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, resources, infographics, coalition-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.

No Data No More Scorecard Tool

This scorecard advocacy tool synthesizes the visions put forth in the No Data No More Manifesto to Align HIV Prevention Research with Trans and Gender-Diverse Realities into scorable indicators to help realize trans-inclusivity in research.

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

A resource that provides background on the need for research in pregnant and lactating populations and how advocates can advance inclusion.

This Week at AVAC: US election, new LEN resources, STI pipeline and PrEP service delivery

As we continue to grapple with the results of the US presidential election and what this means for our work and for global health evidence- and rights-based policies and programs generally, we wanted to share a range of new tools and resources you may find helpful in your advocacy for choice, science and rights.

Injectable Lenacapavir for PrEP

Register


Additional LEN Resources

Webinars on the STI Pipeline, Advances in Research Ethics, and Money for the DVR and More!

Register

In Case You Missed It

Recording / Slides / DVR Early Market Access Vehicle page

And stay tuned for a new PxPulse podcast featuring Jen Kates of KFF and AVAC’s Suraj Madoori, The Votes Are In: What’s next for the US’ role in global health and HIV prevention. The podcast hits airways November 14.

Avac Event

Understanding Anal Pleasure and Health for Clinicians, Behavioral Health Specialists, Peers & HIV Workers


Forty years into the epidemic, people are still seeking accurate, reliable information about anal play that isn’t just about HIV and STI prevention. They want to understand how to engage in ways that maximize pleasure and reduce harms beyond infectious disease. Often, they end up encountering harmful myths rather than facts, and then learn by ‘trial and error’.

This 90-minute webinar is appropriate for HIV and STI clinicians, behavioral health workers, social workers, case managers, peers and anyone else with a responsibility for delivering or referring to HIV services like treatment, PrEP, testing and support services.

Participants learned the rationale for why addressing anal pleasure and health is essential in HIV service settings as well as ways to respond to frequently asked questions, including via a new client- and worker-facing website.

Recording I Slides I Resources

Speakers included:

  • Bryan Kutner, PhD, MPH, Albert Einstein College of Medicine
  • Samuel Anyula Gorigo, Hoymas (Health Options for Young Men on HIV/AIDS and STIs) Kenya

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

Avac Event

Join the Fight Against HIV: Discover the latest breakthroughs

Are you passionate about medical breakthroughs and advocacy? Don’t miss out on this pivotal community event where leading scientists and dedicated advocates gather to discuss with you the latest strides in HIV cure research.

Meet Two People Cured of HIV: Hear their stories, learn about their journeys, and discover the breakthroughs in medical science that made their cures possible. This is a unique opportunity to gain insight into the advancements in HIV and the hope it brings to many.

Explore Cutting-Edge Research: Get insights into the latest advancements towards finding a cure for HIV. Hear directly from the experts who are at the forefront of this critical work.

Engage in Thought-Provoking Discussions: Participate in conversations that matter. Share your thoughts a cure for HIV and learn from others who are just as committed to this cause.

Network with Like-Minded Individuals: Connect with those who share your dedication to making a difference. Build relationships that could shape the future of HIV advocacy and research.

Be Inspired to Take Action: Leave feeling motivated and equipped with new knowledge to contribute to the fight for a cure for HIV in meaningful ways.

Eventbrite Registration / Zoom Registration

People’s Research Agenda: New dimensions to the “3D” pathway

Launched at HIVR4P in Lima, Peru in October 2024, the People’s Research Agenda (PRA) is a collaboratively developed framework for aligning the needs and priorities of affected communities with the agenda for HIV prevention research. 130 advocates from more than 20 countries contributed to the framework, which offers guidance on both research conduct and what products to develop. Read more in PxWire.

PxPulse: The Advocacy Chronicles with Danielle Campbell from PrEP in Black America

In this episode of the Advocacy Chronicles, we’re putting the spotlight on the US, on the dismal statistics on access to PrEP in Black communities, on the state of HIV prevention among Black Americans overall, and the work of one advocacy group— PrEP in Black America (PIBA). Danielle Campbell is one of the founders of PIBA and a long-time advocate for HIV prevention and health equity. She joins the Advocacy Chronicles to talk about PIBA’s call to action for an HIV research agenda that prioritizes the needs of Black communities. And we also explore the tactics that have led this group to quickly rise as a powerhouse, bringing together communities and government to find solutions that improve the US HIV response.

Danielle is a member of the research faculty at the Charles R. Drew University of Medicine and Science and a member of the community scientific subcommittee for a global HIV research network. She is an experienced clinical research manager who integrates principles of health equity and implementation science into biobehavioral research into HIV treatment, prevention and cure research and she is a past Chair of the HIV/AIDS Section of American Public Health Association (APHA) and has served as Chair of the Science Board and Co-Chair of the Joint Policy Committee.

Listen

Resources