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

Drug Use Clinical Trial

— PROUD-R2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03885024
• Other study ID #: PROUD-R2
• Status: Completed
• Phase: N/A
• Start date: August 31, 2020
• Est. completion date: July 25, 2023

Study information

• Verified date: December 2023
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 850
• Est. completion date: July 25, 2023
• Est. primary completion date: July 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Drug Use
• Peer Influence

Intervention

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.

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	Ohio State University	Columbus	Ohio
United States	University of Kentucky	Lexington	Kentucky

Sponsors (5)

Lead Sponsor	Collaborator
Oregon Health and Science University	Emory University, Ohio State University, University of Kentucky, University of North Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	12 Month Retention Rate	Participants receiving the peer retention intervention will have 20% higher retention at 12 months (primary outcome) than those receiving the standard retention approach, alone.	12 months
Secondary	6 Month Retention Rate	Participants receiving the peer retention intervention will have higher retention at 6 months (secondary outcome) compared with those receiving the standard retention approach, alone.	6 months