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NCT Number: NCT06573476

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

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.

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Key information

Conditions

Opioid Use Disorder Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

START Treatment and Recovery

New York, 11238, United States

Location status: Recruiting

Location contact

Ana Ventuneac, PhD

CONTACT

[email protected]

718-260-2931

About this study

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

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PRC supported text + AI driven CSDH-enhanced text

Behavioral

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.

AI driven CSDH-enhanced text only

Behavioral

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.

Treatment as Usual (TAU)

Behavioral

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 outcomes

  1. Estimated Rate of PRC-PWUO Contact

    Time frame: 3 months

    The number of contacts between Peer Recovery Coaches (PRC) and People Who Use Opioids (PWUO), measured through communication logs.

  2. Rate of AI-Driven Texting Use Among PWUO

    Time frame: 3 months

    The frequency of AI-driven text interactions initiated by PWUO, captured through software logs.

  3. Change in Felt and/or Anticipated Stigma

    Time frame: 3 months

    The change in felt and/or anticipated stigma pre- and post-intervention, measured by a validated stigma assessment questionnaire.

  4. Amount of time to Initial Receipt of Buprenorphine (Self-Reported)

    Time frame: 3 months

    The time (in days) to the initial receipt of buprenorphine, as self-reported by participants.

  5. The Amount of Self-Reported Social Services Use

    Time frame: 3 months

    The self-reported utilization of social services at baseline, 1 month, and 3 months, addressing social determinants of health (SDH) to assess intervention effect sizes.

  6. Cost (Amount of Money) of Implementing and Sustaining the Multimodal Intervention

    Time frame: 3 months

    The associated cost of implementing and sustaining the multimodal intervention, including cost-per quality-adjusted life year (QALY) and cost-per opioid use disorder (OUD) treatment days.

Secondary outcomes

  1. The Amount of Participants That Retain in Treatment

    Time frame: 3 months

    The number of participants continuously retained in buprenorphine treatment over a 12-week period, assessed at the 12-week mark.

Study contacts

Contact information is provided by the study sponsor or research team.

Ana Ventuneac, PHd

CONTACT

[email protected]

718-260-2931

Sponsors and collaborators

Lead sponsor

Friends Research Institute, Inc.

Other

Collaborators

  • NYU Langone Health
  • Nathan Kline Institute for Psychiatric Research

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 27, 2024
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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