Phase 3 efficacy trial of monthly oral PrEP in African women (EXPrESSIVE-10), in partnership with Merck, MSD, and Gates Foundation (EXPrESSIVE Study, Celum, PI)
The EXPrESSIVE-10 trial is evaluating the efficacy and safety of a once monthly oral PrEP candidate, MK-8527, which is a potent Nucleoside Reverse Transcriptase Translocator Inhibitor (NRTTI) that has a long half-life allowing monthly dosing. This efficacy trial is being conducted in 31 sites in Kenya, South Africa, and Uganda among young women and which will compare monthly oral MK-8572 to daily oral emtricitabine/tenofovir (FTC/TDF) for HIV prevention. ICRC is supporting Merck and MSD and the 31 sites in study implementation. If MK-8527 is found to be efficacious as long-acting oral PrEP, it would provide a cost-effective PrEP option that would facilitate adherence, community-based PrEP delivery, and impact.
Adherence efficacy relationships for tenofovir-based PrEP in African women; (Benchmark study, Mugwanya, PI)
Pharmacologic measures of adherence have become key to accurate interpretation of HIV prevention trials and programs. But they require clear understanding of the relationship between drug dosing and the resulting concentrations in multiple biologic matrices. This portfolio of studies will conduct comprehensive study to comprehensive define the pharmacology of daily oral tenofovir disoproxil fumarate and emtricitabine and emtricitabine/tenofovir alafenamide pre-exposure prophylaxis (PrEP) in African women. Specifically, this work will help to define the adherence concentrations thresholds in dried blood spot and peripheral blood mononuclear cells, concentration associated with HIV protection in African women and quantify and compare matrix-specific kinetics in non-pregnant and pregnant women.
PrEP integration in FP clinics (FP Plus and HIV Testing Services studies, Mugwanya, PI)
Family planning clinics offer broad coverage of sexually active women and may HIV an efficient platform to reach women at elevated risk for HIV acquisitions. In this portfolio of studies, we are using rigorous implementation science methods in collaboration with local public health system to define women-centered, efficient, and sustainable models to integrate pre-exposure prophylaxis (PrEP) delivery in real-world public health family clinics in Kenya.
Adolescents Girls and Young Women Pharmacy PrEP (AGYW Pharmacy PrEP RCT, Pintye, PI)
We are partnering with the Kenya Ministry of Health to expand a successful pilot funded by the Gates Foundation that offered HIV PrEP at local pharmacies in Kisumu, Kenya. Our ongoing NIH-funded study offers both daily oral HIV PrEP and the dapivirine vaginal ring to adolescent girls and young women seeking contraception at local pharmacies. By integrating these services at 20 pharmacies, we aim to find practical, cost-effective ways to bring HIV prevention to more adolescent girls and young women.