The Peer-Based Retention of People Who Use Drugs in Rural Research
NCT ID: NCT03885024
Last Updated: 2023-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
850 participants
INTERVENTIONAL
2020-08-31
2023-07-25
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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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.
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.
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.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
18 Years
ALL
No
Sponsors
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University of Kentucky
OTHER
Ohio State University
OTHER
Emory University
OTHER
University of North Carolina
OTHER
Oregon Health and Science University
OTHER
Responsible Party
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P. Todd Korthuis, MD
Professor
Principal Investigators
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Todd Korthuis, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Oregon Health and Science University
Locations
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Emory University
Atlanta, Georgia, United States
University of Kentucky
Lexington, Kentucky, United States
Ohio State University
Columbus, Ohio, United States
Countries
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References
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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.
Other Identifiers
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PROUD-R2
Identifier Type: -
Identifier Source: org_study_id