The Peer-Based Retention of People Who Use Drugs in Rural Research (PROUD-R2)

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.

Study Overview

• Status: Completed
• Conditions: Drug Use; Peer Influence
• Intervention / Treatment: Other: Retention Video

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.

• Study Type: Interventional
• Enrollment (Actual): 850
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
  • Kentucky
    • Lexington, Kentucky, United States, 40506
      • University of Kentucky
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Retention Video; Participants the peer-driven retention arm will receive video-based and in-person training from Retention Specialists on how to encourage study retention. Participants will watch a 7 minute video that standardizes retention messages. A brief face-to-face conversation with the Retention Specialist follows the video viewing to answer questions and reinforce video messages. At the end of the training, participants receive information about their recruit(s) who consented to release their information to their recruiters. Peers remind their enrolled "study buddy" to attend their scheduled follow up assessments. Participants meet with a study Retention Specialist by phone or in person, at 3 and 9 months after enrollment to answer questions about peer retention strategies and remind participants of their peers' contact information and follow-up schedules.	Other: Retention Video; 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.
No Intervention: Standard Retention Strategy; Control arm: At NROI enrollment, all participants provide detailed information to assist with retention and/or contact for future research, and contact information for up to three people who should know how to reach the participant if contact information changes. Participants randomized to receive the standard retention strategy are contacted at the mid-point of each follow-up interval (i.e., at 3-month post enrollment and 9-months post-enrollment) to update locator information and remind them about their follow-up appointment date. Study associates contact the participant using their contact information and, if not successful, will try to reach one of their contacts in the locator form.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
12 Month Retention Rate	Participants receiving the peer retention intervention will have 20% higher retention at 12 months (primary outcome) than those receiving the standard retention approach, alone.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6 Month Retention Rate	Participants receiving the peer retention intervention will have higher retention at 6 months (secondary outcome) compared with those receiving the standard retention approach, alone.	6 months

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Collaborators: Emory University; Ohio State University; University of Kentucky; University of North Carolina
• Investigators: Principal Investigator: Todd Korthuis, MD, MPH, Oregon Health and Science University

Publications and helpful links

General Publications

• Young AM, Lancaster KE, Bielavitz S, Elman MR, Cook RR, Leichtling G, Freeman E, Estadt AT, Brown M, Alexander R, Barrie C, Conn K, Elzaghal R, Maybrier L, McDowell R, Neal C, Lapidus J, Waddell EN, Korthuis PT. Peer-based Retention Of people who Use Drugs in Rural Research (PROUD-R2): a multisite, randomised, 12-month trial to compare efficacy of standard versus peer-based approaches to retain rural people who use drugs in research. BMJ Open. 2022 Jun 15;12(6):e064400. doi: 10.1136/bmjopen-2022-064400.

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2020
• Primary Completion (Actual): July 25, 2023
• Study Completion (Actual): July 25, 2023

Study Registration Dates

• First Submitted: March 19, 2019
• First Submitted That Met QC Criteria: March 19, 2019
• First Posted (Actual): March 21, 2019

Study Record Updates

• Last Update Posted (Actual): December 22, 2023
• Last Update Submitted That Met QC Criteria: December 20, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: PROUD-R2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No