A Year in the Life of GPP: What’s actually happening, and how do we know it’s working?

The Good Participatory Practice (GPP) Guidelines have been shaping and improving HIV prevention research since 2007. They provide a global reference guide for ethical and effective stakeholder engagement, helping ensure the priorities of trial participants and their communities are centered in clinical trials and broader research agendas.   

One year ago, AVAC published the Good Participatory Practice (GPP) Body of Evidence, an online clearinghouse of tools, best practices and analyses showcasing the power of GPP. Here, we bring you a report from the year since – how this clearinghouse of resources continues to demonstrate the value of GPP, and concrete examples from 2024 of GPP’s impact on major research agendas and mechanisms. Read on for highlights. 

Critical Learnings from GPP: The Body of Evidence Webinar Series

Throughout 2024, AVAC and partners facilitated a series of webinars in collaboration with The Global Health Network, Wellcome Trust, and WHOfeaturing resources housed in the Body of Evidence. These conversations expanded the traditional understanding of GPP – highlighting that GPP is not just about trial implementation; that its practices evolve from product discovery to delivery and are important at every step of the way; and that monitoring and evaluation are complex and critical nuances are required to ensure its meaningful application. Look out for a final webinar on elevation of GPP in global clinical trials guidance in 2025. The full recordings and presentations are on the AVAC website.  

View the webinar series
A Few of our Favorite Moments from the Webinar

Our great leader Nelson Mandela said, ‘everything that is done for me, without me, is done against me,’ and we really must see our community members as having a role beyond that of as just a potential trial participant but to engage them right from the beginning, from the protocol design, from all our planning pre-study, the conduct of the study, and most important to the dissemination of the results – whether they be positive or negative. — Dr. Michelle Temeris, University of Capetown

How can we craft research questions so that when we have an answer at the end of the day it’s really something meaningful and impactful to communities? We can answer scientific questions that might be interesting to a researcher but at the end of the day that doesn’t get us very far if it’s not also equally impactful for community. — Sarah Read, US National Institute of Allergy and Infectious Diseases 

Thinking about community engagement moving forward we need to think about building relationships over time and beyond particular studies. We need to make sure that we’re not only giving accurate information but we’re also listening and responding to issues that are being raised in the course of our interactions. — Sassy Molyneux, KEMRI-Wellcome Trust, University of Oxford

One really important perspective would be to monitor the impact that engagement has on the trial, the way it’s run. That would be a really important aspect of monitoring and evaluation – to make note of the real changes that community stakeholders can have on the way trials are selected in the first place but also modified to make them appropriate. — Alun Davies, Global Health Network

GPP in Action: Influencing Research Programs

Advocates’ Consultation on Merck’s Monthly Pill Program

In recent years HIV prevention efficacy trial design has become one of the hottest topics. As the HIV prevention toolbox improves, researchers, statisticians, and regulators grapple with the best way to incorporate these options into efficacy trials. The key to all of this, they say? Community.  

ImageEnter GPP! In June, AVAC convened a community and advocates’ consultation with Merck around their program testing MK-8527 as a monthly pill for PrEP. With an efficacy program on the horizon, Merck set out to consult with communities – before any other stakeholder – about issues like choice of a comparator arm, the evolving standard of prevention, and how a trial could best reflect the reality of implementation in peoples’ countries, communities, and own lives. Consultation members consolidated feedback that is now being fed into Merck’s protocol development. Priorities included a design that would get to an efficacy answer most efficiently, but that would incorporate contextual issues of prevention choice as possible. Participants concluded that a monthly pill would be an important addition to the prevention toolkit, and thus support for the research program. But they also expressed ongoing frustration around community support for research that does not translate into access for their communities.  

Watch this space for further updates on the MK-8527 program, as engagement continues through protocol development, trial planning, implementation, and beyond!   

Pediatric Adolescent Virus Elimination (PAVE) Community Advisory Board (CAB)

Communities have been a key stakeholder advancing HIV cure research from the bench to early phase clinical trials. GPP has been the guiding principle as engagement has moved further upstream.   

The Pediatric Adolescent Virus Elimination (PAVE) Community Advisory Board (CAB) is an example of this impact as the only group dedicated to advancing an HIV cure in pediatric populations. Through its digital Voices Project featuring young people with HIV, clinicians, caregivers and researchers, the CAB has raised awareness of the research among youth in Sub-Saharan Africa who engaged with ministries of health to push for the inclusion of children in research. They also worked with PAVE investigators to simplify and convey complex scientific and ethical issues inherent in cure research.  

As research moves from the bench to the clinic, the CAB and community partners, will continue to play a strategic role in shaping future protocol designs and addressing community support needs.  

Elevating GPP: WHO’s New Clinical Trials Guidance

In September, 2024, the World Health Organization published their new Guidance for Best Practices for Clinical Trials. The guidelines state that centering patient, participant, and community engagement will lead to more efficient and equitable trials. Input from AVAC and partners, including Wellcome Trust, The Global Health Network, University of Oxford, and others helped ensure the new guidance centered the importance of community engagement in creating more equitable and actionable clinical trials research. 

Save the Date

On December 13, 2024, WHO is hosting a webinar, WHO launches new clinical trials guidance – What do I need to know? Registration is free, and during the webinar WHO will highlight key areas of change in the guidance for everyone involved in clinical trials.  

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Since AVAC and UNAIDS launched the GPP guidelines in 2007, the science and politics have grown ever more complex – and GPP implementers have continued to adapt, evolve and engage. We are committed to continuing our efforts to curate insights and resources, including further building out the Body of Evidence, and to support our collective advocacy for ethical and effective stakeholder engagement throughout clinical trials, research agendas and implementation in the months and years to come. 

Avac Event

I Am More Than HIV Prevention – Results from the HPTN 091 Study with Transgender Women

HPTN 091, the I Am study, evaluated the impact of a multicomponent HIV prevention strategy to increase the uptake and adherence of pre-exposure prophylaxis (PrEP) among transgender women. The strategy included HIV prevention services, gender-affirming hormone therapy, and peer health navigation.

This webinar will feature Dr. Tonia Poteat, study co-investigator, who will review the study findings and discuss implications.

Speakers:

  • Tonia Poteat, Ph.D., Duke University School of Nursing, Division of Healthcare in Adult Populations

This webinar will feature Portuguese and Spanish translation thanks to HPTN.

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

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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