Integrated PrEP Interventions for People Who Inject Drugs in Rural Kentucky

March 4, 2025 updated by: Hilary L Surratt, PhD
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University Of Kentucky

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
Behavioral: CDC-PrEP
1 session PrEP education following CDC guidelines
Experimental: 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
Behavioral: SBCM-PrEP
Multi-session SBCM intervention adapted for PrEP initiation focus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Initiating PrEP
Time Frame: 3 months post-baseline
Documented PrEP initiation, measured by dispensed PrEP prescription.
3 months post-baseline
Number of Participants Initiating PrEP
Time Frame: 6 months post-baseline
Documented PrEP initiation, measured by dispensed PrEP prescription.
6 months post-baseline

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hilary L Surratt, PhD

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Hilary L Surratt, PhD, University Of Kentucky

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2021

Primary Completion (Actual)

April 9, 2024

Study Completion (Actual)

April 9, 2024

Study Registration Dates

First Submitted

August 5, 2021

First Submitted That Met QC Criteria

August 31, 2021

First Posted (Actual)

September 8, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 4, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 67933
  • R34DA053140 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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