Embedding Good Participatory Practice in PURPOSE 1

Ethical conduct of HIV clinical trial research improves as product developers, researchers, and other stakeholders become increasingly intentional about community partnership and engagement. When AVAC and UNAIDS developed the Good Participatory Practice (GPP) guidelines, the goal was to create a framework for trial funders, sponsors and implementers to engage communities across the HIV prevention research continuum. From trial design and implementation to results dissemination and access planning, GPP provides a guide for ensuring prevention products are responsive to community priorities and accessible to the people they aim to serve. For almost 20 years of GPP implementation, AVAC has collaborated with partners around the world to embed the principles within advocacy strategies and partnerships and cultivating a diverse network of advocates, civil society organizations, journalists, researchers, and implementers who champion GPP and are equipped to engage with, question, and influence HIV clinical trial research.

The Good Participatory Practice Guidelines, developed by AVAC and UNAIDS

Promoting Transparency and Accountability in Gilead’s PURPOSE Program

Gilead’s PURPOSE program is comprised of six clinical trials investigating long-acting injectable lenacapavir (LEN) for PrEP among diverse populations. PURPOSE 1, one of the two efficacy trials in the program, was conducted among cisgender women in South Africa and Uganda, while PURPOSE 2 expanded the reach to include men who have sex with men (MSM), transgender men and women, and gender non-binary people. Both trials found LEN highly safe and effective among participants. Beyond the clinical findings, the trials also demonstrated that embedding GPP principles promotes accountability, transparency, and meaningful community engagement throughout trial design and conduct.

A case study of GPP implementation in PURPOSE 1 highlights how GPP strengthens ethical conduct and inclusion. AVAC staff and partners participated as members of the Global Community Accountability Group (GCAG), a formal mechanism for providing community perspectives on the trial. GCAG members provided community recommendations on trial design, including protocol considerations, participant recruitment and retention, and trial implementation to Gilead and researchers. Advocacy by the GCAG contributed to expansion of the inclusion criteria to enroll adolescents and to allow pregnant and breastfeeding people to remain in PURPOSE 1 after re-consent, reinforcing the principle that communities should help shape research that directly affects them and allowing the study to gather critical data on the safety and efficacy of LEN in populations often excluded from research.

Nombeko Mpongo of the Desmond Tutu Health Foundation and a member of the African Women’s Prevention Community Accountability Board served on the GCAG for PURPOSE 1 and describes how early involvement translated into influence and accountability:

“What was important was that communities were involved from the beginning. We received the protocol early, before the study began, and had the opportunity to scrutinize it and identify what we thought needed to change. One of the issues we raised was ensuring that women who became pregnant during the study would not automatically be excluded, so we could better understand prevention during pregnancy. We were not there as tokens—we took ownership of our role in the GCAG. We made sure Gilead was accountable to us, and we were also accountable to our communities. It was a flow of accountability in both directions.”

Through this structured forum and sustained engagement, community concerns were heard, researchers and the developer remained responsive, and the priorities of women and young girls remained central to decision making.

Members of the PURPOSE-1 GCAG

Championing Good Participatory Practice

Impactful community engagement in clinical trials requires sustained investment in community leadership, scientific literacy, and trusted partnerships. Years before PURPOSE 1, AVAC and partners established the Coalition to Accelerate and Support Prevention Research (CASPR), an Africa-led advocacy coalition of civil society organizations working to advance biomedical HIV prevention research and equitable access to proven HIV prevention products. CASPR supported a network of advocates with the knowledge and relationships to engage with emerging HIV prevention research. Many of these advocates went on to serve on the PURPOSE 1 GCAG while remaining connected to the broader communities and networks they worked with through CASPR. This helped extend engagement and understanding of the trial beyond the GCAG, and strengthened the pathway from engaging in research to product introduction and access planning.

As Navita Jain, Senior Program Manager and Team Lead for AVAC’s Partnership Network Team explains, “CASPR provided the connective tissue that made meaningful engagement possible. Advocates weren’t starting from scratch when they joined the GCAG—they were already informed, connected and prepared to engage, and could bring that knowledge back to their communities well before conversations about rollout began.”

Because AVAC, CASPR partners, AWPCAB and the broader network of informed advocates were already equipped with the expertise, partnerships, and communities’ trust, they helped bridge the transition from research implementation to disseminating trial results and planning for access. This continued engagement with Gilead, funders and decision makers supported community confidence in the results and accelerated momentum toward equitable LEN rollout in comparison to the delivery of previous PrEP products. This contribution was recognized when Yvette Raphael, Executive Director of APHA, accepted the American Association for the Advancement of Science’s (AAAS) Mani L. Bhaumik Breakthrough of the Year Award on behalf of CASPR, AWPCAB, and the GCAG, affirming the critical role of community advocacy in LEN’s development.

Yvette Raphael, the Executive Director of APHA and a PURPOSE-1 GCAG member accepted the AAAS Breakthrough of the Year Award.

From Research to Rollout

GPP guided community engagement in PURPOSE 1, creating meaningful opportunities for advocates to influence the trial. However, the GPP guidelines recommend continued engagement to shape access and rollout once a product has been proven safe and effective, achieves regulatory approval, and becomes available. After the PURPOSE 1 results were announced, Gilead discontinued the GCAG, even though many of the decisions that would determine equitable access, including licensing, pricing, manufacturing, and product introduction, were still ahead. For HIV activist Saidy Brown, a member of CASPR’s Young Women’s HIV Prevention Council (YWHPC) and GCAG member, continuing the GCAG through product introduction would have been a natural extension of the partnership that began during research:

“We were there from the beginning, supporting the research, and it would have made sense for that partnership to continue through rollout. As much as communities supported the trial, there was also an opportunity to bring that support back to communities as LEN became available. Keeping GCAG members engaged through introduction would have helped create that continuity from research to rollout.”

While the GCAG was discontinued, the networks and relationships built through CASPR have provided a platform for advocates to continue pushing for equitable access, with demands including: a role in access planning, speed and equity in rollout, price transparency, and accelerated access to generics. As a result, donors and ministries of health are engaging with and investing in civil society partners to secure community buy-in, inform rollout planning and generate demand. While LEN rollout across early adopter countries reflects this community leadership, advocates remain vigilant in identifying and addressing challenges around equitable access.

Even so, global access has been far from perfect. Advocates’ demand that all PURPOSE efficacy trial countries be included in voluntary licensing agreements has not been met, reflecting that strong incorporation of GPP during a trial does not automatically translate into access once the trial is over; the work of and commitment to engagement must carry through. Nevertheless, the positive lessons from PURPOSE 1 are informing AVAC’s recent work in Merck’s EXPrESSIVE program assessing the efficacy of a new monthly oral PrEP pill. As new HIV prevention products advance through the research pipeline, AVAC and partners will continue to call for developers, donors and other stakeholders to apply the lessons and practice of GPP – strengthening community engagement throughout research & development, policy, and product introduction so that scientific innovation translates into equitable access and real-world impact.

⮐ Return to the the Impact Report

From Research to Access: The Community Statement from the Global Community Advisory Group (GCAG) on the Future of Alima (Alimatravir) for HIV Prevention

The EXPrESSIVE-10 Global Community Advisory Group (GCAG) released a statement on the future of alimatravir and HIV prevention. The statement reflects community perspectives and priorities around prevention choice, meaningful community engagement, equitable access, and ensuring that communities have a voice as research progresses toward potential introduction. As the GCAG writes, “The test is now whether early planning can translate into faster, more equitable action. An access plan is valuable not because it is announced, but because it creates a pathway that can be tracked, challenged, and delivered.”

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The State of HIV Prevention: Big News, Big Moves: Reflections from AIDS 2026 in Rio de Janeiro, Brazil 

By Grace Kumwenda, AVAC Regional Program Manager: Research Engagement 

AIDS 2026 in Rio was extraordinary.

Big science across HIV prevention, treatment and cure headlined from podiums; in side rooms, we had difficult conversations around greater access to available products; and throughout, ongoing tensions played out over the future of the AIDS response and the role of the US Government. And—if you are like me—there was also a lot of trying to understand some very complicated vaccine and broadly neutralizing antibody (bNAb) science and immediately asking: What does this actually mean for people and the People’s Research Agenda? What does it mean for the field and the future? Simply put, Rio did not disappoint.

Big treatment news

A first-in-class once-weekly oral combination of islatravir plus lenacapavir achieved viral suppression as effectively as daily oral antiretroviral therapy (ART) at week 48 in the ISLEND trial, another exciting indication of where longer-acting and less frequent HIV treatment is headed. We also heard important data on long-acting treatment for adolescents. In the LATA study, injectable cabotegravir (CAB) and rilpivirine administered every eight weeks performed better than daily oral tenofovir disoproxil, lamivudine, dolutegravir (TLD) at 96 weeks, and the overwhelming majority of adolescents said they found injections easier than daily oral pills. That matters because long-acting treatment cannot only be designed for adults who already navigate health systems better than youth; adolescents and others who struggle with daily adherence also need to be part of this innovation story.

Then came the bNAbs 

The CAPRISA 012C results readout was a powerful reminder that science does not always move in a straight line. A prevention trial evaluating two bNAbs together—CAP256-V2LS plus VRC07-523LS— administered subcutaneously every six months was reported to be safe but did not reduce overall HIV incidence. Unexpectedly high levels of viral resistance seen in the trial population raised important questions for the field, including whether it is time to pivot away from research on bNAbs for prevention.

It was disappointing that two bNAbs together did do any better than a single bNAb in Antibody-Mediated Prevention (AMP) studies a couple of years. These findings raise important questions about whether and how a combination bNAb approach can work for HIV prevention, as well as the implications for vaccine, treatment and cure research. In treatment and cure research, the bNAb story is more nuanced and, frankly, fascinating. Studies including RIO and FRESH are suggesting that bNAbs may be able to do something ART does not: in a small proportion of participants, immune control may persist even after the antibodies themselves have washed out of the body. There were also promising signals in children. In Botswana, two bNAbs kept 44 percent of children in the Tatelo study undetectable at six months after stopping ART, while early results from the ongoing Tatelo+ study using three bNAbs showed all participants remaining undetectable at week 24. But this is also where we have to manage expectations. The science is exciting, but effects are still seen in relatively small subsets of people, while resistance and incomplete HIV strain coverage remain challenges, strain sensitivity testing is complex and costly, and we still need much more evidence about who benefits and why. That is exactly why continued research matters.

Vaccine science is getting more precise 

HIV vaccine science continues to make important—if sometimes complicated—progress. The challenge has not changed: HIV is extraordinarily diverse, it mutates rapidly and it has evolved sophisticated ways of escaping the immune system. But what has changed is the precision with which scientists are now trying to solve that problem. Instead of simply asking whether a vaccine candidate produces an immune response, researchers are increasingly asking: Can we deliberately guide the immune system, step-by-step, toward producing the exact bNAbs needed to recognize many different HIV strains? Several studies presented in Rio focused on doing exactly that.

Researchers are refining sequential vaccination, where one vaccine primes very rare B cells and subsequent vaccinations guide those cells through stages of maturation toward bNAbs. Work presented on coaxing the creation of V3 glycan-targeting antibodies showed that carefully designed vaccine sequences can steer antibody responses away from non-neutralizing pathways and toward potentially protective ones. Other approaches are trying to generate antibodies against several vulnerable sites on the HIV envelope at once. That may ultimately be critical because an effective vaccine is unlikely to rely on one antibody class alone. Scientists are increasingly exploring how to induce bNAbs targeting two or three different vulnerable sites, potentially making it harder for HIV to escape.

Grace advocates for the pursuit of a preventive HIV vaccine at the AVAC HIV Cure and Prevention Research Networking Zone

New vaccine platforms are also opening possibilities. An mRNA approach designed to express HIV envelope trimers produced neutralizing antibody responses in rhesus macaques and protected a proportion of animals from SHIV challenge. None of this means an HIV vaccine is around the corner. But it does mean that vaccine development is becoming increasingly deliberate. Scientists are not simply hoping the immune system will produce the right antibodies. They are learning how to engineer and guide the immune response toward them. And despite highly effective PrEP, the case for a vaccine remains strong. PrEP only works when people can access it, choose it and use it.

A vaccine could eventually reach people who face barriers to ongoing PrEP use, people who do not perceive themselves to be at risk and communities where sustaining repeated prevention visits remains difficult and/or expensive.

So yes—we still need a vaccine.

And the MPT pipeline is getting interesting 

The multipurpose prevention technology (MPT) pipeline is another space that caught my attention at the HIV Prevention pre-conference in Rio. A removable injectable depot combining CAB with the contraceptive medroxyprogesterone acetate studied for three- and six-month durations in macaques provided complete suppression of ovulation through six months, with return to fertility shortly after depot removal and a relatively short CAB tail. And in another study, a 3D-printed, 90-day intravaginal ring containing islatravir, ethinyl estradiol and etonogestrel provided protection across 12 weekly HIV exposures in macaques. If we can develop products that respond to several needs at once—and importantly, products people actually want to use—that could be transformative. But again, the key phrase is want to use. A scientifically brilliant product that does not fit into people’s lives will struggle to achieve population-level impact.

Innovation in ARV-based prevention is moving 

Grace advocates for the pursuit of a preventive HIV vaccine at the AVAC HIV Cure and Prevention Research Networking Zone

We are all watching closely the efficacy program for the once-monthly oral PrEP candidate now named alimatravir (AMI). What caught my attention was not only the science, but also how Merck/MSD, the developers, are thinking about the product in people’s lives: a small, discreet tablet that could potentially be delivered beyond traditional clinics, including through pharmacies, community settings and other entry points.

Access is already part of the conversation even as alimatravir is still more than a year out from phase 3 study results. MSD announced an initial access plan that includes voluntary licensing arrangements intended to support future generic production. That matters. Access cannot be a conversation we begin after approval; it needs to sit alongside product development from the beginning. And, to be fair, the access conversations around both LEN and AMI were some of the biggest—and at times hardest—conversations in Rio. Questions around pricing, licensing, manufacturing, financing speed to scale, and equity in access were not answered. But they are exactly the conversations we need to be having now, not later. Science is moving quickly, and access planning has to move one step ahead.

Rio also provided encouraging implementation data on existing long-acting prevention options. In the PURPOSE 1 open-label extension, 95% of eligible participants chose twice-yearly lenacapavir (LEN) for PrEP, with no HIV acquisitions during follow-up and 96% injection adherence. PURPOSE 2 also reported very low HIV incidence, while real-world CAB studies continued to show strong effectiveness even as questions around late injections, testing and delivery remain important. The pipeline continues to widen, with early data on 90-day dapivirine-levonorgestrel vaginal rings adding to the range of longer-acting and MPT options under development. All this data adds another dimension to an increasingly diverse prevention pipeline—one that is more responsive to people’s different prevention and reproductive health needs.

PEP also needs its own innovation moment 

And if we are talking about innovation in PrEP, then we also have to talk about post-exposure prophylaxis—PEP. PEP is one of our oldest biomedical HIV prevention interventions, yet it can still feel like the mis-placed or forgotten tool in the prevention box. We heard several times in Rio that PEP is a race against time: it needs to be started as quickly as possible after a potential exposure. But accessing it can still mean travelling to a facility, explaining what happened, navigating stigma, finding a provider who understands PEP and then completing a 28-day regimen. That hardly sounds like an intervention designed for success.

Amidst the ongoing normalization of long-acting PrEP, AIDS 2026 addressed the implications of long-acting ARVs for PEP. But how do we generate strong evidence for new and potentially better PEP products when traditional efficacy trials may be extremely difficult—or even unethical—to conduct? Researchers are now exploring innovative approaches, including zero-event trial designs, that could help us build credible evidence without relying on HIV incidence as an endpoint or traditional trial models.

But just as with PrEP, product innovation alone will not be enough. Policy and delivery have to move to address the gaps we have today. During an AVAC side meeting, we discussed the need to simplify national PEP guidelines, address gaps across different types of exposure, support differentiated service delivery, strengthen provider information and rethink how we communicate about PEP. One point from that discussion stayed with me: we celebrate someone choosing PrEP as responsible self-care, yet someone seeking PEP can still be met with judgement—as though needing PEP means they did something wrong.

That has to change.

Seeking PEP is also an act of responsibility and self-care. If we want people to use it quickly, we need to make PEP easier to find, easier to understand and easier to use—and we need the next generation of PEP products and delivery models to reflect the urgency of the moment in which people need them.

And then there is community 

Grace provides a community perspective at the session “From Community to Innovation to Scale”

If the Global Village was the heart of AIDS 2026, then community remains the heartbeat of the HIV response and the “why” behind the HIV prevention pipeline. I had the opportunity to share community perspectives during a symposium on moving from community to innovation to scale, and one thing stayed with me: we still too often imagine innovation as a straight line from basic science to clinical trials, regulatory approval, implementation and then community.

Trials such as EXPrESSIVE and PURPOSE have reshaped that line, and we need to keep pushing. Community should be there from the moment we define the unmet need, through research priorities and trial design, to access, affordability, implementation and the final question that matters most: is this intervention actually working in people’s lives? And as prevention science becomes more complex, community engagement cannot simply mean inviting advocates into technical rooms; it also means investing in the knowledge and tools that allow communities to ask difficult questions and influence decisions. That is one reason I remain so passionate about initiatives like AVAC’s Clinical Trial Design Academy.

I left Rio thinking that perhaps the biggest shift is not only in the big news about what products are being developed and evaluated in the HIV prevention pipeline. The questions need to change.

For years, the biggest question in HIV prevention was: Can we develop highly effective tools to prevent HIV? Today, we increasingly know that we can. We have daily oral PrEP, two injectable PrEP products, the dapivirine ring, condoms, circumcision, and, hopefully, in the near future a monthly oral pill, with even longer-acting products anticipated in the near future. The harder questions now are: Can people get them? Can they actually choose between them – when and where and from whom they want them? Can countries afford them? Can health systems deliver them? And are we building the systems today that will be ready for the products coming tomorrow? That is where the big moves become important.

The big move we need NOW is from innovation to impact. That means moving from products to programs at scale; clinics to community-centered delivery platforms; product-focused interventions to choice-based prevention; and scientific breakthroughs to political courage, financing, solidarity and accountability.

The science is moving. “The science delivered beyond our wildest dreams,” said Dr. Raphy Landovitz in a moving plenary session.

Now everything around the science needs to move just as boldly. We need resources, moral compass, political will and government-owned prevention programs to move the science to people.

From Rio to the People’s Research Agenda: What next? 

So where does all of this leave us? For me, Rio reinforced that the People’s Research Agenda has to keep pushing the field on whether the science will actually matter in people’s lives. 

  • HIV vaccines: keep investing—but design for the real world now. We still need an HIV vaccine, and we need to stay the course. But as scientists refine sequential immunization and increasingly precise vaccine approaches, the field must also ask early what a future vaccine regimen would look like in people’s lives: how many doses, over what period, for whom, at what cost and how it could realistically be delivered at scale. 
  • MPTs: start with people’s lives, not just what science can combine. We need to develop MPTs around the lives and priorities of the people who will use them. The research question cannot only be: what products can we technically combine? It must also be: what combinations, durations and delivery forms do people actually want—and what gives them meaningful choice and control? 
  • ARV-based prevention: match the speed of innovation with the speed of access. Affordability, licensing, manufacturing, financing, country readiness and delivery must be planned alongside product development, not after approval. At the same time, implementation research must tell us how long-acting products work in the real world, including persistence, late injections, switching and what it truly takes to deliver genuine choice. 
  • PEP: give PEP the innovation and urgency it deserves. PEP needs a new research, product and delivery agenda. We need shorter, simpler and more forgiving regimens; innovative trial designs that can generate credible evidence; and delivery models that get PEP to people within hours, not after they have navigated multiple barriers in the health system. And perhaps just as importantly, we need to reposition PEP as what it is: an act of self-care and responsibility. 

Announcing AVAC’s 2026 HIV Cure Academy Alumni Fellows 

AVAC is pleased to announce the 2026 Alumni Fellows from the HIV Cure Academy Program. This year, five alumni are putting what they gained through the Academies into action—strengthening community engagement, informing policy and advancing HIV cure research in diverse settings across Africa and the US. These grants build on a growing network of Cure Academy alumni who are translating what they learn into meaningful advocacy and action in their communities. 

Each year, AVAC convenes a global HIV Cure Academy in collaboration with the International AIDS Society (IAS) and a US Academy organized through the Martin Delaney Collaboratories (MDCs) community engagement program under REACH, PAVE and I4C, equipping advocates with the skills and connections to champion HIV cure research, strengthen supportive research environments and promote ethical community engagement in clinical research. Following the Academy, participants can apply for an alumni grant to design and implement a year-long project that advances HIV cure research in their communities.

The HIV Cure Academy Alumni Fellowship is one component of AVAC’s broader HIV cure advocacy portfolio, which strengthens civil society engagement, advances meaningful community participation and ensures the development of HIV cure strategies is guided by affected communities. AVAC supports stakeholders with the information, connections and tools needed to engage in critical conversations about the future of HIV cure research. 

Read on to learn more about the 2026 Cure Fellows and their projects and check back throughout the year for updates on their work to advance HIV cure research. 

Global HIV Cure Academy Alumni Fellows in Partnership with the Africa HIV Cure Consortium (AHCC) 

Charles Brown: High-Level Stakeholders Dialogue on Advancing and Sustaining HIV Cure Research and Advocacy in Uganda

Charles Brown is the Founder and Executive Director of Preventive Care International, a civil society organization based in Uganda. He is a 2014 AVAC Fellow alum, coordinator for the Africa HIV Cure Advocacy Coalition, member of the Uganda PrEP technical working group, the Uganda communicable and non-communicable diseases technical working group, the Uganda civil society advocates network and a steering committee member of the Uganda HIV Prevention Coalition. The High-Level Stakeholders Dialogue on Advancing and Sustaining HIV Cure Research and Advocacy in Uganda aims to strengthen and advance stakeholder involvement in HIV cure research through the creation of a platform for HIV cure researchers, policymakers, funders and advocates to dialogue on advancing and sustaining HIV cure research and the formation of an African Hub for HIV cure advocacy.

Laurel Kevine Tchmada Tayo: TheImpactVoices

Laurel Kevine Tchamda Tayo is an early-career researcher at the Centre for Research on Emerging and Re-emerging Diseases (CREMER) in Cameroon. She holds a Master’s degree in Public Health Biotechnology and is a field investigator for HIV research, with a specific focus on HIV cure-related studies. TheImpactVoices initiative aims to bridge the gap between HIV research and the community to improve awareness and community engagement around HIV prevention, care and cure research through accessible and contextualized research dissemination, youth-centered communication and digital storytelling. TheImpactVoices hopes to empower young people and people living with HIV to actively contribute to advocacy, education and sustainable health solutions in Cameroon. 

Mandisa Tyadi Dukashe: SA HIV Cure Knowledge Hub Project

Mandisa Tyadi Dukashe is a public health expert, HIV specialist and PhD candidate with over 25 years of experience delivering health systems strengthening, multi-disease management and patient-centered care in South Africa (SA). She has been living with HIV openly for over 23 years. Mandisa is a founding member of the HIV Survivors and Partners Network, a co-founder of the U=U Africa Forum, a pioneer for the South African HIV Cure Knowledge and Innovation Hub, a 2020 AVAC Fellow alumni and served as a PAVE Collaboratory and CureRoar Community Advisory Board member. The SA HIV Cure Knowledge and Innovation Hub aims to strengthen collaboration among researchers, policymakers, advocacy partners and communities to advance equitable and community-centered HIV cure research and implementation. Ultimately, the Hub aims to translate collaboration and innovation into sustainable health outcomes and improved quality of life for people affected by HIV.

US HIV Cure Academy Alumni Fellows

Amelia Poulin: SPEAK: HIV Cure

Amelia Poulin, MPH, PMP, CPH is the Assistant Director for Emerging Infectious Disease at the Association of State and Territorial Health Officials, where she supports state and territorial health departments prepare for, and respond to, infectious diseases. Amelia is a Doctor of Public Health student at the University of Illinois – Chicago and was named a 2025 de Beaumont 40 Under 40 in Public Health honoree for her dedication, creativity and innovation in working towards healthier communities. SPEAK: HIV Cures is a novel dialogue academy that aims to strengthen system readiness to implement HIV cure research by bringing together alumni from the 2026 US HIV Cure Academy, leading HIV cure researchers and university students for a structured training series on dialogue and rhetoric, HIV cure science, lived experience and health policy. The project will explore how community-centered dialogue and reasoned persuasion can strengthen public health system readiness for policy implementation around HIV cure research.

Kennedy Walker: The CLEAR (Communication, Literacy, Education and Research) Toolkit

Kennedy Walker is a Psychology and Human Development & Family Studies student at the University of North Carolina at Greensboro, where he is an Honors College and Guarantee Scholar. Kennedy has worked across community engagement, advocacy and research through organizations including the Florida State University Adult Trials Network, Charlotte Pride and the Office of Intercultural Engagement at UNCG. The CLEAR Toolkit is a community-informed communication and health literacy initiative designed to strengthen conversations between people living with HIV, healthcare providers, researchers and community advocates. Through stakeholder listening sessions and collaborative development, the project will create practical resources to improve communication, shared decision-making and understanding of HIV treatment and cure research. The CLEAR Toolkit aims to build trust, increase health literacy and create a scalable resource that can be adapted across HIV care, research and community settings.

The Second Injection

In her Substack, Skye Grove unpacks the distance that still lies between products and services and the people who need them. Reflecting on AIDS 2026 conversations and sessions, she shares insights from AVAC’s Executive Director Mitchell Warren, Access Bridge’s Executive Director Wawira Nyagah, and AVAC partners like Yvette Raphael and Adaobi Lisa Olisa.

Accelerating policy approval and uptake of the dual prevention pill in Zambia through early stakeholder engagement

The Dual Prevention Pill (DPP), a combination of PrEP and combined oral contraception (COC), offers a novel, female-controlled option for HIV and unintended pregnancy prevention. However, new technologies like the DPP often face delays in regulatory approval and uptake due to limited stakeholder involvement early in the introduction process. This article in AIDS Care, authored by AVAC Fellow Rhoda Msiska, AVAC staff members Kate Segal and Cindra Feuer, and Newton Donkola, demonstrates how early, multisectoral stakeholder engagement could accelerate DPP approval and adoption in Zambia.

Read the article.

Beyond AIDS 2026: AVAC’s Top 10

Our team compiled a list of AVAC’s top 10 takeaways from AIDS 2026. These topics sparked discussions and ideas among our team and AVAC’s larger partner network, and will carry our work well into the future. 

1. The implications of US government cuts 

The implications of the US administration’s efforts to dismantle its longstanding role as the global leader in the HIV response are coming into focus – and it’s not a pretty picture. 

Credit: amFAR

First, amfAR released a report providing the first concrete detail on the impact of PEPFAR cuts: surveying 166 organizations in 46 countries, they found that nearly 2,000 service sites had been forced to shutter.

Almost no organizations were able to fill the funding gap with other donors. Services for key populations (KPs) were “decimated”: among implementing partners, 73% stopped at least one KP service and 67% stopped outreach services.

Prevention overall took a huge hit: almost half of respondents stopped activities like condom or PrEP distribution. Two-thirds reported interruption of PMTCT and nearly one in four stopped providing prevention of mother-to-child transmission services entirely. As AVAC’s Navita Jain told POZ, when foreign aid funding was frozen, “We were in year eight of a 10-year project, really getting momentum going and accelerating prevention research, and the cuts had a massive effect, with no guidance provided or a plan for a way forward.”  

As widely reported, first by former AVACer Emily Bass, and then by most major media outlets, a US State Department official displayed a mislabeled map of African countries, with African government officials in the room. As Jirair Ratevosian said, the map “should never have made it onto the screen, especially during a presentation about partnerships with African governments,” but more importantly, it’s a disappointment “that this mistake became one of the conference’s biggest media stories. Because AIDS 2026 produced important science, serious policy analysis and real progress on issues ranging from PrEP delivery to global aid transitions.”  

2. Prevention innovation includes speed, scale and equity…

One of the most exciting developments arrived days before the conference, when Merck/MSD announced seven direct licenses to generic manufacturers to produce their investigational monthly pill for HIV prevention, known as alimatravir, while Phase 3 clinical trials are still enrolling.

The announcement reflects responsiveness to advocates’ longstanding calls to accelerate access to PrEP options, and deep engagement with advocates throughout the clinical trial program. Since 2012, each successive PrEP introduction has gone faster than the previous one, yet the time to market and to public health impact remains too slow.

Granting licensing agreements to generic manufacturers while clinical trials are still enrolling, before it is known if the product is effective, should significantly reduce the time to market for the product. The current timeline gives the field ample opportunity to work with ministries of health, donors, communities, and Merck to plan for broad access to the monthly PrEP pill, which lends itself to innovative delivery models – from pharmacies to community-based distribution approaches.

3. …but too often, Latin America is still left behind  

It is cruel irony that Brazil was host country to the conference, a key site for clinical trials of cabotegravir, lenacapavir and alimatravir, but has been left out of voluntary licenses for all three products.

While Merck/MSD shared information about a memorandum of understanding with Fiocruz to manufacture alimatravir for the region, the timing and next steps remain unclear: “Now is the time to plan for even speedier and wider access if alimatravir works,” said Access Bridge Executive Director Wawira Nyagah. “This must include pricing transparency from Merck and their generic licensees, accelerated investments by donors to design and implement integrated programs that offer the monthly pill as part of choice of product and service delivery models that actually reach people who need it, everywhere. This should be based on public health imperatives; not on World Bank country classifications or geographical location. Anywhere the HIV epidemic is increasing must be included, full stop.”

4. Innovative delivery and community involvement are expanding access… 

AIDS 2026 showcased exciting models for HIV prevention service delivery that are removing barriers to access, reducing stigma and burden on healthcare systems. In São Paulo, vending machines delivering HIV tests, PrEP and PEP are available in subways, normalizing widespread access to HIV prevention.

Sri Lanka and the Ukraine have introduced mobile PrEP delivery programs, and in Kenya and South Africa, pharmacy delivery is reducing the load on health clinics following the drastic cuts to PEPFAR service delivery programs. The recently launched SCALE-IT project in Zambia is implementing a model for community-based delivery of PrEP options, including injectable PrEP, with more information expected soon. As we look ahead to alimatravir, the potential for a monthly PrEP pill opens the door to innovative delivery models. While alimatravir trials are still enrolling, AVAC has called on the stakeholders to ensure models are well-conceived and planned, adequately funded, and set up for success. With this timeline in hand, there’s no excuse for getting it wrong.

5. …but supply issues pose a serious threat to LEN rollout. 

From countries across the globe, the same message echoed across AIDS 2026: there is demand for LEN now and the current supply is not enough. While recent commitments from PEPFAR and the Global Fund are encouraging, demand is rapidly outpacing supply across the globe – and there is an urgent need from donors to address bottlenecks and place more orders.

Access Bridge’s Nyagah reinforced this point: “People are being offered products that fit their lives, but the systems are not growing fast enough to supply it.” If supply issues are not urgently addressed, the field risks losing the demand, community trust, and current progress in LEN uptake that we have collectively worked so hard to achieve. For more on this topic, Jon Cohen’s recent piece in Science provides a deep dive into the challenges facing LEN rollout in South Africa and Zambia amidst the current political and funding landscape.

6. The urgency of vaccines: advancing the science, deepening our understanding  

At a plenary session, Sandhya Vasan described why a vaccine is still needed, even with expanded PrEP options like lenacapavir, echoing AVAC’s recent commentary on the scientific challenges and emerging insights in the vaccine field and what’s in the research pipeline. Vasan highlighted long-standing partnerships with communities as foundational to vaccine research and vaccine confidence, as well as the need for continued investment and support for upstream vaccine research.

Community engagement was on full display at the HIV Cure & Prevention Research Networking Zone, where one of the best-attended sessions was the People’s Research Agenda Think Tank on HIV vaccines. AVAC’s resources on preventive vaccines and bNabs explain the science behind vaccine research.

In addition, the CAPRISA team announced results from the CAPRISA 012c Phase 2 trial examining a potential combination of two broadly neutralizing antibodies (bNAbs) as prevention. The trial found that a six-monthly combination of the CAP256 and VRC07 bNAbs was safe but did not provide protection against HIV acquisition in young women in South Africa and Zambia. As AVAC Executive Director Mitchell Warren noted, “We had hoped that combining two bNAbs in this study would provide greater protection than a single antibody, but sadly it did not.” Antibody research has always been about more than product development – research shared at the conference continues to deepen the understanding of HIV and the immune system and will continue to inform the next generation of vaccine and cure strategies. 

7. Cure took another step forward 

Two case presentations at the conference shared two more patients with HIV and cancer were cured following stem cell transplants for cancer treatment.

As AVAC’s senior program manager for HIV cure, Jessica Salzwedel says, “Thirteen people have now been cured via stem cell transplant. Every cure is an exciting step forward, but we must stay focused on the inequity of all 13 of these occurring in high-income countries – and ensure that our work expands access to cure information, research opportunities, and solutions.” 

Cure strategies must go well beyond the science: efforts must include confronting the stigma of HIV and expanding research advocacy and engagement, especially in Africa.  At pre-conference and conference sessions, along with a session at the HIV Cure & Prevention Research Networking Zone, attendees explored promising elements of the “kick and kill” strategy, gene editing technologies, the role of broadly neutralizing antibodies in “control” strategies, and how community members can get more involved.  

8. Harnessing the power of AI for HIV while centering communities in the response

Many sessions explored the promise of AI to strengthen design and delivery of HIV programs, while highlighting potential pitfalls if we neglect to prioritize transparent regulatory frameworks and partnership with communities in the design, use, and oversight of AI systems.

ITPC Executive Director and AVAC Board member Solange Baptiste noted the urgency of approaches to AI that are human-centered: “We need a community governance layer built into the AI ecosystem…one that ensures communities help shape priorities, oversee the implementation, identify harms and hold systems accountable throughout the AI lifecycle.” The final plenary of the conference for the first time included a presentation on AI by Global Fund’s Izukanji Sikazwe, highlighting the dangers when the right innovations fail to scale and balancing the concept of AI as a partner with the risks AI can bring. For more insights from AVAC on the evolving discussions around AI, check out our quarterly AI and HIV Newsletter and Advocates Guide to AI and HIV Programs.

9. Partnerships power the HIV response by advancing community-centered priorities 

As the field faces devastating funding cuts, strong partnerships between national, regional and global advocates are more important than ever. AVAC’s partnerships underpinned so much of the critical work discussed at AIDS 2026: to ensure key populations are not left behind, to advance community-led monitoring and community-based delivery, and translate choice into impact.

In each case, success was made possible by bringing together diverse stakeholders with the singular goal of developing innovative, community-centered approaches to the HIV response. As AVAC’s Warren reflected following the conference, “Communities are the leaders of AIDS programming. All over the conference they led plenaries, symposia, abstracts. These are not recipients, they are leaders who are driving the conversations.”

10. Communities are the heart of the AIDS response, and the Global Village is the heart of the AIDS conference.  

In conversations, meet-ups, and protests coordinated across the Global Village, the power of advocates and coalition-based advocacy was a key theme of the conference. AVAC’s HIV Cure and Prevention Research Networking Zone brought delegates, researchers, advocates, and community members together for interactive discussions, expert-led sessions and networking conversations.

The Zone featured the “HIV Funding Saves Lives” quilt created by COMPASS and the Global Advocacy Data Hub to convey the impact of funding cuts on communities. Attendees signed the quilt, adding their voices to the demands for HIV funding to be restored. As advocates look ahead, connections built at the Networking Zone will strengthen for future coalition-based advocacy.

AIDS 2026: Rising Above to Meet the Moment 

The World Must Act with Speed, Scale and Equity

By Mitchell Warren, Executive Director, AVAC 

One of the most memorable moments for me at AIDS 2026 wasn’t a scientific presentation. It wasn’t a late-breaking abstract, or a standing-room-only session. It was a conversation with a ministry of health official from one of the first countries preparing to introduce lenacapavir (LEN) for HIV prevention. We weren’t discussing whether people wanted the product. We weren’t debating whether it worked. We were talking about running out.

Countries preparing for rollout of this groundbreaking prevention method – one that provides near-perfect protection from infection – are already worried they won’t have enough supply to meet demand.

For decades, the HIV field has worried about generating demand for prevention. At AIDS 2026 in Rio, we confronted a very different challenge: the demand is building. The question now is whether the world is prepared to meet it.

This was a conference defined by something arguably more important than any single scientific breakthrough. It was the recognition that as a field, we must confront the pressing challenge of political will and moral decision-making. As Raphy Landovitz asked in a stirring plenary session: do we have the courage, partnerships, and urgency to fight for science, which remains under attack?

After this week in Rio, I believe we absolutely have the courage, and the conference theme – Rethink. Rebuild. Rise. – provides a roadmap for how we turn it into impact.

Slides presented at AIDS 2026 by AVAC partner Access Bridge during a session on the promise of long-acting PrEP

First, we must rethink what success looks like. For years, success in HIV prevention meant developing new products to prevent new infections. Today, though, success means ensuring people can actually get the option that best meets their needs – how do we deliver this extraordinary range of options?

The range of HIV prevention options has grown in ways we only dreamed of a decade ago: beyond condoms which remain as essential today as they were at my first AIDS conference 30 years ago, we now have injectable PrEP which provides near-perfect protection in clinical trials and is becoming more widely available; a vaginal ring that provides a unique female-initiated option; and a monthly oral PrEP pill is in late-stage trials (and accelerated access planning).

But more options do not automatically mean more choice. Choice is not simply a shelf full of medicines. Choice is a health system capable of delivering them. It is procurement systems that can purchase multiple options instead of one. It is healthcare workers trained to welcome diverse individuals and counsel people without bias, rather than steering everyone toward the same intervention or the one the health provider thinks is best for them. It is financing that rewards access instead of rationing it.

In Rio, I heard government representatives, implementers, and community advocates ask operational questions about choice that would have sounded impossible just a few years ago. How do we effectively forecast demand and introduce multiple long-acting options? How can we ensure speed, scale and equity across environments, from rural clinics to urban hospitals? How can we simplify delivery and offer PrEP where people want it, and not just where systems want them?

We must think big. In a matter of months, a once-in-a-generation opportunity will present itself as generic lenacapavir becomes available, and this highly effective prevention option, hopefully, becomes more accessible. Governments, donors, manufacturers, and global procurement agencies should be planning for millions of people—not thousands—to access long-acting PrEP. Importantly, we also heard in Rio how the new interest in LEN is actually motivating people who had not come forward to test and are found to already be living with HIV. The novelty of LEN is becoming a catalyst for universally testing and connecting all people with the products and services they need – whether or not they are living with HIV.

The HIV response has always moved fastest when those most affected have shaped research questions, demanded accountability, challenged institutions, and insisted that innovation reach the people who need it most.

As countries begin introducing long-acting prevention, community leadership becomes even more important. Communities that trust delivery systems, prevention methods and messages are much more likely to accept new methods. And ultimately, it will be communities that tell us whether products are truly accessible, whether health systems are delivering meaningful choice, and whether equity is more than just a conference slogan.

The “HIV Funding Saves Lives” quilt, created by COMPASS and the Global Advocacy Data Hub to convey the impact of funding cuts on communities

Second, we must rebuild. Rio was also the first global AIDS conference that had data presentations about the impacts of the dismantling of USAID and the dramatic restructuring of U.S. foreign assistance.

Since then, prevention programs have been diminished, services for key populations have been interrupted, research has been halted, partnerships have been strained. Organizations have closed their doors. Communities are feeling those consequences every day. Jerop Limo, an AVAC advocacy partner and adolescent HIV programming expert, summed it up perfectly in the recent POZ piece on the impact of funding cuts, “People are disengaging from healthcare spaces and missing appointments. This is not the system we had, the one that was working.”

The release of UNAIDS’ United to End AIDS special report and a companion KFF-UNAIDS analysis show the challenge of translating scientific progress into the impact needed to end AIDS as a public health threat by 2030. The report shows HIV financing entering one of its most precarious periods in decades, with international assistance declining 18% between 2024 and 2025. Donor government funding fell by $2.1 billion in 2025—the largest annual decline since global HIV funding began scaling up. This is not just a warning. It’s not just a ‘cautious stabilization of where things are. It is an alarm bell that we have to change how we do what we do, and how we fund what we do, if we want to succeed.

As colleagues from Duke and Friends of the Global Fight underscore, rebuilding cannot mean returning to the systems that existed before.

We can’t go back, but we also can’t stay still. We have to build something new.

The good news is that new opportunities and promising signs are emerging. Countries are assuming greater ownership of their HIV responses. Regional institutions are stepping forward. New partnerships are forming, and new institutions are stepping up to lead.

Across conversations in Rio, there was broad consensus that sustainability of the HIV response cannot remain overly reliant on any one country government and the whims of its leadership. A broad coalition of countries, communities, philanthropy, industry, and global institutions working toward shared goals must equally share responsibility for the future of the HIV response.

In fact, hosting the conference in Brazil was a powerful reminder that political commitment to universal HIV services can achieve a lot. But even Brazil cannot introduce every new prevention technology without strong partnerships. Manufacturers must be willing to expand access, multilateral organizations must be willing to commit to volume guarantees and investments that meet demand, and donors must prioritize and be willing to invest in what’s required to ensure equitable rollout.

Raphy Landovitz’s plenary highlighted the critical choices the field has ahead of us to ensure we meet this moment.

Lastly, we must rise to meet this moment. After every setback, whether political or scientific, the global HIV community has found a way to turn adversity into action, setbacks into solidarity, and uncertainty into progress. That was on display more than ever in Rio, where we were reminded that disappointment also moves science forward.

One of the week’s significant scientific presentations came from the CAPRISA antibody study. The results were disappointing: the trial found that a six-monthly combination of two broadly neutralizing antibodies (bNAbs) was safe but did not provide protection against HIV acquisition in young women in South Africa and Zambia. Researchers concluded that while the antibody combination demonstrated strong potency in laboratory studies, it did not achieve antibody levels needed for protection in people.

With this study, we had hoped that combining two bNAbs would provide greater protection than a single antibody, but sadly it did not. But antibody research has always been about more than product development. The CAPRISA 012c study continues to deepen our understanding of HIV and the immune system, and will continue to inform vaccine design, cure research and the next generation of prevention strategies.

Every carefully conducted study answers important questions. Every unexpected result helps redirect investments toward more promising approaches. That is how scientific progress works.

AIDS 2026 convened at a pivotal time: we now have just four years until 2030—the deadline for global HIV targets and the Sustainable Development Goals.

By the end of this year, we should know whether long-acting PrEP is reaching people at scale. By the International AIDS Society conference in Geneva next July, we should know whether generic lenacapavir is expanding access, whether research investments are holding, whether community-led programs have been restored, and whether countries are closing the equity gap. If those indicators are moving in the wrong direction, we must change course in real-time.

The legacy of Rio will be determined by whether we seize this extraordinary moment. Even as we rethink and rebuild things, we must ensure that we center communities, follow their lead, and rise up to support the populations that need this work more than ever. And just like a well-conducted clinical trial, a conference should answer some questions and raise new ones:

Will donors and governments purchase enough lenacapavir to meet demand instead of limiting access? Will pharmaceutical companies accelerate voluntary licensing and affordable pricing so new innovations reach everyone, everywhere without years of delay? Will donors invest boldly enough to match the science? Will countries protect community-led organizations and programs for key populations, recognizing that these are not optional additions but essential pillars of an effective response? Will researchers continue pushing the boundaries of vaccines, antibodies, cures, and long-acting treatment, even when some studies disappoint?

The science has never been stronger, communities have never been more ready, and the need has never been more urgent. Rio reminded us that ending HIV is no longer limited by what we know, it is limited only by the courage to act.

CASPR Impact Report

The Coalition to Accelerate and Support Prevention Research (CASPR) is an Africa-led advocacy network and movement, focused on advancing biomedical HIV prevention research and equitable access to proven HIV prevention products. This report highlights the Coalition’s achievements and key wins over the course of eight years. These include significant impact on elevating community needs, expanding the field of HIV advocacy, promoting inclusive engagement in research, and improving ethical standards in HIV prevention research.

Read the PDF below, or view as a webpage.

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Advancing the inclusion of pregnant and lactating populations in HIV PrEP research: ethical, regulatory, and surveillance recommendations from a multisectoral working group

Approximately one-quarter of vertical HIV transmissions are linked to infections during pregnancy and lactation, yet data on PrEP use in these populations remains generally limited due to their exclusion from clinical trials. A multisectoral working group, including AVAC’s executive director Mitchell Warren, held meetings and a scientific symposium to inform evidence-based strategies for improving the inclusion of pregnant and lactating women in PrEP trials. They recommend reframing pregnant and lactating women as needing protection through research, alongside standardized data systems, stronger incentives, global collaboration, and digital innovation to ensure equitable inclusion in HIV prevention efforts.