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Status
Ongoing
Phase
Demo Project
Principal Investigator(s)
Connie L Celum, MD, MPH, Jared M Baeten, MD, PhD
Objective
The POWER Cohort study is a PrEP implementation project to demonstrate Pre-exposure prophylaxis (PrEP) delivery for young women in Cape Town and Johannesburg, South Africa and Kisumu, Kenya.
PrEP will be delivered to young women according to emerging national guidelines in family planning clinics (Kisumu, Kenya), youth friendly clinics (Johannesburg, South Africa), and mobile youth friendly clinics (Cape Town, South Africa). The investigators will evaluate PrEP delivery and follow cohorts of young women at each clinic location to understand PrEP uptake and use. In the Kisumu clinics, the investigators will also offer expedited partner therapy and partner HIV self-tests to women who test positive for chlamydia and/or gonorrhea. At one clinic in Johannesburg, the investigators will evaluate the use of a decision support tool to improve the decision to initiate PrEP.
Prevention Option(s)
Microbicides
PrEP
Observational
Prospective Cohort
Study Design
Open label
Arms and Assigned Interventions
Description
Drug: Truvada
A fixed dose of oral co-formulated tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) will be used as PrEP.
Mode of Delivery
Tablet
Products
TDF/FTC (Truvada)
ARMs
Experimental
Description
Young women
Sexually active HIV-uninfected women between 16-25 years of age will be given Truvada.
Mode of Delivery
Tablet
Products
TVF/FTC
ARMs
Placebo Comparator
Trial Sponsors
University of Washington ICRC, Carnegie Mellon University, DTHF, Harvard U., KEMRI, Massachusetts General Hospital, RTI, Wits RHI, USAID
June 2017
June 2021
Enrollment
2 255
16
Years
25
Years
Population
Women
Sites
Desmond Tutu Clinical Research Center
Cape Town, South Africa
South Africa
Wits Reproductive Health and HIV Institute (Wits RHI)
Johannesburg
South Africa
Kenya Medical Research Institute
Kenya