The Peer-Based Retention of People Who Use Drugs in Rural Research (PROUD-R2)
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|ClinicalTrials.gov Identifier: NCT03885024|
Recruitment Status : Recruiting
First Posted : March 21, 2019
Last Update Posted : August 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Drug Use Peer Influence||Other: Retention Video||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1060 participants|
|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|
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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03885024
|Contact: Todd Korthuis, MD, MPHfirstname.lastname@example.org|
|Contact: Ceilidh Nichols, BS, CCRPemail@example.com|
|United States, Georgia|
|Atlanta, Georgia, United States, 30322|
|Contact: Hannah Cooper firstname.lastname@example.org|
|United States, Kentucky|
|University of Kentucky||Recruiting|
|Lexington, Kentucky, United States, 40506|
|Contact: April Young, PhD, MPH 859-218-2090 email@example.com|
|United States, Ohio|
|Ohio State University||Recruiting|
|Columbus, Ohio, United States, 43210|
|Contact: Kathryn Lancaster, PhD firstname.lastname@example.org|
|Principal Investigator:||Todd Korthuis, MD, MPH||Oregon Health and Science University|