The Nyanza Reproductive Health Society (NRHS) is participating in the EXPrESSIVE-11 Study, an international Phase 3 clinical trial evaluating a new once-monthly oral medication for HIV prevention known as MK-8527.

The study seeks to determine the efficacy and safety of MK-8527 as a form of HIV-1 pre-exposure prophylaxis (PrEP) among populations at increased likelihood of HIV exposure. The investigational medication is being compared to the currently approved daily oral PrEP regimen consisting of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF).

About the Study

EXPrESSIVE-11 is a randomized, double-blind, active-controlled Phase 3 study involving approximately 4,390 participants globally. Participants are randomly assigned to one of two study groups:

• Monthly oral MK-8527 plus daily placebo
• Daily FTC/TDF plus monthly placebo

The purpose of this design is to fairly compare the effectiveness and safety of the investigational monthly oral PrEP against the current standard daily oral PrEP.

Why This Research Matters

Despite major progress in HIV prevention, adherence to daily medication remains a challenge for many people. Long-acting and simplified HIV prevention options may improve accessibility, convenience, privacy, and consistent protection against HIV acquisition.

MK-8527 is a novel nucleoside reverse transcriptase translocation inhibitor (NRTTI) currently under investigation for HIV prevention. Earlier Phase 1 and Phase 2 studies demonstrated encouraging safety and tolerability results, supporting continued evaluation in larger populations.

If proven safe and effective, a once-monthly oral PrEP option could significantly expand HIV prevention choices globally and contribute to reducing new HIV infections.

Who Can Participate?

The study is enrolling HIV-negative individuals aged 16 years and above who may be at greater likelihood of HIV exposure, including:

• Cisgender men
• Transgender women
• Transgender men
• Gender nonbinary individuals

Additional eligibility criteria apply, including behavioral and medical screening assessments.

Study Procedures

Participants attend monthly study visits during the study period. Study procedures include:

• HIV testing
• Physical examinations
• Blood sample collection
• STI screening
• Prevention counseling
• Questionnaires
• Pregnancy testing where applicable

The study intervention period may continue for up to 30 months depending on study endpoints and outcomes.

NRHS Commitment to Research Excellence

NRHS remains committed to advancing evidence-based interventions that strengthen public health outcomes and improve access to HIV prevention services. Through participation in global clinical research initiatives such as EXPrESSIVE-11, NRHS contributes to scientific innovation while ensuring ethical, community-centered, and participant-focused research practices.