HIV Testing Counselor-led Care to Catalyze Integration of PrEP Delivery in Family Planning Clinics: The HIV Testing Services PrEP Integration (HTS PrEP) Project
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Washington
- Enrollment
- 30,000
- Locations
- 1
- Primary Endpoint
- PrEP screening
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 15 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts 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
Exclusion Criteria
- Not provided
Arms & Interventions
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.
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.
Intervention: HTS counselor-led PrEP care model (Other)
Outcomes
Primary Outcomes
PrEP screening
Time Frame: 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
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Kenneth K Mugwanya
Associate Professor: School of Medicine, Global Health
University of Washington