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Recruiting Not applicable NCT06573476

Addressing Racial Disparities in Opioid Overdose Using Peer Recovery Coach Training and mHealth Platform

No applicable phase (e.g. observational)
Conditions: Opioid Use Disorder

Sponsor: Friends Research Institute, Inc.

trial.available_in: БГ
Overview
The study aims to adapt an existing Cultural Structural Humility (CSH) training into a video format for peer recovery coaches (PRCs) and refine an AI-driven texting tool to reinforce the training. After refining these tools using user-centered design, a pilot test will be conducted to assess their impact on the uptake of opioid treatment and social services. The study will also evaluate the feasibility and effectiveness of the intervention to inform future large-scale trials.
Description
The purpose of this study is to adapt an evidence-supported, currently staff-led Cultural Structural Humility (CSH) training to an interactive video format (7 brief video modules) for PRCs (Aim 1) while concurrently, refining a validated AI-driven texting tool that will newly reinforce core CSH training principles (Aim 2) that focus upon cultural and structural determinants of health (CSDH). After completing iterative refinement per user-centered design strategies based on the Technology Acceptance Model (TAM) for Aim 1 and 2, the investigators will pilot test CSH-trained PRCs delivering telephone based care/services coordination combined with refined AI-driven texting to enhance uptake of MOUD services, and social services (Aim 3). Aim 3 is sized for feasibility testing, final 'de-bugging' of the platform, and informing study conceptualization for a future large-scale efficacy trial. In this R34, the intervention effects will be assessed on the primary clinical outcome (i.e., receipt of buprenorphine), secondary outcome (i.e., uptake of social services), and implementation of the proposed multimodal intervention platform per the RE-AIM framework.
Who can participate
Inclusion Criteria: * ≥18 years of age * fluent in English * self-reported non-prescription opioid use \<30 days prior to consent * provision of informed consent * planned stay in NYC ≥3 months * Black and/or Latinx race/ethnicity * positive urine toxicology for opioids per EMR records or study staff administered random saliva drug testing * diagnosis of OUD per the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) * self-reported interest in initiating buprenorphine in primary care, or elsewhere. Exclusion Criteria: * inability to comprehend text content written at a 3rd grade reading level * physical or visual disability preventing mobile phone use
Interventions
PRC supported text + AI driven CSDH-enhanced text
BEHAVIORAL
AI driven CSDH-enhanced text only
BEHAVIORAL
Treatment as Usual (TAU)
BEHAVIORAL
Locations 1
United States (1)
START Treatment and Recovery
New York , New York
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
99 Years
Healthy volunteers
No
Start date
25.11.2025
Completion date
15.03.2027
Registry ID
NCT06573476
Source
clinicaltrials.gov
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