Global Health Watch: NIH Orders Pause on HIV Trials, Zimbabwe + Zambia Health MoUs, WHO + Global Fund leadership, Foreign Assistance Funds

Issue 89

The US National Institutes of Health (NIH) said its HIV clinical trial networks should “temporarily hold off on launching new studies that had not yet enrolled participants and that would not be complete by November 30, 2027, when their current funding is set to expire.” This potentially devastating development comes as new questions emerge about how billions in US foreign assistance funding were spent, and details on the impacts of an end of US health assistance to Zimbabwe emerge. Also, a new candidate for WHO leadership and growing civil society calls to protect UNAIDS.

NIH Orders Pause on New HIV Clinical Trials Amid Funding Delays 

The National Institutes of Health (NIH) instructed leaders of its four HIV clinical trials networks to temporarily pause launching new studies that have not yet begun enrolling participants and would extend beyond November 30, 2027 (when funding expires). As The New York Times reports, this comes amid continued delays in releasing Notices of Funding Opportunities (NOFOs) to renew the networks and the Centers for AIDS Research (CFARs) for the next seven years, threatening research infrastructure built over decades and potentially disrupting clinical trials and services for participants. In response, AVAC, along with allies PrEP4All, HIVMA, TAG, and AIDS Action Baltimore as part of the Save HIV Funding Campaign are inviting sign-ons to a letter to Congress demanding that the US Department of Health and Human Services (HHS) authorize the long overdue funding announcements. Organizations can sign-on by October 15. 

IMPLICATIONS: The affected clinical trial networks include the Advancing Clinical Therapeutics Globally for HIV (ACTG), HIV Prevention Trials Network (HPTN), HIV Vaccine Trials Network (HVTN), and the International Maternal Pediatric Adolescent AIDS Clinical Trial Network (IMPAACT). The delayed renewal of the networks and the directive to hold off on launching new studies create uncertainty for the research pipeline, potentially delaying scientific advances, disrupting services for trial participants and weakening infrastructure built over decades. These networks have yielded critical advancements for HIV treatment and prevention and are important catalysts for tuberculosis treatment and prevention research, and for other emerging infectious diseases. Simultaneously, the proposed NIAID reorganization raises questions about the future of centralized clinical research oversight and support. As AVAC shared with the NIAID Council and the AIDS Research Advisory Committee (ARAC) at their meeting September 27, “Collectively, these programs have saved millions of lives over the last several decades and advanced some of the most important scientific discoveries and implementation science advances. Delays in the release of the NOFOs are forcing clinical trial sites to prepare for lapses in funding that could harm study participants, halt promising clinical trials, and erode the scientific workforce and infrastructure that has taken decades to develop.” In sum, the continued attacks on the HIV research infrastructure could reshape the trajectory of research for years to come.

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US Health Assistance Ends in Zimbabwe as Zambia Signs New Agreement 

The US Department of State was said to begin implementing its America First Global Health Strategy across 35+ partner countries on October 1, the start of the US fiscal year. But this is all evolving differently across countries. In Zimbabwe, US bilateral health assistance ended September 30 after the two countries failed to reach an agreement. Health GAP details the disagreements, which include sharing health data and biological specimens, but more importantly, major reductions in US funding and co-financing requirements that would have required Zimbabwe to increase its contributions by 290% in the first year. It proposes several next steps to avert the crisis. Health Policy Watch reports that “researchers project that there could be over 75,000 new HIV infections in Zimbabwe within a year ‘as a consequence of full PEPFAR withdrawal and no additional government or international support’.” 

In contrast, the US and Zambia signed a five-year, $2.49 billion health agreement yesterday, following months of negotiations. Zambia reports that requirements to share patient-level health data and biological specimens were removed, while negotiations over critical minerals were separated from the health agreement. Meanwhile, South Africa is preparing for the phaseout of PEPFAR support by March 2027, raising concerns about the future of community-based HIV prevention and treatment services. 

IMPLICATIONS: The withdrawal of US health assistance in Zimbabwe could dismantle decades of progress against HIV, TB and malaria, with consequences beyond the immediate term. Health GAP warns that the crisis could disrupt Zimbabwe’s introduction of injectable lenacapavir for HIV PrEP, jeopardizing access to one of the most important recent advances in HIV prevention. The implications are particularly alarming because these are interconnected programs: disruptions to community health workers, laboratories, supply chains and service delivery can undermine responses to all three diseases simultaneously. 

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Foreign Assistance Funds Committed as Questions Over Spending Persist 

The US 2026 fiscal year ended on September 30, and the picture is becoming slightly clearer on how billions of dollars of Congressionally-appropriated global health funding was actually spent. According to Devex and in court filings, the US Department of State committed more than $4 billion in foreign assistance funding just before the end of the fiscal year, preventing much of that money from expiring. A new filing in the Global Health Council and AVAC court cases shows that only $18,919 in Global Health Programs funding for which the State Department was responsible expired without being committed. However, the filing also identifies funds committed to covering the costs of closing out USAID, rather than supporting health and development programs as Congress had intended.  

IMPLICATIONS: This adds to concerns raised last week about the transfer of $2.5 billion originally intended for global health and development assistance into an alternative or ‘miscellaneous’ account. While the government appears to have met much of the deadline for committing funds, questions remain about where the money is going, whether it is being used as Congress intended and when it will actually reach programs and communities. As AVAC’s Mitchell Warren summarized last week, “the issue extends beyond foreign assistance or the HIV response; it is fundamentally about Congress’s constitutional power of the purse.” 

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WHO and Global Fund Leadership Updates

Last week, leadership candidates for the Global Fund to Fight AIDS, Tuberculosis and Malaria, and WHO were announced. This week, China confirmed its nomination for WHO Director-General, expanding the known candidates to seven and raising questions about geopolitical influence as the US withdraws from the organization. On his Global Health Insights Substack, former WHO Adviser Peter Singer published a scorecard examining how specifically candidates have articulated plans to deliver measurable results and protect WHO’s scientific independence. And in Lights. Camera. Equity!, former Global Fund Board member Jirair Ratevosian called for greater public engagement in the Global Fund’s selection process. He reported that the Fund confirmed it has no plans for a public candidate forum, with engagement instead taking place through Board constituencies. 

IMPLICATIONS: These developments raise questions about transparency and accountability in choosing the next generation of global health leadership. These new leaders will face immediate decisions that will shape how these institutions define their roles in an evolving architecture. WHO is already reducing its staff significantly after the US refused to support it, and the Global Fund is facing difficult decisions about where and how to invest its smaller Grant Cycle 8 budget. 

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Civil Society Calls for Protecting UNAIDS

Ahead of the October 26 UNAIDS Programme Coordinating Board (PCB) meeting, more than 225 civil society organizations signed an open letter urging members of the PCB to protect the Joint Programme from being dismantled through proposed funding, staffing and operational cuts. Advocates warn that proposals to reduce UNAIDS to a $30 million budget and just 34 staff could undermine its ability to coordinate the global HIV response, defend human rights and ensure meaningful community leadership and accountability. 

IMPLICATIONS: The upcoming UNAIDS PCB meeting will be a defining moment in determining the Joint Programme’s essential functions and whether and how reform can preserve UNAIDS’ leadership, accountability and community engagement.

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What We’re Reading

Resources

HIV Prevention Pipeline: Products to Watch

From the People’s Research Agenda, this graphic tracks the pipeline of potential new HIV prevention options across broadly neutralizing antibodies, preventive vaccines, pre-exposure prophylaxis, and multipurpose technologies.

An interactive version of this graphic is available.

ARV-Based and Multipurpose Prevention Technology R&D Pipeline

The pipeline of non-vaccine HIV prevention products includes oral pills, vaginal rings, vaginal and rectal gels, vaginal films, long-acting injectable antiretrovirals and more. Also pictured are the range of MPTs in development that aim to reduce the risk of HIV and STIs and/or provide effective contraception for women.

Click here for a view of all large-scale prevention trials.

At A Glance: The MPT R&D Pipeline

This graphic shows the status of products in development.

Lenacapavir Regulatory Approval

Regulatory approvals, pending decisions, and appeals as of September 2026. For product approvals, volumes, implementation, and price comparisons of long-acting PrEP, visit our dashboard on PrEPWatch.org.

AVAC’s Remarks to the NIAID Council and the ARAC on the proposed NIAID reorganization

AVAC delivered a public comment for the record at the NIAID Council meeting raising concerns about the proposed NIAID reorganization and its potential impact on HIV research, including the elimination of the Division of Clinical Research, disruption to global research and community engagement, and delays in funding for HIV Clinical Trials Networks and Centers for AIDS Research. AVAC urged NIH to withdraw the proposal, provide greater transparency and meaningful opportunities for community input, and immediately release the delayed funding opportunities.

Artificial Intelligence in the HIV response: All the good stuff from AIDS2026

An analysis by Jirair Ratevosian of the Duke Global Health Institute looked comprehensively at AI-related abstracts, key themes from use cases, and emerging trends at AIDS 2026. His review shows the potential of AI to support HIV testing and prevention, including PrEP, and improve linkages to care and services, particularly in sub-Saharan Africa. “AI is becoming a new front door to HIV services,” he writes, but the analysis also shows that while most of the research was focused on feasibility and pilot implementation of AI, a significant evidence gap around health outcomes, as well as privacy, community engagement, and governance remains. He concludes that: AI is working, but trust is what makes or breaks the product; specialized tools beat generics; human-in-the-loop is becoming standard; the field needs to move from pilots to proof of outcomes; and scale depends on systems, not just models.

Is Aspen betting on the right HIV prevention product?

Following Aspen Pharmacare’s announcement that it will not be manufacturing the lenacapavir HIV prevention injection and will instead focus on producing alimatravir, Spotlight explores the reasoning behind Aspen’s decision and assesses what it all means for local pharmaceutical production. The article features infographics produced by AVAC, tracking PrEP price comparisons and alimatravir clinical trials.

Avac Event

Combo bNAbs for HIV Prevention – Latest Developments

Broadly neutralizing antibodies (bNAbs) remain at the center of research toward an HIV vaccine and immune-based HIV prevention. In particular, researchers are advancing the concept of “combo AMP” – passive delivery of a combination of bNAbs targeting multiple sites on the viral envelope – achieving broader and stronger protection than with a single bNAb, as in the original AMP trial.  

At AIDS 2026, the CAPRISA team from Durban, South Africa announced results from the CAP 012c Phase 2 trial examining a combination of two bNAbs, which unfortunately showed no statistically significant difference in HIV incidence rates between the combo bNAb and placebo arms.  

The HIV Vaccine Trials Network (HVTN) is currently designing a three bNAb combination study. Additional bNAb research is tracked as part of AVAC’s People’s Research Agenda. 

In this webinar, we shared the latest updates on the bNAb pipeline and discussed what the future holds. 

All things alimatravir (AMI)

Alimatravir (AMI, known as MK-8527) is an investigational monthly pill being studied for PrEP in the EXPrESSIVE program. The addition of a monthly PrEP pill, if proven safe and effective in the EXPrESSIVE trials, will expand the number of prevention options and open the door to new and innovative delivery models.

AVAC and partners have been engaging with Merck/MSD since the very start of the Alimatravir product development program and helped conceptualize the EXPrESSIVE efficacy trial design. Building on this foundation of community-centricity, advocates can now push for AMI to be rolled out with speed, scale and equity. Since 2012, each successive PrEP introduction has gone faster than the previous one, yet the time to market and to public health impact for PrEP remains too slow. Read on for AVAC’s insights on AMI, from accelerated licensing and affordability to community priorities and meaningful engagement.

The Latest on AMI

Just before the AIDS 2026 conference in July, AMI developer Merck/MSD granted seven direct licenses to generic manufacturers to produce and market the drug in 129 low- and middle-income countries, including all of Africa and much of Asia, while the trials are still enrolling. These agreements are in place 18 months before a possible efficacy result, and substantially earlier than for lenacapavir or cabotegravir. If AMI is found safe and effective, these agreements could greatly accelerate the introduction process. AVAC and Access Bridge welcomed the announcement, highlighting the challenges that remain to ensure future access is equitable and widespread among the populations that need it most.  

While overall good news, several countries that are hosting the EXPrESSIVE 11 trial are left out of the voluntary license territory, reflecting a broader trend of ;excluding Latin American countries and some Asian countries from voluntary licenses. Merck/MSD did subsequently sign a memorandum of understanding with Fiocruz, a Brazilian manufacturer, to supply AMI for Brazil and the region, but the terms, timing and next steps remain unclear. Furthermore, key populations in high-income countries also face access disparities.

Find all the latest updates on AVAC’s alimatravir page.

PxWire Explores AMI Generic Licensing Agreements

AVAC’s latest edition of PxWire features an analysis of generic licensing for AMI and what it means for the field, and an explainer on generic licensing agreements and current coverage across long-acting prevention products. The explainer examines the promise of generics for advancing affordable, equitable access and raises questions about the persistent and worrying gaps in these agreements. 

Read the latest edition of PxWire.

AMI Could Be the Cheapest HIV Prevention Option Yet, But Does Affordable Mean Accessible? 

Photo credit: aidsmap

A new academic analysis presented at AIDS 2026 suggests that AMI could be manufactured at large scale by generic companies and sold for as low as $3 per person per year, and a separate New York Times report highlighted estimates that generic AMI could be sold to national health systems for as little as $5 per person per year. But an affordable product is only impactful if people can access it. As the Gates Foundation’s Max Lataillade said in an AVAC satellite session at AIDS 2026, “Innovation without global access or implementation does not create the impact that we want. Science creates the possibility, collaboration creates the impact, but communities create the future.”

Read AVAC’s coverage of the AMI modeling data presented at AIDS2026.

From Research to Access: Community Statement from the Global Community Advisory Group (GCAG) on the Future of Alimatravir for HIV Prevention 

Following Merck/MSD’s generic licensing announcement for AMI, the EXPrESSIVE-10 Global Community Advisory Group (GCAG) released a statement on community perspectives and priorities around prevention choice, meaningful community engagement, equitable access and ensuring that communities have a voice as research progresses toward potential introduction. As the GCAG writes, “The test is now whether early planning can translate into faster, more equitable action. An access plan is valuable not because it is announced, but because it creates a pathway that can be tracked, challenged, and delivered.” 

Read the EXPrESSIVE-10 GCAG statement.

Putting Communities at the Center of EXPrESSIVE 

The EXPrESSIVE program includes two phase 3 efficacy trials studying AMI for HIV prevention—EXPrESSIVE-10 among cisgender women and EXPrESSIVE-11 among cisgender men who have sex with men, transgender men, transgender women and gender non-binary individuals. The trials are anticipated to have results in the latter half of 2027. With support from the Gates Foundation, AVAC is supporting strong, consistent community engagement across the program. As a part of this work, AVAC partnered with community-based organizations in Argentina, Brazil, Kenya, Peru, the Philippines, South Africa, Thailand and Vietnam to develop educational materials for EXPrESSIVE-11 through a participatory human-centered design (HCD) process. Luciana Kamel, the Community Education Team Lead for HIV studies at Fiocruz, AVAC’s partner in Brazil for this work, described how this approach changed what was possible: “The trust, openness and respect for our work with the community made it possible to move beyond simply producing recruitment materials and instead build something that reflected the people and contexts the study was intended to engage.”  

Learn more about community-led design in EXPrESSIVE-11.

Check out all the communications materials here.

Additional AMI Resources