PxWire Volume 13, Issue No. 4

PxWire is AVAC’s quarterly update covering the latest in the field of biomedical HIV prevention research and development, implementation and advocacy. Each issue includes updates, emerging issues and upcoming events. Also available as a PDF.

From Research to Rollout: A look at where we are in HIV prevention

As we look back on 2023, powerful crosscurrents confront HIV prevention and global health equity. More options than ever before could be available, but many forces threaten to undermine access to proven prevention options that exist today and the development of additional options that are still needed. Threats to PEPFAR and hate laws targeting LBGTQI+ people are just a sample.

Upstream research and development is dynamic, but robust stakeholder engagement and sustainable funding must still be secured and integrated into a people-centered research agenda. These commitments are the compass that will ultimately lead to impact in the real world. The highlights below provide a snapshot of key updates in Q3 of 2023 and resources to inform advocacy on these critical questions.

Progress in PrEP Uptake

These updates from AVAC’s Global PrEP Tracker explore trends in 2023 and highlight new data as of September 2023.

PEPFAR and PrEP

PEPFAR’s role has been instrumental to accelerating global uptake of PrEP to date. This year, four countries started providing PrEP for the first time, and seven countries exceeded 70,000 new PrEP initiations, most of which are attributable to PEPFAR. This lifesaving, uniquely effective, program must see continued full funding and a 5-year reauthorization to carry on this work and help to put the world on track to control the epidemic.

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Cumulative PrEP Initiation Milestones

Global Milestones

  • The world surpassed 5.6 million cumulative PrEP initiations as of September 2023. Initiations increased by 700,000+ since Q2 2023. Though comparable to previous quarterly increases, it is the highest ever recorded quarterly increase by the Global PrEP Tracker.
  • At the same time last year the world had reached 3.3 million cumulative PrEP initiations, representing a doubling of initiations since then.

Country Level Milestones

  • Early adopting African countries continue to show the most rapid increases in PrEP uptake. South Africa has shattered 1 million cumulative initiations. Nigeria, Uganda, and Zambia have all surpassed 500,000 initiations, Kenya has surpassed 400,000, and Zimbabwe has surpassed 200,000.
  • Malawi and Brazil saw jumps of approximately 20,000 initiations over this quarter, while Lesotho had more modest increases of 10,000 initiations.
  • Dozens of countries continue to grow their programs. For example, El Salvador, Honduras, and South Sudan all surpassed 1,000 cumulative initiations.
  • Cyprus and Malta recorded their first oral PrEP initiations, at 29 and 579 respectively.

Spotlight on West Africa

As of Q3 2023, the top five West and Central African countries for PrEP initiation have surpassed 10,000 initiations; Cameroon, Cote d’Ivoire, Democratic Republic of the Congo (DRC), Ghana and Nigeria. Nigeria has marked almost 550,000 cumulative initiations as of this quarter, ranking it second, behind South Africa, worldwide. These milestones can be credited to targeted PEPFAR investments. But despite these successes, West and Central Africa make up only 14 percent of PrEP initiations recorded in Africa, compared to 85 percent reported by East and Southern Africa. These same countries are home to two thirds of all people living with HIV in West Africa. There is vital work to be done to close the gap.

West and Central Africa can and must continue to leverage this recent growth in oral PrEP by making additional HIV prevention options available. In September, Nigeria’s regulators approved injectable cabotegravir (CAB for PrEP)—approving the first new biomedical HIV prevention option in a West and Central African country since oral PrEP. But at this time, only one other CAB for PrEP application has been submitted in the region, in Côte d’Ivoire, and none for the dapivirine vaginal ring (DVR). Only one CAB for PrEP implementation study is planned for the region.

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PrEParing for New Products

Current HIV prevention options aren’t reaching all who need them. Access to a range of options that meet the needs of diverse people, especially those most at risk, will be essential to meeting global targets for ending the HIV epidemic.

  • CAB for PrEP Supply: In October 2023, ViiV, the developer and sole manufacturer of CAB for PrEP for now, announced a 40 percent increase in forecasted doses that could be available for non-commercial use in low- and middle-income countries through 2025, an increase to 1.2 million potential doses. Of these, 116,000 have been allocated to post-trial access for HPTN 083 and 084 participants; 129,000 for an initial set of eight implementation studies; 326,000 to PEPFAR programs in Malawi, Ukraine, Vietnam, Zambia and Zimbabwe; leaving at least 629,000 doses available for procurement by PEPFAR, Global Fund and national governments. See more details in our Country Planning Matrix. Three generic manufacturers could begin to deliver doses in 2026 or 2027.
  • Implementation Science (IS): As DVR and CAB for PrEP supplies arrive in countries, dozens of implementation science studies are underway in 22 different countries. Check out AVAC’s Integrated Study Dashboard for more details and stay tuned for updates.
  • PrEParing for Choice: For the first time since oral PrEP was introduced in 2012, PrEP users will have a range of methods to choose from—but only if they have access to them. Policy makers, donors, governments and implementers must commit to making these methods available, accessible and affordable. The HIV Prevention Choice Manifesto, launched in September by the African Women’s HIV Prevention Community Accountability Board, outlines what needs to happen to make choice a reality.

Approval Information

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The HIV Prevention Pipeline: The latest in research, development and more

The HIV prevention pipeline has evolved: Few products are in late stage or efficacy trials, newly proven products are rolling out, and early phase clinical trials are exploring innovative strategies. R&D is focused on ARV and non-ARV based prevention products and HIV vaccines that build on new knowledge about the virus. The late-stage trials of recent years and basic science have brought deepening insights that are being applied today to a diversity of ‘upstream’ interventions.

  • MK-8527 Announced: Merck announced a new Phase 2a trial to evaluate the safety, tolerability, and pharmacokinetics of a monthly oral pill, MK-8527. The trial began in November 2023 in participants at low-risk for HIV acquisition. If successful, Phase 3 trials could start in 2025.
  • PURPOSE Program: A new Phase 2 study, PURPOSE 5, will evaluate lenacapavir as a twice-yearly prevention option in France and the United Kingdom, as part of the larger PURPOSE program. Purpose 5 is recruiting participants who are disproportionally affected and often underrepresented in HIV clinical trials. PURPOSE 1 and 2 are Phase 3 efficacy studies in Argentina, Brazil, Mexico South Africa, Thailand, Uganda and the United States. PURPOSE 3 & 4 are smaller studies focused on populations facing disproportionate risk.
  • The Dual Prevention Pill (DPP): In September, the DPP, which would protect against pregnancy and HIV, moved to the next stage in R&D. A pilot bioequivalence study has shown the pill’s combined drugs—an antiretroviral and a contraceptive—are absorbed at an equivalent rate as taking them separately. The DPP now moves to a larger bioequivalence study needed for a regulatory submission. Check out the updated DPP Market Preparation and Introduction Strategy for highlights. The Population Council and Medicines360 are also developing a second-generation DPP with F/TAF.
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Prevention Playlist

The most effective advocacy is based on smart analysis and accurate information. AVAC develops a wide range of materials and resources to inform decision making and action. Check out these essential resources to the global conversation on HIV prevention and global health equity.

JOIN

  • ICASA: The biennial International Conference on AIDS and Sexually Transmitted Infections in Africa. Dec 4-9. Register
  • How Our Environment Impacts Cure, webinar, Dec 13. Register
  • Sex, Gender & HIV Cure Research, Dec 6. Register

READ

WATCH AND LISTEN

Vaccine Research and Development: Key Lessons and Ways Forward

From Lab to Jab

This issue brief on the vaccine research and development (R&D) process is one of a series of four briefs, which provide a roadmap for advocacy to advance the development of essential vaccines for HIV, COVID-19, tuberculosis, and other global public health threats, and approaches to ensure equitable access to these life-saving vaccines. Additional topics cover the role of mRNA technology, the need for local vaccine production, and issues around global access.

Vaccine Access: What’s Working and What’s Next

From Lab to Jab

This issue brief covers the web of issues that influence access to vaccines. It is one of a series of four issue briefs, which provide a roadmap for advocacy to advance the development of essential vaccines for HIV, COVID-19, tuberculosis, and other global public health threats, and approaches to ensure equitable access to these life-saving vaccines. Additional topics cover the research and development (R&D) process, the role of mRNA technology; and the need for local vaccine production.

mRNA Technology: What It Might Mean for Future Vaccines

From Lab to the Jab

This issue brief on mRNA technology covers what it is, how it works, current knowledge gaps and ideas for advocacy to harness its potential. It is one of a series of four issue briefs, which provide a roadmap for advocacy to advance the development of essential vaccines for HIV, COVID-19, tuberculosis, and other global public health threats, and approaches to ensure equitable access to these life-saving vaccines. Additional topics cover the research and development (R&D) process, the need for local vaccine production, and issues around global access.

Local Vaccine Production: Harnessing Its Potential for Equity

From the Lab to the Jab

This issue brief on local vaccine production covers the current state of local production, what is needed to facilitate it, and ideas for advocacy to harness its potential. It is one of four briefs in a series providing a roadmap for advocacy to advance the development of essential vaccines for HIV, COVID-19, TB and
other global public health threats, including approaches to ensure equitable access to these life-saving vaccines once developed. Additional topics cover the research and development (R & D) process, issues around global access; and the advent of the mRNA platform for vaccines.

FAPP Letter: Vote NO on House L-HHS Bill to Continue Progress Against HIV/AIDS

The FAPP AIDS Budget and Appropriations Coalition (ABAC) wrote letter urging Members of Congress to vote no on the House L-HHS Appropriations Bill (H.R. 5894), which includes $767 million in cuts and eliminations of domestic HIV programs.The letter also urges members to vote down two amendments which would eliminate funding for the Minority HIV/AIDS Fund and cut NIAID funding.

Read the Full Letter Here

Civil Society Analysis: Negotiating Text of the WHO convention, agreement or other international instrument on pandemic prevention, preparedness and response (WHO Pandemic Agreement)

This analysis is a compilation of recommendations from civil society and community organisations on the DRAFT Negotiating Text of the WHO convention, agreement or other international instrument on pandemic prevention, preparedness, and response (WHO Pandemic Agreement).

Read the full analysis here.

Blueprint for Sexual & Reproductive Health, Rights & Justice

AVAC joined more than 100 organizations to endorse the 2023 Blueprint for Sexual and Reproductive Health, Rights, and Justice Policy Agenda. Check it out to see recommendations to the US Executive Branch that would protect and expand access to sexual and reproductive health, rights and justice around the world. This Blueprint comes as several major threats to sexual health, rights and justice are gaining ground: the loss of abortion access and gender-affirming care in the US, and criminalization of LGBTQ people around the world.

CASPR Results Bulletin

October 2023

The Results Bulletin is a Monitoring, Evaluation, Results and Learning (MERL) newsletter providing updates, news and insights on results from CASPR activities, practices, trends and tools on a quarterly basis. The purpose of this newsletter is to inform and engage CASPR partners and other stakeholders about the progress, achievements, challenges and lessons learned from CASPR initiatives.

A Legacy of Impact: The power and reach of AVAC’s Advocacy Fellows

For more than a decade, alumni from AVAC’s Advocacy Fellows program have been expanding the reach of HIV prevention and advancing global health equity around the world. They are influencing research and strengthening healthcare to become more effective and equitable across the continent of Africa and beyond. A review of their career achievements shows how this unique program is contributing to the strength of a generation of leaders, and how their cumulative efforts are shaping the HIV response for the better.

Founded in 2009, the Advocacy Fellows program offers technical and financial support to individuals living in areas where HIV incidence is high, with a particular focus on African countries. The program invests in a select group of advocates who have an interest in improving the HIV response in their communities. The program pairs individuals with a community-based host organization where they pursue an 18-month advocacy project. Both the individual fellow and the host organization develop expertise and advocacy skills, gain access to influential stakeholders and networks, and receive intensive mentoring. 

Nearly 100 advocates working with 70+ partner organizations across 15 countries have participated in the program. In that time, Fellows have:

  • Founded or leads more than 85 influential organizations, coalitions and campaigns.
  • Changed more than 84 national policies in support of HIV prevention or greater equity in public health. 
  • Won significant funding* increases for more than 83 different high-priority prevention programs and projects.
  • Gained approval for over 35 innovative programs (including implementation, service delivery or community projects) and research projects. 
  • Led nearly 200 high-impact efforts** to create an enabling environment for HIV prevention such as rallies, media placements, and research literacy initiatives.
  • Served on at least 150 high-level decision-making bodies, affecting policies, programs and funding at national and global levels.

A look at the careers of three alumni – Kenya’s Grace Kamau, Uganda’s Kenneth Mwehonge and South Africa’s Yvette Raphael – exemplifies the importance of this program in preparing future leaders, and showcases the extensive influence that alumni Fellows have on public health. 

Grace Kamau, Kenya

Grace Kamau joined the 2011 Fellows program with experience as a peer-to-peer educator for a sex worker advocacy organization, the Bar Hostess Empowerment and Support Programme (BHSP). She describes herself at the time as shy, uncertain of how and when to speak her mind. “I didn’t even apply for a conference scholarship because I was intimidated to travel”. As she worked on her project— raising awareness of PrEP and microbicides research among a sex worker community  in Kenya, and engaging with policy makers to support the provision of PrEP to sex workers— elements of the program’s mentoring brought a seismic shift in her advocacy. “The Fellowship builds the whole person, far beyond expertise in HIV prevention, I came out a changed person.” A host of skills came together: mastering a two minute speech in case of encountering a key official in a hall, making quick follow up a standard practice, retaining command of the facts, understanding HIV science and policy trends.  “Ever since I came out of the Fellows program, I have stood out. I pinpoint what needs to be said and to whom. I understand the power of my voice to speak out for sex worker rights and welfare. That confidence was built during my fellowship, and I use it to advance a movement.” 

Grace’s advocacy has contributed to more than 175,000 sex workers in five countries receiving access to HIV services through the Hands Off Project, which she chairs. Her advocacy has also given voice and visibility to sex workers from 35 African countries on the need for decriminalization, access to care and other anti-stigma work in her current role as Regional Coordinator of the Africa Sex Workers Alliance (ASWA).  

Kenneth Mwehonge, Uganda

Kenneth Mwehonge grew up in a region of Uganda burdened with some of the highest rates of HIV found anywhere in the world. He saw one sister die, unable to get treatment and another finally gain access to life-saving drugs after living with HIV for many years. In 2014, he applied for a fellowship, work with HEPS-Uganda as his host organization. At the tine, he had only local level experience in grassroots organizing and a desire to fight for broader access to treatment. “My Fellowship with AVAC was the turning point in my career.”  Kenneth said his exposure to the alumni network, introductions to decision-makers, education about HIV prevention and the research process,  and AVAC’s mentoring boosted his confidence and taught him the value of mashalling evidence, working with data, and tracking progress closely. “When the fellowship began I was sometimes quite intimidated to talk to leaders, but overtime that wasn’t true anymore.”  By the end of his project, Kenneth had profoundly impacted the HIV response in Uganda, designing and promoting a plan for universal viral load monitoring that was embraced by both PEPFAR and the Uganda government. His leadership and advocacy continued to grow.

Today, Kenneth is the executive director of HEPS, the organization that once hosted him as a Fellow, and it has grown into one of the most trusted civil society institutions in the country. Kenneth is also the coordinator of the Uganda Coalition for Access to Essential Medicines. He devotes significant time to mentoring emerging advocates. “It does take a lot of time, but there is so much work to be done and it is so important to see young people with fresh thinking taking the work across the finish line.” Kenneth’s leadership is also prized at the international level; he currently serves as a member of the UNAIDS Global HIV Prevention Coalition and the lead for coordinating the 2025 roadmap for prevention in Uganda and Tanzania.

“For the first time, we have options—PrEP, the ring, and cabotegravir as an injection. But advocates from my hometown, where [HIV] prevalence is 17%, don’t even know these options exist! In the years ahead I will be working to see every proven option for HIV prevention is scaled up and rolled out.” 

Yvette Raphael, South Africa

A veteran human rights activist, Yvette Raphael joined the AVAC Advocacy Fellowship cohort of 2014, with the Centre for Communication Impact (CCI) as her host organization. As a woman living with HIV, she wanted to develop a program to mobilize young women to fight for HIV prevention. She said the fellowship taught her how to implement advocacy, create a process, and be accountable to a grant. She emerged from the program with a laser focus and has since become one of the most prominent advocates for HIV prevention on the national and global stage. To name a few of her roles: Yvette is the Executive Director of South Africa’s Advocacy for Prevention of HIV and AIDS (APHA), an organization she co-founded with two other Fellow alumni – Ntando and Brian Kanyemba. She also serves on the South Africa National AIDS Commission. She was the keynote speaker at the 2023 Conference on Retroviruses and Opportunistic Infections. In the Journal of the International AIDS Society, Yvette recently co-authored Antibodies for HIV prevention: the path forward with world renowned scientists, issuing a call to action for a research agenda focused on ensuring equitable access. 

She co-founded the African Women’s Prevention Accountability Board, which engages industry, research and government on ongoing and future research and is leading efforts to advance  The HIV Prevention Choice Manifesto. She has helped to shape numerous programs and campaigns aimed at reaching vulnerable populations with HIV prevention and she mentors young advocates.

“The Fellows program took a chance with an unpolished, street smart activist and turned me into a boardroom eloquent and knowledgeable advocate.  It was mentorship , contacts, support from the team, and solidarity with other fellows. I look down the road and I see there’s a chance to end this epidemic, but greed and power hoarding will derail all this, without advocates who are prepared and committed. I will be among them, with young advocates I am mentoring now, and so many fellow alumni by my side.” 

For a comprehensive understanding of the impact of the Fellows program in its first decade, please see the AVAC Advocacy Fellows Program Evaluation, conducted in 2020.

Significant funding*- This data comes from advocacy that won funding increases from PEPFAR, Global Fund, philanthropy, bilateral government entities, and private industry for programs with extensive reach and impact, such as PrEP for AGYW and Community-led monitoring.  

High-impact efforts**- This data reflects initiatives that were covered by the media, media placements in national press, social media campaigns that went viral.