NCT05905640

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,400 (estimated)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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).

Conditions

• HIV Infections

Interventions

Type	Name	Description
OTHER	Method of PrEP delivery and consultation	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.

Timeline

• Start date: 2024-01-01
• Primary completion: 2027-04-30
• Completion: 2027-07-31
• First posted: 2023-06-15
• Last updated: 2025-04-17

Locations

1 site across 1 country: Kenya