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.
Advancing Choice and Equity: New tools and a changing landscape
As a new US presidential administration takes shape, our commitment to championing choice, science, and rights remains unwavering. This critical moment demands intentional strategies to protect progress in HIV prevention and global health equity while staying true to our mission and values.
Given the concerning rise of health misinformation on X (formerly Twitter), we must find new ways to share accurate, science-based information. Starting this week, we’ll begin to transition our presence to BlueSky, an open-source alternative to X, alongside Instagram and Facebook. Learn more about Blue Sky here and be sure to follow us.
Read on for the latest insights on CAB for PrEP and new resources on PrEP delivery, STI R&D, and the political challenges and the priorities in 2025 and beyond.
Trials to Impact: The Latest Insights on CAB for PrEPAn Advocate’s Guide to Research in Pregnant and Lactating Populations
The Biomedical Prevention Implementation Collaborative (BioPIC) is leading an integrated and adaptable strategy to deliver new HIV prevention products, with a particular focus on longer-acting PrEP methods. The BioPIC’s Adaptable Product Introduction Framework, emphasizes 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. Read more on recent CAB for PrEP insights and visit the Evidence Gap Tracker.
In the days, months and years ahead under a new US Presidential Administration, 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, and to safeguard policies and programs that advance it. And there will be major implications for the global AIDS response.
An Advocate’s Guide to Research in Pregnant and Lactating Populations
Check out our updated graphic in this advocates’ guide, which shares background on the need for research in pregnant and lactating populations and how advocates can advance inclusion.
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.
What’s next for the US’ role in global health and HIV prevention?
In the days, months and years ahead under a new US presidential administration, 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, and to safeguard policies and programs that advance it. What to do?
For a start, listen to AVAC’s newest PxPulse podcast. Jen Kates, Senior Vice President, Director of Global Health & HIV Policy at KFF, a nonpartisan health policy research organization and AVAC’s Director of Policy, Suraj Madoori lay out the challenges and the priorities in 2025 and beyond.
As the field prepares for new US leadership, advocates must take stock, identify allies, work in solidarity and seize opportunities. In the months and years to come, AVAC will be there, offering tools, analysis, and perspectives to support our collective work to advance HIV prevention and equity in global health.
The Trump administration will likely have a fundamentally different worldview about US engagement in global health and in development. One that is much more isolationist, much more transactional. Why should the US be engaged in these programs? What is in it for us? And I think the challenges that will come up there, is where or will the US continue to play a leadership role diplomatically, financially, because the US is the largest funder of all global health programs.
Jennifer Kates
SVP and Director of Global Health & HIV Policy at KFF
There’s such a vibrant advocacy community outside the United States who want to engage their own governments in mobilizing domestic resources for HIV, who want to share their stories to Congress about the impact of PEPFAR and other lifesaving programs. That is a lot of untapped advocacy and a lot of North-South collaboration that will be so important to get us through at least the next two years into the midterms, if not the entire four years of this new administration.
Suraj Madoori
Director: Policy & Advocacy, AVAC
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.
There are no words that can adequately, or appropriately, describe the state of the world right now and how AVAC and I are feeling about it. I expect it is a similar sentiment for all of us — irrespective of where we live and vote.
AVAC was founded 30 years ago — in a very different time, with very different political and economic dynamics and epidemiologic realities. But from that beginning, AVAC has always championed an evidence- and rights-based, equitable response to the HIV epidemic — honoring choice and dignity for all.
And we will not stop — not until we are done, and most definitely not now!
We will all need time to process these US election results and strategize how we navigate through them in the days and years ahead — as individuals, as a network of partners, as citizens of the world, and — most importantly — as advocates for choice, freedom, science, and rights.
There will, undoubtedly, be major implications for global health and the global AIDS response. We look forward to working with our partners in protecting hard-fought gains and in assessing the potential impact on PEPFAR and Global Fund support; on USAID, NIH, CDC and the FDA; on the US relationship to WHO and other UN agencies; and on evidence- and rights-based policies and programs generally.
We will be in touch soon with an initial analysis, starting with the release of a podcast next week with Jen Kates from KFF and our own Suraj Madoori as we begin to unpack it all. And we look forward to working with all of you in reviewing it and making it actionable.
Thank you; stay tuned; and stay strong.
Mitchell J. Warren Executive Director AVAC
STIWatch Newsletter, November 2024
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.
To learn more about AVAC’s STI Program, visit STIWatch.org and avac.org/sti. Email sti@avac.org for questions or additional information. And to sign up for specific updates on STIs, click here.
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.
HIVR4P Highlights, Inclusive Prevention Pipeline, Policy Shaping & More
AVAC’s round-up of resources, updates and insights this week includes highlights from HIVR4P, a new vision for an inclusive prevention pipeline, shaping policy and more!
HIVR4P 2024 conference highlights and recap
The 5th HIV Research for Prevention (R4P) conferencewas held last week in Lima, Peru. The data and discussions centered on accomplishments in HIV prevention, how far the field remains from reaching targets, understanding how choice works and why it matters, and where the research agenda is headed. As AVAC’s Mitchell Warren told Axios, “lenacapavir is on everybody’s lips here at HIVR4P 2024. That’s probably the second-most popular word this week; I think the most popular word is access.
Partners and AVAC launched The People’s Research Agenda (PRA), a global initiative driven by communities and advocates to envision an inclusive HIV prevention pipeline and ensure the voices of those most affected by HIV are integrated into HIV prevention research and development.
AVAC’s Suraj Madoori Joins Developed Country NGO Delegation (DelDev)
Policy Director, Suraj Madoori is one of four new members to join DevDel, one of the 20 voting delegations to the Board of the Global Fund to fight AIDS, Tuberculosis and Malaria. DevDel plays a critical role in the development and evolution of organizational strategy, the funding model, the work of the Secretariat and policy.
AVAC’s Jessica Salzwedel Talks Community Engagement with National Co-ordinating Centre for Public Engagement
In a mini series on community engagement, the National Co-ordinating Centre for Public Engagement interviewed AVAC’s Jessica Salzwedel, Senior Program Manager of Research Engagement on what centering communities truly means.
