A Cohort for Evaluation of Open-label PrEP Delivery Among Kenyan and South African Women: The POWER Cohort
Overview
- Phase
- Not Applicable
- Intervention
- Truvada
- Conditions
- HIV/AIDS
- Sponsor
- University of Washington
- Enrollment
- 2255
- Locations
- 3
- Primary Endpoint
- Demonstrate PrEP delivery models for young women in different settings and geographies.
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Connie Celum
Prof of Medicine & Global Health, Adjunct Prof of Epidemiology, SOM: Global Health
University of Washington
Eligibility Criteria
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
Arms & Interventions
Young women
Sexually active HIV-uninfected women between 16-25 years of age will be given Truvada.
Intervention: Truvada
Outcomes
Primary Outcomes
Demonstrate PrEP delivery models for young women in different settings and geographies.
Time Frame: Up to 36 months
Mixed methods assessment of how PrEP is implemented at the user, provider, health care facility, and community levels.
Secondary Outcomes
- PrEP initiation(Up to 36 months)
- PrEP adherence(Up to 36 months)
- HIV seroconversion(Up to 36 months)