Introducing the Gears of Lenacapavir Rollout and The People’s Research Agenda

This World AIDS Day, the HIV/AIDS response stands at a crossroads, with injectable lenacapavir set to transform HIV prevention. But as the new UNAIDS report highlights, it also comes at the same time as restrictive policies, economic instability, and geopolitical challenges threaten to frustrate access and rollback so much of the progress that has been achieved over the past two decades. 

AVAC’s 2025 advocacy agenda prioritizes collaboration and strategies for equitable and accelerated product introduction that maximize the public health potential of new prevention options and simultaneously sustains investment in critical research and development. AVAC’s newest publication, The Gears of Lenacapavir for PrEP Rollout, provides a clear pathway for the speed, scale and equity needed to translate exciting science into public health impact, while our recent The People’s Research Agenda (PRA) meets this high-stakes moment for HIV prevention with a clear, concise and collaboratively developed set of priorities for how prevention research should be conducted and what products should be developed in the future. 

Despite the challenges, 2025 holds immense potential for ensuring the equitable rollout of new options and the accelerated development of a pipeline of additional options, the combination of which can help move the field closer to ending HIV/AIDS.  

For the latest information on injectable lenacapavir for PrEP, be sure to join us for our webinar Tuesday, December 3. And read more below about both the Gears of LEN for PrEP Rollout and The People’s Research Agenda

The Gears of Lenacapavir for PrEP Rollout: Driving Speed, Scale, and Equity

Lenacapavir’s rollout is not just about making a new drug available as quickly as possible; it is about ensuring that it reaches the people who need it most, as swiftly and equitably as possible. Gilead has announced its readiness to manufacture up to 10 million doses for 2026, but this potential hinges on coordinated action by governments, donors, and civil society. The roadmap outlines the essential gears driving this effort, from robust demand generation and procurement strategies to equitable distribution and community-driven implementation. Crucially, the roadmap emphasizes lessons learned from previous PrEP interventions: that availability alone is not enough. With global HIV targets still unmet and disparities persisting, this effort demands decisive action and long-term planning.

Download the infographic

The People’s Research Agenda: A Community-Driven Vision

The People’s Research Agenda (PRA) brings the voices of affected communities to the forefront of HIV prevention research and product development. With limited resources, the stakes for decisions about which products to develop and eventually deliver become even higher for funders, communities, policy makers and governments. The PRA offers a bold vision for aligning scientific innovation with community needs. By amplifying the perspectives of those most affected by the epidemic, the PRA is a tool for driving accountability among funders, developers, and policymakers. As a living, adaptable framework, it ensures that evolving needs and challenges in the prevention landscape remain at the center of decision-making.

A Call to Action

The rollout of lenacapavir and the implementation of the PRA come at a critical moment in the global HIV/AIDS response. Achieving their full potential will require sustained collaboration, strategic investments, and unwavering commitment to equity. Together, we can transform this pivotal moment into lasting progress.

Advocacy: Now more than ever

We are in a period of profound uncertainty, remarkable progress and tremendous concern—for the state of the world, for the state of global health and HIV, and for the specific work that AVAC and our partners do. We’ve seen incredible advances in biomedical prevention in 2024 with the introduction of the dapivirine vaginal ring (DVR) and injectable cabotegravir (CAB) for PrEP and the spectacular clinical trial results of injectable lenacapavir—the combination of which could transform lives if rolled out with speed, scale and equity.  

For many of us, the unfolding developments in the United States, which continue to ripple across the global health community, are sparking anxiety around whether we can sustain the progress the field has made over decades while continuing to develop effective HIV prevention options and ensure access to those options for everyone who needs and wants them.  

At AVAC, we see strength in staying focused on developing what we need and delivering what we have. We are doubling down on delivering high-quality, impactful work, supported by ongoing collaboration with our partners to meet our mission in a shifting environment.

Your help is instrumental to the success of this work. If you appreciate our insights, resourcesinfographicscoalition-building, and evidence- and rights-based advocacy, please consider making a contribution to ensure that this work can continue.

As we recognize World AIDS Day this weekend and next week’s #GivingTuesday, a global day dedicated to giving back, we ask you to consider supporting AVAC so that we and our partners can continue to deliver the effective and impactful advocacy that is needed now more than ever. This means continuing to put people and communities at the center of our work, ensuring that the global response is connected to the real needs of affected people.

Many thanks in advance for your partnership and support.

Advancing Choice and Equity: New tools and a changing landscape

As a new US presidential administration takes shape, our commitment to championing choice, science, and rights remains unwavering. This critical moment demands intentional strategies to protect progress in HIV prevention and global health equity while staying true to our mission and values.

Given the concerning rise of health misinformation on X (formerly Twitter), we must find new ways to share accurate, science-based information. Starting this week, we’ll begin to transition our presence to BlueSky, an open-source alternative to X, alongside Instagram and Facebook. Learn more about Blue Sky here and be sure to follow us.

Read on for the latest insights on CAB for PrEP and new resources on PrEP delivery, STI R&D, and the political challenges and the priorities in 2025 and beyond.

Trials to Impact: The Latest Insights on CAB for PrEPAn Advocate’s Guide to Research in Pregnant and Lactating Populations

The Biomedical Prevention Implementation Collaborative (BioPIC) is leading an integrated and adaptable strategy to deliver new HIV prevention products, with a particular focus on longer-acting PrEP methods. The BioPIC’s Adaptable Product Introduction Framework, emphasizes the need to conduct early-stage activities alongside Phase III clinical trials, and conducts Think Tanks to pinpoint evidence gaps and share insights from modeling and implementation studies. This work is driving more effective, people-centered product delivery. Read more on recent CAB for PrEP insights and visit the Evidence Gap Tracker.

READ THE INSIGHTS

Resources on PrEP Delivery, STI R&D, and More!

Video Recording and English Audio / Ukrainian Audio / Portuguese Audio / Spanish Audio / Slides / Resources

Recording / Alison Footman Slides / Mandisa Mdingi Slides Cécile Ventola Slides / Birgitta Gleeson Slides

KFF’s Jen Kates and AVAC’s Suraj Madoori lay out the challenges and the priorities in 2025 and beyond. 

In the days, months and years ahead under a new US Presidential Administration, advocacy for choice, freedom, science, and rights will require intentional strategies to protect hard fought gains in HIV treatment and prevention and in global health generally, and to safeguard policies and programs that advance it. And there will be major implications for the global AIDS response.

LISTEN TO THE PODCAST

An Advocate’s Guide to Research in Pregnant and Lactating Populations

Check out our updated graphic in this advocates’ guide, which shares background on the need for research in pregnant and lactating populations and how advocates can advance inclusion.

READ MORE

The Votes Are In

What’s next for the US’ role in global health and HIV prevention?

In the days, months and years ahead under a new US presidential administration, advocacy for choice, freedom, science, and rights will require intentional strategies to protect hard fought gains in HIV treatment and prevention and in global health generally, and to safeguard policies and programs that advance it. What to do?

For a start, listen to AVAC’s newest PxPulse podcastJen Kates, Senior Vice President, Director of Global Health & HIV Policy at KFF, a nonpartisan health policy research organization and AVAC’s Director of Policy, Suraj Madoori lay out the challenges and the priorities in 2025 and beyond.

As the field prepares for new US leadership, advocates must take stock, identify allies, work in solidarity and seize opportunities. In the months and years to come, AVAC will be there, offering tools, analysis, and perspectives to support our collective work to advance HIV prevention and equity in global health.  

The Trump administration will likely have a fundamentally different worldview about US engagement in global health and in development. One that is much more isolationist, much more transactional. Why should the US be engaged in these programs? What is in it for us? And I think the challenges that will come up there, is where or will the US continue to play a leadership role diplomatically, financially, because the US is the largest funder of all global health programs.

Jennifer Kates
SVP and Director of Global Health & HIV Policy at KFF

There’s such a vibrant advocacy community outside the United States who want to engage their own governments in mobilizing domestic resources for HIV, who want to share their stories to Congress about the impact of PEPFAR and other lifesaving programs. That is a lot of untapped advocacy and a lot of North-South collaboration that will be so important to get us through at least the next two years into the midterms, if not the entire four years of this new administration.

Suraj Madoori
Director: Policy & Advocacy, AVAC

Today — in the US and around the world

There are no words that can adequately, or appropriately, describe the state of the world right now and how AVAC and I are feeling about it. I expect it is a similar sentiment for all of us — irrespective of where we live and vote. 

AVAC was founded 30 years ago — in a very different time, with very different political and economic dynamics and epidemiologic realities. But from that beginning, AVAC has always championed an evidence- and rights-based, equitable response to the HIV epidemic — honoring choice and dignity for all.  

And we will not stop — not until we are done, and most definitely not now! 

We will all need time to process these US election results and strategize how we navigate through them in the days and years ahead — as individuals, as a network of partners, as citizens of the world, and — most importantly — as advocates for choice, freedom, science, and rights.  

There will, undoubtedly, be major implications for global health and the global AIDS response. We look forward to working with our partners in protecting hard-fought gains and in assessing the potential impact on PEPFAR and Global Fund support; on USAID, NIH, CDC and the FDA; on the US relationship to WHO and other UN agencies; and on evidence- and rights-based policies and programs generally.  

We will be in touch soon with an initial analysis, starting with the release of a podcast next week with Jen Kates from KFF and our own Suraj Madoori as we begin to unpack it all. And we look forward to working with all of you in reviewing it and making it actionable. 

Thank you; stay tuned; and stay strong. 

Mitchell J. Warren
Executive Director
AVAC

HIVR4P Highlights, Inclusive Prevention Pipeline, Policy Shaping & More

AVAC’s round-up of resources, updates and insights this week includes highlights from HIVR4P, a new vision for an inclusive prevention pipeline, shaping policy and more!

HIVR4P 2024 conference highlights and recap

The 5th HIV Research for Prevention (R4P) conference was held last week in Lima, Peru. The data and discussions centered on accomplishments in HIV prevention, how far the field remains from reaching targets, understanding how choice works and why it matters, and where the research agenda is headed. As AVAC’s Mitchell Warren told Axios, “lenacapavir is on everybody’s lips here at HIVR4P 2024. That’s probably the second-most popular word this week; I think the most popular word is access.

Read more.

Partners and AVAC launched The People’s Research Agenda (PRA), a global initiative driven by communities and advocates to envision an inclusive HIV prevention pipeline and ensure the voices of those most affected by HIV are integrated into HIV prevention research and development. 

Read the report.

Media Highlights

Shaping policy, centering people

AVAC’s Suraj Madoori Joins Developed Country NGO Delegation (DelDev)

Policy Director, Suraj Madoori is one of four new members to join DevDel, one of the 20 voting delegations to the Board of the Global Fund to fight AIDS, Tuberculosis and Malaria. DevDel plays a critical role in the development and evolution of organizational strategy, the funding model, the work of the Secretariat and policy. 

Read more.

AVAC’s Jessica Salzwedel Talks Community Engagement with National Co-ordinating Centre for Public Engagement

In a mini series on community engagement, the National Co-ordinating Centre for Public Engagement interviewed AVAC’s Jessica Salzwedel, Senior Program Manager of Research Engagement on what centering communities truly means.

Listen now.

AVAC’s Guide to HIVR4P 2024 in Lima

We are looking ahead to the biennial HIV Research for Prevention 2024 conference  in Lima, Peru next week, 6-10 October. HIVR4P is a space where biomedical HIV prevention research, policy and programs takes center stage. Whether you’ll be in Lima or are following from afar, AVAC will keep you connected!

Read on for information on AVAC sessions, a sortable roadmap, the Advocates’ Corner (open all week) and more!  

Resources

  • Use AVAC’s Prevention Roadmap of conference sessions and satellites to find what interests you the most. You can download it as a sortable spreadsheet or PDF.
  • Advocates’ CornerIf you plan to be in Lima, be sure to join us and our CASPR partners at the Advocates’ Corner to take the conversations and themes deeper. The Advocates’ Corner will be open throughout the conference hosting a program of activities along with materials displays and opportunities for informal networking. Be sure to check the events page for updates on programming.
  • AVAC’s Coverage: From the latest news on injectable lenacapavir, to updates on the development of next generation prevention options, to the complex work of implementing the tools that exist today and all the advocacy needed to get it all done, our email dispatches to the Advocates’ Network keep you informed. Follow events in real time on Twitter at #HIVR4P2024 and Instagram.
  • People’s Research Agenda: During HIVR4P, we’ll be releasing the new People’s Research Agenda, a global initiative driven by communities and advocates to define the most urgent priorities, research questions and recommendations for HIV prevention research. We hope it serves as a guide to what is – and should be – discussed at HIVR4P and beyond.

Satellites and Sessions Featuring AVAC and Partners

Sunday, 6 October

Monday, 7 October

Tuesday, 8 October

Wednesday, 9 October

  • Symposium: Reducing burdens and barriers to expand the use of HIV prevention options, 13:30 – 15:00
    This session will explore the promise, potential and risks of using remote tools, such as telemedicine, virtual tools, apps and self-testing and the impact of other tools used to expand access and uptake of HIV prevention modalities. It will also review approaches to overcome misinformation and mistrust.

Thursday, 10 October

Find these resources, conference highlights and more at AVAC’s dedicated HIVR4P 2024 page. And watch this space for new opportunities to come together and shape what happens next.

SRH + HIV integration advocacy, Pandemic Accord, GPP and more!

AVAC’s round-up of resources, updates and insights this week includes a new roadmap for sexual and reproductive health (SRH) and HIV integration, resources to support an equitable Pandemic Accord, innovations in Good Participatory Practices (GPP) and more!

The power of choice in contraception, sexual health and HIV prevention this World Contraception Day

Roadmap: Sexual and Reproductive Health (SRH) Integration Roadmap

Copper Rose Zambia, as a part of CASPR and AVAC launched a new resource addressing the critical need for integrated SRH and HIV services. This roadmap provides key steps for success, focusing on collaboration, strategic mapping and targeted advocacy.

Read the roadmap

Advocate’s Guide: Advocates’ Guide to Multipurpose Prevention Technologies (MPTs)

MPTs are products designed to simultaneously address more than one sexual and reproductive health concern. This advocates’ guide shows the pipeline of products in development, discusses why MPTs are needed, investment, and what advocates can do to push for MPT development and introduction.

Read more

What will it take for an equitable Pandemic Accord?

Call to Action: Pandemic Accord Priorities from the Coalition of Advocates for Global Health and Pandemic Preparedness

A group of organizations advocating for an integrated and holistic approach to preparedness that emphasizes equity, inclusion, and synergies of multiple global health programs in advancing preparedness, shares five priorities in Pandemic Accord negotiations.

Read more

UNGA Side Event: Restrategizing Civil Society Engagement for Pandemic and Global Governance

AVAC’s Sam Rick moderated CISDI’s event alongside Nina Schwalbe, Lawrence Gostin, Eloise Todd and others, reminding the audience that for pandemic prevention, preparedness and response (PPPR) to succeed, lessons from the HIV response must be integrated into the architecture being built for PPPR.

Read the summary

Good Participatory Practices in action

Call for Applications: Now Accepting Applications for the 2024 Good Participatory Practice Online Course

The 2024 Good Participatory Practice Online Course is now accepting applications for 30 spots! This course offering will run 14 October – 20 December 2024. The application deadline is 9 October.

Apply now

Recording: Innovations in GPP

Recording / Clever Chilende Slides / Sarah Read Slides / Ntando Yola Slides

Anna Miti Joins The Choice Agenda (TCA) as Co-Moderator

AVAC and The Choice Agenda (TCA) are delighted to welcome Anna Miti as the TCA’s new co-moderator. Based in Harare, Zimbabwe, Anna is a seasoned journalist, advocate for gender equality, an AVAC Cure Fellow, former AVAC Advocacy Fellow and co-convener of the Zimbabwe Media Science Cafe, who brings her passion for amplifying community voices to this role. 

Launched by AVAC with Jim Pickett in April 2022, TCA is a global forum for advocacy on the latest in HIV prevention. With monthly webinars hosting informed discussions and a moderated listserv of nearly 3,000 subscribers from 40+ countries, TCA offers the HIV prevention community a platform to come together, learn from one another and chart the way forward.  Anna will work alongside Jim and the AVAC team to foster inclusive advocacy around efforts to expand equitable access to HIV prevention tools around the world. 

“As a long-time member of the TCA, I have valued it as a place for robust discussions and a vital platform to access new, timely and relevant information. I am excited to now contribute to this platform as co-moderator. Together with other advocates, I aim to strengthen the TCA’s impact and contribute even more to HIV and science advocacy.” – Anna Miti, TCA co-moderator

“On behalf of the TCA community, I am thrilled to welcome Anna into the brand-new role of co-moderator. Her dedication to HIV prevention research advocacy, her deep well of experience, and her exceptional communication skills will help us improve and expand our work to support HIV prevention research literacy and advocacy. The sun never sets on TCA, and I couldn’t be happier to have such a savvy, partner to help us take TCA to the next level.” – Jim Pickett, AVAC senior consultant and TCA moderator.

Join our Q&A with Anna, September 24

As part our webinar, Do Vaginas Demand Perfection? Implications for Event-Driven PrEP, we’ll host a 30-minute Q&A with Anna. We hope you’ll join us!

For more information about The Choice Agenda, upcoming events, or to join the listserv, visit AVAC’s The Choice Agenda page. 

Brand-new PxPulse Podcast on LEN’s Impact on HIV Prevention

The promise of long-acting PrEP has been super-charged this year by studies showing the powerful efficacy of an injectable antiretroviral known as lenacapavir (LEN). 

PxPulse’s new episode, Lenacapavir: The case for investing in delivering HIV prevention, goes deep on LEN. Recorded just days before Gilead’s announcement that PURPOSE 2, its second major trial of LEN as injectable PrEP, also found very high efficacy, Dr. Flavia Kiweewa, a principal investigator of PURPOSE 1, the first trial to announce efficacy, lays out the research findings and what they mean. And Chilufya Kasanda Hampongo of Zambia’s Treatment Advocacy and Literacy Campaign and Mitchell Warren of AVAC talk about how to change a long history of squandered opportunities to get rollout right. 

The PURPOSE 1 trial announced findings in June that a twice-yearly injection of LEN was 100% effective among cisgender women, with zero new cases of HIV. And the PURPOSE 2 trial among cisgender men, and trans and non-binary people, was shown to reduce the risk of HIV by 96%.  

LEN now enters a select category, one of five ARV-based options for PrEP that all protect against HIV if you take them. But many of the people applauding the results from PURPOSE 1 and 2 will tell you that breakthrough science like this, as hard as it is, is still the easy part. Breaking the back of the HIV epidemic demands overcoming an altogether different challenge — coordinating and accelerating every step in rolling out new products so that everyone who needs HIV prevention can get it.   

Listen to this podcast to learn what must be done to finally deliver on the promise of highly effective HIV prevention, from pills to rings to injectable PrEP and beyond.