The Prevention Options for Women Evaluation Research (POWER) Cohort

NCT03490058 | Completed

• 3 other identifiers: STUDY00000950R01MH114544AID-OAA-A-15-00034
• Study Type: observational
• Target: 2,255
• Locations: 2 countries
• Sites: 3

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.

Conditions

HIV/AIDS

Keywords

pre-exposure prophylaxis; young women; delivery of health care; HIV infections/prevention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• PrEP initiation

  Up to 36 months

• PrEP adherence

  Up to 36 months

• HIV seroconversion

  Up to 36 months

Other Outcomes (4)

• Assess cost and cost-effectiveness of PrEP when delivered in public health clinics.

  Up to 36 months

• Evaluate the acceptability of delivering expedited partner therapy.

  Up to 36 months

• Assess the effect of a decision support tool on PrEP uptake

  Up to 36 months

Study Arms (1)

Young women

Sexually active HIV-uninfected women between 16-25 years of age will be given Truvada.

Drug: Truvada

Interventions

Truvada DRUG

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

Young women

Eligibility Criteria

• Age: 16 Years - 25 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (3)

Kenya Medical Research Institute

Kisumu, Kenya

Location

Desmond Tutu HIV Foundation

Cape Town, South Africa

Location

Wits Reproductive Health and HIV Institute

Johannesburg, South Africa

Location

Related Publications (4)

• Katz AWK, Roberts S, Rousseau E, Khoza MN, Mogaka F, Bukusi E, Delany-Moretlwe S, Bekker LG, Morton JF, Johnson R, Baeten JM, Celum C, van der Straten A. Qualitative Analysis Using Social Maps to Explore Young Women's Experiences With Social Support of their Oral PrEP Use in Kenya and South Africa. J Assoc Nurses AIDS Care. 2023 Jan-Feb 01;34(1):45-57. doi: 10.1097/JNC.0000000000000363. Epub 2022 Sep 23.

  PMID: 36170124 DERIVED

• 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.

  PMID: 35822945 DERIVED

• 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.

  PMID: 35354456 DERIVED

• 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.

  PMID: 33859147 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Dried blood spots

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; HIV Infections

Interventions

Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Tenofovir; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Emtricitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Connie L Celum, MD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

• Jared M Baeten, MD, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

• Rachel Johnson, MPH

  University of Washington

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof of Medicine & Global Health, Adjunct Prof of Epidemiology, SOM: Global Health

Study Record Dates

• First Submitted: March 19, 2018
• First Posted: April 6, 2018
• Study Start: June 14, 2017
• Primary Completion: December 4, 2020
• Study Completion: July 23, 2021
• Last Updated: December 6, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share

Locations

KE (1); ZA (2)