Addressing Racial Disparities in Opioid Overdose Using Peer Recovery Coach Training and mHealth Platform
1 other identifier
interventional
180
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 21, 2024
CompletedFirst Posted
Study publicly available on registry
August 27, 2024
CompletedStudy Start
First participant enrolled
November 25, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 15, 2027
April 22, 2026
April 1, 2026
1.3 years
August 21, 2024
April 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Estimated Rate of PRC-PWUO Contact
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
The frequency of AI-driven text interactions initiated by PWUO, captured through software logs.
3 months
Change in Felt and/or Anticipated Stigma
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)
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
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
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 Outcomes (1)
The Amount of Participants That Retain in Treatment
3 months
Study Arms (3)
Intervention Arm-1: PRC supported text+ AI driven CSDH-enhanced text
EXPERIMENTALIndividuals randomized to Arm-1 will receive PRC-supported text check-ins and AI-driven CSDH-enhanced text messaging.
Intervention Arm-2: AI driven CSDH-enhanced text only
EXPERIMENTALIndividuals randomized to Arm-2 will receive the AI-driven CSDH-enhanced text messaging only
Control Arm 3- Treatment as Usual
PLACEBO COMPARATORIndividuals randomized to the control arm will receive treatment as usual.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- ≥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.
You may not qualify if:
- inability to comprehend text content written at a 3rd grade reading level
- physical or visual disability preventing mobile phone use
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Friends Research Institute, Inc.lead
- Nathan Kline Institute for Psychiatric Researchcollaborator
- NYU Langone Healthcollaborator
Study Sites (1)
START Treatment and Recovery
New York, New York, 11238, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ana Ventuneac
START Treatment and Recovery
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2024
First Posted
August 27, 2024
Study Start
November 25, 2025
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
March 15, 2027
Last Updated
April 22, 2026
Record last verified: 2026-04