NCT06573476 · Friends Research Institute, Inc.
Addressing Racial Disparities in Opioid Overdose Using Peer Recovery Coach Training and mHealth Platform
What this study is about
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.
View original scientific description
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.
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
The number of contacts between Peer Recovery Coaches (PRC) and People Who Use Opioids (PWUO), measured through communication logs.
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.
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.
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.
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.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- New York, New York
Collaborators
Nathan Kline Institute for Psychiatric Research, NYU Langone Health
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 27, 2026 · Source of record for eligibility and locations