First Full Day of AIDS 2024

Lenacapavir for PrEP has taken center stage at the 25th International AIDS Conference, #AIDS2024, which opened Monday with many highlighting its potential for long-acting PrEP for HIV prevention. Some advocates took to the halls in protest calling on LEN’s maker to price the product low. Leaders across HIV voiced the need for urgency in galvanizing support for the introduction of lenacapavir. “It is gobsmackingly exciting to see zero in a clinical trial” AVAC’s Mitchell Warren told Forbes. The potential to bend the curve of the epidemic depends on speeding access to prevention options like LEN, that show high efficacy. 

At the same time, it’s imperative to remember that neither lenacapavir, nor any other single product, now or in the future, will ever be a ‘miracle drug’, and LEN must not be equated with a vaccine, as seen in some conference media reports.  

Ongoing investment in the pipeline for HIV prevention must be founded on the principle of choice, offering a range of products to meet diverse needs among people facing the risk of HIV. We hope that vaccines will one day be among those choices, as will long and short-acting products, and topical and systemic products. Clear communication that allows product users to understand how products are different supports widespread adoption of HIV prevention and moves the world toward finally ending the epidemic.  

See AVAC’s statement calling for early planning to accelerate LEN’s regulatory review and for ambitious introduction plans, and the joint civil society call to action with specific priorities about what needs to happen next. Our primer, the Lens on LEN, also offers advocates a guide in explaining the findings from the Purpose 1 trial and next steps for advocacy. 

As Albert Liu from UCSF’s Center for AIDS Research told delegates in the symposium on breakthrough and insights in long-acting technologies, “It’s never just the ‘product.’ New options can’t solve everything.” Atul Gawande of USAID reiterated a similar message at the satellite focused on women’s prevention, “The critical message to understand is that there isn’t going to be a magic bullet for prevention. What we have to understand is that there are also considerations that affect the likelihood that women will have what they want and what they’re likely to use.”

People First

The conference theme, “Put People First,” is the main message we all must hear. Lillian Mworeko of the International Community of Women living with HIV/AIDS East Africa (ICWEA) captured the essence of the meeting: “I am not just a recipient of care. I need a seat at the table to meaningfully engage and tell people what I need and how I need it.” 

Monday’s opening session underscored the vital role of community engagement and the necessity for inclusive policies that address disparities affecting marginalized populations. Jay Mulucha of Fem Alliance, Uganda, the first trans man to speak at the International AIDS Conference, delivered a compelling message to the 12,000+ delegates attending both in person and online: “As a trans man living in Uganda, I am asking you to stop leaving us behind. Nothing about us, without us.”

New UNAIDS Report

UNAIDS released a report, The Urgency of Now, AIDS at a Crossroads calling out funding disparities and the need to dismantle the discrimination and stigma that are pushing the most marginalized people away from health care. The report warned of the peril in delayed funding decisions; investment needs to happen urgently for long-acting treatment and prevention options to reach all low- and middle-income countries and meet 2025 targets.

Money, Money, Money

Making the most of investment in HIV prevention fundamentally depends on political will, but the field needs the right data, too. Monday’s satellite session, Money, money, money: Building towards a sustainable end state for HIV prevention, called for better data that goes beyond PrEP initiation numbers. “[PrEP initiations] alone do not tell us how much product is needed or how long people stay on PrEP. We are not collecting the right data,” said Katherine Kripke of Avenir Health. AVAC’s Mitchell Warren described the vicious cycle of small pilot projects generating limited data on PrEP use, resulting in unpredictable demand and cautious investment. “We have lots of small examples, and then we don’t scale it up because governments don’t know what it will cost. And still the world has 1.3 million new infections. We have to break the cycle.”

The Future of Women’s Prevention

At the session organized by CASPR (Coalition to Accelerate & Support Prevention Research) and MATRIX (Microbicide R&D to Advance HIV Prevention Technologies through Responsive Innovation and Excellence), New ways for the next wave: Innovative R&D for the future of women’s prevention, MATRIX laid out their innovative approach that involves very early engagement of all stakeholders in the research, development and delivery of new products for HIV prevention. The session emphasized the equitable inclusion of women in all phases and in every aspect of R&D—as researchers, potential users, and advocates.

Sharon Hillier of Magee-Women’s Research Institute noted, “What we’ve learned in our research is that women care about efficacy, but it’s just one element of what they consider when they decide on prevention. They’re quite interested in safety, ease of use, discretion, price, availability, and accessibility.”  

Stay tuned for more highlights from AIDS 2024 and visit our curated conference webpage, which includes new resources and summaries of the preconference sessions.

MPT R&D Funding 2018-2021

This graphic tracks funding levels for a variety of multipurpose technologies for several years. Excerpted from our Advocates’ Guide to Multipurpose Prevention Technologies.

PxPulse: The Advocacy Chronicles with Ruth Akulu

On this episode of the Advocacy Chronicles: a look at advocacy in Uganda for the Dual Prevention Pill (DPP), a new product combining oral PrEP and oral contraception.

Ruth Akulu is a Youth Representative of the Uganda Country Coordinating Mechanism Board for Global Fund, member of the DPP Civil Society Advisory Group, and a 2022 AVAC Advocacy Fellow. Akulu talks about her work to mobilize regulatory authorities to prepare for the DPP. And while she was at it, the establishment of a groundbreaking new initiative, the Product Regulator’s Engagement Committee, which is supporting ongoing engagement between government regulators and young women representing their communities.  

Listen to learn why the DPP is a priority for young women and HIV prevention, the challenges Ruth confronted and tactics that supported the success of this advocacy.

Listen

Resources

Avac Event

AIDS 2024: New Ways for the Next Wave: Innovative R&D for the future of women’s prevention

This session will be 9:30AM to 11:00AM Munich time.

Women need a range of HIV prevention options to meet different needs, preferences and life circumstances. Currently available pills, rings and injectables are necessary but insufficient. How might we accelerate the delivery of methods we have while developing additional ones – including systemic and non-systemic methods, short-acting and on-demand products, to complement longer-acting ones? Product developers and advocates are collaborating on new approaches to expedite R&D of additional HIV prevention options. Notably, MATRIX is taking a unique approach, endorsed by the CASPR network of advocates, that aims to improve the odds of success of new products – through development, delivery and use.

This session will focus on new efforts to identify and develop promising options, strategically engage all stakeholders, decolonize R&D and involve potential users in all their diversities throughout the process.

Speakers:

  • Jeanne Marrazzo, National Institute of Allergy and Infectious Diseases
  • Sharon Hillier, University of Pittsburgh / Magee-Womens Research Institute
  • Thesla Palanee-Phillips, Wits RHI

Followed by a moderated panel with:

  • Chimwemwe Chamdimba, African Medicines Regulatory Harmonization (AMRH) initiative- AUDA/NEPAD
  • Kelly Chibale, Holistic Drug Discovery and Development Centre -H3D, University of Cape Town
  • Nyaradzo Mgodi, University of Zimbabwe- Harare Health Research Centre
  • Jerop Ruth Limo, Ambassador for Youth and Adolescents Reproductive Health Program (AYARHEP)

Moderators:

  • Navita Jain, AVAC
  • Kenneth Ngure, Jomo Kenyatta University of Agriculture and Technology

Session Chairs:

  • Sharon Hillier, University of Pittsburgh / Magee-Womens Research Institute
  • Imelda Mahaka, Pangaea Zimbabwe

This satellite session will be co-hosted by CASPR and MATRIX, with support from USAID and PEPFAR.

Tracking PrEP Rollout & Learning Lessons

Accelerating the rollout of the full range of proven HIV prevention options depends on learning from what’s been done in the past and investing in coordination and innovation to put improved solutions in place. The Biomedical Prevention Implementation Collaborative (BioPIC) is doing just that. Over the last two years, BioPIC—a project led by AVAC with support from the Gates Foundation—has been gathering and sharing evidence on these critical lessons to ensure the next generation of HIV prevention products reaches everyone who needs and wants them with much greater speed and equity.  

What We’re Learning—Highlights from 2024 Convenings

An ongoing series of think tanks, convened by BioPIC and WHO since 2021, are generating key insights for people-centered product delivery. Below, read the latest reports from these think tanks that are informing decision-making on priorities for accelerating access to PrEP. Go to the BioPIC’s page on PrEPWatch to find reports on all think tanks since 2021.  

  • Early Insights from EBONI and PILLAR, February 2024: Early insights from ViiV Healthcare, the manufacturer of CAB for PrEP, from two CAB for PrEP implementation studies, EBONI and PILLAR. Conducted by ViiV in the US, these are among the first studies gathering data in real-world settings. Learn more
  • Taking Stock of PrEP Evidence, March 2024: An analysis of current data and priority evidence gaps. This inquiry was not focused on any one PrEP product, and its findings are informing the focus of future think tanks. Learn more
  • Linking Modellers with the Latest Implementation Science Evidence, March 2024: A consideration of the latest modelling data and insights on injectable cabotegravir (CAB) for PrEP. Read about the biggest takeaways from CAB for PrEP modelling here, and learn more about the big questions that require further inquiry here
  • Discussing Early Results from the SEARCH Dynamic Choice Study, April 2024: Professor Moses Kamya of Makerere University shares early insights from the SEARCH Dynamic Choice Study in Kenya and Uganda, which gave participants a choice between oral PrEP, PEP, and CAB for PrEP, and analyzes the role of choice in PrEP coverage. Watch here
  • PrEP and the Role of HIV Self-Testing, May 23: Highlights from the WHO guidance on use of self-testing (HIVST) as an innovative way to increase PrEP access and coverage and further simplify PrEP delivery. Panelists also share experiences with procurement, costing, rollout and scale-up. Watch Here

As other new biomedical HIV prevention products roll out, BioPIC will continue to hold strategic convenings, identify and address evidence gaps, and work to accelerate equitable product introduction. To learn more efforts to coordinate the introduction of CAB for PrEP, check out the JIAS article Shaping and coordinating the implementation science agenda for injectable cabotegravir for PrEP: the role of the Biomedical Prevention Implementation Collaborative (BioPIC). To learn what’s needed to better coordinate rollout for not-yet-approved products in Phase III clinical trials, check out BioPIC’s Adaptable Product Introduction Framework

We hope you will book mark these resources, and stay up to date on findings from future think tanks and webinars in 2024 on the BioPIC page of PrEPWatch.

Avac Event

The More We Know: Evolving our understanding of PrEP for cisgender women

Science and real-world experience continue to demand a re-assessment of our collective understanding of the safety and effectiveness of PrEP options for women, including oral, vaginal ring, and injectable options. For instance, a new paper in the Journal of the American Medical Association by Dr. Jeanne Marrazzo (HIV Pre-Exposure Prophylaxis with Emtricitabine and Tenofovir Disoproxil Fumarate Among Cisgender Women) challenges the notion, baked into policies, programs and “conventional wisdom”, that cisgender women need to be “super-adherers” to achieve protection utilizing oral PrEP. In this webinar, we discussed this important paper and more.

Speakers:
• Dr. Jeanne Marrazzo, National Institute of Allergy and Infectious Diseases
• Joyce Ng’ang’a, WACI Health

Moderator:
Raniyah Copeland, Equity & Impact Solutions

Materials:
Recording / Ukrainian AudioSlides / Resources / Audio Transcript (English/Ukrainian)

Remembering a Legacy and Celebrating AVAC Fellow Alumni

For over a decade, the AVAC Advocacy Fellows Program has played a role in shaping the landscape of HIV prevention by strengthening leadership skills and building a growing and evolving network of fierce and unstoppable advocates. Last year, AVAC released A Legacy of Impact: The power and reach of AVAC’s Advocacy Fellows to tell the story of the Fellows program and to share testimonies of impact from research to policy, and beyond.  

Today, on Martin Luther King Jr. Day, a day dedicated to the importance of advocacy to influence change, AVAC honors its nearly 100 Fellow alumni and applauds our most recent class which closed out their fellowship in December.  

Read on for testimonies from the AVAC 2022/2023 Fellows and explore their work in their individual pages. 

AVAC 2022/2023 Fellows in their words

Learn about Ruth’s work around the approval and rollout of the dual prevention pill (DPP) in Uganda here

Learn about Onward’s work with engaging religious institutions on adolescent sexual and reproductive health in Zimbabwe here.

Learn about Prince’s work ensuring access to injectable CAB for PrEP for trans people in Malawi here

Learn about Catherine’s work in the rollout and implementation of the dapivirine vaginal ring for adolescents and young women (AGYW) in Tanzania here

Learn about Natasha’s advocacy for the approval of the dapivirine vaginal ring and injectable CAB for PrEP in Zambia here

Learn about Peter’s work with differentiated service delivery of PrEP and expediting new PrEP tools in Lesotho here

Learn about Elizabeth’s work advocating for sex workers and people who use drugs (PUD) here

Learn about Liyema’s work on advocating and implementing the decriminalization of sex work in South Africa here.  

Get to know the full AVAC Fellows community by exploring the full alumni database and stay tuned to meet the 2024/2025 class to be announced in April! 

New Year, New PrEPWatch Resources

In 2024 we look forward to continuing to provide advocates with tools to support our collective work to ensure access to PrEP in all its forms to all who can benefit from it.  

PrEPWatch.org has grown significantly in the past year, reaching a growing number of implementers, policy makers and advocates with continually updated tools and information that are instrumental to delivering the growing range of HIV prevention options. Throughout 2023, visitors from every country in the world have used PrEPWatch.org, a one-stop online clearinghouse of data, guidelines, tracking tools and other resources to help the global community speed the delivery of every proven method of PrEP to everyone who needs it. Check out what’s new and updated on PrEPWatch.org! 

New on PrEPWatch

Modelling the Scale-Up of Injectable CAB for PrEP 

Our Biomedical Prevention Implementation Collaborative (BioPIC) teamed up with the HIV Modelling Consortium to produce this analysis of the potential impact of scaling up injectable cabotegravir (CAB) for PrEP, What can modelling tell us about the scale-up of CAB for PrEP? The findings can help implementers and policymakers understand what to expect and guide early policy decisions to maximize the impact of CAB for PrEP on the HIV epidemic. 

Country Pages 

PrEPWatch has added 35 new country pages where you can find the status of drug registration for PrEP products, data on PrEP initiations by product, country-level PEPFAR targets, and links to key policy documents and guidelines.  

The Integrated Study Dashboard  

Produced under the BioPIC project, the Integrated Study Dashboard tracks all currently known activities relating to implementation research, modelling, clinical research, and landscaping for new biomedical HIV PrEP options, including CAB for PrEP and the dapivirine vaginal ring (DVR), and has been recently expanded to include links to study results and study websites. The dashboard is updated in real time, and links to results will be added as they become available. 

More Essential Resources on PrEPWatch.org

Tracking Country Planning for Product Introduction 

The Country Planning for Product Introduction Matrix tracks key indicators for the introduction of injectable CAB and the DVR by country, including regulatory status, late-stage clinical trials and implementation research, procurement plans, and recent oral PrEP provision. 

Training PrEP Champions  

Among the most popular resources on PrEPWatch, the HIV Prevention Ambassador Training Package and Toolkit prepares potential and current PrEP users to be leaders – and “Ambassadors” – in the rollout of PrEP for HIV prevention in their communities. Developed as part of the MOSAIC project, it includes a training manual and resources for Ambassadors to use in peer outreach and community education.  

Trends in PrEP Initiations  

The Global PrEP Tracker provides quarterly updates on global trends in PrEP initiation by geography, delivery models, and more. The Global PrEP Tracker has become an indispensable resource for following the state of the field in delivering PrEP.  

We hope these tools, created through strong partnerships and joint effort, support your work to accelerate the delivery of HIV prevention options. We are always interested in collaboration to ensure needed resources are developed and up to date.  If you have information to share or resource needs, please let us know by reaching out to [email protected] and [email protected].  

Px Pulse: A season of listening

As we look ahead to 2024 and the vital work AVAC and partners will be carrying forward, the conversations from 2023 offer guidance and insights. Px Pulse, AVAC’s podcast on critical issues facing HIV prevention research, hosted several not-be-missed conversations in 2023 that will reverberate into the year ahead.  

From a stalled PEPFAR reauthorization to LGBTQIA+ voices fighting persecution in Uganda; from efforts to bring equity to a new global architecture for pandemic readiness to advances in HIV vaccine science and advocacy to include pregnant people in research—we hope that all of these conversations can inform our advocacy in 2024. Click on the episode for both recordings and resources.

PEPFAR at 20: Keeping the promise (23:16)

Considered one of the greatest US foreign policy and global development achievements of the century, the program has saved upwards of 25 million lives since it launched in 2003. But PEPFAR is marking its 20th anniversary while fighting for its future. LISTEN HERE.

LGBTQIA+ Advocacy in Uganda: Facing down fear and fighting for justice (24:19)

In March 2023, the Ugandan Parliament moved forward broad-reaching legislation to further criminalize LGBTQIA+ people. This podcast features Ugandan advocates and AVAC partners discussing the specifics of how these attacks have gained momentum and their ties to US-based religious extremists. The advocates discuss what needs to happen next. LISTEN HERE.

The Shape of Pandemic Preparedness is Being Decided. Now is the Time for Collective Action (15:14)

Health leaders around the world are in the midst of creating a new architecture to deal with pandemics. Chris Collins, the CEO and President at Friends of the Global Fight Against AIDS, Tuberculosis and Malaria, talks about what’s at stake, which policymakers get it already, why this year matters so much, and what advocates can do about it. LISTEN HERE.

PPPR Advocacy 101: Find out what it means to you (19:05)

Over the coming months, global leaders will make key decisions about several initiatives to prepare for the next pandemic. This podcast explores what they commit to, how much they will spend and how well these plans safeguard equity. LISTEN HERE.

Inclusion of Pregnant and Lactating People in HIV Research: What you need to know (34:28)

AVAC’s Manju Chatani-Gada takes us through conversations with a trial participant who became pregnant, researchers, policymakers and donors to understand why this population gets excluded, the impact it has and what to do about it. LISTEN HERE.

Evolving Strategies for an HIV Vaccine: One researcher explains where the field is going and why? (21:23)

Evolving Strategies for an HIV Vaccine: One researcher explains where the field is going and why? Dr. Katy Stephenson explores the implications of recent trial results, the big questions driving next generation vaccine development, and new strategies underway in early phase research. LISTEN HERE.

Happy listening—and let us know what topics you want to hear more about in 2024! 

New Episode of the Px Pulse Podcast

The intersection of HIV research and pregnancy

AVAC’s Px Pulse podcast has a new episode: Inclusion of Pregnant and Lactating People in HIV Research: What you need to know. 

People who are pregnant or lactating (PLP) have historically been excluded from research because of concerns for the developing fetus. But this has led to a dearth of data on new interventions against health threats for this population. In the case of HIV, pregnancy raises the risk of acquiring HIV by up to three times, but providers often do not have the data to know whether a new intervention is safe or how it will work for pregnant patients. As a result, PLP and their physicians are left to make difficult decisions around the use of proven HIV prevention products as they await more data specific to pregnancy and lactation. 

But change is in the air. Champions for the inclusion of PLP in research are paving the way for a paradigm shift— one that will redefine this population from needing protection from research to being better protected through research. In this episode of Px Pulse, AVAC’s Manju Chatani-Gada takes us through conversations with a trial participant who became pregnant, researchers, policy-makers and donors to understand why this population gets excluded, the impact it has, and what to do about it.   

Tune in to hear

  • Dr. Anne Drapkin Lyerly, Principal Investigator of the PHASES Project to advance equitable inclusion of pregnant women in HIV research and its follow-on project, PREPARE, focused on ethical HIV research in adolescents who are pregnant.  
  • Elisia Madende, Trial participant in the HPTN 084 trial in Zimbabwe
  • Dr. Ashley Lima, Health Science Specialist and Lead Technical Advisor for Socio-behavioral Research – USAID Office of HIV/AIDS Research Division 
  • Dr. Takunda Sola, HIV Prevention and Key Populations Medical Officer- Zimbabwe MoH AIDS/TB Unit 

Advocacy resources