CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 80 enrolled
Drug / intervention
SBCM-PrEP +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05037513
NCT05037513N/ACompleted

Integrated PrEP Interventions for People Who Inject Drugs in Rural Kentucky

Hilary L Surratt, PhD·interventional·Posted Sep 8, 2021·Updated Mar 20, 2025

In Brief

A clinical study evaluating SBCM-PrEP and CDC-PrEP for HIV Prevention. Completed, enrolled 80 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Prevention
CountriesUnited States

Timeline

N/ACompletedFinished
20222023202420252026
First PostedSep 8, 2021
Enrollment StartSep 16, 2021
Primary CompletionApr 9, 2024
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 4.8 years ago

Interventions

SBCM-PrEPbehavioral

Multi-session SBCM intervention adapted for PrEP initiation focus

CDC-PrEPbehavioral

1 session PrEP education following CDC guidelines