Integrated PrEP Interventions for People Who Inject Drugs in Rural Kentucky

Not Applicable

Completed

• Conditions: HIV Prevention
• Interventions: Behavioral: CDC-PrEP; Behavioral: SBCM-PrEP

• Registration Number: NCT05037513
• Lead Sponsor: Hilary L Surratt, PhD

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-05
• Study First Submitted QC: 2021-08-31
• Study First Posted: 2021-09-08
• Study Start: 2021-09-16
• Primary Completion: 2024-04-09
• Study Completion: 2024-04-09
• Status Verified: 2025-03
• Results First Submitted: 2025-03-04
• Results First Submitted QC: 2025-03-04
• Last Update Submitted: 2025-03-04
• Results First Posted: 2025-03-20
• Last Update Posted: 2025-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Age 18 years or older;
• HIV-negative status;
• Past month drug injection;
• Client of SSP in targeted sites

Exclusion Criteria

• HIV-positive status

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CDC-PrEP	CDC-PrEP	1 session PrEP education following CDC guidelines delivered one on one by an Advanced Practice Registered Nurse to individual clients in the syringe service program setting
SBCM-PrEP	SBCM-PrEP	Multi-session Strengths-Based Case Management intervention adapted for PrEP related educational content delivered one on one by an Advanced Practice Registered Nurse to individual clients in the syringe service program setting

Primary Outcome Measures

Name	Time	Method
Number of Participants Initiating PrEP	6 months post-baseline	Documented PrEP initiation, measured by dispensed PrEP prescription.

Secondary Outcome Measures

Name	Time	Method
Level of Intervention Engagement Assessed by Session Checklist	8 weeks post-baseline	5 item Session Checklist completed by Interventionist post-session; range is 5-20, lower scores are higher engagement
Level of Intervention Satisfaction Assessed by the IAQ	8 weeks post-baseline	10 item Intervention Acceptability Questionnaire (IAQ) completed by participants post-intervention; range is 10-50, lower scores are higher acceptability

Trial Locations

Locations (1)

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States