Global Health Watch News Brief

New guidance, confusion, and advocacy in action

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.  

New Developments

  • Humanitarian Aid, PEPFAR Freeze and HIV Prevention 
    A pause on all US foreign assistance was announced January 20, leading to layoffs and halted delivery of life-saving medication and services, with severe consequences for communities. Last weekend, PEPFAR finally received a waiver for some treatment and programs for the prevention of mother-to-child transmission (PMTCT). However, guidance has been lacking as to which programs can resume. On Thursday, the US Department of State issued guidance allowing for the continuation of HIV testing for all populations and HIV care and treatment for all people living with HIV. But primary prevention and key population programming was excluded, and the guidance goes so far as to state: “people other than pregnant and breastfeeding women who may be at high risk of HIV infection or were previously initiated on a PrEP option cannot be offered PEPFAR-funded PrEP during this pause of US Foreign Assistance or until further notice”. In the meantime, almost all USAID staff were put on administrative leave and all contract staff at PEPFAR were laid off on Wednesday. Advocates and implementers in dozens of countries are already reporting significant setbacks, including closed drop-in centers and halted PrEP distribution. In an attempt to fight back and advance HIV prevention as core in the global HIV response, the African Women Prevention Community Accountability Board issued a powerful Call to Action for Sustaining HIV Prevention Gains for Women and Girls in Africa.

    IMPLICATIONS: The situation remains deeply concerning and riddled with confusion: while some waivers are being granted, many implementing partners continue to face stop-work orders, stalling critical services. Most alarmingly, disallowing individuals already on life-saving PrEP from continuing these services threatens to reverse hard-won progress in controlling the HIV epidemic. As Kenneth Ngure explains in the New York Times article on the USAID withdrawal’s impact on clinical trials: “Without regular [PrEP] injections or a carefully-managed discontinuation, the participants will not have enough cabotegravir to stop a new infection, but there will be enough in their systems that, if they were to contract the virus, it could easily mutate to become drug-resistant.” 

    READ: 
    Abandoned in the Middle of Clinical Trials, Because of a Trump Order – New York Times
    Too little, too late: What a PEPFAR waiver can’t do – Bhekisisa  
    The Status of President Trump’s Pause of Foreign Aid and Implications for PEPFAR and other Global Health Programs – KFF
  • USAID Shutdown and Dismantling 
    The majority of USAID staff and contractors were fired or placed on administrative leave and locked out of their accounts and out of the building in Washington, DC. Most essential functions of the agency have been stopped. Many lawmakers on both the Democrat and Republican sides have opposed these orders, but attempts to pass resolutions supporting USAID have been blocked in the Senate. Also, Secretary of State Marco Rubio informed lawmakers that he would also serve as Acting USAID Administrator and has given Peter Marocco, a political appointee at the State Department, additional responsibility at USAID. This allowed Marocco to start reviewing and possibly restructuring USAID’s programs. The State Department also began a review of USAID’s foreign aid activities, with the goal of potential reorganization. Reports late on Thursday were that USAID would have less than 300 staff left (down from over 10,000) and 800 awards and contracts were being canceled. Labor groups representing employees at USAID brought a lawsuit against the new administration over efforts to freeze foreign assistance and HIV advocates protested in Washington, DC Thursday demanding that the administration fully restore PEPFAR funding. So much for a 90-day pause and review – all done in two weeks? 

    IMPLICATIONS: This dismantling includes efforts to completely dissolve USAID, raising significant concerns about the future of global health and development programs. Many argue that a shutdown of the agency undermines US power and global influence, especially as China and Russia look to fill in the foreign aid gaps. As we wrote last week, contractors at USAID and the State Department Bureau of Global Health Security and Diplomacy (GHSD) are essential to the Bureau’s operations, and their expulsion paralyzes USAID, GHSD and PEPFAR. 

    READ:
    USAID may be reorganized, absorbed by the State Department, Rubio says – Devex 
    USAID Workforce Slashed From 10,000 to Under 300 as Elon Musk’s DOGE Decimates Agency – Wired 
  • New Gender Policy
    The US CDC, NIH and other federal health agencies removed hundreds of HIV-related web pages on 8,000+ websites following executive orders targeting “gender ideology” and “DEI.” This week, many of the pages have been restored, but without reference to transgender individuals. The restored pages show a rushed revision to content on HIV, STIs and sexual and reproductive health and important information for key populations has been removed. This censorship is further exacerbated by instructions from the new administration demanding that scientists at the US Centers for Disease Control and Prevention (CDC) retract scientific articles that include “forbidden terms” such as gender, transgender, LGBT, or transsexual. 

    The recent removal of HIV- and LGBTQ-related content undermines public health and health equity. Key resources, including HIV PrEP guidance and transgender-focused materials, were deleted or revised, leaving significant gaps in data and care recommendations. Though some information has been restored, critical omissions jeopardize effective HIV prevention, care, and outreach, particularly for marginalized populations at higher risk of infection. In response to the censorship of scientific publications, at least the British Medical Journal editors stood up in their editorial: Medical journal editors must resist CDC order and anti-gender ideology: “The US was considered a world leader in public health and research. With one repressive stroke that reputation risks being shattered and broken. If anything is forbidden now, it is that medical and science journals, whose duty is to stand for integrity and equity, should bow to political or ideological censorship.” 
  • Robert F. Kennedy Jr. Confirmation Hearings  
    The Senate Finance Committee voted to advance Robert F. Kennedy Jr.’s nomination for Secretary of Health and Human Services (HHS). His nomination now moves on to the full Senate after a 14-13 vote. Senator Bill Cassidy, a medical doctor and Republican from Louisiana, who voiced support for PEPFAR previously, ended up voting for Kennedy.  

    IMPLICATIONS: Despite concerns over Kennedy’s vaccine skepticism, AIDS denialism and racist views of immunology, his confirmation appears likely with a full Senate vote imminent. As HHS Secretary, Kennedy would have control over the US CDC, NIH, FDA and other important health agencies, including how funding is spent, how programs are administered and how science is communicated.  

Seeking Visuals and Videos

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.

Contact or send to [email protected] for more details

What we’re reading

Resources

  • Litigation Tracker: A public resource tracking the legal challenges to the Trump administration’s executive orders, Just Security 

Tracking the impact

  • USAID Stop-Work, a resource tracking the impact of the stop work order to USAID 

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. 

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. 

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. 

Trials to Impact

The Latest Insights on CAB for PrEP

The Biomedical Prevention Implementation Collaborative (BioPIC) is leading an integrated and adaptable strategy to deliver new long-acting HIV prevention products, including injectable cabotegravir (CAB) for PrEP. The HIV prevention products that exist today hold the potential to curb incidence, but their impact relies on stronger coordination to ensure they reach those who need them most. BioPIC unites a group of over 100 diverse stakeholders—civil society, donors, researchers, policymakers, implementers, and normative agencies like WHO and UNAIDS—across more than 20 countries to address these challenges. To support this, BioPIC introduced the Adaptable Product Introduction Framework, emphasizing 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, and is described in this article with colleagues at WHO: Shaping and coordinating the implementation science agenda for injectable cabotegravir for PrEP: the role of the Biomedical Prevention Implementation Collaborative (BioPIC).

To ensure lessons around early CAB for PrEP implementation are consolidated and captured, AVAC developed the CAB for PrEP Priority Evidence Gap Tracker, which tracks progress against addressing the highest priority CAB for PrEP evidence gaps identified in BioPIC Think Tanks. As data from the open label extension studies of the two CAB for PrEP Phase III trials, HPTN 083 and 084, as well as early implementation studies and modelling studies, has begun to emerge, AVAC has continued to update the tracker, with some of the latest major insights summarised below.

Rapid testing is the right choice for CAB for PrEP initiation and continuation

CAB is from a class of antiretrovirals called integrase strand transfer inhibitors (INSTIs), the same class as dolutegravir (DTG), a common first-line HIV treatment. There is a risk that people using CAB for prevention could develop resistance to INSTIs, which could compromise the effectiveness of DTG as treatment. Preventing the development of INSTI resistance is, therefore, a high priority for CAB for PrEP implementers. Resistance may develop if a person living with HIV (but unaware of their status) initiates CAB for PrEP or continues to use it after a breakthrough infection, so implementers need to feel confident in the results of HIV tests used at initiation and continuation visits. During the initial stages of programmatic rollout of CAB, there were questions as to whether rapid HIV tests were sensitive enough to be used for this purpose, or if more expensive, lab-based RNA testing would be required. After reviewing emerging evidence, WHO confirmed that rapid diagnostic tests can be used for CAB for PrEP initiation and continuation. Moreover, the HPTN 083 study team concluded that RNA testing performed poorly as a screening tool for CAB for PrEP continuation, as it led to false positives.

CAB for PrEP is safe to use during pregnanc

The HPTN 084 trial of CAB for PrEP amongst cisgender women included a requirement for participants to use contraception while enrolled in the trial, and participants who did become pregnant were immediately discontinued from CAB for PrEP. This meant that at the end of the trial, researchers were unable to conclude whether CAB for PrEP was safe and effective to use during pregnancy. The open label extension phase of the trial removed these restrictions, and with this new data, the HPTN 084 team has been able to confirm that CAB for PrEP is safe and well-tolerated in pregnancy. Delay in confirming this has led to confusion amongst implementers and variation across countries in whether CAB for PrEP is permitted for use in pregnancy, highlighting the importance of including pregnant and lactating people in clinical trials from the start, as has been done in the PURPOSE 1 trial of lenacapavir.

Offering choice increases PrEP uptake

For the first time, PrEP users in an increasing number of countries have the ability to choose from an array of options, including oral PrEP, CAB for PrEP, and the dapivirine vaginal ring.  The SEARCH study, in Kenya and Uganda, looked at the impact of choice on PrEP coverage, by comparing two groups of PrEP users: one offered the choice of oral PrEP or post-exposure prophylaxis (PEP), and the second offered oral PrEP, PEP, or CAB for PrEP.  Researchers found a highly significant impact, with PrEP coverage reaching 70% in the group whose options included CAB for PrEP, compared to 13% in the group offered only oral PrEP or PEP. 56% of users in the group offered CAB for PrEP took it up, and 42% of those who chose CAB for PrEP were not using any HIV prevention method at the time, demonstrating that adding more options can bring in more users as people are able to find products that better suit their preferences. Even more importantly, HIV incidence in the group offered CAB for PrEP was 0, compared to 1.8% in the other group. In addition to demonstrating the impact of choice in product, the SEARCH study demonstrated the impact of choice in delivery channel, by successfully offering a variety of HIV prevention options via outpatient facilities, antenatal clinics, and community health workers going door-to-door.

What’s next?

There are currently 31 ongoing CAB for PrEP implementation studies, all looking at different aspects of CAB for PrEP delivery among different populations across geographies. As interim insights continue to emerge from these studies, AVAC will continue to track them.  Check back regularly on the PrEPWatch Events page for webinars where these insights will be shared.

Resources

Think Tanks