The drug maker Merck recently announced its plans to start two new trials, known as the EXPrESSIVE program, testing a monthly pill for PrEP. A once-a-month PrEP pill holds great potential for the field. Even with daily pills, a monthly ring, or long acting injectables such as cabotegravir and recently FDA-approved lenacapavir, there’ll be people who can’t find what they really need for prevention.   

For advocates who follow prevention, there’s a lot to know about these trials, and powerful lessons to learn about Good Participatory Practice (GPP) and impactful involvement of stakeholders—especially community—in research. GPP has been a cornerstone of the process of design and protocol development for the EXPrESSIVE trials, and it doesn’t stop there.  

This episode features Merck Senior Principal Scientist Rebeca Plank and AVAC’s Regional Manager for Research Engagement Grace Kumwenda. They explain why a monthly pill could be so important to HIV prevention and how GPP is shaping the design and rollout of the trials. 

The upending of US policy by the new presidential administration has collapsed the foundation for global health and the HIV response at every level, from research to program delivery.  It’s been a desperate scramble for everyone who cares the lives and wellbeing of those impacted by HIV. Wading into the chaos, all over the world are advocates who began organizing within days, even minutes—as soon as the US government federal executive orders started coming down.  

Positive change depends on fierce and effective community leadership, and pressuring powerbrokers to do the right thing.) 

Two veteran global health leaders from civil society talk about how civil society is responding. Amanda Banda is Strategic Advisor to the COMPASS Coalition and Asia Russell is Executive Director of Health Gap, and both are members of CHANGE, a coalition with more than 1,500 people, from organizations in nearly every continent, working in coordination to defend global health and the HIV response.

https://avac.org/resource/critical-advocacy/

Key Resources

Research Matters – Resources to Protect Research Funding 

Despite USG Global Health Collapse, Here Are Several Data Trackers To Support Your Advocacy 

On February 10, AVAC and the Journalism Development Network came forward with Public Citizen to sue the new US presidential administration, seeking emergency relief from the funding freeze on all foreign assistance. We know the impact of the withdrawal of funds has been devastating. AVAC’s lawsuit is one of several efforts to fight back in the courts.

AVAC’s Executive Director, Mitchell Warren and Public Citizen Litigator, Lauren Bateman explain these lawsuits and why they matter. For resources and other background go to https://avac.org/resource/lawsuit-wins-and-whats-at-stake/

Community-Led Monitoring has been on the rise in the HIV response. Known as CLM for short, it’s a tactic being championed and implemented to ensure that communities play a direct role in monitoring and improving HIV services.

This episode of PxPulse: The Advocacy Chronicles puts a spotlight on CLM in Malawi, where civil society and communities are successfully using CLM to connect government decision makers to gaps in HIV services and to what people really need. Thanks to persistent advocacy, both PEPFAR and Global Fund now recognize, through their funding, the critical role of CLM.

David Kamkwamba, a journalist and health advocate and the former chair of the Civil Society Advocacy Forum on HIV and related diseases (CSAF),  tells us what advocates have accomplished in Malawi and just how they did it. CSAF and AVAC are partners in the Coalition to Build Momentum, Power, Activism, Strategy & Solidarity (COMPASS) which has supported extensive work on community-led monitoring in Malawi and across the region.

In this episode of PxPulse:The Advocacy Chonicles, Atuswege Mwangomale goes deep on the advocacy work behind the passage of Tanzania’s Universal Healthcare Law. Atu serves as Head of Health Programs for Sikika, a Tanzania-based advocacy organization with a long track record of promoting best practices in governmental financing in the health sector, and advocating for improved health outcomes. Sikika, along with AVAC, is also a member of the COMPASS coalition, which uses data and coalitions across Africa to identify strategic campaigns to advance the HIV response. 

Sikika’s advocacy has been crucial to the ultimate passage of Tanzania’s Universal Health Insurance Bill in 2023, but full funding must still be secured for the law to achieve full impact.  

Atu explains the promise of UHC in Tanzania, how Sikika won the trust of government allies, and why working in coalition was essential to success.

In the days and years ahead under a Trump Administration, advocacy for choice, freedom, science, and rights will require deep strategic shifts to protect hard-fought gains in global health generally, and to safeguard policies and programs that advance it. And there will be major implications for the global AIDS response. Joining us to navigate all this and to better understand the landscape for advocacy are Jen Kates from KFF, a nonpartisan health policy research organization, and our own Suraj Madoori.  

  

In this episode of the Advocacy Chronicles, we put the spotlight on the US, on the dismal statistics on access to PrEP in Black communities, on the state of HIV prevention among Black Americans overall, and the work of one advocacy group—PrEP in Black America (PIBA). Danielle Campbell is one of the founders of PIBA and a long-time advocate for HIV prevention and health equity. She joins the Advocacy Chronicles to talk about PIBA’s call to action for an HIV research agenda that prioritizes the needs of Black communities.

The promise of long-acting PrEP has been super-charged this year by studies showing the powerful efficacy of an antiretroviral known as lenacapavir (LEN). 

This episode of PxPulse goes deep on LEN for PrEP. Recorded just days before Gilead’s announcement that PURPOSE 2 also found very high efficacy, Dr. Flavia Kiweewa, a principal investigator of PURPOSE 1, the first trial to announce efficacy, lays out the research findings and what they mean. And Chilufya Kasanda Hampongo of Zambia’s Treatment Advocacy and Literacy Campaign and Mitchell Warren of AVAC talk about how to change a long history of squandered opportunities to get rollout right. 

The PURPOSE1 trials announced findings in June that a twice-yearly injection of LEN was 100% effective among cisgender women, with zero new cases of HIV. And the PURPOSE 2 trial among cisgender men, and trans and non-binary people, was shown to reduce the risk of HIV by 96%. 

LEN now enters a select category, one of five ARV-based options for PrEP that all protect against HIV if you take them.  But many of the people applauding the results from PURPOSE 1 and 2 will tell you that breakthrough science like this is, as hard as it is, is still the easy part. To break the back of the HIV epidemic demands overcoming an altogether different challenge—coordinating and accelerating every step in rolling out new products so that everyone who needs HIV prevention can get it.   

Listen to this podcast to learn what must be done to finally deliver on the promise of highly effective HIV prevention, from pills to rings to injectable PrEP and beyond.  

Resources 

Second Pivotal Trial of Twice-Yearly HIV Prevention Injection Safe and Highly Effective: PURPOSE 2 Trial Among Gay Men, Trans and Nonbinary People, AVAC Press Release 

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

Country planning matrix, PrEPWatch 

Moving a Product to the Real World, AVAC 

The long wait for long-acting HIV prevention and treatment formulations, Lancet 

A game-changer for PrEP if access is adequate, Lancet 

Allocation of Non-Commercial CAB for PrEP Supply in Low- and Middle-Income Countries, 2023-2025, AVAC 

Generic Cabotegravir Timelines, AVAC 

UNAIDS Exec Summary, UNAIDS 

Lenacapavir: What it would it take to get the 6-monthly anti-HIV jab to SA, Bhekisisa 

On this episode of PxPulse:The Advocacy Chronicles, Mandisa Tyadi Dukashe, Treatment Technical Lead at the South African National AIDS Council (SANAC) describes her work in helping to inspire and launch a National U=U Campaign in South Africa in 2024.  

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 member of the DPP Civil Society Advisory Group, part of the Uganda Country Coordinating Mechanism Board for Global Fund,  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. 

To support your advocacy for the DPP and other multipurpose prevention technologies check out AVAC's Advocates' Guide on MPTs  https://avac.org/resource/advocates-guide-to-multipurpose-prevention-technologies-mpts/

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