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.

Listen now!

Webinar

From Promise to Progress: Overcoming barriers to long-acting PrEP uptake among Black gay men

October 21, 2024 @ 09:00am EDT

This webinar hosted by GBGMC and partners will delve into the challenges preventing Black gay men from accessing and adopting long-acting PrEP.

Register now!

Town Hall

Restrategizing Civil Society Engagement for Pandemic and Global Governance

October 23, 2024 @ 11:00am EDT

Join PIBA and partners to discuss the status of PrEP in Black communities in Arkansas, Mississippi and Tennessee.

Register here!

Upcoming Webinars

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.

Register now!

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.

Register now!

An Update on the STI R&D Pipeline and Investments

November 14, 2024 @ 08:00am EDT

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.

Register now!

On the final day of HIVR4P 2024, we saw a focus on how to center communities from a number of angles—from the role of artificial intelligence in HIV prevention and details from a study on PrEP choices among African women to a manifesto for the inclusion of trans communities and a journalism initiative to translate HIV science into African languages.

Read on for details! 

The high stakes of inclusion

Key sessions highlighted the importance of ensuring equitable access to prevention tools for transgender and gender-diverse individuals (TGD), as well as addressing the policy and legal barriers that hinder care, particularly in countries with anti-LGBTQI+ legislation. 

“Trans people are giving our blood, our bodies, our time to clinical trials, and we need to make sure that findings from clinical trials—the right to science—the right to benefit from science comes back to us when we participate,” said Brian Minalga at the session, Policy and legal barriers to HIV services. Minalga pointed to the No Data No More manifesto and scorecard tool, resources for envisioning, designing, and grading clinical trials for meaningful trans and gender-diverse inclusivity. The scorecard uses 13 indicators to assess the inclusion of TGD people in clinical trials. The scorecard assessment found that prior to the IMPOWER and PURPOSE trials, TGD individuals made up less than 1% of HIV prevention studies.  

Adding to the conversation, Sara Melillo of USAID in Uganda discussed the adverse impact of Uganda’s 2023 Anti-Homosexuality Act (AHA), which has resulted in evictions, forced relocations, and a 60% drop in HIV services, though some services have since recovered. Read more from the updated report, Unwanted, Outlawed and Illegal: The cry from LGBTIQ+ Ugandans from Convening for Equality (CFE), and advocacy from LGBTQ+ Ugandans, AIDS activists and supporters during the recent UNGA meeting urging the World Bank to withhold lending to Uganda until the AHA is repealed.  

AI’s role in HIV prevention services

Artificial intelligence (AI) in HIV prevention is just beginning to unfold. Maaya Sundaram of the Gates Foundation explored this in the session, The Digital Revolution and HIV Prevention: Social Media, Artificial Intelligence and Machine Learning, showcasing AI’s impact on drug discovery, PrEP delivery and on patient and provider support. Sundaram spoke to a 2023 study demonstrating that AI can provide high-quality, empathetic responses to patient questions and concerns, but was also clear that humans still need to be actively involved where AI is used, ensuring quality and accuracy of the AI responses to questions, and making sure the information they’re providing to patients is up-to-date. She reported that AI can use a predictive model to provide population-level insights such as how to support people who have fallen out of care, and highlighted its benefits in streamlining administrative tasks such as data entry.   

But even with these benefits, data security and privacy protection must be ensured for trial participants, patients and program clients, particularly for key populations seeking care in highly stigmatized and/or criminalized environments. Sundaram stressed the need for data from programs all over the world, not just the US and Western Europe, for AI tools to be culturally appropriate for all contexts. Beyond this, delegates cautioned the panel about the potential environmental impacts of AI noting that it’s a space advocates are watching.

Delivering on the promise of PrEP choice

If you didn’t hear the word “choice” this week, you probably missed the HIVR4P 2024 conference! The session Delivering on the Promise of PrEP Choice shared data and perspectives from health providers and clients across Africa. Elizabeth Irungu of Jhpiego presented initial findings from the MOSAIC project’s CATALYST study among women in five African countries on the factors driving their selection of either oral PrEP or the PrEP ring. Both options were seen as “easy to use” (59% for oral PrEP, 57% for the PrEP ring), but oral PrEP users felt more “protected” (32%), while PrEP ring users appreciated not having to swallow pills (53%). Despite initial challenges in offering choice, provider training and sensitization helped overcome these barriers. (CATALYST is now adding injectable cabotegravir, so future data will look at choices across three options). Nicolette Naidoo from Wits RHI in South Africa shared data showing that while oral PrEP remained the dominant choice (69%), there was moderate uptake of the PrEP ring (27%). The key takeaway: When given the option, people choose what best suits their needs.

At a parallel session, PrEP in pregnancy and lactation, Ashley Mayo of FHI360 and the former Microbicide Trials Network (MTN) shared new data on the PrEP ring, emphasizing the need for more prevention options for pregnant and lactating individuals. She showed new data from the open label extension of the ASPIRE Phase 3 trial, MTN-025, testing the PrEP ring during preconception and early pregnancy. The results were “very similar to pregnancy outcomes observed in ASPIRE” with no differences in adverse pregnancy outcomes. These data “add to the growing evidence that the dapivirine ring may be safe to use throughout pregnancy,” she said.

Science journalism in local languages can make the difference

Groundbreaking science cannot fulfill its promise unless impacted communities are leading the discussion about its benefits, implications and priorities—it’s imperative for affected communities to be able to advocate for their own needs.  

In a rare presentation by a journalist at a scientific conference, Esther Nakkazi, a Ugandan journalist and member of the AVAC-supported Media Science Café program, shared how journalists help shape public opinion, understanding of science and the issues involved in research, the regulatory process and access to prevention and treatment. Writing or speaking in local languages enhances the accuracy and impact of scientific storytelling, makes scientific knowledge more accessible and relevant to diverse communities and helps bridge the gap and deepens trust between communities, scientists and journalists.  

“Using local languages in media science cafes is key to effective communication and audience engagement, especially in Africa where community radio is the primary medium,” said Nakkazi. “This approach broadens access to scientific information, particularly in regions where broadcasts are exclusively in local languages, ensuring complex concepts are understood and promoting clearer understanding of science across diverse communities.” 

At the session, Driving PrEP Implementation Through Community Engaged Science, Nakkazi also shared the Translation Index, a resource for journalists that translates medical and scientific terms into 10 African languages, supporting journalists from those regions to communicate scientific findings in the most accessible terms. Media Cafe attendees meet monthly with researchers and other experts on key areas of HIV policy and science or to discuss new research findings. Learn more.

Realizing the promise

From the streets of Lima to the stage of the final plenary session, Realizing the Promise, Leyla Huerta of Féminas Perú called for meaningful engagement of trans communities and investment in HIV prevention research and programs that prioritizes their health and wellbeing: “We demand that research includes authentic community components, that stops instrumentalizing transgender women and does not use us as a convenient resource.”  

Sharon Lewin, the past International AIDS Society (IAS) president and current director of Peter Doherty Institute for Infection and Immunity, concluded the conference by sharing how research on HIV cure can help inform HIV prevention (and vice versa), and called for advocacy to sustain support for experimental medicine across all research domains, reinforcing the key messages of the People’s Research Agenda that was launched at the beginning of the conference. “I want to end by reminding people that antiretrovirals alone will not see the end of an HIV pandemic. We need a vaccine, we need a cure, and we can’t be deterred by the complexity of both challenges.”

There is a lot to take away from HIVR4P 2024—and stay tuned for further analyses and reflections. But it’s about what the entire field does after this conference—and how we do it—that really matters.  

So, let’s get to work.

Access, access, access. At the plenary Back to the future, Sharonann Lynch of Georgetown University called for a transformational approach that would harness ambition and finally disrupt the “mediocre pace of scale-up” that squandered the global opportunity to leverage oral PrEP in 2012 and bend the curve of the epidemic. Instead, the world saw the slow and fragmented 10-year rollout of oral PrEP. In this alternative vision, donors and global health leaders can and must create the conditions for both high demand of promising HIV prevention options and, ultimately, affordable choices by investing now in large volumes of new interventions such as injectable lenacapavir (LEN). Without this ambition, cautious investment will signal low expectations for demand, resulting in “a massive chilling effect” on the timelines for generics and delays in access to more affordable products. “It will ration eligibility and result in the slow drip of uptake,” said Lynch.  

Lynch also called for access to generic injectable lenacapavir (LEN) to places where the HIV epidemic is concentrated, regardless of the wealth status of the country. Gilead Science’s licensing agreement with six generic manufacturers does not include the middle-income countries that hosted the PURPOSE 2 trial testing LEN for PrEP, including Peru (the conference host country), Brazil, Argentina, Mexico. This was one of the talking points of a protest from the trans advocacy group Féminas Perú who highlighted that vulnerable communities are often used for research and the outcomes fail to benefit targeted populations. “We are more than just studies” they said at the demonstration on Monday.

See AVAC’s updated Lens on LEN, and new Plan for Accelerating Access to Injectable Lenacapavir for PrEP for details on what must come next for LEN to successfully act on Sharonann’s and activists’ calls to action. 

At the conclusion of the plenary, Gastón Devisich of Fundación Huésped was honored as the recipient of the 2024 Omololu Falobi Award for Excellence in HIV Prevention Research Community Advocacy. Presented biannually in honor of Omololu Falobi who helped transform advocates’ roles in HIV prevention research, Devisich embodies his legacy, helping to raise the profile of critical research in Latin America and ensuring the inclusion of the LGBTQ+ people in clinical trials. “Access is a fundamental human right,” Gastón said in his acceptance speech. Read more about Gastón Devisich and the Omololu Falobi Award in our press release.

A longer-acting PrEP ring and a nonhormonal MPT?

New data on a three-month dapivirine vaginal ring (DVR) was presented at a session on late-breakers. An open label, Phase 1 study compared pharmacokinetics (PK) of a three-month DVR with the approved one-month DVR. The rings are identical except the longer-acting DVR contains 100 mgs of dapivirine, compared to 25 mgs in the monthly ring. Data showed no difference in safety and demonstrated the PK superiority of the 3-month ring, “suggesting efficacy of the three-month ring will be at least equal to the one-month ring,” said Jeremy Nuttall of the Population Council who presented the findings. The Population Council ultimately intends to pursue regulatory approval and expects a longer-acting DVR, requiring 4 rings per year instead of 12, to reduce production cost by as much as 60% and ease the burden on both ring users and health services.

Sanyukta Mathur, also of the Population Council shared findings from a national online survey of women in the US regarding their preferences for a nonhormonal ring in the session, Prevention advances: PrEP, DoxyPEP and MPTs. Using a hypothetical target profile of an MPT vaginal ring—it lasts for a month; offers 80% effectiveness at preventing pregnancy and 50% effectiveness in preventing HIV and STIs; contains no hormones and has no impact on their menstrual cycle—researchers found that nearly 3/4 of all women would likely or very likely want to use this ring. The highest interest in this product was from older women who already had children, and those who perceived themselves to be at high risk for HIV acquisition.

STI prevention: We need to do more!

Diagnostics are key to making progress against STIs around world, according to presentations at the session STI prevention: We need to do more. Judith Kyokushaba from the Ministry of Health, Uganda presented findings that multipurpose rapid tests were highly acceptable, usable, and feasible by health workers to detect HIV, syphilis and hepatitis B in Uganda among pregnant women attending antenatal care health facilities. Scaling up these tests and making them accessible throughout Uganda and worldwide is the challenge for the field.  

Thesla Palanee of Wits RHI drew parallels between the STI and HIV epidemics at the session. Africa is faced with a growing STI epidemic, with many asymptomatic infections, which leads to a lack of awareness and continued transmission. Because of cost, many countries rely on patient reporting of symptoms (syndromic management), which is ineffective. The lack of available diagnostic tools hinders effective prevention and management of HIV and STIs. More accessible point-of-care tests, as well as better screening tools to identify asymptomatic infections are imperative. As one session participant said, “We need to get a community advocating for continued diagnostic and testing.” We couldn’t agree more. See AVAC’s STIWatch.org website, a new resource to support communities to better understand and advocate for STI vaccine and diagnostics research, development and rollout.

Increasing bNAb options: Target product profiles for prevention strategies  

Nyaradzo Mgodi opened the session, Increasing bNAb options: Target product profiles for prevention strategies by asking, “in this era of antiretroviral excitement, are bNAbs still relevant?” The answer is YES, she said. “bNAbs are on the path to join the prevention toolbox, alongside condoms, pills, injectables, and structural/behavioral interventions.” Despite this robust prevention toolbox, the world still has unacceptably high HIV incidence. Presenters discussed progress in bNAb research, but disappointingly, the session did not include mention of a target product profile (TPP), which, as we’ve heard from the People’s Research Agenda, is critical, as the field envisions a prevention pipeline that serves communities.

Misinformation, fear-based approaches and other challenges hindering progress

A session focused on breaking a paradigm of stalled progress in rolling out effective prevention, Reducing burdens and barriers to expand the use of HIV prevention options, featured research and initiatives with vital lessons for the field. Yvette Raphael of the African Women Prevention Community Accountability Board (AWPCAB) said “Biomedical prevention is at a turning point, but success depends on countries and funders to heed evidence-based demands of advocates and emphasize choice over products, both long-acting and user controlled.” See the AWPCAB’s Choice Manifesto to learn more.  

Michael Stirrat of the US National Institute of Mental Health described strategies to overcome misinformation and its pernicious effects on public health, that include vaccine skepticism, reduced PrEP adherence, and adverse health outcomes among marginalized communities. In addition to a list of “do’s”, such as tailored messaging by community, leadership from trusted messengers and framing public health interventions as a social norm, Stirrat called for investment in communication research. And he presented results from examples that used “pre-bunking” to make advanced communication investments in communities with accurate information.   

Sarit Golub from Hunter College of City University of New York presented on the urgent need for the research community to examine and transform an ineffective fear-based and risk-oriented approach to public health, from screening tools to research questions. Calling this approach “the most harmful” impact of the field, Golub called for assessments, counseling strategies and research tools across the board to commit to approaches that put less focus on which methods of HIV preventions people adopt and more focus on sexual well-being and how to make their choices work for them. 

“Nobody identifies as “high-risk” and nobody goes out on a Saturday to have “risky behavior,” said Golub.

Lessons in implementing PrEP, DoxyPEP and MPTs locally & in key populations 

Implementing PrEP, DoxyPEP, and MPTs in local communities and among key populations is where the rubber meets the road. Wednesday’s session Prevention advances: PrEP, DoxyPEP and MPTs highlighted studies on delivering these options to communities. One presentation featured Project PEACH, a study on PrEP and DoxyPEP use among MSM in Atlanta, GA. Of 240 participants (63% Black, 17% Latino), 219 chose PrEP (166 daily oral, 43 on-demand, 10 LA-CAB). Among PrEP users, 74% also opted for DoxyPEP, 18% chose only PrEP. 7% of the study participants chose doxyPEP only, and 2% stayed engaged via the study app without using either. 

Of the 100 participants who completed follow-up, 20 chose to switch their initial form of PrEP, with most moving from daily oral PrEP to either 2-1-1 dosing or LA-CAB. This is significant, as past research shows young Black MSM often stop PrEP after a few months. According to study presenter Oumaima Kaabi, “offering comprehensive and flexible sexual health options, along with motivational interviewing, can enhance persistence.” 

A study in Milan, Italy, involving 754 MSM, assessed the impact of DoxyPEP on bacterial STI rates over two years. Angelo Roberto Raccagni presented findings showing that 222 men reported using DoxyPEPafter being prescribed it. Among users, there was an 87% reduction in chlamydia, 80% in syphilis, and 74% in gonorrhea (the latter consistent with other studies showing DoxyPEP’s lower effectiveness against gonorrhea), in a region with higher rates of drug-resistant gonorrhea among MSM. See AVAC’s guide to DoxyPEP for more.

There is much more to come in Lima, so be sure to look out for our ongoing coverage and see reports from earlier this week here and here. 

The data and discussions at HIVR4P 2024 in Lima, Peru, so far this week have been setting the stage for understanding what’s been accomplished 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. But, 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.” 

Read on for highlights!  

Access and Choice: Inextricably linked

Results of the PURPOSE 2 trial of injectable lenacapavir (LEN) for PrEP were presented to a packed room of conference attendees reflecting the magnitude of what a twice per year injectable that works across populations could mean for HIV prevention. Co-chaired by leading researcher and IAS President Beatriz Grinsztejn and leading advocate and Choice Agenda moderator Jim Pickett, the session began with Pickett’s clarion call for accelerating equitable access—for everyone, everywhere.

PURPOSE 2 investigator, Colleen Kelley of Emory University, presented initial safety, efficacy and demographic data and reiterated that only two HIV acquisitions occurred among the 2,179 trial participants receiving LEN injections twice per year – resulting in a 96% reduction in risk compared to the estimated background incidence and an 89% reduction compared to individuals taking daily oral F/TDF. See AVAC’s updated Lens on LEN and the new Plan for accelerating access to LEN. 

While these data have captured global interest and attention since the announcement of the PURPOSE 1 results in June, advocates have made it clear that more choices are needed to translate options and access into impact! In addition to PURPOSE 2 results, the session, Novel Antiretrovirals and Formulations for Prevention, featured several presentations focused on other kinds of new HIV prevention options in the research and development phase that, should they make it to market, would be new and innovative ways for more people to protect themselves from HIV. 

Two researchers, Renee Heffron and Raphy Landovitz presented data on a now shut-down program of a once-a-month oral islatravir (ISL) PrEP option. Landovitz and Heffron presented long-awaited safety data from IMPOWER-22 and IMPOWER-24, the sibling efficacy studies of ISL in cisgender women, MSM and transgender women that were halted in late 2021, and ultimately discontinued. Data showed that ISL was well-tolerated, but importantly, that the effect on lowering T-cell lymphocytes, for which the program was stopped, did return to normal in the 18-month follow-up period after participants were taken off ISL. This information is helping inform the ongoing development program of Merck’s next-generation monthly oral PrEP option MK-8527, now in a Phase 2 trial, with a possible Phase 3 efficacy trial slated to begin next year.  

Research was also presented on the acceptability of an on-demand, single-dose tenofovir rectal douche in a small number of young men who have sex with men of which 80% found it preferable to daily oral PrEP to use as needed before participating in receptive anal sex. While research continues on its efficacy as a PrEP option, the study presented by Renata Arrington-Sanders suggests a rectal douche may also be a desirable tool for some populations.    

Others presented on a new long-acting biodegradable hydrogel injectable system for single or multi-purpose prevention of HIV and/or pregnancy (currently in animal studies) and a study proving that most people maintained viral suppression if switched from a 3-drug ARV regimen to a 2-drug regimen. 

At the session Manifest Choice: Enabling a future free of HIV presenters described the diverse needs and complex challenges of different populations. “We all know that there’s never going to be a miracle drug or a miracle intervention, but in navigating how we manifest choice, we really need to keep our eye on choice as a priority and ensure decision makers in this process don’t get laser-focused on one product. We must continue to drive a nuanced advocacy agenda for a range of options,” said AVAC’s Stacey Hannah.  

The African Women Prevention Community Accountability Board’s (AWPCAB) HIV Prevention Choice Manifesto provides an advocacy tool for increasing political and financial support for integrating every proven method of HIV prevention into the HIV response. “We’re at a historic turning point—but only if countries and funders listen to evidence-based calls for programs that prioritize choice, not just individual products,” said veteran advocate Yvette Raphael.  

“We need to be grounded in a human rights approach; people have the RIGHT to choose,” these words brought a thunderous applause during the session, Prevention Product Profiles for Future Options, Including Long-acting PrEP Formulations and Products from Laio Magno of Universidade do Estado da Bahia in Brazil.  

Magno discussed key insights from the PrEP1519 study out of Brazil where researchers looked at a key population at risk for HIV, young adolescents. Adherence and lack of awareness of PrEP options, including the recently approved long-acting injectable cabotegravir, were major challenges, the study found. Making participants aware and providing them with a “playlist” of approved PrEP options (daily oral, event-driven and long-acting injectable), supports them to make choices that fit in their lives.

The Future of Vaccines

Exciting new insights are informing early phase vaccine research, as the field builds on lessons learned from large phase trials that all ended without efficacy in recent years. The session, HIV Vaccines: The Quest Continues, made the case for the essential role of HIV vaccines. With approximately 40% of new cases arising among populations that would not be defined as at risk for HIV exposure, said the HVTN’s Larry Corey. That means population coverage of PrEP or PEP would need to be unrealistically high—200 people on PrEP and PEP to prevent one case among populations at low risk of HIV. In the history of infectious disease, “there’s only one way we’ve ever done that [reached such high coverage] and that’s through a vaccine. If we really want to achieve what we need to do in HIV, it’s going to be a vaccine,” said Corey.    

At the session, Quo vadis: Future design and conduct of vaccine and bNAb clinical trials, AVAC’s Grace Kumwenda agreed and reminded attendees that despite progress in early-phase bNAb and vaccine development (and many challenges), and a late-stage toolbox of highly effective prevention options including new long-acting PrEP, the world continues to see high HIV incidence. Strategies toward an HIV vaccine are part of the upstream pipeline that must continue to be supported. The newly released People’s Research Agenda (PRA) shares a clear, concise and collaboratively developed set of priorities for how prevention research should be conducted and what products should be developed. “There are several questions that have been raised through community engagement [in developing the PRA]. We are asking ourselves about target product profiles, what are ideal characteristics of a vaccine, of an antibody combination? How do we conduct future HIV vaccine trials, and what is the right comparator for that? These are vital considerations,” said Kumwenda. The NIH’s Jeanne Marazzo added her voice of support for the PRA, calling it a manifesto.

PrEP Around the World

Global PrEP uptake may be up, but it’s nowhere near where we need to be. At the session, The Big Picture: Global trends in HIV prevention, AVAC’s Catherine Verde Hashim discussed data on PrEP typologies across the world. Findings demonstrate that countries with strong PEPFAR support and/or who have led on approvals of PrEP options saw greater distribution and volume of PrEP. Another study, presented by Ribhav Gupta from the University of Minnesota Medical School, found an overall decline in HIV incidence in certain US municipalities that was correlated to Ending the Epidemic (EHE) programming. But data also showed some increase since 2019. These new cases could be connected to rising HIV/STI prevalence and decreased testing during the COVID-19 pandemic. As Carlos Toledo from the US CDC stated during discussion, “initiations are just a starting point and doesn’t say anything about impact.” 

GPP: From clinical trials to the research agenda for prevention at large 

“GPP is often thought of as a tool for conducting clinical trials, and it very much is that, and that’s very much how it was developed, but it is also about ensuring that broader research agendas move forward with the community’s heart at its core. And that communities and other stakeholders are able to hold the research process accountable for doing that,” said AVAC’s Stacey Hannah at the session Advancing Good Participatory Practices (GPP) in Research: Enhancing Community Engagement for Impact, co-hosted by AVAC and Wits RHI, as part of the Coalition to Accelerate and Support Prevention Research (CASPR). Three case studies covered strategies for meaningful engagement and discussed the challenges of GPP implementation—it looks different in every context, outcomes can be difficult to quantify, engagement work must overcome being seen as secondary to clinical processes, and engagement risks being undervalued and under-resourced. See AVAC’s GPP Body of Evidence, an important resource that brings together a set of tools highlighting the value of GPP, as well as the nuts and bolts of how to get it done.

Rising to the Challenge

As NIAID Director Jeanne Marrazzo helped open the meeting providing a snapshot of the global epidemic, which is still far from reaching global targets for controlling the epidemic, even with highly efficacious products now approved, she pointed to regions where incidence is on the rise and to emerging threats from global conflicts, which further drag down progress. “For these reasons, we cannot rest. We have to remember that people need more choices! Sexual encounters may be infrequent, not planned, or not consensual—it cannot be said enough.”  

Lima to date is a whirlwind of passion, a sobering confrontation with the work that remains to be done, but most of all it is an inspiration, because the interventions moving forward hold great promise and because the advocacy tracking it all is demanding that the field rise to the challenge.

The HIV Research for Prevention 2024 (R4P) conference in Lima, Peru began with a suite of satellites that put the HIV prevention pipeline in context and pulled out key priorities from upstream research to gaps in PrEP coverage today, to progress toward connecting excluded populations with an array of choices.  

Read on for highlights!  

Upstream Research

Key discussions in Lima focused on the promise of early phase research for next-generation HIV prevention, and priorities for future research. A satellite, Creating a Menu of Options: Early R&D of HIV prevention products for women, the MATRIX way showcased innovation such as a dapivirine vaginal film and on-demand options for vaginal or rectal use. Presenter Thesla Palanee-Phillips of Wits RHI emphasized that product success depends on providing options that fit into people’s lives. “Unless people use a product, they’re not going to take us anywhere.” Presenters talked about the importance of human-centered design to inform the research agenda, and Nyaradzo Mgodi from the University of Zimbabwe pointed to the need for dual prevention technologies that address both HIV and pregnancy. 

All these discussions inform and advance the just launched People’s Research Agenda, 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. 

PrEP in Latin America and the Caribbean

The satellite, Enhancing service providers’ engagement in PrEP delivery, uptake, and retention in Latin America & the Caribbean, featured data from the PrEPWatch PrEP tracker on Latin America and the Caribbean (LAC), and highlighted the region’s role in the lenacapavir PURPOSE 2 study that included sites from across South America. AVAC’s Catherine Verde Hashim, Kelika Konda of USC/Universidad Peruana Cayetano Heredia, Mayara Secco Torres da Silva of Fiocruz and Jared Baeten from Gilead discussed the ongoing challenge to reach young people in the region with PrEP services and the vital role that both industry and community partnerships play in closing the gaps.

Expanding Inclusion

Advocates, researchers and regulatory authorities each have unique contributions to ensure pregnant and lactating populations are included in research. Critical conversations between these stakeholders was the focus of the satellite, Catalyzing Progress in the Inclusion of Pregnant and Lactating People in HIV Prevention Research.  

Renowned researcher and AVAC board member, Linda-Gail Bekker explored the historical exclusion of women from research, where outcomes from trials among men were wrongly assumed to apply to women. Advocates called for deep collaboration to close this gap and Bekker pointed to the ground broken by the PURPOSE 1 trial that included PLP and other populations who have historically been excluded from clinical trials. “This is now a benchmark—we must move forward, not back. The key is teamwork, collaboration, and amplifying voices.” 

PrEP and Choice for Adolescent Girls and Young Women

Yes, Girls DO wanna have fun! But adolescent girls and young women (AGYW) also want to be in control of their sexual and reproductive health options. The presentations on the satellite session co-chaired by AVAC’s Director of Research Engagement, Stacey Hannah, What’s Really Going to Work in the Lives of AGYW? Innovations in Acceptability and Mobile Health Support Interventions for HIV Prevention, focused on choice for AGYW in HIV prevention. Presentations covered how AGYW respond to various PrEP options and tools for adherence, except long-acting injectable PrEP, which faces challenges in daily oral PrEP efficacy trials. Studies explored preferences between F/TAF and F/TDF, the vaginal ring’s role, the acceptability of injectables, and adherence tools. The key takeaway? There’s no one-size-fits-all solution—just like other groups, AGYW need different PrEP options tailored to their lives and circumstances. 

Update on the Dual Prevention Pill

The Dual Prevention Pill (DPP) is our next big opportunity to expand the HIV prevention toolbox. But it’s not just about the product, it’s also the delivery of the product that makes the difference in the end. At a satellite on how best to deliver the DPP, Delivering on the promise: Defining optimal implementation strategies and service delivery packages for the Dual Prevention Pill, AVAC’s Kate Segal said the next product close to seeking regulatory approval will prevent both HIV and pregnancy and bring a much-desired product to young women. “Research found that the DPP was a tool that helped women navigate the unpredictability of life and supported them to take control of their sexual health,” said Segal. Users also resonated with messaging that celebrated their individuality, life goals, enjoyment and self care. Incorporating the DPP into adolescent youth services and busting myths about both PrEP and contraception are some of the considerations for delivering this option effectively. The DPP could reach the market as early as 2026. 

Advocates Corner

Stay tuned for more from AVAC at HIVR4P 2024 and be sure to visit us in the Advocates’ Corner on Level 1 if you are in Lima. And join us for our daily virtual debriefs from 7:00–8:00 am PET to reflect on key discussions and ask questions. Register here.

As the HIV Research for Prevention (HIVR4P) conference opens in Lima, Peru, AVAC and partners are thrilled to introduce the People’s Research Agenda: Community & Advocacy Priorities in HIV Prevention Research and Development to help guide what will be—and should be—discussed at the meeting and beyond.

The People’s Research Agenda (PRA) is 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. 

As the global community gathers, in person and virtually, this week in Peru (check out our conference guide here), the field is at a critical juncture—with a range of new ARV-based prevention products approved and in delivery, HIV vaccine and antibody studies in complex stages, and HIV incidence still far too high to hit global targets for ending the epidemic.  

As options have increased, resources for research, implementation science and delivery have flattened or dwindled. And even as new ARV-based PrEP options have entered the market, the majority of next-generation prevention options are in upstream safety, dosing and immunogenicity trials.  

This context intensifies the stakes for decisions about which products to develop—and how to develop them. The 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.  

Developed through a collaborative community-inclusive process, supported by AVAC, CASPR, PEPFAR and USAID, the PRA is a living document, to be used as a tool for communities to amplify their priorities and for funders, product developers and policy leaders to keep at hand as crucial decision are made about what to invest in, where and why.  

Tell us what you think! Email avac@avac.org.

We learned of progress this week in building a sustainable market for choice in prevention with the news of generic licensing agreements for lenacapavir as injectable PrEP. We are moving faster than the first decade of oral PrEP and the beginning rollout of injectable cabotegravir, which is an example of advocacy at its best, but making lenacapavir and new prevention options available to all who need it, requires even greater speed, scale and equity. Coordination and strategic actions among numerous and varied stakeholders are urgently needed, as outlined in this article from the New York Times.

See AVAC’s updated Lens on LEN, our new Plan for Accelerating Access to Injectable Lenacapavir for PrEP, along with additional resources on LEN!

From Clinical Trial Efficacy to Public Health Impact: A Plan for Accelerating Access to Injectable Lenacapavir for PrEP

This plan provides a comprehensive view of all the moving parts and identifies priority actions and actors responsible for ensuring time is not wasted and opportunity not squandered.

Read the Plan

The Lens on LEN: The basics on injectable lenacapavir as PrEP

This updated advocates’ primer with the PURPOSE 2 data provides background on lenacapavir and its trials, raises key questions, and explores next steps.

Read the Primer

Lenacapavir: The case for investing in delivering HIV prevention

This episode of PxPulse 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, 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.

Listen Now

Breaking Ground: Expanding Access to Lenacapavir

This webinar hosted by UNITAID brought together global health experts, community advocates, and civil society organizations to discuss the challenges and opportunities in ensuring equitable access to Lenacapavir.

View the Recording

An Overview of Lenacapavir PrEP Trials

The PURPOSE trials evaluate the safety and efficacy of injectable lenacapavir (LEN), an investigational antiretroviral (ARV) drug being studied as a potential PrEP product. This graphic shows the latest status of all five trials including the groundbreaking results of PURPOSE 1 and PURPOSE 2.

Gilead Agrees to Allow Generic Version of Groundbreaking HIV Shot in Poor Countries

This news New York Times article raises key questions on access and pricing of lenacapavir. “Mr. Warren said he hoped the major global health agencies would work together to place orders large enough to have at least a million people on lenacapavir by the end of 2026, which would help send a clear signal to generics makers about the potential market for the product.”

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