Global Health Watch: Africa Rises, Legal Battles Mount, and NIH in Turmoil 

This week’s issue covers African governments’ efforts to address the gaps left by the US foreign aid freeze, escalating legal battles, policy changes at NIH and communities mobilizing against it all.  

African Governments Stepping Up to Lead  

Over the years, AVAC-supported projects such as CASPR and COMPASS have been advocating for African governments to invest more in health. Now, in response to the US foreign aid freeze and the dismantling of USAID, African governments are beginning to address the enormous challenges ahead. This week, Nigerian lawmakers approved $200 million for its health sector; the Ministry of Health in Zambia committed to ensure uninterrupted HIV, TB and Malaria services despite the freeze; and health departments in South Africa are implementing contingency plans by offering HIV patients six-month supplies of medication to cope with freeze of US-funded HIV projects. Some leaders are arguing that the rollback of critical programs like PEPFAR, expose a long-standing dependence imposed by the Global North and see the crisis as an opportunity for African nations to invest in their own healthcare, research, and collaborative networks.  

READ: This commentary from the president of the South African Medical Research Council Ntobeko Ntusi: US aid cuts are an opportunity to reimagine global health. 

AVAC vs. Department of State

In new developments in the AVAC vs. Department of State case against the foreign aid freeze,  last Thursday, the US judge granted AVAC’s request for a “temporary restraining order” (TRO) that theoretically would restart funding. This week, the US government, in a court filing, argued it had the authority to suspend the foreign aid freeze, despite the restraining order issued by the judge. Public Citizen’s Litigation Group that is representing AVAC, filed a further motion on February 19 to hold USG officials in contempt for ignoring the order and to fully enforce the TRO. Read more about it in this Politico story. In the government’s response on February 20, they say they are following the TRO. We’ll see what the judge says! 

And perhaps the most interesting part of our motion on the 19th is the exhibit from a “Jessica Doe”, the alias for a USAID whistleblower whose story in her declaration describes the toll in human suffering of the freeze. It is alarming.

IMPLICATIONS: Regardless of the court’s ultimate ruling, many programs will likely be eliminated or redesigned according to the State Department’s waiver process—one that excludes primary prevention beyond PMTCT and eliminates rights-based, science-driven advocacy.

FOLLOW ALONG: You can follow along with progress on the case at, https://avac.org/avac-vs-dept-of-state/. 

JOIN US: Today at 9:00am ET / 17h00 EAT where the lead lawyer from Public Citizen, Lauren Bateman, and Mitchell will discuss the case on a Public Citizen call that’s open to all; you can join here. 

Reduced NIH Workforce and Indirect Cost Cap 

The US administration significantly reduced staffing across the Department of Health and Human Services (HHS), firing approximately 3,600 employees. Many of those dismissed worked at the National Institutes of Health (NIH) and on emergency preparedness and at National Institute of Allergy and Infectious Diseases (NIAID).  

Later today, Friday, a judge will review another lawsuit challenging the executive order which would cap indirect costs at the NIH at a far lower level—a temporary restraining order was granted last weekend pausing this action. However, if the government is successful in executing the order, the new cap is expected to result in the loss of billions of dollars to support NIH-funded research at academic campuses around the country, forcing labs closures and significant job losses among researchers around the world.  

IMPLICATIONS: Reducing NIH’s workforce and indirect cost rates could cripple critical biomedical research and compromise the nation’s ability to address both chronic and emerging health threats. While the administration defends these actions as necessary streamlining and cutting wasteful spending, critics argue that the indiscriminate nature of the firings jeopardizes vital health initiatives and undermines public trust in government support for scientific innovation. 

READ: Mass firings decimate US science agencies–Science

USAID Employees’ Lawsuit 

In the latest legal challenge against the administration’s dismantling of USAID, 26 former and current USAID employees have filed a lawsuit against Elon Musk. They allege that Musk, through his leadership of the Department of Government Efficiency (DOGE), decimated the agency without proper authority, acting without a formal appointment or congressional nomination. 

IMPLICATIONS: This case, the fourth of its kind targeting actions against USAID, underscores the chaotic and reckless nature of these measures, which are dismantling decades of progress in global health and humanitarian aid. 

Communities Respond to Executive Orders 

Civil society advocates across global health continue to organize and drive action through the new Community Health & HIV Advocates Navigating Global Emergencies (CHANGE) coalition, developing resources for advocates and organizing to protect access to HIV treatment and prevention. Find their resources featured in Global Health Watch and contact them at [email protected]. Community-led organizations are also mobilizing rapidly in response to the foreign aid funding freeze and the immediate disruptions they are experiencing—clinics closing, staff layoffs, and shortages of critical supplies like ARVs and HIV testing kits. Emergency meetings, such as those convened by UNAIDS, are underway to assess the damage and coordinate mitigation measures.   

The science and academic communities are also mobilizing, articulating the impacts of NIH’s cap on indirect costs, filing class action lawsuits to stop the firings, and organizing the March 7 event, Stand Up for Science, in Washington, D.C.  

IMPLICATIONS: With policies changing overnight, legal decisions being ignored, and funding being abruptly halted, there’s an urgent need for health systems that do not rise and fall with political whims. This crisis is an opportunity to create a stronger, more sustainable and more resilient global health framework that truly protects and empowers communities.  

ICYMI

As HIV activists disrupt PEPFAR hearing, an expert explains the damage Trump has already done to U.S. global AIDS fight

Read in Positively Aware

Resources

What we’re reading:

In other news, there was more progress in HIV prevention: the US FDA agreed to an expedited review of the new drug application of lenacapavir for PrEP. Read Gilead’s press release. The FDA has until June 19 to issue its decision. The Lancet also published new data from the B-PROTECTED clinical trial, finding the dapivirine vaginal ring is safe to use during breastfeeding. And The 8th replenishment of the Global Fund has launched. 

Donate today to help fund our efforts. Every contribution helps us keep the pressure on!

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Avac Event

Can Africa Finance its Own Non-profit Sector?

The webinar will explore whether shifts in the US government’s funding is a setback or an opportunity to rethink Africa’s reliance on Western aid.

Featuring:

  • Angelo Katumba — Senior Program Manager: AVAC
  • Yvette Raphael — Executive Director of Advocates for the Prevention of HIV in Africa
  • Dr. Michael Kiragu — AICS Associate & Grant Fundraising Expert

Avac Event

The Impact and Implications of Recent US Government Federal Funding Reductions on Health Programmes

The University of the Witwatersrand‘s Steve Biko Centre for Bioethics presented a webinar featuring:

  • Mia Malan, founder and editor-in-chief of the Bhekisisa Centre for Health Journalism – an independent media organisation that specialises in narrative, solutions journalism focusing on health and social justice issues across Africa.
  • Dr Ntombifikile Nokwethemba Mtshali, Chief Executive Officer of Shout-It-Now, an organisation focused on providing sexual and reproductive health and rights services
    to youth in the Gauteng and North-West provinces.
  • Mitchell Warren, Executive Director of AVAC – an advocacy organisation focused on accelerating access to effective HIV prevention options and ensuring access to everyone who needs them. Mitchell also worked with Population Services International (PSI) designing and implementing social marketing, communications and health promotion activities, including five years running PSI’s project in South Africa.

Avac Event

Updates to the PEPFAR Stop-Work Order and the Role of CCM

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

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. 

Community-Led Monitoring: Transforming the HIV response in Malawi

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.

Listen

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

Resources

An Advocacy Chronicle on Universal Healthcare in Tanzania, with Atuswege Mwangomale of Sikika

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.

Listen

Resources

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.