We are delighted to share our 2025 update of The People’s Research Agenda (PRA), offering an online, interactive dashboard for tracking, translating, and advocating for HIV prevention research and development (R&D). First developed in 2024 in partnership with global advocates and communities (and launched at the HIV Research for Prevention (R4P) conference in Lima), the PRA sets out a people-centered framework for equitable and accelerated R&D and product introduction. The PRA tracks the science, shows where investments align—or fail to align—with community-defined priorities, and spotlights critical gaps in the pipeline of prevention options needed to meet the diverse realities of all populations.
Because HIV prevention R&D must remain a core priority in the HIV response, the PRA offers the evidence and insight needed to secure support for a community-centered research pipeline. More than a report and data tool, the PRA is a continually updated accountability mechanism that can transform information into influence.
Since the People’s Research Agenda first launched in 2024, much has happened. US funding cuts terminated an entire portfolio of critical HIV prevention research programs, including ADVANCE and BRILLIANT, which were studying African-led vaccine concepts; MATRIX, which was studying shorter-acting, user-controlled ARV-based PrEP and dual-purpose options; and MOSAIC, which was conducting an implementation science study of PrEP options. But new efficacy trials are now underway testing a monthly PrEP pill and several early-phase vaccine candidates are investigating a number of strategies.
The field must face head-on this new reality with sharper priorities and smarter investments. We invite you to dig into this 2025 update of the PRA, to join in our calls to action, and continue the fight for critical research that will finally bring the HIV epidemic to an end.
Global Health Watch: World AIDS Day advocacy, first injections of LEN for PrEP, CDC turmoil, Kenya signs US MoU
Issue 45
In 1990, the US Centers for Disease Control and Prevention (CDC) codified five principles under the late Walter Dowdle as its pledge to the American people, including a promise to ground every public-health decision in the highest-quality scientific data and to treat all people with dignity, honesty and respect. But today, as political forces undermine science and erase commitments like World AIDS Day, we are reminded just how fragile those principles have become, and how essential they remain.
This week we track both momentum and mounting threats in the HIV response: powerful World AIDS Day advocacy even as the US refused to recognize it; first recipients of lenacapavir for PrEP in Brazil, Eswatini, South Africa and Zambia; continued CDC turmoil that threatens trust in vaccines and science-based public health; the US’ “New G20” without South Africa; and Kenya signs the first US global health Memo of Understanding (MoU).
World AIDS Day
Despite the current US administration refusing to recognize December 1 as World AIDS Day (as described here in National Public Radio’s Goats & Soda), global media coverage and action were strong. On South Africa’s eNCA evening newscast, CAPRISA’s Slim Abdool Karim and AVAC’s Mitchell Warren underscored the need for smart, strategic decisions to prevent infections and ensure access to treatment. ABC News featured additional warnings about the devastating impact of US cuts and politics, and CNN highlighted what happens when ideology trumps epidemiology.
For additional reflection, Emily Bass and Ben Plumley offered a powerful—and sobering—conversation via the Shot in the Arm podcast about how political decisions can upend global HIV progress, and how affected countries are increasingly taking control of their responses.
At ICASA, the Lancet published a six-paper series on Sustainable HIV prevention in Africa, which shares why epidemic control depends on shifting from fragmented, donor-led programs to country-led, integrated systems, using examples of impact from seven African countries.
And in New York City, the #SaveHIVFunding campaign rang the NASDAQ stock market’s opening bell in recognition of World AIDS Day and a national week of action, sending a powerful message of unity, resilience, and national resolve to protect the lifesaving HIV programs that millions of people in the US and around the world rely on.
First Injections of LEN for PrEP
This week people in Brazil, Eswatini, South Africa and Zambia received the first injections via implementation programs outside of the US of lenacapavir for PrEP (LEN). The Global Fund to Fight AIDS, Tuberculosis and Malaria anticipates additional deliveries of LEN in the coming months to both Eswatini and Zambia as well as to Kenya, Lesotho, Mozambique, Nigeria, South Africa, Uganda and Zimbabwe. See AVAC’s updated map of Global Fund and PEPFAR supplies to early introduction countries. Meanwhile, national regulatory agencies in Malawi and Zimbabwe approved LEN for PrEP, bringing the total number of approvals to six. See AVAC’s updated LEN regulatory map.
IMPLICATIONS: These milestones signal a new dawn for HIV prevention—the speed at which LEN is being approved and delivered shows what’s possible when political will, funding, community engagement and innovation align. But this speed must now be matched by scale and equity: to truly change the trajectory of the epidemic, LEN must reach all who need it and be sustained over time. Read more about the events by advocates and partners on LinkedIn here, here and here. Also GBGMC’s Micheal Ighodaro explored the transformative potential of LEN for PrEP if countries commit to access, especially for key populations in Think Global Health.
Continued Chaos at the US Centers for Disease Control and Prevention (CDC)
A recent New Yorkerinvestigation captures the political interference at the CDC under Health and Human Services (HHS) Secretary, Robert F. Kennedy Jr., which includes changes that are undermining the scientific consensus that vaccines do not cause autism. This week the Advisory Committee on Immunization Practices (ACIP), which was dismissed and replaced with vaccine-skeptical members, meets to consider delaying the hepatitis B vaccine dose at birth, which would be a major departure from decades of proven public-health practice. The Committee meets under a new chairperson, Kirk Milhoan, who has blamed vaccines for causing cardiovascular disease, and began his post just this week. Meanwhile, the CDC issued a warning to clinicians to watch for Marburg virus cases linked to an outbreak in Ethiopia, highlighting emerging global health threats amid institutional instability.
IMPLICATIONS: By dismantling long-standing expert advisory processes and politicizing vaccine guidance, the US is undermining domestic immunization programs and also global confidence in science-driven public health. The potential delay or rollback of routine immunizations threatens to reverse decades of progress, fueling distrust that could spill over into HIV, TB, and other health areas. At such a pivotal moment for HIV prevention, cure research, and vaccine development, destabilizing vaccine policy in the US risks eroding momentum worldwide.
Following the closure of the widely hailed G20 summit in South Africa last week where the US was notably absent, this week, the US shared plans for a “New G20” for 2026, which adds new members and excludes South Africa from the summit in Miami next December. In a statement, US Secretary of State, Marco Rubio unfairly and alarmingly called out South Africa’s current government: “Rather than take responsibility for its failings, the radical ANC-led South African government has sought to scapegoat its own citizens and the United States”. In response, South Africa signaled it will take a “commercial break” from G20 participation during the US-led presidency.
IMPLICATIONS: The exclusion of South Africa in the US-led 2026 summit is a warning sign. South Africa has been a leading voice for African and Global South priorities, including equitable access to health, the HIV/AIDS response, and social justice. By sidelining the country with mis- and dis-information, the US risks marginalizing regions already facing unequal burden of disease and limited resources. Key funding, efforts to expand access to medicines and HIV prevention tools may suffer from fractured governance and most vulnerable communities could lose out on representation, accountability, and the collective leverage needed to secure health equity worldwide.
Kenya Signs MoU Under New US Global Health Strategy For $1.6B
Kenya became the first country to sign the controversial US Health Memos of Understanding (MoU) earning $1.6B in funds disbursed through the next five years in exchange for health care data and specimens for the next 25 years. US Secretary of State Rubio suggested this was the first of many countries (up to 50) to sign the MoUs.
IMPLICATIONS: Kenya’s decision trades long-term access to health data and biological samples for short-term funding raising serious concerns about sovereignty, consent, and accountability. If this agreement becomes the model for dozens more countries, the future of global health cooperation could shift toward transactional arrangements that prioritize US geopolitical interests over community rights and health equity.
Now streaming on Hulu: HIVUnwrapped: Where Fashion Meets Science — a powerful look at how HIV researchers and fashion designers are teaming up to bring information on HIV to new audiences.
Join us for a conversation on the state of HIV cure research in Africa and the opportunities to strengthen and scale Africa-led innovation with leaders from Africa Health Research Institute, KwaZulu-Natal, Root to Rise and moderated by Anna Miti.
In the Midst of Chaos, a Historic Opportunity this World AIDS Day
World AIDS Day in 2025 comes at a moment of unprecedented change. Over 60 years of investment in global health, forty years of innovation and progress in the fight to end the HIV epidemic, and many of the critical programs that provide access to HIV prevention in high burden countries are in disarray and at risk of collapse. As the US government withdraws and redirects resources, the just-launched UNAIDS report shows the number of people living with HIV is predicted to increase from 40 to 50 million people by 2050, unless HIV incidence reduces dramatically. Yet, in the midst of the chaos, there’s a historic opportunity to defeat HIV by scaling-up the breakthrough technology of long-acting injectable PrEP.
As governments and HIV prevention champions around the world scramble to reimagine a people-centered HIV response and build anew, what will it take to finally achieve targets to drive down incidence and reach epidemic control?
1. Fulfill the promise of science with accelerated, equitable access to injectable lenacapavir (LEN) for PrEP, delivered at scale
Science and advocacy have delivered astounding progress in developing biomedical options for HIV prevention. Injectable LEN for PrEP is moving from research to rollout faster than any product before.
Current commitments from the Global Fund and PEPFAR to provide doses for two million people by 2028 in 12 initial countries represent a good start, but fall far short of reaching targets to achieve impact, which calls for 20 million PrEP users by 2030.
Making LEN for PrEP available for all who need and want it is possible. Coordination among all stakeholders, and a shared priority to achieve epidemic control, can build a sustainable market for LEN that drives volume up and prices (and HIV incidence) down; puts communities at the center of program planning and implementation; is supported by inclusive policies; and integrates with sexual and reproductive health services that offer choices in HIV prevention to meet diverse needs. To learn more about who and what must come next to realize this potential, check out AVAC’s suite of LEN resources and track updates on rollout with our long-acting PrEP dashboard.
2. Expand, strengthen and sustain community and civil society leadership in the HIV response
Engaged advocates are fundamental to the success of HIV prevention R&D and rollout and to the larger global health movement. Involving community, civil society and global health advocates too little or too late has taught the field valuable lessons. Community leadership was on full display at last week’s Global Fund replenishment. Informed and supported community leadership has reshaped and improved both clinical trials and the broader landscape of policies, planning and programs for HIV prevention. From the strategic organizing and monitoring by the Coalition to build Momentum, Power, Activism, Strategy & Solidarity (COMPASS) Africa, to the policy wins and mentoring successes of AVAC’s Fellows & Advocacy Navigator programs, to the high-impact reach of Coalition to Accelerate & Support Prevention Research (CASPR), these initiatives represent highly effective models for community engagement. Stay tuned for detailed reports on the impact of these models in the weeks ahead.
3. Double down on the research pipeline for HIV prevention and a People’s Research Agenda
The US government’s attack on HIV research has been just as evidence-free, ideological and devastating as the drive to dismantle foreign assistance. With epidemic control in sight against one of the fastest mutating viruses ever known, HIV prevention scientists and advocates know that now is the time to press on the gas, not stall out. From vaccines and bNAbs to multipurpose technologies (such as the Dual Prevention Pill), to novel long-acting PrEP (such as a monthly PrEP pill), advancing the development of options to meet diverse needs and offer choice is key to effective HIV prevention and ending the epidemic.
As the new year approaches, there’s no doubt what needs to happen: deliver effective options with speed, scale and equity; invest robustly in developing the options we still need; and center the leadership of communities at every level of the HIV response. The world has every capacity to end the HIV epidemic in our lifetime, now we must summon the political courage to do it.
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.
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, educatedpolicy 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.”
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.
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: 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.
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.
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.
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.
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 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.
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.
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.
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 Thousands. Devex 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.
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.
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.
