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

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborators:

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)

Information provided by (Responsible Party):

Connie Celum, University of Washington

Study Description

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.

Condition or disease	Intervention/treatment
HIV/AIDS	Drug: Truvada

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.

Study Design

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Truvada

U.S. FDA Resources

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Other Outcome Measures:

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

Dried blood spots

Eligibility Criteria

Information from the National Library of Medicine

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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

Study Population

Sexually active HIV uninfected women ages 16-25 will be recruited from family planning clinics, youth clinics, and youth outreach programs.

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

Contacts and Locations

Information from the National Library of Medicine

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

Locations

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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

Sponsors and Collaborators

University of Washington

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)

Investigators

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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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Celum CL, Bukusi EA, Bekker LG, Delany-Moretlwe S, Kidoguchi L, Omollo V, Rousseau E, Travill D, Morton JF, Mogaka F, O'Malley G, Barnabee G, van der Straten A, Donnell D, Parikh UM, Kudrick L, Anderson PL, Haberer JE, Wu L, Heffron R, Johnson R, Morrison S, Baeten JM; POWER Study Team. PrEP use and HIV seroconversion rates in adolescent girls and young women from Kenya and South Africa: the POWER demonstration project. J Int AIDS Soc. 2022 Jul;25(7):e25962. doi: 10.1002/jia2.25962.

Roche SD, Barnabee G, Omollo V, Mogaka F, Odoyo J, Bukusi EA, Morton JF, Johnson R, Celum C, Baeten JM, O'Malley G. Implementation strategies for integrating pre-exposure prophylaxis for HIV prevention and family planning services for adolescent girls and young women in Kenya: a qualitative study. BMC Health Serv Res. 2022 Mar 30;22(1):422. doi: 10.1186/s12913-022-07742-8.

Omollo V, Bukusi EA, Kidoguchi L, Mogaka F, Odoyo JB, Celum C, Morton J, Johnson R, Baeten JM. A Pilot Evaluation of Expedited Partner Treatment and Partner Human Immunodeficiency Virus Self-Testing Among Adolescent Girls and Young Women Diagnosed With Chlamydia trachomatis and Neisseria gonorrhoeae in Kisumu, Kenya. Sex Transm Dis. 2021 Oct 1;48(10):766-772. doi: 10.1097/OLQ.0000000000001430.

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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.

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Connie Celum, University of Washington:


pre-exposure prophylaxis young women delivery of health care HIV infections/prevention

Additional relevant MeSH terms:

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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

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