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Clinical Trials/NCT05037513
NCT05037513
Completed
Not Applicable

Integrated PrEP Interventions for People Who Inject Drugs in Rural Kentucky

Hilary L Surratt, PhD1 site in 1 country80 target enrollmentSeptember 16, 2021
ConditionsHIV Prevention

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV Prevention
Sponsor
Hilary L Surratt, PhD
Enrollment
80
Locations
1
Primary Endpoint
Number of Participants Initiating PrEP
Status
Completed
Last Updated
last year

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
September 16, 2021
End Date
April 9, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Hilary L Surratt, PhD
Responsible Party
Sponsor Investigator
Principal Investigator

Hilary L Surratt, PhD

Associate Professor

University of Kentucky

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

Outcomes

Primary Outcomes

Number of Participants Initiating PrEP

Time Frame: 6 months post-baseline

Documented PrEP initiation, measured by dispensed PrEP prescription.

Secondary Outcomes

  • Level of Intervention Engagement Assessed by Session Checklist(8 weeks post-baseline)
  • Level of Intervention Satisfaction Assessed by the IAQ(8 weeks post-baseline)

Study Sites (1)

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