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

Sponsor

Oregon Health and Science University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03885024

Collaborator

University of Kentucky (Other), Ohio State University (Other), Emory University (Other), University of North Carolina (Other)

850

Enrollment

Locations

Arms

Anticipated Duration (Months)

283.3

Patients Per Site

8.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Drug Use Peer Influence	Other: Retention Video	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

850 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Aug 31, 2020

Anticipated Primary Completion Date :

Apr 14, 2023

Anticipated Study Completion Date :

Jul 31, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

12 Month Retention Rate [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 Outcome Measures

6 Month Retention Rate [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Emory University	Atlanta	Georgia	United States	30322
2	University of Kentucky	Lexington	Kentucky	United States	40506
3	Ohio State University	Columbus	Ohio	United States	43210

Sponsors and Collaborators

Oregon Health and Science University
University of Kentucky
Ohio State University
Emory University
University of North Carolina

Investigators

Principal Investigator: Todd Korthuis, MD, MPH, Oregon Health and Science University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

P. Todd Korthuis, MD, Professor, Oregon Health and Science University

ClinicalTrials.gov Identifier:

NCT03885024

Other Study ID Numbers:

PROUD-R2

First Posted:

Mar 21, 2019

Last Update Posted:

Aug 24, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Aug 24, 2022