This week major shifts in development finance make headlines as do the real-time consequences of the US cuts to foreign aid and withdrawing from the WHO. AVAC’s new issue of PxWire amplifies issues of access, equity, and accountability with an update on biomedical prevention research and rollout. 

Rethinking Health Aid  

The World Bank‑IMF Annual Meetings wrapped up last week highlighting a critical shift in development finance. African leaders and multilateral agencies signaled a move away from traditional aid models and toward investment‑led growth. They emphasized the need for stronger institutions, locally driven capacity, and private‑sector engagement rather than just grants. At a side event, Dr. Jean Kaseya, Director General of the Africa Centres for Disease Control and Prevention (Africa CDC), stated that up to 60% of the continent’s past foreign health aid may have been largely “wasted” (attributed to fragmentation in the health sector among other things), prompting calls for smarter, more accountable finance for health.  

IMPLICATIONS: With traditional aid shrinking and philanthropic models racing to adapt, the world may see healthcare investment shifting as a core aspect of economic development, which may lead to more investment in robust national health systems, supply chains, local research and development, and an expanded workforce to make countries less dependent on external aid. For HIV prevention, this means country ownership, and innovative and sustainable financing must take the lead to ensure that evidence-based programs, services and products reach everyone in need and access is not derailed by donor funding shifts.  

READ:  

• From aid to investment: Reshaping Africa’s path to growth—Devex  
• As aid shrinks, top philanthropies test new ways to spur economic growth—Devex  
• Africa CDC chief: 60% of foreign health aid was effectively wasted—Devex  
• Africa Seeks More Self-Reliance Amid Disease Outbreaks and Decline in Donor Funds—Health Policy News

Politics Reshaping Global Health 

In parallel to the discussion at the World Bank, Politico’s recent piece highlights the implications of the United States’ withdrawal from the World Health Organization and other key multilateral initiatives. This reporting underscores how deeply politics is reshaping global health. The US Administration’s “America First” strategy, combined with steep foreign aid cuts, continues to leave countries grappling with uncertainty over how to sustain essential programs once supported by US funding.  

IMPLICATIONS: Many articles this week are showing the health impacts of the upended global health system, with many questioning how the global health community will navigate not only budget cuts but recasting health aid as bilateral, strategic, and conditional rather than universal and humanitarian. 

READ:  

• Trump is cutting foreign aid. He’s not the only one.—Politico   
• The Story of the Unfolding HIV Crises As Seen in Three Countries: Uganda, Thailand and Malawi—Geneva Health Files 
• Botswana faces new HIV scare as shortage of medicines deepens—The Mail and Guardian 
• National Institutes of Health funding cuts will ‘impact us for years’—NPR 
• A Somali Hospital Closed After U.S. Aid Cuts. Fired Employees Reopened It Without Pay.—New York Times 
• Ritshidze report spotlights ‘system-wide slide’ in basics for health facility standards after Pepfar cuts—Daily Maverick 

Tracking the HIV Prevention Landscape

AVAC’s new issue of PxWire shows the promise of PrEP – across R&D and delivery. Long-acting injectable lenacapavir for PrEP is advancing toward rollout, with the first supplies expected to reach select countries before the end of the year. Simultaneously, this quarter’s issue tracks updates to pricing of existing PrEP products and the launch of Phase 3 trials for a once-monthly prevention pill. 

READ:  

• PxWire Volume 15, Issue 4—AVAC  
• The Promise of PrEP for HIV—Foreign Policy

What We’re Reading

• NEJM and public health group are launching rival to CDC’s MMWR publication—STAT
• Urgent action needed as Treatment Action Campaign highlights 50 percent cut in HIV funding—IOL South Africa
• Are Cabotegravir Injections More Tolerable Than Lenacapavir?—POZ
• Gilead agrees not to raise prices on HIV medicines for state AIDS drug programs—STAT
• CVS Caremark tells AIDS activists Gilead needs to lower the price of its new HIV drug to get on formularies—STAT
• Who should get the first doses of the twice-a-year HIV prevention jab? It could be in 360 clinics by February—Bhekisisa
• Overcoming disruption, transforming the AIDS response – World AIDS Day 2025—UNAIDS
• More Europeans are dying from HIV now than 15 years ago—Aidsmap
• Join the PrEP Revolution: How to Fight for HIV Prevention [VIDEOS]—POZ
• Anti-science bills hit statehouses, stripping away public health protections build over a century—STAT
• Can Africa’s drug regulators be both fast and trusted?—Devex

New & Updated AVAC Resources

• PxWire Volume 15, Issue 4
• Source of Programmatic Cabotegravir for PrEP Supply
• Source of Lenacapavir for PrEP Supply to Early Adopter Countries
• EXPrESSIVE Phase 3 Trials Countries of MK-8527
• Years Ahead in HIV Prevention Research: Time to Market
• Lenacapavir Implementation Studies 

Upcoming Webinar

This issue provides a range of maps to help orient the field on critical HIV prevention activities: the status of delivering injectable cabotegravir (CAB for PrEP); funders and countries on track for early introduction of injectable lenacapavir (LEN for PrEP); and where new Phase 3 efficacy trials testing MK-8527 as a monthly pill for PrEP are taking place.

Key Takeaways

• Supply of LEN is due to begin arriving in countries in late 2025 with service delivery planned to start in early 2026.
• The Global Fund, with support from CIFF, and PEPFAR have jointly committed to reaching up to two million people with LEN for PrEP over three years.
• Seventeen countries are hosting sites for the Phase 3 efficacy trials of a monthly PrEP pill, MK-8527, being developed by Merck. Merck announced the launch of the Phase 3 trials at IAS 2025 in Kigali. MK-8527 was found to be safe and well-tolerated in Phase 2 clinical trials.
• Merck’s commitment to stakeholder engagement to date contributes an important model of Good Participatory Practice (GPP) to the field, by putting global advocates at the forefront of planning for the program and trial design. Merck has expressed a commitment to sustain this vital engagement throughout the program and next steps.

The US government shutdown escalated this week as the Administration acted on its Reduction in Force (RIF) threats across federal health agencies, laying off thousands and then retracting many of these notices, yet again increasing the chaos and confusion. The UK-based Children’s Investment Fund Foundation (CIFF) abruptly cut all funding to US-based NGOs, and world leaders urged a streamlined global health system amid funding cuts, as Germany pledged €1B to the Global Fund at the World Health Summit.

US CDC Layoffs

Late Friday, the US Centers for Disease Control and Prevention (CDC) issued more than 1,300 layoff notices in response to the US government shutdown. These RIFs eliminated entire units across global health, epidemiology, disease surveillance and the writers of the Morbidity and Mortality Weekly Report (MMWR), one of the most valued public health publications. However, within days, chaos and confusion intensified as many notices were retracted due to “coding errors”. Despite the backtracking, critical offices such as IRB, ethics, human resources, and policy liaison remain shuttered.  

IMPLICATIONS: These disruptions are not just a domestic crisis; they are derailing global health efforts. The CDC is central to surveillance, epidemic response, vaccine research, and technical guidance for implementing programs in the US and around the world. When it loses capacity, these critical initiatives falter.  
READ:  

• Haphazard US CDC staff cuts leave questions around impact—Devex  
• Trump’s shutdown firings at CDC cause whiplash, despair: What to know—The Hill  
• ‘Instability and whiplash’ as CDC slashes 1,300 jobs before reinstating half—The Guardian  
• With new cuts at CDC, some fear there’s ‘nobody to answer the phone’—NPR  
• Trump Administration Admits It Laid Off Twice as Many HHS Employees as Intended—NOTUS  
• Trump Administration Lays Off Dozens of C.D.C. Officials—New York Times  
• ‘A Kick in the Mouth’: Trump Administration Makes Staffing Cuts to CDC’s Safety Office Months After Shooting—NOTUS

CIFF Cuts US Funding

The UK-based Children’s Investment Fund Foundation (CIFF), a major global funder in child health and HIV prevention (including to AVAC), announced that it will immediately stop all grants to organizations based in the US amid increasing ambiguity in US laws governing foreign philanthropy. This decision terminates all active US contracts effective at the end of October, including grants to many organizations, including AVAC, that are still reeling from USAID stop-work orders earlier this year. According to Devex, in 2024, CIFF gave $12.7 million to the Rockefeller Philanthropy Advisors, $7.3 million to PATH; $7.1 million to Piramal Foundation USA; $6 million to The Carter Center, and $2.6 million to AVAC. The decision to cease funding in the US follows weeks of pressure, including a critical National Review article targeting CIFF’s founder Sir Chris Hohn.  

IMPLICATIONS: US foreign policy is becoming more hostile toward philanthropy—both inside and outside the US—and is reshaping the future of HIV prevention and global health funding. As donors like CIFF bypass US-based institutions, NGOs are confronting a new reality where political pressure—not program performance—can sever funding overnight. While these changes in the funding landscape can align with broader calls to recenter global health and accelerate investment in local organizations, it also creates challenges for organizations in the Global South to rapidly scale their governance, compliance, and financial systems to receive direct investment.  

READ:   

• Update for Our Partners—CIFF  
• Major foundation pauses grants to US, citing unclear policy changes—Devex  
• EU Foundation Suspends Partnering With U.S. Charities—Nonprofit Times

World Health Summit Updates

Global health leaders, civil society, and policy makers were in Berlin, Germany, this week for this year’s World Health Summit. With the theme of Taking Responsibility for Health in a Fragmenting World, this year’s Summit reflects the converging challenges of funding cuts, broken systems and geopolitics. Leaders from WHO, Gavi and Global Fund urged the sector to reduce duplication across agencies and consolidate the global health architecture, calling the aid system “too fragmented” and “too confusing” and urging fast action. Meanwhile, Germany committed €1 billion over three years to support the Global Fund. Despite being 25 percent lower than Germany’s previous pledge, it is an important sign of the importance of global health in German foreign policy and, hopefully, a catalyst for other European funders to step up in support of the Global Fund. Also, African leaders recommitted to local manufacturing of vaccines, diagnostics, therapeutics, and health technologies as part of a push toward sovereignty in health systems. 

IMPLICATIONS: The financial crisis facing global health, with the abrupt withdrawal of US aid as well as reductions from other donors, exposes structural problems that many acknowledge have existed for years—and now need urgent attention. The latest data from the Institute for Health Metrics and Evaluation showed global development assistance for health fell 21% between 2024 and 2025, driven almost entirely by a 67% drop in US financing, more than $9 billion. As Global Fund Executive Director, Peter Sands said, “I do think we’re actually going to have to reduce the number of entities. The system is too fragmented. There are too many underfunded institutions. There’s too much duplication. It’s too complex. That diagnosis, I think, is pretty straightforward.” 

READ:  

• Global Health Leaders Urge Fewer Agencies Amid Funding Crisis—Health Policy Watch 
• Africa inches toward local production of vaccines and more—Devex  
• Germany commits €1B to Global Fund as aid cuts shape World Health Summit—Devex  

What We’re Reading

• The only thing standing between humanity and the end of HIV—Vox
• New HIV preventive drug under discussion—Newzroom Afrika
• They Fought Outbreaks Worldwide. Now They’re Fighting for New Lives.—New York Times
• PEPFAR’s Contributions to Health Systems and Global Health Security—Journal of Infectious Diseases
• Inside FDA, career staffers describe how political pressure is influencing their work—STAT
• Judge says she plans to order Trump administration to pause shutdown layoffs—Washington Post
• As US shutdown drags on, ‘it’s just one blow after another’—Science
• Maldives becomes the first country to achieve ‘triple elimination’ of mother-to-child transmission of HIV, syphilis and hepatitis B—WHO
• No eradication without innovation: the EU at a crossroads to eliminate HIV/AIDS, TB, and malaria—Global Health Advocates
• Foreign Aid Is Mostly Gone. It Could Be Replaced With Something Better.—New York Times (opinion)
• Pharma’s shift away from infectious disease research could spell disaster for the world’s poorest people—STAT

AVAC Resources

• Lenacapavir Regulatory Approval
• Potential Demand for LEN for PrEP
• HIV Prevention Product Overview
• Where We Are Now With LEN
• PrEP Price Comparison

Upcoming Webinars

Join our panelists for an unflinchingly honest—and interactive—conversation as we assess the impacts of the ongoing assault on transgender communities, gender affirming health care, data collection, and Diversity, Equity and Inclusion writ large. Strategies to restore trust, sustain programming, and rebuild from the ashes will be explored.

Join Funders Concerned About AIDS (FCAA) to explore how shifting legal and policy environments are shaping HIV responses, why bold and intersectional advocacy strategies matter, and where philanthropy can make catalytic investments to protect and advance progress. 

As the US government is in its second week of being shut down, the ripple effects across global health shows the interconnectedness of the public health infrastructure in the US and globally and uncertainty about the future of foreign aid. Amid this turmoil, the World Health Organization has prequalified injectable lenacapavir for PrEP in record time, using a new, expedited process. This development marks an important bright spot, signaling momentum toward broader HIV prevention access.

WHO Prequalifies Oral and Injectable Lenacapavir 

The World Health Organization (WHO) prequalified both the oral tablet and injectable forms of lenacapavir (LEN) for PrEP. The prequalification was done through a new, expedited prequalification pathway that can facilitate national registration through the Collaborative Registration Procedure for Prequalified Products (CRP-PQ), which may streamline access to these products beyond the traditional approval routes. WHO prequalification followed the European Medicines Agency’s (EMA) positive scientific opinion and happened 36 days after filing. As Meg Doherty, WHO’s Director of Science for Health and former visionary director of WHO’s Global HIV, Hepatitis and STI Programmes, pointed out, this is the first example of 12-month alignment of WHO guidelines and prequalification of a product within 12 months of the clinical trial evidence. 

IMPLICATIONS: This milestone represents major advances in speeding access for global HIV prevention. The speed and flexibility of WHO’s accelerated process represents regulatory innovation that can accelerate access to essential health products. For lenacapavir, prequalification means that countries may be able to move more quickly through the process of licensing and delivering the product with fewer regulatory barriers and faster timelines. Now, other aspects of the delivery chain – procurement, supply chains, equitable distribution mechanisms, demand creation, monitoring and evaluation and implementation science – need to adapt this commitment to speed in reaching large-scale impact.  

READ:  

• First lenacapavirs prequalified—WHO  
• The six-monthly anti-HIV jab is coming. But can SA keep track of millions of users?—Bhekisisa  
• Panel Discussion: The Role of Basic Science, Global Clinical Trials and Community Engagement in the Development of Lenacapavir—24 Hours to Save AIDS Research marathon

US CDC Deleted Critical Health Information from Websites Silently 

The decisions and actions at the US Centers for Disease Control and Prevention (CDC) continue to spiral downward. Earlier this week, key public health content was removed from its websites, including guidance on HIV and STI prevention, testing, and treatment. These deletions occurred without notice or explanation, which prompted public health leaders and organizations, including AVAC, to condemn the actions: “Removing these resources undermines transparency, public trust, and efforts to eliminate health disparities, especially for communities most affected by these epidemics.” 

IMPLICATIONS: The CDC’s quiet removal of crucial HIV and STI content has not been done in isolation. We’ve witnessed a quick erosion of scientific leadership and transparency and an uptick in mis-information. Together, these actions continue a troubling shift, where political agendas override scientific transparency. 

READ:  

• HIV, STI Leaders Condemn the Recent Deletion of Critical Public Health Information From CDC Websites—POZ

NIAID Initiates Network Renewal Process 

The US National Institute of Allergy and Infectious Diseases (NIAID) initiated a public consultation to gather feedback on the future of its four Division of AIDS (DAIDS)-sponsored HIV clinical research networks: the AIDS Clinical Trials Group (ACTG), International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT), HIV Prevention Trials Network (HPTN), and HIV Vaccine Trials Network (HVTN). The goal of this process is to incorporate external perspectives from researchers, advocates, and others into the planning and renewal of network cooperative agreements and the priorities they reflect. These agreements are set to be recompeted in 2026 and awarded for the 2027–2034 cycle.  

IMPLICATIONS: The NIH has a longstanding mandate to advance fundamental scientific knowledge. Many of the most transformative innovations in HIV prevention and treatment are the direct result of decades of NIH investments in the clinical trial networks. This mandate must be protected and strategically resourced, even amid broader funding pressures. An evidence-based, balance research portfolio, including robust clinical trial infrastructure globally, is essential to ending the HIV/AIDS epidemic in the US and around the world. 

READ:  

• AVAC Input for Recompetition of the NIAID HIV/AIDS Clinical Trials Networks—AVAC  
• TAG’s Recommendations to NIAID on the Future of the HIV Clinical Trials Networks—TAG  
• Panel Discussion: HIV Clinical Trials and Research Networks—24 Hours to Save AIDS Research marathon 

What We’re Reading

• The Global Fund works—these stories remind us why it’s essential—Gates Foundation
• The global health landscape will never be the same — and it shouldn’t be—Devex
• Inside the EU’s private assessment on Trump’s massive aid cuts—Euractiv
• US ‘undermining global health’ by threatening to strip funding from aid projects that do not fit its political agenda—The Guardian
• How the Trump administration learned to love foreign aid—The Economist
• The Fallout From the Dismantling of USAID Continues—Newsweek
• ‘Trump plans to block funding to groups who promote diversity policies abroad—Politico
• The impact of cuts in the US President’s Emergency Plan for AIDS Relief funding for HIV pre-exposure prophylaxis in sub-Saharan Africa: a modelling study—Lancet HIV
• Supporting RECs/IRBs to Review the Enrolment of Pregnant/Lactating Individuals in HIV Prevention Trials using International Ethical Guidance—Research Ethics
• WHO launches the Global Clinical Trials Forum—WHO
• Broader access urged for affordable HIV drug—SciDevNet
• CDC, its advisers quietly expand access to Covid-19 shot for pregnant women—Politico
• US aid cuts are being felt across Africa. Here’s where.—Washington Post
• New study shows all-in-one coronavirus vaccines could save millions of lives in future pandemics—CEPI
• ‘Bluetoothing’: Blood-Sharing Drug Trend Fuels Alarming Global HIV Surge—New York Times

AVAC Resources

• Lenacapavir Regulatory Approval
• Potential Demand for LEN for PrEP
• HIV Prevention Product Overview
• Where We Are Now With LEN
• PrEP Price Comparison

Upcoming Webinar

Presented by The Choice Agenda: join our panelists for an unflinchingly honest—and interactive—conversation as we assess the impacts of the ongoing assault on transgender communities, gender affirming health care, data collection, and Diversity, Equity and Inclusion writ large. Strategies to restore trust, sustain programming, and rebuild from the ashes will be explored.

This roundup from AVAC highlights key developments across the field of HIV prevention from accelerating access to injectable lenacapavir (LEN) for PrEP, to advancing inclusion of pregnant and lactating people, and trans and gender-diverse communities in research. It also features a new initiative reinforcing the highest standards in ethical research conduct and tools for the fight to sustain funding in HIV research.

Read on for the details!

The Latest on Speed, Scale and Equity in the Rollout of LEN for PrEP 

In the midst of profound disruptions to US leadership in global health, the world has seen sustained momentum behind the rollout of injectable LEN for PrEP.  

The latest news came on October 6, with the WHO issuing a prequalification for Gilead’s lenacapavir pill and injection products using a new “abridged prequalification pathway” that took just 36 days. WHO prequalification, based on the positive scientific opinion of the European Medicines Agency (EMA), adds lenacapavir to a list of products evaluated as safe, effective, and crucial for improving public health. Speeding up evaluation and regulatory approvals has been a long-standing advocacy priority in HIV prevention, and spurs momentum toward scaling up LEN for PrEP. 

AVAC’s updated infographics and resources feature the latest information on the price and the process for accelerating access:

• Lenacapavir Regulatory Approval
• Potential Demand for LEN for PrEP
• HIV Prevention Product Overview
• Where We Are Now With LEN
• PrEP Price Comparison
• Factsheets on action steps for stakeholders to take now and other essential resources on AVAC’s dedicated page on advocacy for the ethical rollout of LEN for PrEP

WHO Launches Global Clinical Trials Forum 

This week, the World Health Organization launched the Global Clinical Trials Forum (GCTF), a global network to strengthen clinical trial environments and infrastructure at national, regional and global levels. The GCTF has shown vision and commitment to the ethical conduct of research by incorporating the Good Participatory Practice Guidelines into its work.

“The work of the Global Clinical Trials Forum (GCTF) is exciting and necessary. Best practices in clinical trials can be strengthened and sustained with meaningful and informed guidance and coordination such as that under the GCTF. AVAC applauds the WHO’s ongoing commitment to the Good Participatory Practice Guidelines within the GCTF, which ensure ethical, inclusive and effective stakeholder engagement in research. We are proud to be founding member.” — Cindra Feuer, AVAC Senior Program Manager

Advancing the Inclusion of Pregnant and Lactating Populations in Research

Cathy Slack of HAVEG, AVAC’s Breanne Lievense, former AVACer Manju Chatani and partners published a review of ethics guidelines supporting access to HIV clinical trials for pregnant and lactating individuals, a population too often excluded from research. Find related resources, including an Advocate’s Guide on the issue created as part of the Coalition to Accelerate & Support Prevention Research (CASPR), on AVAC’s dedicated page.

A Scorecard for Including Trans and Gender Diverse Communities in HIV Prevention Research

The American Journal of Public Health just published Addressing Transgender Erasure in HIV Clinical Trials: The Scorecard for Transgender and Gender-Diverse Inclusion, by AVAC’s Cindra Feuer and Brian Minalga of HANC. In it, they share findings from this first cross-sectional review of trans participation in HIV clinical trials and chart the movement from TGD invisibility to a recent uptick of inclusion. In addition to the article, Cindra and Brian’s blog, Inclusion Made Simple, In Difficult Times, puts these findings in the context of the US policy attacks on TGD people. Find additional advocacy resources at avac.org/transgender-manifesto.

Upcoming Webinar
And coming up, don’t miss The Choice Agenda & AVAC hosted webinar on this critical issue, Do Not Check That Box—Impacts From the Assault on Transgender Communities and DEI + Strategies to Sustain and Rebuild.

Advocating for Sustained Investment in HIV Prevention Research

The field of HIV prevention is confronting an unpreceded need to defend sustained investment in research. AVAC and our partners have been meeting the moment—these resources can support advocacy across the field.

• AVAC input on the re-competition of the NIAID HIV/AIDS Clinical Trials Networks
• The People’s Research Agenda 
• 24 Hours to SAVE AIDS Research 
• HIV Prevention R&D at Risk: Tracking the Impact of US Funding Cuts 

We hope these resources support our collective advocacy. We know the scope of the threats to HIV prevention research and global health are broad and deep. But the fight is ours to win, with an abiding passion and commitment from fierce advocates. Together we have already achieved major gains against HIV, and the fight continues.  

Jirair Ratevosian said it well: “Hope isn’t naïve—it’s an act of defiance. And in a moment like this, choosing hope is its own kind of leadership.” 

By Cindra Feuer and Brian Minalga

Not even a week after the American Journal of Public Health published our paper entitled, Addressing Transgender Erasure in HIV Clinical Trials: The Scorecard for Transgender and Gender-Diverse Inclusion, the US National Institutes of Health (NIH) moved to prohibit scientists from collecting data about gender, according to draft policy reported in the Chronicle of Higher Education.   

It’s one of the latest blows from the Trump Administration’s anti-science antipathy for trans and gender diverse (TGD) people. Starting on his first day in office, Trump himself proclaimed, by executive order, federal recognition of only two, unchangeable, biological sexes determined at birth. And thus, he halted diversity programs. His administration has also sought to end gender-affirming medical care–deeming it chemical and surgical mutilation—while trying to prohibit changes to gender in national passports, among other moves to obliterate trans visibility.  

Most glaring is the administration’s termination of more than 1,000 US NIH grants on lesbian, gay, bisexual, trans and queer (LGBTQ) health, according to the database Grant Witness. The New York Times estimates that together these grants are worth more than $800 million. More broadly, the US Supreme Court, in a 5-4 decision on August 21, sided with the Trump Administration and allowed some $783 million in cuts to NIH grants related to diversity, equity and inclusion. 

Trump’s timing slaps up against a swelling undercurrent of trans resiliency, which was just starting to pay off in the field of HIV research after decades of neglect. The AJPH paper is the first cross-sectional review of trans participation in HIV clinical trials, which charts the movement from TGD invisibility to the recent uptick of inclusion. The key takeaway: a mere 1 percent (2,532 out of 178,893) of trial participants identified as TGD, between 1991-2023, in 41 milestone studies (table 1, page 4). 

The first study to report TGD enrollment was the iPrEx PrEP trial in 2007, with TGD representation continuing to increase over time. However, more than two thirds of studies conducted since 2007 still failed to account for TGD participation, including studies implemented as recently as 2020. This despite evidence that no community is in greater need of HIV prevention than TGD populations.  According to the most recent data from UNAIDS, the median HIV prevalence of TGD communities, among reporting countries, is 8.5 percent. The next highest is among gay men, at 7.6 percent. Data by region can show astounding prevalence in some communities, as high as 50 percent, indicating extreme levels of unmet need for HIV prevention.  

This urgent need for inclusion can be advanced by attention to critical indicators, outlined in the HIV Research Scorecard for Trans and Gender Diverse Inclusivity (Figure 1, page e3), a twin-purpose tool to both guide study design and provide metrics for TGD-inclusive research. The scorecard, informed by global TGD advocates and their contributions to the Trans Manifesto: No Data No More, assesses 14 indicators under four primary areas for inclusion: study design; study implementation; study reporting; and language. As an example, within trial design, it asks if eligibility criteria explicitly include gender-nonbinary individuals, and transgender men and women. If they are not included, is their exclusion explicitly justified? Are measurable goals for the enrollment of TGD participants set forth? Is gender-affirming hormone use accounted for as a variable?  

Other indicators ask if data collection captures TGD HIV status, if TGD inclusion in a study is made explicit in published findings, and if TGD participation is in alignment with best practices, such as DAIDS’ data collection recommendations. Similarly, the scorecard grades whether language related to study documents, outreach materials and communications adheres to best practices in gender-inclusive language as outlined in NIAID’s HIV Language Guide.  

The scorecard’s continued use could lead to much needed and long overdue equitable representation of TGD people in HIV research. Researchers can and should use the scorecard when designing and implementing trials, and advocates must use it to hold them accountable when they do not. It’s a purpose-built tool for ensuring greater inclusivity in these challenging times.   

But the inclusion of TGD populations in research relies on the very language the US administration is trying to erase, with the latest policy attack aimed at NIH research. According to the Chronicle, researchers inside and outside the agency “shall not use NIH funds to request, collect, or disseminate information related to gender…” unless that, data on sex reflects Trump’s flawed view that there are only two sexes.  

To measure only sex and not gender jeopardizes scientific accuracy and equity, especially against a global backdrop where TGD communities are among the most stigmatized people. TGD communities struggle to access care, resulting in a staggering unmet need for prevention.  

As we lay out in our article, “the lack of TGD representation in HIV clinical trials indicates a historical erasure of TGD communities with potential public health consequences.” These consequences are indeed grave; they result in missing data, poor access to newly proven options, a research and development pipeline that is not built to reach those who need it most, and a stalled HIV response at large, with countless lives needlessly left exposed to virus and disease.  

This is not the time to scrub TGD inclusion from HIV trial designs and protocols, regardless of attacks and misguided fury aimed at our communities. In fact, now is the moment to use everything at our disposal, including the new scorecard, to set in motion an era of HIV research that meaningfully responds to TGD needs.

As the US government approaches its September 30 fiscal year deadline, the Supreme Court of the United States (SCOTUS) is weighing whether to uphold the District Court’s order in the AVAC v. Department of State lawsuit, which compels the US government to spend billions in congressionally-appropriated foreign aid, or allow the Administration to “run out the clock” as part of the “pocket rescission” maneuver. This ruling, alongside SCOTUS decisions on tariffs, could dramatically expand executive power over spending historically controlled by Congress. Coupled with CDC and vaccine policy turmoil, changes to PEPFAR’s planning process, and the State Department’s new “America First” global health strategy, these developments represent high stakes for HIV programs and the future of foreign aid for global health. 

New “America First” Strategy for Global Health Released

Under the plan, the US would initially cover 100% of commodity and frontline healthcare worker costs through the start of the next fiscal year but would shift an increasing share of expenses to partner governments over time. The plan also signals a reshuffling of which countries will receive US investments and may involve “third-country” allies in future agreements to reduce overlap. The plan does prioritize “innovation” and specifically names the importance of lenacapavir (LEN) for PrEP and the recent re-commitment of the Biden Administration first announced in December.  

IMPLICATIONS: This new strategy prioritizes US interests over traditional development goals and represents a fundamental overhaul of US global health assistance, with major consequences for HIV prevention and treatment programs worldwide. Moving toward bilateral agreements and compacts risks fragmenting coordination, intensifying the politicalization of assistance, slowing disbursements, and creating uncertainty for countries already grappling with budget shortfalls. While the new strategy appears to reaffirm US commitments to global targets for ending the HIV epidemic, there is concern whether current indicators will continue to be tracked and many unknowns in the details of pending bilateral agreements. For programs like PEPFAR, which have long relied on predictable, multi-year, large-scale US support, the new approach could mean sudden funding gaps and weaker negotiating leverage on pricing or access for new prevention tools. And while it is good (and smart) to see LEN prioritized, the continued unilateral focus on PrEP for mother-to-child transmission reflects a continued blind-eye to the epidemiology of HIV/AIDS and the need to provide LEN and prevention generally more broadly. 

READ:  

• America First Global Health Strategy—Department of State 
• State Department revamps global health aid around bilateral deals—Semafor  
• New US global health plan prioritizes drugs, recipients’ self-reliance—Reuters  
• The New US Global Health Strategy Gets Personal—To End A Plague Substack 

Where Are We With PEPFAR?

PEPFAR has initiated a “Bridge Plan” process to determine programming for a six-month stopgap funding period running from October 2025 to March 2026 and incorporating a 40% budget cut from previous allocations. For decades, countries and civil society have prepared Country Operational Plans (COPs) months in advance with clear budgets, targets and plans. Instead, this Administration began by freezing foreign aid and proposing a 40% cut to global health in the President’s fiscal year 2026 (FY26) Budget Request. In place of COPs meetings, PEFPAR instituted this temporary bridge plan process—with limited time and no stakeholder engagement. Country plans are due on September 24, leaving partner governments and civil society scrambling to meaningfully engage in decisionmaking with sharply reduced resources. Advocates warn that prevention services, key population programs, and the introduction of innovations like lenacapavir could all be delayed or excluded. The process also signals an attempt to go around Congress to enact the President’s requested FY26 budget cuts. 

IMPLICATIONS: The Bridge Plan keeps PEPFAR technically alive but with scaled-back funding, compressed timelines, and weaker accountability structures. If granular targets and community voices are sidelined, countries may lose hard-won gains in prevention and treatment and see stalled or reversed progress on HIV. Missing or delaying the rollout of LEN for PrEP, especially for key populations, would exacerbate the setback. Over the next six months, how these plans are finalized will shape the trajectory of global HIV programming for years to come.

READ: 

• PEPFAR Approach to Bridge Plan Targets Keeps Data Use Alive—To End A Plague Substack 
• Whether PEPFAR Lives or Dies, HIV Leaders Seek a New Way Forward—The Body  

US CDC Recommends LEN for PrEP

After the departure of US Centers for Disease Control and Prevention (CDC) leadership in the last month and Senate testimony by its former Director a day prior (see below), the CDC issued new clinical recommendations endorsing injectable lenacapavir as a twice-yearly option for HIV PrEP, marking a major milestone in the expanding PrEP landscape. 

IMPLICATIONS: These recommendations are an important step forward, but equitable implementation remains a challenge in the US, especially the very high list price. This progress underscores the importance of strong policy protections like the Affordable Care Act, which requires most private health plans to cover PrEP, including visits and labs at no cost. However, ongoing legal threats to the ACA’s preventive coverage mandate could jeopardize access to LEN and all PrEP options. Tools alone don’t end epidemics; they must be delivered with equity. 

Given the political turmoil at CDC, these recommendations reflect – as so eloquently stated by Francisco Ruiz, former director of the White House Office of National AIDS Policy – “the tireless work of colleagues and partners who push science forward despite adversity. Their dedication underscores the need to keep investing in research, our workforce, and the infrastructure that ensures providers, communities, and people everywhere have access to proven HIV prevention tools. This is CDC in action … dedicated people, strong science, healthier communities.”

READ:  

• CDC Recommends New Injectable HIV PrEP—CDC MMWR 
• CVS holds off adding Gilead’s new HIV prevention shot to drug coverage lists—Reuters 

CDC Turmoil as Former Director Testifies Before Senate Committee and ACIP Prepares Vaccine Recommendations 

Meanwhile, former CDC Director, Susan Monarez, testified Wednesday at the Senate HELP Committee hearing on her unjust firing. Monarez said she was forced out of the CDC after refusing to pre-approve vaccine recommendations and to fire career officials without cause. “He [HHS Secretary Robert F. Kennedy Jr.] just wanted blanket approval…Even under pressure, I could not replace evidence with ideology.” Monarez’s former chief medical officer, Debra Houry, who resigned shortly after Monarez was removed, echoed these concerns and called for RFK Jr.’s resignation warning that the upcoming Advisory Committee on Immunization Practices (ACIP) meeting could cement dangerous new policies.  

As this issue went to publication, the ACIP had just voted 8 to 3 to change the current recommendations that allow children under 4 to receive the combination vaccine for measles, mumps, rubella and varicella (MMRV). The ACIP is expected to vote today on shifting routine Hepatitis B vaccination (HBV) currently given at birth and to make recommendations on vaccines for COVID-19. These shifts raise important questions about sustainability, access, and equity moving forward. 

IMPLICATIONS: The testimonies of Monarez and Houry, their departures and the departures of other trusted CDC leaders are eroding confidence in the agency’s ability to make independent, evidence-based decisions. This raises serious questions about whether future CDC guidance will be evidence-based and can maintain credibility in an increasingly politicized environment. When public health decisions are perceived as politically pre-determined rather than evidence-based, public confidence in recommendations will erode and public health will be compromised. Departed leaders are encouraging individuals to seek advice of their medical professional over national recommendations. Health officials are warning that vaccine uptake will be lower, disease outbreaks will be more likely and health responses will be weaker.  

READ:  

• Ousted CDC director testifies she was fired for resisting pressure from RFK Jr.—NPR  
• What It’s Like to Work Inside a Broken CDC—The Atlantic 
• Monarez details her ouster, challenges Kennedy’s vaccine changes in heated Senate hearing—Endpoints  
• The fate of the CDC hinges on this new, three-page table—Inside Medicine Substack 
• I’m a former CDC director. I’m deeply concerned about the future of vaccines in the US— 
• STAT 
• CDC advisers vote to change guidance on MMRV vaccines—NPR 

24 Hours to Save AIDS Research

Earlier this week, nearly 5,000 scientists, researchers, advocates and members of the community came together for the online marathon to showcase and support decades of US investment in HIV research: what it has achieved and what’s now at risk. Since January 20, the US Presidential Administration has been making massive cuts to HIV research, dismantling the infrastructure for conducting research and spreading disinformation on the benefits of research. For 24 hours, more than 60 researchers from all over the world broadcast the facts, countered the lies and showed what HIV research has achieved. All recordings will be posted soon.

What We’re Reading

• Foreign agent laws are spreading like wildfire and crippling NGOs—Devex
• Africa CDC’s rocky road to stability—Devex
• Wellcome’s “Future of Global Health” Initiative: What is the bottom line?—Nina Schwalbe Substack
• ‘HIV Unwrapped’ combines science and style for New York Fashion Week—Gay City News
• How Mpox revealed an epidemic of untreated HIV in Sierra Leone—The Independent
• Trump asks the Supreme Court to give him total control over the US economy—Vox
• US lawmakers propose sweeping State Department reforms—Devex
• An HIV Outbreak in Maine Shows the Risk of Trump’s Crackdown on Homelessness and Drug Use – KFF Health News—KFF
• White House Plans Broad Crackdown on Liberal Groups—New York Times
• Despite fear of retaliation, hundreds of federal workers urge Congress to protect medicine and science—STAT

Resources

• Analyzing USAID Program Disruptions: Implications for PEPFAR Programming and Beneficiaries, CDG
• WHO released updated guideline on HIV service delivery, WHO
• On the Brink of Catastrophe: U.S. Foreign Aid Disruption to HIV Services in Tanzania and Uganda, Physicians for Human Rights (PHR)

This week Global Health Watch covers major developments from a Supreme Court decision stalling foreign aid disbursements (again), to the US House’s fiscal year (FY26) budget drafts, and the Global Fund’s updated report and shifting focus.

Supreme Court Pause in AVAC’s Foreign Aid Case 

The AVAC and Global Health Council cases against the US presidential administration on the foreign aid freeze continue to play out in the courts. Tuesday, US Supreme Court Chief Justice John Roberts issued a one-person decision, which granted the Administration a temporary administrative stay (or pause) on the recent District Court ruling. This temporary ruling means the government would not have to spend the congressionally appropriated funds by the September 30th fiscal year deadline despite the District Courts order last week that required them to do so.   

IMPLICATIONS: Chief Justice Roberts’ order effectively keeps the Administration’s “pocket rescission” strategy alive by temporarily suspending the District Court’s order. AVAC and its partners are preparing their Supreme Court brief due by Friday to make clear that allowing the Administration to “run out the clock” would not only devastate lifesaving programs but also set a dangerous precedent that erodes democratic oversight of federal spending. 

READ: 

• Chief Justice Roberts Lets Trump Block Foreign Aid for Now—New York Times 
• Trump Asks Supreme Court to Keep Freeze on Expiring Foreign Aid—Bloomberg  
• US foreign aid legal showdown heads to the Supreme Court—Devex

US FY26 Budget Proposal Maintains NIH Budget, but Cuts CDC 

The US House Labor, Health and Human Services (LHHS) Appropriations Subcommittee released its fiscal year 2026 (FY26) draft spending bill, which allocates $184.5 billion, of which $108 billion is designated for Health and Human Services (HHS). This is approximately 6% less than the current year funding levels, and, notably, the proposal includes steady funding for the National Institutes of Health (NIH) at $48 billion. However, the bill includes deep cuts to the HIV prevention program at the Centers for Disease Control and Prevention (CDC) at 19-20% and eliminates the Title X family planning program. 

IMPLICATIONS: While NIH funding is preserved for now in the House bill, deep cuts to CDC, Title X, and key public health infrastructure pose a serious threat to HIV prevention, STI research, and community health programs. The upcoming full committee markup and potential amendments by Democrats will reveal where bipartisan opportunities remain, and where the fight for global health funding must focus next. 

READ:  

• House appropriators snub Kennedy, include mRNA vaccine funding in spending bill—STAT  
• Democrats Press GOP on Cuts to CDC, HHS in House Budget Bill—MSN

Global Fund Results and Shifting Focus 

The Global Fund released its 2025 Results Report, which shows increased access to HIV treatment and historic progress on TB and malaria prevention in countries where it invests. 

However, the Fund is facing serious funding shortfalls. As foreign aid declines, especially from major donors like the US, the Global Fund on Wednesday said it will prioritize funding “even more to the very poorest countries,” especially those facing conflict, high disease burden, and climate stressors, which have fewer alternative funding options.  

IMPLICATIONS: As we’ve been saying for months, gains in HIV, TB, and malaria could stall or reverse without urgent intervention. Prioritizing the poorest is necessary, but cuts could still undermine infrastructure, limit access, and exacerbate inequities globally. There is also a risk that countries dependent on Global Fund grants may face disruptions just when demand for prevention tools is growing and when new options (like long-acting PrEP) need stable funding to scale. 

READ:  

• Global health group to prioritize poorest amid aid cuts—Reuters  
• Global health fund battles Trump’s aid cuts by giving more to poorest nations—The Independent 
• Results Report 2025—The Global Fund

SA AIDS 2025 Highlights

The South African AIDS Conference spotlighted resilience across communities amid funding shocks and setback with advocates insisting that their work must intensify. AVAC and partners emphasized that products don’t end epidemics, programs do – and called for urgent, scalable, and people-centered approaches to turn innovation in research and development into options and choices that impact lives. The takeaway: protect prevention, invest in locally led systems, and keep communities at the heart of HIV response and research.

What We’re Reading

• NIH whistleblower details clash over childhood vaccines with Trump administration: “We became inconvenient”—CBS News
• Inside the NIH whistleblower complaints—Politico
• NIH is talking a lot about implementation science. I should be excited, but I’m nervous. Here’s why—Elvin Geng Substack
• PEPFAR Releases the Shortest, Least-Specific Planning Guidance and Budget Letters in Program History—To End A Plague Again Substack
• PEPFAR’s Transition Breeds New Opportunities for HIV Care—Think Global Health
• Devex Newswire Special Edition—Devex
• Can health systems keep pace with HIV prevention’s breakthrough?—Devex
• Effects of Stop-Work orders on HIV testing, treatment and programmes for prevention of vertical transmission in four sub-Saharan African countries—JIAS
• NIH chief sidesteps controversy while other officials court it—Axios
• In April NPR profiled people who couldn’t get their HIV drugs. How are they faring now?—NPR
• CDC Chaos Spurs Demands for HHS Secretary Kennedy to Step Down—JAMA
• Inside the Chaos at the C.D.C.—The New Yorker
• Scientists take on Trump: these researchers are fighting back—Nature
• How RFK Jr.’s misguided science on mRNA vaccines is shaping policy − a vaccine expert examines the false claims—CNN
• Corporate philanthropy surges, led by pharma giants—Devex
• Remembering David Baltimore, a titan who transformed biology and spoke bluntly—Science
• Twists and turns in the race to be SA’s first widely used HIV prevention injection—Spotlight, SA
• Trump administration to help share new HIV drug with impacted nations—Washington Post
• World Health Organization says US CDC needs to be protected—Reuters
• Why the World Turned on NGOs—Financial Times

Resources

• Expanding global health finance: Convening report and agenda for action, Friends of the Global Fight
• HIV Research on Pause: Impacts of US government cuts on HIV R&D, AVAC
• Getting PrEP Rollout Right This Time: Considerations for LEN for PrEP Introduction, AVAC

Join Us September 16-17

AVAC and partners are hosting a 24-hour livestream event with scientists, researchers and advocates from around the world to share insights, answer questions, and inspire action!

Join AVAC and partners as we host 24 Hours to Save AIDS Research on September 16-17. This all-day, online marathon will include more than 70 speakers from around the world sharing their work and experiences with HIV research. Registration is open and the interactive event will stream on YouTube.

Since January 20, the US Presidential Administration has been making massive cuts to HIV research, dismantling the infrastructure for conducting research and sharing misinformation on the benefits of research. The commitment and actions of the scientific and advocacy communities have been successful in reversing some of these actions and the pressure must continue. 

For more ways to make the case for sustained investments in biomedical research and development and to track the devastating impacts of recent cuts on HIV and STI research and development, visit Research Matters, which shares a toolkit for researchers, and see our impact trackers below. 

Impact Trackers

HIV Prevention R&D at Risk
Want to understand how the US policy shifts are endangering the future pipeline of HIV prevention tools? Check out our HIV Prevention R&D at Risk tracker.

Impact of PEPFAR Stop Work Orders
Want an in-depth look at how the PEPFAR stop work orders and contract terminations have disrupted PrEP access? Check out our PEPFAR PrEP impact tracker.

Why STI Funding Matters: Worldwide Prevention, Shared Protection
Want to know about the global threat posed by defunding STI research and programming? See our Why STI Funding Matters tracker.

Delivering Lenacapavir for PrEP

As the fight to protect HIV research from devastating cuts continues, we must also push to ensure that the breakthroughs it generates, like innovative new PrEP options, reach the populations most in need of prevention. 

PEPFAR Reemerges to Support Rollout of Lenacapavir for PrEP 

PEPFAR and Gilead Sciences announced plans to procure injectable lenacapavir for PrEP (LEN) in “countries with the largest HIV/AIDS epidemics… with a focus on preventing mother-to-child transmission” last week. This is not new news, since PEPFAR and the Global Fund had already announced an ambition to reach two million people with LEN in the first three years—and the Global Fund recommitted to the ambition in their July announcement with Gilead. “It’s a step forward from where we’ve been in a fairly paralytic state for the last seven months, and I hope that this breaks the logjam and at least can get prevention back on the agenda,” AVAC’s Mitchell Warren told NPR.

Resources to Deliver LEN with Speed, Scale and Equity

See AVAC’s in-depth resources to inform an equitable and effective rollout of LEN. 

• The Gears of Lenacapavir for PrEP Rollout: Outlines a plan to specifying priorities by stakeholder and evaluates volume and pricing strategies with near term priorities over the next few years.  
• Moving a Product to the Real World graphic shows the delays in past efforts to rollout PrEP and hopeful signs for accelerated rollout this time, if we work collectively with speed, scale and equity. 
• Getting PrEP Rollout Right This Time shares key insights from earlier rollouts of PrEP (such as oral PrEP) to inform a faster, smarter and more equitable introduction of LEN and future PrEP products. 
•  Now What with Injectable LEN for PrEP? summarizes what is actually known – and not – and what needs to happen next with LEN.

The miracle of mRNA: What’s possible beyond SARS-CoV-2—understanding mRNA, its history and potential challenges for HIV vaccines

Thursday, September 11 at 9am ET
Approved in July, lenacapavir for PrEP has tremendous potential to increase access and engagement in the United States, reaching individuals who have been unable to embrace PrEP in its previous formulations. Please join the Choice Agenda and the HIV BLUPrInt team for a deep dive into rolling out LEN in the US.