Clinical trial NCT05905640: One-stop PrEP Care Pathway to Simplify PrEP Delivery in Kenya: The One-Stop PrEP Care Project
Official title: One-stop PrEP Care Pathway to Simplify PrEP Delivery in Kenya: The One-Stop PrEP Care Project
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV Infections
Keywords: PrEP
HIV Prevention
PrEP adherence
Sexual behavior
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Kenya Medical Research Institute
name: Jomo Kenyatta University of Agriculture and Technology
First posted: 2023-06-15
Enrollment: 2400
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomized trial of twelve public health clinics assigned 1:1 to implement either the intervention of One stop PrEP care pathway or usual clinic flow as control.
Primary purpose: OTHER

Brief 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).

Eligibility 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

Primary outcomes:
measure: PrEP initiation
timeFrame: Years 2-4 of the study, up to 36 months.
measure: PrEP continuation
timeFrame: up to 12 months of PrEP use.
measure: PrEP adherence
timeFrame: Years 2-4 of the study, up to 36 months.
measure: Acceptability
timeFrame: Throughout the study period, up to 36 months
measure: Adoption
timeFrame: Throughout the study period, up to 36 months
measure: Fidelity
timeFrame: Throughout the study period, up to 36 months
measure: Total client wait time and staff time spent on PrEP services
timeFrame: Throughout the study period, up to 36 months
measure: Satisfaction with services
timeFrame: Throughout the study period, up to 36 months
measure: Sustainability
timeFrame: up to 12 months after technical assistance support is scaled back
Secondary outcomes:
measure: Incremental cost of one-stop PrEP services, including costs averted, and reduced client wait times.
timeFrame: up to 36 months.
Other outcomes:
Locations:
city: Kisumu
country: Kenya
facility: Kenya Medical Research Institute -KEMRI
Study officials:
affiliation: University of Washington
name: Kenneth Mugwanya, MBChB, MS, PhD
role: PRINCIPAL_INVESTIGATOR
References: