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

Not Applicable

Not yet recruiting

• Conditions: HIV Pre-exposure Prophylaxis; Human Immunodeficiency Virus (HIV)

• Registration Number: NCT07089966
• Lead Sponsor: University of Washington

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-05-05
• Study First Submitted QC: 2025-07-22
• Last Update Submitted: 2025-07-22
• Study First Posted: 2025-07-29
• Last Update Posted: 2025-07-29
• Study Start: 2026-04-01
• Primary Completion: 2028-12-31
• Study Completion: 2029-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30000

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
PrEP screening	Up to 42 months	Using individual client-level data at clinics, compare proportion of clients completing PrEP eligibility screening in usual care (control) versus intervention time points
PrEP initiation	Up to 42 months	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.
PrEP continuation	Up to 42 months	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.

Trial Locations

Locations (1)

Kenyatta National Hospital; 🇰🇪 Siaya, Kenya