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EMPOWER Consortium Demonstration Project

Status
Completed
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
Randomized
Open label
Arms and Assigned Interventions
Description
To 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 Delivery
Tablet
Products
TDF/FTC (Truvada)
ARMs
Experimental
Description
Participants 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 Delivery
Tablet
Products
TDF/FTC (Truvada)
ARMs
Placebo Comparator
Official Code
PACTR202006754762723
Related Publications
Disclosure of PrEP use by young women in South Africa and Tanzania: qualitative findings from a demonstration project
Exploring the feasibility and acceptability of integrating screening for gender-based violence into HIV counselling and testing for adolescent girls and young women in Tanzania and South Africa
- Limitations - Local people may 'be biased' not answer wrong; Interviewers are assumed to be trained, but how will they be trained to identify these biases, and what is there fit within the community
Trial Sponsors
Wits RHI, LSHTM, USAID
September 2016
March 2018
Enrollment
431
16
Years
24
Years
Population
Women
Sites

Site(s) - South Africa

South Africa

Site(s) - Tanzania

United Republic of Tanzania

Wits Reproductive Health and HIV Institute (Wits RHI)

Johannesburg
South Africa