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OpenTrials
Completed

NCT Number: NCT05037513

Integrated PrEP Interventions for People Who Inject Drugs in Rural Kentucky

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.

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Key information

Conditions

HIV Prevention

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky

Lexington, Kentucky, 40536, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SBCM-PrEP

Behavioral

Multi-session SBCM intervention adapted for PrEP initiation focus

CDC-PrEP

Behavioral

1 session PrEP education following CDC guidelines

Primary outcomes

  1. Number of Participants Initiating PrEP

    Time frame: 3 months post-baseline

    Documented PrEP initiation, measured by dispensed PrEP prescription.

  2. Number of Participants Initiating PrEP

    Time frame: 6 months post-baseline

    Documented PrEP initiation, measured by dispensed PrEP prescription.

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Hilary L Surratt, PhD

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Sep 8, 2021
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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