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NCT05037513Completed

Integrated PrEP Interventions for People Who Inject Drugs in Rural Kentucky

Source: ClinicalTrials.gov · Last updated 20 Mar 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
80 (actual)
First submitted
5 Aug 2021
Start date
16 Sept 2021
Primary completion date
9 Apr 2024
Lead sponsor
Hilary L Surratt, PhD
Diseases
HIV
NCT number
NCT05037513

What you commit to

  • Study type: Interventional
  • Participants enrolled: 80
  • From 16 Sept 2021 to the primary completion date, 9 Apr 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • HIV-positive status

Who the study is looking for

  • Age 18 years or older;
  • HIV-negative status;
  • Past month drug injection;
  • Client of SSP in targeted sites

Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Kentucky
Coordinator of this site? Confirm its status
LexingtonUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.