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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03885024
Recruitment Status : Recruiting
First Posted : March 21, 2019
Last Update Posted : August 7, 2020
Sponsor:
Collaborators:
University of Kentucky
Ohio State University
Emory University
University of North Carolina
Information provided by (Responsible Party):
P. Todd Korthuis, MD, Oregon Health and Science University

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1060 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.
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 : March 1, 2019
Estimated Primary Completion Date : April 14, 2023
Estimated Study Completion Date : July 31, 2023
Arms and Interventions
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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
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Primary Outcome Measures :
  1. 12 Month Retention Rate [ Time Frame: 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 :
  1. 6 Month Retention Rate [ Time Frame: 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
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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. No eligible participants are excluded.

Exclusion Criteria:

  • Under 18 years of age
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03885024


Contacts
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Contact: Todd Korthuis, MD, MPH 503-494-8044 korthuis@ohsu.edu
Contact: Ceilidh Nichols, BS, CCRP 503-494-3165 nicholce@ohsu.edu

Locations
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United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Hannah Cooper       hcoope3@emory.edu   
United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40506
Contact: April Young, PhD, MPH    859-218-2090    april.young@uky.edu   
United States, Ohio
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Kathryn Lancaster, PhD       lancaster.111@osu.edu   
Sponsors and Collaborators
Oregon Health and Science University
University of Kentucky
Ohio State University
Emory University
University of North Carolina
Investigators
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Principal Investigator: Todd Korthuis, MD, MPH Oregon Health and Science University
More Information
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Responsible Party: P. Todd Korthuis, MD, Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT03885024    
Other Study ID Numbers: PROUD-R2
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: August 7, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No