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NCT Number: NCT03490058

The Prevention Options for Women Evaluation Research (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.

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Key information

Conditions

HIV/AIDS Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

16 year–25 year

Sex eligibility

Female

Study type

Observational

Primary location

Kenya Medical Research Institute, Kisumu, Kenya

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Truvada

Drug

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

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • 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

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Apr 6, 2018
Registry last updated
Dec 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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