This study is a two-arm open label acceptability study that will examine acceptability of,
and adherence to, once daily dosing regimen of F/TDF (Truvada) and an investigational once
daily dosing regimen of F/TAF (Descovy) under standard of care counselling. The study will
recruit approximately 330 healthy, HIV negative, AGYW in up to three sites in Africa.
Eligible participants will be randomized 1:1 to receive F/TAF 200 mg/25 mg or F/TDF 200
mg/300 mg for once daily oral administration for 24 weeks.
Study visits will take place according to standard of care at month 1, month 3 and month 6.
Acceptability and adherence will be assessed by questionnaires and DBS at months 3 and 6;
questionnaires will assess acceptability of product attributes; perceived pill side effects;
ease of pill-taking and reasons for missed pills, and future interest in PrEP use beyond the
trial context. Exit interviews at the final visit and additional qualitative interviews and
focus group discussions with a subset of participants as well as other key stakeholders will
further inform potential differences in acceptability and adherence between the two products.
Data collection will also focus on gathering insights and input from participants that will
aid uptake and continuation and inform future programming of oral PrEP.
Phase:
Phase 2
Details
Lead Sponsor:
Eastern Virginia Medical School
Collaborators:
CONRAD FHI 360 Gilead Sciences United States Agency for International Development (USAID)