N/A
Completed N=80
Integrated PrEP Interventions for People Who Inject Drugs in Rural Kentucky
Source: ClinicalTrials.gov NCT05037513 ↗Enrolled (actual)
80
Serious AEs
1.3%
Results posted
Mar 2025
Primary outcomePrimary: Number of Participants Initiating PrEP — 1; 6 Participants — p=<0.05
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Initiating PrEP |
1; 6 | <0.05 sig |
| SECONDARY Level of Intervention Engagement Assessed by Session Checklist |
8.68 | — |
| SECONDARY Level of Intervention Satisfaction Assessed by the IAQ |
13.2 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05037513). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.