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

HIV Testing Counselor-led Care to Catalyze Integration of PrEP Delivery in Family Planning Clinics: The HIV Testing Services PrEP Integration (HTS PrEP) Project

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07089966

Acronym

HTS PrEP

Enrollment

30000

Registered

2025-07-29

Start date

2025-12-01

Completion date

2029-06-30

Last updated

2026-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

PrEP, HIV Prevention

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.

Interventions

OTHERHTS counselor-led PrEP care model

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

15 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Kenya

Contacts

CONTACTClare Brown, PhD

brownce@uw.edu206-543-8225

PRINCIPAL_INVESTIGATORKenneth Mugwanya, MBChB, MS, PhD

University of Washington

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 19, 2026