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PrEParing Family Planning Clinics to Streamline Integration of HIV Prevention Services for Young Women in Kenya

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ClinicalTrials.gov Identifier: NCT04666792
Recruitment Status : Recruiting
First Posted : December 14, 2020
Last Update Posted : September 20, 2021
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Kenyatta National Hospital
Kenya National AIDS & STI Control Programme
Kisumu County Government
Information provided by (Responsible Party):
Kenneth K Mugwanya, University of Washington

Study Description
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Brief Summary:
This a prospective, open-label implementation project to catalyze integration of HIV prevention and PrEP care services for adolescent girls and young women in family planning clinics in Kenya.

Condition or disease Intervention/treatment Phase
HIV Infections Contraception STI Drug: PrEP Phase 4

Detailed Description:
Investigators will conduct a stepped-wedge cluster-randomized programmatic project to integrate PrEP provision within a combination HIV prevention package in 12 family planning clinics in Kisumu, Kenya- a region with an HIV prevalence of up to 28% among young women. The project will optimize and sustain PrEP delivery with existing family planning staff, supported through training and ongoing technical assistance. The investigators will rigorously evaluate program reach, effectiveness, adoption, implementation, maintenance, and impact using validated implementation science frameworks and how clinics build new efficient delivery systems.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3600 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This a programmatic stepped-Wedge cluster randomized trial
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: PrEParing Family Planning Clinics to Streamline Integration of HIV Prevention Services for Young Women in Kenya
Actual Study Start Date : March 1, 2021
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
PrEP for HIV-1 uninfected for women accessing family planning
Women accessing family planning will be assessed for HIV risk and PrEP eligibility. If eligible and willing to initiate PrEP, they will be provided PrEP in accordance with national guidelines as part of their standard of care at the family planning clinic.
 Drug: PrEP
A fixed-dose, oral co-formulation of emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) is the approved and preferred regimen for HIV-1 prevention in Kenya and the United States. The World Health Organization (WHO) recommends TDF-containing medications as PrEP, which includes TDF combined with FTC as well as potentially TDF alone and TDF combined with lamivudine (or 3TC, a medication closely related to FTC). Any TDF-containing medications that align with WHO and Kenya national guidelines for PrEP will be used. PrEP medication will come from clinic stocks.


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of women accessing family planning services who are screened for HIV risk [ Time Frame: up to 24 months ]
    Measure HIV risk screening completion among women receiving family planning services

  2. Proportion of women accessing family planning services who uptake PrEP for HIV prevention [ Time Frame: up to 24 months ]
    Measure PrEP initiation among women receiving family planning services


Secondary Outcome Measures :
  1. PrEP adherence quantified by tenofovir drug levels in blood [ Time Frame: up to 24 months ]
    Measure PrEP adherence among women who initiate PrEP

  2. Proportion of women who remain HIV-negative [ Time Frame: up to 24 months ]
    Assess HIV status of women receiving family planning services

  3. Proportion of family planning clinics that implement PrEP provision [ Time Frame: up to 36 months ]
    Measure number of clinics that provide PrEP

  4. Proportion of targeted providers who are trained and provide PrEP [ Time Frame: up to 24 months ]
    Measure number of providers in family planning clinics who implement PrEP

  5. Proportion of core PrEP delivery components delivered per protocol [ Time Frame: up to 24 months ]
    Measure fidelity to PrEP delivery procedures in family planning clinics

  6. Facilitators and barriers to PrEP implementation [ Time Frame: up to 24 months ]
    Mixed methods assessment of clinic readiness and ability to implement PrEP per protocol

  7. Programmatic costs of providing PrEP in family planning clinics [ Time Frame: up to 24 months ]
    Conduct micro-costing, cost-effectiveness, and budget impact analyses to estimate the programmatic costs of providing PrEP in family planning clinics

  8. Develop data tools to expand and support delivery of family planning and HIV prevention services [ Time Frame: up to 24 months ]
    Coordinate with key stakeholders to develop and refine data tools and clinical delivery products during project implementation


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female of reproductive age
  • Sexually active
  • Able and willing to provide informed consent
  • HIV negative, according to national HIV testing algorithm
  • Has at least one risk factor for HIV as defined by the Kenya National AIDS and STI Control Program

Exclusion Criteria:

- Otherwise not eligible based on the above inclusion criteria

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04666792


Contacts
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Contact: Justice Quame-Amaglo 206 520-3866 quamaglo@uw.edu

Locations
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Kenya
Kenyatta National Hospital Recruiting
Kisumu, Kenya
Contact: John Kinuthia, MBChB, M.Med., MPH       kinuthia@uw.edu   
Sponsors and Collaborators
University of Washington
National Institute of Mental Health (NIMH)
Kenyatta National Hospital
Kenya National AIDS & STI Control Programme
Kisumu County Government
Investigators
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Principal Investigator: Kenneth Mugwanya, MBChB, MS, PhD University of Washington
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Kenneth K Mugwanya, Assistant Professor, Global Health, School of Medicine and School of Public Health,, University of Washington
ClinicalTrials.gov Identifier: NCT04666792    
Other Study ID Numbers: STUDY00009583
R01MH123267 ( U.S. NIH Grant/Contract )
First Posted: December 14, 2020    Key Record Dates
Last Update Posted: September 20, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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HIV Infections
Blood-Borne Infections
Communicable Diseases
Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
 Retroviridae Infections
RNA Virus Infections
Virus Diseases
Genital Diseases
Urogenital Diseases
Immunologic Deficiency Syndromes
Immune System Diseases