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

Friends Research Institute

Status: Enrolling

Conditions: Opioid Use Disorder

Treatments: Behavioral: Treatment as Usual (TAU); Behavioral: PRC supported text + AI driven CSDH-enhanced text; Behavioral: AI driven CSDH-enhanced text only

Study type: Interventional

Funder types: Other

Identifiers

NCT06573476

R34DA059770 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 3 patient groups, including a placebo group

Intervention Arm-1: PRC supported text+ AI driven CSDH-enhanced text

Experimental group

Description:

Individuals randomized to Arm-1 will receive PRC-supported text check-ins and AI-driven CSDH-enhanced text messaging.

Treatment:

Behavioral: PRC supported text + AI driven CSDH-enhanced text

Intervention Arm-2: AI driven CSDH-enhanced text only

Experimental group

Description:

Individuals randomized to Arm-2 will receive the AI-driven CSDH-enhanced text messaging only

Treatment:

Behavioral: AI driven CSDH-enhanced text only

Control Arm 3- Treatment as Usual

Placebo Comparator group

Description:

Individuals randomized to the control arm will receive treatment as usual.

Treatment:

Behavioral: Treatment as Usual (TAU)