Opioid Use Disorder
Conditions
Keywords
Opioid Use Disorder, Peer Recovery Coach, Cultural Structural Humility, mHealth, People With Opioid Use Disorder, OUD, PWOUD, mHealth Intervention
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.
Interventions
BEHAVIORALPRC 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.
BEHAVIORALAI 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.
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.
Sponsors
Friends Research Institute, Inc.
Nathan Kline Institute for Psychiatric Research
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Estimated Rate of PRC-PWUO Contact | 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 | 3 months | The frequency of AI-driven text interactions initiated by PWUO, captured through software logs. |
| Change in Felt and/or Anticipated Stigma | 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) | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Amount of Participants That Retain in Treatment | 3 months | The number of participants continuously retained in buprenorphine treatment over a 12-week period, assessed at the 12-week mark. |
Countries
United States
Contacts
CONTACTAna Ventuneac, PHd
STUDY_DIRECTORAna Ventuneac
START Treatment and Recovery
Outcome results
None listed