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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Поведенческое 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.
• Поведенческое 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.

Первичные конечные точки

• Estimated Rate of PRC-PWUO Contact [Срок оценки: 3 months]
• Rate of AI-Driven Texting Use Among PWUO [Срок оценки: 3 months]
• Change in Felt and/or Anticipated Stigma [Срок оценки: 3 months]
• Amount of time to Initial Receipt of Buprenorphine (Self-Reported) [Срок оценки: 3 months]
• The Amount of Self-Reported Social Services Use [Срок оценки: 3 months]
• Cost (Amount of Money) of Implementing and Sustaining the Multimodal Intervention [Срок оценки: 3 months]

Вторичные конечные точки (1)

• The Amount of Participants That Retain in Treatment [Срок оценки: 3 months]

Критерии участия

Критерии включения

• ≥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.

Критерии исключения

• inability to comprehend text content written at a 3rd grade reading level
• physical or visual disability preventing mobile phone use

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

США · 1 центр

• START Treatment and Recovery — New York

Идентификаторы

NCT: NCT06573476 · R34DA059770

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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