The Prevention Options for Women Evaluation Research (POWER) Cohort

Completed

• Conditions: HIV/AIDS
• Interventions: Drug: Truvada

• Registration Number: NCT03490058
• Lead Sponsor: University of Washington

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2017-06-14
• Study First Submitted: 2018-03-19
• Study First Submitted QC: 2018-03-29
• Study First Posted: 2018-04-06
• Primary Completion: 2020-12-04
• Study Completion: 2021-07-23
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-02
• Last Update Posted: 2021-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 2255

Inclusion Criteria

• Age 16-25 (16 and 17 year olds, where permissible by national regulations and local IRB approval)
• Able and willing to provide written informed consent
• Recently sexually active (defined as having had vaginal intercourse at least once in the previous three months)
• HIV uninfected based on negative HIV rapid tests, on the date of enrollment

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Young women	Truvada	Sexually active HIV-uninfected women between 16-25 years of age will be given Truvada.

Primary Outcome Measures

Name	Time	Method
Demonstrate PrEP delivery models for young women in different settings and geographies.	Up to 36 months	Mixed methods assessment of how PrEP is implemented at the user, provider, health care facility, and community levels.

Secondary Outcome Measures

Name	Time	Method
PrEP initiation	Up to 36 months	Measure the number of young women who initiate PrEP.
PrEP adherence	Up to 36 months	Adherence by young women to PrEP. Adherence will be measured by the timing of PrEP refills and self-reported PrEP use. Blood samples for detection and quantification of PrEP levels (testing in batch) will be done for those who seroconvert to HIV and a subset who remain HIV uninfected.
HIV seroconversion	Up to 36 months	Assess HIV incidence during PrEP use and non-use.

Trial Locations

Locations (3)

Kenya Medical Research Institute; 🇰🇪 Kisumu, Kenya

Desmond Tutu HIV Foundation; 🇿🇦 Cape Town, South Africa

Wits Reproductive Health and HIV Institute; 🇿🇦 Johannesburg, South Africa