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

May 25, 2026 updated by: Friends Research Institute, Inc.

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • New York, New York, United States, 11238
        • Recruiting
        • START Treatment and Recovery
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Arm-1: PRC supported text+ AI driven CSDH-enhanced text
Individuals randomized to Arm-1 will receive PRC-supported text check-ins and AI-driven CSDH-enhanced text messaging.
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.
Experimental: Intervention Arm-2: AI driven CSDH-enhanced text only
Individuals randomized to Arm-2 will receive the AI-driven CSDH-enhanced text messaging only
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.
Placebo Comparator: Control Arm 3- Treatment as Usual
Individuals randomized to the control arm will receive treatment as usual.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months
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 months
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.
3 months
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.
3 months
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.
3 months
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Friends Research Institute, Inc.

Collaborators

NYU Langone Health
Nathan Kline Institute for Psychiatric Research

Investigators

  • Study Director: Ana Ventuneac, START Treatment and Recovery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 25, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 15, 2027

Study Registration Dates

First Submitted

August 21, 2024

First Submitted That Met QC Criteria

August 23, 2024

First Posted (Actual)

August 27, 2024

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 25, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R34DA059770 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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