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 WHOfeaturing resources housed in the Body of Evidence. These conversations expanded the traditional understanding of GPP – highlighting that GPP is not just about trial implementation; that its practices evolve from product discovery to delivery and are important at every step of the way; and that monitoring and evaluation are complex and critical nuances are required to ensure its meaningful application. Look out for a final webinar on elevation of GPP in global clinical trials guidance in 2025. The full recordings and presentations are on the AVAC website.  

View the webinar series
A Few of our Favorite Moments from the Webinar

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 

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

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

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.  

ImageEnter GPP! In June, AVAC convened a community and advocates’ consultation with Merck around their program testing MK-8527 as a monthly pill for PrEP. With an efficacy program on the horizon, Merck set out to consult with communities – before any other stakeholder – about issues like choice of a comparator arm, the evolving standard of prevention, and how a trial could best reflect the reality of implementation in peoples’ countries, communities, and own lives. Consultation members consolidated feedback that is now being fed into Merck’s protocol development. Priorities included a design that would get to an efficacy answer most efficiently, but that would incorporate contextual issues of prevention choice as possible. Participants concluded that a monthly pill would be an important addition to the prevention toolkit, and thus support for the research program. But they also expressed ongoing frustration around community support for research that does not translate into access for their communities.  

Watch this space for further updates on the MK-8527 program, as engagement continues through protocol development, trial planning, implementation, and beyond!   

Pediatric Adolescent Virus Elimination (PAVE) Community Advisory Board (CAB)

Communities have been a key stakeholder advancing HIV cure research from the bench to early phase clinical trials. GPP has been the guiding principle as engagement has moved further upstream.   

The Pediatric Adolescent Virus Elimination (PAVE) Community Advisory Board (CAB) is an example of this impact as the only group dedicated to advancing an HIV cure in pediatric populations. Through its digital Voices Project featuring young people with HIV, clinicians, caregivers and researchers, the CAB has raised awareness of the research among youth in Sub-Saharan Africa who engaged with ministries of health to push for the inclusion of children in research. They also worked with PAVE investigators to simplify and convey complex scientific and ethical issues inherent in cure research.  

As research moves from the bench to the clinic, the CAB and community partners, will continue to play a strategic role in shaping future protocol designs and addressing community support needs.  

Elevating GPP: WHO’s New Clinical Trials Guidance

In September, 2024, the World Health Organization published their new Guidance for Best Practices for Clinical Trials. The guidelines state that centering patient, participant, and community engagement will lead to more efficient and equitable trials. Input from AVAC and partners, including Wellcome Trust, The Global Health Network, University of Oxford, and others helped ensure the new guidance centered the importance of community engagement in creating more equitable and actionable clinical trials research. 

Save the Date

On December 13, 2024, WHO is hosting a webinar, WHO launches new clinical trials guidance – What do I need to know? Registration is free, and during the webinar WHO will highlight key areas of change in the guidance for everyone involved in clinical trials.  

Register

Since AVAC and UNAIDS launched the GPP guidelines in 2007, the science and politics have grown ever more complex – and GPP implementers have continued to adapt, evolve and engage. We are committed to continuing our efforts to curate insights and resources, including further building out the Body of Evidence, and to support our collective advocacy for ethical and effective stakeholder engagement throughout clinical trials, research agendas and implementation in the months and years to come. 

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.

Resources

Think Tanks

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.

Injectable Lenacapavir for PrEP

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Additional LEN Resources

Webinars on the STI Pipeline, Advances in Research Ethics, and Money for the DVR and More!

Register

In Case You Missed It

Recording / Slides / DVR Early Market Access Vehicle page

And stay tuned for a new PxPulse podcast featuring Jen Kates of KFF and AVAC’s Suraj Madoori, The Votes Are In: What’s next for the US’ role in global health and HIV prevention. The podcast hits airways November 14.

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 Conference in 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.

Analysis on the Pandemic Agreement

Guest post by Spark Street Advisors

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.

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!

HIVR4P 2024 Thursday Highlights

Centering Communities

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.

HIVR4P 2024 Wednesday Highlights: Access Access Access

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. 

HIVR4P 2024 Highlights Access and Choice: Inextricably Linked

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.

Pre-conference Highlights from HIVR4P 2024 🌟

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.