POWER
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
Study Design:Open label
Arms and Assigned Interventions
DescriptionDrug: Truvada
A fixed dose of oral co-formulated tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) will be used as PrEP.
Mode of DeliveryTablet
ARMsExperimental
DescriptionYoung women
Sexually active HIV-uninfected women between 16-25 years of age will be given Truvada.
Mode of DeliveryTablet
ARMsPlacebo Comparator
Official Code:
The Prevention Options for Women Evaluation Research (POWER) Cohort (https://www.clinicaltrials.gov/ct2/show/NCT03490058)
Trial Sponsors:
Carnegie Mellon University, DTHF, Harvard, KEMRI, Massachusetts General Hospital, RTI, University of Washington ICRC, USAID, Wits RHI
Start Date
End Date
June 14, 2017
June 1, 2021
Enrollment:2,255
Age range:
16 Years ↔
25 Years
Population:Cisgender Women