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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

2400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2027-07-31

Brief Summary

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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.

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Detailed Description

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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

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HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Control arm- Usual PrEP care pathway

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention Arm- One Stop PrEP care pathway

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.

Group Type OTHER

Method of PrEP delivery and consultation

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes