PEPFAR: advancing health in U.S. foreign policy decision-making (qualitative research)

Introduction

The President’s Emergency Plan for AIDS Relief (PEPFAR) was established by the U.S. government in 2003. Precipitating events, globally and domestically, moved executive leaders to work in a bipartisan fashion to implement the policy. These included the development of anti-retroviral therapies to treat those infected with human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS). The entrance of non-state actors to the global health ecosystem advanced investments in health and highlighted the link between public health, economic vitality, and health equity in the delivery of services.

The HIV/AIDS epidemic: highlighting the impetus for the development of PEPFAR

In the late 1980s, the U.S. became more aware of the role of HIV/AIDS when prominent figures were impacted by it. These included Rock Hudson (a well-known actor who died of AIDS), Larry Kramer (an activist and playwright), and Elizabeth Taylor (a humanitarian and actress). Public awareness of HIV/AIDS during this period centered on a narrative, particularly by conservatives, that it was primarily associated with illicit behavior and homosexuality.

In the 1990s, that narrative began to pivot following the deaths of two prominent figures whose lifestyles could not be attributed to homosexuality or intravenous drug use. They were Arthur Ashe (a renowned tennis champion) and Elizabeth Glaser (wife of prominent actor Paul Michael Glaser). Both contracted the disease following blood transfusions.

Within the U.S., the political narrative began to shift. There was growing awareness that HIV/AIDS could also infect women and girls resulting from heterosexual relationships if one partner was infected and transmitted the virus to another or to newborns during childbirth.

When the narrative surrounding HIV/AIDS pivoted from a homosexual or illicit drug use disease to one that could potentially infect anyone, this acted as a catalyst to unite unlikely associations in the fight to prevent and treat HIV/AIDS.

Connecting the dots: the global burden of diseases and their impact on U.S. national security concerns

In the late 1990s, with the help of the Gates Foundation, non-state actors focused more attention on the monetary resources needed to address certain disease priorities which heightened the interest in global health as an investment. Three priorities emerged in a World Development Report (1) and provided a rationale for investing in global health. The priorities included: specific spending by governments to build out robust public health efforts to prevent and treat diseases, tying economic prosperity to healthy families, and encouraging competitive government procurements which also included the private sector to advance diverse delivery of services. The World Bank became more involved in the health sector resultant to it becoming a large portion of the gross domestic product (GDP). The purpose of highlighting the global economic ecosystem is to help the reader to understand how state and non-state actors advanced their interests in investing in global health.

In 1993, the Harvard School of Public Health, collaborating with the World Health Organization (WHO) and the World Bank (2) produced a Global Burden of Disease study. The HIV/AIDS epidemic in Africa grew in priority as a result of this study because of the political interest in and increased security concerns for human lives in this region. In a Declaration of Commitment by the United Nations, “by the end of 2000, 36.1 million people worldwide were living with HIV/AIDS, 90 percent in developing countries and 75 percent in sub-Saharan Africa. Noting with grave concern that all people, rich and poor, without distinction as to age, gender or race, are affected by the HIV/AIDS epidemic, further noting that people in developing countries are the most affected and that women, young adults and children, in particular girls, are the most vulnerable.” (3).

Worldwide, the high death rates at the beginning of the 21^st century were cited as “22 million men, women and children” (4). This data on the HIV/AIDS epidemic drew attention to the risk to human capital and its potential to negatively impact economic instability and social development.

The emergence of anti-retroviral therapies (ARVs)

ARVs were discovered in 1996 (5). Prior to discovery, a diagnosis of HIV/AIDS meant a death sentence. The availability of treatment and/or a cure didn’t exist. Those who were dying spanned across communities, including essential workers such as public servants, teachers and military members.

Over a period of years, 1998–2003, a series of international summits and U.S. Congressional actions sought to fund AIDS treatment in the developing world (6). These events, detailed in a Congressional Research Report developed by (6) depict the multilateral organizational cooperation that was essential to transnational policymaking and common concerns over this global health threat. In January 2002, a funding mechanism was established to accelerate funding for HIV treatment. The goal was to supply “anti-retroviral therapy to 500,000 patients over five years” (6). These precipitating events showcase the dynamic nature of multilateral and diplomatic negotiations and propelled the global response to HIV/AIDS forward.

Activists prioritized and advocated to increase the accessibility and affordability of ARVs for those infected with HIV/AIDS. Their advocacy put pressure on pharmaceutical companies to enable low-income countries to gain equal access to the treatments. A cooperative effort globally between the UN and the World Trade Organization (WTO) enabled greater response to global health threats by minimizing regulatory and price barriers for critical medicines.

Linking health to national security

A critical milestone in this process which linked a health risk (HIV/AIDS) to a security risk (7) took place on July 17, 2000, when the UN Security Council adopted resolution 1308. This was a pivotal moment in the response to the HIV/AIDS crisis on the continent of Africa. Key leaders who were involved in this milestone included UN Secretary General Kofi Annan, Vice President Al Gore (representing the United States), and U.S. Ambassador to the UN, Richard Holbrooke. The U.S concurred with the view of the HIV/AIDS epidemic as a security concern. Strong political leadership was highlighted by the Executive Director of Joint United Nations Programme on HIV/AIDS (UNAIDS), Peter Piot (8).

The securitization presentation of the HIV/AIDS epidemic is the milestone believed to have driven the establishment of PEPFAR and the Global Fund.

How PEPFAR came about

The national security risks in 2001, anthrax and the events of 9/11, seized the attention of the Bush Administration. Anthrax spores were sent via the postal service in envelopes to recipients. This constituted a bioterror threat. The treatment for anthrax is ciprofloxacin and concerns were raised in the Administration about availability and cost of the medicine. This national security focus created an opportunity for broader discussions about drugs (access and cost) to respond to the HIV/AIDS epidemic. Parallel to this, the attacks on 9/11 shifted the U.S. focus on threats from domestic to international (9). President Bush brought a focus of compassionate conservatism which influenced the US foreign policy strategy. As the HIV/AIDS epidemic grew, the U.S. sought to mitigate security risks coming to the U.S. The strategy was to address them abroad.

Drs. Mark Dybul and Anthony Fauci utilized scientific data which presented the idea of developing an ARV basic care package to affected areas in Africa with a goal of saving lives. There was an impassioned desire to provide equitable care to women and children and men who were infected with HIV/AIDS.

With vision and executive leadership, Tommy Thompson, Secretary of Health and Human Services (HHS) successfully harnessed the power to coalesce advocates in supporting the establishment of a U.S. Government organization to treat HIV/AIDS. In East Africa, he led a delegation to East Africa in Botswana that was hosted by its U.S. Ambassador, John Lange. The U.S. delegation included Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases (NIAID), and other experts in global health. Secretary Thompson’s report to President Bush of this visit was instrumental in the Congressional funding support for an International Mother Baby Prevention initiative in June 2002. President Bush’s policy decision to lead as the champion of HIV/AIDS was driven by the moral imperative (10).

HHS and Centers for Disease Control (CDC) scientists had been working in Uganda for decades. A Joint Clinical Research Center (JCRC), led by Dr. Peter Mugyenyi, promoted access and compliance in the distribution of medicines utilizing community-led resources (11). The value of trust in developing in-country resources proved to be an essential element in the successful policy formulation of PEPFAR. Diplomats working abroad furthered this observation of the value of trust.

Dr. Jonathan Mermin, a CDC scientist, detailed the in-country work to the Senate Committee on Foreign Relations and the Subcommittee on African Affairs (12). Separately, the United States Agency for International Development (USAID) Administrator was more resistant to developing an HIV treatment program for sub-Saharan Africa. He doubted the ability of Africans to comply with the ARV treatment regimen (13).

The White House made a policy decision to establish PEPFAR, but the plan was largely kept secret (14). They didn’t want the usual and customary bureaucratic processes to slow them down (14). The Ambassador to Uganda, Jimmy Kolker [2018], highlighted that “the HIV treatment model for PEPFAR was developed with Uganda in mind” (11).

Congressional leaders (Senate and House) and civil society advocates were instrumental in shepherding PEPFAR legislation to deliver it to the White House for signature. Alliances that previously seemed unlikely, Christians, celebrities like Bono, Senator Bill Frist, Senator Jessie Helms, and many others were equally moved with the moral courage to limit the numbers of women and children dying. I discovered this during the semi-structured interviews: an attribute that arose from personal stories highlighting that it superseded politics, power and agenda setting (10).

U.S. interests in global health security, the risk of an economic crisis abroad, and the deaths that were stripping away core elements of a country’s workforce (teachers, engineers, doctors) and negatively impacting future generations helped to catalyze Bipartisan support in Congress. Contemplating the role of government, a focused investment in global public goods and cultural sustainment could be addressed by providing affordable treatment.

On January 29, 2003, President Bush, in his State of the Union Address, announced PEPFAR which he hailed as a “5-year, $15 billion initiative to turn the tide in combating the global HIV/AIDS epidemic” (15). This was the “largest investment ever by any government to address a single disease” (16).

The current state of HIV/AIDS management under PEPFAR policy is undergoing review following the recent U.S. Presidential election. A summary of things to watch, which include organizational governance changes, reauthorization funding, and the impact of the dissolution of USAID within the U.S. State Department, can be found here: https://www.kff.org/policy-watch/the-outlook-for-pepfar-in-2025-and-beyond/

Leadership in global health requires a commitment to short- and long-arc horizons. Health threats, a recent example is the coronavirus disease 2019 (COVID-19) pandemic, occur episodically. When a pandemic rages, there is urgency to achieve a state of readiness to abate the threat. A short arc is intended to depict planning and response that occurs out of urgency. When the threat recedes, cycles of complacency emerge (10). Planning and readiness can decline. A long-arc horizon, in contrast, assumes the threat and maintains a state of readiness over time to stay prepared for when the health threat emerges. The case of PEPFAR highlights that it takes time to establish trust through bilateral and multilateral cooperation, in-country laboratory capabilities, sustainable governmental and non-governmental funding. All were essential elements to the implementation of PEPFAR.

A strategy that emerged during the Bush Administration between the 2001–2003 timeframe focused on transnational policymaking. This necessitated a move beyond the Cold War era National Security Strategy (NSS) focus which related to threats from Russia (10). The NSS also focused on the dignity of human beings. Diplomats facilitated in-country visits so that delegations from Washington, DC could travel to the areas in Africa (e.g., Uganda, Botswana) where the HIV/AIDS epidemic was unfolding. The presence of diplomats led to stronger relationships with Country leaders, Ministries of Health, local health clinics, and associated CDC scientists on-the-ground conducting research. Diplomats were instrumental in helping to shape U.S. foreign policy strategy in coordination with the U.S. President.

Background

The strategies that underpin the prioritization of health in U.S. foreign policy decision making are not known. This study focused on the gap in research and sought to identify the conditions under which the health policy agenda enters U.S. foreign policy decision-making and for what purpose or value.

The purpose of the study is to identify the core assumptions and themes that drive the conditions under which a health policy agenda gets incorporated into U.S. foreign policy and for what purpose or value. The COVID-19 global pandemic served as a reminder that global health issues are at the forefront of everyday life. This research attempts to bridge the policy domains of practice in global health diplomacy, international relations, and foreign policy. The historical case of PEPFAR and the HIV/AIDS epidemic are utilized in this research. However, it is not the attempt of this article to recount the details of that era, as there are many texts solely devoted to that effort. Rather, it provides a sampling of the events at the time to showcase the collective action required to elevate a health policy agenda into a foreign policy priority.

Rationale and knowledge gap

PEPFAR highlighted how linking health to national security elevated awareness of the HIV/AIDS epidemic, but it has limitations. Substantive policy changes emerge from the role of champions and leaders prioritizing the political and policy importance of public health threats. Examining the causal factors that led to collective action in the case of PEPFAR emphasizes to leaders the importance of stakeholder engagement at all levels and the value of diplomacy in fostering trusted relationships over time.

Objective

The purpose of the phenomenological study was to summarize the state of literature, investigate Global Health Diplomacy (GHD), and to determine under what conditions the health policy agenda enters foreign policy decision making and for what purpose or value (research question). This required an analysis of the complex nature of U.S. foreign policy. The implications of the research served to advance the health policy agenda within the U.S. national security strategy and foreign policy decision-making in a post-COVID-19 environment, to advance the applied practice of GHD, and to enhance the collaboration between health and foreign policy scholars. The author presents this article in accordance with the SRQR reporting checklist (available at https://jphe.amegroups.com/article/view/10.21037/jphe-24-113/rc).

Methods

The methodology for this qualitative phenomenological study included a review of public documents, interviews, and an examination of two historical cases (PEPFAR and the Global Fund to Fight AIDS, Tuberculosis, and Malaria). Document reviews included a review of public documents and 205 references to support the overall dissertation research. Key documents reviewed included: all U.S. NSS publications (17), the U.S. Global Health Security Strategy (GHSS) (18), the U.S. Global Health Security Agenda (GHSA) (19), Aspen Strategy Group Papers detailing the bioterror attacks (anthrax)-privately held unclassified papers (20), International Health Regulations (IHRs) (21), the USAID Policy Framework (22), the Goldwater-Nichols Defense Reorganization Act of 1986 (23), and Congressional Research and Bills relevant to topics in this research (24).

The initial criteria for determining an elite’s participation were performed through purposive selection. Additional selection criteria were based on contributions in literature on this topic and/or introductions that were facilitated by research faculty who had knowledge of my topic. A snowballing process was utilized to identify participants (25). I had no prior personal knowledge or interaction with the participants that could contribute to bias in this research. My role in this research was as a doctoral candidate and this research was completed to fulfill the requirements of my doctoral dissertation. IRB review of human subjects research was determined to be exempt.

Fourteen participants shared lived experiences from leadership roles and insights about the key drivers which moved health to a higher priority on the health policy agenda. The diverse group of participants, focused on the period of 2001–2003. The characteristics of the participants include: ambassadors, policymakers, bioterror experts, national security strategists, scientists, and activists. Age and sex were not criteria for participation selection.

Due to the COVID-19 pandemic, elite interviews were conducted via Zoom. Semi-structured interviews were administered utilizing an interview guide and recorded on Zoom. Transcripts were produced from these interviews and field notes (metadata) were also used to code the data. The data analysis process was repeated until patterns were identified and no new themes emerged. A numbering system was used to isolate 10 total themes.

Data was triangulated from participant interviews with public documents associated with PEPFAR and the Global Fund to Fight AIDS, Tuberculosis, and Malaria, and documents known to me through the course of completing the participant interviews.

This article does not require additional ethical clarifications as the research was deemed exempt by the University of Southern California IRB during an application process associated with the author’s doctoral dissertation research.

Results

This research utilized the cases of PEPFAR and the Global Fund to Fight AIDS, Tuberculosis, and Malaria (not detailed in this article) to determine the conditions under which the “decision-making process advances the health policy agenda.” (10). The research did not focus on replicating detailed case studies of the HIV/AIDS epidemic which are available from other public sources. What is new is that I utilized the NSS to understand the formulation and priorities that shaped each president’s foreign policy strategy with particular attention to the period from 2001–2003 which aligned with the AIDS epidemic.

Ten themes and related sub-themes (Table 1) highlighted the role that various actors played in enabling the emergence of PEPFAR from an inchoate agenda (10): they serve as a skeletal structure of a historical initiative which can serve as a strategic framework for policy development and action.

Discussion

In the case of PEPFAR, the HIV/AIDS epidemic and the anthrax (bioterror) threats are what contributed to the health policy agenda rising in prominence within the U.S. It took champions and leaders to accelerate this policy priority and they did so in response to collective action on the national and international stage.

Key findings

A window of opportunity emerged to elevate the global health policy agenda when the HIV/AIDS crisis was identified as a security issue on a global stage. This accelerated foreign policy decision-making. More work is needed to strengthen the interdisciplinary collaboration between health policy and security leaders. To achieve this, the U.S. needs to broaden the definition of what constitutes a national security priority and to solve the problem of where health fits in the national security strategy and within U.S. foreign policy.

At the time of this journal submission, this is an evolving situation as the U.S. has recently completed a presidential election cycle. New policy priorities are emerging.

Strengths and limitations

The strength of this research is that it will help to advance GHD and U.S. foreign policy decision making following a global pandemic. Pivoting to a lifecycle framework, meaning an assumption of a constant state of readiness, will aid in mitigating cycles of complacency which have hindered global health policy prioritization. Limitations of the study were presented during the data collection stage. The pandemic prohibited me from interacting face-to-face with the participants.

Comparison with similar research

This research is unique as it incorporates a transnational view of policy, not just a domestic lens. Most literature that was reviewed for this study focused on the latter. Utilizing a transnational lens, I present a conceptual lifecycle framework that builds upon past research on how health is prioritized alongside security and economics (10).

Explanations of findings

Champions and leaders serve as the key catalyst for moving an inchoate agenda to an actualized policy initiative. This coupled with moral reasoning was a human element that drove passionate leaders to establish the PEPFAR program. It was a disease that could infect everyone, women and children, teachers and lawyers, government leaders and any other resource who served as the stabilizing backbone of regional economies.

Activists and public figures used their influence to pressure pharmaceutical companies to lower the price of anti-retroviral drugs. This increased accessibility which was essential to prevention and treatment initiatives already underway by scientists and country leaders.

There are different approaches used by government organizations when health emerges as a foreign policy issue. Communication interdepartmentally requires that the importance of a global health policy issue not be lost in translation to security leaders.

Implications and actions needed

PEPFAR represents an example of a legacy U.S. bilateral health initiative. In August 2023, the Biden Administration established a Bureau of Global Health Security and Diplomacy within the U.S. Department of State. Its establishment builds upon the learnings from this case study (26). According to its site, the U.S. Government has demonstrated the largest investment, “$110 billion in global HIV/AIDS response” by any nation focused on prevention and treatment of a single disease. Following the COVID-19 pandemic, global health leaders will benefit from incorporating new technology tools to predict global health threats, such as artificial intelligence (AI) or change prediction strategies, to incorporate global health threats into a nation’s security planning.

This research builds upon (27) work which depicts a high-low politic continuum as an indicator of health rising and falling as a policy priority. In contrast, I propose the advancement of a different measure for the prioritization of health alongside economics and security in U.S. foreign policy: a lifecycle conceptual framework (Figure 1) to mitigate cycles of complacency, one global health event to another (10). The case of PEPFAR highlighted the importance of establishing core pillars, in-country, to support the programmatic elements that were necessary to distribute anti-retroviral treatments (10). Likewise, institutionalizing this concept of readiness across a lifecycle within U.S. government organizations, such as the National Security Council, supports knowledge-sharing between departments.

Figure 1 A conceptual framework for the prioritization of health in U.S. foreign policy: a dynamic transnational lifecycle.

Drawing upon a lifecycle model utilized in other disciplines, cybersecurity strategy threat readiness (a European Union Agency for Cybersecurity approach) supports a more flexible and adaptive framework for future readiness in response to global health threats. It assumes a constant state of readiness and planning. I also utilized Zelikow-Allison’s decision making models (28) in my research. I found that the lifecycle approach (depicting the global ecosystem of state and non-state actors) incorporated different perspectives, through roles and lived experiences; thereby, enhancing the inputs which are assessed at the “blurred and bloody border” (10).

Thematic analysis, a form of qualitative research, teased out themes and sub-themes to understand “the conditions under which U.S. foreign policy decision making advances the health policy agenda and for what value or purpose” (10).

As global health leaders, the establishment of PEPFAR from an inchoate agenda raises questions to ponder, such as:

• What incentives did the U.S. have to engage in treating HIV/AIDS in Africa? Women and children were dying of HIV/AIDS and the narrative of the disease being only one due to illicit behavior was no longer aligned to past political rhetoric.
• Who were the stakeholders involved in positioning the passage and implementation of PEPFAR, how did they come together, and why did they eventually align? Champions and leaders were key.

Conclusions

PEPFAR stands as an exemplar program demonstrating the value of advocacy and collective action by a nation focused on the prevention and treatment of a single disease. Key events that led to the implementation of PEPFAR include lowering the cost of antiretroviral drugs to expand accessibility globally, the elevation of health to the UN Security Council as a matter of security and international peace, overcoming U.S. government bureaucratic processes, and the role of champions and leaders at the highest level of government to drive policy action.

The COVID-19 pandemic highlighted the trade and economic risks associated with global health threats and events. The complexity of these types of events necessitates a look at the interdependencies in the global economy and the imperative for stakeholders with differing end objectives to negotiate for their own interests. As with PEPFAR, the role of diplomats is key in leveraging soft power and optimizing long-term trusted relationships regionally.

Discussion questions

As you lead discussions among your own organizations and teams reflecting on the PEPFAR case example, you might consider an examination of the following:

• Why would the U.S. want to take a leadership role in establishing the PEPFAR program even though it is not benefitting directly from it?
• Why is it important for global health leaders to engage with diverse stakeholder groups when seeking to advance health as a strategic priority?
• How can the PEPFAR case study be utilized to inform global health decision-making in a post-COVID-19 pandemic era?

Acknowledgments

None.

Footnote

Provenance and Peer Review: This article was commissioned by the Guest Editor (Mellissa Withers) for the series “Case Studies in Global Health Leadership and Management” published in Journal of Public Health and Emergency. The article has undergone external peer review.

Reporting Checklist: The author has completed the SRQR reporting checklist. Available at https://jphe.amegroups.com/article/view/10.21037/jphe-24-113/rc

Data Sharing Statement: Available at https://jphe.amegroups.com/article/view/10.21037/jphe-24-113/dss

Peer Review File: Available at https://jphe.amegroups.com/article/view/10.21037/jphe-24-113/prf

Funding: None.

Conflicts of Interest: The author has completed the ICMJE uniform disclosure form (available at https://jphe.amegroups.com/article/view/10.21037/jphe-24-113/coif). The series “Case Studies in Global Health Leadership and Management” was commissioned by the editorial office without any funding or sponsorship. The author has no other conflicts of interest to declare.

Ethical Statement: The author is accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. This article does not require additional ethical clarifications as the research was deemed exempt by the University of Southern California IRB during an application process associated with the author’s doctoral dissertation research.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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