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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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.

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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.

Navigating Change

Young Advocates Lead the Future of HIV Prevention

By Bridget Jjuuko and Jeanne Baron

Last year, Gloria Nawanyaga decided to do something about the devastating numbers of adolescent girls and young women (AGYW) who acquire HIV in her country, Uganda. At approximately 10,000 new cases of HIV among AGYW each year, it’s an HIV rate that demands urgent attention and better access to prevention. Gloria found the support she needed to take action when she became an AVAC Advocacy Navigator, a program that combined virtual coursework, personalized mentorship, and opportunities to directly apply learning through a community advocacy project over the course of six months.

She developed a plan to reach communities of young women with information about injectable cabotegravir for PrEP. Gloria explains her campaign in this short video. By the end of her project, she’d reached one million people through social media and other outreach, and kicked-off policy discussions with the Uganda AIDS Commission to improve access to new PrEP methods.

The Advocacy Navigator Model

Gloria was one of twelve navigators who developed concrete, on-the-ground, advocacy projects that advanced HIV prevention in ways that are relevant to their communities. A look at the work of the 2024-2025 AVAC’s Advocacy Navigators is testimony to the value of this model of supported mentoring. These stories also demonstrate the essential power of advocacy to make policy, inform communities, improve the HIV response and change lives.

Mentorship has been a cornerstone of the Advocacy Navigator Program, and this approach offers a sustainable model for supporting emerging advocates in the HIV field. This unique, low resource approach to building a new generation of HIV prevention advocates leverages digital learning, volunteer mentors, and community driven initiatives, making it highly cost effective and adaptable across contexts. With minimal resources, this model of structured mentorship strengthened individual advocacy know-how, built confidence, fostered strong networks, and if adopted by others across the field, it will support a future generation of leaders who can innovate, adapt and sustain progress in the HIV response.

“The advocacy navigator program is something I wish I had access to when I started my advocacy journey because it provides guidance, mentorship as well as the practical experience through seed funding. You get the experience of doing a project but with guidance and mentorship,” said Anna Miti a former AVAC Fellow and journalist who now is the co-moderator of of The Choice Agenda listserv.

More Highlights of Advocacy in Action in the Navigator Model

Takunda Clement Chanetsa worked at the grassroots and policy-level in Zimbabwe to address stigma and mental health needs among young people living with HIV. He ran focus groups, developed advocacy toolkits, engaged traditional leaders and government agencies, and ultimately secured concrete commitments to improve youth access to healthcare. “I knew I was making a difference when young people started telling me they felt safe to talk about their challenges for the first time. I saw them transform and become advocates. Now I am going to fight for policies that include mental health services in HIV care. Never underestimate the power of youth advocates.”

Madalitso Juwayeyi’s university student community faced barriers to access to PrEP, and Malawi’s existing strategic planning for HIV prevention made no unique provisions for university students. Her project created platforms for student advocates, clinic personnel and National AIDS Commission policymakers to meet and learn from each other, resulting in agreements to develop strategies for PrEP distribution to Malawi’s university students. “This is a proof that when young people are given a chance to demand what they want then change comes.”

Joseph Linda saw that vast areas of Kampala, Uganda, were home to youth who needed HIV services but with few pathways to find them. He created an accessible database of HIV providers that for the first time connected vulnerable communities to landscape of care. He trained a cadre peer educators to raise awareness of life-saving options in HIV treatment and prevention and where to find them. “The problem I saw was the young people in the slum areas had no direct access or information about where to get HIV prevention. My long-time goal is that young people know about HIV services and can find them.”

Other highlights from Navigator projects include:

  • Jessica Booysen created comprehensive workshops on reproductive health and rights in her South African community.
  • Gcebile Yvette Dlamini worked in Eswatini to educate community leaders and youth, particularly young women, about HIV prevention.
  • Renny Mulala deployed a multi-media campaign in Zambia, including print and radio, to reach youth and dispel myths about long-acting injectable cabotegravir as PrEP, promoting access and informed choice.
  • Rumbidzai Munhanzi of Zimbabwe and Sharon Ramantele of Botswana championed the equity and health challenges faced by people who use or inject drugs (PWID).
  • Nicole Ondisa Oduya’s advocacy reshaped access to PrEP among sex workers in her Kenya community.
  • Elizabeth Zahabu’s project in Tanzania introduced sexually transmitted infection (STI) self-testing kits, trained a cadre of peer educators, and engaged government leaders who became allies in supporting reproductive rights, and ultimately achieving increased funding for local clinics.

Mentoring Future Leaders: Next Generation Advocacy for Equity and Impact in HIV prevention

Civil society and advocacy organizations can adapt and implement the Advocacy Navigator model to fit their context. This model is designed to be flexible and respond to opportunities in a given community rather than a rigid curriculum. Virtual training, mentorship, and local advocacy projects are core components which can be easily tailored to different contexts, populations, and priorities to address specific health or social issues beyond HIV prevention.

Mentorship can also be aligned with local expertise and deliver sessions in local languages or through accessible digital platforms such as WhatsApp or Zoom. The model allows for variation in project scope depending on available resources, ranging from small grassroots initiatives to national advocacy campaigns. Because it relies on partnerships, peer learning, and virtual engagement, it can be implemented in both urban and rural settings with minimal cost while maintaining high impact.

“The model demonstrates that meaningful advocacy can thrive through mentorship, collaboration, and locally driven action, even in resource-limited settings. It’s simple but incredibly effective. The model gives mentors and advocates the confidence and structure to make real change where it matters most,” said Cleopatra Makura, Pangaea Zimbabwe.

“The Advocacy Navigator program model is inspirational. It empowers individuals to advocate for themselves and others, creating a ripple effect of positive change. Its effectiveness lies in its tailored approach, building confidence and skills, while being low-resource due to its adaptable, peer-led, and community-based design,” said Eric Mcheka of Edukans Country Office in Malawi.

“It’s a transformative process with impact though executed in few months,” said Chilufya Hampongo, Ascend Futures Foundation.

The range and depth of the work of these young leaders is an inspiration and an opportunity. In the current environment, where investment in HIV prevention has constricted, the Advocacy Navigator model provides a dynamic, effective way forward for advocacy that is needed now more than ever.  

Advocacy and HIV Cure Research Agenda

Highlights from the Advocacy-for-an-HIV-Cure Academy

By Jessica Salzwedel

Advances over the past ten years toward an HIV cure have moved cure research from a dream to an attainable goal. The field has learned more about the power of the innate immune system through individuals who have controlled their virus, either spontaneously or post-treatment, and these insights have spurred innovation and momentum in cure research.

With such advances underway, advocacy from affected communities is essential to guide HIV cure research. When communities help shape the research agenda, it ensures alignment with real-world needs, avoids misunderstandings, and increases the chances of meaningful, lasting impact.  AVAC and the International AIDS Society have hosted an Advocacy-for-a-Cure Academy every year since 2017, which helps build the capacity of advocates in low-and-middle income countries to advance the research agenda for an HIV cure in their local context. The Academy focuses on building foundational knowledge—reviewing current approaches, major scientific barriers, and population specific concerns—and building practical skills in research translation.

The 2025 Advocacy-for-a Cure Academy was hosted in October in Lomè, Togo, the first convening in West Africa. It brought together 15 skilled advocates, representing 13 countries in East, West and Southern Africa, including former AVAC Fellows Ulanda Matamba (Malawi), Paul Sixpence (Zimbabwe), and Samuel Gorgio (Kenya). Faculty for the academy included, AVAC’s Senior Program Manager Jessica Salzwedel and IAS’s Riccardo Maddalozza, who oversee the Academy program, as well as Gabriella Chromhout of the University of Kwa-Zulu-Natal, Paul-Alain Taagnouokam of CREMER, past AVAC Fellow Charles Brown of Prevention Care International, and Katherine Bar of University of Pennsylvania.

“The experience was both inspiring and enriching,” said Kenya’s Joyce Adhiambo of Partners in Health and Development in Africa.

Academy participants developed communication and advocacy plans to disseminate the latest research news on cure strategies within their local context. Participants drew from in-depth dialogue with faculty and fellow advocates to explore what is needed for cure to be conducted within their communities.

“We emerge not only informed but equipped to bring HIV cure advocacy to the communities we serve and to shape research agendas grounded in our local realities,” said Cameroon’s Laurel Kevine of the Research Center on Emerging and Reemerging Diseases.

“This experience was eye-opening. I went in thinking a cure meant total eradication, but I left understanding that remission is also part of the story. I’m excited to turn this new knowledge into action in my communities,” said Burundi’s Ravel Gatoto, of Réseau National des Jeunes Vivant avec le VIH.

The Advocacy-for-Cure Academy will award one participant with an alumni grant to execute their plan over the course of 12 months. The 2026 Academy will be an alumni academy designed to deepen the knowledge of alumni over the past eight years of the program.

The Advocacy-For-A-Cure Academy represents sustained programming to support cure advocacy. This is essential investment in a key component of successful research—informed and supported advocates who are empowered and integrated into the process. As much as the broader HIV response recognizes how important this work is, cure research will be on track to maximize its potential. That means, on the day cure strategies show efficacy and become a reality, communities that need it most will be working hand in glove with other global health leaders to ensure not one more day is lost in speeding access to the end of AIDS.

Global Health Watch: South Africa registers LEN for PrEP, US global health MoU, EU may cut $ for Gavi + Global Fund, new Lancet SRH series

Issue 40

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. 

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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. 

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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. 

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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.

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What We’re Reading

AVAC Resources

Upcoming Webinar

Transforming HIV Prevention in 2025

Advocates’ Critical Questions

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!  

Global Health Watch: Development finance, impact of foreign aid cuts + new PrEP resources to track PrEP access, pricing and the pipeline

Issue 39

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.  

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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. 

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Release Critical Global Health Funding!

Partners in Health and others are urging the timely and full disbursement of Global Fund and PEPFAR funding to prevent disease outbreaks, strengthen health systems, and protect vulnerable communities.

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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. 

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What We’re Reading

New & Updated AVAC Resources

Upcoming Webinar

Moving the STI Research, Development and Diagnostics Agenda Forward

Despite being one of the world’s most urgent and growing health crises, sexually transmitted infections (STIs) remain underfunded, underdiagnosed, and underprioritized around the world. In response, with support from the Gates Foundation, AVAC launched an STI advocacy initiative in 2023, partnering with seven civil society organizations across East and Southern Africa to build a stronger, more coordinated effort. From national policy landscaping to multi-stakeholder dialogues and technical briefs, this first wave of work laid a powerful foundation for reframing STIs as issues of equity, integration, and community power.

Why STI Advocacy and Why Now?

The global burden of STIs is staggering with more than one million treatable STIs being acquired daily, and new threats like antibiotic-resistant gonorrhea and rising syphilis cases (including congenital syphilis) demanding urgent action. Yet funding, research, and political attention lag far behind the need. 

Civil society voices are critical to closing this gap. AVAC’s STI advocacy partner initiative was designed to support organizations already rooted in HIV and sexual and reproductive health (SRHR) work to sharpen their STI policy agendas, develop actionable priorities, and advance country-level and global conversations, especially around new tools like point-of-care diagnostics and vaccine research. 

Meet the Partners

Nyanza Reproductive Health Society (Kenya)
They identified low STI testing rates due to stigma, lack of awareness, and test shortages, emphasizing the urgent need for local data to inform advocacy and policy change.

Lesotho Network of AIDS Service Organizations (Lesotho)
They found major gaps in STI information and condom access in Mapholeneng, where rapid population growth has strained services. Partners emphasized the need for open dialogue and community engagement.

Journalists Association Against AIDS (Malawi)
Highlighted the lack of up-to-date STI data and outdated policies. To lay groundwork, they mobilized civil society, media, and policymakers to align around a coordinated national STI advocacy agenda.

HIV Survivors and Partners Network (South Africa)
They documented test kit shortages and gaps in HPV vaccination, advocating for civil society leadership in advancing STI literacy, diagnostics, and vaccine access.

ACTS-101 (Uganda)
They found that STI programming is overshadowed by HIV services, calling for targeted STI advocacy and investment in vaccines and diagnostics.

LATU Human Rights Foundation (Zambia)
They spotlighted the treatment gap for key populations and helped integrate STIs into new CAB-LA and Hep B guidelines.

Pangaea Zimbabwe (Zimbabwe)
They exposed gaps in STI prevention and care across nine districts, driven by costs, stigma, and stockouts; urged the creation of an inclusive, well-funded movement for STI services and innovation.

Across all projects, partners identified critical needs: more accessible and accurate diagnostics, better integration of STI and HIV services, updated national guidelines, and increased political will to fund the STI response.  

Learn more and hear these advocates share the results of their work and insights for moving ahead.

What’s Next with STI Advocacy

The momentum continues in 2025, with new landscaping efforts now underway in Kenya, South Africa, and Zimbabwe. These projects aim to map opportunities for building national advocacy networks in countries facing high STI burdens—ensuring that investments in STI research, diagnostics, and services are driven by community priorities and deployed where they are needed most. 

Read a new blog post with three leading advocates: Cleopatra Mpaso of Pangaea Zimbabwe, Mandisa Mdingi of the Foundation for Professional Development (FPD) in South Africa, and Felix Mogaka of the Kenya Medical Research Institute (KEMRI) who are each conducting national STI landscaping assessments. They share insights on the state of STI advocacy, the role of civil society in shaping R&D priorities, and the importance of connecting global conversations to local needs. 

Join Us October 29