NCT05037513

Integrated PrEP Interventions for People Who Inject Drugs in Rural Kentucky

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Hilary L Surratt, PhD · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV Prevention

Interventions

Type	Name	Description
BEHAVIORAL	SBCM-PrEP	Multi-session SBCM intervention adapted for PrEP initiation focus
BEHAVIORAL	CDC-PrEP	1 session PrEP education following CDC guidelines

Timeline

• Start date: 2021-09-16
• Primary completion: 2024-04-09
• Completion: 2024-04-09
• First posted: 2021-09-08
• Last updated: 2025-03-20
• Results posted: 2025-03-20

Locations

1 site across 1 country: United States