Integrated PrEP Interventions for People Who Inject Drugs in Rural Kentucky

Not Applicable

Completed

• Conditions: HIV Prevention

• 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

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