Clinical trial NCT06573476: Addressing Racial Disparities in Opioid Overdose Using Peer Recovery Coach Training and MHealth Platform
Official title: Addressing Racial Disparities in Opioid Overdose Deaths Using an Open Source Peer Recovery Coach Training and Multimodal Mobile Health Platform
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Opioid Use Disorder
Keywords: Opioid Use Disorder
Peer Recovery Coach
Cultural Structural Humility
mHealth
People With Opioid Use Disorder
OUD
PWOUD
mHealth Intervention
Lead sponsor: Friends Research Institute, Inc.
Sponsor class: OTHER
Collaborators: name: Nathan Kline Institute for Psychiatric Research
name: NYU Langone Health
First posted: 2024-08-27
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Estimated Rate of PRC-PWUO Contact
timeFrame: 3 months
measure: Rate of AI-Driven Texting Use Among PWUO
timeFrame: 3 months
measure: Change in Felt and/or Anticipated Stigma
timeFrame: 3 months
measure: Amount of time to Initial Receipt of Buprenorphine (Self-Reported)
timeFrame: 3 months
measure: The Amount of Self-Reported Social Services Use
timeFrame: 3 months
measure: Cost (Amount of Money) of Implementing and Sustaining the Multimodal Intervention
timeFrame: 3 months
Secondary outcomes:
measure: The Amount of Participants That Retain in Treatment
timeFrame: 3 months
Other outcomes:
Locations:
city: New York City
country: United States
facility: START Treatment and Recovery
state: New York
Study officials:
References: