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.
Advancing Clinician Support in the United States Through a Unique Distance-Based Model
Join us for an engaging webinar showcasing an innovative program that provides real-time, expert guidance to clinicians in the United States through a unique distance-based support model. For over 30-years, the National Clinician Consultation Center (NCCC) has provided cost-free, point-of-care teleconsultation to health care providers across the United States on HIV, viral hepatitis and substance use evaluation and management.
This session will highlight how our program leverages a distance-based model to provide real-time, expert guidance to a wide-range of healthcare professionals. Designed to meet the diverse needs of clinicians across varied geographic and clinical settings, our model ensures equitable access to high-quality support—anytime, anywhere.
Discover how this approach has transformed clinical decision-making and patient outcomes and learn how it can be adapted to address pressing challenges in global healthcare delivery. Whether you’re a clinician, healthcare leader, or policymaker, this webinar offers valuable strategies for enhancing clinician support in your region.
Presenters:
Chris Bositis, MD, National Clinician Consultation Center
Brenda Goldhammer, MPH, National Clinician Consultation Center
Key Takeaways:
An overview of the distance-based support model and its impact on clinical care.
Real-world examples of how the program supports clinicians in navigating different clinical scenarios.
Insights into how this model promotes equity, accessibility, and collaboration across healthcare systems.
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.
AVAC’s Most Downloaded Resources of 2024
From the implementation of DoxyPEP to the game-changing trial results of lenacapavir for PrEP, 2024 has been a landmark year for advancements in HIV and STI prevention. AVAC’s most downloaded resources capture these pivotal milestones, offering essential insights and tools to power your advocacy. Dive into the highlights and stay informed about the strategies shaping the future of HIV prevention.
AVAC’s Top 10
This episode of PxPulse looks at why and how the decisions that shape global health must be made by those facing the greatest risks. As the world evaluates the pandemic response and debates on decolonizing global health gain momentum, equity in global health has never been more urgent.
This graphic shows currently available options for HIV prevention, newly approved and recommended treatment, and those in development.
This plan provides a broad view of all the moving parts and identifies actions and actors responsible for ensuring time is not wasted and opportunity not squandered.
This PxPulse podcast episode goes deep on LEN for PrEP. Recorded just days before Gilead’s announcement that PURPOSE 2 also found very high efficacy, Dr. Flavia Kiweewa, a principal investigator of the first trial to announce efficacy, lays out the research findings and what they mean. And Chilufya Kasanda Hampongo of Zambia’s Treatment Advocacy and Literacy Campaign and Mitchell Warren of AVAC talk about how to change a long history of squandered opportunities to get rollout right.
This report examines disbursements by the U.S. NIH and the Bill & Melinda Gates Foundation and is one of few reports to track funding trends in vaccine and diagnostics R&D, and pipeline investments for some of the most common STIs.
Led by AVAC alongside a network of partners, the People’s Research Agenda puts forward recommendations to diversify and strengthen the HIV prevention pipeline, enhance investment and financial support for HIV prevention research and development, and guide an advocacy strategy that truly addresses the needs of communities across the prevention pipeline.
This roadmap aims to build on existing progress while accelerating the pace of HIV prevention. With anticipated regulatory approvals and production scaling, this plan targets over 2.5 million LEN users in low- and middle-income countries by 2027. It focuses on structural barriers and integration of generics into national programs.
Good Participatory Practice Guidelines have been shaping and improving clinical 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.
DoxyPEP is a post-exposure prophylaxis used to prevent the acquisition of some bacterial STIs after sex. This advocates’ guide addresses questions regarding who will benefit most from DoxyPEP and how to implement this strategy broadly to ensure equitable access.
In 2024, Gilead Sciences released findings from the PURPOSE 1 and PURPOSE 2 trials testing lenacapavir (LEN) as HIV prevention. This advocates’ primer provides background on the product and trials; a summary of the early findings of PURPOSE 1 & 2; key questions and next steps.
Avac Event
CROI 2025
The 32nd annual Conference on Retroviruses and Opportunistic Infections (CROI) will take place from March 9-12 in San Francisco, California. CROI is the go-to forum for groundbreaking science in the HIV field, and this years program will be full of groundbreaking research.
Avac Event
African Workshop on HIV & Women 2025
The inaugural edition of the African Workshop on HIV & Women will take place in hybrid format on 27 – 28 February 2025 in Nairobi, Kenya.
The time zone that will be used for this meeting is East Africa Time (EAT). If you need to convert the times to your timezone, this website might be of interest to you: www.WorldTimeBuddy.com.
This exciting new initiative is a regional workshop paired to the annual “International Workshop on HIV & Women”. It is an outstanding opportunity for both local and international healthcare providers, researchers, government, industry, and community representatives to discuss and further increase their knowledge on the issues related to HIV and women living in Africa.
The primary purpose of this workshop is to support changes that will provide a better quality of life for women living with HIV and reduce HIV transmissions in the region.
The format of the workshop enables attendees to learn from renowned HIV experts, discuss challenges, gaps, and opportunities for further learning and research. The debates and roundtables are an especially important vehicle to discuss issues and challenge dogma.
The workshop also provides a forum for early-career investigators to present their research and to personally meet with experts they view as mentors and inspiration for their work.
The meeting organizers hope this workshop will catalyze forming a community, where attendees continue to participate yearly and form valuable relationships and partnerships that lead to collaborative projects and positive changes.
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.
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.
Since AVAC and UNAIDS launched the GPP guidelines in 2007, the science and politics have grown ever more complex—and GPP implementers have continued to adapt, evolve and engage. We are committed to continuing our efforts to curate insights and resources, including further building out the Body of Evidence, and to support our collective advocacy for ethical and effective stakeholder engagement throughout clinical trials, research agendas and implementation in the months and years to come.
Avac Event
I Am More Than HIV Prevention – Results from the HPTN 091 Study with Transgender Women
HPTN 091, the I Am study, evaluated the impact of a multicomponent HIV prevention strategy to increase the uptake and adherence of pre-exposure prophylaxis (PrEP) among transgender women. The strategy included HIV prevention services, gender-affirming hormone therapy, and peer health navigation.
This webinar featured Dr. Tonia Poteat, study co-investigator, who will review the study findings and discuss implications.
Speakers:
Tonia Poteat, Ph.D., Duke University School of Nursing, Division of Healthcare in Adult Populations
This webinar featured Portuguese and Spanish translation thanks to HPTN.
Introducing the Gears of Lenacapavir Rollout and The People’s Research Agenda
This World AIDS Day, the HIV/AIDS response stands at a crossroads, with injectable lenacapavir set to transform HIV prevention. But as the new UNAIDS report highlights, it also comes at the same time as restrictive policies, economic instability, and geopolitical challenges threaten to frustrate access and rollback so much of the progress that has been achieved over the past two decades.
AVAC’s 2025 advocacy agenda prioritizes collaboration and strategies for equitable and accelerated product introduction that maximize the public health potential of new prevention options and simultaneously sustains investment in critical research and development. AVAC’s newest publication, The Gears of Lenacapavir for PrEP Rollout, provides a clear pathway for the speed, scale and equity needed to translate exciting science into public health impact, while our recent The People’s Research Agenda (PRA) meets this high-stakes moment for HIV prevention with a clear, concise and collaboratively developed set of priorities for how prevention research should be conducted and what products should be developed in the future.
Despite the challenges, 2025 holds immense potential for ensuring the equitable rollout of new options and the accelerated development of a pipeline of additional options, the combination of which can help move the field closer to ending HIV/AIDS.
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.
The People’s Research Agenda: A Community-Driven Vision
The People’s Research Agenda (PRA) brings the voices of affected communities to the forefront of HIV prevention research and product development. With limited resources, the stakes for decisions about which products to develop and eventually deliver become even higher for funders, communities, policy makers and governments. The PRA offers a bold vision for aligning scientific innovation with community needs. By amplifying the perspectives of those most affected by the epidemic, the PRA is a tool for driving accountability among funders, developers, and policymakers. As a living, adaptable framework, it ensures that evolving needs and challenges in the prevention landscape remain at the center of decision-making.
A Call to Action
The rollout of lenacapavir and the implementation of the PRA come at a critical moment in the global HIV/AIDS response. Achieving their full potential will require sustained collaboration, strategic investments, and unwavering commitment to equity. Together, we can transform this pivotal moment into lasting progress.
Advocacy: Now more than ever
We are in a period of profound uncertainty, remarkable progress and tremendous concern—for the state of the world, for the state of global health and HIV, and for the specific work that AVAC and our partners do. We’ve seen incredible advances in biomedical prevention in 2024 with the introduction of the dapivirine vaginal ring (DVR) and injectable cabotegravir (CAB) for PrEP and the spectacular clinical trial results of injectable lenacapavir—the combination of which could transform lives if rolled out with speed, scale and equity.
For many of us, the unfolding developments in the United States, which continue to ripple across the global health community, are sparking anxiety around whether we can sustain the progress the field has made over decades while continuing to develop effective HIV prevention options and ensure access to those options for everyone who needs and wants them.
At AVAC, we see strength in staying focused on developing what we need and delivering what we have. We are doubling down on delivering high-quality, impactful work, supported by ongoing collaboration with our partners to meet our mission in a shifting environment.
As we recognize World AIDS Day this weekend and next week’s #GivingTuesday, a global day dedicated to giving back, we ask you to consider supporting AVAC so that we and our partners can continue to deliver the effective and impactful advocacy that is needed now more than ever. This means continuing to put people and communities at the center of our work, ensuring that the global response is connected to the real needs of affected people.
Many thanks in advance for your partnership and support.
