The Prevention Options for Women Evaluation Research (POWER) Cohort

A Cohort for Evaluation of Open-label PrEP Delivery Among Kenyan and South African Women: The POWER Cohort

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.

Study Overview

• Status: Completed
• Conditions: HIV/AIDS
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 2255

Contacts and Locations

Study Locations

• Kenya
  • Kisumu, Kenya
    • Kenya Medical Research Institute
• South Africa
  • Cape Town, South Africa
    • Desmond Tutu HIV Foundation
  • Johannesburg, South Africa
    • Wits Reproductive Health and HIV Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 25 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demonstrate PrEP delivery models for young women in different settings and geographies.	Mixed methods assessment of how PrEP is implemented at the user, provider, health care facility, and community levels.	Up to 36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PrEP initiation	Measure the number of young women who initiate PrEP.	Up to 36 months
PrEP adherence	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.	Up to 36 months
HIV seroconversion	Assess HIV incidence during PrEP use and non-use.	Up to 36 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess cost and cost-effectiveness of PrEP when delivered in public health clinics.	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.	Up to 36 months
Evaluate the acceptability of delivering expedited partner therapy.	Measure the number of women who accept STI expedited partner therapy and HIV self-test kits for their partners.	Up to 36 months
Assess the effect of a decision support tool on PrEP uptake	Using a randomized design, evaluate if a decision support tool increases PrEP uptake.	Up to 36 months
Evaluate the impact of HIV self-testing on PrEP delivery among young women receiving PrEP	Using a pretest posttest design, evaluate the feasibility of integrating HIV self-testing into PrEP delivery.	Up to 12 months

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: Harvard Medical School (HMS and HSDM); National Institute of Mental Health (NIMH); University of Pittsburgh; United States Agency for International Development (USAID); Kenya Medical Research Institute; RTI International; Desmond Tutu HIV Foundation; Wits Reproductive Health and HIV Institute
• Investigators: Principal Investigator: Connie L Celum, MD, MPH, University of Washington; Study Director: Rachel Johnson, MPH, University of Washington

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 14, 2017
• Primary Completion (ACTUAL): December 4, 2020
• Study Completion (ACTUAL): July 23, 2021

Study Registration Dates

• First Submitted: March 19, 2018
• First Submitted That Met QC Criteria: March 29, 2018
• First Posted (ACTUAL): April 6, 2018

Study Record Updates

• Last Update Posted (ACTUAL): December 6, 2021
• Last Update Submitted That Met QC Criteria: December 2, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: delivery of health care; pre-exposure prophylaxis; young women; HIV infections/prevention
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
• Other Study ID Numbers: STUDY00000950; R01MH114544 (U.S. NIH Grant/Contract); AID-OAA-A-15-00034 (OTHER_GRANT: US Agency for International Development)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data from the POWER Cohort Study will be available at the end of the project by contacting the Principal Investigators.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No