NCT02732730

Uptake and Adherence to Daily Oral PrEP as a Primary Prevention Strategy for Young African Women: A Vanguard Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 451 (actual)
• Sponsor: HIV Prevention Trials Network · Network
• Sex: Female
• Age: 16 Years – 25 Years
• Healthy volunteers: Accepted

Summary

To assess the acceptance rate, adherence, acceptability, and continuation of oral pre-exposure prophylaxis (PrEP) among young southern African women.

Detailed description

A Phase IV randomized multi-site prospective study to assess PrEP acceptance and adherence among HIV-uninfected young women. All women who accept open-label daily oral PrEP will be randomized 1:1 to receive enhanced adherence counselling based on feedback from observed drug levels or standard adherence support. A subset of up to \~25 women per site (maximum 75), will participate in qualitative assessments of facilitators and barriers for PrEP acceptance, adherence and continuation.

Conditions

• HIV

Interventions

Type	Name	Description
DRUG	Truvada	400 women who accept to initiate PrEP
BEHAVIORAL	Drug level counseling at Weeks 8 and 13	Women who are randomized to enhanced counselling will have adherence monitoring based on plasma TFV levels obtained 4 and 8 weeks after PrEP acceptance

Timeline

• Start date: 2016-10-12
• Primary completion: 2018-10-25
• Completion: 2018-10-25
• First posted: 2016-04-11
• Last updated: 2025-06-12
• Results posted: 2025-06-12

Locations

3 sites across 2 countries: South Africa, Zimbabwe