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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
330
200mg/25mg tablet, once daily dosing for 24 weeks
200mg/300mg tablet, once daily dosing for 24 weeks
MatCH Research Unit
Durban, KwaZulu-Natal, South Africa
CAPRISA Vulindlela
Pietermaritzburg, KwaZulu-Natal, South Africa
Harare Health and Research Consortium (HHRC)
Harare, Zimbabwe
Compare the discontinuation rate between arms
Acceptability will be assessed by discontinuation of study product
Time frame: 3 months
Adherence to study product
Concentrations of TFV-DP and FTC-TP in dried blood spots (DBS)
Time frame: 3 months
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