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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 this study if they successfully refer at least on other participant within 3 months of NROI enrollment, or are a part of a respondent-driven sampling chain. No eligible participants are excluded.

Exclusion Criteria

  • Under 18 years of age

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
This study proposes a two-arm, cluster-randomized trial with allocation by respondent-driven sampling (RDS) chain.
Primary Purpose
Health Services Research
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Retention Video
Participants the peer-driven retention arm and who have recruited at least one peer will receive video-based and in-person training from Retention Specialists on how to encourage study retention. Participants will watch a 15 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 receive a "retention coupon" to disseminate to peers one week and one day before the peer's scheduled follow up assessment. 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.

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

University of Kentucky
Lexington, Kentucky 40506
Contact:
April Young, PhD, MPH
859-218-2090
april.young@uky.edu

More Details

NCT ID
NCT03885024
Status
Recruiting
Sponsor
Oregon Health and Science University

Study Contact

Todd Korthuis, MD, MPH
503-494-8044
korthuis@ohsu.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.