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

NCT03885024 | Completed

• 1 other identifier: PROUD-R2
• Study Type: interventional
• Target: 850
• Locations: 1 country
• Sites: 3

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.

Conditions

Drug Use; Peer Influence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 6 Month Retention Rate

  6 months

Study Arms (2)

Retention Video

ACTIVE COMPARATOR

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

Standard Retention Strategy

NO INTERVENTION

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.

Interventions

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.

Retention Video

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Under 18 years of age

Sponsors & Collaborators

• Oregon Health and Science University: lead
• University of Kentucky: collaborator
• Ohio State University: collaborator
• Emory University: collaborator
• University of North Carolina: collaborator

Study Sites (3)

Emory University

Atlanta, Georgia, 30322, United States

Location

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

• 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.

  PMID: 35705346 DERIVED

Study Officials

• Todd Korthuis, MD, MPH

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This study proposes a two-arm, individual-level randomized trial in which those in the intervention condition refer a "study buddy" peer who will be trained to help retain the index participant in their follow-up visits.

Study Record Dates

• First Submitted: March 19, 2019
• First Posted: March 21, 2019
• Study Start: August 31, 2020
• Primary Completion: July 25, 2023
• Study Completion: July 25, 2023
• Last Updated: December 22, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)