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Peer-Driven Intervention for Substance Use (PROUD-R2 Trial)
N/A
Waitlist Available
Led By Todd Korthuis, MD, MPH
Research Sponsored by Oregon Health and Science University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
PROUD-R2 Trial Summary
This trial will test if a peer-driven intervention can help increase engagement in research among people who use drugs in rural America.
Who is the study for?
This trial is for adults over 18 living in the study area who currently inject drugs or use opioids to get high. It's also open to 'study buddies' from the same area, regardless of their substance use history, as long as they're adults.Check my eligibility
What is being tested?
The study is testing a peer-driven video intervention designed to help retain people who use drugs (PWUD) in rural research programs by leveraging peer influence and support.See study design
What are the potential side effects?
Since this trial involves a non-medical intervention (a retention video), there are no direct physical side effects expected from participating.
PROUD-R2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
12 Month Retention Rate
Secondary outcome measures
6 Month Retention Rate
PROUD-R2 Trial Design
2Treatment groups
Active Control
Group I: Standard Retention StrategyActive Control1 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.
Group II: Retention VideoActive Control1 Intervention
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.
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Who is running the clinical trial?
University of KentuckyOTHER
185 Previous Clinical Trials
225,792 Total Patients Enrolled
1 Trials studying Substance Use
234 Patients Enrolled for Substance Use
Ohio State UniversityOTHER
828 Previous Clinical Trials
504,901 Total Patients Enrolled
6 Trials studying Substance Use
3,944 Patients Enrolled for Substance Use
Emory UniversityOTHER
1,636 Previous Clinical Trials
2,559,723 Total Patients Enrolled
2 Trials studying Substance Use
2,114 Patients Enrolled for Substance Use
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Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Standard Retention Strategy
- Group 2: Retention Video
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are participants able to join this clinical research at the present moment?
"Clinicaltrials.gov indicates that this particular clinical trial is not presently recruiting participants, with its original posting on August 31st 2020 and final edit occurring on August 22nd 2022. However, 26 other medical studies are actively seeking to enrol patients at the moment."
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