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

University of Washington

Status: Begins enrollment in 1 month

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

Treatments: Other: HTS counselor-led PrEP care model

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07089966

R01MH136842-01 (U.S. NIH Grant/Contract)

STUDY00022678

Details and patient eligibility

About

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.

Enrollment: 30,000 estimated patients

Sex: All

Ages: 15+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30,000 participants in 2 patient groups

Control (Usual care)

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Other: HTS counselor-led PrEP care model