Join AVAC, COMPASS and other partners to update CCMs on the PEPFAR freeze.

Avac Event
Join AVAC, COMPASS and other partners to update CCMs on the PEPFAR freeze.

The sustained attacks on global health and the dismantling of critical infrastructure by the US government continued this week. Here is an overview of developments in US policies and their implications for the HIV response and global health equity.
Leading groups in Washington, DC are urgently trying to collect videos and photos of what’s happening “on the ground” because of the freeze, such as clinic closures despite the waiver. Non-professional phone videos and photos are welcome. Contact or send to [email protected] for more details.
In other news, there was progress in HIV prevention: Gilead Sciences submitted lenacapavir for PrEP to the European Medicines Agencies (EMA) for review, both to market in Europe as well as for an EU-Medicines for All (EU-M4all) application that would facilitate availability of LEN for PrEP in low- and lower-middle-income countries. This marks a big step toward ensuring injectable PrEP reaches those who need it most, which was also highlighted in this week’s Lancet HIV editorial: Steps toward quick and equitable roll-out of lenacapavir. This makes fighting to restart PEPFAR-supported PrEP programs all the more important, so the world can prepare for LEN introduction. If we can’t drive down new infections with all options, we can’t imagine a sustainable HIV response.
The last week has brought an alarming series of developments affecting global health and human rights. Here’s a brief overview of critical changes and their implications:
AVAC and PrEP4All urged donors at last week’s FCAA Summit to mobilize emergency funding and unite against these threats.Together, we can protect global health and human rights.
The last week has been intense and sobering. As strategic and dedicated advocates, we already know the profound impact elections have on our work and our world. Recent developments in the United States underscore the challenges ahead, especially with the new administration’s alignment with the Project 2025 agenda—a playbook designed to reshape US federal agencies and policies drastically.
There are already Executive Orders—which are directives issued by the President of the United States—that have significant implications for our collective work, in the US and around the world. This is, we fear, just the beginning. Administrative actions, such as pausing foreign assistance, including the lifesaving PEPFAR program; halting diversity, equity and inclusion (DEI) initiatives; curtailing public communications; and “scrubbing” agency websites represent a systematic effort to control narratives and stifle dissent. And many of the Executive Orders from this past week are aimed at changing who is in control of information.
Some of the new political and policy shifts that we are tracking and what they mean for the programs and systems that matter most to HIV prevention efforts, include:
AVAC will continue to track these developments, analyze their implications, and convene and coordinate with partners to strategize responses. Beginning this week, we will share a weekly synthesis and insights report, Global Health Watch to help navigate this challenging terrain and ensure our advocacy for an evidence- and rights-based, equitable response to the HIV epidemic continues.
In addition, AVAC and PrEP4All published a new commentary in POZ magazine asking philanthropic funders gathered at this week’s Funders Concerned About AIDS (FCAA) Summit to adapt to these urgent threats. AVAC urges donor partners and advocates to support one another, and join together in an emergency effort, with immediate funding. As a united front, we can and must defend global health and human rights at this crucial time when collective action by donors, multilaterals, advocates and impacted communities is imperative.
Stay strong, stay safe, and stay sane. It’s a long road ahead, but with our partnerships, we must persevere.

For several years now, Community-Led Monitoring has been on the rise in the HIV response, and particularly in East and Southern Africa. Known as CLM for short, it’s a tactic being championed and implemented to ensure that communities play a direct role in monitoring and improving HIV services.
In this episode of PxPulse: The Advocacy Chronicles we delve into CLM in Malawi, where civil society and communities are successfully using this approach to connect government decision makers to the gaps in HIV services and to what people really need. Thanks to persistent advocacy, both PEPFAR and Global Fund now recognize, through their funding, the critical role of CLM.
The episode features David Kamkwamba, a journalist and health advocate and the former chair of the Civil Society Advocacy Forum on HIV and related diseases, commonly known as CSAF tells us what advocates have accomplished in Malawi and just how they did it. CSAF and AVAC are partners in the Coalition to Build Momentum, Power, Activism, Strategy & Solidarity (COMPASS) which has supported extensive work on community-led monitoring in Malawi and across the region.

Download the full podcast (19:55) or listen below.

In this episode of PxPulse: The Advocacy Chonicles, Atuswege Mwangomale goes deep on the advocacy work behind the passage of Tanzania’s Universal Healthcare Law. Atu serves as Head of Health Programs for Sikika, a Tanzania-based advocacy organization with a long track record of promoting best practices in governmental financing in the health sector, and advocating for improved health outcomes. Sikika, along with AVAC, is also a member of the COMPASS coalition, which uses data and coalitions across Africa to identify strategic campaigns to advance the HIV response.
Sikika’s advocacy has been crucial to the ultimate passage of Tanzania’s Universal Health Insurance Bill in 2023, but full funding must still be secured for the law to achieve full impact.
Atu explains the promise of UHC in Tanzania, how Sikika won the trust of government allies, and why working in coalition was essential to success.
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.


Throughout 2024, AVAC and partners facilitated a series of webinars in collaboration with The Global Health Network, Wellcome Trust, and WHO featuring 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.
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
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
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
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.
Enter 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!
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.
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.

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.
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.
Led by AVAC alongside a network of partners, the People’s Research Agenda puts forward recommendations to diversify and strengthen the HIV prevention pipeline, enhance investment and financial support for HIV prevention research and development, and guide an advocacy strategy that truly addresses the needs of communities across the prevention pipeline.
The PRA is a living document developed through intentional consultative processes that used multiple modalities, including surveys, focus groups, convenings, to gather insights about the processes and products needed to actualize HIV prevention justice.
In this summary of the People’s Research Agenda, you’ll find the PRA’s core insights into the processes involved in HIV prevention research and implementation, and the types of products that should be developed through these processes.
A visual roadmap illustrating the key stages transitioning a product from clinical trials to large-scale real-world implementation.

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.
Navigating through the work ahead involves 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. Joining us to begin those efforts and better understand the landscape for advocacy are Jen Kates from KFF and our own Suraj Madoori.