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Clinical Trials/NCT03885024
NCT03885024
Completed
Not Applicable

The Peer-Based Retention of People Who Use Drugs in Rural Research

Oregon Health and Science University3 sites in 1 country850 target enrollmentAugust 31, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Drug Use
Sponsor
Oregon Health and Science University
Enrollment
850
Locations
3
Primary Endpoint
12 Month Retention Rate
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The purpose of this study is to, through several aims, test the effectiveness of peer-driven intervention and inform methods to optimize engagement in research in people who use drugs (PWUD) in rural America.

Detailed Description

This study builds on the National Rural Opioids Initiative (NROI), a multi-state consortium studying access to care, overdose, and infectious consequences of opioid use disorder (OUD) in Rural America. It includes counties in rural Oregon and Appalachian Kentucky and Ohio with high rates of drug overdose. Aim 1: Conduct a randomized trial to evaluate the effectiveness of a peer-driven study retention intervention for retaining PWUD in Kentucky, Ohio, and Oregon Rural Opioid Initiative sites. Aim 2: Elicit preferences of PWUD in the Kentucky, Ohio, and Oregon Rural Opioid Initiative sites Aim 2a: Administer baseline survey of discrete choice experiment preferences for participating in clinical trials of potential medical innovations (e.g. new treatments for OUD, HIV, and HCV vaccination). Aim 2a will be accomplished as part of the NROI studies. The data will then be merged for PROUD-R² analyses. Aim 2b: Compare participant survey preferences regarding willingness to participate in clinical trials at baseline, 6, and 12 months. Aim 3: Explore participant perceptions of clinical research participation and retention among PWUD in rural America.

Registry
clinicaltrials.gov
Start Date
August 31, 2020
End Date
July 25, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

P. Todd Korthuis, MD

Professor

Oregon Health and Science University

Eligibility Criteria

Inclusion Criteria

  • NROI eligibility criteria: Participants are eligible to enroll in the NROI if they 1) live in the study area, 2) have recently injected drugs or report opioid use to get high without injection, and 3) are age 18 or older.
  • NROI participants enrolled after April 2019 are eligible to participate in the PROUD R2 study.
  • Participants enrolling as study buddies will be eligible if they 1) live in the study area, 2) are age 18 or older; they do not need to have recent or past substance use to qualify.
  • No eligible participants are excluded.

Exclusion Criteria

  • Under 18 years of age

Outcomes

Primary Outcomes

12 Month Retention Rate

Time Frame: 12 months

Participants receiving the peer retention intervention will have 20% higher retention at 12 months (primary outcome) than those receiving the standard retention approach, alone.

Secondary Outcomes

  • 6 Month Retention Rate(6 months)

Study Sites (3)

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