NCT05458765

Project Engage: Oral PrEP Acceptability

A Phase II Acceptability Study of Oral Emtricitabine/Tenofovir Alafenamide (F/TAF) vs Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) for the Prevention of HIV Acquisition in Adolescent Girls and Young Women (AGYW)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 330 (actual)
• Sponsor: Eastern Virginia Medical School · Academic / Other
• Sex: Female
• Age: 15 Years – 24 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Acceptability of Health Care
• Adherence, Medication

Interventions

Type	Name	Description
DRUG	emtricitabine/tenofovir alafenamide	200mg/25mg tablet, once daily dosing for 24 weeks
DRUG	Emtricitabine / Tenofovir Disoproxil Oral Tablet	200mg/300mg tablet, once daily dosing for 24 weeks

Timeline

• Start date: 2022-06-21
• Primary completion: 2023-12-13
• Completion: 2024-07-25
• First posted: 2022-07-14
• Last updated: 2024-07-29

Locations

3 sites across 2 countries: South Africa, Zimbabwe

Regulatory

• FDA-regulated drug study