Global Health Watch News Brief: Issue 1

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:

  • Pause on PEPFAR and humanitarian programs: On Monday, US officials announced a suspension of all PEPFAR programs, threatening access to lifesaving HIV treatment and prevention for millions worldwide and jeopardizing decades of progress in global health. US officials were told to stop providing technical assistance to national ministries of health and PEPFAR’s data and computer systems were taken offline. On Tuesday, Secretary of State, Marco Rubio, a longtime supporter of PEPFAR, approved an “Emergency Humanitarian Waiver”, allowing “life-saving medications” to continue to be delivered. However, official guidance on how to interpret the waiver is lacking and it’s unclear whether providing HIV treatment can resume.

    IMPLICATIONS: More than 20 million people living with HIV could lose access to treatment, with widespread job losses expected across multiple countries. Most urgently, the delivery of ARVs funded by PEPFAR has already been disrupted. According to an analysis from amfAR, 222,333 people start new ARVs daily, meaning that many individuals now face the life-threatening possibility of interrupted treatment. Beyond these immediate impacts, the broader cessation of ARVs for over 20 million people would have catastrophic consequences. 

    Learn more from amfAR’s Country Analysis on treatment, testing and other social determinants of health. 
  • Federal financial freeze: Also on Monday, the new administration issued (via the Office of Management and Budget, OMB) a freeze on federal financial assistance, which impacts funding for research, healthcare, diversity programs, and energy projects among other efforts. Democrats are arguing that the freeze is unlawful and would harm communities across the US. Some states are pursuing lawsuits. Due to substantial community backlash and legal challenges, the administration rescinded the memo in less than 24 hours. The administration meanwhile asserts the Executive Order is still in effect

    IMPLICATIONS: The President’s pause on foreign assistance at the State Department remains in effect. Most international health and humanitarian efforts remain frozen, except for those covered by the waiver for “life-saving medications” referenced above. Even as the status of these federal funding freezes are still being clarified, the administration can be expected to continue to pursue strategies to impound, rescind, and limit access to federal funding for public health research and programs, and use misinformation and rhetoric to justify these actions. 

    Listen to Mitchell Warren on the Bhekisisa podcast, Weaponising aid: The cruel ways of #Trump2025. 
  • USAID leadership shake-ups: The new administration has placed career USAID officials on administrative leave, including leaders who run USAID’s Bureau for Global Health, impeding HIV prevention and civil society support worldwide. In addition, many of the agency’s institutional support contractors (ISCs), who comprise more than 50% of the Global Health Bureau, have already been, or are expected to be, let go. Contractors at the State Department Bureau of Global Health Security and Diplomacy (GHSD), including PEPFAR, were also laid-off Wednesday.

    IMPLICATIONS: This signals a deliberate effort by the administration to remove anyone seen as disloyal. Reports of loyalty tests for staff, including inquiries about their “moment of MAGA revelation,” reflect a broad-reaching plan to remove anyone or anything that could scrutinize the administration’s orders. Contractors at USAID and GHSD are essential to the Bureau’s operations, and their expulsion paralyzes the USAID, GHSD and PEPFAR.
  • Emerging threat as Uganda confirms new Ebola outbreak: Uganda’s Ministry of Health confirmed a new outbreak of the Ebola virus in its capital, Kampala. One death has been reported on Wednesday. This is the first outbreak since 2022, when it took four months to contain the spread of the virus.  

    IMPLICATIONS: The US intent to withdraw from the WHO and the suspension of communication with the US CDC, the country’s lead government agency, makes it impossible for infectious disease control to coordinate with their international counterpart to mitigate this threat.
  • National Institutes of Health employees may move to schedule F: In a publicly shared memo, employees of the National Institutes of Health (NIH) may be reclassified as “schedule F”, which strips them of key worker protections as civil servants. This move could allow the administration to dismiss or vet career employees and scientists based on their perceived loyalty to the administration’s political and ideological positions, including the research they oversee.  

    IMPLICATIONS: This shift could have a chilling effect on new researchers entering the field, potentially undermining the integrity and independence of scientific research. 
  • NIH clinical trials and participant travel continues with uncertainty: Despite NIH restrictions, clinical trials and participant travel to trial sites may still continue, according to an email to staff at the NIH from its Acting Director, Matthew Memoli. Scientists may also discuss ongoing research that was initiated before January 20, given there is no data sharing or public communication outside of those who are part of the research or its funding, leaving the impact on new research uncertain.

    IMPLICATIONS: Critical purchases and contracts related to human and animal health, security, and biosafety could proceed, but there are many unanswered questions, especially over the pause in grant reviews and funding decisions. 
  • Fighting the Global Gag Rule: One of the early actions of the new administration was the Executive Order to reinstate the Global Gag Rule. However, the Global Health, Empowerment, and Rights Act, a bill to permanently end the Global Gag Rule, was reintroduced in the House and Senate on January 28, making this Act all the more important. AVAC and partners have endorsed the act. Read Congresswoman Lois Frankel’s statement here and watch this space for further updates.
  • Confirmation Hearings for Russell Vought, nominee for Director of Office of Budget and Management: Russell Vought may be selected to lead the Office of Management and Budget (OMB), an influential office, which plays a key role in developing the annual budget request. In this position, Vought will essentially serve as a key gatekeeper, shaping the Executive Branch’s agenda. Confirmation hearings were scheduled for January 30. However, Democratic senators are demanding the vote be delayed, while debate escalates around federal domestic funding freeze.

    IMPLICATIONS: Vought, one of the authors of Project 2025, the conservative blueprint for reshaping the US government, is poised to implement the vision at the highest levels of government. If confirmed, he will have power over foreign assistance, research, and all the programs that save lives in the US and abroad. He will be able to accelerate firings, work stoppages, and withhold federal grants/funds already underway. His leadership represents a direct threat to public health and human rights.

    Live in the US? Call your Senator (202) 224-3121 to vote “no” on this confirmation and send a message to Washington that HIV prevention advocates stand firmly against Project 2025 and its writers.

In Case You Missed It

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.

Read the opinion editorial in POZ Magazine.

What we’re reading

  • The New Yorker: Behind the Chaotic Attempt to Freeze Federal Assistance: Discusses the new administration’s attempt to freeze federal assistance, which led to widespread confusion and concern among federal agencies and aid organizations, highlighting the challenges and potential consequences of such a sudden policy shift. Discusses the new administration’s attempt to freeze federal assistance, which led to widespread confusion and concern among federal agencies and aid organizations, highlighting the challenges and potential consequences of such a sudden policy shift. 
  • Brownstone Institute: The State of Pandemic Preparedness, the WHO, and the US Withdrawal: Discusses the Executive Order withdrawing the United States from the World Health Organization (WHO) and ceasing negotiations on the WHO Pandemic Agreement and International Health Regulations, highlighting concerns about the potential impact on global pandemic preparedness. 
  • Project Syndicate: Trump at Davos: Reviews the new presidential policies in a world of competing crises, eroding institutions, and increasing geopolitical instability and how these actions are accelerating these challenges. and how these actions are accelerating these challenges. 

Resources

Working in Solidarity: Join the effort to track the Impact 

Introducing Global Health Watch! Tracking US actions and their impact

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. 

The Trump Administration Announces US Withdrawal from WHO

By Samantha Rick

Among the first actions of the new US Presidential administration, was the announcement of the intent to formally withdraw the US from the WHO, which jeopardizes global health collaborations, data sharing, and inhibits WHO’s ability to address global health emergencies (the US contributes 15% of its overall budget and 34% of emergency funding) among other things.

What Does It Say?

The Executive Order states that the US intends to withdraw from the WHO immediately, pause any future transfer of funds to the WHO, recall US government personnel who have been working in any capacity with the WHO, identify other partners who can take on the tasks previously undertaken by the WHO in partnership with the US government, replace the recently released 2024 US Global Health Security Strategy, and cease negotiations on the Pandemic Accord and International Health Regulations.

What Does it Mean for Global Health Advocacy?

While global health advocates were anticipating an announcement of withdrawal from the WHO, there isn’t a blueprint for how this works as it has never happened before. There is no public information about the number of US government employees that will be recalled and how far-reaching that order will be.

There are concerns about immediate impacts, such as WHO Executive Board resolutions that the US was leading or co-sponsoring (such as one on UHC last year) and what will happen to those resolutions. It is not expected that any US government personnel will attend the Executive Board.

The longer-term impacts of withdrawal from the WHO would be catastrophic. The US provides 15% of the WHO’s overall budget, including 34% of the funding for global health emergencies. There are 70 WHO Collaborating Centers hosted in the US. These Centers are an essential and cost-effective cooperation mechanism, which enables the WHO to fulfill its mandated activities. The impact on data sharing is even messier, as researchers and companies across the country depend on data shared through the WHO and vice versa for disease surveillance, to guide protocols and policies, direct aid and funding, and much more. Outside of the impact on global research collaboration, the halting of funds to the WHO would have a severe impact on the WHO’s ability to fulfill the mandate and obligations that Member States have assigned to them, such as providing centralized data repositories and supporting increased surveillance efforts.

The withdrawal from the Pandemic Accord and International Health Regulations negotiations may seem on the face of it to be a boon, given some historical US positions that are aimed at protecting industry partners. However, the US has long been a stabilizing force in international negotiations, and particularly in these two. Over the past three years of negotiations, US leadership has kept negotiations on track. For example, the US has not been the main adversary in negotiations on the Pathogen Access and Benefits Sharing system (probably the most contentious section of the agreement) and its influence was useful in moving countries that were more opposed. Without that influence, it’s hard to see a force with more leverage to move all countries toward a concrete agreement.

Across the globe, there are interests with large platforms that are placing blame for the COVID-19 pandemic on the WHO as a scapegoat for the negative effects on people’s lives (the deaths, the loss of employment, the curtailing of social life, the feeling of imposition of masks and other public health measures). Many of the Executive Orders coming out are aimed at changing who is in control of information, including this one.

What’s Next?

Restricting access to information is a global phenomenon and a public health threat. Many countries follow the US’s lead, so partners and activists will need to mount sustained grassroots campaigns to protect public health and educate communities. Civil society must demand that governments continue their commitments to multilateralism and the advance of global public health.

This MLK Day, Advocacy to Keep Moving towards Equity

As we honor the memory of Martin Luther King Jr. in 2025, his legacy calls on us all to unite in solidarity and persevere in activism, even amid loss, inequity, and injustice.  

His words from A Letter from a Birmingham Jail in 1963, are ringing a call to action for us all. 

“Injustice anywhere is a threat to justice everywhere. We are caught in an inescapable network of mutuality, tied in a single garment of destiny. Whatever affects one directly, affects all indirectly.” 

Advocacy for HIV prevention and global health equity must heed MLK’s call — today and always. This series of AVAC’s advocates’ guides shares essential information, tools, and strategies to advance HIV prevention and sexual and reproductive health as part of a comprehensive and integrated pathway to global health equity in 2025 and beyond. 

We hope they inspire fierce advocacy to center the rights and needs of communities who are shouldering the impact of the HIV epidemic and facing intensifying systemic inequities in global health.

AVAC’s Advocates’ Guide

AVAC’s Advocates’ Guides support informed advocacy by breaking down complex topics, fostering community engagement, and promoting evidence-based action to accelerate ethical development and equitable delivery of effective HIV prevention options.

Advocates’ Guide to Lenacapavir: The Basics on Injectable Lenacapavir as PrEP

Provides background on lenacapavir for PrEP and its trials; a summary of the early findings of PURPOSE 1 and 2; key questions and next steps.

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. 

Advocates’ Guide to Doxycycline to Prevent Bacterial STIs (DoxyPEP)

Explores who will benefit most from DoxyPEP to prevent the acquisition of some bacterial STIs after sex and how it could be implemented to ensure equitable access.

Advocates’ Guide to Multipurpose Prevention Technologies (MPTs)

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.

Advocates’ Guide to Pandemic Prevention, Preparedness and Response

Explains the major initiatives in global pandemic planning, and how to get involved and make sure your priorities are heard by decision makers.

Advocate’s Guide to Research in Pregnant and Lactating Populations

Provides background on the need for research in pregnant and lactating populations and how advocates can advance inclusion.

Advocates’ Series: From the Lab to the Jab

Provides a roadmap for advocacy to advance the development and delivery of essential vaccines for HIV, COVID-19, tuberculosis, and other global public health threats, and approaches to ensure equitable access to these life-saving vaccines.

Language Guide for HIV Cure

Shares up-to-date, community-preferred terminology within cure research.

Whatever your role in the fight for equity and justice, we thank you for your service.  

“If you can’t fly, run. If you can’t run, walk. If you can’t walk, crawl. But by all means keep moving.” — MLK Jr. from a 1960 address at Spelman College. 

Community-Led Monitoring, PrEP Advances, and What’s Next for Global Health

Welcome to January 2025! This update shares new resources to keep you informed and inspired in the fight for choice, science, equity and sustainability in the HIV response in 2025 and beyond. 

New Podcast Alert!

Tune in to our latest Advocacy Chronicles podcast as we spotlight the transformative power of Community-Led Monitoring (CLM) in Malawi’s HIV response. David Kamkwamba is leading journalist and advocate, former chair of the Civil Society Advocacy Forum on HIV and related diseases and a COMPASS partner. In this podcast, he shares how CLM is improving HIV services, forging collaboration between communities and government, and strengthening the health system.

Listen Now

Revisit Our Episode on HIV Prevention and the US Administration

As the US prepares this week for its presidential inauguration and confirmation hearings for Cabinet nominees, it’s a great time to listen to 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, 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. It’s imperative to understand the implications for the global AIDS response, and to safeguard policies and programs that advance it.

Listen Now

Save the Date, March 5

Advancing Clinician Support in the United States Through a Unique Distance-Based Model
March 5, 2025 from 12:00-1:30pm

Join the TCA and the National Clinician Consultation Center (NCCC) for a webinar featuring NCCC’s innovative, cost-free teleconsultation program, which provide a free, real-time, expert guidance on HIV, viral hepatitis, and substance use to clinicians across the US, regardless of location or clinical setting. Participants will discuss this model and strategies to adapt it for global healthcare challenges.

Register Now

Navigating the PrEP Landscape

With a growing number of PrEP options in, or soon in the market, and others in advanced development, and an increase in PrEP initiations worldwide, the future of PrEP has never been more exciting – and challenging. 

As we navigate an uncertain political landscape and embrace the promise of innovative PrEP products, advocacy will remain our most powerful tool. 

Much Accomplished, Much to Do

2024–2025 Fellows Progress Update

As we enter a new year, we also enter the midway point of the AVAC 2024-2025 Fellowship program, which runs 18 months. Fellows and their projects are taking giant strides in new areas of advocacy, and realizing strategic wins toward epidemic-bending goals, with much more to come! For more than a decade, Fellows have tackled critical issues for the field, focusing on U=U and new technologies, including long-acting PrEP, the Dual Prevention Pill (DPP) and the dapivirine ring (DVR). 2024-2025 fellows have added new areas of focus including on Pandemic Prevention, Preparedness and Response (PPPR); anal health; and HIV prevention in prisons. 

Here are some of their accomplishments of the 2024–2025 Fellows Program

Ezra Meme (Uganda) is AVAC’s first Fellow to advance a Pandemic Prevention, Preparedness and Response (PPPR) agenda. He contributed to the development of the Uganda National Action Plan for Health and Security to bolster public health emergency centers throughout the country. While the billions committed in Ugandan shillings still need to be secured, Ezra will continue to monitor and advocate for this unprecedented public health project. He also successfully advocated for the government’s launch of the Antimicrobial National Action plan. And, he’s been closely monitoring Mpox, advocating for a digital mapping tool to track its control efforts. 

Bahati Thomas Haule (Tanzania) is laser focused on scaling up and normalizing U=U and the accompanying need for timely viral load testing and results. She’s gotten buy-in from PEPFAR and UNAIDS to support a substantial U=U media campaign and she’s collaborating with the Elizabeth Glaser Pediatric AIDS Foundation to spread knowledge of their model U=U program for “nationwide utilization.” She’s also in dialogue with Global Fund to support increased lab capacity and provider training. Bahati presented to the UK Parliament on the need to support LEN for PrEP and for World AIDS Day, she published an opinion piece in the Swahili newspaper Mwananchi, advocating for ARV-based prevention. 

Mokone Rantsoelaba (Lesotho) is AVAC’s first Fellow to advocate for HIV services in prison. After visiting nearly all his country’s correctional facilities, he released an assessment of HIV services for the incarcerated in Lesotho. His work was so well received that he was asked to integrate many of his recommendations into Lesotho’s Correctional Services Healthcare Policy, including the training of providers and fast-tracking all new prevention methods for scale-up in prisons. Mokone initiated and continues to convene the Southern African Development Community (SADC) regional correctional institutions along with the United Nations Office on Drugs and Crime (UNODC) to share best practices. Mokone has also been invited as a guest columnist for one of Lesotho’s top publications.   

Sammy Anyula Gorigo (Kenya) is AVAC’s first Fellow to spotlight anal health. Specifically, Sammy’s been promoting HPV vaccines, screening and treatment for all men, particularly gay and bisexual men and other MSM. Thus far, he integrated HPV screening as a standard of practice into Nairobi County Health Management. He updated two separate guidelines to include anal health care for men—Kenya’s Standard Operating Manual for Prevention and Management of STIs and the National Guidelines for HIV and STI Programming with Key and Vulnerable Populations. He’s been invited to PEPFAR’s COP planning and writing process to develop an anal package of care. Lastly, for World AIDS Day, he published an opinion piece landing in The Nation, The Star and The Standard.  

Rhoda Msiska (Zambia) is ensuring a swift introduction of the DPP. She’s earned a leading advocacy role, engaging the Ministry of Health to fast-track and de-medicalize PrEP and ensuring DPP inclusion in the national PrEP implementation plan. She’s working with the MoH to set aside DPP funding through the Global Fund and taking to the radio airwaves to create demand. Importantly, Rhoda has secured a first meeting with ZAMRA, Zambia’s regulatory body, to encourage moving forward with civil society support. And, at R4P Conference in Lima Peru in October, Rhoda spoke on a panel addressing strategies for the delivery of the DPP.   

Elina Mwasinga (Malawi) is dually focused on HIV prevention for pregnant women and lactating mothers and HIV cure research. Thus far, she’s secured commitment from the National AIDS Commission to integrate cure into Malawi’s Technical Working Group on Research to coordinate activities and ensure a robust cure research portfolio. Likewise, Elina secured integrated PrEP-family planning services with specified inclusion of pregnant and lactating mothers, as reflected in the MOH’s EMTCT Accountability Roadmap. And, she presented on the use of broadly neutralizing antibodies (bNAbs) to prevent vertical transmission during a WHO consultation and on advocacy as a panelist speaker at the 2024 International AIDS Conference. 

Pamela Fuzile (South Africa) is focused on boosting youth engagement in prevention and supporting young champions. She’s establishing a national level youth platform for new technologies in nine provinces where members can influence decisions in the HIV and PrEP technical working groups at SANAC. A key objective is youth advocacy for the inclusion of injectable PrEP and the dapivirine ring in all public health facilities responsive to the needs of young people.

Congrats to all the Fellows on their impressive work thus far. We’ll report on their total accomplishments in late 2025.

Accelerating Access to Lenacapavir

Everyone has a role to play

This year, the HIV prevention community witnessed a landmark moment with the results of the lenacapavir (LEN) for PrEP PURPOSE 1 and 2 trials, which showed nearly complete protection against HIV. Named as “breakthrough of the year” by Science Magazine, LEN’s every-six-month injectable dosing has the potential to transform the HIV response, but only if it is rolled out with speed, scale and equity. Gilead Sciences, the developer of LEN,  just began the process to submit applications to national regulatory agencies to market LEN for PrEP. WHO is also beginning to develop guidelines for LEN for PrEP. And just this week, PEPFAR and the Global Fund announced a coordinated effort to reach two million people with access to LEN. So, the clock is ticking and achieving this vision—and significantly reducing global HIV infections requires coordination at every level. 

We released a new framework, the Gears of LEN for PrEP Rollout, which provides more details about all the moving parts needed to accelerate equitable access – and the necessary lubrication to ensure the world does not squander this opportunity. Read a new op-ed penned by Jirair Ratevosian and Mitchell Warren in Devex describing this process and read more below about this framework and tools and strategies to support the advocacy needed.

The Gears of Lenacapavir for PrEP Rollout underscores that each stakeholder—whether governments, donors, civil society, or manufacturers—must function like the gears in a finely-tuned clock. Everyone has a role to play–each component is essential, and only by working together in synchronization can we keep to time and ensure a seamless and impactful rollout.

Recent LEN for PrEP News

Resources

  • Update on Lenacapavir for PrEP, Webinar recording
    AVAC hosted a webinar focused on updates for the PURPOSE trials. Gilead provided an overview of the PURPOSE 1 and 2 trial results and insight into the status of PURPOSE 3, 4, and 5.

Choice, Not Miracles

AVAC Communications Director, Kenyon Farrow breaks down the potential of LEN to make choice a reality. View the video.

Instagram Reel

An Overview of Lenacapavir PrEP Trials
This graphic shows the latest status of all five trials including the groundbreaking results of PURPOSE 1 and PURPOSE 2. Download the graphic here.

Additional Infographics

Lenacapavir isn’t just another medication; it could be a catalyst for transformation. Together, we can seize this pivotal moment to revolutionize HIV prevention, paving the way for a future where innovative tools like lenacapavir reach everyone who needs them.

A Season of Listening

AVAC’s PxPulse podcast has you covered

AVAC’s PxPulse podcast is back with its final episode of the year! This episode of PxPulse: The Advocacy Chronicles features Atuswege Mwangomale from Sikika, a COMPASS Africa partner. Host Manju Chatani-Gada takes listeners behind the scenes to learn about Sikika’s advocacy strategy around the successful passage of Tanzania’s Universal Health Insurance Bill, which made health insurance mandatory for all citizens.

2024 has been a year of rich and invigorating conversations on PxPulse! Join us for a season of listening with episodes ranging from the future of HIV vaccine research with the Gates Foundation’s Nina Russell to Madhukar Pai‘s call to action on recentering global health, to the latest on lenacapavir for PrEP, and the implications of the US election on global health featuring KFF’s Jen Kates and AVAC’s Suraj Madoori. Tune in and explore the episodes!

2024 Podcast Episodes

The Advocacy Chronicles

We hope you will tune into these conversations, stay connected to critical advocacy and join us in 2025 for many more conversations.

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 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.  

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

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

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.  

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!

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.  

Register

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. 

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.

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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.