This week, South Africa became the first African nation to register injectable lenacapavir (LEN) for PrEP. The US released a draft global health “Memorandum of Understanding” (MoU) with serious omissions related to HIV prevention and community engagement; and a leaked document indicates that the European Union may cut future funding to Gavi and the Global Fund. And just as this issue was being published, The Lancet issued a new series, Innovations in Sexual and Reproductive Health.

South Africa Registers Injectable Lenacapavir for PrEP  

South Africa has become the first African country to register the twice‑yearly injectable lenacapavir for PrEP (LEN). The approval by the South African Health Products Regulatory Authority (SAHPRA) is the fastest Africa approval of PrEP ever and opens the door for a national rollout beginning in early 2026. Additional regulatory approvals are pending in Kenya, Malawi, Zambia and Zimbabwe. In addition, earlier in October, the WHO pre-qualified both the oral and injectable forms of LEN using an expedited process. 

IMPLICATIONS: LEN’s registration in South Africa is significant progress, and reflects one of several milestones in product introduction that have happened faster for LEN than for any previous PrEP product. See AVAC’s comparative graphic on Moving PrEP Options to the Real World. At the same time, so much more needs to happen to translate this option into public impact, including securing price and volume transparency, aligning global funders, and enabling rapid country-level introduction. A robust and accelerated global rollout will create a foundation for further reduced pricing, greater choice, and real momentum in HIV prevention. See AVAC’s report, Getting PrEP Rollout Right This Time, which can support countries in the early stages of LEN planning. And visit AVAC’s LEN page for a range of resources and graphics, and PrEPWatch.org to track the rollout of all long-acting PrEP. 

READ:

• SA becomes the first African country to register the twice-a-year anti-HIV jab — at record speed—Bhekisisa  
• Access Strategy for Lenacapavir for PrEP in Low- and Middle-Income Countries—Gilead Sciences  

US Global Health MoU Template Raises Urgent Concerns

This week, US government country teams at embassies and missions around the world received a draft memorandum of understanding (MoU) template and guide that will shape bilateral US global health investments. These MoUs between the US and individual countries are being developed for PEPFAR but will also extend across other US global health foreign assistance programs, establishing a framework for how the US engages partner governments on health priorities. The bilateral agreements, which the Administration is aiming to finalize by mid-December, outline process and outcome metrics focused on treatment, such as ART coverage and viral suppression. However, the draft template omits HIV prevention indicators, including any reference to PrEP or new products such as injectable lenacapavir, and also also bypasses multilateral coordination, ignoring institutions like WHO or regional public health agencies, and suggests that policies favoring US commercial interests would factor into funding decisions, while providing no framework for civil society or key population engagement. 

IMPLICATIONS: The shift to direct government-to-government MoUs sidelines the community and erodes decades of progress grounded in data-driven, inclusive approaches—violating the core principle of “nothing about us without us.” The exclusion of key populations and civil society voices from these negotiations raises serious concerns about accountability and equity. Equally alarming is the fact that the US government has not released any PEPFAR data this year, leaving advocates, partners, and decisionmakers without the basic transparency needed to evaluate impact or guide decisions. These omissions must be challenged immediately by in-country advocates and Congress. 

READ: 

• Breaking: First Look at the USG Draft Memorandum of Understanding for Global Health—To End A Plague Again Substack 
• How will America’s new global health strategy change PEPFAR?—Devex  
• Devex CheckUp: ‘America First,’ but what about PEPFAR?—Devex  
• PEPFAR’s Missing Data: Why Transparency Matters More Than Ever—Center for Global Development (CGD) 
• PEPFAR Has No Plan for World AIDS Day Data Release—Emily Bass Substack

European Commission May Shift Away from Gavi and the Global Fund

The European Commission (the executive body of the European Union) plans to potentially phase out funding to Gavi, the Vaccine Alliance, and the Global Fund by 2030 according to a leaked document, which was prepared for the European Union’s Commissioner for International Partnerships. The document makes the case for concentrating EU support on initiatives where the bloc can “truly shape governance.” 

IMPLICATIONS: This signals a dramatic pivot away from institutions that have helped save 90+ million lives through vaccine access and disease prevention. While no formal decision has been made, this move mirrors similar cuts by the US under the new administration, and underscores growing skepticism in major donor governments about traditional multilateral aid. Global health financing is already under significant strain, with donors prioritizing national interests and public-private investments over long-term, predictable health aid. A shift away from core multilateral partners may leave critical gaps in vaccine delivery, HIV prevention and response to emerging disease threats. 

READ:  

• EXCLUSIVE: EU mulls copying US with end to aid for global health funds—Euractiv

Launch of The Lancet’s Innovations in Sexual & Reproductive Health Series

Fenway Health will help launch The Lancet’s five-paper series on sexual and reproductive health, edited by Profs. Kenneth Mayer and Linda-Gail Bekker. Begins October 31 at 8am ET.

Stream

What We’re Reading

• How HIV research drives health innovation in multiple diseases—Nature Medicine
• Transforming HIV Prevention in 2025, AVAC
• Gates Foundation skews global health agenda after US retreat, study says—Financial Times
• Trump Revives Foreign Aid, Helping Needy Billionaires—New York Times
• Private donors gave more than $125M to keep foreign aid programs going after US cuts—Associated Press
• Ritshidze report spotlights ‘system-wide slide’ in basics for health facility standards after Pepfar cuts—Daily Maverick
• Global security is impossible without sufficient support for global health—STAT
• African Public Health Conference Calls for ‘Health Sovereignty’ and Prioritizing Primary Care Ahead of G20—Health Policy Watch
• African Center for Economic Transformation tries to humanize debt—Devex
• John Roberts Is a Threat to the Health of Every American—The Nation
• Behind the Dismantling of the C.D.C.: Reform or ‘Humiliation’?—New York Times
• Her refusal to approve a dangerous drug changed medical history—19th News
• How Moderna, the company that helped save the world, unraveled—STAT

AVAC Resources

• Vaccine-Preventable Disease: A Global Tracker, Think Global Health
• PEPFAR’s Missing Data: Why Transparency Matters More Than Ever, CGD
• Getting LEN Rollout Right: Resources and Tools, AVAC
• Do Not Check That Box – Impacts From the Assault on Transgender Communities and DEI + Strategies to Sustain and Rebuild, AVAC

Upcoming Webinar

Enormous changes are underway in HIV prevention and across global health. Global advocates know that we play an indispensable role as these changes take shape. It’s our work to vigilantly track new agreements, new policies and new investments in research, development and delivery. It is our voices that call out inequity, greed, misinformation, and misguided assumptions. Here are three questions we advocates are asking along with resources to support our collective work.

Q1: How do we speed access to LEN for PrEP and why is building a sustainable market a critical next step?

October 27, 2025, brought the latest news on injectable lenacapavir for PrEP (LEN). Just yesterday, South Africa’s regulatory authority approved injectable lenacapvir as PrEP, the first approval in Africa and the fastest Africa approval of PrEP ever. Additional regulatory approvals are pending in Kenya, Malawi, Zambia and Zimbabwe. In addition, earlier in October, the WHO pre-qualified both the oral and injectable forms of LEN using an expedited process. This is progress, but so much more needs to happen to translate this option into a real choice, including: securing price and volume transparency, aligning global funders, and enabling rapid country-level introduction.

To achieve impact against the epidemic and realize the potential of the full suite of HIV prevention options, policies, planning and targets can and should be bolder, with advocacy and additional investments needed.  

Building a sustainable market for LEN—and for PrEP and prevention generally—is essential for affordable and sustainable access and to achieve impact. Demand creation is fundamental to this effort, and so is setting more ambitious goals for total numbers of people on PrEP, which requires upfront investments and coordinated donor support now. Without such action, LEN’s promise could stall, delaying equity and impact. A robust and accelerated rollout will create a foundation for reduced pricing, greater choice, and real momentum in HIV prevention. Our dedicated LEN page on AVAC.org offers additional resources including:

Resources

• Getting PrEP Rollout Right This Time provides key insights from the rollout of oral PrEP and early introduction of injectable cabotegravir (CAB) and the dapivirine vaginal ring (DVR) to inform a faster, smarter and more equitable introduction of future HIV prevention tools, including lenacapavir.
• Gears of Lenacapavir for PrEP Rollout outlines a focused plan for LEN for PrEP rollout over the next few years, specifying priorities by stakeholder and evaluating volume and pricing strategies. 

Infographics

View all our LEN infographics

Q2: Global health funding is shrinking, but how is the field adapting in this period of disruption?

Global health funding is in steep decline. The Institute for Health Metrics and Evaluation estimates assistance for health dropped by 21% between 2024 and 2025 and will continue dropping over the next five years. In response, the global health field is entering a period of transition, which is marked by smaller pledges from donors, such as Germany’s 1 billion euro commitment to the Global Fund to Fight AIDS, Tuberculosis and Malaria (GF) over the next three years, which is a 25% reduction. There are also increasing calls for consolidation of the fragmented architecture of funding for global health. Leaders at last week’s World Health Summit echoed this urgency, pushing for streamlined agencies and faster reform.

Simultaneously, a new, bold framework for global health sustainability and equity known as The Accra Reset builds upon the public health leadership of African countries to counteract disruptions to the global health governance. It calls for co-creation and mutual accountability, with Global South countries determining agendas and investment in national health systems, data sovereignty, local production, and more in an effort to transform global health as a platform for prosperity rather than a cost. 

As global health undergoes a profound transformation, the central task for advocates is to ensure equitable and effective access to care among communities hardest hit by health threats.

Issue Brief

Friends of the Global Fight Against AIDS, Tuberculosis and Malaria (Friends) published an issue brief, How the Global Fund Makes America Stronger and Safer and a call to action for the US to continue its longstanding commitment to pledge $1 for every $2 from other countries.

Q3: What’s the status of the R&D pipeline and what action steps are essential now?

From basic science to implementation studies, public support for HIV research has never been more important. An evolving, balanced and innovative pipeline of HIV prevention options is essential to epidemic control and ensuring everyone who needs HIV prevention has access to something that works for them. These resources can inform and support our collective work to defend continued investment in an inclusive and diverse pipeline of HIV prevention research and development (R&D). 

These questions are guiding our work at AVAC. We know it will continue to be up to advocates, allies, and global health champions to demand answers, transparency, and programs that deliver sustainable impact. See you in the fight!  

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.