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The Prevention Options for Women Evaluation Research (POWER) Cohort

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ClinicalTrials.gov Identifier: NCT03490058
Recruitment Status : Recruiting
First Posted : April 6, 2018
Last Update Posted : March 26, 2020
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
University of Pittsburgh
Information provided by (Responsible Party):
Connie Celum, University of Washington

Study Description
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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
Estimated Enrollment : 3000 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
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Truvada

Groups and Cohorts
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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
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Primary Outcome Measures :
  1. 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 :
  1. PrEP initiation [ Time Frame: Up to 36 months ]
    Measure the number of young women who initiate PrEP.

  2. 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.

  3. HIV seroconversion [ Time Frame: Up to 36 months ]
    Assess HIV incidence during PrEP use and non-use.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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.

  4. 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
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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
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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


Contacts
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Contact: Jennifer Morton, MPH 206-520-3832 jfmorton@uw.edu
Contact: Rachel Johnson, MPH 206-520-3864 rjohnso@uw.edu

Locations
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Kenya
Kenya Medical Research Institute Recruiting
Kisumu, Kenya
Contact: Elizabeth Bukusi, MBChB, MMed, MPH, PhD         
South Africa
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         
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
University of Pittsburgh
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
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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
First Posted: April 6, 2018    Key Record Dates
Last Update Posted: March 26, 2020
Last Verified: March 2020
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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Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
 Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents