As the global research community confronts drastic cuts and extraordinary opposition to its work by the US government, the world cannot lose focus on the critical need for high-quality, impactful clinical research.
This Friday, The World Health Organization (WHO) will host a webinar to launch a series of articles to be published later today in Lancet Global Health, Shaping the Future of Clinical Trials.
At AVAC, we are especially pleased that one of the seven papers highlights the essential role of community engagement, referencing the Good Participatory Practice (GPP) guidelines, to improve research conduct and outcomes. This paper—Better engagement, better evidence: working in partnership with patients, the public, and communities in clinical trials with involvement and good participatory practice—is co-authored by AVAC’s Stacey Hannah and Jessica Salzwedel and partner, Catherine Slack of the HIV/AIDS Vaccine Ethics Group in South Africa. (For more about GPP, be sure to check out our online GPP Body of Evidence.)
We hope you will look out for the series of papers later today and join the conversation Friday to learn more about WHO’s call to make engagement central to clinical trials. Together we will discuss systemic gaps, structural inequities, and solutions—including stronger policies, increased funding, better regulatory oversight, and a research culture that integrates GPP as essential to future clinical trials around the world.
Global Health Watch: CDC Cuts to HIV Prevention, Restructuring Foreign Aid
Issue 8: March 21, 2025
From proposed elimination of the CDC’s HIV prevention program in the US to the uncertain future of foreign assistance around the world, the US administration’s sweeping policy changes threaten decades of progress in both domestic and global HIV efforts. This week’s newsletter examines these proposed cuts, ongoing lawsuits against the foreign aid freeze, plans to dismantle USAID, while also exploring the fate of NIH grants in South Africa and the mounting repercussions on communities and lives. Read on for more.
US CDC’s Uncertain Future
The administration is looking to slash an estimated $700M to $1B from the CDC’s Division of HIV Prevention (DHP), a vital pillar in the national fight against the HIV epidemic. These cuts mark a significant shift from the first Trump administration’s goal to end HIV in the US by 2030 when it launched the landmark US Ending the HIV Epidemic (EHE) initiative in 2019. In a sharp turn, the administration is now considering a proposal to defund many aspects of DHP and shift HIV prevention programs from CDC to the Health Resources and Services Administration (HRSA), which leads HIV care and treatment programs but has no HIV prevention experience.
IMPLICATIONS: Cuts to HIV prevention funding at the CDC would disrupt programs within each state, which rely on federal funding to carry out critical services. This can be expected to trigger a dramatic rise in HIV, STIs, and tuberculosis cases, reversing decades of progress and imposing heavy financial burdens on state healthcare systems. Moreover, key populations most vulnerable to HIV in the US may see disruptions in vital access to prevention services, in addition to the ongoing, systematic, erosion of rights of these communities. The cruel irony of dismantling the President’s own vision of EHE, is only matched by the tragic timing: as AVAC’s Mitchell Warren told The Well News, “So just as we are poised to deliver the newest innovation [with approval of injectable lenacapavir for PrEP expected in June] that could dramatically impact the epidemic and achieve the goal of his first term, the administration is pulling the rug out from under the whole ecosystem—in the US and internationally.”
AVAC vs. Department of State and Other Court Cases
The AVAC vs. Department of State and Global Health Council vs. Trump twin lawsuits against the foreign assistance freeze made small steps forward this week. Following last week’s ruling requiring the government to pay USAID partners for billions of dollars in foreign aid work completed before Feb. 13, a new status report from the government, as required by the Court, indicates that payment for overdue bills has begun – slowly. Even though overall foreign assistance has yet to be restarted, more organizations report that they are finally receiving payments—new obligations beyond February remain uncertain. The Government is considering whether to pursue further appeals.
In related news, on Tuesday, a different US District Judge temporarily blocked the US DOGE Service from further dismantling USAID. The judge ordered the government to restore the agency’s headquarters and reestablish email access for thousands of employees.
IMPLICATIONS: It is unlikely that many of USAID’s implementing partners and programs will receive the funding needed to continue their critical work given the mass termination of contracts and jobs and overall dismantling of the agency. As Mitchell Warren told the New York Times, “We’ve got to snap out of any paralysis or any disbelief or shock, and we’ve really got to look at what needs to be built in the future.” The additional ruling about DOGE found the executive branch actions to eliminate USAID’s functions and issue mass layoffs to be a violation of the constitutional separation of powers. This ruling marks a critical setback for the administration. It remains in effect pending further court order.
FOLLOW ALONG: Follow progress of the case on our website.
US Government’s New Plan for Restructuring Foreign Aid
A proposal to overhaul US foreign aid programs to “better serve strategic interests” appeared this week. The plan calls for renaming USAID as the US Agency for International Humanitarian Assistance—narrowing its scope to global health, food security, and disaster response—and moving it under the State Department. It also proposes merging the Millennium Challenge Corporation and the US Trade and Development Agency with the US International Development Finance Corporation to leverage private sector investment, counter China’s Belt and Road Initiative, and promote a more transactional approach to foreign policy. The proposal deems current aid efforts “inefficient and fragmented” and suggests that programs should have clear end dates, measurable success, and enhanced accountability through technologies like blockchain.
IMPLICATIONS: This restructuring could narrow the scope of assistance available to vulnerable populations and low-income countries and leave less room for long-term capacity building.
In 2024, PEPFAR was reauthorized for just one year, breaking a 20-year trend of successive five-year reauthorizations that the lifesaving program has historically seen with strong bipartisan support in Congress. The current reauthorization expires next week, on March 25, amid unprecedented challenges. 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 13 US Congressional briefing.
Hosted by Congresswoman Robin Kelly (D-IL), the Congressional Caucus on Black Women and Girls, AVAC and the Global AIDS Policy Partnership (GAPP), participants all referenced the UNAIDS goal of ending AIDS as a public health threat by 2030. Angeli Achrekar, Deputy Executive Director of 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.”
Nearly two months into the dismantling of foreign aid and funding for research, the threat to vulnerable communities is starkly evident. Last week, we highlighted how these cuts are affecting clinical trials and the development and rollout of new HIV prevention tools—such as long-acting injectables and HIV vaccines. This week, the World Health Organization, in a press conference, reported that the new administration’s pause on foreign aid has “substantially disrupted” HIV treatment supplies in eight countries, including Haiti, Kenya, Lesotho, South Sudan, Burkina Faso, Mali, Nigeria, and Ukraine, which will soon run out of life-saving medications.
Separately, former USAID Global Health director, Atul Gawande said in an interview that an estimated that 160,000+ will die from malaria per year, “hundreds of thousands [of the 20 million people dependent on HIV medicines] will die in a year” if USAID programs are not restored.
It has been reported that the new administration is considering terminating NIH grants that support work in South Africa. This comes after an executive order in February alleging discrimination against Afrikaners. The potential cuts could impact the extensive South African research infrastructure and top institutions like the University of Cape Town, University of the Witwatersrand, and Stellenbosch University. The latest slew of proposed terminations come amid NIH turmoil where many grants have already been cut, including any related to diversity and vaccine hesitancy.
IMPLICATIONS: This would severely disrupt critical HIV and tuberculosis research. Such abrupt funding cuts would halt or undermine clinical trials and have far-reaching global repercussions, while undermining decades of collaborative progress.
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.”
“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.
“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 Watch: Responding to new cuts, new losses and new data
Issue 7: March 14, 2025
This week’s issue covers the latest developments in the AVAC vs. Department of State lawsuit, NIH’s termination of vaccine hesitancy research, new data revealing the deadly impact of foreign aid cuts on HIV, and renewed calls for African-led, sustainable health funding. Read on for more.
AVAC vs. Department of State
On Monday, US District Court Judge Amir Ali issued a 48-page ruling in AVAC vs. Department of State and Global Health Council vs. Trump, the twin lawsuits against the foreign aid freeze. The ruling orders the government to pay for work already completed and to spend congressionally appropriated funds for foreign assistance. However, Judge Ali’s order did not reinstate the mass cancellations of aid grants, leaving thousands of lifesaving programs in limbo. Lauren Bateman, lead counsel on AVAC’s case with Public Citizen Litigation Group, said “Today’s decision affirms a basic principle of our Constitution: the president is not a king. But we are painfully aware that, without unwinding the mass termination of foreign assistance awards, winning on the constitutional issues does not avert the humanitarian disaster caused by the Trump Administration’s freeze on foreign assistance. And it does not undo the damage that the freeze has already inflicted on millions of vulnerable people across the world. Deaths will continue to mount. While the courts have an important role to play in standing up for the rule of law, Americans need more than just the courts. We need Congress, which has always supported foreign aid on a bipartisan basis, to assert itself.”
IMPLICATIONS: Secretary of State Marco Rubio confirmed that 5,200 USAID programs—about 83% of the agency’s overall work—have been terminated, citing “tens of billions of dollars” spent in ways that allegedly “did not serve US interests”. The new administration will retain about 1,000 programs under the State Department’s oversight. Even if some contracts are eventually reinstated, the State Department has already eliminated a significant majority of USAID’s work and tens of billions of dollars in Congressionally approved spending. It is unlikely implementing partners and programs will receive the funding they need to start back up and continue their critical work.
In a sweeping move, the National Institutes of Health (NIH) is terminating or scaling back dozens of grants focused on vaccine hesitancy and boosting vaccine acceptance, citing “misalignment with NIH funding priorities.” It is unclear whether new Department of Health and Human Services (HHS) Secretary, Robert F. Kennedy Jr. directed the cuts—his longstanding anti-vaccine views are concerning, especially since the Centers for Disease Control and Prevention (CDC) was recently instructed to revisit the debunked link between vaccines and autism. The NIH is also canceling grants tied to transgender issues, diversity, equity, and inclusion, and research involving Chinese institutions, reflecting the administration’s broader push to cut spending and reshape federal research priorities.
IMPLICATIONS: Defunding these projects comes at a perilous time, given the reemergence of measles and declining immunization rates. By terminating research on vaccine hesitancy and acceptance, the NIH undermines efforts to build trust and increase uptake of essential prevention strategies, particularly among marginalized communities. This short-sighted approach risks widening existing health disparities and eroding decades of global progress toward equitable HIV prevention.
Researchers are proposing strategic reforms to PEPFAR, which is up for reauthorization later this month. The recommendations would trim PEPFAR program costs by 20% in five years, and transition financial responsibility to local governments in high-burden regions. They focus on ramping up long‐acting PrEP as a key component of HIV prevention. As highlighted in the opinion piece by Jirair Ratevosian, PEPFAR has evolved far beyond its original “emergency plan,” becoming indispensable to global HIV prevention and treatment. Embracing these reforms, he writes, would ensure PEPFAR remains resilient and impactful amid rising infections, geopolitical strains, and domestic political uncertainty.
Nearly two months into the dismantling of foreign aid and the research enterprise, the scale of the threat to vulnerable populations and global health is coming into sharper focus. New modeling data presented at CROI shows that nearly one in five children under one with HIV who experienced a treatment interruption in 2024 died, based on a review of over half a million children in US-funded PEPFAR programs. With major challenges to sustaining access to treatment since the new administration froze PEPFAR funds, the findings from this modeling study are a dire warning of the toll on lives to be expected from these policy changes. Meanwhile, clinical trials for new prevention tools, such as long-acting injectables and HIV vaccines, have been halted or scaled back, while organizations that built local research capacity and trust with communities now face staff layoffs and funding shortfalls.
IMPLICATIONS: The loss of data from these canceled projects will undermine governments’ ability to sustain the HIV response, with or without U.S. support, and reduced investment in infectious disease research could drive up costs in the long run.
Global health leaders are joining calls from civil society for African nations to break free from donor dependency by building self-sufficient, locally-driven health systems that prioritize their own needs and strategies. A rethinking of traditional aid models in favor of sustainable, equitable investments in health infrastructure and local research is needed and holding donor countries accountable for supporting true development rather than perpetuating reliance on external funding is imperative.
In case you missed it, check out the special edition of PxWire, which dives into the assault on global health and its devastating impact on HIV prevention—from crippling existing PrEP delivery to threatening the rollout of LEN for PrEP and paralyzing R&D.
Many researchers and advocates are on their way home from San Francisco where the Conference on Retroviruses and Opportunistic Infections (CROI) just wrapped up. The science showcased the great promise and importance of research and made clear just how much is at stake. You can read more about the promise of scientific advances against the backdrop of the US government’s priorities here and here.
CROI 2025 Shows the Promise of Research at its Best
The science offered at the Conference on Retroviruses and Opportunistic Infections (CROI) 2025 is a showcase of the great promise and importance of research. With broadside attacks and a sweeping funding withdrawal by the US government affecting science and global health, these advances in the field make clear how much is at stake. Innovation in long-acting PrEP could transform global health, new evidence to support on-demand PrEP among women, insights coming from cure research, and expanding efforts to confront an epidemic in sexually transmitted infections (STI), if the field can unite behind the evidence and refuse to be defeated.
New data presented Monday underscores these dire realities: nearly one in five children under one with HIV who experienced a treatment interruption in 2024 died, based on a review of over half a million children in US-funded PEPFAR programs. These findings emphasize the critical need to maintain uninterrupted care for young children with HIV, who are especially vulnerable to rapid disease progression, and starkly highlight the catastrophic risks associated with halting funding for treatment programs.
Read on for more important scientific highlights.
The Power of LEN for PrEP
A once-yearly injection of lenacapavir (LEN) for PrEP took a step forward. Renu Singh of Gilead Sciences presented data from an ongoing, open-label study of the pharmacokinetics (how a drug is absorbed, distributed and eliminated in the body at a given dose), safety and tolerability of two LEN injections testing an intramuscular formulation. Singh reported that drug concentrations were as good as or better than the 6-monthly subcutaneous dose that showed 100% efficacy in 2024.
“It gives me a great pleasure to see a small molecule last this long. It’s never been done before. Once yearly injectable LEN for PrEP has the potential to offer high efficacy.”
The doses were safe and well tolerated. A Phase 3 study is expected to launch later this year, with possible regulatory submissions in 2027. Gilead’s application for twice-yearly LEN for PrEP is currently under FDA priority review with a decision expected by June 19. (ViiV Healthcare is similarly advancing their four-month injectable cabotegravir (CAB) towards possible regulatory submission, while the two-month formulation is rolling out.)
More data from the PURPOSE Trials were presented showing that a cohort of 16-17 year-old females were just as well protected by 6-month injections of LEN for PrEP as adults in the larger study. Katharine Gill of the Desmond Tutu HIV Foundation, South Africa credited the PURPOSE trials and Good Participatory Practice for the landmark study, the first large-scale trial to include adolescents in the initial study design. Despite having high HIV incidence, adolescents have historically been excluded from Phase III HIV trials, resulting in prolonged delays in access to PrEP.
“PURPOSE 1 shows us that working with community and including adolescent stakeholders, we can design ethical studies that are effective and inclusive, especially for young women who need prevention the most,” said Gill.
On Demand PrEP for Cis-gender Women: 3 days or 4?
Findings from a modeling study explored how to optimize an on-demand protocol for HIV protection in the female genital tract. On-demand PrEP, sometimes called event-driven PrEP or 2-1-1, is a CDC approved protocol for men who have sex men who opt to take PrEP over a three-day period, starting 2-24 hours before the time of a specific sexual exposure, then 1 pill every 24 hours for the following two days. Mackenzie Cottrell of the University of North Carolina reported findings that adding a fourth day of dosing heightened protection from vaginal exposure to HIV.
Dosing of 2-1-1-1 showed 84% protection, 2-2-2-2 showed 95% protection. Cottrell said,“While limited data suggest 2-2-2-2 dosing is safe for short-term use, the 2-1-1-1 regimen may better balance safety, efficacy, and tolerability while maintaining effectiveness” Cottrell recommended the 2-2-2, 2-1-1-1, and 2-2-1-1 regimens be considered in future clinical studies of on-demand PrEP in cisgender women.
Merck presented an analysis of animal and Phase I data that informed the MK-8527 doses chosen to be tested in its ongoing Phase II PrEP trial. Looking at protection provided in monkeys, as well as pharmacokinetic data in humans, Merck determined that a monthly dose of at least 6 mg would provide adequate protection in more than 90% of the population intended for MK-8527 use. The Phase II trial is testing 3mg, 6mg, and 12mg doses in participants with low risk of HIV exposure. Watch this space for further information about how the Phase II trial will inform the upcoming efficacy program of MK-8527 expected to start later this year.
F/TAF Works in Women With Med-High Adherence
Flavia Kiweewa of Makerere University-Johns Hopkins University Research Centre in Uganda presented important new prevention evidence from the PURPOSE 1 trial that tested both injectable LEN and F/TAF among cisgender women for PrEP. This new analysis found the chance of acquiring HIV was 89% lower when adherence to F/TAF reached two pills per week or more.
Kiweewa reported that “nearly all incident HIV cases in participants receiving F/TAF in PURPOSE 1 were attributable to low oral PrEP adherence… taken together, these results suggest that HIV infections in PURPOSE 1 occurred almost always in the context of nonadherence to F/TAF, with rare emergence of HIV resistance and low risk of HIV diagnosis delay.” Kiweewa concluded that F/TAF is another prevention tool that should be considered for women who prefer a daily oral HIV prevention option.
Advances in Cure Research
A key focus for cure research at this year’s CROI was data from the FRESH Cohort in South Africa looking at delivery of the CAP 256 broadly neutralizing antibody (bNAb) in combination with TLR9, an immune activator developed by Gilead Sciences, to women identified and treated extremely early in infection. The trial involved an analytical treatment interruption (ATI) and allowed for eight weeks of consecutive viral loads above 1,000 copies before treatment was restarted. This allowed the researchers to see interesting viral dynamics, including about a third of the women experiencing multiple periods of viremia off therapy, some even getting close to 100,000 copies/mL in blood. The viral loads quickly returned to undetectable (after re-starting therapy?). Four women in the trial continue to remain off therapy.
Investigators from another key cure study, the RIO study, shared results that bNAbs at the time of treatment initiation were able to achieve durable control. Twenty-one individuals had delayed rebound with seven experiencing rebound over one year. The numbers are small, but combined with other basic and clinical trial data, bNAbs are an intervention to watch—for possible prevention, treatment and cure!
The Latest on DoxyPEP
While doxyPEP is already in use as an STI prevention intervention in several countries, ongoing research continues to address key questions regarding antimicrobial resistance, adherence, and identifying the populations that would benefit most. The PRIDOX study looked at the impact of doxyPEP in “high-risk MSM” who were also using PrEP in a real-world setting. Christina Gómez-Ayerbe presented data showing that the 197 study participants who started doxyPEP saw lower incidence of syphilis, gonorrhea and chlamydia at the end of the study than the incidence rates at the beginning of the study before starting doxyPEP. And similar to most doxyPEP studies, there were higher rates of gonorrhea than the other bacterial STIs studied. Even among participants who contracted gonorrhea while on doxyPEP, no cases of drug-resistant strains or other forms of microbial resistance were observed—a notable finding given that some other studies have reported modest increases in AMR among doxyPEP users.
Another study from Milan, Italy, looked at doxyPEP use among MSM using the U.S. CDC’s doxyPEP guidelines (which suggest prescribing doxyPEP for MSM and transgender women who have had one STI in the past 12 months). It found that out of 251 participants, 85 infections could have been prevented with doxyPEP, yet 164 individuals would have been unnecessarily prescribed it since they had no further STIs. Dr. Roberto Rossotti suggested the CDC guidelines might be too broad and should instead consider condomless sex acts as the prescribing criterion. Download AVAC’s Advocacte’s Guide to Doxycycline to Prevent Bacterial STIs.
HPV Vaccination and Global Inequities
Namwa Wongkalasin of Imperial College delivered an impressive presentation on the potential of HPV vaccination to prevent non-cervical cancers (i.e., oral and anal cancers), while highlighting the grave challenge of global inequities in vaccine access and coverage—particularly in regions that would benefit most. “Due to unprecedented cuts in global aid funding, this disparity will increase further,” she warned. We are likely to see these effects immediately amid troubling developments at NIH, where grants focused on studying vaccine hesitancy, acceptance, and uptake—particularly those examining HPV and gonorrhea vaccine attitudes—have been terminated. These NIH-funded studies have been pivotal in shaping strategies to boost HPV vaccination rates.
Community Breakfast Club Sessions
Catch up on our CROI 2025 Community Breakfast Club recordings! These virtual sessions, hosted by the CROI Community Liaison Subcommittee, the European AIDS Treatment Group, AVAC, and partners featured researchers and advocates discussing cutting-edge advances in HIV cure, reflections on 40 years of the epidemic, and insights on living long-term with HIV. Watch the recordings now!
“HIV is an incredibly diverse pandemic. Getting three quarters of all people living with HIV on this planet access to treatment is the greatest achievement of equity in global health. We all did that together. We can’t give it up and we are not going to.”
– Chris Beyrer, CROI 2025 plenary session
Defeating HIV has demanded heroics since the first report of a deadly new syndrome in the 1981 Morbidity and Mortality Weekly Report of the Centers for Disease Control. People devastated by AIDS, advocates putting their lives on the line to demand care, doctors and researchers struggling to find options—all facing down a plague that meant certain death.
Those gathered at the Conference on Retroviruses and Opportunistic Infections (CROI) 2025, which is ongoing in San Francisco through March 12, are taking stock of a grim new reality that will once again demand heroics of us all. Today the science is on our side with better solutions than ever before to control the epidemic (stay tuned for a roundup of the science). But the HIV response, from basic science research to community service providers, is now practically paralyzed by a despotic U.S. government, newly in power, that is attacking every aspect of scientific enterprise, global health, and foreign aid. Voices across sessions at CROI joined in calling for courage and solidarity.
Rebecca Denison, found of WORLD and a 42-year HIV survivor, opened the conference (slides here) with a stark assessment of the policies of the new US Administration as “going beyond persecution” and demanded action from us all.
“Silence ensures the abuse of power will continue… Now is the time for moral courage.”
Denison said too few Americans understand the dividends HIV research and development has paid out to them over the decades, accelerating technology from testing to vaccines. Communicating the impact and value of these historic investments is essential.
“Many Americans don’t know that the world waited four years for a test for HIV, which made possible the development of a COVID test in a matter of weeks.”
Chris Beyrer of Duke Global Health Institute at the Monday plenary address (slides here) put a spotlight on the historic achievements of U.S. President’s Emergency Plan for AIDS Relief (PEPFAR), now in jeopardy. Before PEPFAR, Gross Domestic Product (GDP) and life expectancy were in decline. After 20 years of PEPFAR investment, GDP is on the rise, 25 million lives have been saved and 5.5 million at-risk babies were born HIV free. It took diversity, inclusion and equity to achieve these results.
The staggering impact of withdrawing PEPFAR supported programs has been recently estimated in a JIAS publication: “Each day of the funding freeze about 220,000 including over 7000 children, will be unable to access their needed treatment.” For the latest on the foreign aid freeze and the AVAC vs, Department of State lawsuit, visit our frequently updated webpage.
Beyrer called for restoring PEPFAR, sustained support for community partners especially those serving key populations, restoring the functions of the National Institutes of Health, the Centers for Disease Control and Prevention, and the US Food and Drug Administration, and for safeguarding human rights.
At Tuesday’s Community Breakfast Club, where advocates met with CROI researchers, Chilufya Kasanda Hampongo of TALC in Zambia said advocacy must be unswerving in protecting the gains in HIV prevention. “We got here, as Rebecca Denison reminded us, by building coalitions, using our voices, and demanding inclusive dialogues. We cannot abandon equity, inclusion and diversity.”
The calls for researchers to be in solidarity with advocates and communities that benefit from their research spilled out of the Mascone Center and into the streets of San Francisco on Monday as well. Several researchers and activists addressed a crowd of hundreds at the Save Our Sciences Rally to Protect HIV Research. The rally, organized by the San Francisco AIDS Foundation demanded restoration of cuts to research and implementation programs that have been gutted at USAID, PEPFAR and NIH. Speakers called for the kinds of activism necessary to create the infrastructure for HIV research and programs, as well as the impact that HIV researchers have had on other issues, including vaccines and therapies now widely used to treat, cure or prevent Hepatitis B & C, COVID-19 and other disease areas.
Photo credits: Brooke Anderson, @MovementPhotog
The latest science presented at CROI represents a stunning achievement, built on 40 years of advocacy, coalition, toil and discovery. As we wrote in a recent newsletter, “These are immensely challenging times for all of us, 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.”
Stay tuned for our round up of HIV prevention research and development at CROI including exciting new data on a one-year injection of LEN for PrEP, on-demand PrEP protocols for women, LEN for PrEP among adolescents, a monthly oral PrEP pill, the impact of DoxyPEP, the latest on cure, and so much more.
Join Us for CROI 2025
This week, the 32nd annual Conference on Retroviruses and Opportunistic Infections (CROI) kicks off, running March 9–12 in San Francisco, CA. CROI opens under drastically altered circumstances, as the new US Administration’s assault on global health and research devastates the HIV response. Foreign aid programs are frozen, US agencies championing science and global health are being dismantled, and US leadership around the world is receding at a critical moment.
Despite these challenges, scientists and advocates will come together—though many from pivotal US health agencies will be missing—to confront the impact and implications of these changes and join in solidarity to strategize a future for public health, help advance research and ensure that hard-won progress in HIV is not lost.
Whether attending in person or not, this email shares ways to follow along and join in the discussion and debate.
New Issue of PxWire
This issue released just ahead of CROI dives into the devastating impact of the new US administration on HIV prevention—from crippling existing PrEP delivery to threatening the rollout of LEN for PrEP and paralyzing R&D.
In the midst of it all, we’re tracking several promising PrEP developments including new data on the investigational monthly oral PrEP pill, MK-8527; data from lenacapavir for PrEP’s PURPOSE 1 study on preferences for injectable versus oral PrEP; the dapvirine vaginal ring (DVR) in pregnancy; doxycycline as post-exposure prophylaxis (DoxyPEP) to prevent sexually transmitted infections (STIs); the latest in HIV cure and control; and more.
Be part of the conversation by following AVAC on BlueSky at @hivpxresearch.bsky.social, and be sure to sign up and follow our partner, Aidsmap, which we’re delighted to know is back in action and reporting from the conference.
Community Breakfast Clubs
Join the CROI Community Liaisons, AVAC, the European AIDS Treatment Group, and partners for daily Community Breakfast Clubs. These live webinars feature researchers and advocates exploring some of the most consequential science and discussions from CROI. They are open to all; CROI registration not required.
Click here to determine the time in your location.
Sessions of Interest
Monday, March 10
8:30 – 09:30am PT: Plenary 1, The Global HIV/AIDS Pandemic: Where Are We Now? Chris Beyrer, Duke Global Health Institute, Durham, NC, USA
10:30am PT: Oral Abstract Session 3, Lenacapavir Pharmacokinetics, Safety, and Efficacy in Adolescents and Adults in PURPOSE 1
1:30 – 2:30pm PT: Themed Discussion, Meeting the Treatment and Prevention Needs of Transgender Women
4:00 – 5:30pm PT: Symposium 3, Closing the Gaps in the HIV Response
6:00 – 7:00pm PT: Save Our Sciences Rally to Protect HIV Research!
Tuesday, March 11
10:00 – 11:00am PT: Oral Abstract 7, Antivirals for HIV, MPXV, and SARS-CoV-2: New Drug Strategies and Resistance; and Oral Abstract 8, New Frontiers in STI Prevention
4:00 – 5:30pm PT: Interactive Symposium 7, Long-Acting Preexposure Prophylaxis for HIV Prevention
4:00 – 5:30pm PT: Interactive Symposium 10, Putting People at the Center of Prevention: New Models of Delivery
Looking forward to seeing you at the daily Breakfast Club sessions and to working together to ensure science and open discussion and debate continue.
Global Health Watch: NIH Challenges, PEPFAR uncertainty & the battle over foreign aid
Issue 6: March 7, 2025
This week’s issue covers challenges confronting the US National Institutes of Health under the new administration, the uncertain future of PEPFAR, continued legal battles over the foreign aid freeze and urgent efforts in Africa to secure sustainable health funding amid drastic aid cuts. Read on for more.
AVAC vs. Department of State
On Wednesday, in response to the US government’s request, the Supreme Court ruled that the administration must release up to $2 billion in frozen foreign aid funding for work completed before February 13. This overturned a temporary stay granted by the Chief Justice last week. This was a small victory along the way. And on Thursday, the case was back in the District Court for a four-hour hearing where the judge ordered from the bench that the government must pay AVAC, the Global Health Council and other plaintiffs the outstanding balances they are owed by Monday evening.
IMPLICATIONS: Thursday’s ruling is a “concrete step” forward, said the judge overseeing the case, but it does not rule on or indicate the fate of the $2 billion in payments owed to other aid organizations. Even if some contracts are eventually reinstated, the State Department has already cancelled 90% of USAID’s work and tens of billions of dollars in Congressionally approved spending, so it is unlikely implementing partners and programs receive the funding they need to continue this critical work.
At a March 5 congressional hearing on threats to US-funded research, representatives debated strategies to counter security threats while investing in the US scientific enterprise. Republican committee members focused on restricting international students and researchers from US institutions, whereas Democrats focused on the threats from within. Specifically, administration and Congressional attacks on federal agencies, which jeopardize US leadership in discovery and innovation, and cuts to “indirect costs”, which are essential for maintaining research infrastructure and administrative overhead. “The money has to come from somewhere. The result [of these cuts] will be less research, driving many out of business. The impacts are potentially huge,” said MIT’s Maria Zuber who gave testimony at the hearing.
In a related and unprecedented move, the NIH on Wednesday initiated mass terminations of active research grants that no longer align with its new “agency priorities.” Internal documents reveal that NIH staff are required to review projects for ties to diversity, equity, and inclusion—especially those involving transgender issues, or research in China—and to classify them into categories for easier cancellation decisions.
And further, the NIH announced that it will centralize peer review of all grant and cooperative agreements, and research and development contracts within its Center for Scientific Review.
IMPLICATIONS: Forcing federal grants and programs to adhere to partisan ideology is anti-science and anti-evidence. Subjecting funding decisions to political tests will undermine essential research and jeopardize long-term research and future discovery. Further excising key populations from research ultimately limits the benefits and interventions that result from publicly funded biomedical research for those most vulnerable to HIV and other diseases.
The Future of the NIH: Jay Bhattacharya’s Confirmation Hearing
At his confirmation hearing to become NIH Director, nominee Jay Bhattacharya faced tough questioning on future NIH priorities, and how he would balance scientific integrity and political pressures. When questioned about the proposed indirect cost rate cuts and their ramifications, Bhattacharya defended the policy, saying it would enhance research efficiency while sustaining vital infrastructure. Bhattacharya pledged to focus the NIH on chronic diseases, rebuilding public trust in science through transparency and debate, and undergoing structural changes to support innovative research.
IMPLICATIONS: Despite concerns over Bhattacharya’s vaccine skepticism, AIDS denialism and racist views of immunology, his confirmation appears likely with a full Senate vote imminent. If confirmed, Bhattacharya would serve under Health and Human Services (HHS) Secretary Robert F Kennedy Jr. (RFK Jr.), who controls funding, administration and how science is communicated via the US CDC, NIH, FDA and other important health agencies. As the potential lead for NIH, Bhattacharya will be tasked with carrying out elements of RFK Jr.’s agenda of ‘Making America Healthy Again’. RFK Jr. was confirmed in February despite concerns over his vaccine skepticism, AIDS denialism, and racist views of immunology.
HHS Secretary Kennedy issued a policy statement rolling back a 1971 policy that requires public comment on rules related to grants, loans, public property and benefits. This policy shift veils the decision-making process and could enable controversial changes to be imposed without public discussion or debate.
IMPLICATIONS: This new directive will inalterably transform how NIH operates and significantly restrict the research community’s ability to engage in policymaking. It guts a critical mechanism established nearly 50 years ago for public and expert scrutiny of policy and stifles collaboration between scientists and government that has long driven scientific innovation and progress in public health. Moreover, this move further limits community engagement in NIH processes and research, losing valuable perspectives and insights that are necessary to enrich the impact of publicly funded biomedical research.
Advocates continue to fight for the PEPFAR program. On Wednesday, AVAC, the Global AIDS Policy Partnership (GAPP) and The U.S. Congressional Caucus on Black Women & Girls Co-Chairs Representatives, Robin Kelly (D-IL), Yvette Clarke (D-NY), and Bonnie Watson Coleman (D-NJ) hosted, the congressional briefing, The State of PEPFAR. The briefing featured a broad panel with AVAC’s Senior Policy Manager John Meade, Jr. serving as co-moderator. Panelists included Friends of the Global Fight’s Chris Collins, Desmond Tutu HIV Center Director and AVAC Board member Linda Gail Bekker, Angeli Achrekar of UNAIDS and Jirair Ratevosian of the Duke Global Health Institute. They offered insightful analysis on how recent administrative decisions threaten global progress in HIV.
“The hardest hit are key populations—Black gay men, sex workers, transgender people, people who inject drugs and Adolescent girls and young women—those already on the margins of society. Their clinics are shutting down, their communities are losing access to PrEP and HIV treatment,” noted AVAC’s John Meade, Jr. “Congress must act immediately to restore and protect funding for PEPFAR and global HIV programs. This is not a partisan issue—PEPFAR has enjoyed strong bipartisan support for over two decades because it works. It has saved lives, strengthened economies, and reaffirmed America’s role as a leader in global health.”
The foreign aid freeze, dismantling of USAID and many other US actions under the new administration are accelerating discussions on how African governments will tackle the immense challenges ahead. At this week’s Africa Health Agenda International Conference (AHAIC) in Kigali, African leaders, advocates, and delegates confronted the funding crisis head-on, exploring urgent, innovative financing models to ensure the long-term sustainability of essential health programs. While some see this moment as an opportunity to build capacity and reduce dependence on external aid, others warn that without significant domestic reforms, the sudden loss of aid will intensify poverty, strain resources, and further impede development across the continent.
The new edition dives into the assault on global health and its devastating impact on HIV prevention—from crippling existing PrEP delivery to threatening the rollout of LEN for PrEP and paralyzing R&D.
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:
Follow: For updates on our case and one filed by Global Health Council, visit AVAC vs. Department of State. For the latest on the policy environment in the US, subscribe to our weekly Global Health Watch.
Donate: Your financial contributions are vital to fund our legal actions and advocacy efforts! Give here.
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.
Global Health Watch: Lawsuit Rollercoaster, USAID Grants Terminated, NIH Research Funding in Limbo
Issue 5, February 28, 2025
This week has been marked by a further flurry of intense developments in global health, with aggressive political and legal actions by the new presidential administration and implications for PEPFAR, research, global health and more. Below is a roundup of the key issues and events shaping our work this week.
AVAC vs. Department of State
Court cases against the US administration’s foreign aid freeze, including AVAC vs. Department of State, saw a lot of activity this week. Tuesday, the Federal Court ordered the administration to pay all invoices submitted and ensure reimbursement for work by midnight Wednesday. In response, the administration sought a temporary stay from the US Supreme Court. Chief Justice John Roberts, who handles emergency requests like this, granted the stay, allowing the Court more time to review the case and relieve the USG of its obligation to meet the February 26 payment deadline set by the lower court. At the same time, the overall case is still proceeding, and the lower court will hold a hearing of AVAC’s case (in combination with the related case brought by Global Health Council and partners) early next week (by March 4).
IMPLICATIONS: The temporary stay issued by the Supreme Court does not imply how the Court will rule next week, and this is just one of a flood of cases challenging the new administration’s many questionable executive actions. We are witnessing a time when the US judicial system will be tested by the sheer volume of unconstitutional acts, and if the administration will comply with the rulings.
Nearly 10,000 contract awards from USAID and the State Department were terminated on Wednesday, impacting a wide range of global programs. These cuts affect not only HIV programs, but also tuberculosis research and treatment access, malaria prevention, food and nutrition aid, and many other vital humanitarian assistance projects and programs worldwide.
These cuts, affecting over 90% of the agency’s work and tens of billions of dollars in Congressionally approved spending, could bankrupt many implementing partners and shutter lifesaving programs, including critical components of PEPFAR.
IMPLICATIONS: By cutting 90% of USAID’s work, including programing for HIV, like PEPFAR, many implementing partners do not have capacity to deliver live-saving HIV treatment and prevention programming, services and supplies. Tens of thousands of in-country health workers are unemployed; clinics shuttered; trust and confidence of patients, partners and governments are now gone. While the administration insists that foreign aid, which represents roughly 1% of the federal budget, has become wasteful and detached from US interests. However, these actions dangerously undermine the US’ global influence and soft diplomatic power.
PEPFAR, the US government’s flagship HIV/AIDS program, is confronting unprecedented challenges under President Trump’s second term. The executive order to pause foreign aid, the dismantling of USAID, which implements approximately 50% of PEPFAR’s investment, and intensified political scrutiny of PEPFAR, have all destabilized the program’s once-stalwart support, with reauthorization coming in late March.
IMPLICATIONS: Jirair Ratevosian, who previously was PEPFAR’s chief of staff and Legislative Director for former US Congresswoman Barbara Lee of California, explores what a post-Trump global HIV response might look like with Mia Malan on this must-listen Bhekisisa podcast. “I think where all this is leading is to a State Department-led foreign assistance effort that will be implemented through partnerships that are not going to be as diverse and complicated as there were before. And there are some consequences…I think that we’re going to an era where the operating part will look very different, but I think we have to look at it as an opportunity…I’m hopeful this is one of those bright spots where, when you reduce the number of intermediaries, so to speak, you could actually save some money, give more of it to the program itself, and then that can hopefully lead to more productivity at the country itself.”
NIH funding continues to be at a standstill as final funding decisions remain in limbo—research grants are still frozen amid ongoing legal battles. In the meantime, an investigation suggests that individuals connected to Elon Musk’s Department of Government Efficiency (DOGE) task force now have access to the NIH’s financial systems, raising fresh concerns about the agency’s internal oversight.
As scientists and advocates are confronted with the new administration’s assaults on scientific integrity, many are mobilizing.
At the nation’s capital this week, protestors staged a “die-in,” to spotlight the dismantling of USAID and foreign aid, and the impact on countless lives and livelihoods under the new administration’s orders. A recent editorial in Science detailed how scientific leaders, universities, and professional organizations are organizing—through lawsuits, public statements, and advocacy efforts—to defend the integrity of science. “We will not change the principles and processes by which we serve the scientific community; those outside the United States should not have to alter their research agenda or methods because of bad decisions about science policy in the US.”
The Community Health & HIV Advocates Navigating Global Emergencies (CHANGE) coalition is developing resources for advocates and organizing to protect access to HIV treatment and prevention. Find their resources featured in Global Health Watch and contact them at [email protected].
