The Prevention Options for Women Evaluation Research (POWER) Cohort
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ClinicalTrials.gov Identifier: NCT03490058 |
Recruitment Status :
Completed
First Posted : April 6, 2018
Last Update Posted : December 6, 2021
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Condition or disease | Intervention/treatment |
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HIV/AIDS | Drug: Truvada |
Study Type : | Observational |
Actual Enrollment : | 2255 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
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 |
Actual Primary Completion Date : | December 4, 2020 |
Actual Study Completion Date : | July 23, 2021 |

Group/Cohort | Intervention/treatment |
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Young women
Sexually active HIV-uninfected women between 16-25 years of age will be given Truvada.
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Drug: 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

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Ages Eligible for Study: | 16 Years to 25 Years (Child, Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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

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
Kenya | |
Kenya Medical Research Institute | |
Kisumu, Kenya | |
South Africa | |
Desmond Tutu HIV Foundation | |
Cape Town, South Africa | |
Wits Reproductive Health and HIV Institute | |
Johannesburg, South Africa |
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 |
Responsible Party: | Connie Celum, Prof of Medicine & Global Health, Adjunct Prof of Epidemiology, SOM: Global Health, University of Washington |
ClinicalTrials.gov Identifier: | NCT03490058 |
Other Study ID Numbers: |
STUDY00000950 R01MH114544 ( U.S. NIH Grant/Contract ) AID-OAA-A-15-00034 ( Other Grant/Funding Number: US Agency for International Development ) |
First Posted: | April 6, 2018 Key Record Dates |
Last Update Posted: | December 6, 2021 |
Last Verified: | December 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Data from the POWER Cohort Study will be available at the end of the project by contacting the Principal Investigators. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
pre-exposure prophylaxis young women delivery of health care HIV infections/prevention |
Acquired Immunodeficiency Syndrome HIV Infections Blood-Borne Infections Communicable Diseases Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Slow Virus Diseases |
Immunologic Deficiency Syndromes Immune System Diseases Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Anti-HIV Agents Anti-Retroviral Agents |