One-stop PrEP Care Pathway to Simplify PrEP Delivery in Kenya: The One-Stop PrEP Care Project

University of Washington

Status: Enrolling

Conditions: HIV Infections

Treatments: Other: Method of PrEP delivery and consultation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05905640

R01MH129234-01A1 (U.S. NIH Grant/Contract)

STUDY00015873

Details and patient eligibility

About

The goal of this cluster randomized study is to understand if using a One stop PrEP delivery model can improve the efficiency of PrEP service delivery, reduce the cost of providing PrEP and allow continuation on PrEP. The investigators will evaluate data from men and women ≥15 years of age unknown to be living with HIV seeking PrEP services at public health facilities in western Kenya.

Full description

This study will evaluate the effectiveness of one-stop PrEP services in 12 public health facilities in Kenya. The core implementation strategies to optimize one-stop PrEP care will include training of healthcare providers, technical assistance, joint clinic supervision with the county health officials, and abstraction of program data regarding PrEP initiations and continuations including characteristics of PrEP users for quality improvement. Within this large program, the study team will recruit a nested observational cohort to obtain detailed complementary individual clinical, behavioral, and mental health outcomes (including for clients who discontinue PrEP).

Enrollment: 2,400 estimated patients

Sex: All

Ages: 15+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• ≥15 years of age
• Accessing PrEP services at implementing clinics.
• Eligible for PrEP per Kenya national guidelines

For in-depth and key delivery informant interviews

• Able and willing to provide consent
• Provides services at participating clinics (healthcare providers)
• Key policy maker

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,400 participants in 2 patient groups

Control arm- Usual PrEP care pathway

No Intervention group

Description:

At clinics that will serve as contemporaneous control clinics, eligible persons will receive PrEP according to the current client flow, which typically involves multiple room consultations. Quality improvement strategies will be promoted throughout the implementation period.

Intervention Arm- One Stop PrEP care pathway

Other group

Description:

In a one-stop arm, the number of client consultation rooms in the PrEP care pathway will be reduced to a single consultation room. All core PrEP services that include HIV testing, risk assessment, clinical review PrEP initiation, prescription, dispensing, and follow-up will be performed in a one-stop consultation with a single provider. Quality improvement strategies will be promoted throughout the implementation period.

Treatment:

Other: Method of PrEP delivery and consultation