Recruiting

Cultural Structural Humility

Sponsor:

Friends Research Institute, Inc.

Code:

NCT06573476

Conditions

Opioid Use Disorder

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

PRC supported text + AI driven CSDH-enhanced text

AI driven CSDH-enhanced text only

Treatment as Usual (TAU)

Study Details

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.

Conditions

Opioid Use Disorder

Study ID

NCT06573476

Start date

Jun 25, 2025

Status verified date

May, 2026

Completion date

Mar 15, 2027

Anticipated

Primary completion date

Mar 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Intervention Arm-1: PRC supported text+ AI driven CSDH-enhanced text

Individuals randomized to Arm-1 will receive PRC-supported text check-ins and AI-driven CSDH-enhanced text messaging.

experimental: Intervention Arm-2: AI driven CSDH-enhanced text only

Individuals randomized to Arm-2 will receive the AI-driven CSDH-enhanced text messaging only

placebo comparator: Control Arm 3- Treatment as Usual

Individuals randomized to the control arm will receive treatment as usual.

Interventions

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.

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.

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 measure

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

Central Contacts and Locations

Central contacts

Ana Ventuneac, PHd

718-260-2931aventuneac@startny.org

Locations

START Treatment and Recovery

Recruiting

New York, New York, United States, 11238

Contacts

Ana Ventuneac, PhD

718-260-2931aventuneac@startny.org

More Information

Sponsor

Friends Research Institute, Inc.

Last update posted

May 27, 2026

Last verified

May, 2026

Keywords

  • Opioid Use Disorder
  • Peer Recovery Coach
  • Cultural Structural Humility
  • mHealth
  • People With Opioid Use Disorder
  • OUD
  • PWOUD
  • mHealth Intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Friends Research Institute, Inc. on 2026-05-27.