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.
“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.
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.
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.
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.
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.
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.
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.
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.
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.
Global PrEP Tracker — AVAC’s interactive Global PrEP Tracker provides up-to-date information on PrEP initiations by country and delivery model, offering insights into the progress and impact of PrEP programs around the world.
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.
Lenacapavir: The case for investing in delivering HIV prevention, Podcast AVAC’s PxPulse podcast 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 PURPOSE 1, 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.
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.
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.
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.
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.
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.
This Week at AVAC: US election, new LEN resources, STI pipeline and PrEP service delivery
As we continue to grapple with the results of the US presidential election and what this means for our work and for global health evidence- and rights-based policies and programs generally, we wanted to share a range of new tools and resources you may find helpful in your advocacy for choice, science and rights.
The past few months have brought exciting developments in the field of Sexually Transmitted Infections (STIs). The World Health Organization released the global priorities for STIs, which included the need to develop low-cost, rapid, STI point-of-care tests, vaccines, and communication strategies to increase STI awareness, prevention, service engagement. But we continue to see a soaring rise in STI incidence and an underfunded infrastructure for researching new treatment, prevention and testing tools. It’s up to the global community to ensure that research and development continues to see funding for better, faster, less expensive tools to reduce the toll of STIs. Read on for resources and insights to guide your advocacy.
Conference updates
The annual conference of the International AIDS Society in July highlighted the troubling trend in the soaring rise in STI incidence. A preconference, Mobilize for Action on Sexually Transmitted Infections addressed the urgent need to confront the global spike in STI rates, particularly syphilis, gonorrhea, chlamydia, and trichomoniasis. Dr. Jeanne Marrazzo, director of NIAID, when discussing the number of global deaths from syphilis, which is treatable, said, “I think some of the more staggering statistics here, in addition to the sheer number of new infections, is the fact that we had in 2022 over 200,000 syphilis-associated deaths, which to me is practically medieval.” The meeting hosted a rigorous debate exploring the question of implementing DoxyPEP, given there’s no efficacy data for cisgender women in light of fears of creating drug resistant strains of STIs from wider use of doxycycline. Strong arguments were made on both sides, but this controversy is one of the reasons AVAC recently published an Advocate’s Guide to Doxycycline to Prevent STIs.
The STI Prevention Conferencein Atlanta, Georgia convened attendees in-person for the first time in four years and discussed the rise in syphilis rates, emerging gonorrhea treatments, STI funding and policy initiatives, and doxycycline post-exposure prophylaxis (DoxyPEP). Notably, much discussion centered on NIAID’s support for a biorepository to advance diagnostic development. This biorepository would streamline access to necessary specimens to support the research and development of new diagnostics.
Save the date
New resources
Discover STIWatch.org!
STIWatch.org is an updated platform designed to enhance understanding and advocacy for STI vaccine and diagnostics research, development, and rollout. It offers comprehensive information on common STIs, a clinical trials dashboard, advocacy priorities, and a range of resources and tools to support STI prevention and treatment efforts.
STI Clinical Trials Dashboard
This dashboard provides information about trials focused on vaccines, diagnostics, and the use of doxycycline post-exposure prophylaxis (DoxyPEP) to detect, treat, and prevent chlamydia, gonorrhea, hepatitis B, herpes simplex virus (HSV), human papillomavirus, syphilis, trichomoniasis infections, and Mycoplasma genitalium.
Webinar Summary
Regulatory Pathways to Promote Access to STI Diagnostics. This webinar co-hosted with World Health Organization (WHO) supported researchers, product developers and the global advocacy community in identifying and discussing ways to bring new STI diagnostics to market with speed, equity and scale.
What We’re Reading
Special Issue: Sexually Transmitted Diseases. This leading journal celebrated 50 years by publishing a series of editorials that review the careers of some of the leading experts in the field. These stories are both inspiring and enlightening, highlighting the decades of efforts and growth in addressing STIs. AVAC’s own, Alison Footman, PhD, wrote about her experiences in the STI field and how instrumental mentorship has been in her career growth.
Gonorrhea point-of-care diagnostics technology and market landscape. This landscape report provides an overview of gonorrhea point-of-care diagnostics that can be offered closer to patients and communities and limit time to results and ultimately treatment. Gonorrhea touches on multiple public health priorities including the need to reduce STI rates, growing antimicrobial resistance, and its impact on sexual and reproductive outcomes and HIV transmission.
FDA Marketing Authorization Enables Increased Access to First Step of Syphilis Diagnosis. The US Food and Drug Administration approved the first syphilis self-test. This is a monumental step in expanding syphilis testing options as infections have increased drastically over the past five years. Self-tests can provide people with the option to learn their syphilis status and seek additional testing and treatment options from a healthcare provider.
Partner Spotlight
AVAC partners have been busy moving the needle to improve STI prevention, testing, and treatment options in their respective countries. The Latu Human Rights Foundation partnered with HEP Initiative Zambia on a symposium to foster ideas on how to better address viral hepatitis and integrate hepatitis B interventions into other government funded health programs.
Last week relevant stakeholders were invited to a meeting with the Bureau for an Intergovernmental Negotiating Body (INB) for a pandemic agreement.
The jury is out on whether or not negotiating states come to a consensus by mid-November, which is the deadline for calling a Special Session of the World Health Assembly (WHA) before the end of 2024. If they don’t meet this deadline, negotiations would de facto continue through May 2025, when the WHA is next scheduled to meet.
Beginning on the 4th of November, the INB will begin their 12th session in Geneva, which will be make or break. They continue to discuss the latest version of the draft, last published on Friday 20th September.
In preparation for these meetings, a group of stakeholders, including Resolve to Save Lives, AIDS Health Care Foundation Global Public Health Institute at the University of Miami, AVAC, the Independent Panel Secretariat, and Spark Street Advisors, have prepared an analysis of the current text. We are available to discuss our analysis.
In summary, the current text is very weak, and there is little time left to agree more than 100 paragraphs which still remain TBC. Core issues, including Pathogen Access and Benefit Sharing, Financing, and One Health, remain unresolved. And there is no clear path to accountability.
We will keep you updated when the formal negotiations resume. Until then, the INB continues to have informal drafting group meetings, including on Chapter I and specific articles. The openings and closing of the INB12 will be public, with daily briefings with stakeholders. The Bureau has also promised to circulate a revised version of the text prior to the opening.
PrEP in Black America: New podcast and events + a lineup of webinars
This week our Advocacy Chronicles podcast casts a spotlight on the state of HIV prevention among Black people in the US and particularly, the dismal statistics on access to PrEP in Black communities. It features Danielle Campbell, one of the founders of PrEP In Black America (PIBA) and a long-time advocate for HIV prevention and health equity. The episode explores the tactics that have led PIBA to quickly rise as a powerhouse advocacy group by bringing together communities and government to find solutions that improve the US HIV response.
For more on PrEP in Black America and the issues Danielle covered in our podcast, tune in to a webinar today and a town hall conversation Wednesday. Details are below. And read on for additional upcoming AVAC and partner events.
New Podcast
In this episode of the Advocacy Chronicles, AVAC’s Manju Chatani speaks with PrEP in Black America (PIBA) co-founder, Danielle Campbell, who discusses PIBA’s call to action for an HIV research agenda that prioritizes the needs of Black communities.
Integrating HIV and PrEP Services in US Correctional Facilities
October 24, 2024 @ 9:00am EDT
This webinar, hosted by The Choice Agenda, will explore the integration of HIV prevention and PrEP services in diverse US correctional settings and during the critical period following release. It will also highlight innovative HIV status-neutral approaches, fostering holistic and comprehensive HIV care, treatment, and prevention services in these settings.
Launch of the CIFF/Global Fund Initiative for the PrEP Ring
October 30, 2024 @ 09:00am EDT
Join AVAC and partners for the launch of the PrEP Ring Early Market Access Vehicle (EMAV), recently announced by CIFF in partnership with the Global Fund. This initiative will provide up to US$2 million to purchase up to 150,000 dapivirine vaginal rings in countries implementing Global Fund HIV grants.
Join AVAC and Policy Cures for a webinar on the current STI R&D pipeline. Discussion will feature leading experts sharing the latest advancements in STI diagnostics and treatments, discussing their potential impact on public health and where investments stand.
