The Prevention Options for Women Evaluation Research (POWER) Cohort

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Cohort for Evaluation of Open-label PrEP Delivery Among Kenyan and South African Women: The POWER Cohort

Conditions
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HIV/AIDS

Intervention / Treatment
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* Drug: Truvada


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Young women<br>Sexually active HIV-uninfected women between 16-25 years of age will be given Truvada. | Drug: Truvada<br>* A fixed dose of oral co-formulated tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) will be used as PrEP.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PrEP initiation | Measure the number of young women who initiate PrEP. | 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. | Up to 36 months | 
| HIV seroconversion | Assess HIV incidence during PrEP use and non-use. | Up to 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pre-exposure prophylaxis, young women, delivery of health care, HIV infections/prevention