Clinical trial NCT03490058: The Prevention Options for Women Evaluation Research (POWER) Cohort
Official title: A Cohort for Evaluation of Open-label PrEP Delivery Among Kenyan and South African Women: The POWER Cohort
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV/AIDS
Keywords: pre-exposure prophylaxis
young women
delivery of health care
HIV infections/prevention
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Desmond Tutu HIV Foundation
name: Wits Reproductive Health and HIV Institute
name: Kenya Medical Research Institute
name: United States Agency for International Development (USAID)
name: RTI International
name: Harvard Medical School (HMS and HSDM)
name: University of Pittsburgh
name: National Institute of Mental Health (NIMH)
First posted: 2018-04-06
Enrollment: 2255
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Demonstrate PrEP delivery models for young women in different settings and geographies.
timeFrame: Up to 36 months
Secondary outcomes:
measure: PrEP initiation
timeFrame: Up to 36 months
measure: PrEP adherence
timeFrame: Up to 36 months
measure: HIV seroconversion
timeFrame: Up to 36 months
Other outcomes:
measure: Assess cost and cost-effectiveness of PrEP when delivered in public health clinics.
timeFrame: Up to 36 months
measure: Evaluate the acceptability of delivering expedited partner therapy.
timeFrame: Up to 36 months
measure: Assess the effect of a decision support tool on PrEP uptake
timeFrame: Up to 36 months
measure: Evaluate the impact of HIV self-testing on PrEP delivery among young women receiving PrEP
timeFrame: Up to 12 months
Locations:
city: Kisumu
country: Kenya
facility: Kenya Medical Research Institute
city: Cape Town
country: South Africa
facility: Desmond Tutu HIV Foundation
city: Johannesburg
country: South Africa
facility: Wits Reproductive Health and HIV Institute
Study officials:
affiliation: University of Washington
name: Connie L Celum, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Jared M Baeten, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Rachel Johnson, MPH
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.