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OpenTrials
Completed

NCT Number: NCT03885024

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emory University, Atlanta, Georgia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Retention Video

Other

Participants assigned to the retention training arm will watch a brief training video that will include information on how to retain peers in clinical trials.

Primary outcomes

  1. 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

  1. 6 Month Retention Rate

    Time frame: 6 months

    Participants receiving the peer retention intervention will have higher retention at 6 months (secondary outcome) compared with those receiving the standard retention approach, alone.

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • Emory University
  • Ohio State University
  • University of Kentucky
  • University of North Carolina

Registry information

Acronym: PROUD-R2

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Mar 21, 2019
Registry last updated
Dec 22, 2023

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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