Integrated PrEP Interventions for People Who Inject Drugs in Rural Kentucky

Hilary L Surratt, PhD80 enrolled

Overview

The overarching goal of this study is to adapt and feasibility test an evidence-based strengths-based case management (SBCM) intervention for pre-exposure prophylaxis (PrEP) initiation, and examine preliminary efficacy of the intervention comparators (SBCM-PrEP) and (Centers for Disease Control (CDC)-PrEP). Within this context, the Specific Aims are to: 1) Assess client, provider, organization, and structural-level facilitators and barriers to integration of a PrEP focused SBCM (SBCM-PrEP) intervention into routine syringe service program (SSP) practice; 2) Adapt an evidence-based SBCM protocol to provide PrEP intervention services for people who inject drugs (PWID) in SSP sites; and, 3) Examine feasibility, acceptability and preliminary efficacy of the adapted SBCM-PrEP. 80 participants will be randomized into: CDC-PrEP (an in-use PrEP intervention based on CDC guidelines) or SBCM-PrEP.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

HIV Prevention

Interventions

Outcomes

Primary Outcomes

Number of Participants Initiating PrEP

Documented PrEP initiation, measured by dispensed PrEP prescription.

Time frame: 3 months post-baseline

Number of Participants Initiating PrEP

Documented PrEP initiation, measured by dispensed PrEP prescription.

Time frame: 6 months post-baseline

Secondary Outcomes

Level of Intervention Engagement Assessed by Session Checklist

5 item Session Checklist completed by Interventionist post-session; range is 5-20, lower scores are higher engagement

Time frame: 8 weeks post-baseline

Level of Intervention Satisfaction Assessed by the IAQ

10 item Intervention Acceptability Questionnaire (IAQ) completed by participants post-intervention; range is 10-50, lower scores are higher acceptability