HIV/AIDS
Conditions
Keywords
pre-exposure prophylaxis, young women, delivery of health care, HIV infections/prevention
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.
Interventions
DRUGTruvada
A fixed dose of oral co-formulated tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) will be used as PrEP.
Sponsors
Desmond Tutu HIV Foundation
Wits Reproductive Health and HIV Institute
Kenya Medical Research Institute
United States Agency for International Development (USAID)
RTI International
Harvard Medical School (HMS and HSDM)
University of Pittsburgh
National Institute of Mental Health (NIMH)
University of Washington
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 25 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| HIV seroconversion | Up to 36 months | Assess HIV incidence during PrEP use and non-use. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Assess cost and cost-effectiveness of PrEP when delivered in public health clinics. | Up to 36 months | Time-motion studies will be conducted to define the cost and cost effectiveness of the intervention in terms of HIV infections averted, disability-adjusted life years saved, and incremental cost-effectiveness of PrEP over routine HIV care. |
| Evaluate the acceptability of delivering expedited partner therapy. | Up to 36 months | Measure the number of women who accept STI expedited partner therapy and HIV self-test kits for their partners. |
| Assess the effect of a decision support tool on PrEP uptake | Up to 36 months | Using a randomized design, evaluate if a decision support tool increases PrEP uptake. |
| Evaluate the impact of HIV self-testing on PrEP delivery among young women receiving PrEP | Up to 12 months | Using a pretest posttest design, evaluate the feasibility of integrating HIV self-testing into PrEP delivery. |
Countries
Kenya, South Africa
Outcome results
None listed