sustainable response to the deadly epidemic.

HIV Drug and Vaccine Development

A number of new research advances indicate

progress against AIDS and open new areas of investigation. Protease inhibitors, a new class of drugs

used in combination with other antiretroviral therapies, have been shown to remarkably diminish the

amount of HIV in an infected individual. Receptors

for molecules called chemokines have been identified as critical co-factors for HIV infection, provid-
13

ing us with an entirely new set of targets for antiHIV therapies and new approaches for vaccine development. The challenge now is to develop more

effective drugs and to prepare for the possible

emergence of drug-resistant strains of the virus.

Despite these advances, the end of the pandemic

is not in sight. The new drugs, while promising, are

not a panacea. It is not known how long the benefits of the drugs will last. There are many for whom

the new drug regimens have not been effective or

for whom the side-effects are not tolerable. The

challenge now is to develop more effective drugs

and to prepare for the possible emergence of drugresistant strains of the virus.

Developing a vaccine or vaccines that are safe

and effective in preventing HIV infection in exposed

individuals is a major public health priority in the

national and international effort to combat this

epidemic. A safe and effective vaccine for HIV infection is a priority of AIDS research and an important step toward bringing the HIV epidemic under

control. The goal is a preventive vaccine to slow

and eventually end the HIV pandemic and to protect the individual from HIV infection and/or disease.

Without a vaccine, AIDS will soon overtake TB

as the leading infectious cause of death in the world.

Figure 4. Causes of Death, by Percent, From Infectious Diseases Among People Ages 15 to 59, in

the Developing World, 1990 and 2020.

Source: Murray and Lopez, 1996

Vaccines may be the most cost-effective way to prevent HIV infection worldwide. Therefore, an affordable, safe, and effective vaccine that is also easily

delivered and acceptable to various populations at

risk is urgently needed. President Clinton called

for the development of an HIV/AIDS vaccine by

2007, inviting international scientific collaboration

to meet this goal.

Mitigating the Impact of HIV/AIDS

Mitigation of the impact of HIV/AIDS will need

to focus primarily on three main areas, while maintaining adequate surveillance and flexibility to address other issues as they may arise. Programs for

mitigation should address care and support for HIVinfected individuals, dependency and orphanhood

resultant of HIV/AIDS deaths, and the pandemic’s

affect on women and health.

Due to investments in biomedical research,

steady progress has been made in improving the

care of people with HIV/AIDS. For example, the

usefulness of a tuberculosis prophylaxis has been

confirmed that will now allow more effective action against this coepidemic. Widespread access

to highly effective antiretroviral therapy has significantly prolonged life and improved the quality of

Other Malaria HIV Respiratory TB

1990

2020

54.7

2.6 1.3

4.4

37.1 51.4

10.0

23.5

6.4

8.6
14

life for people living with HIV in the Western world

and has resulted in a spectacular decline in AIDS

deaths in these countries. But because of the high

cost and complexity of these drug regimens, most

infected individuals in the developing world have

no access to the latest therapies—and often not

even to simple treatments to fight their infections

and to diminish their pain.

Despite advances in biomedical research, the

absence of affordable therapies in developing countries, where 90 percent of the epidemic is concentrated, will only exacerbate the already enormous

human and economic costs of AIDS. It also risks

becoming a major contributing factor to social and

political instability in those countries with hundreds

of thousands to millions of infected and affected

citizens.

More needs to be done to document and improve understanding of the nature, magnitude, prevention, and mitigation of HIV/AIDS-related adverse

socioeconomic impacts in the different levels and

sectors of society. Surveillance of the disease itself, as well as tabulation of infection rates, is absolutely necessary to ensure that programs are

implemented and that funds are used adequately.

Including HIV/AIDS sentinel surveillance in regional

and national surveillance for emerging and reemerging infectious diseases will serve both to better follow the epidemic and strengthen surveillance systems worldwide. Linking surveillance systems will

not only serve to better understand the path of the

disease but will also ensure that all information is

available and encourage sharing of effective strategies worldwide.

Care and Support for HIV-Infected

Individuals

With 33.4 million people infected with HIV worldwide and with infection rates on the rise, the need

to create comprehensive care systems is great. The

numbers of HIV-infected individuals and people living with AIDS-related illnesses will be so large that

governments and donor agencies will have to have

developed cost-effective intervention strategies to

improve the accessibility and quality of care and

support services for HIV-infected individuals. They

also will need strategies to reduce the adverse socioeconomic consequences of AIDS. Healthcare

for HIV/AIDS-infected individuals must be designed

and administered in an equitable manner. It must

also be in agreement with human rights, as stipulated by the International Guidelines for HIV/AIDS

and Human Rights: that vulnerability to HIV/AIDS

be reduced; that those infected with HIV/AIDS live

a life of dignity without discrimination; and that the

personal and societal impact of HIV infection is alleviated.

AIDS-Orphaned Children

During the Twelfth World AIDS Conference in

Geneva, the problems posed by this issue were

referred to as a “massive social time bomb” as the

number of children affected by AIDS, including

those who are orphans or caring for sick parents,

continues to escalate. By the year 2000, 15.6 million will have lost one or both of their parents in 23

countries heavily affected by HIV/AIDS. Largely as

a result of the pandemic, that number will increase

to 22.9 million by 2010. When paternal orphans

are included, the total number of orphans from all

causes is projected to increase from 34.7 million

in 2000 to 41.6 million in 2010 in these 23 countries.

HIV has often caused huge increases in death

rates among younger adults—just the age when

people are forming families and having children.

This inevitably leads to an increase in orphans.

UNAIDS estimates that, in rural areas of east Africa, 4 out of every 10 children who have lost one

of their parents by age 15 have been orphaned by

HIV/AIDS.

The loss of a parent poses tremendous challenges for a child. These children may suffer from

depression, malnutrition, lack of immunizations or

healthcare, increased demands for labor, loss of

schooling, forfeiture of inheritance, forced migration, homelessness, vagrancy, starvation, crime,

and increased exposure to HIV infection.

The growing number of children who lose parents will, in turn, have a profound impact on their

societies. With children who have lost parents eventually comprising up to one-third of the population

under age 15 in some countries, this outgrowth of

the HIV/AIDS epidemic will create a lost generation—a sea of youth who are disadvantaged, vulnerable, undereducated, and lacking both hope and

opportunity. The creation of such a large and disaffected demographic “youth explosion” could propel some of these societies to significant unrest

and destabilization over the long term. The threat

to the prospects for economic growth and development in the most seriously affected countries is

considerable.
15

Women and Health

One of the most striking trends in the HIV/AIDS

pandemic during the past decade has been its rapid

spread among women. Worldwide, women are becoming infected at faster rates than men, and the

total number of HIV-infected women is fast approaching that of men. Young women are particularly vulnerable, and it is estimated that 70 percent

of women infected with HIV are between the ages

of 15 and 24.

Women and girls face greater biological vulnerability than males. The female reproductive tract

is more susceptible to infection with HIV and other

STDs, a susceptibility that is particularly great in

young girls. Sexual transmission of the virus is four

times more efficient from men to women than from

women to men. Nine in ten HIV-infected women

became infected through heterosexual intercourse.

But social and economic forces can play an even

greater role in increasing women’s risk of acquiring HIV infection. The imbalance of power between

men and women in most cultural settings limits

women’s ability to protect themselves. Many

women and young girls are forced to accept sexual

partnerships that put them at high risk of contracting the virus and are unable to insist on condom

use by their partners. More than half the young

women in a Malawi study reported coercion; over

20 percent of young women surveyed in Nigeria

reported being forced to have sex. The reasons for

forced sexual intercourse range from social pressure through coercion by older men in authority, to

having sex with virgins prescribed as a remedy for

a range of “illnesses,” to outright violence. Young

girls are often targeted because they are believed

“safe” and uninfected with HIV. Rape has become

lethal with the advent of HIV. Adolescent girls face

the greatest threat, as their extreme biological vulnerability is amplified by their psychological and

cultural subordination and their lack of access to

reproductive health information and services.

Topical microbicides are chemical barriers that

women can apply to inhibit HIV infection. Although

none have been shown to be effective now,

microbicides are needed due to the high prevalence

of nonconsensual sex, lack of condom use, and

need for reproductive choices. Products also are

needed to allow conception while preventing HIV

infections and other STDs.

Collaboration is important in addressing both

common and individualized concerns for women

addressing HIV/AIDS issues. Such collaboration

should include the public and private sectors, international organizations, NGOs, the media, and

women.

Donor Coordination

While the HIV/AIDS pandemic continues to grow,

it is apparent that current worldwide programs and

financial resources available to combat this disease

are insufficient. An improved worldwide response

to the pandemic in the developing world will require enormous increases in resources. Regardless of increases, it is unlikely that there will ever

be adequate resources available to effectively meet

all the needs associated with HIV/AIDS.

There is a critical need for developing effective

coordination mechanisms within the donor community, multilateral coordinating bodies, the private

sector, and host-country governments to ensure that

available resources meet the most urgent program

needs. The coordination of donor efforts for HIV/

AIDS will assure that the limited resources currently

available will maximize the comparative advantage

donors have in various program areas. For example,

some bilateral donors, such as USAID, may have

strength in service delivery programs while other

bilateral donors may play important complementary roles in other areas, such as policy dialogue

and training. Efforts to enhance UNAIDS’ activities

and to enhance donor coordination should be supported.

Donor coordination also will become even more

important in the future as efforts increase to identify additional resources needed to combat HIV/

AIDS. Increasingly, HIV/AIDS is recognized not only

as a health problem but also as a development problem that adversely impacts all sectors of a developing country—education, finance, agriculture, and

other labor sectors. Therefore, the search for additional financial resources must extend to funds that

may be available within the budgets of these other

sectors. It may be possible through effective donor coordination/collaboration to mobilize increased private-sector resources for HIV/AIDS prevention and mitigation efforts. A critical need exists for improved collaboration and coordination

between those organizations that are performing

biomedical research and those who are implementing programs and delivering services. Improved
16

collaboration will allow better exchange of information about the current status, effectiveness, cost,

and availability of potentially useful technologies.

Likewise, organizations that implement service delivery may be able to contribute critical insights during research design to assure that key operational

questions can be addressed during initial research

endeavors.

To effectively prevent transmissions and mitigate impacts there must be coordination of various programs designed to address the entire spectrum of the epidemic. It has been shown that the

key to any effective program or strategy is the full

commitment by all involved, particularly the involvement and commitment of government officials at

the highest levels. Serious information gaps and

lack of leadership and sustained commitment on

the part of government and donors have significantly slowed efforts to advance and sustain HIV/

AIDS prevention and mitigation programs throughout the world.

In the protracted battle against HIV/AIDS, two

of the greatest factors inhibiting effective program

planning and implementation are cost and

sustainability. Sustainability plays a major role in

cost due to the fact that the need for repeated creation, implementation, and staffing of effective programs requires great investment. Therefore, the

development of programs that are self-sustaining

and easily administered at all levels of implementation is absolutely integral to countering the epidemic.

To design sustainable systems for effective prevention and mitigation, a foundation must be laid

to locally train technical workers and to locally plan,

manage, and implement programs. Developing linkages between various institutions and international

research centers and developing regional networks

of health and nonhealth experts involved in fighting HIV/AIDS, who can assist in the review and improvement of regional training curricula, will prove

highly beneficial in fighting HIV/AIDS. Planning future programs must involve national and local investment in building professional and institutional

capacity to ensure sustainability at all levels of administration. Working with the international community, the collective efforts of all concerned are

needed to effectively address the myriad issues

involved in addressing this pernicious epidemic.

The U.S. Government calls upon all nations, international organizations, and the public and private sectors to work together in effective partnerships to advance vaccine research efforts and to

promote more effective use of limited technical and

financial resources in the fight against HIV/AIDS.
17

Agency Strategies

Office of National AIDS Policy

Role and Structure

In 1993, President Clinton created the Office of

National AIDS Policy (ONAP) to provide a national

focus and direction to the U.S. Government’s response to HIV and AIDS. ONAP provides broad

guidance for Federal AIDS policy and fosters interdepartmental communication and coordination.

ONAP works closely with non-profit and for-profit

organizations at the national, state, and community-based levels, as well as internationally, to ensure the broadest input into policy development

and implementation. The Director of ONAP is a

member of the President’s Domestic Policy Council, and provides ongoing input into the development of the Administration’s annual budget request

to Congress. She serves as the chair of the Interdepartmental Task Force on HIV/AIDS, an intra-governmental coordinating body working to develop a

unified approach to HIV/AIDS in the Federal government.

The ONAP director has taken a leadership role

on international AIDS issues, having led delegations

to Africa, Russia and India to study first-hand the

impact that HIV/AIDS is having on developing countries. In December 1998, the President directed

the ONAP director to visit South Africa and report

back with recommendations on additional measures the United States could implement to assist

South Africa in addressing the impact of HIV/AIDS

in that country. The ONAP director also participates

as an official representative of the United States to

UNAIDS.

In 1997, ONAP developed “The National AIDS

Strategy,” a comprehensive, long-term plan to address the HIV/AIDS epidemic. The Plan contains

detailed descriptions of the objectives, goals and

budgets of all Federal agencies involved in the Federal response to HIV in six major areas of HIV policy:

prevention, research, care and services, civil rights,

international activities, and translation of research

advances into practices. The Plan identifies key

areas for further effort. This Report was developed

in consultation with many individuals and groups,

public and private, both inside and outside the Federal government.

ONAP also serves as a liaison to the Presidential

Advisory Council on HIV/AIDS (PACHA), which was

established by Executive Order to provide advice,

information and recommendations to the President,

his Administration and particularly, the Secretary

of Health and Human Services regarding programs

and policies affecting or affected by HIV/AIDS. Its

mission is to advise the President on what his Administration can and should do to stop the spread

of the epidemic; to find a cure and vaccine for HIV;

to provide the best possible treatment and care to

those who are infected; and to end HIV-related discrimination and intolerance. The Advisory Council

has adopted HIV/AIDS in racial and ethnic communities as its primary focus for the remainder of its

term. The Advisory Council also focuses on appropriations, international issues, prison issues and

discrimination.
18

U.S. Department of State

Agency Mandate Relevant to

HIV/AIDS

The Department of State is the lead U.S. foreign

affairs agency. It advances U.S. objectives and interests through formulating, representing, and

implementing the President’s foreign policies. The

United States maintains diplomatic relations with

some 180 countries and also maintains relations

with many international organizations. The Department of State has more than 250 diplomatic and

consular posts around the world: country mission

components—including embassies and consulates;

and delegations and missions to international organizations.

The Department of State implements its mission

through overseas posts; in its Washington, D.C.

headquarters; and through other offices in the

United States. In addition to representing U.S. policy

and interests at these posts, the Department of State

is the primary provider of foreign affairs information used to formulate policy. Information received

from U.S. posts—including in-depth analyses of the

politics, economic trends, and social forces at work

in foreign countries—is provided to some 60 Federal agencies.

In the area of international health, the role of

the Department of State is to develop and coordinate support from other nations and international

bodies to raise the level of priority accorded HIV/

AIDS and infectious diseases. Through the coordinating efforts of the Bureau of Oceans and International Environmental and Scientific Affairs/Emerging Infectious Diseases and HIV/AIDS Program (OES/

E/EID), the Department works with USAID and other

Federal agencies to develop the bilateral and multilateral partnerships for international collaborations

to address the unique implications of HIV/AIDS and

other infectious diseases. Through the diplomatic

infrastructure, OES/E/EID negotiates cooperative

agreements with other nations to establish a global

surveillance and response network. It works with

other agencies to enhance awareness and national

capacities around the world to prevent, diagnose,

report, and respond to the threat of disease.

The Bureau of Population, Refugees and Migration (PRM) coordinates efforts among the Department of State, other U.S. Government agencies, private voluntary organizations, and international agencies to implement a more comprehensive international population policy. PRM’s oversight includes

broadening population assistance programs to

cover a wider range of reproductive health services,

including family planning. It also provides assistance to refugees in first-asylum countries.

The Bureau of Democracy, Human Rights, and

Labor (DRL) oversees initiatives and policies to promote and strengthen civil society and respect for

human and worker rights. DRL ensures that human rights in foreign countries are taken into account in the U.S. policymaking process and submits an annual report to Congress extensively reviewing human rights practices in each country.

The President’s Interagency Council on Women,

which is chaired by the Secretary of State, is charged

with coordinating the implementation of the Platform for Action adopted at the UN Fourth Conference on Women. The Platform recommends actions to increase women’s access to appropriate,

affordable, and quality healthcare, information, and

related services; encourage both women and men

to take responsibility for their sexual and reproductive behavior; and undertake gender-sensitive initiatives that address sexually transmitted diseases,

HIV/AIDS, and sexual and reproductive health issues.

Agency Strategy for

Specific Issues

Promoting Active Involvement by

National Governments

The Department of State hopes to bring the message to leaders around the world that HIV/AIDS and

infectious diseases are the silent enemies of economic and social development, political stability,

and economic productivity. No member of the global community can afford, either in terms of human suffering or economic costs, to fail to recognize or to forestall the impending devastation that

has already begun to ravage national economies,

security and social infrastructure. Political commitment at the highest level of national government

makes the critical difference in stemming the spread
19

of HIV/AIDS. Where such commitment is present,

such as in Uganda and Thailand, the transmission

rates are being effectively reduced.

Working in cooperation with U.S. Government

technical agencies, through regional bureaus, embassies and missions abroad, the Department’s goal

is two-fold: to enhance U.S. diplomatic efforts to

raise the level of priority by all governments to more

effectively meet the challenges of HIV/AIDS and infectious diseases of all kinds, and to enhance international collaboration on international health.

HIV/AIDS will be introduced to a greater extent

in the U.S. diplomatic and policy dialogue to underscore the recognition of HIV/AIDS as an international problem with political, social, and economic impacts that go well beyond the boundaries

of the traditional health sector. Nations should address HIV/AIDS as a pandemic fueled by socioeconomic inequities, human rights issues, and questions of gender status.

The Department of State and senior officials must

play a central role in raising the subject of HIV/

AIDS in international fora and is redoubling efforts

to put the full weight of the U.S. diplomatic infrastructure behind enhanced political commitment

for overseas national action.

Recognizing the problem and promoting AIDS

education and prevention programs by high-level

government officials is vital to the success of AIDS

prevention. Posts, through our mission-planning

process, will be charged and held accountable for

their active interventions to raise awareness with

host-government officials. Ambassadors and other

foreign policy officials at posts are directed to:

• Urge foreign leaders to openly address the

HIV/AIDS pandemic in their own countries;

• Urge governments to consider the adverse

economic, political and social impact of HIV/

AIDS in their countries;

• Urge governments to increase spending or to

reallocate funds to prevent the spread of HIV/

AIDS and facilitate AIDS research efforts;

• Emphasize the importance of National AIDS

Action Plans, which involve all relevant governmental agencies, ministries, NGOs, and the

private sector;

• Encourage foreign leaders to support the Joint

U.N. Programme on AIDS (UNAIDS); and

• Incorporate AIDS issues into foreign policy interactions with all government and international organizations.

The Department of State, through formalized

briefings as part of our National Foreign Affairs Training Center curricula and by country-specific regional

briefing to senior officials, is working to heighten

the awareness of the foreign policy implications of

HIV/AIDS to the foreign policy community through

all available mechanisms.

The Department will convene regular interagency

meetings to discuss the international calendar and

to develop common approaches on HIV/AIDS and

other infectious disease issues.

The Department of State seeks to enhance diplomatic support for HIV/AIDS programs in developing countries and HIV/AIDS vaccine research and

policy collaborations with international partners.

Using the HIV/AIDS component of the Common

Agenda with Japan as a model, the Department of

State and USAID will pursue agreements with other

donors to work more closely on HIV/AIDS in priority countries.

Promoting Human Rights

The United States regularly supports UN resolutions before the Commission on Human Rights for

the protection of human rights in the context of

HIV/AIDS. The resolutions set out guidelines nations may follow in dealing with the health crisis

and human toll of AIDS and HIV. The resolutions

also ask the UN Secretary General to solicit input

from countries, specialized agencies, and related

governmental and non-governmental organizations

in order to provide progress reports to the Commission on follow-up. The next session of the Commission at which an HIV/AIDS resolution is expected

for consideration will take place in March 1999.

The Department of State will continue to include

HIV/AIDS-related discrimination and human rights
20

abuses in regular embassy reporting and in its annual “Country Reports on Human Rights Practices”

and represent these interests before the Human

Rights Commission.

The United States helped to negotiate a partnership arrangement between the Office of the High

Commissioner for Human Rights (OHCHR) in

Geneva and UNAIDS. It strongly supports OHCHR’s

efforts to mainstream human rights into the activities of other UN departments and agencies and especially the cooperation this partnership represents

in combating the devastating worldwide crisis of

HIV/AIDS.
21

U.S. Agency for International Development

Agency Mandate Relevant

to HIV/AIDS

The U.S. Agency for International Development

(USAID) is the global leader in developing and implementing international HIV/AIDS/sexually transmitted infections (STI) prevention and control programs. USAID’s HIV/AIDS/STI mandate is to achieve

a sustainable reduction in HIV/STI transmission

among key populations in developing countries and

to reduce the impact of the epidemic on individuals, communities, and societies in general. This

mandate fits within the broader Agency goal of stabilizing world population and protecting human

health in a sustainable fashion.

USAID’s regional and bilateral programs are the

core of the Agency’s HIV/AIDS/STI prevention activities, while the central programs provide complementary technical and programmatic support. The

Global Bureau, Center for Population, Health and

Nutrition, Office of Health and Nutrition, HIV/AIDS

Division (G/PHN/HN/HIV–AIDS) is the Agency unit

charged with the primary responsibility for developing program interventions. In collaboration with

USAID field missions and other partners and stakeholders, the HIV/AIDS Division has developed a detailed strategic framework that is consistent with

the overall Agency mandate and lays out a futureoriented HIV/AIDS/STI program for the next 7–10

years.

USAID’s strategy continues to focus on three key

approaches to HIV/AIDS prevention, each of which,

over time, has had demonstrable impact in multiple country settings:

• Reducing high-risk sexual behavior through behavioral change interventions (BCI). These include not only mass and interpersonal communication strategies but also policy and legislative reforms that enhance communication

strategies and campaigns and build awareness

and support for health infrastructure change;

• Increasing demand for and access to condoms, mainly through condom social marketing (CSM) programs;

• Treating and controlling sexually transmitted

infections (STI) and sexually transmitted diseases (STD).

The first decade of HIV/AIDS programming has

revealed that effective, individually focused approaches must be complemented or supplemented

by services more attuned to the environment in

which individuals live and make sexual and health

decisions. This implies greater emphasis on interventions that address couples, parents, and children, social networks, religion, worksites; the interaction of sexual and health beliefs; and the

norms, values, and policies that determine the social and sexual context in which people live.

In addition to continuing the three major interventions stated above, the expanded strategy now

includes selected basic care and psychosocial support for HIV-infected individuals and their survivors.

This will enhance the prevention agenda, and slow

the deterioration of economic and social development. The expanded strategy includes increased

emphasis on supporting HIV/STI surveillance systems that will assist in our understanding of the

growth of the epidemic, as well as allow the assessment of the impact of interventions. There are

now innovative initiatives to perform operations

research to identify best practice, to expand policy

dialogue to include issues such as discrimination

and resource allocation, to increase private voluntary organization (PVO) and non-governmental organization (NGO) capacity-building, and to conduct

targeted biomedical research.

The expanded strategy responds to concerns

raised by many observers (field mission staff, stakeholders, other donors, PVO/NGO representatives,

and program evaluators and auditors) that USAID’s

HIV/AIDS/STI program interventions should concentrate on achieving well-defined program targets and

results at country, regional, and G/PHN levels. Interventions should be closely coordinated with, and

provide technical support to, regional bureau and

field mission programs. Likewise, to expand global knowledge of the status of the regional and global HIV/AIDS epidemics, AIDS Control and Prevention Project (AIDSCAP) formed the Monitoring the

AIDS Pandemic (MAP) Network of more than 120

HIV/AIDS specialists in 50 countries with its founding partners, UNAIDS and the Harvard School of

Public Health.

To operationalize the strategic framework presented above, the HIV/AIDS Division developed a
22

results-oriented program of grants, cooperative

agreements, interagency agreements, and contracts

that will continue the Agency’s focus on preventing

sexual transmission of HIV. This program is accomplished through the following 10 activities:

• Horizons: This cooperative agreement with

the Population Council (and collaborating partners: International Council for Research on

Women; Program for Appropriate Technology

in Health; International HIV/AIDS Alliance; University of Alabama; and the Futures Group)

will develop and disseminate the most effective ways of combating HIV/AIDS, through operations research, field testing of program interventions, and the review of scientific studies and publications.

• IMPACT: This cooperative agreement with

Family Health International (and collaborating

partners: Program for Appropriate Technology

in Health; Population Services International

Management Sciences for Health, University

of North Carolina; and Institute of Tropical

Medicine in Brussels) offers opportunities for

field support (technical assistance, training,

materials production, support for HIV/AIDS/

STI programs, including the development of

behavior change communication campaigns

and delivery of STD clinical services and HIV/

STI care programs, as well as surveillance,

monitoring, evaluation, and voluntary testing

and counseling) to missions and countries to

implement prevention and mitigation programs.

• AIDSMark: This cooperative agreement with

Population Services International (and collaborating partners: Program for Appropriate Technology in Health; Management Sciences for

Health; International Planned Parenthood Federation; International Council for Research on

Women; DKT International; and Family Health

International) provides support for developing regional and country HIV/AIDS social marketing program interventions. AIDSMark will

focus on the social marketing of critical public-health products that are appropriate and

timely for the setting (male and female

condoms, STI treatment drugs, STD diagnostics, etc.)

• DMELLD: This contract will be awarded in

early 1999 and will offer field missions access

to technical assistance for program design,

monitoring, and evaluation. It will also collect technical lessons learned from all components of the portfolio and disseminate these

to field missions, cooperating agencies, governments, and international donors.

• UNAIDS WHO, UNICEF, UNDP, UNICEF, UNFPA,

World Bank): USAID is the lead donor to the

Joint Coordinated UN Programme on HIV/AIDS

(UNAIDS). UNAIDS coordinates UN activities at

country level; supports national strategic planning; generates best-practice recommendations; and advocates for increased resources

to combat the pandemic.

• PVO/NGO Capacity-Building: USAID supports

this activity through four separate agreements

with the National Council for International

Health, International HIV/AIDS Alliance, CDC,

and Peace Corps. These organizations focus

on building indigenous PVO/NGO capacity

through technical assistance, training, technology exchange, and institutional partnering.

• Operations Research for Implementing the

Prevention to Care Continuum: This activity supports focused operations and applied

research and provides selected technical assistance to missions and selected service delivery projects in order to address key questions regarding the prevention to care continuum.

• Biomedical Research: USAID provides support for biomedical research for developing

selected technologies, including an effective

topical microbicide to reduce sexual transmission of HIV/STIs; rapid, simple, inexpensive

STI diagnostic tests; and realistic interventions

to reduce mother-to-child HIV transmission.

• Policy Reform: USAID supports policy initiatives that focus on increasing commitment to

prevention/care interventions, assisting with

resource allocation decisionmaking, discrimination, and other key policy areas that enhance and facilitate prevention and mitigation

activities.

• Strengthening Surveillance Systems:

Through agreements with CDC, the U.S. Bureau of Census, and UNAIDS, consensus guidelines will be finalized on minimum surveillance

packages for developing countries based on

the phase of the epidemic. Technical assistance to missions and host governments will

be available to establish and maintain cred-
23

ible surveillance systems, and operations research will develop and refine methodologies to estimate HIV incidence.

In addition to the strategic framework of the

Global Bureau, outlined above, USAID’s regional

bureaus have also developed HIV/AIDS programs

that are tailored to meet the needs of each region

and are consistent with the Agency’s overall HIV/

AIDS strategic objective. Each of USAID’s geographic bureaus has its own approach.

Africa Bureau—USAID’s Africa Bureau provides leadership in the area of integration of HIV/

AIDS activities into ongoing maternal-child health

programs. It has been in the forefront for its

strong support for developing a solid research

and analytical agenda for HIV/AIDS. Topics include information, education, and communication strategies for behavioral change; evaluation

of integration strategies; analysis of HIV/AIDS inputs from other development sectors; STD service delivery system strengthening; and monitoring/evaluation. The Africa Bureau also is a strong

proponent of sensitizing policymakers to the adverse impact of HIV/AIDS on other development

sectors, such as education and agriculture.

Latin America/Carribean Bureau (LAC)—

The LAC Bureau’s HIV/AIDS strategy focuses on

countries where the majority of HIV/AIDS infections occur, e.g., Brazil, Haiti, Mexico. The LAC

HIV/AIDS program approaches vary by country

depending upon the country’s experience level

with the epidemic. In some countries, such as

those in Central America, USAID’s HIV/AIDS efforts stress improving the policy environment,

NGO strengthening, and condom promotion. In

other countries such as Brazil and Haiti, HIV/AIDS

activities focus on targeting high-risk groups such

as women, youth, commercial sex workers and

men who have sex with men.

Eastern Europe/Newly Independent States

(ENI)—HIV/AIDS programs in this region are just

beginning as policymakers become increasingly

aware of the significance of the skyrocketing problem in this region. HIV/AIDS specific interventions currently are being developed in Russia and

Ukraine. HIV/AIDS assessment activities have

been completed and initial program plans have

been developed. The focus of these early program efforts will be on policy formulation, public education regarding HIV/AIDS prevention,

STD/diagnosis and treatment, NGO capacity-building, condom promotion, and targeting high-risk

groups, such as youth and injecting drug users.

USAID-financed HIV/AIDS interventions in other

countries of the region remain to be developed.

Some beginning HIV/AIDS education and counseling activities exist in countries such as Romania, where HIV/AIDS information is integrated

within an overall women’s health strategy.

Asia Near East (ANE)—This region has been

identified as the site of the next wave of the HIV/

AIDS epidemic. The ANE Bureau has developed

a regional strategy that includes the funding of

an Asia Regional Office in Bangkok, which provides critical technical support to many USAIDmission bilateral programs. The ANE regional

strategy depends heavily on the services provided

by cooperating agencies through agreements

managed by the HIV/AIDS Division of the Global

Bureau PHN Center. Many countries, such as

Bangladesh, Cambodia, India, Indonesia, Nepal,

and the Philippines, have developed full-scale,

USAID-financed bilateral HIV/AIDS prevention

programs. Other countries will rely on USAID assistance provided through the ANE regional bureau in close cooperation with the G/PHN/HIVAIDS Division. The focus of these regional efforts

will be on limiting cross-border and seafarer’s HIV/

AIDS transmission routes; developing prevention

programs in low-prevalence countries; upgrading

surveillance systems to improve analysis of HIV/

AIDS regional trends; targeting high-risk groups,

such as commercial sex workers; and working

on specialized issues, including the trafficking of

women, condom social marketing, HIV/AIDS/STI

case management, behavioral change communications, and policy advocacy. Other regionally

supported activities include building and strengthening local NGO programs and identifying local

sources of HIV/AIDS technical assistance.
24

Funding

Since 1986 USAID has committed nearly $1 billion for HIV/AIDS/STI prevention and mitigation programs in developing countries, where more than

90 percent of the current and new infections occur. The Agency has maintained an HIV/AIDS annual funding level of approximately $121 million

since 1993. For FY-1999 a modest increase to $125

million was authorized. Also, an additional $10

million was authorized for FY-1999 only to be used

for children affected by HIV/AIDS. These resources

are distributed within geographic regions in a pattern that reflects the severity of the pandemic. Approximately 45 percent of the total HIV/AIDS/STI

funding goes to Sub-Saharan Africa; 17 percent to

Asia/Near East; 12 percent to Latin America/Caribbean; and the remaining 26 percent is provided for

worldwide programs, including UNAIDS. If, as experts predict, the severity of the pandemic shifts

toward Asia, USAID will need to reconsider resource

allocations to reflect the new situation. USAID provides approximately 25 percent of the UNAIDS’ budget ($15 million of a total $60 million annual budget).

In spite of the fact that USAID is a major international funder for HIV/AIDS/STI prevention programs

in the developing world, the financial resources

available to combat the pandemic clearly are inadequate to mount an effective, truly global response

in view of the steadily increasing HIV/AIDS/STI infection rates. Approximately $550 million is currently expended per year for HIV prevention and

care in the developing world. This includes funding from the international donor community, loans

through the World Bank and expenditure by host

country governments. By comparison, the annual

U.S. expenditure for HIV/AIDS/STI prevention activities domestically is approximately $700 million.

In order to deal with the implications of this funding inadequacy, USAID has strategically focused its

efforts on key countries and targets its programs to

those most likely to transmit or acquire HIV infection. (The emphasis countries for USAID prevention and mitigation programs are listed on page 31.)

Agency Strategy for Specific

Issues

Prevention

While HIV infection is deadly, it is also preventable. In the developing world, where costly, complex antiretroviral therapies are only accessible to

a few, primary prevention remains the best, most

cost-effective response to the pandemic. Some 80

percent of infections worldwide are attributed to

sexual transmission. Over the past 10 years, in

over 70 countries worldwide, USAID’s prevention

strategy has focused first on promoting and facilitating sustained reduction in sexual risk behavior

and, more recently, on modifying environmental

conditions, such as poverty and the subordination

of women, that provoke or facilitate risk behavior.

The behavioral outcomes that increase protection against sexual transmission of HIV and STI are

clear: abstinence, long-term mutual monogamy

among seroconcordant partners (i.e., HIV status for

both partners is the same), reduced rates of partner change (reduced number of partners), and correct, consistent condom use. Unfortunately, only

approximately 10 percent of persons in the developing world currently have access to accurate and

confidential HIV testing. However, no two countries and target audiences are alike, and USAID has

learned that there is no single blueprint for prevention programs to achieve these outcomes. Rather,

the agency has established a process for developing and implementing HIV prevention programs in

partnership with host-country governments, nongovernmental organizations, technical experts, and

intended beneficiaries. This enables USAID-funded

services to reach the people at the grassroots level

and are shaped to meet the needs of specific target audiences and their cultural, economic, and

political environments.

The three pillars of USAID’s HIV/AIDS prevention strategy respond to the principal determinants

of sexual risk behavior. The first, behavior change

communication, is used to transmit information and

to engage people in dialogue about HIV/AIDS, STI,

reproductive health, gender power, and sexual

norms—because people must understand the risks

and means of protection, and must be motivated

to act to protect themselves and others. The sec-
25

ond is condom social marketing, which uses private-sector advertising and commercial distribution

approaches to make condoms more widely and

sustainably accessible to people who know and are

motivated to use them. The third is improved STI

services, including improved and more accessible

curative care, partner referral, and prevention counseling, because STIs are health threats in their own

right, and because they significantly increase the

risk of HIV transmission.

Our three core prevention strategies are supported by policy dialogue, behavioral research, and

monitoring and evaluation. Improving policy dialogue, for example, through assisting communitybased organizations and government officials to

consult and work together, helps to shape policy

and normative environments so that they facilitate

rather than impede risk reduction. Behavioral research is essential for identifying and understanding risky behaviors and the populations who practice them, the characteristics and preferences of

key audiences, the language and content of messages that will appeal and “speak” to particular audiences, and other site-specific details. Transferring skills in monitoring and evaluation enables

USAID and our partners to track our programs, test

assumptions, make mid-course corrections, and

document the successes and shortcomings of our

activities to inform future programming.

In nascent and concentrated epidemics, our programs prioritize work with so-called “high-frequency

transmitters,” such as sex workers and their clients,

other men whose work takes them away from home

for long periods (e.g., military, long-distance truckers), or women and men with large, open sexual

networks.

USAID programs have developed an array of

methods and innovative models for reaching and

serving even hard-to-reach populations at risk of

HIV, who often include poor, marginalized groups,

such as street children or people living with HIV/

AIDS. Key to the success of the programs are procedures for defining specific audiences and tailoring interventions to fit the need, which have been

shared among AIDS and reproductive health researchers worldwide. The AIDSCAP program alone

supported over 800 projects in over 45 countries,

reaching urban university students to rural traders,

secondary school students to factory employees,

legions of women attending antenatal care clinics

to fledgling networks of people living with HIV, and

private medical practitioners and pharmacists to

traditional healers.

Whether focused services for localized groups

or national programs reaching the general population, behavior change interventions strive for both

consistency and dynamism. The most effective

programs deliver not one but an array of consistent messages through multiple, mutually reinforcing channels (e.g., newspaper, radio, billboards,

community theater). And while coherent, these

messages need to move with the public ethos, the

stage or readiness of the audience to change, and

evolution of the epidemic itself. Thus, new to our

programs in the second decade is a more balanced

set of messages about HIV/STI prevention, HIV/AIDS

care, and clarifying and defending the human rights

of people already HIV positive. USAID and its partners across the globe have found that people living

with HIV or AIDS are the most convincing educators and advocates in prevention programs, and in

high-prevalence settings, communities need help

in devising ways to care for families and orphans

devastated by HIV/AIDS.

Creating environments where Persons Living with

HIV and AIDS (PLWHA) can come forward safely to

serve as HIV/AIDS educators and community

mobilizers requires confronting and overcoming

HIV/AIDS stigma, and combating discrimination and

oppression of people with or associated with HIV.

This has become an important new focus in USAID’s

strategy for prevention. In addition, the

sustainability of programs hinges upon local participation and ownership, and upon resources that

require local private-sector and political support.

Overcoming HIV/AIDS stigma both facilitates and

follows community and policymaker support for

HIV/AIDS prevention and care. In short, while carrying forward the successes of the three “pillars”

(BCI, CSM, and STI interventions), plus policy dialogue, behavioral research, and monitoring and

evaluation activities, USAID’s HIV/AIDS prevention

strategy has been expanded, based on a decade of

field experience that shows the importance of preparing communities and service providers to respond to a range of individual, family, and community needs along the prevention-care continuum.

Care and Support

USAID supports care activities because they improve our efforts to achieve sustainable development, enhance overall public health, and support
26

our efforts to prevent further spread of HIV. Rather

than take a narrow biomedical view of care, USAID

advocates care and support activities that are broad

in nature and are critical to the continued efforts of

communities, governments, and donors to promote

sustainable development in the face of the HIV/

AIDS epidemic. Care and support activities include:

• Protection of basic human rights;

• Psychosocial care of persons infected with

and affected by HIV/AIDS;

• Palliative care for persons with HIV-related

symptoms, such as pain, fever, or diarrhea;

• Prevention and treatment of common opportunistic infections;

• Programs that provide economic support to

those communities hard hit by HIV/AIDS; and

• Support for foster and extended families for

the millions of children who have been orphaned by AIDS.

HIV/AIDS care and support activities enhance

sustainable development by shoring up fragile infrastructures. For example, community-based care

and retraining of key personnel are essential to preserve the health and education sectors, where in

some east African countries up to 40 percent of

these workers are already infected with HIV.

HIV/AIDS care and support activities contribute

to decreasing secondary epidemics, most notably

tuberculosis (TB). The global HIV pandemic is driving a secondary explosion of TB, which is responsible for 35 percent of the deaths of HIV-infected

persons in the developing world.

HIV/AIDS care and support enhance all of our

primary prevention efforts. Presenting information

and education messages to include everyone in the

community increases the acceptance, credibility,

ownership, and ultimately the response to behavior-change messages. In addition, programs to protect the basic human rights of HIV-infected individuals and those most at risk for infection open

the door for implementing far more effective behavior change campaigns. Prevention efforts, to

be effective, must mobilize those living with HIV/

AIDS as spokespersons for change. Ultimately, the

person who is carrying the virus, particularly one

with multiple sexual contacts, is the single most

important recruit for prevention programs promoting reduced risk behavior. If programs appear to

abandon people living with HIV/AIDS and their families, or to ignore their needs and concerns, we cannot expect them to be of any help.

USAID is also supporting operational research

to determine the most cost-effective ways to provide care and support to persons infected. USAID

does not at this time support the large-scale procurement of antiretroviral drugs for developing

countries. Using antiviral drugs in treatment regimens similar to those used in the United States

would cost approximately $35 billion per year to

treat those infected in the developing world. In

addition to the enormous cost, these treatments

require sophisticated health provider and laboratory infrastructures that do not exist in most of the

developing world, where the average health expenditure per person per year is about $10.

AIDS-Orphaned Children

The number of children affected by AIDS, including those who are orphans or caring for sick parents, continues to escalate. There has been growing recognition and concern for these children. In

a study funded by USAID, “Children on the Brink,

Strategies to Support Children Isolated by HIV/

AIDS,” the U.S. Census Bureau estimated that 15.6

million children will have lost their mothers or both

of their parents by 2000 in 23 countries heavily

affected by HIV/AIDS. That number will increase

to 22.9 million by 2010, largely as a result of the

HIV/AIDS pandemic. During the Twelfth World AIDS

Conference in Geneva, the problems posed by this

issue were referred to as a “massive social time

bomb.” In 1996, USAID expanded its HIV/AIDS strategic objective to include issues related to care and

support of those affected by the disease.

More recently, USAID completed a series of discussion papers focusing on issues related to care

and support of persons affected by HIV/AIDS. Included among these papers is a document entitled

“Responding to the Needs of Children Orphaned

by HIV/AIDS,” specifically focusing on the effect of

the disease on youth. These papers provide background information that will be used to develop

the HIV/AIDS strategy on care and support. The

strategy will influence future related projects conducted by USAID cooperating agencies and missions.

In addition, “HORIZONS,” the HIV/AIDS operations research project, is currently exploring av-
27

enues for conducting research to develop “best

practices” for setting up community-based methods of providing care and support to people affected

by HIV/AIDS, including children. AIDSCAP supported care projects in Haiti, Tanzania, Nigeria, and

India, and IMPACT has expanded the capacity of

field projects to support community-based care

services. Representatives of the HIV/AIDS Division

have been actively involved in meeting with other

donors and organizations that are working with children and families affected by HIV/AIDS. They have

also established an electronic network to exchange

technical information among a wide variety of donors and other organizations. These activities contribute toward identifying the scope of the problem, sharing information about how to address it,

and coordinating activities to do so.

Women and Health

USAID recognizes that women and girls are at

the epicenter of the HIV/AIDS epidemic in every

community, both as positive agents of change and

as individuals in need of services and support.

Though not recognized as a key audience for HIV

interventions until the early 1990s, in most regions

women and girls represent the fastest-growing segment of the HIV-infected population.

The impact of HIV/AIDS on women is not solely

a function of their greater biological and social vulnerability to infection. It is also because, when family members become ill with HIV disease, the burden of care falls disproportionately on women and

girls. Data from a wide range of studies on health

and nutrition have confirmed the critical role women

can play in improving the health of their families

when they have access to information, skills, and

some control over resources. USAID’s HIV/AIDS

programs aim to alert and mobilize communities

to respond to the care needs of people living with

HIV/AIDS (PLWHA) without sacrificing the progress

achieved in women’s education and economic participation, because that progress is beneficial for

all.

Finally, as noted previously, the ability of an

antiretroviral treatment regimen to decrease the risk

of mother-to-child transmission (MTCT) has focused

attention on another situation where there is a potential risk that a woman’s own health and welfare

may be given lower priority than the health of her

children and family. By aiming to have all USAID

programs examined through a gender lens, and by

listening to and involving women at all stages of

project identification, design, implementation, and

evaluation, the USAID strategy acknowledges the

complexity of women’s lives and roles, and gives

priority to programs and approaches that respond

to their expressed concerns.

Vaccine Research

Although USAID lacks the resources to independently fund vaccine research, it has a strong interest in the vaccine development process, and it is

uniquely positioned to facilitate the implementation of vaccine trials in developing countries. Because of the tremendous genetic diversity of HIV,

one of the greatest challenges facing vaccine developers is to produce a vaccine that can protect

against infection with diverse viral isolates. This

avoids the need for many isolate-specific vaccines.

However, because this type of vaccine may not be

developed in the near future, there is concern that

initial vaccines will be effective only against those

strains of virus found predominantly in North

America and Western Europe.

It is the U.S. Government view that vaccine candidates should have broad activity against the most

common genetic subtypes of virus for two reasons.

First is the issue of impact on the epidemic. Approximately 90 percent of all new HIV infections

occur in sub-Saharan Africa and Asia, whereas about

1 percent occur in North America and Europe. In

order to have an impact on the growth of the epidemic, candidate vaccines should be targeted to

those strains responsible for the most new infections.

The second reason to advocate for vaccines with

the broadest possible coverage is to prevent selective pressure for new epidemics. A vaccine that

provides protection for only the viral subtypes currently prevalent in a community will reduce transmission of those types of virus while leaving the

community vulnerable for a new epidemic caused

by subtypes not covered by the vaccine.

USAID can assist the vaccine development processes in the following ways:

• Take the lead in educating stakeholders in developing countries. This task entails explaining the importance of clinical trials; making

accurate information widely available; responding to questions; ensuring ethical de-
28

signs; countering misinformation; and lining

up high-level support from both host country

and U.S. officials.

• Assist in developing the methodology of community-level interventions; fostering long-term,

sustained relations with local communities;

measuring indirect effects; and doing impact

modeling. By working closely with local communities, USAID could ensure that they are

ready to participate in clinical trials.

• Advocate for research on broad-activity vaccines.

Behavioral Research/Behavioral Change

Interventions

HIV/AIDS prevention and care hinges upon

changes in patterns of risky behavior—be they relating to sex, illicit drugs, or exposure to infected

blood through medical waste or unsterile needles,

razor blades, and other instruments. Even improvements in STI services will not fulfill their potential

impact unless people with STI symptoms and signs

change their help seeking behavior, and unless allopathic and traditional practitioners improve their

diagnostic and therapeutic practices to recruit

people at risk of STI and to satisfy them with their

services. Thus, USAID supports behavioral research

in our partner countries both to develop new intervention models and to adapt and apply existing

models for new settings.

USAID’s cooperating agencies conduct behavioral research in:

• Diagnostic studies to define the specific behaviors that put people at risk in a given setting;

• Defining of the distribution of risky behaviors

in a population, so as to identify subgroups or

target audiences for intervention development;

• Formative research to build understanding of

the causes and meanings of risky practices

and to pretest intervention ideas and messages

with the intended audience; and

• Testing and documentation of the effectiveness of interventions, where changes in behavior are key outcomes of intervention

trials.

Under the AIDS Technical Support Project, completed in 1997, USAID’s investment in behavioral

research comprised a major increase in the resources available for studying the interactions of

culture, health, gender, and sexuality in the developing world. The AIDS Behavioral Research Grants

Program, funded jointly with NIH, supported partnerships between U.S. and developing-country

NGOs (including universities) to revise and adapt

theoretical models of health behavior to strengthen

HIV/AIDS behavioral interventions in non-Western

settings. The nine studies have provided baseline

data for local policy and intervention development.

They are also helping to build a more representative, international base for evaluating the roles of

culture, society, and behavioral biology in human

sexuality and health behavior and for guiding the

design of behavior-change interventions appropriate for particular audiences and settings.

USAID-funded projects have established formative behavioral research as a prerequisite of technically sound intervention development. Most of

our future interventions will contain data collection

components that enrich the knowledge base for understanding HIV risk behavior and opportunities for

prevention and care. In addition, the HORIZONS

project will extend these achievements through a

program of developing research to answer selected

research questions in nine thematic areas: 1) STI

prevention and management; 2) HIV care and support services; 3) stigma and discrimination; 4) risk

assessment and behavior change; 5) policy analysis and change; 6) social marketing and privatesector involvement; 7) NGOs and community mobilization; 8) integration of HIV/STI, family planning,

and maternal and child health services; and 9) community mobilization.

In addition to pursuing some relatively new topics in developing countries (e.g., HIV/AIDS stigma),

USAID has mandated all projects under the Global

Bureau’s HIV/AIDS strategic objectives to document

and develop knowledge about the following crosscutting issues: gender inequalities and their effects

on risk reduction and program success; the vulnerability of youth; involvement of PLWHA in HIV/STI

intervention programs; building local NGO and community-based organization (CBO) capacity; links between prevention and care services; sustainability

of services; costs and cost-effectiveness of service

modalities and models; and methods and costs of

taking successful pilot projects to scale.
29

Microbicide Development

USAID has been a major contributor to the search

for a topical microbicide. Topical microbicides are

products that ideally can be used, without the cooperation or consent of a sexual partner, to protect

from the possibility of acquiring HIV and other sexually transmitted diseases (STD). The agency has

supported laboratory work to identify and test promising compounds, as well as the Women’s Health

Advocates for Microbicides (WHAM), an innovative

group that advocates for the product and promotes

international collaboration and involvement of

women at all stages of product development.

Most products that have been developed and

tested in the past several years have been based

on a product known as Nonoxynol–9 (N–9), which,

unfortunately, has not proved effective as of this

date. In collaboration with the Research Division

in the Office of Population, the HIV/AIDS Division

is currently supporting a trial of a new microbicide,

developed with support from USAID, which has a

unique mechanism of action and has been shown

to be safe in preliminary studies. The study is expected to continue for approximately 2 years and

provide information on safety and effectiveness of

the product.

Donor Coordination

Donor coordination is key to the success of the

U.S. response to the HIV/AIDS global pandemic.

USAID’s G/PHN Strategic Objective 4 “to increase

the use of improved, effective, and sustainable responses to reduce HIV transmission and to mitigate the impact of the HIV/AIDS pandemic,” includes donor coordination and partnership at global, regional, and country levels. USAID has been

an active partner with the United Nations in providing financial support for international HIV/AIDS program efforts. Since 1986, USAID has been a major

contributor to the WHO Global Program on AIDS.

As that program terminated in 1995, USAID support shifted to a new United Nations HIV/AIDS endeavor that officially began in January 1996.

Also, in countries where USAID missions include

HIV/AIDS as part of their country strategy, PHN offices coordinate closely with the Joint United Nations Programme and other donors that may be incountry. In addition, there are a series of specific

donor coordination activities, including the U.S.-Japan Common Agenda, collaboration with the United

Kingdom’s Department for International Development (DFID), the European Union (EU), and a number of other selected partners. There are also excellent examples of strong coordination, through

funded activities with national governments, PVOs/

NGOs, and local organizations.

Capacity-Building

Effective HIV/AIDS programs work to sustain

changes in behaviors that contribute to the risk of

HIV infection and to establish, improve, and maintain systems and practices to appropriately manage the effects of HIV and AIDS. As HIV/AIDS becomes endemic in many countries, the need for

programs to achieve and sustain these results over

the long term is heightened. The time period to

achieve sustained changes in risk behaviors and

manage the effects of HIV will exceed the timeframe

of many external technical inputs and donor contributions. Therefore, a programming strategy that

prioritizes building local capacity within the public

and private sector is essential.

The USAID HIV/AIDS program works to build the

local public- and private-sector response to HIV/

AIDS by increasing political awareness and commitment in local government, and by increasing the

technical and managerial capacity of local public,

commercial, and nonprofit entities to provide services and commodities required for sustainable HIV/

AIDS programs. Within the public sector, USAID

and its partners work with government ministries

of health and other sectors to increase:

• Political awareness of the effects of HIV and

the importance of preventing HIV infection and

appropriately caring for those who are infected;

• Technical quality and use of surveillance information in monitoring the epidemic and in

program management and evaluation;

• Quality and reach of public-sector services

needed in HIV programming, such as STI diagnosis and treatment, logistical systems for

commodities (i.e., essential drugs and

condoms), and training in counseling and

home-based care;

• Collaborations between the public and private

sector.
30

USAID and its partners strengthen the technical

and managerial capacity of indigenous NGOs so that

they have greater competence in, impact on, and

influence over the design, implementation, and

evaluation of sustainable HIV/AIDS prevention and

care programs. USAID also works to build and improve regional and local networks and coalitions.

The networks provide technical support and improve advocacy efforts by building relationships

across public- and private-sector institutions.

USAID works to strengthen commercial-sector

involvement by increasing the awareness of the potential impact of HIV and by building HIV-prevention programs for the business environment. In addition, some USAID programs work to leverage local commercial markets for condoms and other

commodities, such as essential drugs for STI treatment. Sustained local responses to HIV will depend upon public- and private-sector involvements

that supplement and complement each other. As

we enter the second decade of the HIV/AIDS pandemic, it is clear that the populations requiring HIV

prevention and care and support services are changing and increasing. Building the capacity of local

institutions to recognize these changes and respond

to these increasing demands is critical in order to

stem the impact of this pandemic.

Reducing Mother-to-Child

HIV Transmission

Mother-to-child transmission (MTCT) is the second leading route of transmission of HIV in the

world. Annually, over 590,000 infants are infected

by their mothers. This transmission takes place

during one of three times: before birth, during labor and delivery, or during breastfeeding.

Following the ground breaking ACTG 076 study,

in February 1998, researchers from the U.S. Centers for Disease Control and Prevention announced

the results of a randomized placebo-controlled

study in Thailand. This study demonstrated that a

short course of AZT given to HIV-infected women

in the last trimester of their pregnancy, plus high

doses of AZT during labor, could achieve a 50 percent reduction of transmission of HIV to their infants. Because this compared favorably to a much

more costly and complex regimen used in developed countries, the results of the Thai study have

raised global hopes that a significant reduction in

the number HIV-infected infants can be achieved.

Despite the very exciting results of the Thailand

study, a number of questions remain to be answered before the promise of this research can be

realized. These are:

• Breastfeeding: The Thai study worked with

a non-breastfeeding population. Can similar

results be achieved in populations that breastfeed? To do so will require that mothers use

infant formula in settings where this is not a

common practice. What effect will the use of

formula have on infectious disease deaths associated with bottle feeding. Will HIV-negative women stop breastfeeding?

• Voluntary HIV counseling and testing

(VCT): More than 90 percent of HIV infected

women in developing countries do not know

they are infected and have little or no access

to voluntary, confidential HIV counseling and

testing. How can this service be made available at a scale large enough to have a broad

impact without sacrificing the quality and confidentiality of the services?

• Infrastructure and capacity: Many antenatal care settings in developing countries are

struggling to provide basic care for pregnant

women. If MTCT programs are added to existing activities, can they be carried out properly? Will they achieve in practice what was

seen in a clinical trial? Conversely, will the

additional burden of MTCT programs compromise the quality of basic antenatal care?

• Stigma and discrimination: Stepped up VCT,

special antenatal programs, and the use of infant formula all have the potential to reveal a

woman’s HIV status to the community.

Women who reveal their HIV status are at a

very high risk of domestic violence, stigmatization and ostracization by family, friends, and

community. How can MTCT programs prevent

or minimize these negative consequences?

USAID believes that before MTCT initiatives are

taken to a large scale, these and other questions

need to be answered. We are thus collaborating

with UNICEF, UNAIDS, and host-country researchers to conduct a series of operational research studies in two or three developing countries. In 18 to

24 months these studies will give us many of the

tools we need to appropriately and effectively use

the recent scientific findings.
31

Impact of USAID Programs—

Monitoring and Evaluation

At the country level, we can now point to two

major categories of success. In one set of countries (e.g., Senegal, Philippines, Indonesia), early,

comprehensive HIV intervention programs, supported by USAID and other donors, have helped

curtail and prevent a major epidemic. For example,

USAID-supported prevention campaigns that included policy dialogue, behavior change efforts, better treatment of STDs, and improved access to

simple technologies like condoms to reduce HIV

transmission.

Even more dramatic, we now see another set of

countries (e.g., Uganda, Dominican Republic, Thailand) where intensive HIV/AIDS programs were

launched after major epidemics had erupted, yet

the numbers of new infections are now actually

decreasing. For example, sentinel surveillance in

Ugandan antenatal clinics shows that the rate of

HIV has fallen by 35 percent among young women

aged 15–24. In Thailand, USAID supported an intervention study that developed an educational and

sexually transmitted infections screening program

that was expanded for the entire military. The rate

of new infections among military recruits fell from

3 percent to under 1 percent as a result. These are

amazing achievements, every bit as significant as

the breathtaking progress in HIV treatment in the

United States.

Our ability as a global community to achieve

these reductions in new infections is predicated on

a basic lesson learned from the past 10 years of

program implementation: We can reduce unsafe

sexual behavior in a sustainable way. We now have

ample evidence that public health programs can

affect change in the most private and basic of human behaviors, sex. While it is impossible to attribute declining national HIV rates to any single

program, USAID-funded research has shown that

people are responding to widespread, consistent

education messages about HIV/AIDS prevention and

care and to dramatic increases in the availability of

key tools and services.

USAID’s HIV/AIDS-Assisted Countries

Africa Regional Asia Near East Eastern Europe/ Latin America/

Regional Newly Independent Caribbean Regional

States Regional

Benin Bangladesh Russia Bolivia

Congo (Kinshasa) Cambodia Ukraine Brazil

Ethiopia Egypt Dominican Republic

Ghana India El Salvador

Kenya Indonesia Guatemala

Madagascar Laos Haiti

Malawi Morocco Honduras

Mali Nepal Jamaica

Niger Philippines Mexico

Nigeria Vietnam Nicaragua

Senegal Peru

South Africa

Tanzania

Uganda

Zambia

Zimbabwe
32

USAID’s evaluation research in poor urban neighborhoods in the Dominican Republic where our

program operates, found that rates of sexually active youth declined from 73 percent in 1993 to 30

percent in 1996, and rates of participation in “transactional sex” (exchanging food, money, school fees,

etc., for sex)—declined from 27 percent to 7 percent among males. The proportion of Ugandan girls

who have ever had sex declined by almost half between 1989 and 1995. Over half of young sexually

active Ugandans report using condoms in their last

sexual contact; this rate was close to zero at the

outset of the epidemic. In Bali, Indonesia, USAID’s

peer education project with sexually active 15- to

25-year-olds led to an increase in consistent condom use, from 22 percent to 72 percent.
33

U.S. Information Agency

Agency Mandate Relevant

to HIV/AIDS

The U.S. Information Agency’s (USIA) mission is

to promote the national interest and national security of the United States through understanding, informing, and influencing foreign publics regarding

U.S. foreign and domestic policies (including HIV/

AIDS policies). It acts to broaden dialogue between

American citizens and institutions and their counterparts abroad. USIA’s public diplomacy strategy

regarding USAID’s policies extends throughout the

year and employs a full range of public diplomacy

tools. These include:

• Distributing policy information to foreign media, academics, and other government and

civic opinion-makers through U.S. Information

Service (USIS) posts at U.S. embassies abroad;

• Arranging speaking tours and programs/seminars abroad for U.S. experts on AIDS issues.

• Broadcasting policy information on Voice of

America (VOA) radio and USIA television services and providing foreign publics with language-version news clips, editorials, and interactive dialogues featuring prominent U.S.

experts and “best practices” of American individuals and communities meeting the challenge posed by AIDS and other infectious diseases. For example, VOA gave worldwide coverage to World AIDS Day last December 1 in

all 52 languages in which VOA broadcasts.

• Publishing policy statements and analysis on

the USIA International Homepage, which includes frequently updated information for USIS

field officers to use to alert foreign leaders,

NGOs, journalists, and healthcare specialists

to the threat of AIDS-related health issues and

responsibilities of the international community. This information is supplemented with

timely reports highlighting American and foreign achievements and cooperative efforts in

combating AIDS.

• Publishing a USIA electronic journal on “Infectious Diseases/The Global Fight.” The 40-

page journal features commentaries by Dr. Anthony Fauci, U.S. Surgeon General Dr. David

Satcher, and USAID Director J. Brian Atwood,

among other articles.

• Organizing briefings by senior U.S. AIDS experts for foreign journalists at USIA’s Foreign

Press Centers in Washington D.C., New York,

and Los Angeles, as appropriate.

• Developing U.S. programs for international

visitors, including discussions and briefings on

AIDS policies and issues, such as treatment,

prevention, and research efforts.

Funding

The funding level dedicated to HIV/AIDS programs by USIA is difficult to assess. Much of the

programming conducted by the Agency is electronic, e.g., VOA broadcasts, WORLDNET TV programming, and the electronic journal (published in

November 1996). There is no specific budget for

these programs, other than staff salaries and overhead expenses. However, in addition to these programs, USIA exchanges under the Fulbright, International Visitor, and U.S. Speaker programs budgeted $655,200 in FY–1998 on HIV/AIDS programs.

This figure has been relatively constant since 1995.

Agency Strategy for

Specific Issues

The U.S. Information Agency is a multifaceted

public diplomacy organization that uses its multilingual electronic and print media outlets and its

educational and exchange programs to give broad

support to policies aimed at combating HIV/AIDS.
34

U.S. Peace Corps

community outreach activities undertaken by the

Volunteers in addition to their main assignment.

The four major programmatic areas that the Volunteers work in are:

• NGO and community-based organizations

(CBO) development in HIV/AIDS;

• Integrated community health approaches to

HIV/AIDS prevention and care;

• Programs for women and girls; and

• Programs for youth, both in and out of school.

The Peace Corps meets these objectives largely

through training and educational activities that build

host-country capacity in project planning, monitoring/evaluation, and organizational management.

An example of the kind of work that Volunteers

do is illustrated in the participatory development

of a unique, low-cost, content-based approach to

English-language instruction, “Teach English, Prevent AIDS” project in Cameroon. Education Volunteers, Cameroonian educators, and public health

specialists worked together to draft 50 hours of lesson plans. To date the program has provided behavior change education to 300 teachers and

10,800 students, all of whom were also engaged in

community-based HIV/AIDS prevention campaigns

through the learning process. The manual, published with private-sector support, and the curriculum development process itself are being considered by UNAIDS as an international model for student and community education. The program is

sustained as a part of the curriculum and has been

adapted by multiple Peace Corps posts to use

throughout Africa and the rest of the world.

Volunteers have a viable role to play in HIV/AIDS

prevention and education overseas. Most importantly, Volunteers are successful in accessing communities that are often not reached by National AIDS

Programs and in introducing new innovative education methods to achieve their outreach.

Although not quantified, there are a growing

number of Volunteers who, based on their experiences overseas, return to the United States and

continue to work in HIV/AIDS prevention in their

communities. Bringing the lessons home is a valuable contribution that the Peace Corps makes to

the domestic efforts in HIV/AIDS work.

Agency Mandate

Relevant to HIV/AIDS

Peace Corps’ efforts in HIV/AIDS education and

prevention is divided into three spheres of activities: (1) education efforts targeting Peace Corps employees; (2) education efforts targeting Peace Corps

Volunteers (hereinafter “Volunteers”); and, (3) prevention efforts conducted by Peace Corps Volunteers targeting the people in the countries in which

the Volunteers are serving. The focus of this document is on the third sphere—the work that the Volunteers do in the communities in which they serve.

To date, the Peace Corps’ HIV/AIDS prevention and

education activities are being conducted in 48 countries around the world.

Peace Corps does not earmark any of its appropriated budget to a technical area such as HIV/AIDS.

Rather, the agency funding is used to recruit, place,

and support Volunteers—many of whom then work

in HIV/AIDS efforts. Peace Corps does receive funding from USAID through an interagency agreement

to support some of its HIV/AIDS activities. In FY–

1999, these resources will total $450,000.

Agency Strategy for

Specific Issues

Prevention

The focus of Peace Corps work is in prevention,

specifically, targeting women and youth. Since the

mid-1980s when HIV/AIDS was first identified, Volunteers have been working to help individuals and

communities understand the disease and to collectively develop solutions for ways communities

can protect themselves and care for those who become ill. In December 1988, the Peace Corps and

the Government of the Central African Republic negotiated the first formal agreement to place Volunteers in HIV/AIDS education. Since then, the pace

of Volunteers’ involvement has increased dramatically, both in number of volunteers engaged in HIV/

AIDS work and in the range of activities.

Peace Corps Volunteers work in some health

projects focused solely on HIV/AIDS; community

health projects that also have an HIV/AIDS prevention component; projects that are not primarily involved with health, e.g., education projects; and
35

Agency Mandate Relevant to

HIV/AIDS

The National Institutes of Health (NIH) supports

a comprehensive program of basic, clinical, and

behavioral research on HIV infection and its associated opportunistic infections and malignancies.

Each of the 24 NIH Institutes and Centers is involved

in some HIV/AIDS-related research activity consistent with its individual mission. NIH is the world’s

leading biomedical research institution, supporting

more than 5,000 individual HIV/AIDS research

projects at more than 500 research institutions

across the nation and around the world. NIH has

played a leadership role in the discovery and characterization of HIV and continues to lead research

to determine the pathogenesis of AIDS. Findings

from NIH-sponsored studies have resulted in significant advances in the treatment of HIV infection

and its related illnesses and prevention of the opportunistic infections that cause morbidity and mortality of HIV-infected individuals.

The NIH AIDS program supports biomedical and

behavioral research necessary to identify therapeutic regimens, behavioral interventions, and vaccine

candidates to treat and prevent HIV infection and

its associated illnesses in the United States and internationally. The global nature of the AIDS epidemic underscores the critical need to identify interventions for developed and developing nations

that prevent HIV transmission, disease progression,

and mortality. Continued collaboration with international organizations and other nations is required

to achieve these priorities. Research capacitystrengthening in foreign countries is a critical element to NIH’s efforts to address HIV/AIDS, and in

this regard, NIH supports a strong research training

program with partners in 100 countries.

The NIH AIDS program includes collaborations

with numerous international organizations. Ongoing and planned efforts include collaborations with

the following organizations: UNAIDS, in planning for

the initiation of international vaccine clinical trials;

the Pan American Health Organization (PAHO) for

studies on heterosexual transmission of HIV infection and tuberculosis prophylaxis; the World Health

Organization (WHO) in the Antibody Serologic

Project; WHO as one of three AIDS reagent centers;

and WHO for support of several international workshops and conferences.

In addition, since its inception in 1996, NIH has

collaborated with UNAIDS through mutual representation on advisory and coordinating bodies, frequent

exchange of information, and collaboration on specific efforts, such as vaccine development, ethical

issues related to clinical trials, and research training and infrastructure in developing countries. In

this regard, the National Institute of Allergy and Infectious Diseases (NIAID) and the Fogarty International Center (FIC) have been designated UNAIDS

Collaborating Centers. Additionally, NIAID and the

National Institute of Child Health and Human Development (NICHD) have collaborated with UNAIDS

on the Working Group on Prevention of Mother to

Child Transmission of HIV.

The NIH Office of AIDS Research (OAR) is located

within the Office of the Director of NIH and is responsible for the scientific, budgetary, legislative,

and policy elements of the NIH AIDS research program. Congress provided in the NIH Revitalization

Act of 1993 broad authorities to the OAR to plan,

coordinate, evaluate, and fund all NIH AIDS research. The OAR is responsible for developing an

annual comprehensive plan and budget for all NIH

AIDS research. The OAR supports trans-NIH Coordinating Committees to assist in these efforts in

the following areas of program emphasis: Therapeutics, Vaccines, Natural History and Epidemiology, Behavioral and Social Sciences, Etiology and

Pathogenesis, Training and Infrastructure, and Information Dissemination.

The OAR promotes collaborative research activities in both domestic and international settings.

These research studies are conducted by the Institutes and Centers of the NIH, including the NIAID,

National Cancer Institute (NCI), NICHD, National Institute of Mental Health (NIMH), National Institute

on Drug Abuse (NIDA), and FIC.

A report by a group of non-government scientists and AIDS community representatives who were

convened to evaluate the NIH AIDS research program, has had a significant effect on almost every

U.S. Department of Health and Human Services

National Institutes of Health
36

aspect of the AIDS research program—in setting the

scientific agenda, refocusing priorities, and shaping the AIDS research budget. The recommendations in the “Report of the NIH AIDS Research Program Evaluation Working Group of the Office of AIDS

Research Advisory Council” (also known as the

“Levine Report”) helped frame the OAR’s final distribution of the NIH AIDS appropriations for fiscal

years (FY) 1997 and 1998. In addition, the Levine

Report significantly influenced the priority setting

that occurred in the development of the FY–1999

NIH Plan for HIV-Related Research and Budget,

which the OAR is congressionally mandated to develop in concert with the annual NIH AIDS research

budget request. The priorities established by the

Levine Report will have an impact not only on government-supported research but on the research

agendas of industry and private research organizations in the United States and abroad.

The report articulated the importance of coordinating international HIV/AIDS research efforts with

other agencies, international organizations, and

other governments. Further, it listed as one of several high priorities “domestic and international studies testing the efficacy of joint behavioral and biomedical strategies for combined control of HIV and

other sexually transmitted diseases and combined

control of HIV and other adverse health consequences of injection drug use.”

The FY–1998 and FY–1999 NIH AIDS research

priorities include the following:

• A continued increased emphasis on fundamental science, particularly investigator-initiated research;

• A comprehensive effort, including several important new research initiatives, to develop

new vaccine candidates and bring them to

clinical trials as soon as possible, including

a refocusing on the importance of international collaboration at the earliest stages of

vaccine development and testing;

• An augmentation of research efforts to better understand the human immune system;

and

• An emphasis on prevention science research,

including enhanced domestic and international studies of risk-taking behavior and the

development on strategies to avert infection,

such as microbicides, female-controlled barriers, and STD treatment and prevention.

National Institutes of Health

International AIDS Funding

(in thousands of dollars)

FY–1995 FY–1996 FY–1997 FY–1998 FY–1999

 Actual Actual Actual Estimate Estimate

NCI 5,876 3,415 5,641 5,674 5,775

NIDCR — — 782 816 901

NINDS 2,103 1,923 973 973 973

NIAID 21,112 21,691 24,892 26,958 29,958

NIGMS — — 92 89 84

NICHD 2,263 3,302 4,151 4,400 4,700

NIMH 4,301 3,894 3,512 3,656 3,912

NIDA 1,839 140 — 500 500

NCRR 677 590 418 499 588

FIC 9,108 9,694 10,312 10,611 11,305

_________________________________________________________________________________

Totals $47,279 $44,649 $50,773 $54,176 $58,696

Source: National Institutes of Health
37

Agency Strategy for Specific

Issues

Prevention

NIH-sponsored programs targeting the development and evaluation of various preventive interventions have resulted in marked changes in sexual

and drug-using behaviors associated with HIV transmission among at-risk populations, including difficult-to-reach and socially disenfranchised populations in the U.S. and abroad. NIH programs have

demonstrated that behavioral interventions targeting behaviors can be developed and implemented,

including those designed to delay or prevent initiation of sexual activity and drug use. These studies

have demonstrated that multifaceted risk-reduction

programs, including those providing drug treatment,

outreach, and education on HIV risk, and sterile

injection equipment, can produce significant and

sustained decreases in HIV risk behavior among

injection drug users. Prevention research has

shown that interventions must be culturally and

ethnically directed in order to successfully reach

targeted populations. NIH also is studying community-level interventions as an important way to effect behavioral change on a larger scale.

Preventing vertical transmission from HIV-infected mother to child is a priority of NIH intervention research. Implementing the ACTG 076 protocol has significantly reduced the incidence of maternal-fetal HIV transmission in the United States.

Ongoing efforts are designed to identify and test

other interventions that can effectively and easily

be used globally to further reduce the incidence of

vertical transmission of HIV. NIH-funded scientists

are actively studying the timing and mechanisms

by which HIV is transmitted from mother to baby

so that more effective interventions can be developed to block mother-to-child transmission.

NIH also has sponsored several international

conferences on the prevention of perinatal transmission. The second Global Strategies Conference

on Prevention of HIV Transmission from Mother to

Infant will be held in September 1999 in Montreal

Canada. It will bring investigators from developing

countries together with investigators from more

developed countries to plan future collaborative

strategies for the prevention of mother to infant

HIV transmission.

NIH international efforts in prevention research

and related training and research capacity-building

include the following:

• Studies of the role of viral shedding in infectivity for both sexual transmission and mother

to child transmission;

• Studies in several developing countries in Africa, Asia, and Latin America to evaluate interventions for reducing mother-to-child transmission of HIV that may be used in diverse

cultural and economic settings, such as the

use of short courses of treatment with

zidovudine, nutritional supplements, HIV–1

hyperimmune intravenous immune globulin,

vaginal cleansing, and studies of

breastfeeding;

• Development of safe, effective, and acceptable condoms, microbicides, and other female-controlled barriers;

• Studies in Africa on the efficacy of STD treatment and prophylaxis on reducing sexual

transmission of HIV; and

• Development of behavioral interventions to

reduce the risk factors associated with HIV

transmission, including injection drug use and

various sexual behaviors.

In response to the Levine Report recommendation for developing a Prevention Science Agenda

that combines behavioral and biomedical intervention research, the NIH sponsored several agenda

setting activities, including a 1998 Workshop on

International HIV/AIDS Prevention Research Opportunities. The goal of the Workshop was to encourage research that would be feasible and relevant

for developing countries with limited resources. Representatives from 37 countries severely affected by

the epidemic participated in the workshop to develop a “Basic Prevention Package,” a list of HIV

prevention interventions that would be important

in developing countries, and a listing of “Priorities

for International HIV Prevention Research.” Another

outcome of the workshop was a better understanding of the HIV prevention planning process. More

information on this workshop may be found at http:/

/hivinsite.ucsf.edu/ari.
38

Behavioral Research/

Behavioral Change Interventions

NIH supports an extensive portfolio of behavioral and social science research on HIV infection

and AIDS. These studies have demonstrated the

important interaction of biological, psychological,

and social factors that contribute to HIV prevention, transmission, and disease progression among

individuals and population groups. Findings from

these studies have significantly contributed to the

understanding of human behaviors that affect HIV

transmission risk and to the development of successful interventions to encourage sustained behavioral change. NIH-sponsored behavioral and

social science research includes research related

to the following goals:

• Developing, implementing, and evaluating

behavioral and social interventions to reduce

HIV transmission;

• Strengthening the understanding of the determinants, trends, and processes of HIV-related

risk behaviors and the consequences of HIV

infection;

• Developing and evaluating behavioral strategies for preventing or ameliorating the negative physical, psychological, and social consequences of HIV infection; and

• Improving the research methodologies employed in behavioral and social science research.

NIH-supported studies are ongoing, either independently or linked with biomedical studies, in

countries in Africa, Asia, and Latin America.

Vaccine Research

The development of a safe and effective HIV vaccine is of the highest priority for the NIH, and NIH

has pledged to work with the other G–8 nations on

vaccine efforts. NIH supports a broad program of

basic, preclinical, and clinical research on the discovery and development of HIV vaccine candidates.

Basic research on HIV and the immune system provides crucial information for developing potential

vaccines. Various strategies for stimulating a protective immune response against HIV infection are

being explored through basic research, animal

model research, and clinical trials. In recognition

of the need to develop vaccines that are efficacious

against a variety of strains found around the world,

NIH supports studies analyzing genetic and antigenic

variation of HIV and targeted toward eliciting crossreactive immune responses. While the goal of preventive vaccines is to end the HIV pandemic by

protecting individuals from HIV infection, vaccines

also may serve as immunomodulators to improve

immune function and slow disease progression in

infected individuals and may prevent them from

infecting others.

To accelerate the development of NIH’s AIDS

vaccine effort, the AIDS Vaccine Research Committee (AVRC), chaired by Dr. David Baltimore, was established. Specific areas of basic research relating

to HIV vaccines efforts have been identified by the

AVRC and a new, special initiative supporting innovative research in these scientific areas has been

funded during the last 2 years to advance this research field. To further HIV vaccine research in

the NIH intramural programs, the Vaccine Research

Center is being constructed with completion targeted for 2000.

The NIH supports an AIDS Vaccine Evaluation

Group (AVEG), which consists of six sites nationwide that are actively evaluating potential HIV vaccines in phase I and II clinical trials. To date, the

AVEG has conducted or initiated more than 46

trials with 24 different HIV vaccine candidates. All

vaccine candidates to date in AVEG phase I trials

have been shown to be safe and well tolerated. In

preparation for phase III clinical trials, NIH supports

a domestic and international network of sites that

are currently identifying the cohorts of populations

at risk for HIV infection and building the infrastructure necessary to conduct large-scale efficacy trials

of potential HIV vaccine candidates when they become available. These efforts involve strengthening in-country research capacity by training foreign

scientists and health professionals. NIH collaborates with UNAIDS, host country governments, and

in-country scientists in vaccine development and

preparation for efficacy trials. Eleven sites have

been established in Africa, Asia, and Latin America.

Treatment Equity

In an effort to identify options for clinical management of HIV-infected patients that would be

useful in resource-poor settings, NIH is supporting

studies on the use of isoniazid and rifampin to prevent active tuberculosis in PPD-positive, HIV-infected
39

patients in Uganda. In addition, NIH-supported scientists in Thailand are studying risk factors for infection with Penicillium marneffei. These NIHtrained scientists also are working with the pharmaceutical industry in Asia on developing therapeutics for P. marneffei infection.

Women and Health

NIH supports an extensive portfolio of basic,

clinical, and behavioral research focusing on

women and HIV/AIDS. HIV-infected women experience some complications of HIV disease that are

unique or more prevalent in them than in men, such

as vaginal and esophageal candidiasis, chronic herpes simplex infections, other STDs, and cervical

dysplasia. NIH-sponsored programs target studies

on the natural history and epidemiology of the disease in women through a number of studies in Africa, Asia, and Latin America.

Studies on the etiology and pathogenesis of HIV

infection and disease progression in women are ongoing. These studies focus on the role of STDs and

other factors in acquiring HIV infection and the

pathogenic mechanisms associated with HIV disease progression. Studies on biologic determinants

of infectiousness and susceptibility are important

areas under investigation. Specific attention is

being given to the possible correlation between the

level of cell-free or cell-associated HIV in blood,

semen, urine, cervical/vaginal secretions or oral

fluids, and the probability of transmission. In addition, NIH-funded researchers are investigating the

cellular and molecular aspects of mucosal immunity and other infectious diseases as cofactors, as

they impact HIV susceptibility and transmission.

Results from these studies are critical to developing safe and efficacious AIDS vaccines and

microbicides.

A critical area of concern is the impact of HIV

on cervical cancer. Co-infection with human papilloma virus (HPV) is common in HIV-infected women,

and HPV has been shown to act synergistically with

HIV to increase expression of individual viral genes.

A study in Africa is examining the natural history of

cervical neoplasia in women infected with HIV–1

and HIV–2 and the role of HPV as a risk factor.

Of similar critical importance is a current NIHsponsored multi-site international trial to determine

any possible increase in risk acquisition of HIV

through heterosexual contact by uninfected women

who use hormonal contraceptives. Other studies

are planned to examine the possible effects of steroidal hormones on early, acute HIV infection and

later progression to AIDS among hormonal contraceptive users, and on the possible effect of steroidal hormone use on the infectiousness of HIV-infected women.

NIH-supported behavioral and social science research that relates to or focuses on women include

studies on (1) determinants of HIV risk and prevention; (2) specific elements of social and cultural life

that contribute to HIV risk and protective behaviors; (3) the development of appropriate interventions to reduce risk behaviors; (4) community-level

interventions; (5) acceptability of both biomedical

and behavioral interventions among different individuals and communities; (6) the behavioral aspects

of the adoption of new HIV prevention technologies, such as microbicides and the female condom;

and (7) social and psychological factors influencing treatment adherence and compliance as well

as participation in clinical trials.

Microbicide Development

NIH sponsors a comprehensive biomedical and

behavioral program for the discovery, development,

preclinical testing, and clinical evaluation of topical microbicides and other female-controlled barrier methods for prevention of HIV transmission.

Population-based research is essential to ensure

both the efficacy and acceptability of these interventions to decrease or eliminate HIV transmission.

It is an NIH priority to develop a safe, inexpensive,

reliable, and acceptable microbicide for the prevention of HIV and other STDs.

The development of screening assays to test

compounds and agents for their microbicidal/spermicidal activity, as well as developing suitable animal models for safety and efficacy-testing of potential microbicides, are vital parts of the developmental efforts supported by NIH in this field of research.

Close collaboration with industry is important in

conducting the important phase I through III clinical testing of these agents in various populations

and to ensure their eventual availability. While a

number of microbicidal substances have been clinically tested in phase I and II studies to date, a safe,
40

effective, and acceptable microbicide has yet to be

identified. NIH has placed a high priority on developing an efficacious microbicide and continues to

look at new compounds, as well as other barrier

interventions. In FY–1999, NIH will establish a Prevention Trials Network that will focus on the testing at U.S. and international sites of various interventions, including microbicides, the expansion of

the Topical Microbicide Program Projects involving

multidisciplinary research to develop and test new

agents and the expansion of programs targeting the

developing and clinical testing of spermicidal

microbicides and other female-controlled barrier

methods.

Other Activities

Basic biomedical and behavioral research has

significantly contributed to advances in AIDS research. Findings from basic research have provided

the scientific basis for developing potential AIDS

drugs, vaccine candidates, and effective behavioral

interventions to halt the AIDS epidemic.

The NIH has the primary responsibility for the

Federally-supported clinical trials evaluating potential treatment regimens against HIV infection and

its associated opportunistic infections and malignancies. NIH supports an extensive network of

more than 100 clinical trial sites, including adult

and pediatric units in major domestic medical centers and community-based primary care settings.

More than 50,000 patients have been enrolled to

date in these studies that have involved evaluating

more than 200 different drugs. The enrollment and

accrual in these clinical trials of women, minorities, children, adolescents, injection drug users, and

other populations is a high priority for the NIH.
41

Centers for Disease Control and Prevention

Agency Mandate Relevant to

HIV/AIDS

The U.S. Department of Health and Human Services (DHHS) is committed to working in partnership with others to reverse the toll that HIV/AIDS is

taking on millions of lives by halting the further

spread of HIV and mitigating its effects on those

already infected through research, prevention, service delivery and education efforts. Scientists at

DHHS have contributed significantly to international

progress in understanding how HIV infection is transmitted, how it affects the body, and how to treat

and prevent it. As new information becomes available, increased knowledge about this disease and

better ways to treat and prevent it should be forthcoming to address this critical health problem.

As the Nation’s prevention agency, CDC integrates prevention science, research and practice.

Through basic and laboratory research, epidemiologic research, and surveillance, behavioral, communications, and social science research, CDC supports a comprehensive approach to issues which

impact prevention. CDC collaborates with governmental and non-governmental organizations, international and domestic, awarding grants to national

organizations, state and local health departments,

community-based organizations and other institutions to support prevention activities based on science. This integration of science and practice is

consistent across all of CDC’s Centers, Institutes,

and Offices supporting prevention science activities. These include the National Center for HIV,

STD and TB Prevention (NCHSTP), the National Center for Infectious Disease (under which falls the Division of AIDS, STD, and TB Laboratory Research),

the National Center for Chronic Disease Prevention

and Health Promotion (under which falls the Division of Adolescent and School Health and the Division of Reproductive Health), the Office of Women’s

Health and the Public Health Practice Program Office (which ensures the quality of laboratory testing).

Funding

In FY–1998, DHHS received more than $6.8 billion dollars for HIV/AIDS activities. The majority of

these funds (nearly two-thirds) were distributed for

care and treatment of Americans through the Health

Care Financing Administration (HCFA) authorized

under Medicaid and Medicare programs and through

the Health Resources and Services Administration

(HRSA) authorized under the Ryan White Care Act.

Funding for international collaborative HIV/AIDS activities is limited within the offices and agencies

within DHHS, with no formal budget allocation for

international activities. Therefore, only a tiny percentage of HIV/AIDS funds are allocated for international HIV/AIDS activities.

Agency Strategy for Specific

Issues

Prevention

CDC has two programmatic approaches to international collaboration in HIV/AIDS prevention: fieldbased research collaborations and limited CDCbased technical assistance, training, and project

management.

Field-Based Research

Epidemiology of HIV. Field-based research provides collaborative assistance to Côte d’Ivoire,

Uganda, South Africa and Thailand. Studies are

designed to increase the understanding of the epidemiology of HIV and to evaluate intervention methodologies in the host country and the United States.

Because of the variation in the virus itself throughout the world, CDC, through two of its centers in

Côte d’Ivoire and Thailand, conducts international

surveillance of the genetic diversity of HIV research

collaborations in numerous countries throughout

the world.

Perinatal Transmission. Earlier this year, researchers from CDC and the Ministry of Public

Health in Thailand announced dramatic findings that

offer real hope for extending perinatal prevention

successes to many developing nations. Researchers found that a short course of AZT given late in

pregnancy and during delivery reduced the rate of

HIV transmission to infants of infected mothers by

half and is safe for use in the developing world.

CDC is continuing collaborative research in West

Africa to establish the longer term efficacy of short
42

course zidovudine for populations in whom safe

alternatives to breast feeding may not be available.

Microbicide Development. CDC has also supported international collaboration on the development of microbicidal products, as well as international studies in acceptability of microbicides in Zimbabwe and Thailand. In addition, a number of domestic and international activities have included

research about the potential impact of including

information on microbicides, once available, as part

of the prevention messages about condoms. CDC

participates with NIH and FDA in the International

Working Group on Microbicides, which also includes

UNAIDS, the Population Council and some industry

representatives.

Prophylaxis of Opportunistic Infections. In

Côte d’Ivoire, a placebo controlled trial of

cotrimoxazole in patients in treatment for tuberculosis showed a significantly reduced mortality in

immuno-suppressed patients taking the active drug.

The recently completed trial of preventive therapy

for tuberculosis in Uganda, conducted by Case

Western Reserve University in collaboration with

Ugandan colleagues was supported by CDC as well.

Vaccine Research. CDC has a number of research activities related to the development of HIV

vaccines. This includes participation in efficacy trials in the United States and Thailand, as well as in

the development of novel candidate vaccines in

collaboration with academic centers. In addition,

behavioral research and communication efforts

about vaccine related issues are ongoing. CDC

expertise in vaccine implementation will be a valuable resource once candidates become available.

Technical Assistance

In addition, CDC provides both long and short

term technical assistance internationally. Long-term

technical assistance and management capacity has

been established by CDC field assignees to Uganda

and South Africa, working in conjunction with

USAID, as well as India and Vietnam. In addition to

these field-based staff, CDC provides short-term

technical assistance and training to numerous countries including Brazil, Russia, The Republic of South

Africa, and Mali, and to international organizations

including UNICEF, UNAIDS, and WHO.

Training

In conjunction with these technical assistance

activities, CDC provides training in the areas of

epidemiology, evaluation, prevention methodologies and other technical areas through an extensive program of training based in Atlanta as well as

at field sites in Thailand and Côte d’Ivoire. CDC

has also designed a program, in collaboration with

USAID, to link U.S.-based community organizations

and their prevention interventions with counterparts

in developing countries. This was established in

order to provide a mechanism to share relevant

experiences, provide materials and resources, and

training opportunities across countries. Other activities will support USAID-assisted countries with

access to CDC epidemiologic and surveillance expertise.

Other Activities

Although not specific to HIV/AIDS, it is important to note that CDC’s international work focuses

heavily on strengthening public health infrastructure, and such work can contribute to sustainable

HIV/AIDS control. For example, the CDC established field epidemiology training programs in developing countries. Epidemiology is the cornerstone

of public health science, and trained epidemiologists are valuable countries to detect, monitor and

help control their key public health programs. Secondly, CDC has established a sustainable management development program to provide practical

training in management of public health programs

in developing countries.

Recognizing the urgency of the epidemic and its

impact on many domestic issues, CDC is committed to HIV/AIDS research within, as well as outside

of, U.S. borders. To understand HIV/AIDS at a global level, research must address issues and conditions unique to different countries and communities within countries. Many developing countries

severely affected by the epidemic lack the research

capacity, public health infrastructure, and financial

and human resources to respond to the epidemic.

CDC’s international research underscores the importance of developing and implementing diverse

interventions to address issues among varied populations and to do so quickly and cost-effectively.
43

Food and Drug Administration

Agency Mandate Relevant to

HIV/AIDS

The Food and Drug Administration (FDA) is the

only agency within the U.S. Public Health Service

whose responsibilities are regulatory in nature. Its

purview is product-driven and encompasses products worth approximately 25 percent of the U.S.

gross national product. FDA activities respond to

product applications—the agency reviews what is

brought to it.

FDA’s level of commitment to prevention, diagnosis, and treatment of HIV/AIDS is broad-based.

FDA, like all of its component agencies in the U.S.

Public Health Service, is committed to finding more

and better ways to prevent, diagnose, and ultimately

cure HIV/AIDS. FDA performs research and review

involving AIDS therapeutic and diagnostic vaccine

products. Major research priorities include: (1) new

more sensitive blood safety testing for HIV; and (2)

methods, standards, and studies on mechanisms

of action of new AIDS therapeutics and vaccines.

Funding

FDA and its budget is organized around the products within its regulatory framework and is not, generally, a grant-making institution nor an entity organized in terms of line items for particular diseases

or disease groups. FDA does not have a specific

international budget allocation.

Agency Strategy for Specific

Issues

Prevention

Medical Devices. FDA has an ongoing responsibility to help ensure the safety and effectiveness

of AIDS-related medical devices through its regulatory activities. This includes sampling and testing

of medical gloves and latex condoms; reviewing

submissions to market devices that reduce the risk

of HIV transmission, including donor screening

tests; conducting HIV-related regulatory research involving medical devices; and evaluating the role of

devices in the transmission of bloodborne infections.

FDA has cleared for marketing over 280 needle

and intravenous cannulas with safety features that

reduce the risk of sharps injuries to healthcare

workers. Among sharps containers FDA has recently

cleared for marketing are devices that electrically

oxidize all types and sizes of needles immediately

after use, further reducing the risk from used

needles.

As condoms remain the best means of protection against the transmission of HIV and other sexually-transmitted diseases, FDA must be vigilant in

its regulation. FDA is working to develop better

tests for condom strength and is investigating the

barrier capability of condoms manufactured of different materials.

Blood and Blood Products. FDA is responsible for ensuring the safety of the U.S. blood supply. Regulatory mechanisms designed to ensure

blood safety include establishing policies; approving authority for blood products and establishments;

and surveilling and enforcing blood safety standards. The blood safety system FDA has established

consists of five layers of overlapping safeguards that

start at the blood collection centers and extend to

the manufacturers and distributors of the blood

products made from donated blood.

The first level of precautions seeks to eliminate

high-risk donors by encouraging those whose blood

may pose a health hazard to exclude themselves,

and by evaluating their behavioral and medical history as a basis for deferral. The second safeguard

entails constant updating of a list of unsuitable donors and checking donors’ names against the list

to prevent using their blood. The third consists of

testing the blood for such bloodborne agents as

HIV, hepatitis, and syphilis. The fourth safeguard

FDA enforces is a quarantine of donated blood until tests and other control procedures establish its

safety. Finally, the blood collection centers are obligated to investigate incidents, audit their systems,

and correct deficiencies. FDA also sets quality and

safety standards for blood-derived products such

as viral inactivation of clotting factor concentrates

and immune globulins.
44

Treatment Equity

Therapeutic Agents. FDA is responsible for

approving safe and effective drugs and biologics

used in the United States for treating HIV infection,

AIDS, and AIDS-associated opportunistic infections.

FDA is also responsible for regulating the investigation of new drugs. It places special emphasis on

ensuring the most timely and efficient premarketing

review possible of products that offer promise for

diagnosing, treating, or preventing HIV and HIV-related illnesses. FDA has approved 37 applications

for products to treat HIV/AIDS. Twelve drugs are

antiretroviral agents that are used to treat the virus, and the remaining 25 are used to treat opportunistic infections that can complicate HIV infection. In addition, FDA is responsible for monitoring the safety of the drugs and biologics post marketing and places special emphasis on ensuring that

new safety information is disseminated widely and

in a timely manner.

Vaccine Research

Within the framework of the Public Health Service-wide vaccine program for prevention and

therapy, FDA is continuing its efforts to guarantee

that any promising products for immunization

against HIV will receive expedited regulatory review,

and when appropriate, will be approved in the shortest possible time.

Diagnostic Capability

Diagnostic Reagents and Test Kits. FDA conducts a variety of regulatory, testing, and research

activities to approve for marketing satisfactory test

methodologies for detection of HIV. FDA has approved 2 HIV–1 Antigen tests; 20 anti-HIV–1 assays;

3 anti-HIV–2 assays; 1 anti-HIV assay on urine; 1

anti-HIV testing service using home collection; 1

anti-HIV–1 oral specimen collection device; and 1

HIV–1 viral load assay. FDA currently is facilitating

development of gene-based screening tests.
45

U.S. Department of Commerce

Agency Mandate Relevant

to HIV/AIDS

The mission of the Department of Commerce is

to foster, serve, and promote U.S. economic development and technological advancement. Data collection and analysis programs conducted by the

Bureau of the Census and the Bureau of Economic

Analysis affect the distribution of funds and other

resources for private and public health initiatives,

including HIV/AIDS research, treatment, and service programs. The Bureau of the Census maintains the broadest and most current numeric database in the world on HIV prevalence and incidence

information for sub-Saharan Africa.

Scientific standards, methodologies, and technologies developed through the programs of the

National Institute of Standards and Technology

(NIST) affect laboratory procedures and equipment

calibration at HIV/AIDS research facilities. The

Patent and Trademark Office Biotechnology Examining Groups review and research patent applications for immunological testing apparatus and processes, apparatus for chemical and clinical analysis, immunoassay and pharmaceutical compositions, and apparatus and processes related to sterilization, cell biology, and blood and blood products.

Agency Strategy for

Specific Issues

Vaccine Research and Other

HIV/AIDS-Related Research

Patent Database. On its homepage on the

World Wide Web, the U.S. Patent and Trademark

Office provides a searchable database containing

the full-text and images of patents related to AIDS

research. This free service is available to anyone

with access to the Internet, in the United States or

internationally. Currently, there are almost 3,000

U.S. patents available for searching, as well as almost 800 Japanese patent documents and approximately 700 European patent documents in this database. This project was coordinated by the Patent

and Trademark Office and the National Science

Foundation and developed in cooperation with private and nonprofit organizations.

Advanced Technology Program. The Department has funded biotechnology development

projects through NIST’s Advanced Technology Program (ATP). The ATP is a unique partnership between government and private industry to accelerate the development of high-risk technologies that

promise significant commercial payoffs and widespread benefits for the economy. The ATP encourages a change in how industry approaches R&D,

providing a mechanism for industry to extend its

technological reach of what can be attempted. The

ATP supports enabling technologies that are essential to developing new products, processes, and services across diverse application areas. Private industry bears the costs of product development, production, marketing, sales, and distribution.

ATP awards are made strictly on the basis of rigorous peer-reviewed competitions designed to select those proposals that are best qualified in terms

of the technological ideas, the potential economic

benefits to the nation, and the strength of the plan

for eventual commercialization of the results. One

project currently being funded through the ATP is a

project on the Evolution of a Murine Model for AIDS:

Applications to Discovery of Small Molecule and

Vaccine Therapeutics. This project aims to provide

a small-animal model for research on AIDS therapies and vaccines by developing a variant of HIV–1

that will replicate in mice. This approach will be

less expensive than the current practice of using

primates and has the potential to accelerate discovery and improve the quality of new AIDS therapies and vaccines.

Accelerated Processing of Patent Applications. The Patent and Trademark Office offers accelerated processing of applications for inventions

related to HIV/AIDS.

Trade. The Department of Commerce works

closely with the U.S. pharmaceutical and biotechnology sectors in the battle against HIV/AIDS. Commerce is proud that the U.S. industry is one of the

leaders in research and development that produces

new medical products to combat HIV/AIDS.
46

Through Commerce trade missions and seminars,

the Department works with industry to spread information about new medical products and discoveries in the pharmaceutical and biotechnology areas. Commerce will work with industry and other

governments to create a trade environment that

maximizes the exposure of new HIV/AIDS treatments. It will continue to combine efforts with industry, non-governmental organizations (NGOs),

and other government agencies in a coordinated

effort against the HIV/AIDS epidemic.

HIV/AIDS Surveillance. The U.S. Bureau of the

Census, International Programs Center, compiles,

evaluates, and analyzes selected health and related

data for all countries overseas. With funding from

USAID through an interagency agreement, the

Health Studies Branch maintains and updates the

HIV/AIDS Surveillance Data Base, which is a compilation of information on HIV prevalence and incidence from all available studies from Africa, Asia,

Latin America, and some select countries in Europe. Using this information, the Bureau of the

Census tracks patterns and trends in HIV infection

among subpopulations within countries. This information is then used to estimate AIDS mortality

and is incorporated into our world population estimates and projections. These estimates are available from the Bureau of the Census’ International

Data Base.

The International Programs Center has been

designated a UNAIDS Collaborating Centre and contributed to the development and production of the

UNAIDS Epidemiological Fact Sheets.
47

U.S. Department of Defense

Agency Mandate Relevant

to HIV/AIDS

The threat that HIV/AIDS poses to the capabilities and readiness of the U.S. military forces is of

great concern. In response to that threat, the military research program was initiated in 1986 to minimize the impact of HIV on military readiness by

monitoring the spread of HIV infection in military

forces and developing methods to prevent infection. The Tri-Service effort, which includes the

Army, Navy, Air Force, and Marines, is a highly targeted research program that addresses the military

concerns of HIV. This includes surveilling infection

rates and HIV subtypes around the world; developing vaccines and education strategies to prevent

infection; and originating clinical studies to slow

progression and prevent immune deficiency.

The Military HIV Research Program has as its primary goal the prevention of HIV infection in the

fighting force. Once infected, the soldier, sailor, airman, or Marine is, irrevocably, a casualty, and that

service member and his or her family and the country will feel the effects—physically, emotionally, and

economically. Knowledge that HIV infection is possible and that HIV is present in the environment

can have deleterious effects on unit morale and

cohesion of deployed forces. Preventing HIV decreases casualties and improves unit effectiveness;

helps protect the replacement blood supply; and

preserves the available recruitment population in

the civilian community.

Agency Strategy for

Specific Issues

Vaccine Research

The Military HIV Research Program’s preventive

vaccine strategy involves developing several vaccine candidates in concert with industry, academia,

and collaborators in Thailand. An initial Phase I

safety trial of an HIV recombinant protein vaccine

was successfully completed in Thailand in 1997.

The vaccine was safe and well tolerated, with immunogenicity similar to that observed in U.S. trials. This current trial is the first of its kind to match

the HIV vaccine to the HIV subtype of the population. The Program is conducting the first Phase II

vaccine trial with a vaccine prepared from HIV subtype E, which is prevalent in the population of Thailand. The Military Program has a comprehensive

vaccine development strategy with clear milestones

leading to a large-scale efficacy evaluation of candidate vaccines in the year 2001.

The military research program is highly leveraged

through cooperative development initiatives with

private industry. In 1998 alone, three new cooperative research and development agreements were

established, and two new HIV candidate vaccines

have entered Phase I trials at the Walter Reed Army

Institute of Research (WRAIR) and the Army overseas laboratory in Thailand.

Cooperation and coordination with other Federal agencies (including NIH/National Institutes of

Allergy and Infectious Diseases and the Centers for

Disease Control) and international agencies (WHO

and UNAIDS) and a strategic alliance with the Royal

Thai Government has resulted in an unprecedented

opportunity to conduct advanced development and

testing of protective vaccines.

Regarding vaccine testing, an initial Phase I vaccine trial of an HIV DNA vaccine began in 1998

with volunteers at WRAIR. Another protocol for an

HIV vaccine involving unique boosting strategy with

a novel envelope protein also began at WRAIR. The

Military Program has secured a commitment from

several of its industrial partners to produce large

batches of these vaccines and plans to proceed

with a large-scale multiple-arm efficacy vaccine trial

in Thailand. The possibility of conducting vaccine

trials in east Africa is also being investigated where

it would be possible to test the effectiveness of

vaccines against the subtypes of HIV found in Africa. Continued development and testing of second-generation vaccines with significantly improved

biological properties generates optimism for the

rapid advancement of vaccines effective against the

various HIV subtypes found throughout the world.

In the area of diagnostic and clinical research,

the Program is working on post-exposure prophylactic measures to deal with mass casualty situations in HIV-endemic areas overseas involving U.S.

military personnel. These emergency situations require using rapid, sensitive diagnostic field tests
48

for HIV, which are currently being developed and

evaluated. In a clinical study, the Program has assessed using an HIV gp160 vaccine as therapy for

persons already infected with HIV. The results of

this long-term, Phase II study involving over 600

volunteers demonstrated that the amount of virus—

a patient’s viral load—predicts disease progression.

In addition, certain antibody responses altered disease progression so that the production of these

antibodies will be the target of future vaccine development. In another clinical research project,

there is an ongoing effort to monitor the development of resistance to antivirals in patients receiving triple drug therapy. This will assure the most

effective use of these drugs while extending the

lives and health of HIV-infected military healthcare

beneficiaries.

Finally, DOD representation and numerous presentations of DOD conducted research have occurred at HIV/AIDS international meetings.
49

National Intelligence Council

Mandate Relevant to HIV/AIDS

The intelligence community and its various components produce analyses on the scope and impact of HIV/AIDS in response to Presidential decision directives, the needs of their associated agencies, and ad hoc requests from senior policymakers.

Strategy for HIV/AIDS Issues

The National Intelligence Council will produce

an assessment on the global threat from infectious

diseases, including HIV/AIDS; the capacity of foreign governments and international organizations

to deal with such diseases; and the implications

for the United States.

The Defense Intelligence Agency’s Armed Forces

Medical Intelligence Center (AFMIC) will continue

to assess systematically worldwide HIV/AIDS incidence and prevalence. AFMIC also will forecast the

impact of HIV/AIDS and other infectious diseases

on U.S. national security interests and deployed

forces. It will also examine the impact of such diseases on foreign military force readiness, military

and civilian healthcare infrastructures and

transnational health trends.

Other intelligence community collection and analytical components will focus on HIV/AIDS issues

as necessary and upon authorized request.
50

Role of the Pharmaceutical Industry

Agency Mandate Relevant to

HIV/AIDS

In general, the role of the pharmaceutical industry is to find sustainable long-term solutions that

will marshal the expertise and resources of all stakeholders to improve the health of those infected with

HIV/AIDS, and to help establish balanced approaches to education, prevention, and treatment

of HIV/AIDS. Effective responses to the HIV/AIDS

challenge must take into consideration all the relevant factors such as available therapies and their

applicability for developing countries, medical infrastructure, available resources, disease awareness

and prevention initiatives, and national commitment

and leadership to make HIV/AIDS a public health

priority.

The principal role of the research-based U.S.

pharmaceutical industry in confronting HIV/AIDS (in

the developing world) is to continue to marshal the

expertise and capacity in basic biomedical research

and drug development to discover new and more

effective treatments, make treatments more affordable and, in the longer term, to develop an effective HIV vaccine.

As corporate entities, the pharmaceutical industry seeks a return on the sizable investment for research and development of new drugs. Annually,

the U.S. pharmaceutical industry spends approximately $2 billion on research and development of

HIV/AIDS-related drugs. As citizens of the larger

global community, however, the industry has a commitment to bring to bear its vast resources to help

those in need.

The research-based U.S. pharmaceutical industry is also well-positioned to provide input in the

area of national health education and policy through

contacts with government and health agencies

around the world. This expertise should supplement the responsibilities and expertise of other

members of the world health care community, both

public and private.

Major U.S. companies are active across a broad

front to try to improve the quality, delivery, and

outcome of HIV/AIDS care in the developing world.

The pharmaceutical industry has aggressively pursued prevention and treatment efforts for HIV and

related illnesses. Although not uniformly available,

the following is a summary of the pharmaceutical

sector’s efforts:

• A new class of drugs called non-nucleoside

reverse transcriptase inhibitors became available for use in combination therapy.

• There are more than 120 new medicines for

HIV/AIDS in development, including:

• 40 antiviral medicines, including new protease inhibitors;

• 23 medicines to fight AIDS-related cancers

such as Kaposis sarcoma;

• 12 vaccines;

• 12 immunomodulators designed to stimulate the patient’s own immune system to

fight the virus;

• 11 anti-infective medicines to fight against

such deadly diseases as Pneumocystis

carinii pneumonia, a lung infection that

affects eight out of ten AIDS patients;

• 8 antifungal medications aimed at thwarting fungal infections that can prove deadly

to people with compromised immune systems; and

• 5 gene therapies designed to genetically

alter cells in patients’ bodies to make them

more resistant to the virus or to alter the

virus itself.

• Two protease inhibitors have been approved

to treat children with AIDS.

• A new medicine that combines two widely prescribed AIDS drugs in a single tablet has been

approved by the FDA, a first important step

toward simplifying the highly effective, but

complex, combination drug therapy.

• The treatment of HIV-infected pregnant women

with an antiretropviral drug has shown to be

highly effective in preventing transmission of

the virus to babies, even in women with advanced AIDS.

• In 1997, a pharmaceutical became the first

HIV therapy simultaneously cleared for use

both in adults and in children 2 through 13

years of age.
51

Strategy for Specific Issues

Prevention

In light of the pharmaceutical industry’s efforts,

the most beneficial solution to the HIV/AIDS challenge worldwide would be the prevention of new

HIV infection via a safe and effective vaccine, especially for those areas of the world where

antiretroviral therapy is not yet feasible or practical.

A vaccine, however, will require adequate distribution and supply programs. In some disease

areas where vaccines exist, for example, there are

insufficient mechanisms for funding and supplying

vaccines. To increase the availability of needed

pharmaceuticals, the pharmaceutical industry must

work with nations and many others to build a cooperative relationship and to develop appropriate expertise and infrastructure to facilitate distribution.

Treatment Equity

The conventional view is that there needs to be

greater equity in access to treatments between patients in developed and developing countries. Although this is a straightforward and laudable goal,

the issue is complex. In many developing countries, the lack of medical infrastructure and a basic

health care system undermine best efforts to make

advanced AIDS therapies more widely available.

Even if an unlimited amount of drugs were made

available, access to HIV/AIDS therapies in the developing world may be thwarted by the lack of basic medical care, poor infrastructure, and the lack

of political will and commitment at national levels.

In addition to battling the complex HIV/AIDS problem, developing countries are faced with the dilemma of allocating scarce resources to effectively

implement prevention, education, and treatment

programs and effectively cope with the complex

social, cultural, and economic factors involved in

improving health.

In many respects, price is not the only issue.

Even at a substantially lower price, many of the

world’s poorest regions still would not be able to

obtain optimum clinical benefit from the new treatment drugs, like protease inhibitors or other

antiretroviral therapy. This is due in part to the

lack of properly trained medical personnel and supporting public health infrastructure, inadequate distribution mechanisms, and other challenges. Using

protease inhibitors and other antiretroviral therapy

under such circumstances would not only be impractical and potentially ineffective, but even hazardous, as the combination therapies require strict

dosage schedules and substantial HIV medical support care to ensure ongoing and uninterrupted use.

Inappropriate use of therapy increases the risk of

emergence of drug-resistant virus, which exacerbates the impact of HIV/AIDS in affected populations.

To reduce the spread of HIV/AIDS there is a need

for reduced treatment costs, better health infrastructure and government commitment. Government

action is required to provide incentives for private

individuals and firms to pursue responsible development of new drug therapies and to develop the

necessary public health infrastructure. This will permit the development of therapies that are consistent with internationally recognized rights and standards and promote the distribution of safe and effective medical supplies and services.

Improving Infrastructure for HIV/AIDS. The

international community at large is working to

strengthen public health infrastructures to address

a wide array of disease problems. The pharmaceutical industry can and should play a part in addressing infrastructure inadequacies. Clinical trials, with

the support and agreement of national governments, can be a vehicle for improvement if they

are based on a commitment to make sustainable

the infrastructure created for the purpose of conducting such trials. This will provide mutual benefits to both the sponsors and the participating

entities.

An example of a successful private/public partnership is the clinical trial of a new antiretroviral

drug in Brazil. Brazil’s medical community had considerable experience with clinical trials, but to date

had not engaged in large-scale studies of HIV infection. Merck & Co., Inc.’s medical department in

Brazil worked closely with U.S. colleagues, Brazilian health and regulatory officials, clinical investigators, and their staffs to meet the challenges of

finding personnel to serve as clinical monitors. They

also trained the staff to collect and interpret the

data on safety and clinical efficacy correctly;

equipped the clinics with the necessary equipment

to manage sophisticated clinical tests; expanded

the capabilities of the local clinical laboratory to

handle the thousands of blood samples from patients; and recruited patients within the trial guide-
52

taking behaviors and determinants of such behaviors among HIV positive individuals. Industry also

stands ready to work with governments, international organizations and others to address public

health infrastructure needs in developing countries.

At the Twelfth World AIDS Conference in 1998,

Merck & Co., Inc., announced a $3 million grant

from the Merck Company Foundation to underwrite

the Enhancing Care Initiative, an initiative coordinated by the Harvard AIDS Institute and the

Francois-Xavier Bagnoud Center for Health and

Human Rights at the Harvard School of Public

Health. The Enhancing Care Initiative will address

the issue of HIV/AIDS in the developing world by

bringing together the best possible expertise within

specific countries, including representatives of the

local HIV community. The goal is to customize concrete, practical improvements that will help to advance the quality, delivery and outcomes of HIV

care for men, women and children living with HIV/

AIDS, not only in the initial countries selected (beginning with Senegal and Brazil), but in a broad

range of developing world countries.

The kind of commitment that the pharmaceutical industry is making to this type of responsible

partnership is exemplified in industry’s efforts in

Africa. In South Africa and Botswana, the BristolMyers Squibb Company supports medical education activities for local HIV specialists. One project

called AIDSFACT is designed to educate healthcare

professionals on the management of HIV. It is

authored by HIV experts in South Africa and was

distributed to 10,000 general practitioners in 1998.

To help improve the care that African physicians

are able to give to their patients with HIV infection,

Merck & Co., Inc., has worked with leading HIV/

AIDS treatment specialists at clinical centers in Paris,

using a “train the trainer” approach to provide physicians from Uganda, Côte d’Ivoire, and Senegal experience with the best international standards of

HIV care. The physicians then disseminate this

knowledge to colleagues at home, which over time

will improve the level of understanding and expertise in meeting the challenges of HIV/AIDS throughout the medical community in their countries. The

information gained from these types of studies can

then be used to guide government decisions on

making additional resources available to expand

programs of HIV/AIDS treatment.

lines, ensuring both that their rights were protected

and that their care was delivered appropriately.

As a result, the treatment program has generated almost R$1 billion of savings for the government (R$l.05 equals approximately U.S. $1) and in

Sao Paulo, the number of AIDS-related deaths fell

by 35 percent in the first half of 1997, compared

with the first half of 1996. In Rio de Janeiro, the

number of deaths was 21 percent lower. Other

ancillary effects include a 20 percent reduction, in

1998, on government spending for related medication; in Sao Paulo, the use of emergency facilities by AIDS patients fell by 40 percent and one

entire floor of an AIDS wing in the city’s largest

hospital was closed due to insufficient demand; and

patients receiving the antiretroviral drugs required

less treatment for opportunistic diseases. Another

indirect effect of the program is the increased ability for HIV-infected individuals to retain the physical vigor to continue in their jobs.

 The successful findings from the clinical endpoint trial played a vital role in making the new

therapy available in the countries of the European

Union, in Brazil, and elsewhere. For the Brazilian

medical community, the completion of the trial was

a significant accomplishment. The community had

carried to successful completion a complex trial

that generated massive amounts of data. The investigators and their teams had solved a variety of

logistical and organizational problems and developed the kind of meticulous statistical data on which

physicians in Brazil and around the world could,

with assurance, base their decisions about HIV/AIDS

therapy for their patients.

This example demonstrates the power of partnerships among key stakeholders—the private and

public sectors, the medical and patient communities—to improve the framework for HIV/AIDS care

in the developing world. Examples like this can set

the stage for reallocation of government resources

to address access to effective new medicines in a

more comprehensive way, with confidence that the

treatment algorithms will work in the local context.

The industry plans to continue to work in partnership with governments, non-governmental organizations, advocacy groups and academic institutions to lead, support, or initiate projects on AIDS

awareness. This can result in a better understanding of the patterns of HIV-related illnesses, care-
53

These activities in the private sector complement

the initiatives of other stakeholders—including the

HIV community, governments, international organizations, and non-governmental organizations—to

help improve medical infrastructures and support

the efforts to find long-term, sustainable solutions

to the problems of HIV/AIDS faced by countries in

the developing world.

Women and Health

Some gender analysis, though limited, has begun. An analysis of data from Merck, Sharp and

Dohme’s study 028 (the Brazil trial) shows comparable effects on disease progression among men

and women as a result of treatment with a protease

inhibitor. The study, a clinical endpoint trial of 996

previously untreated HIV patients in Brazil included

277 women (28 percent of total patients), which

constitutes one of the largest representations of

women in a long-term protease inhibitor study in

the world. The objective of the analysis was to

determine whether there was consistency of treatment effects across gender in the testing of various new therapies. This type of study is only a

beginning. There is a strong need for more research

on women’s risks, prevention and care needs. Also,

funding for women-specific interventions programs

needs to be increased.

Related to the issue of HIV/AIDS and women is

pediatric health care. The Bristol-Myers Squibb

Foundation and Bristol-Myers Squibb Company -

Mexico have jointly funded a pediatric AIDS initiative to address prevention and education, treatment, and access to care. Through community

outreach and education of pregnant women and

women of childbearing age, the program aims to

reduce the incidence of pediatric AIDS. With the

Baylor College of Medicine, the program provides

medical training to pediatricians, infectious disease

specialists, and nurses on the management and

treatment of pediatric AIDS. A third component of

the program provides anti-retroviral drugs for approximately 200 pediatric AIDS patients in need and

infant formula for approximately 100 infants. The

program began in 1998 and the total commitment

for this initiative will be U.S. $4.4 million over three

years.

Vaccine Research

In November 1997, the Pharmaceutical Research

Manufacturers of America (PhRMA) reported that 12

vaccines under development from member companies, including the first AIDS vaccines, were in

clinical trials or under review by the U.S. Food and

Drug Administration (FDA). Currently, there are no

FDA-approved vaccines for HIV.

Biopharmaceutical research and development

companies are involved in the development of

therapeutic and preventive vaccines that can induce

protective immunity against HIV-1 subtypes prevalent in different parts of the world.

Industry also must commit to make therapies

available where clinical trials are performed. In

research programs underway in Côte d’Ivoire and

Thailand, one Merck & Co., Inc., designed its protease inhibitor clinical trials so that patients in these

trials will continue to get access to the therapy after the studies are completed.

Vaccine research is difficult and expensive. The

risk of failure is high. Of an initial five thousand

compounds in basic research, only one will emerge

from the laboratories and actually reach the market. According to PhRMA, promising new vaccines

require an average of 10 to 15 years of intense

study and development. Nonetheless, U.S. pharmaceutical companies active in the HIV/AIDS field

remain committed to developing new and innovative vaccines as well as developing combination

vaccines and multiple antigens in a single inoculation. For vaccine researchers, the ideal would be

converting multidose vaccination regimens into a

single time-released shot.

Vital to the continued progress in developing new

pharmaceutical defenses against HIV/AIDS is strong

intellectual property protection. Intellectual property protection provides the indispensable incentives to invest in pharmaceutical research, which

leads to the discovery and development of better

treatments for patients with AIDS all over the world.

Strong worldwide patent protection is essential to

spur pharmaceutical innovation.

Behavioral Research/Behavioral Change

Interventions

As part of its ongoing effort to work with partners

to improve environments through which health care

is delivered in developing countries, PhRMA underwrote AIDS education work in Africa, in partnership

with Africare.

In Nigeria, Merck & Co., Inc., joined forces with

the World Health Organization (WHO) in Geneva,

Women’s Health & Action Research Centre in Be-
54

nin, Nigeria, the Ford Foundation in Beijing and

three U.S. Universities (University of Pennsylvania

Medical School, Princeton University, and Harvard

School of Public Health) in a project aimed at identifying choices made by Nigerian youth to treat symptoms of sexually transmitted diseases (STDs) and

identify targets for improving treatment of STDs.

The findings will guide an intervention to reduce

the prevalence of STDs and incidence of HIV among

Nigerian youth.

Microbicide Development

Pharmaceutical companies are working to develop topical microbicides that women can apply

to inhibit HIV infection. Although none have been

shown to be effective to date, a potential microbicide that is spermicidal is in later stages of efficacy

testing against HIV. Other formulations of

microbicides are still in early development and testing.

The pharmaceutical industry realizes that women

need microbicides that allow conception, but prevent infection with HIV and other STDs.

Donor Coordination

The pharmaceutical companies sponsor billions

of dollars of research and development into new

treatments as well as donate products. To facilitate product donations, U.S. research-based pharmaceutical companies created the Product Donations Steering Committee (steering committee), an

organization of innovative companies and key U.S.-

based voluntary organizations. The Committee was

organized to facilitate experience-sharing regarding

obstacles to donations and to formulate guidelines

for responsibly managing donations.

The Steering Committee has forged a “Statement

of Principles” and has taken other actions such as

educational meetings and seminars to help ensure

that donations are carried out and coordinated between the donor company, private voluntary organizations and recipients in a way that assures the

highest level of quality and ethics.

Donor coordination requires consideration of

what is needed for a successful donation in general. The need for coordination goes far beyond

the donors, it extends to all of those involved in

the donation process—donors, private voluntary

and/or non-governmental development organizations, local ministry of health, governments, field

staff, and patients. In addition, coordination of

organizations working in any one particular area is

needed to avoid overlap, duplication of efforts, and

to ensure appropriate coverage.

Sustainability of treatment is crucial and must

be considered when planning donor coordination.

Sustainability of treatment is contingent on a number of factors: available product supply, program

funding, government/minister of health involvement, and recipient fatigue. For diseases like AIDS

that require long term treatment and medicines with

complex administration protocols, a reliable medical staff is needed to administer the medicines.

Failure to ensure proper and continued administration could actually harm the patient. Other requirements for a successful donation include a reliable

delivery system on the ground in the recipient country; assurances of adequate and appropriate storage of the medicines; and a system for recording

adverse reactions and monitoring patients.
55

Role of International Non-governmental

Organizations (NGOs)

Mandate Relevant to HIV/AIDS

Progress in halting the spread of the HIV/AIDS

pandemic and its consequences can only be made

if public sector efforts are supplemented by private

sector involvement in HIV/AIDS prevention and mitigation. Over the past decade, selected non-governmental organizations (NGOs) have demonstrated

that they are often in the best position to mobilize

communities worldwide for HIV/AIDS prevention

and care. Their close relationship with target communities and their experience in community development enables NGOs to work with community

members to develop responsive, cost-effective programs. To build effective and sustainable HIV/AIDS

programs, it is essential to improve and enhance

the performance of these local organizations to

provide appropriate HIV prevention and care services.

The functions of NGOs in a democratic society

are many: they monitor the action of governments

in meeting the needs of poor and disenfranchised

populations; are instrumental in building community awareness and support for efforts by international organizations and government agencies; and

help to provide a seamless transition from externally sponsored immediate assistance to long-term,

domestic assistance.

Strategy for Specific Issues

Prevention

NGOs work to educate the media, private sector, development organizations, multilateral and

bilateral institutions, domestic and international

AIDS organizations, the U.S. Government, and others about the importance of international HIV/AIDS

prevention efforts.

International NGOs in the HIV/AIDS movement

also work to create linkages with other health programs, domestic AIDS organizations, and advocacy

institutions. The NGO-coordinated strategy for improving and creating linkages with other health programs includes: educating domestic AIDS service

organizations on global HIV/AIDS issues to ensure

that they will create linkages with indigenous NGOs,

and the creation of a working group dedicated to

looking at development issues, health, and HIV/

AIDS.

NGOs engage in HIV/AIDS behavioral prevention

strategies that traverse several levels of impact,

highlighting best practices and exemplary behavior change programs. Conference workshops are

organized to feature behavior change issues and

specific interventions designed on the premise that

personal behavior is profoundly influenced by broad

contextual factors, including service accessibility

and social norms, and that sustained individual behavior change is unlikely unless there is also a

change in relevant contextual factors.

Interventions targeting individuals include activities such as peer counseling, couples counseling

and testing, and small group interventions. Initiatives at the societal level, such as mass media campaigns and school and workplace interventions, mobilize communities to provide a supportive environment for reducing risk, and support individually-based interventions. Advocacy activities targeting environmental or structural constraints contribute as well. In short, accurate knowledge and sustained behavior change at the community level is

directed at the demand side to create understanding and awareness and to spur the adoption of appropriate HIV/AIDS behaviors at the community

level.

NGO prevention programs target the population

as a whole, as well as groups most vulnerable to

HIV, including adolescents, women, refugees, migrant workers, miners, commercial sex workers, and

intravenous drug users. For instance, NGO HIV/

AIDS prevention projects target young adults with

information and services that address their specific

issues. Communication material targeting young

adults promotes safer sexual behavior, encouraging abstinence as a viable alternative to early sexual

activity, and making condoms the right choice for

protection when sexual activity does take place.

Advice, information, and products are made readily

available where youth spend their leisure time.

Additionally, NGOs collaborate with traditional con-
56

dom outlets (e.g., pharmacies) to make them youthfriendly. Call-in radio shows in India, Zambia, and

South Africa invite and respond to young people’s

questions about sex and send out additional, youthoriented information booklets to interested callers.

A comic book is used in Haiti to encourage teens

to discuss sexual matters with their parents. Youthoriented “photonovellas” in Bolivia capture in print

the same stories portrayed in popular TV miniseries

on unwanted pregnancies, STIs, and HIV/AIDS.

Over the last 15 years, NGOs have targeted

women in their prevention strategies as well. NGO

initiatives encourage women to purchase condoms

and to insist on their use with partners. Women in

Cameroon and Côte d’Ivoire can purchase condoms

in self-service shops where the anonymity of a

checkout counter is preferred over direct interaction with sales staff. In Burkina Faso, the Griottes,

an organized union of female historians and storytellers, go door to door to talk about AIDS with

women. Women street vendors do the same in Haiti,

where free samples are included in boxes of female hygiene products.

Further, international NGOs have worked collaboratively to open markets for female condoms in

developing countries, and to create a video training program on their benefits and use. NGOs have

also collaborated with UNAIDS to communicate with

local governments, NGOs, and health providers in

developing countries about this product and to assess their demand and technical assistance needs

for starting or sustaining female condom projects.

Recognizing that injecting drug use has played a

critical role in fueling the epidemic in various regions, particularly in some countries in Asia, Eastern Europe, and the Commonwealth of Independent States, NGOs support at least three major prevention components, including: early implementation of prevention initiatives while HIV prevalence

is low; community outreach to injecting drug users

(IDUs) to provide HIV/AIDS information and help

develop trust between IDUs and healthcare providers; and widespread provision of sterile injection

equipment.

Workplace Interventions

For over 5 years, labor unions have conducted

an ongoing effort in the U.S. to combat the scourge

of HIV/AIDS and STDs through unique programs of

workplace peer education. Despite vast cultural

differences, two things nearly all people the world

over share in common are the need to work and

the need to receive medical care. People, rich or

poor, uneducated or educated, active in community organizations or not, are best reached where

they work. This is particularly true in developing

countries and among workers who are most at risk

of contracting HIV/AIDS. Truckers, transit workers,

miners, and others whose jobs require them to

travel through porous borders are the ones most

often associated with the spread of HIV/AIDS. Few

ways exist to reach these people other than through

their jobs and at their place of employment.

 What began as a practical effort to cope with

issues of occupational safety and health at the beginning of the AIDS pandemic has now become a

deep commitment to share the special strengths of

labor movements worldwide to open a new front in

a global war against this tragic disease. Now more

than ever, a mounting body of evidence suggests

that the workplace peer education strategy can respond to program needs with practical low-technology methods to help arrest the explosion of HIV/

AIDS infection rates in developing nations.

Social Marketing

An example of a specific HIV/AIDS prevention

and mitigation methodology utilized by NGOs to

make condoms available to low-income people in

developing countries is a technique called social

marketing. Condom social marketing involves the

distribution of condoms to lower-income persons

by marketing through the existing local commercial and NGO infrastructures. NGOs procure products using donor funding or obtain them directly

from donors; establish an office and a distribution

system in the developing country, often acting as

its own distributor; and sell the products, through

the existing wholesale and retail network in the

country. Products are branded and attractively packaged, and sold at low prices, making them affordable to the poor. Since this retail price is often

lower than even the manufacturing cost, donor contributions are a vital element of the social marketing process.

A key ingredient to successful social marketing

is effective communications to stimulate demand

and encourage the adoption of appropriate health

practices. This is done in a culturally and linguistically appropriate manner through both brand advertising and generic educational campaigns, using a mix of strategies and channels, such as mass
57

media and interpersonal communications, to reach

the targeted audience. Activities range from brand

advertising informing the public that a quality product is available and where it can be purchased, to

generic educational efforts that help people understand why changing behavior is necessary and important.

A project in Côte d’Ivoire provides an illustration of communications initiatives designed to effect behavioral change. Saturation-level brand promotion informs the public about condoms and that

their use protects against contracting HIV/AIDS.

That activity is complemented by producing and

broadcasting a popular and award-winning television soap opera, SIDA dans la Cité (AIDS in the

City). The multipart program engages viewers in a

gripping drama about a family in which the father

is diagnosed with AIDS because he was unfaithful

and did not use protection. This dual approach,

based on research and testing, recognizes that

people learn in different ways and a variety of messages will more effectively reach a larger audience.

In Guinea, local religious leaders now use their

mosques to preach messages on marital fidelity and

abstinence—all part of the national campaign in

Guinea to prevent HIV/AIDS. In seven countries,

mobile video units, equipped with camcorders and

large screens, take health messages to the rural

countryside. In Tanzania, these video-equipped

vehicles show films that educate about AIDS, encourage fidelity, and promote condoms. These multimedia presentations are extremely popular among

entertainment-starved populations; in Pakistan and

Bolivia mobile video units have attracted audiences

of thousands of people.

Some of the other communications activities

used by NGOs include point-of-sale material; radio

call-in shows, soap operas, documentaries, profiles

and other programs; television documentaries, debates, and other informational programs; musical

songs and videos; cinema ads and trailers; theater

troupe presentations and puppetry; product demonstrations and information distribution at work

places, community meeting places, and special

events; print materials, posters, brochures, cartoons, and inserts; informational kiosks and peer

education activities at special and sporting events,

and in high traffic areas throughout communities;

and providing information to and training to those

with the ability to reach larger, affected populations.

Treatment Equity

The international NGO community recognizes

that very few people living with HIV in the developing world have access to many life prolonging drugs,

including basic antibiotics. As the number of people

living with HIV/AIDS continues to reach alarming

levels, programs dedicated to providing services to

these individuals are drastically needed. Recognizing that prevention has been a priority for most

multilateral, bilateral, and private voluntary organizations (PVOs), NGOs advocate for the development

and inclusion of programs focused on care that

address the needs of people living with AIDS and

their family members. Care programs should include access to appropriate life-saving therapeutic

treatments, development of counseling and related

services, and the development of human rights

projects to curb discrimination against persons affected by HIV/AIDS.

The coordinated NGO strategy that emphasizes

the necessity of creating care projects and monitors the development of these projects includes:

offering seminars and workshops on the prevention to care continuum and arranging meetings with

PVOs and multi- and bilateral institutions. NGOs

can also be advocates and work to broaden the

policy dialogue on issues such as drug pricing, calling for price reductions, and aggressively working

through all available private and public networks

to engender an informed and supportive policy environment to effect change.

An example of a strategy to improve treatment

equity is the use of mechanisms such as private

sector leveraging to help communities and governments tap into additional financial resources.

AIDS-Orphaned Children

Currently, the future of millions of children is

threatened because of HIV/AIDS. In addition to

the 1.2 million children that UNAIDS estimates are

infected with HIV, a growing number of children

are being orphaned as a result of AIDS-related adult

mortality. Young people whose family controls are

lacking may seek emotional support and security

through sexual relations, thereby increasing their

risk of HIV infection. In addition, they may be

abused and forced into prostitution. Children living in the streets are forced to fend for themselves,

with few options for survival. With an estimated
58

100 million street children alive today, the implications for the spread of HIV are alarming.

To avoid infection, children need a supportive,

enabling environment that provides them not only

with knowledge about how to protect themselves,

but also with the motivation and the power to do

so. Care is also essential for the survival of children. NGOs have worked with local collaborators

to develop a methodology for orphan assessment,

which identifies priority needs of orphans and their

caretakers. Activities are also focused on orphan

care and support, which include care, counseling

services, and vocational training. In addition, income-generating activities with NGOs, mobilization

of local resources, and psychosocial support and

training are supported by NGOs at the country level.

Finally, in response to the growing number of children left parentless due to HIV/AIDS, NGOs have

made efforts to highlight this crisis through conference workshops, briefings, and media articles.

Women and Health

The international NGO community works to bring

attention to the growing vulnerability of women to

HIV/AIDS through: workshops at domestic and international conferences, briefings for government

leaders, media articles, and monthly E-mail broadcasts.

NGOs have worked tirelessly to:

• Promote access to reproductive health services, such as family planning and antenatal

care, that protect the health of women and

their families.

• Encourage earlier access to treatment through

the development of voluntary HIV counseling

and testing services.

• Promote improved treatment by encouraging

early management of symptoms and treatment

of opportunistic infections.

• Improve STI case management at the clinic

level and to make services, including drugs,

more accessible to populations at risk.

• Promote dialogue between men and women.

• Expand women’s prevention efforts through

female condom studies.

• Educate younger women about reproductive

health, providing the information they need

to make informed choices about abstinence,

the initiation of sexual activity, selection of

partners, and the use of condoms and other

available protection methods.

Vaccine Research

NGOs advocate the development of vaccines for

global use. Although spending allocated to research

in both the public and private sector has increased

over the past few years, NGOs point out that issues

concerning the allocation of funding and the ethics

surrounding some of the clinical trials being conducted require continuing attention. The international NGO community provides a venue for debate on the ethics of individual clinical trials and

monitors and reports on spending and profits generated by the development of vaccine,

antiretrovirals, therapeutic interventions and

prophylaxsis by private pharmaceutical companies.

Microbicide Development

NGOs are involved in clinical trials of vaginal

microbicides to evaluate efficacy and acceptability

in preventing STIs, HIV, and pregnancy. More than

200 scientific publications on barrier methods have

been produced, including a monograph for the

1994 International Conference on Population and

Development in Cairo.

Three existing trials are Phase I safety and acceptability studies of candidate products taking

place both in the United States and at seven international sites in six countries. A fourth trial, a Phase

III non-Oxynol (N–9) efficacy study in Zimbabwe and

Malawi (two sites), is currently in the final planning

stages and the first phase of study enrollment is

expected to get underway in early 1999.

A randomized control trial evaluating the impact

of N–9 film on the transmission of HIV and STIs in

Cameroon has been completed. Results showed

N–9 film was safe but did not protect against HIV/

STI. Methodological and operational lessons learned

from this study have influenced directions of new

microbicide development. Other related research

includes a number of clinical trials of vaginal

microbicides with STI infection as the primary study

endpoint, and HIV infection as a secondary endpoint.
59

Donor Coordination

NGOs play a role in facilitating dialogue among

multilateral donors, such as UNAIDS, bilaterals, including USAID, and private funding bodies in order

to maximize donor effectiveness and minimize overlap.

In addition, at the country level, NGOs develop

programs that complement those of other donors.

For instance, NGOs collaborate with the World Bank

on specific technical areas such as STI research,

and work jointly with UNAIDS and the World Health

Organization (WHO) on the development of guidelines for behavioral data collection needs of national

HIV/AIDS/STI programs.
60

Role of International Organizations

Mandate Relevant to HIV/AIDS

Where possible, the U.S. Government works

closely with international organizations to leverage

both human and financial resources for the greater

benefit of those in need. International organizations are uniquely positioned to provide support

for HIV/AIDS prevention and mitigation efforts

worldwide. The U.S. Government provides direct

assistance to these important institutions and supports the critical role international organizations play

in the international fight against HIV/AIDS. The role

of international organizations is characterized as

follows:

• International organizations have a wide funding base and are able to provide significant

financial backing and multisectoral support.

• International organizations are able to effect

cooperation without political ramifications or

restrictions that bind local and national governmental actors.

• International organizations are nonpartisan.

• International organizations are able to bridge

gaps between countries and donor nations and

provide a fora to bring various international

players together on issues.

UNAIDS

The Joint United Nations Programme on HIV/

AIDS (UNAIDS), an international organization created specifically to address the HIV/AIDS pandemic,

was established as an independent UN agency on

January 1, 1996. UNAIDS brings together the efforts of five UN organizations: United Nations International Children’s Emergency Fund (UNICEF),

United Nations Development Programme (UNDP),

United Nations Population Fund (UNFPA), United

Nations Educational, Scientific, and Cultural Organization (UNESCO), World Health Organization

(WHO), and the World Bank. The primary focus of

UNAIDS is to strengthen the capacities of national

governments for an expanded response to HIV/

AIDS. UNAIDS will achieve this objective through

work at national, regional, and global levels in the

following four mutually reinforcing areas: policy

development and research, technical support, advocacy, and coordination.

Prevention

Testament to the multisectoral reach of UNAIDS

are its numerous prevention efforts, ranging from

collaboration with the religious sector to assessment of the cost-effectiveness of HIV prevention

strategies. Examples of the range of UNAIDS prevention strategies are detailed below.

Recognizing that truly effective prevention efforts

must begin at a young age, UNAIDS activities target

school-aged children through outreach and prevention efforts. In 1997, UNAIDS published a position

paper on integrating HIV/STD prevention in the

school setting; produced a technical update on

learning and teaching about AIDS at school; and

participated in the organization of seminars on

school-based AIDS education at the three regional

conferences on AIDS held in Côte d’Ivoire, Peru,

and the Philippines.

Within the religious sector, UNAIDS employs a

two-pronged prevention approach. The first is to

promote the exchange of ideas and training for community-based prevention and care programs. The

second is to encourage religious institutions to

strengthen life-skills training approaches for HIV

education in schools operated by their congregations. UNAIDS also collaborates with the Roman

Catholic organization CARITAS International and is

supporting a forum of religious leaders in Africa.

UNAIDS’ efforts to reduce risk and vulnerability

in institutional settings, such as prisons and workplaces, have largely focused on strengthening national and regional networks and facilitating information exchange on effective programming. A joint

undertaking with the Civil-Military Alliance to Combat HIV/AIDS, and its regional affiliates, helps to

establish and strengthen AIDS programs with military services in Africa, Asia, and Latin America.

To prevent intravenous transmission, UNAIDS

works to strengthen regional HIV/injecting drug use

harm reduction networks, focusing on exchanging

lessons learned and sharing technical resources.

In the area of sexual transmission, UNAIDS’ principal efforts in 1997 and 1998 have been identification and dissemination of best practices in HIV prevention and care, strengthening of regional networks, and development of tools and guidelines to
61

facilitate project development. UNAIDS has supported specific initiatives in the Asia-Pacific region,

central and Eastern Europe, and west and central

Africa. With regard to men who have sex with men,

UNAIDS is building several regional networks of experts in HIV prevention.

Finally, to assess the efficiency and effectiveness

of HIV prevention efforts, UNAIDS has initiated a

number of studies evaluating the cost-effectiveness

of HIV prevention strategies. The studies have led

to the preparation of costing guidelines for such

strategies; a UNAIDS’ point-of-view document on

cost-effectiveness analysis; and three computerized

models covering blood safety, prevention programs

for sex workers, and school education, all of which

will be published in 1998.

Treatment Equity

Recognizing that there are often insurmountable

barriers to obtaining access to available HIV/AIDS

treatment, UNAIDS and the WHO Action Program

on Essential Drugs are developing an operational

plan to improve access to drugs for HIV infection.

UNAIDS supported several consultations on this

subject in Senegal and during the AIDS conference

in Abidjan. UNAIDS also is supporting preparation

of case studies on treatment equity and access to

care and drugs in Asia, Latin America and the Caribbean, and West Africa; and, in collaboration with

the Ministries of Health and a number of pharmaceutical companies, UNAIDS is initiating pilot

projects to improve access to drugs of interest to

people living with HIV/AIDS, in Chile, Côte d’Ivoire,

Uganda, and Vietnam.

Further, UNAIDS is currently collaborating with

local partners to document case studies on the process of introducing antiretrovirals in Argentina, Brazil, Colombia, and Mexico, where the drugs have

been made available despite resource constraints.

The objective of the studies is to assess the extent

to which their introduction was successful, and to

learn about difficulties encountered in introducing

the new technology. These lessons can serve as a

learning tool for other countries.

Women and Health

UNAIDS coordinates the Informal Working Group

on Mother-to-Child Transmission of HIV, which focuses on the coordination and design of clinical

trials on the prevention of HIV transmission from

mothers to their children. UNAIDS also supports the

Ghent International Working Group on Perinatal

Transmission of HIV, sponsored by the European

Union, which conducts studies on the acceptability

of prenatal voluntary counseling and testing in the

context of ongoing clinical trials in Africa, as well

as cost-effectiveness studies related to the use of

AZT and alternatives to breastfeeding.

Vaccine Research

In collaboration with the WHO Global Program

for Vaccines and Immunization, UNAIDS is supporting a project to promote the development of a novel

vaccine approach—the International AIDS Vaccine

Initiative (IAVI)—whose mandate is to accelerate

progress toward an AIDS vaccine for use in developing nations where the epidemic is spreading most

rapidly. IAVI is designed to complement, not compete with, existing AIDS vaccine programs, which

have emphasized basic research. IAVI’s strategy

consists of accelerated product development and

human testing through international collaboration.

In addition, UNAIDS, WHO, and the Council for International Organizations of Medical Sciences are

developing a guidance document for ethical standards in the conduct of HIV vaccine trials.

Behavioral Research/Behavioral Change

Intervention

In the area of behavioral prevention, UNAIDS,

USAID, and WHO collaborated to assist in the multi-site voluntary counseling and testing (VCT) study

carried out from 1995 to 1997 in Kenya, Tanzania,

and Trinidad and Tobago. The study concluded that

VCT significantly reduces sexual risk-taking behavior and does not increase such negative life events

as disintegration of relationships and discrimination.

Another behavioral intervention project combined the efforts of UNAIDS, UNESCO, UNICEF, and

the World Bank in the development of communication strategies and regional networks for national

AIDS and health-promotion programs.

Microbicide Development

UNAIDS advocates for the development of vaginal microbicides and serves as the Secretariat for

the International Working Group on Microbicides.

In 1996–1997, UNAIDS launched a multicenter
62

study on the efficacy of COL–1492 in preventing

HIV infection and sexually transmitted diseases

among female sex workers in Benin, South Africa,

and Thailand. In addition, preparatory work is proceeding in Côte d’Ivoire and Senegal. A first interim

analysis is expected in 1999 but final results will

not be available before the end of 2001. It is hoped

that microbicides will also be useful in preventing

HIV infection in men.

UNAIDS’ Cosponsors

Although the majority of HIV/AIDS activities on

the part of UNAIDS’ cosponsors fall under the rubric of UNAIDS, there are continuing independent

cosponsor efforts to prevent and mitigate the impact of HIV/AIDS:

• UNESCO is developing curriculum and teacher

training in India, and planning seminars in

Nepal and Cambodia;

• UNFPA is focusing on integration of HIV/STD

prevention in family life/reproductive health

programs in more than 150 countries;

• WHO is integrating school-related health services for adolescents with action-research

projects in six African countries, as well as

integrating HIV/STD prevention into the

“Health-Promoting Schools Network” in six

regions. WHO also supports the Government

of China in extending HIV/STD education in

all schools in the most-affected southern provinces;

• UNICEF is developing youth-friendly health services and promoting life-skills education which

integrate AIDS information;

• UNDP is preparing a series of issue papers on

gender and the HIV epidemic;

• UNICEF is developing resource materials for

integrating gender awareness into adolescent

sexual health programs;

• UNESCO is implementing a project to reduce

the rate of HIV transmission among women

by empowering them with awareness, knowledge, and skills;

• WHO is providing technical support to an International Center for Research on Women

(ICRW) project on reproductive-health rights

of HIV-infected women.

In addition, since 1995, WHO, joined later by

UNAIDS, has supported the PETRA study, in South

Africa, Tanzania, and Uganda, to test the efficacy

of a short-term regimen of AZT and 3TC for reducing the risk of mother-to-child transmission of HIV.

Finally, after the results of the Thai/CDC trial on

mother-to-child transmission, UNICEF-WHO-UNFPAUNAIDS set up an international initiative to demonstrate the feasibility of prevention of mother-to-child

transmission of HIV in some of the countries worstaffected by HIV infection. Under this initiative, pilot interventions are being implemented in the following countries: Zimbabwe, Zambia, Uganda, Côte

d’Ivoire, Burkina, Honduras, Vietnam, Cambodia,

Thailand, Botswana, and Rwanda.

The World Bank

The World Bank—one of the six UNAIDS cosponsors—is an example of an international organization that provides direct assistance to client governments in the form of loans, technical assistance,

and policy guidance. The World Bank’s comparative advantage lies in its ability to engage in dialogue with client governments, enabling the creation of an environment for the development of

sustainable and multisectoral prevention and care

programs, and in its capacity to finance large national programs to combat HIV.

Most of the World Bank’s loans for HIV/AIDS are

provided on highly concessionary terms through the

World Bank’s concessionary lending arm, the International Development Association (IDA). While the

approval of new loans for HIV/AIDS fluctuates considerably from year to year, the World Bank is continuing to expand its portfolio of HIV/AIDS projects

and loan disbursements, which reflect efforts to

implement AIDS control activities. The World Bank

has committed over $800 million to HIV/AIDS

projects over the past decade, and there are indications that the pace of lending will rise in the next

3–5 years as more clients turn to the World Bank

for financial assistance to address HIV/AIDS in their

countries.

Additionally, the World Bank incorporates HIV/

AIDS components into other loans such as reproductive health and rural development programs.

The World Bank’s commitment to HIV/AIDS is also

reflected in its technical and operational assistance.

Further, the World Bank attempts to ensure that HIV/

AIDS strategies are effective and appropriate for
63

the specific challenge facing each country. Although

individual governments are ultimately responsible

for project implementation, the World Bank works

closely with government officials in designing, monitoring, and evaluating HIV/AIDS projects. The World

Bank is also increasingly focusing on capacity building as part of country specific responses to HIV/

AIDS.

Prevention

The World Bank regularly funds regional prevention projects. For example, in collaboration with

UNAIDS, the World Bank is providing grants for initiatives which tackle the AIDS epidemic at the regional level, dealing with cross-border issues such

as migration and transport, that are central to the

spread of HIV. These regional problems, covering

western Africa, southern and eastern Africa, Southeast Asia, and Latin America and the Caribbean,

are managed by UNAIDS on behalf of the World

Bank. They aim to strengthen regional cooperation

and improve the capacity for neighboring countries

to consult and work jointly on policy and implementation issues.

The World Bank is also working closely with

UNAIDS at the country level in developing programs

in a number of nations. Country-level projects are

ongoing in India, China, Zimbabwe, and Brazil.

AIDS-Orphaned Children

In the area of AIDS-orphaned children, the World

Bank supports the production of public service announcements, picture exhibits, and video documentaries to bring attention to the millions of children

orphaned by AIDS. In 1997, the World Bank developed a Public Service Announcement, which has

been aired on CNN and many other international

outlets to highlight the theme of the 1997 World

AIDS Campaign: Children Living in a World with

AIDS. On World AIDS day 1997, the World Bank

hosted a picture exhibit titled: “Dying Branches: The

Impact of HIV/AIDS on the Villages of Mpondas,

Malawi.” The goal of the exhibition was to portray

both the vulnerability and resiliency of grandparents who are forced to provide for children who

have lost one or both parents in a community devastated by HIV/AIDS. Finally, the World Bank, with

UNAIDS, developed an MTV documentary on the

1998 theme for World AIDS Day, entitled “Youth—

a Force for Change.”

Vaccine Research

The World Bank recognizes that the HIV/AIDS

epidemic in many of the World Bank’s client countries has increased the priority for developing a preventive vaccine that will be effective and affordable in the developing world. As such, a World

Bank task force is exploring the market failures leading to under investment in an HIV/AIDS vaccine and

examining the feasibility and optimal design of innovative financing instruments. This would stimulate private investment. The task force also is responsible for developing new World Bank instruments that will increase private incentives to invest in related research and development.

Further, the World Bank is part of a global collaboration of organizations that has created and

funded the International AIDS Vaccine Initiative

(IAVI).

UN Commission on

Human Rights

The UN Commission on Human Rights regularly

considers resolutions for the protection of human

rights in the context of HIV and AIDS. The resolutions set out guidelines nations may follow in dealing with the health crisis and human toll of HIV and

AIDS. Resolutions also ask the UN Secretary General to solicit input from countries, specialized agencies, and related governmental and non-governmental organizations in order to provide a progress report to the Commission on follow-up. The next

session of the Commission at which an HIV/AIDS

resolution is expected for consideration will take

place in March 1999.
64

Conclusion

The 1999 U.S. International Response to HIV/

AIDS represents the continued commitment by the

United States Department of State working with

other Federal agencies, our partners in the international community, non-governmental organizations,

and industry to stem the spread of HIV/AIDS. Although this report highlights the U.S. response to

the international situation, it serves to intensify U.S.

resolve to maintain its leadership role in initiating

needed action to forestall unnecessary human suffering and related socioeconomic impacts from HIV/

AIDS. The U.S. has made the battle against HIV/

AIDS a national and international priority and calls

upon other governments of the world to do the

same.

We have defined some of the impending problems which will confront us as a result of the HIV/

AIDS pandemic. It is up to all nations to structure

solutions in anticipation of their occurrence, knowing that many unavoidable deaths will occur unrelated to our collective actions. Unfortunately, our

initial lack of knowledge about HIV/AIDS and inability to acknowledge and address it swiftly has

given temporary advantage to the disease. Yet new

tools for prevention, growing knowledge, and the

collaborations of governments, non-governmental

entities, industry, and international organizations

are making effective interventions possible. While

maintaining a strong emphasis on other prevention

interventions, it is critical that concerted efforts be

focused on the development of a safe and effective vaccine or vaccines against the many strains

of HIV. President Clinton has placed the development of an HIV vaccine on the international agenda

and efforts to garner partnerships to meet the 2007

goal will be a priority for our domestic and international research.

Undermining primary prevention, research and

vaccine and drug development efforts is the problem of inadequate or non-existent public health infrastructure in many parts of the world. Addressing this problem can be part of the solution for HIV/

AIDS and other infectious diseases. Inadequate

national and international political commitment to

fully address HIV/AIDS around the world has contributed to the escalation of the global pandemic

that now threatens the health and security of every

nation. Any weak link in the global health chain,

which binds the nations of the world, weakens us

all. We all benefit from enhancing public health

infrastructures around the globe. The United States

and the international community must strengthen

partnerships with all entities that can bring needed

resources and expertise to expedite improvement.

The magnitude of the worldwide HIV/AIDS pandemic calls for strong political commitment at the

highest levels of government and collaborative support from the full range of in-country technical expertise and the greater international community.

This multi-partite approach can leverage the vital

resources to effectively bring practical solutions to

the HIV/AIDS epidemic. Stemming the continued

global spread of HIV/AIDS requires developing and

industrialized nations, international organizations,

the pharmaceutical industry, and non-governmental organizations to work effectively together for the

sake of all concerned.
65

Appendix A

U.S. Government Contact List for

International HIV/AIDS Issues

Office of National

AIDS Policy

National AIDS Policy Director Sandra Thurman

(202) 456–2437

Deputy Director Todd Summers

(202) 456–2437

U.S. Department of State

(www.state.gov)

Under Secretary for Global Affairs

Under Secretary Frank Loy

(202) 647–6240

Bureau of Oceans and International Environmental and Scientific Affairs—Emerging Infectious

Diseases and HIV/AIDS Program

(www.state.gov/www/global/oes/health/index/

html)

Director Nancy Carter-Foster

(202) 647–2435

ncarterf@state.gov

Bureau of Democracy, Human Rights, and Labor

Assistant Secretary Harold Koh

(202) 647–2126

Bureau of International Organization Affairs

Deputy Assistant Secretary E. Michael Southwick

(202) 647–9604

U.S. Agency for International

Development

(www.usaid.gov)

Office of the Administrator

Administrator J. Brian Atwood

(202) 712–4040

Bureau for Global Programs, Field Support and

Research—Center for Population, Health and

Nutrition

Deputy Assistant Administrator Duff Gillespie

(202) 712–4120

dgillespie@usaid.gov

HIV/AIDS Division

Division Chief Paul DeLay

(202) 712–0683

U.S. Information Agency

(www.usia.gov)

Office of the Director

Director Joseph D. Duffey

(202) 619–4742

Office of Strategic Communication

Senior Advisor James W. Kelman

(202) 619–4150

U.S. Peace Corps

Center for Field Assistance and Applied Research

(202) 692–2666

U.S. Department of Health and

Human Services

(www.os.dhhs.gov)

Surgeon General and Assistant Secretary for

Public Health and Science

Surgeon General and Assistant Secretary

David Satcher

(202) 690–7694

(301) 443–4000

Office of HIV/AIDS Policy

Director Eric Goosby

(202) 690–5560
66

Office of International and Refugee Health

Acting Director Greg Pappas

(301) 443–1774

National Institutes of Health

(www.nih.gov)

Office of AIDS Research

(www.nig.gov/od/oar/index.htm)

Director Neal Nathanson

(301) 496–0357

Fogarty International Center

(www.nih.gov/fic/)

Director Gerald T. Keusch

(301) 496–1415

Division of International Relations

Acting Director Sharon Hrynkow

(301) 496-5903

Centers for Disease Control and

Prevention

(www.cdc.gov)

Office of the Director

Director Jeffrey P. Koplan

(404) 639–7000

Office of Global Health

Director Steve Blount

(404) 488–1085

National Vaccine Program Office

Director Robert F. Breiman

(404) 639–4452

National Center for HIV, Sexually Transmitted

Diseases and Tuberculosis Prevention

Director Helene D. Gayle

(404) 639–8000

Division of HIV/AIDS Prevention—Surveillance

and Epidemiology

Director Kevin DeCock

(404) 639–0900

Division of HIV/AIDS Prevention—Intervention

Research and Support

Director David Holtgrave

(404) 639–5200

National Center for Infectious Diseases

Director James M. Hughes

(404) 639–3401

Division of AIDS, Sexually Transmitted Diseases

and Tuberculosis Prevention

Director Harold W. Jaffe

(404) 639–4581

National Center for Environmental Health

Director Richard J. Jackson

(770) 488–7000

National Center for Health Statistics

Director Edward J. Sondik

(301) 436–7016

Food and Drug Administration

Office of Special Health Issues

Associate Commissioner Terry Toigo

(301) 827–4460

ttoigo@oc.fda.gov

Office of International Affairs

Director Walter Batts

(301) 827–4480

wbatts@oc.fda.gov

U.S. Department of Commerce

(www.doc.gov)

Bureau of the Census

International Programs Center

Chief Peter O. Way

(301) 457–1390

Health Studies Branch

Chief Karen A. Stanecki

(301) 457–1406

Bureau of Economic Analysis

Office of the Director

Director J. Steven Landefeld

(202) 606–9602

john.landefeld@bea.doc.gov
67

International Trade Administration

Assistant Secretary for Trade Development

Michael J. Copps

(202) 482–1461

National Institute of Standards and

Technology

Director Ray Kammer

(301) 975-2300

Office of International and Academic Affairs

Director B. Stephen Carpenter

(301) 975–4119

Patent and Trademark Office

Office of the Assistant Secretary

Deputy Assistant Secretary and Deputy

Commissioner of Patents & Trademarks

Todd Dickinson

(703) 305–8600

Biotechnology Examining Groups

Director John J. Doll

(703) 308–1123

U.S. Department of Defense

Office of the Deputy Assistant Secretary for

Clinical and Program Policy

Director of Health Promotion/ Health Affairs

Lynn Pahland

(703) 681–1703

Walter Reed Army Institute of Research

Division of Preventive Medicine,

Lt. Col. Patrick Kelley

(202) 782–1353
68

Appendix B

List of Acronyms

AFMIC Armed Forces Medical Intelligence

Center

AIDS Acquired Immune Deficiency

Syndrome

AIDSCAP AIDS Control and Prevention

Project

ANE Asia/Near East Bureau (USAID)

ATP Advanced Technology Program

AVRC AIDS Vaccine Research Committee

AZT Antiviral Therapy

BCI Behavioral Change Intervention

CAPS Center for AIDS Prevention Studies

CBO Community-based Organization

CDC Centers for Disease Control and

Prevention

CSM Condom Social Marketing

DFID Department for International

Development, United Kingdom

DHAP/IRS Division of HIV/AIDS PreventionIntervention Research and Support

(CDC)

DHAP/SE Division of HIV/AIDS Prevention -

Surveillance & Epidemiology (CDC)

DHHS Department of Health and Human

Services

DOC U.S. Department of Commerce

DOD U.S. Department of Defense

DOJ U.S. Department of Justice

DOS U.S. Department of State

DRL Bureau of Democracy, Human

Rights and Labor (State)

ENI Eastern Europe/Newly Independent

States Bureau (USAID)

EU European Union

FDA Food and Drug Administration

FIC Fogarty International Center (NIH)

G–7 Group of Seven

G–8 Group of Eight

HIV Human Immunodeficiency Virus

IAVI International AIDS Vaccine

Initiative

ICH International Council for Harmonization

ICRW International Center for Research

on Women

IDA International Development

Association

IDU Intravenous Drug User

IO International Organization

HCFA Health Care Financing Administration

HRSA Health Care Resources Administration

LAC Latin America/Caribbean Bureau

(USAID)

MTCT Mother-to-child Transmission

N–9 Non-Oxynol–9

NCHSTP National Center for HIV, STD and

TB Prevention (CDC)

NCI National Cancer Institute (NIH)

NCIH National Council on International

Health
69

NCRR National Center for Research Risks

(NIH)

NGO Non-governmental Organization

NHLBI National Heart, Lung and Blood Institute (NIH)

NIAID National Institute of Allergy and

Infectious Diseases (NIH)

NIC National Intelligence Council

NICHD National Institute of Child Health

and Human Development (NIH)

NIDCR National Institute of Dental and

Craniofacial Research (NIH)

NIDA National Institute on Drug Abuse

(NIH)

NIGMS National Institute of General

Medical Sciences (NIH)

NIH National Institutes of Health

NIMH National Institute of Mental Health

(NIH)

NINDS National Institute of Neurological

Disorders and Stroke (NIH)

NOAA National Oceanic and Atmospheric

Administration

OAR Office of AIDS Research (NIH)

OES/E/EID Office of Emerging Infectious

Diseases and HIV/AIDS, Bureau of

Oceans and International Environmental and Scientific Affairs (State)

OHAP Office of HIV/AIDS Policy (DHHS)

OHCHR Office of the High Commission for

Human Rights

ONAP Office of National AIDS Policy

PHN Population, Health and Nutrition

(USAID)

PhRMA Pharmaceutical Research

Manufacturers of America

PHS U.S. Public Health Service

PLWHA People Living with HIV/AIDS

PRM Bureau of Population, Refugees

and Migration (State)

R&D Research and development

SO Strategic Objective

STD Sexually Transmitted Disease

STI Sexually Transmitted Infection

TB Tuberculosis

TIR Targeted Intervention Research

UNAIDS United Nations Joint Programme

on AIDS

UNDP United Nations Development

Programme

UNESCO United Nations Educational, Scientific and Cultural Organizations

UNFPA United Nations Population Fund

UNICEF United Nations International

Children’s Emergency Fund

USAID U.S. Agency for International

Development

USG United States Government

USIA U.S. Information Agency

USIS U.S. Information Service

VCT Voluntary HIV Counseling and

Testing

VOA Voice of America

WHAM Women’s Health Advocates for

Microbicides

WHO World Health Organization

WRAIR Walter Reed Army Institute of

Research