Primary Objective: Acceptability
- Acceptability: To explore user attitudes, beliefs, experiences, side effects on acceptability of study products
Secondary Objective: Adherence
- Adherence: To explore subjective and objective adherence to study product
Psychometric scales: To evaluate the predictive validity of adherence-related screening and monitoring scales to identify participants with low or inconsistent adherence to study product;
This two arm acceptability study will examine acceptability of, and adherence to, standard oral PrEP once daily dosing regimen of F/TDF and an investigational once daily dosing oral PrEP regimen of F/TAF under standard of care counselling. The study will recruit approximately 300 healthy, HIV negative, AGYW (aged 15-24) in up to three sites. 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. Pregnant/BF women will be allowed to enroll or continue in the study depending on regulatory approval.
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 month 3 and 6, asking women if they had problems taking the pill, what were any side effects, and if it was easy or difficulty to remember to take the pill every day in addition to other questions to learn about potential barriers. Exit interviews at the final visit and additional qualitative interviews and focus group discussions with a subset of participants 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 on interventions that will aide uptake and continuation to inform future programming.
Location: Zengeza CRS