Clinical Trials Directory

Trials / Recruiting

RecruitingNCT06573476

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

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

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
180 (estimated)
Sponsor
Friends Research Institute, Inc. · Academic / Other
Sex
All
Age
18 Years – 99 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALPRC supported text + AI driven CSDH-enhanced textIn 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.
BEHAVIORALAI driven CSDH-enhanced text onlyIn 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.
BEHAVIORALTreatment 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.

Timeline

Start date
2025-06-25
Primary completion
2025-09-15
Completion
2025-12-01
First posted
2024-08-27
Last updated
2025-08-07

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT06573476. Inclusion in this directory is not an endorsement.