Project Engage: Oral PrEP Acceptability

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

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

Sponsors & Collaborators

• CONRAD

  collaborator OTHER

• FHI 360

  collaborator OTHER

• United States Agency for International Development (USAID)

  collaborator FED

• Gilead Sciences

  collaborator INDUSTRY

• Eastern Virginia Medical School

  lead OTHER

Principal Investigators

• Gustavo Doncel, MD,PhD · CONRAD/EVMS

• Homaira Hanif, PhD · CONRAD/EVMS

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

15 Years

Max Age

24 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-06-21

Primary Completion

2023-12-13

Completion

2024-07-25

FDA Drug

Yes

Countries

• South Africa
• Zimbabwe

Study Locations