Clinical trial NCT03885024: The Peer-Based Retention of People Who Use Drugs in Rural Research
Official title: The Peer-Based Retention of People Who Use Drugs in Rural Research
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drug Use
Peer Influence
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: University of Kentucky
name: Ohio State University
name: Emory University
name: University of North Carolina
First posted: 2019-03-21
Enrollment: 850
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility 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.

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

Primary outcomes:
measure: 12 Month Retention Rate
timeFrame: 12 months
Secondary outcomes:
measure: 6 Month Retention Rate
timeFrame: 6 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
Study officials:
affiliation: Oregon Health and Science University
name: Todd Korthuis, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Young AM, Lancaster KE, Bielavitz S, Elman MR, Cook RR, Leichtling G, Freeman E, Estadt AT, Brown M, Alexander R, Barrie C, Conn K, Elzaghal R, Maybrier L, McDowell R, Neal C, Lapidus J, Waddell EN, Korthuis PT. Peer-based Retention Of people who Use Drugs in Rural Research (PROUD-R2): a multisite, randomised, 12-month trial to compare efficacy of standard versus peer-based approaches to retain rural people who use drugs in research. BMJ Open. 2022 Jun 15;12(6):e064400. doi: 10.1136/bmjopen-2022-064400.