Impact of PEPFAR’s Stop Work Order on PrEP

The impact of the stop-work order on PrEP is expected to be severe. These slides reflect the results of an analysis drawing on key informant interviews with representatives of Ministries of Health and PrEP implementers between 27 January 2025, when stop-work orders were issued by the US government, and the end of February 2025, when the vast majority of USAID-funded projects received official termination notices.

Avac Event

WHO-Lancet Global Health Series: Shaping the Future of Clinical Trials

WHO and partners will convene to launch the Lancet Global health series: Shaping the Future of Clinical Trials. Details and registration link below.

PEPFAR: A Strategic Necessity for US Leadership and Global Health

By Jeanne Baron

The US President’s Emergency Plan for AIDS Relief (PEPFAR) is one of the greatest investments in global health and US diplomacy. With over 20 years of partnership and huge impact, PEPFAR is critical to ending HIV as a public health threat for everybody, everywhere. Champions of global health and evidence-based HIV prevention made clear the potential to end the epidemic or to lose decades of progress in fighting HIV at a March 5th US Congressional briefing, hosted by Congresswoman Robin Kelly, the Congressional Caucus on Black Women and Girls, AVAC and the Global AIDS Policy Partnership (GAPP).

PEPFAR and its lifesaving services have been threatened by the new US administration’s executive order freezing all foreign aid funding. While some PEPFAR programs received waivers to restart some HIV treatment and prevention of mother-to-child transmission (PMTCT) services, many of its activities continue to be suspended indefinitely, including programs for girls, young women, orphans, and vulnerable children. PEPFAR’s authorization expires on March 25.  

“The hardest hit are key populations, those already on the margins of society,” said AVAC’s John Meade Jr., Senior Manager for Policy who co-moderated the briefing. “Clinics are shutting down, and communities are losing access to prevention and treatment. Congress must act immediately to restore funds to this extraordinary program. This is not a partisan issue. PEPFAR has enjoyed bipartisan support because it works, because it saves lives. It strengthens economies and reinforces America’s role as a leader in global health.” 

Chris Collins, President and CEO of the Friends of the Global Fight Against AIDS, Tuberculosis and Malaria and AVAC co-founder, said that since 2003 when PEPFAR began, it has delivered an unprecedented success in mounting a response against HIV/AIDS, saving 26 million lives and building systems and infrastructure that effectively deliver treatment and prevention.  

“People need to understand, we are on a trajectory to end the epidemic with PEPFAR. What it would mean for the United States to continue to lead this global effort would be one of the greatest accomplishments of the century. And it would be an American accomplishment with our partners around the world. There’s a huge prize out there waiting.” 

Participants all referenced the UNAIDS goal of ending AIDS as a public health threat by 2030. Angeli Achrekar, Deputy Executive Director of the UNAIDS, described the grave risks of missing this moment: “The end is almost in sight. Yet, if we do not get to the end, we risk serious resurgence. Those gains, that have been made with so much investment and engagement by governments and American taxpayers, will be reversed. We risk backsliding in all this strategic engagement. It’s a reality we all have to face.” 

Achrekar said PEPFAR’s fight against HIV/AIDS has led to extensive public and private investment, and among many US businesses, who have strengthened lab and surveillance technology, supply chains, data science, monitoring and evaluation, and healthcare systems at large. 

“The result is that countries are not just able to respond to HIV but also to COVID, mpox, Ebola, H1N1 and other threats. That is so important, to stop diseases where they are and prevent them coming to the US,” said Achrekar. 

Linda-Gail Bekker, CEO of the Desmond Tutu Health Foundation in South Africa and an AVAC board member, shared the results of a recent modelling study, Potential Clinical and Economic Impacts of Cutbacks in the President’s Emergency Plan for AIDS Relief Program in South Africa: A Modeling Analysis, which found that eliminating PEPFAR would lead to 600,000 additional HIV-related deaths and 565,000 additional HIV infections over 10 years, and increased healthcare expenditures across the population by approximately $1.7 billion. And Bekker decried the additional impact on HIV R&D from US policy under the new administration.  

“We are damaging our ability to do ethical clinical research, which I fear because although we have made strides, we have yet to discover an HIV vaccine that is effective, we still have a real quest for a cure, and it takes great effort to stay one step ahead of this virus with treatment and prevention.”  

Jirair Ratevosian of the Duke Global Health Institute detailed a 2 to 5 year transition plan for PEPFAR countries to achieve 50% co-financing of their programs, repurpose funding to places where the epidemic is intensifying, and cost-savings through scaled-up prevention of long-acting PrEP for 5 million new users by 2030. Read the recommendations in Reform and Renewal: Five Recommendations for PEPFAR. The prevention target builds on a landmark agreement, announced in December 2024, between PEPFAR, Global Fund, the Children’s Investment Fund Foundation and the Gates Foundation, to provide affordable access to injectable lenacapavir, aiming to reach 2 million people over three years in PEPFAR and Global Fund–supported countries.

“Let’s not forget the amazing opportunity in front of us right now, which is scale-up of long-acting PrEP,” said Ratevosian. “There are two long-acting prevention products right now. If we can get those out to the people most at risk, we can drive down HIV incidence dramatically, in combination with getting treatment to everybody who needs it. That’s the real sustainability in HIV, where countries can take on their own response if we can get these epidemics under control—and that’s do-able if we go to scale with the technology we have.”

In the midst of chaos and confusion, Congress and the new administration need to recognize that ending an epidemic is both the right thing to do and completely possible at this moment in history. Embracing the policies and funding to make it happen makes America and the world stronger, safer, and more prosperous.

Global Health in the Lurch: What’s happening now and who is pushing back?

 KFF’s Jen Kates and AVAC’s John Meade break it all down on PxPulse Live.

A snapshot of global Health in the first weeks of the Trump Administration, this episode covers the impact of the US freeze on foreign aid to critical federal agencies and the HIV research pipeline and explores action in Congress and among civil society to push back.

Resources

PxWire Volume 15, Issue No. 1

In this special edition of Px Wire, AVAC is going beyond a quarterly update of biomedical HIV prevention. In this issue, we look at how the new US Administration’s attack on global health can be expected to devastate HIV prevention, including the capacity to deliver existing PrEP options, the scale up of new PrEP products, and the paralyzing impact on research and development. A PDF version of this report is also available.

From Research to Rollout: The impact of USG global health pullout

New Vision newspaper frontpage thumbnail

The United States’ presidential regime has launched a sustained, multi-pronged attack against foreign assistance, scientific inquiry, due process and good governance. It threatens economies, human rights, international partnerships, global health at large, and the rule of law. For HIV prevention, a single sentence, issued in a February 6 advisory from the US Department of State, has derailed the entire field, potentially setting back the HIV response by years, if not decades. Read on for resources to support your advocacy and fortify our solidarity at this critical time.

Progress in PrEP Uptake: Threatened

global PrEP uptake and PEPFAR's role

PEPFAR has been pivotal to accelerating PrEP uptake, significantly expanding HIV prevention coverage. The freeze on foreign aid prohibits funding to PEPFAR’s PrEP programs and poses a serious threat to global efforts to control the epidemic.

AVAC’s Global PrEP Tracker has documented cumulative PrEP initiations on a quarterly basis for nearly a decade. This graph presents the final data collected while PEPFAR was fully operational—PEPFAR support was responsible for 79% of PrEP uptake globally in the last year and reached 83% by the end of September of 2024. Data on the fourth quarter of 2024 is inaccessible since PEPFAR was taken offline in late January.

At the time of the foreign aid freeze, PrEP uptake had reached 8 million initiations since 2016, an achievement that’s taken almost 10 years to reach—too slow and too small to reach UNAIDS targets, but a robust foundation to finally accelerate PrEP uptake with next-generation PrEP. Current US policies, instead of expanding PrEP coverage, are leading to the closure of programs, and will reverse global progress against HIV.

Without primary prevention, the HIV epidemic is poised to rage on, with incidence among adults on track to triple over the next ten years. This HIV Synthesis model, developed by the HIV Modelling Consortium, estimates the impact of stopping all HIV prevention services across Africa from now through 2036—including PrEP, voluntary medical male circumcision (VMMC), and free condom distribution.

For the last 8 years, AVAC has proudly worked with PEPFAR to document PrEP uptake and its impact around the world. That stopped in January with a stop work order from the US government. But protecting access to PrEP is vital. Are you leading a PrEP program? Whether supported by PEPFAR or not, we invite you to work with us to ensure global data on PrEP is not lost. Find us at [email protected].

PrEParing for New Products: Is rollout still possible?

Wired magazine headline: this new drug could help end the epidemic—but US funding cuts are killing its rollout

Read more in The Gears of Lenacapavir for PrEP Rollout.

The chaos in foreign assistance programs (including discontinuation of major PrEP programs), cuts in staffing and new demands on donor commitments will make decisions on the procurement of LEN for PrEP more complex and uncertain. In December 2024, the Global Fund and PEPFAR announced a plan to reach 2 million people with LEN for PrEP over three years. Exactly how funding to support this unprecedented introduction program will move forward, in the absence of significant US investment, is far from certain. The other stakeholders, including Global Fund, Gilead, CIFF and the Gates Foundation expressed commitments to the deal, but major questions remain. In the meantime:

The Latest R&D in the Prevention Pipeline: Supported or undermined?

Representative headlines from the New York Times and Science magazine.

The stop-work orders have disrupted USAID-supported HIV prevention research, halting critical investigations in vaccine and next-generation PrEP strategies.

  • The BRILLIANT and ADVANCE projects’ clinical, preclinical, and experimental trials testing HIV vaccine candidates have been suspended.
  • The MATRIX projects’ driving innovation with next-generation PrEP and MPT products, fast-dissolving inserts and vaginal films and rings, have been forced to stop their clinical trials.
  • The MOSAIC projects’ have suspended all implementation science activities, including the CATALYST study, investigating choice among oral PrEP, injectable cabotegravir and the dapivirine vaginal ring. Other implementation studies are continuing, but access to the commodities, much of which was procured by PEPFAR is questionable. See AVAC’s Integrated Study Dashboard for details.
  • The Coalition to Accelerate and Support Prevention Research (CASPR) has also been paused. Led by AVAC in partnership with a number of leading African civil society organization, CASPR focuses on building an enabling environment for HIV prevention R&D. (Note: In early February, AVAC lead a lawsuit against the State Department seeking emergency relief from the freeze on foreign assistance, including funding for CASPR. The case, AVAC v. United States Department of State, is pending.)

These disruptions delay the development of urgently needed HIV interventions and threaten the sustainability of research infrastructure all over the world, with particularly egregious impacts on the research capacity of regions most impacted by the epidemic.

The abrupt suspension of these trials also raises serious ethical concerns. Stopping trials mid-course undermines trust in research, jeopardizes community engagement, and abandons participants who volunteer their bodies for scientific discovery. It will take years to build back this critical infrastructure—for HIV research and beyond—as well as the community partnership and trust needed to ensure smooth and ethical research.

Prevention Playlist

AVAC develops a wide range of resources to inform decision making and action. Check out the latest:

Join

  • Subscribe to Global Health Watch: AVAC’s weekly newsletter dedicated to breaking down critical developments in US policies and their impact on global health. avac.org/signup
  • Seeking Visuals and Videos: Leading groups in Washington, DC, are urgently trying to collect videos and photos documenting the impact of the US government’s foreign aid freeze, such as clinic closures despite the waiver. Non-professional phone videos and photos are welcome. Send to [email protected] for more details
  • CHANGE: In response to the unfolding crisis, more than 1,300 people from civil society organizations around the world have launched CHANGE—Community Health & HIV Advocate Navigating Global Emergencies—a coalition formed to support urgent action. [email protected]

Use

Watch/Listen

Read

  • AVAC v United States Department of State. On February 10, 2025, AVAC and another nonprofit organization sued the new US Administration, seeking emergency relief from an Executive Order that inhumanely froze all funding for foreign assistance, AVAC

We’re Going Back to Court

New developments in our legal battle against the United States government

Three weeks ago, AVAC, as well as the Global Health Council and partners, sued the U.S. State Department and government officials including the President, to end the freeze on foreign assistance funding that is harming global health and development programs, including lifesaving HIV prevention efforts. 

On February 13, a US federal district court immediately granted a temporary restraining order and directed the government to lift the freeze and restore funding while our lawsuit progresses. Since then, the administration has repeatedly refused to restart funding, and the court has made clear more than once that the continued freeze is unlawful.  

“The government comes to this Court with an emergency of its own making,” our lawyers wrote in a filing.

The lengths that the government is willing to go to flout a court order, all for the goal of ending life-saving humanitarian assistance, is staggering,” they said.

Now we have a court date: this Thursday, March 6 at 2pm Eastern Standard Time, we will be in Washington, DC, to make the case for human rights, health and dignity – and the government paying its bills.

This fight is far from over, and your support has been instrumental in reaching this point, and together, we can continue to champion the rights and health of communities worldwide. 

How you can stay connected:

These are immensely challenging times for all of u, and it is easy to be paralyzed, overwhelmed and depressed. But we’ve all come too far for that to be the new normal.  Lives, economies and democracies depend on our collective ability to stand up and fight back. 

Avac Event

Can Africa Finance its Own Non-profit Sector?

The webinar will explore whether shifts in the US government’s funding is a setback or an opportunity to rethink Africa’s reliance on Western aid.

Featuring:

  • Angelo Katumba — Senior Program Manager: AVAC
  • Yvette Raphael — Executive Director of Advocates for the Prevention of HIV in Africa
  • Dr. Michael Kiragu — AICS Associate & Grant Fundraising Expert

Avac Event

The Impact and Implications of Recent US Government Federal Funding Reductions on Health Programmes

The University of the Witwatersrand‘s Steve Biko Centre for Bioethics presented a webinar featuring:

  • Mia Malan, founder and editor-in-chief of the Bhekisisa Centre for Health Journalism – an independent media organisation that specialises in narrative, solutions journalism focusing on health and social justice issues across Africa.
  • Dr Ntombifikile Nokwethemba Mtshali, Chief Executive Officer of Shout-It-Now, an organisation focused on providing sexual and reproductive health and rights services
    to youth in the Gauteng and North-West provinces.
  • Mitchell Warren, Executive Director of AVAC – an advocacy organisation focused on accelerating access to effective HIV prevention options and ensuring access to everyone who needs them. Mitchell also worked with Population Services International (PSI) designing and implementing social marketing, communications and health promotion activities, including five years running PSI’s project in South Africa.

Avac Event

Updates to the PEPFAR Stop-Work Order and the Role of CCM

Join AVAC, COMPASS and other partners to update CCMs on the PEPFAR freeze.

Global Health Watch News Brief

New guidance, confusion, and advocacy in action

The sustained attacks on global health and the dismantling of critical infrastructure by the US government continued this week. Here is an overview of developments in US policies and their implications for the HIV response and global health equity.  

New Developments

  • Humanitarian Aid, PEPFAR Freeze and HIV Prevention 
    A pause on all US foreign assistance was announced January 20, leading to layoffs and halted delivery of life-saving medication and services, with severe consequences for communities. Last weekend, PEPFAR finally received a waiver for some treatment and programs for the prevention of mother-to-child transmission (PMTCT). However, guidance has been lacking as to which programs can resume. On Thursday, the US Department of State issued guidance allowing for the continuation of HIV testing for all populations and HIV care and treatment for all people living with HIV. But primary prevention and key population programming was excluded, and the guidance goes so far as to state: “people other than pregnant and breastfeeding women who may be at high risk of HIV infection or were previously initiated on a PrEP option cannot be offered PEPFAR-funded PrEP during this pause of US Foreign Assistance or until further notice”. In the meantime, almost all USAID staff were put on administrative leave and all contract staff at PEPFAR were laid off on Wednesday. Advocates and implementers in dozens of countries are already reporting significant setbacks, including closed drop-in centers and halted PrEP distribution. In an attempt to fight back and advance HIV prevention as core in the global HIV response, the African Women Prevention Community Accountability Board issued a powerful Call to Action for Sustaining HIV Prevention Gains for Women and Girls in Africa.

    IMPLICATIONS: The situation remains deeply concerning and riddled with confusion: while some waivers are being granted, many implementing partners continue to face stop-work orders, stalling critical services. Most alarmingly, disallowing individuals already on life-saving PrEP from continuing these services threatens to reverse hard-won progress in controlling the HIV epidemic. As Kenneth Ngure explains in the New York Times article on the USAID withdrawal’s impact on clinical trials: “Without regular [PrEP] injections or a carefully-managed discontinuation, the participants will not have enough cabotegravir to stop a new infection, but there will be enough in their systems that, if they were to contract the virus, it could easily mutate to become drug-resistant.” 

    READ: 
    Abandoned in the Middle of Clinical Trials, Because of a Trump Order – New York Times
    Too little, too late: What a PEPFAR waiver can’t do – Bhekisisa  
    The Status of President Trump’s Pause of Foreign Aid and Implications for PEPFAR and other Global Health Programs – KFF
  • USAID Shutdown and Dismantling 
    The majority of USAID staff and contractors were fired or placed on administrative leave and locked out of their accounts and out of the building in Washington, DC. Most essential functions of the agency have been stopped. Many lawmakers on both the Democrat and Republican sides have opposed these orders, but attempts to pass resolutions supporting USAID have been blocked in the Senate. Also, Secretary of State Marco Rubio informed lawmakers that he would also serve as Acting USAID Administrator and has given Peter Marocco, a political appointee at the State Department, additional responsibility at USAID. This allowed Marocco to start reviewing and possibly restructuring USAID’s programs. The State Department also began a review of USAID’s foreign aid activities, with the goal of potential reorganization. Reports late on Thursday were that USAID would have less than 300 staff left (down from over 10,000) and 800 awards and contracts were being canceled. Labor groups representing employees at USAID brought a lawsuit against the new administration over efforts to freeze foreign assistance and HIV advocates protested in Washington, DC Thursday demanding that the administration fully restore PEPFAR funding. So much for a 90-day pause and review – all done in two weeks? 

    IMPLICATIONS: This dismantling includes efforts to completely dissolve USAID, raising significant concerns about the future of global health and development programs. Many argue that a shutdown of the agency undermines US power and global influence, especially as China and Russia look to fill in the foreign aid gaps. As we wrote last week, contractors at USAID and the State Department Bureau of Global Health Security and Diplomacy (GHSD) are essential to the Bureau’s operations, and their expulsion paralyzes USAID, GHSD and PEPFAR. 

    READ:
    USAID may be reorganized, absorbed by the State Department, Rubio says – Devex 
    USAID Workforce Slashed From 10,000 to Under 300 as Elon Musk’s DOGE Decimates Agency – Wired 
  • New Gender Policy
    The US CDC, NIH and other federal health agencies removed hundreds of HIV-related web pages on 8,000+ websites following executive orders targeting “gender ideology” and “DEI.” This week, many of the pages have been restored, but without reference to transgender individuals. The restored pages show a rushed revision to content on HIV, STIs and sexual and reproductive health and important information for key populations has been removed. This censorship is further exacerbated by instructions from the new administration demanding that scientists at the US Centers for Disease Control and Prevention (CDC) retract scientific articles that include “forbidden terms” such as gender, transgender, LGBT, or transsexual. 

    The recent removal of HIV- and LGBTQ-related content undermines public health and health equity. Key resources, including HIV PrEP guidance and transgender-focused materials, were deleted or revised, leaving significant gaps in data and care recommendations. Though some information has been restored, critical omissions jeopardize effective HIV prevention, care, and outreach, particularly for marginalized populations at higher risk of infection. In response to the censorship of scientific publications, at least the British Medical Journal editors stood up in their editorial: Medical journal editors must resist CDC order and anti-gender ideology: “The US was considered a world leader in public health and research. With one repressive stroke that reputation risks being shattered and broken. If anything is forbidden now, it is that medical and science journals, whose duty is to stand for integrity and equity, should bow to political or ideological censorship.” 
  • Robert F. Kennedy Jr. Confirmation Hearings  
    The Senate Finance Committee voted to advance Robert F. Kennedy Jr.’s nomination for Secretary of Health and Human Services (HHS). His nomination now moves on to the full Senate after a 14-13 vote. Senator Bill Cassidy, a medical doctor and Republican from Louisiana, who voiced support for PEPFAR previously, ended up voting for Kennedy.  

    IMPLICATIONS: Despite concerns over Kennedy’s vaccine skepticism, AIDS denialism and racist views of immunology, his confirmation appears likely with a full Senate vote imminent. As HHS Secretary, Kennedy would have control over the US CDC, NIH, FDA and other important health agencies, including how funding is spent, how programs are administered and how science is communicated.  

Seeking Visuals and Videos

Leading groups in Washington, DC are urgently trying to collect videos and photos of what’s happening “on the ground” because of the freeze, such as clinic closures despite the waiver. Non-professional phone videos and photos are welcome. Contact or send to [email protected] for more details.

Contact or send to [email protected] for more details

What we’re reading

Resources

  • Litigation Tracker: A public resource tracking the legal challenges to the Trump administration’s executive orders, Just Security 

Tracking the impact

  • USAID Stop-Work, a resource tracking the impact of the stop work order to USAID 

In other news, there was progress in HIV prevention: Gilead Sciences submitted lenacapavir for PrEP to the European Medicines Agencies (EMA) for review, both to market in Europe as well as for an EU-Medicines for All (EU-M4all) application that would facilitate availability of LEN for PrEP in low- and lower-middle-income countries. This marks a big step toward ensuring injectable PrEP reaches those who need it most, which was also highlighted in this week’s Lancet HIV editorial: Steps toward quick and equitable roll-out of lenacapavir. This makes fighting to restart PEPFAR-supported PrEP programs all the more important, so the world can prepare for LEN introduction. If we can’t drive down new infections with all options, we can’t imagine a sustainable HIV response.