Drug Use, Peer Influence
Conditions
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.
Interventions
OTHERRetention 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.
Sponsors
University of Kentucky
Ohio State University
Emory University
University of North Carolina
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 12 Month Retention Rate | 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
| Measure | Time frame | Description |
|---|---|---|
| 6 Month Retention Rate | 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. |
Countries
United States
Outcome results
None listed