Overview
An experimental monthly pill, called MK-8527 or alimatravir, is in Phase 3 efficacy trials for HIV prevention. Known as the EXPrESSIVE program, these clinical trials represent a bold new program to expand the toolbox for HIV prevention with an innovative option that could fill a critical gap alongside daily pills, a monthly vaginal ring and longer-acting injections.
AVAC’s Role
With support from the Gates Foundation, AVAC has worked to influence the design of the Phase 3 trials and their implementation, and ensure strong engagement with community representatives in the MK-8527 program. Since 2024, AVAC has convened stakeholders to help shape trial design, operational aspects of the MK-8527 efficacy program, and advance critical issues, including possible use of MK-8527 as PEP and its uptake by people who use drugs. AVAC, working closely with community-based organizations, also oversaw a transformative human-centered design process to develop educational materials for one of the trials. These efforts coincide with broader AVAC efforts to engage advocates and other drivers in preparation for results of the EXPrESSIVE program, and, in the case of positive results, building the foundation for a swift path to wide-scale uptake and access to a monthly oral prevention option.
Objectives
- Ensure the trial follows Good Participatory Practices: Support a cadre of informed, engaged advocates who serve as effective liaisons throughout the EXPrESSIVE program, ensuring smooth trial conduct and readout, clear articulation of next steps, and responsiveness to community and other key stakeholders.
- Plan for accelerated access: Ensure stakeholders’ perspectives and priorities are incorporated into the efficacy program and accelerated access planning well in advance of efficacy results so that trial conduct and implementation programs are smooth and community-centric, and no time is lost if trial results are positive.
- Socialize the concept of a monthly PrEP pill in focus communities early: Develop communications materials to support awareness and understanding of MK-8527, including trial education and access planning.
- Mobilize a comprehensive ARV strategy: Promote and draw consensus around a comprehensive policy, advocacy and communications strategy to support ARVs in all their forms – PrEP, PEP and treatment, with a particular focus on long-acting methods.
Project Materials
AVAC has produced several resources to explain and contextualize the EXPrESSIVE program and the monthly PrEP pill.
EXPrESSIVE Program
Under the EXPrESSIVE program, MK-8527, an investigational ARV drug, is being studied as a potential PrEP product. EXPrESSIVE-10 is enrolling approximately 4,580 cisgender women and adolescent girls and young women (AGYW) aged 16–30 in Kenya, South Africa and Uganda. EXPrESSIVE-11 is enrolling approximately 4,390 men who have sex with men (MSM), gender non-binary individuals, and transgender individuals in 16 countries in the Americas, Africa, Asia and Europe. Results from the trails are anticipated in mid-2027.
“This is not just another trial; it’s a signal that the needs of young women and other key groups most affected by HIV really matter. A monthly pill will offer a new kind of freedom – something discreet, something manageable, something we can own on our terms.”
Chilufya Kasanda Hampongo
Chair of the Young Women’s HIV Prevention Council (YWHPC)
“Choice is the superpower in HIV prevention. Even with injectable CAB and LEN, we still have gaps, and a monthly pill will add a vital option. We need ongoing research to fill these gaps in prevention; not everyone wants or will be able to access an injection, and daily pills don’t work for many people in need. It’s about options and access.”
Nandisile Sikwana
AVAC’s Regional Stakeholder Engagement Manager based in South Africa and a member of the EXPrESSIVE-10 Global Community Accountability Group (GCAG)
“As the Global Community Advisory Group for EXPrESSIVE-10, we are committed to ensuring that this trial is both scientifically sound and deeply rooted in the actual realities of the African communities it aims to serve. As a GCAG, we will strive to uphold the Good Participatory Practices from the initial design to results dissemination, as well as amplify community voices, and advocate for timely, equitable access if MK-8527 is shown to be effective. Our responsibility is to ensure that research protects communities, and that innovation is matched with real-world impact.”
Simon Odiwuor Ondiek
Former Chair, EXPrESSIVE-10 GCAG
“Access to existing and new products is not optional; it’s a fundamental right. HIV prevention will only achieve impact if everyone who needs it can access it. Populations who contribute their time and their bodies to research — gay, bisexual, MSM, trans, non-binary, AGYW – must benefit first. Access cannot wait until a trial ends; it must be built into every step, from research to delivery.”
Rena Janamnuaysook
Leading HIV prevention advocate based at the Institute of HIV Research and Innovation (IHRI) in Bangkok, Thailand
