The Prevention Options for Women Evaluation Research (POWER) Cohort
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03490058|
Recruitment Status : Recruiting
First Posted : April 6, 2018
Last Update Posted : March 26, 2020
|Condition or disease||Intervention/treatment|
|Study Type :||Observational|
|Estimated Enrollment :||3000 participants|
|Official Title:||A Cohort for Evaluation of Open-label PrEP Delivery Among Kenyan and South African Women: The POWER Cohort|
|Actual Study Start Date :||June 14, 2017|
|Estimated Primary Completion Date :||July 1, 2020|
|Estimated Study Completion Date :||July 1, 2020|
Sexually active HIV-uninfected women between 16-25 years of age will be given Truvada.
A fixed dose of oral co-formulated tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) will be used as PrEP.
- 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.
- PrEP initiation [ Time Frame: Up to 36 months ]Measure the number of young women who initiate PrEP.
- PrEP adherence [ Time Frame: 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 [ Time Frame: Up to 36 months ]Assess HIV incidence during PrEP use and non-use.
- Assess cost and cost-effectiveness of PrEP when delivered in public health clinics. [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Up to 12 months ]Using a pretest posttest design, evaluate the feasibility of integrating HIV self-testing into PrEP delivery.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03490058
|Contact: Jennifer Morton, MPHfirstname.lastname@example.org|
|Contact: Rachel Johnson, MPHemail@example.com|
|Kenya Medical Research Institute||Recruiting|
|Contact: Elizabeth Bukusi, MBChB, MMed, MPH, PhD|
|Desmond Tutu HIV Foundation||Recruiting|
|Cape Town, South Africa|
|Contact: Linda-Gail Bekker, MBChB, PhD|
|Wits Reproductive Health and HIV Institute||Recruiting|
|Johannesburg, South Africa|
|Contact: Sinead Delany-Moretlwe, MBChB, PhD|
|Principal Investigator:||Connie L Celum, MD, MPH||University of Washington|
|Principal Investigator:||Jared M Baeten, MD, PhD||University of Washington|
|Study Director:||Rachel Johnson, MPH||University of Washington|