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Recruiting NCT06573476

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

No phase Interventional Opioid Use Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PRC supported text + AI driven CSDH-enhanced text, AI driven CSDH-enhanced text only, Treatment as Usual (TAU).
Who it may be relevant to
Registry conditions: Opioid Use Disorder. Basic parameters: 18 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Addressing Racial Disparities in Opioid Overdose Deaths Using an Open Source Peer Recovery Coach Training and Multimodal Mobile Health Platform

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.

Detailed 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.

Interventions

  • Behavioral PRC supported text + AI driven CSDH-enhanced text
    In interventional Arm-1, PRC-supported text check-ins to participants (3x/week) will be provided by PRC study staff in addition to automated AI-driven texts. The PRC will personalize text "check-ins" to participants based on: (a) baseline CSDH needs (e.g., food insecurity, legal aid); (b) initial intake visit in primary care or challenges with service entry; and (c) content outlined in the CSH training addressing emerging participant challenges.
  • Behavioral AI driven CSDH-enhanced text only
    In interventional Arm-2, participants will receive the AI-driven CSDH-enhanced text messaging only. Participants in this arm will not receive text support from the PRC.
  • Behavioral Treatment as Usual (TAU)
    In Arm-3, the control group, individuals randomized to the control arm will receive treatment as usual (i.e., verbal instructions and NYC Dept of Health pamphlets detailing access to OUD and social services). No services will be provided except for social/clinical service referrals given at the end of each REDCap visit.

Primary outcome measures

  • Estimated Rate of PRC-PWUO Contact [Time frame: 3 months]
  • Rate of AI-Driven Texting Use Among PWUO [Time frame: 3 months]
  • Change in Felt and/or Anticipated Stigma [Time frame: 3 months]
  • Amount of time to Initial Receipt of Buprenorphine (Self-Reported) [Time frame: 3 months]
  • The Amount of Self-Reported Social Services Use [Time frame: 3 months]
  • Cost (Amount of Money) of Implementing and Sustaining the Multimodal Intervention [Time frame: 3 months]
Secondary outcome measures (1)
  • The Amount of Participants That Retain in Treatment [Time frame: 3 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • START Treatment and Recovery — New York

Identifiers

NCT: NCT06573476 · R34DA059770

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗