HIV Testing Counselor-led Care to Catalyze Integration of PrEP Delivery in Family Planning Clinics

NCT ID: NCT07089966

Last Updated: 2025-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-04-01

Study Completion Date

2029-06-30

Brief Summary

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This is a cluster randomized, stepped wedge implementation study to introduce HIV testing services (HTS) counselor-led PrEP care in public health clinics in Kenya.

Detailed Description

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Conditions

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Human Immunodeficiency Virus (HIV) HIV Pre-exposure Prophylaxis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Stepped-wedge cluster randomized trial of 20 public health clinics implementing the intervention of HTS counselor-led PrEP care
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control (Usual care)

The control period (usual care) will be when the clinics are still implementing the usual care model, prior to implementing the intervention. Prior to launching the intervention, all facilities will have a baseline phase of 3 months. That time, in conjunction with other periods when the clinics are implementing usual care will serve as the control period.

Group Type NO_INTERVENTION

No interventions assigned to this group

HTS counselor-led PrEP care model

During the intervention period, all core components of PrEP delivery - including HIV testing, eligibility assessment, dispensing, adherence counseling, and provision of refills will be conducted by existing facility HTS counselor as part of standard of care.

Group Type EXPERIMENTAL

HTS counselor-led PrEP care model

Intervention Type OTHER

PrEP delivery ,including HIV testing, eligibility assessment, dispensing, adherence counseling, and provision of refills, provided by an HTS counselor

Interventions

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HTS counselor-led PrEP care model

PrEP delivery ,including HIV testing, eligibility assessment, dispensing, adherence counseling, and provision of refills, provided by an HTS counselor

Intervention Type OTHER

Other Intervention Names

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HTS-led PrEP

Eligibility Criteria

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Inclusion Criteria

* ≥15 years of age
* Accessing health services at participating public health facilities.
* Not known to be living with HIV prior to the visit when their clinical data is first abstracted
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Kenneth K Mugwanya

Associate Professor: School of Medicine, Global Health

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kenneth Mugwanya, MBChB, MS, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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Kenyatta National Hospital

Kisumu, , Kenya

Site Status

Kenyatta National Hospital

Siaya, , Kenya

Site Status

Countries

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Kenya

Central Contacts

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Laura Drown

Role: CONTACT

803-403-5487

Facility Contacts

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Daniel Matemo

Role: primary

+254 722 322378

Daniel Matemo

Role: primary

+254 722 322378

Other Identifiers

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R01MH136842-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00022678

Identifier Type: -

Identifier Source: org_study_id

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