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

NCT07089966 | Not Yet Recruiting DMC

• 2 other identifiers: STUDY00022678R01MH136842-01
• Study Type: interventional
• Target: 30,000
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Human Immunodeficiency Virus (HIV); HIV Pre-exposure Prophylaxis

Keywords

PrEP; HIV Prevention

Outcome Measures

Primary Outcomes (3)

• PrEP screening

  Using individual client-level data at clinics, compare proportion of clients completing PrEP eligibility screening in usual care (control) versus intervention time points

  Up to 42 months

• PrEP initiation

  Using individual client-level data at clinics, compare PrEP initiation in usual care (control) versus intervention time points. PrEP initiation will be measured as the proportion of eligible clients starting PrEP use documented on ministry of health (MOH) tools.

  Up to 42 months

• PrEP continuation

  Using individual client-level data at clinics, compare PrEP continuation in usual care (control) versus intervention time points. PrEP continuation among clients initiating PrEP will be determined by clinic visit attendance and pharmacy PrEP refill records obtained by abstraction of MOH clinic records.

  Up to 42 months

Study Arms (2)

Control (Usual care)

NO INTERVENTION

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.

HTS counselor-led PrEP care model

EXPERIMENTAL

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.

Other: HTS counselor-led PrEP care model

Interventions

HTS counselor-led PrEP care model OTHER

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

Also known as: HTS-led PrEP

HTS counselor-led PrEP care model

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

Kenyatta National Hospital

Kisumu, Kenya

Location

Kenyatta National Hospital

Siaya, Kenya

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; 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

Study Officials

• Kenneth Mugwanya, MBChB, MS, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Drown

CONTACT

803-403-5487; ldrown@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor: School of Medicine, Global Health

Model Details: Stepped-wedge cluster randomized trial of 20 public health clinics implementing the intervention of HTS counselor-led PrEP care

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: July 29, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): June 30, 2029
• Last Updated: July 29, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

KE (2)