The Prevention Options for Women Evaluation Research (POWER) Cohort

University of Washington2,255 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

2,255

Conditions

HIV/AIDS

Interventions

TruvadaDRUG

A fixed dose of oral co-formulated tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) will be used as PrEP.

Eligibility

Sex: FEMALEMin age: 16 YearsMax age: 25 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

Demonstrate PrEP delivery models for young women in different settings and geographies.

Mixed methods assessment of how PrEP is implemented at the user, provider, health care facility, and community levels.

Time frame: Up to 36 months

Secondary Outcomes

PrEP initiation

Measure the number of young women who initiate PrEP.

Time frame: Up to 36 months

PrEP adherence

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.

Time frame: Up to 36 months

HIV seroconversion

Assess HIV incidence during PrEP use and non-use.

Time frame: Up to 36 months

Data from ClinicalTrials.gov

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