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

NCT ID: NCT06573476

Last Updated: 2025-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-25

Study Completion Date

2025-12-01

Brief Summary

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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

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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.

Conditions

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Opioid Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

PRC supported text + AI driven CSDH-enhanced text

Intervention Type 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.

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

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

Group Type EXPERIMENTAL

AI driven CSDH-enhanced text only

Intervention Type 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.

Control Arm 3- Treatment as Usual

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

Group Type PLACEBO_COMPARATOR

Treatment as Usual (TAU)

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nathan Kline Institute for Psychiatric Research

OTHER

Sponsor Role collaborator

NYU Langone Health

OTHER

Sponsor Role collaborator

Friends Research Institute, Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ana Ventuneac

Role: STUDY_DIRECTOR

START Treatment and Recovery

Locations

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START Treatment and Recovery

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Ana Ventuneac, PHd

Role: CONTACT

718-260-2931

Facility Contacts

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Ana Ventuneac, PhD

Role: primary

718-260-2931

Other Identifiers

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R34DA059770

Identifier Type: NIH

Identifier Source: org_study_id

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