Global Health Watch: PEPFAR negotiations leave communities behind, Global Fund replenishment falls short, continued chaos at CDC and NIH

Issue 44

UNAIDS World AIDS Day report: Overcoming disruption, transforming the AIDS response

Decisions and actions this week further weaken the global HIV response — from the exclusion of communities in the new PEPFAR US global health strategy negotiations to a Global Fund replenishment that falls short of what’s needed to deliver emerging HIV, TB, and malaria innovations at scale. Major disruptions at the US CDC and NIH – including halted non-human primate research, politicized vaccine messaging, leadership changes that jeopardize HIV research, and “skipping” World AIDS Day — continue the erosion of accountability, trust, and the integrity of the public health system. 

US Global Health Strategy Negotiations Leaving Communities Behind 

African advocacy partners including Eastern Africa National Networks of AIDS and Health Service Organizations (EANNASO) and the Coalition to build Momentum, Power, Activism, Strategy & Solidarity in Africa (COMPASS) have been taking stock of the ongoing country negotiations around the US government’s Memorandums of Understanding (MoUs) as part of its new “America First” global health strategy. They are finding that communities are being systematically excluded from the “government-to-government” negotiations for new 5-year PEPFAR MoUs, a direct reversal of the community engagement that has defined decades of the HIV response. Efforts to ensure program effectiveness, implementer accountability, programs for key populations, and commodity security are all at stake. The new framework would also require partner countries to share pathogens and patient data, potentially with US commercial interests, without privacy safeguards or assured access to resulting products — for decades longer than the life of the actual MOUs. With an MoU signing deadline of December 12, there is a great need to mobilize to demand transparency, inclusion and fair terms for all parties. 

IMPLICATIONS: The exclusion of communities from the new MoU negotiations is an abrupt shift away from the community-centered model that has been at the center of PEPFAR’s success for decades. These closed-door, government-to-government negotiations undermine the hard-won progress on reaching key populations, protecting data privacy, and delivering services that are responsive to the real-life needs of communities. Sidelining communities threatens the effectiveness, and legitimacy of the next phase of the HIV response and without immediate transparency and meaningful engagement, these MoUs risk weakening impact and trust. 

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Global Fund Replenishment Support, But Falls Short of Target 

Last Friday, donors pledged just over $11 billion at the Global Fund’s 8th Replenishment in Johannesburg. This was an important show of support, especially given the challenging political and economic climate, but well short of the $18 billion target needed to fully harness today’s unprecedented scientific advances against HIV, TB and malaria. The US pledged $4.6 billion, a decrease from the previous cycle, even as it reaffirms the 1:2 matching commitment, placing renewed pressure on Congress to fully appropriate funds, and on other donors to step up.  

IMPLICATIONS: As long-acting HIV prevention, new malaria tools and improved TB treatments enter the market, this shortfall threatens the speed, scale and equity of their rollout. And with communities already facing service disruptions, this shortfall could cost millions of lives and squander a historic opportunity to turn innovation into impact. 

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Big Disruptions at US CDC and NIH – and World AIDS Day

In the last week, decisions and actions at the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health’s (NIH) Division of AIDS (DAIDS) further jeopardize the future of HIV research and confidence in vaccines. The CDC abruptly ordered an end to all non-human primate research, including critical macaque studies that have long supported HIV prevention science. The agency also altered language on its website implying a link to vaccines and autism and contradicting established scientific consensus. At the NIH, long-time DAIDS Director, Carl Dieffenbach, was reassigned to the Fogarty International Center, a move that removes a trusted leader who played a central role in guiding HIV research. See AVAC’s resource, HIV Prevention R&D at Risk, which tracks the impact of all this and more. Also, just ahead of December 1, the US administration announced that it will no longer commemorate World AIDS Day. 

IMPLICATIONS: Together, these actions continue the decline in US global health leadership, unraveling decades of scientific progress and trust in vaccines and public health institutions. Halting essential preclinical research in macaques, politicizing vaccine messaging and sidelining experienced leadership weakens the pipeline of innovation and threatens the integrity of HIV science at a moment when sustained investment and credibility are most needed. As for World AIDS Day, Congressman Mark Pocan, who leads the Congressional HIV/AIDS Caucus, said the administration’s refusal was “shameful and dangerous.” But it’s important to remember that World AIDS Day is not decided by the US government; it belongs to everyone – and the new UNAIDS report provides the theme: Overcoming disruption, transforming the AIDS response. Or as the International AIDS Society says: Rethink. Rebuild. Rise

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What We’re Reading

UNAIDS World AIDS Day report: Overcoming disruption, transforming the AIDS response

UNAIDS’ new report shows that we were closer than in decades to ending AIDS by 2030, yet new HIV infections stayed flat in 2024, even before funding cuts, and resources were not enough to drive them down. We must double down with bolder, more strategic action to drive real decline.

Read the Report

24 Hour Marathon to Save AIDS Research

A Global Call to Action

By Cindra Feuer

Since January 20, 2025, the new US Presidential Administration has made massive cuts to HIV research, dismantling the infrastructure for conducting research and pushing misinformation on the benefits of research. In rapid response, AVAC worked together with a volunteer coalition of the nation’s leading HIV researchers and advocates to conceptualize, organize, and host the 24-Hour Marathon to Save AIDS Research.

The virtual marathon featured 24-hours of live, interactive presentations, discussions, and learning sessions to raise awareness about the lifesaving contributions of HIV research and highlight what is at stake if funding continues to be stripped away.

This event is a core component of AVAC’s ongoing advocacy to protect HIV research from drastic cuts to research funding, programs and partnerships. Using our convening power, research expertise, and research translation experience, this group of dedicated individuals brought advocates and researchers together in solidarity and shared critical messages about why HIV research matters with the larger global community.

In the months prior to the marathon, AVAC and partners sounded the alarm that the government’s relentless cuts to critical foreign aid would soon be followed by attacks on public health, scientific research, and science at large. As predicted, in March 2025 the administration began to cancel grants and dismantle federal institutions, with immediate and devastating impact on HIV research. AVAC worked quickly to raise awareness, educate researchers, advocates, and partners, and collaborate with these groups to protect life-saving research. The network mobilized leading voices in research, strengthened advocacy skills through teach-ins, tools, and resources, educated policy makers, and disseminated timely and accurate information to track the impact of cuts to HIV research. Researchers and advocates harnessed this momentum to bring critical messages about the urgency of reversing funding cuts and the real-world impact of breakthroughs in HIV research to a larger audience.

Ultimately, the Save AIDS Research marathon on September 16-17 reached over 7,000 advocates, researchers, stakeholders, policy makers, journalists and community members from 28 countries and 30 U.S. states. The event featured 75 presenters representing major research institutions, public health organizations, civil society organizations and communities impacted by HIV all over the world, along with 42 endorsing organizations and robust engagement from viewers throughout all 24 hours of the livestream. (All 24 hours of content are available online for ongoing advocacy.) The marathon covered an incredible breadth of topics, including the legacy of innovation from HIV research; the role of advocacy in an equitable and effective HIV response; the implications of intersecting and emerging epidemics; advances in prevention, treatment, vaccine and cure research; the growing portfolio of Africa-led HIV prevention research; innovative models for delivering care; and community movements to sustain access to HIV services.

As an interactive, public event, participants also had the unique opportunity to engage directly with researchers, share their personal stories, connect with each other, and discuss ideas to strengthen future HIV research advocacy and action. As one livestream attendee reflected, “This is a valuable example of people uniting across sectors and across the globe to share evidence-based information on the importance of research.”

Dr. Joseph Eron, the Principal Investigator of the HIV/AIDS Clinical Research Unit at UNC-Chapel Hill and chair of the ACTG network, also reflected on the critical role of this kind of community engagement in research, commenting during his presentation in Hour 3, that the event was “a great example of dissemination to the community, something that’s open and accessible.”

What began as a simple idea became an incredible demonstration of the collective power and dedication of the HIV research community. Diverse members of the HIV research community came together to amplify global advocacy messages, counter misinformation, and strategically advocate to protect decades of progress to end the epidemic. Dr. Jeanne Marrazzo, the former Director of NIAID, reinforced this belief in the strength of the field during her presentation in Hour 8: “No one can stop us if we continue to fight together, stand together and continue to tell the truth and advocate for science and for our patients and our community.”

Building on this momentum, AVAC and its partner network continue the fight to save HIV research from additional funding cuts. Materials from the marathon are being translated into tools and products to support further advocacy efforts. AVAC continues to track and update the impact of funding cuts, the recent government shutdown, and ongoing budget negotiations on HIV research.

Later this month, AVAC will relaunch an updated version of its groundbreaking Peoples Research Agenda (PRA) to highlight the risks to and priorities for the HIV prevention pipeline, how federal cuts impact the prevention pipeline, and what is needed to support advocates to take action.

As the field navigates the constantly evolving funding environment, AVAC will continue to do the critical work of tracking and translating the latest scientific and funding developments, and ensuring advocates are informed and supported in the ongoing fight to end HIV. Mitchell Warren, AVAC’s Executive Director affirmed, “Saving AIDS research is not a 24-hour exercise; it is a commitment from all of us involved to tackle this collective challenge.”

Advocacy: Now more than ever – and AVAC needs you more than ever, too

2025 has been a year like no other. During these challenging times, AVAC’s Global Health Watch has been the go-to source for tracking and analyzing attacks on global health and the HIV response, pandemic preparedness, and human rights: from the US government’s foreign aid freeze and subsequent funding collapses to the politicization of science and erosion of public health infrastructure. Thanks to our partners and many supporters, we were able to introduce and push out 43 issues of Global Health Watch, providing consistent, trusted context so you can navigate the turmoil with clarity, purpose and solidarity.

Global Health Watch is about translating chaos into actionable insight, identifying risks early, informing rapid advocacy, and supporting global movements to defend evidence-informed, rights-based and community-centered health responses. In a time when misinformation and political interference threaten decades of progress, AVAC is proud of its role as a steady source of analysis, strategy, and coordination. We’ve done it for the past 43 weeks. We’ll keep going as long as these threats remain.
 
As the US moves into Thanksgiving later this week, we give thanks to our community who stops at nothing to safe-guard hard-won progress against HIV and global health equity. Next week marks our 30th anniversary as an organization. While so much in the field has evolved in this time, what we do and why we do it remains constant—thanks to your support and collaboration.
 
Next week is Giving Tuesday. If you depend on Global Health Watch and the work that AVAC and our partners do, please support us to ensure we can continue tracking developments in real-time, strengthening advocacy networks, and equipping partners with the tools and information they need to respond effectively. Together, we can continue to protect global health and all that communities have fought so hard to build.

Join Us at ICASA and the 8th Biomedical HIV Prevention Forum

Advocacy in Action

As seismic shifts in global health funding and strategy unfold, the 2025 International Conference on AIDS and STIs in Africa (ICASA), happening December 3–8 in Accra, Ghana, comes at a pivotal time. For more than three decades, ICASA has served as a critical platform founded by African scientists, activists, and advocates to fight stigma, drive research, and elevate African leadership in the HIV response. This year, this mission is more urgent than ever. 

AVAC and partners will be in Accra to meet this moment. On December 2, we are joining partners to co-host the 8th Biomedical HIV Prevention Forum (BHPF), an official ICASA pre-conference with the theme Advancing Biomedical HIV Prevention as a National Priority Through Choice.

This forum will bring together prevention champions; advocates, civil society representatives, researchers, youth leaders, development partners, and government officials from the Ministries of Health and Finance and ensure that the promise of biomedical prevention is fully realized.

Other Sessions on Our Radar at ICASA

If you are in Accra, be sure to join the many satellite sessions in which AVAC and partners are involved.

Wednesday, December 3

  • Future Proofing Person Centered HIV Care: Ensuring Appropriate Integration for and with Key Populations, hosted by the International AIDS Society, 17:45-18:30

Thursday, December 4

  • Launch of The Lancet HIV & The Lancet Global Health Joint Series on Sustainable HIV Prevention in Africa, hosted by the Government of Malawi, Malawi’s National AIDS Commission, the African-led HIV Control Working Group (HCWG), and Georgetown University’s Center for Innovation in Global Health; learn more,10:50-11:35

Saturday, December 6

  • Why CHOICE Matters in Ensuring an Integrated, Sustainable Response to HIV, hosted by the African Women Prevention Community Accountability Board (AWPCAB) and African Sex Workers Alliance (ASWA) in partnership with ViiV Healthcare, 13:10-13:55
  • Innovating to Scale PrEP in a New Reality: Country-Led Strategies for Sustainability, Local Ownership, and Impact, hosted by AVAC and the Coalition to Accelerate Access to Long-Acting PrEP; download flyer, 14:05-14:50

Sunday, December 7

  • Voices and Partnerships to Advance Health Innovation and Equity, hosted by Unitaid, 13:10-13:55

Community Booth

AVAC and partners will “takeover” the Unitaid Community Booth on Friday, 5 December between 9:30 and 13:30, and on Sunday, 7 December between 12:00 to 16:00 to feature programming that brings together advocates and community members with other key stakeholders to discuss LEN for PrEP rollout, emphasize prevention as sustainability, and advance youth leadership. Be sure to visit the UNITAID booth on Friday, 5 December between 9:30 and 13:30 to secure a schedule of the program and join the conversations.

As conversations unfold at ICASA, two urgent imperatives must anchor our collective advocacy: accelerating equitable access to approved HIV prevention options and sustaining a forward-looking research agenda that responds to community priorities and drives long-term impact. In the face of historic US funding cuts and a shifting global health architecture, these goals are more essential than ever. 

The People’s Research Agenda (PRA), which is being updated for ICASA, is a vital tool for shaping and demanding the HIV prevention research the world needs. Whether you’re participating in the Biomedical HIV Prevention Forum or broader ICASA conversations, we encourage you to look out for the updated PRA and use it to frame your priorities, raise your voice, and influence what comes next. 

AVAC Statement on the 8th Replenishment of the Global Fund to Fight AIDS, Tuberculosis and Malaria

Global public and private sector donors pledged over $11 billion at last week’s 8th Replenishment of the Global Fund to Fight AIDS, Tuberculosis and Malaria in Johannesburg, South Africa. In the current political and economic context, these pledges represent a recognition of the pivotal role of the Global Fund in saving lives and building health systems. But they fall well-short of the $18 billion goal.

At a time when HIV, TB and malaria science is delivering as never before, with long-acting injectable HIV prevention options, new malaria drugs and vaccines and improved TB treatments entering the market — and a potential TB vaccine in late-stage trials — funding must meet the moment to deliver life-saving new technology with speed, scale and equity. Ensuring highly effective innovations reach those who need them most requires resources. Universal access to effective health technologies is an achievable goal, with robust investment in expert institutions, national public health systems, and aligned private enterprise.

“This moment is a historic opportunity to save lives and meet major milestones against all three epidemics. With political will and commitment, proper investment in the Global Fund will be instrumental in maintaining progress and building on success,” said AVAC Executive Director Mitchell Warren.  

The US pledge of $4.6 billion over three years is a decrease from the $6 billion commitment in the previous replenishment cycle. But the US did reaffirm its 1:2 match, with the US continuing to contribute 1/3 of the total to the Global Fund, hopefully motivating other funders to step-up. Now, the US Congress must appropriate funding to fully meet the new US pledge, with language codifying the 1:2 match. Congress must also ensure funds appropriated for the previous replenishment, including $1.47 billion in matched funds, are distributed. 

Communities with the greatest burden of disease, which have already suffered program cuts, service disruptions and the loss of many trusted local partner organizations, and include marginalized key populations, are at even greater risk now. AVAC joins affected communities and civil society to call on all stakeholders to recommit to solidarity, transparency and global health security. Achieving this requires national governments, foundations, the private sector and civil society to develop new financial tools for sustainable, country-owned and community-led public health systems. One critical step is closing the remaining gap to reach the Global Fund goal and ensure that donors who have yet to step forward to do so with ambitious, robust pledges.

“The impact of this current shortfall will be needless death and disease. Modeling suggests up to 22 million preventable deaths by 2030 if global health funding from all sources continues to decline. Millions of lives have been saved thanks to the Global Fund, and shrinking resources threaten these achievements and risk squandering the opportunities of recent scientific advances,” said AVAC Director of Policy Advocacy Suraj Madoori.

Global Health Watch: Global Fund replenishment, LEN for PrEP arrives, HIV funding uncertain post gov’t shutdown

Issue 43

This week’s newsletter publishes just as the Global Fund’s 8th Replenishment Summit in South Africa is taking place. The Global Fund represents one of the strongest symbols of global solidarity in the fight against HIV, TB, and malaria, but, despite early pledges from several European Union member states and private partners, key donors (including the UK, Germany and France) appear to be stepping back, with smaller or uncertain pledges at this critical moment, and it is not yet clear what the US will do. A budget-constrained Global Fund raises serious concerns about losing ground against all three diseases and failing to seize opportunities to scale up new innovations in all three, including long-acting injectable PrEP for HIV. This Global Fund Advocates Network (GFAN) tracker tallies pledges, and this resource for scenario building shows how potential donor pledges could impact the funds available for health programs. Be sure to watch AVAC’s channels for the latest on the pledges.  

Read on for more including the arrival of injectable lenacapavir for PrEP in Eswatini and Zambia, the uncertain future of US health funding post-shutdown, and new research exposing the impact of NIH clinical trial cuts.

Lenacapavir Arrives in Eswatini and Zambia  

The first doses of injectable lenacapavir for PrEP (LEN) arrived in Eswatini and Zambia. These initial deliveries mark a historic acceleration in PrEP access, moving faster than we’ve seen with past introductions (see  AVAC’s new graphic comparing the rollout of LEN to past PrEP products) and signaling momentum and an ability to apply lessons from past delays. With additional regulatory reviews underway across the region, this early action represents a promising step forward. 

IMPLICATIONS: While these first shipments are worth celebrating, they’re just a down payment on what’s needed to deliver LEN at scale with equity. The joint Global Fund and PEPFAR commitment to reach two million people in the first three years is far more ambitious than past introductions, but falls short of delivering the impact that is needed. For LEN to have maximum impact, global donors and governments must align on transparent volume commitments, prioritize high-need markets and ensure that rollout strategies are rooted in community-led approaches. While South Africa is slated to receive LEN with Global Fund support, the fact that they are excluded from PEPFAR’s program is a huge, missed opportunity. If we really want to build a sustainable market as quickly as possible, one that will drive volume up and prices down and deliver real impact, South Africa must be THE center of the market and needs PEPFAR and Global Fund both to work with the South Africa government. AVAC’s full LEN resource library, including infographics on supply and demand, is designed to support advocates working to make that vision real. 

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US Government Reopens, Health Funding Remains Uncertain 

The US Congress officially reopened the federal government after the longest shutdown (43 days) in the country’s history. Funding for most agencies is now extended until January 30, and three appropriations bills were passed to cover several departments through all of fiscal year 2026 which ends next September. However, key health initiatives remain vulnerable: the deal keeps major health programs, including the nation’s HIV response, on a short-term continuing resolution only through January, and does not address spiking US health insurance costs. 

IMPLICATIONS: HIV prevention, treatment, and care programs will continue at last year’s levels through January 30, which avoid devastating cuts for the time being, with the fight to increase investments ongoing. The broader budget agreement also sidesteps major reforms demanded by lawmakers that threaten to gut these programs. It’s not clear if or when future disruptions might further impact public health programs and US global health engagement. 

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Clinical Trials Affected by NIH Research Grant Terminations 

A new study published in the Journal of the American Medical Association (JAMA) shows that more than 74,000 clinical trial participants were affected when 383 clinical trials lost funding from the National Institutes of Health (NIH) between February 28 and August 15, 2025. These cuts disrupted research across a range of diseases, but most of the targeted trials were outside of the US and were testing preventive or behavioral interventions, primarily in infectious diseases. “Those findings suggest that there’s a bias towards termination of grants that have nothing to do with the quality of research being conducted,” the authors wrote.  

IMPLICATIONS: This is one of the first studies to officially document the impact of the Presidential Administrations’ hostile policies and funding cuts to science. The political willingness to gut science without warning erodes trust in public health institutions and undercuts the foundation of long-term innovation. The impact is being seen across geographies, industries, communities, and diseases. 

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What We’re Reading

Resources

Global Health Watch: Pandemic Accord, US MoU pressure, LEN progress & UK Global Fund cuts

African countries reaffirm support for a new multilateral Pandemic Accord even as pressure mounts to sign bilateral US health agreements. The UK has reduced its upcoming Global Fund pledge just weeks before the replenishment summit. Meanwhile, additional regulatory submissions of lenacapavir (LEN) for PrEP are being made, most recently in Rwanda, reflecting accelerated actions and real lessons learned from earlier PrEP rollouts, as launches in several countries are being planned for World AIDS Day.

African Countries Support Pandemic Accord Under Pressure to Sign Aid Agreements with US 

African governments confirmed support for a multilateral Pandemic Accord under the World Health Organization (WHO) even as they face significant pressure to sign bilateral or government-to-government global health aid agreements with the US. These controversial agreements would require countries to share pathogen data, omit HIV prevention metrics, including PrEP and products like LEN, sideline civil society and key populations by removing requirements for community engagement, and bypass multilateral coordination, ignoring WHO and regional public health institutions. Advocates warn that bypassing the WHO Pandemic Accord negotiations risks repeating the inequities of COVID-19, forcing countries to share pathogen data without securing fair access to the medical countermeasures developed from them, leaving lower-income nations without the leverage needed to protect their own populations. 

IMPLICATIONS: This shift toward government-to-government support and conditional health assistance is shifting global health engagement into more transactional, equity‑challenging territory. Without indicators, community input, guaranteed reciprocity or multilateral coordination, countries may be locked into deals that deprioritize their interests. 

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Global Fund Replenishment at Risk: UK Reduces Pledge

The United Kingdom announced that it will reduce its upcoming pledge to the Global Fund by approximately 15% for the 2026‑2028 replenishment cycle, down from £1 billion in the previous cycle to £850 million. This news comes just two weeks ahead the Global Fund’s replenishment summit, which takes place November 21 in Johannesburg—which the UK and South Africa are co-hosting. The Global Fund proposed a target of $18 billion in its Eighth Replenishment Investment Case to save an estimated 23 million lives and prevent hundreds of millions of infections between 2027 and 2029. “It took the world 18 years to halve the combined death toll from AIDS, TB and malaria; with the right resources we can more than halve it again in only six years.” 

IMPLICATIONS: The cut from a longstanding major donor and summit co-host sets a worrying precedent, potentially signaling a retreat from multilateral leadership. Coupled with US cuts to global health funding generally, falling short of the Global Fund’s replenishment goal would increase disparities in access and likely shift resources and power away from communities and civil society.  

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PrEP Rollout Continues to Accelerate

Rwanda is now the 7th African country to receive a regulatory submission for lenacapavir for PrEP (LEN), which was recently approved in South Africa and Zambia, in addition to the US and European Union. For a full regulatory update,see here). The pace of progress for PrEP rollout continues to accelerate reflecting lessons learned from previous PrEP rollouts and signaling growing capacity and urgency to act. As AVAC’s new infographic below shows, the global community can learn and apply lessons, can move with speed, scale and equity, and might actually seize a PrEP opportunity instead of squandering it. 

IMPLICATIONS: Regulatory submissions and approvals are only one piece in the complex process. Turning regulatory milestones into public health impact depends on aligned global funders, transparent pricing and volume commitments, and community-engaged introduction strategies. Without this, innovation risks stagnation. 

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Download the static version of this graphic or hover over the graphic and click the three dots on the upper right to access full screen mode.

What We’re Reading

Upcoming Webinar

The People’s Declaration—currently with more than 500 signatories, charts out a number of community priorities and demands. Join The Choice Agenda, The Legacy Project, and a global panel to discuss moving these priorities into actions and accountability.

Cruel Ironies

Scientific advances collide with major infrastructure upheaval

We’re seeing one of the most challenging moments in HIV prevention history – and the cruelest ironies. On one side, science and advocacy are delivering unprecedented progress. South Africa and Zambia have approved injectable lenacapavir (LEN) for PrEP just months after US and EU regulatory approvals, with rapid WHO guidelines and prequalification paving the way for rapid rollouts in 2026 and beyond.

On the other, the global systems meant to deliver LEN and other potential innovations, like monthly oral MK-8527 are being dismantled. The US’s new ’America First’ Global Health Strategy replaces multilateralism and broad stakeholder engagement with bilateral government-to-government deals, redirecting and conditioning funds, and sidelining communities, which threatens to unravel decades of progress in HIV prevention, science and equity made possible through meaningful community engagement and leadership. And a new framework is in development to advance this strategy.

LEN Regulatory Milestones and What’s Next

In Africa, the South African Health Products Regulatory Authority (SAHPRA) led the way with a precedent-setting fast-track approval of LEN in October, followed by Zambia last week, with regulatory reviews underway in Botswana, Kenya, Malawi, Namibia, Rwanda, Uganda, and Zimbabwe. (For a full regulatory update, see here) These early wins reflect lessons learned from previous PrEP rollouts and signal growing capacity and urgency to act – the comparative graphic below shows that our global community does learn lessons, can move with speed, scale and equity, and might actually seize a PrEP opportunity instead of squandering it.

Yet as AVAC’s Moving a Product to the Real World graphic shows, approval is only one piece in the complex processTurning regulatory milestones into public health impact depends on aligned global funders, transparent pricing and volume commitments, and community-engaged introduction strategies. Without this, innovation risks stagnation.

Global Health Infrastructure Undermined

At the same time, the US government is pushing through a new global health framework under its “America First” strategy. This week, US embassies around the world began sharing draft Memoranda of Understanding (MoUs)with partner countries, aimed at reshaping how US health aid, including PEPFAR, is negotiated and delivered. These bilateral MoUs:

  • Omit HIV prevention metrics, including PrEP and products like LEN.
  • Sideline civil society and key populations by removing requirements for community engagement.
  • Bypass multilateral coordination, ignoring WHO and regional public health institutions.
  • Favor US commercial interests, raising concerns about procurement policies and equity.

A new Think Global Health article by KFF’s Jen Kates and colleagues explores this strategy’s assumptions including a pivot from multilateralism to bilateralism, a narrow focus on commodities and frontline workers, pooled procurement, and time-limited support with the aim to “graduate” countries from assistance. Meanwhile, Devex offers perspectives from several leaders in the field who weigh opportunities, contradictions, and raise red flags about sidelined NGOs and the communities they serve, reduced ambition in US global health programming, and weakened multilateral partnerships.

These agreements could endanger the rollout of LEN and other innovations, threaten the entire prevention pipeline and violate core principles of transparency, inclusion, and global solidarity. As Jirair Ratevosian wrote this week:

“What matters now are the decisions made in budget rooms, procurement units, regulatory authorities, and community forums…. The next phase of global health will not be defined by what Washington announces, but by what countries build.”

It will be up to countries to put forth strong plans and policies on scaling up LEN and other biomedical prevention during ongoing MOU negotiations with the US government.

Resources to Navigate the Cruel Irony

Global Health Watch: Zambia approves LEN, what “America First” means for global health, new documentary on impacts of foreign aid freeze

Issue 41

This week, Zambia joined South Africa in approving injectable lenacapavir for PrEP (LEN), marking a new era of accelerated efforts to scale-up access. At the same time, there’s sharpening analyses of the major shifts in US strategy for foreign aid and global health leadership, with deep implications for the future of funding, multilateralism, and equity.

What Lies Ahead for “America First” Global Health Strategy? 

It’s been six weeks since the US Department of State issued its “America First” global health strategy, and global health leaders in the US are now sharing insights on the real-world implications of the new strategy. A new Think Global Health piece looks at questions posed by key pillars of the US strategy: a pivot from multilateralism to bilateralism, a narrow focus on funding for commodities and frontline health workers, pooled procurement and time-limited support with the aim to ‘graduate’ countries from assistance. Meanwhile, Devex offers perspectives from several leaders in the field who weigh opportunities, contradictions, and raise red flags about sidelined NGOs and the communities they serve, reduced ambition in US global health programming, and weakened multilateral partnerships. 

IMPLICATIONS: The way forward requires a major recalibration by implementers, partner countries and communities. The next chapter under this new system could exacerbate ongoing service disruptions and existing challenges in HIV prevention and treatment delivery, in particular to key populations. As funding becomes more conditional and bilateral agreements take precedence, mechanisms for community-driven priority setting, program monitoring, comprehensive data collection and sharing, and universal access to prevention tools must be preserved.  

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New Resources on the Foreign Aid Crisis 

Two powerful new resources shed light on the far-reaching impacts of the United States’ foreign aid cuts. The New Yorker released Rovina’s Choice, a new documentary that follows a mother in Kenya navigating the collapse of care for her daughter living with HIV. The film captures the cascading effects of the loss of USAID support, including the dismantling of HIV wards, malaria clinics, refugee camps and health centers. Atul Gawande, the last Assistant Administrator of USAID, penned an accompanying commentary, The Shutdown of USAID Has Already Killed Hundreds of ThousandsDevex also launched The Aid Report, a central hub for tracking funding reductions, program disruptions, and structural shifts across the ecosystem of global aid. 

Meanwhile, The New York Times and Washington Post highlighted AVAC and the Global Health Council’s court cases against the foreign aid freeze as part of a broader test of executive power, with direct implications for foreign assistance policy. See AVAC’s trackers to stay abreast of the impact of US cuts to foreign aid and HIV prevention research.  

IMPLICATIONS: These resources demonstrate the scale and impact of US disengagement from global health leadership. They document how political decisions in Washington are directly destabilizing care systems, reversing progress, and threatening lives—especially in communities already facing high burdens of disease. The loss of predictable US funding has ended vital health programs around the world and is shifting the architecture for global health to a transactional model that may deprioritize equity, local voices, and long-term sustainability. 

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Zambia Approves LEN for PrEP

Zambia is the latest country to approve injectable lenacapavir for PrEP (LEN), following the South African Health Products Regulatory Authority (SAHPRA) approval two weeks ago. These are the first low- and middle-income countries to approve an HIV prevention method within just months of regulatory approvals in the US and EU. Regulatory reviews are also underway in a number of additional countries, with decisions expected over the next few months.

IMPLICATIONS: These swift approvals mark a major milestone in the global HIV response and set a new precedent for accelerating the process of scaling-up biomedical interventions in high-burden regions. But approvals alone are not enough. Turning access into impact will require aligned funding, community engagement, strong demand creation, and clear strategies for equitable rollout. These early regulatory wins are a strong start, but continued advocacy is essential.  

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Webinar: Influencing the New USG Global Health MoUs and PEPFAR Strategy

Monday, November 10 @ 15:30 EAT
Join COMPASS with EANNASO and Data ETC for a webinar sharing tools and strategies to influence the new USG global health MoUs and ensure HIV prevention, community-led delivery, and accountability stay central under the “America First” strategy.

Register

What We’re Reading

Upcoming Webinar

New from AVAC

LEN Resources, DPP in Focus, STI Prevention, Fighting for Key Population Rights & Health

This round up offers on-the-ground tools for stakeholders involved in rolling out injectable lenacapavir for PrEP; updated articles on AVAC’s court case on foreign assistance; resources on the state of defending rights to health and inclusion for key populations; an up-close look at AVAC’s Advocacy Navigator program and the accomplishments of this year’s cohort; updates on the Dual Prevention Pill featured at The International Conference on Family Planning; and several new advocacy resources for cure research and the prevention of sexually transmitted infections (STIs).

Getting Rollout Right for LEN

This collection of tools is for stakeholders working to accelerate access to injectable LEN for PrEP. Continually updated, these tools support critical steps in rolling out LEN, including interactive tools for planning, monitoring and evaluation; toolkits for provider training; templates for technical working groups to establish terms of reference; and adaptable standard operating procedures for country planning to align with WHO guidelines among others. Additional tools will be added as they are available. For more on LEN, visit avac.org/lenacapavir.

Fighting in the US courts for Fairness and Sustainability in Global Health 

AVAC is a lead plaintiff in one of many cases attempting to hold the US Presidential Administration accountable to the US Constitution, Congress, global commitments and the American people. The Washington Post and the New York Times published stories this week on the implications of pending US Supreme Court decisions. As AVAC Executive Director Mitchell Warren told the Washington Post, the high court’s ruling “potentially implies that the Administration can disregard Congressional power of the purse.”

Defending and Demanding the Right to Health and Inclusion for Key Populations

This webinar included an unflinching assessment of the impacts of the ongoing assault on transgender health and rights and strategies to sustain programming.

At the same time, the 4th Conference on Public Health in Africa (CPHIA 2025) reaffirmed Africa’s shift from aid dependency toward health sovereignty, self-reliance, and regional solidarity. The conference culminated in The Durban Promise, a commitment to mobilize Africa’s wealth and innovation for health sovereignty. When it comes to HIV services, COMPASS advocates at the conference, including AVAC’s Richard Muko, made clear that strengthening healthcare systems requires a commitment to person-sensitive care and the leadership of key population (KPs) communities to achieve impact. Learn more about KP priorities for HIV prevention here.

Preparing the Next Generation of HIV Prevention Advocates: Advocacy Navigators 

AVAC’s The Advocacy Navigator program mobilizes ambitious, emerging advocates and provides them with resources to build knowledge, skills and confidence to advance HIV prevention in their communities and countries. Navigators are paired with mentors, alumni of AVAC’s Advocacy Fellows Program, to provide support and guidance to ensure the next generation of HIV advocates are fierce and effective in demanding speed, scale, and equity in the HIV response.

Check out Navigating Change: Young Advocates Lead the Future of HIV Prevention, by AVAC’s Bridget Jjuuko & Jeanne Baron, for an up-close look at how and why the model works and critical accomplishments by this year’s cohort, representing 10 countries across Africa. Their achievements include changing national and regional policies; expanding access to PrEP; connecting youth to HIV services; and establishing youth leadership in the HIV response. 

The DPP at ICFP 

The International Conference on Family Planning (ICFP) 2025, happening in Bogota this week, shines a spotlight on the Dual Prevention Pill (DPP). Still in development, the DPP would prevent both pregnancy and HIV. If approved, the DPP will require integration of contraception and PrEP in guidelines, health systems, delivery approaches, and demand creation. AVAC’s ICFP panel discussion, The Dual Prevention Pill Introduction Plan: Both a Question and an Answer to Integration, covers how programs should think about rolling out novel prevention products like the DPP in the current landscape, learning from projects across sub-Saharan Africa.

Also at ICFP, The Self-Care Trailblazers group is launching a report, 2025 State of Self-Care Report: Self-Care in a Changing World, featuring a DPP case study, authored by AVAC’s Natasha Mwila, Community-Centered Perspectives on the Dual Prevention Pill as a Self-Care Product, covering how community engagement with women and adolescent girls informed design, decision-making in support of the DPP as a self-care product with the potential to advance rights, equity, and choice.

Time for Advocacy for Cure Research

Advocacy and HIV Cure Research Agenda: Highlights from the Advocacy-for-an-HIV-Cure Academy by AVAC’s Jessica Salzwedel showcases the recent AVAC/IAS Academy, the eighth Academy in eight years—and why advocacy for cure research matters and how advocates are preparing their communities for this fast-moving and important area in HIV prevention and treatment.  

For a deep dive on these issues, check out the HIV Cure podcast episode, Community Involvement in HIV Cure and Vaccine Research, featuring Jessica and hosted by Sekgabo Seselamarumo, a member of AVAC’s Clinical Trial Design Academy and alumna of the AVAC and IAS Advocacy-for-Cure Academy.

Advancing Integration and Investment for HIV & STI, from Research to Rollout 

Coming Up!

From Courtrooms to Communities: Funding Advocacy to Protect HIV Responses is a webinar hosted by Funders Concerned About AIDS for representatives of funding and philanthropy serving organizations. Advocacy is one of the most underfunded areas of HIV philanthropy—yet essential to defending rights and sustaining progress.
November 12, 2025 from 10:00-11:30 AM EST

The breadth and depth of the HIV response and the crosscurrent of forces bringing comprehensive change are not easy to track or translate. But it’s vital work. Informed advocates are the world’s best hope for bringing speed, scale and equity to global health and to people who need HIV prevention. We hope these resources help to keep you connected and ready for the fight.