EMPOWER Consortium Demonstration Project

Phase:Demo Project
Principal Investigator(s):Sinead Delany Moretlwe
Objective:An initiative of STRIVE, a research consortium investigating the social norms and inequalities that drive HIV, that integrates violence prevention and combination prevention, including PrEP. Aims to assess whether it is feasible, acceptable, and safe to offer oral PrEP as part of a combination prevention package that addresses gender-based violence (GBV) and HIV.     Last updated May 14, 2021
Prevention Option(s):Microbicides, PrEP
Study Design:Open label, Randomized
Arms and Assigned Interventions
DescriptionTo assess whether it is feasable, acceptable and safe to offer oral PrEP as part of a combination HIV prevention package that addresses GBV, stigma and HIV in AGYW aged 16 - 24 years in two sites. ( South and Tanzania). This study will enrol up to 500 PrEP acceptors in the study. Participants who initially decline PrEP at enrolment have the option to accept PrEP during the first six months of the study until accrual is complete. The study is an open-label study whereby all enrolled participants will be offered oral PrEP as part of the combination prevention package. Within the cohort of women receiving oral PrEP participants will be randomly assigned to receive standard adherence support only or be invited to participate in EMPOWER clubs in addition to the standard adherence support.
Mode of DeliveryTablet
DescriptionParticipants who accept oral PrEP will be randomised in a 1:1 ratio to receive standard adherence support (counselling and SMS support) compared to enhanced adherence support which includes allocation to adherence support clubs that will offer a four-session empowerment intervention in addition to the standard adherence support
Mode of DeliveryTablet
ARMsPlacebo Comparator
Official Code: PACTR202006754762723
Trial Sponsors: LSHTM, USAID, Wits RHI
Start Date
End Date
September 1, 2016
March 30, 2018
Age range: 16 Years ↔ 24 Years
Population:Cisgender Women