The Prevention Options for Women Evaluation Research (POWER) Cohort

HIV/AIDS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03490058
• Other study ID #: STUDY00000950
• Secondary ID: R01MH114544AID-O
• Status: Completed
• Start date: June 14, 2017
• Est. completion date: July 23, 2021

Study information

• Verified date: December 2021
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2255
• Est. completion date: July 23, 2021
• Est. primary completion date: December 4, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS

Intervention

Drug:
• Truvada
A fixed dose of oral co-formulated tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) will be used as PrEP.

Locations

Country	Name	City	State
Kenya	Kenya Medical Research Institute	Kisumu
South Africa	Desmond Tutu HIV Foundation	Cape Town
South Africa	Wits Reproductive Health and HIV Institute	Johannesburg

Sponsors (9)

Lead Sponsor	Collaborator
University of Washington	Desmond Tutu HIV Foundation, Harvard Medical School (HMS and HSDM), Kenya Medical Research Institute, National Institute of Mental Health (NIMH), RTI International, United States Agency for International Development (USAID), University of Pittsburgh, Wits Reproductive Health and HIV Institute

Countries where clinical trial is conducted

Kenya,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Primary	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	PrEP initiation	Measure the number of young women who initiate PrEP.	Up to 36 months
Secondary	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
Secondary	HIV seroconversion	Assess HIV incidence during PrEP use and non-use.	Up to 36 months