Using AI and Peer Coaching to Address Racial Disparities Among People Who Use Opioids

Leveraging Social Determinants Via Artificial Intelligence and Peer Coaching to Address Racial Disparities in Primary Care Among People Who Use Opioids

Black and Latinx people who use opioids are disproportionately impacted by opioid overdose deaths. The proposed study assesses the efficacy of an open source, multimodal artificial intelligence-driven texting tool combined with peer recovery coach-supported text contact that delivers social services, stigma reduction, health habitus, and patient navigation content addressing social determinants of health to enhance receipt of buprenorphine in primary care among emergency department-enrolled Black / Latinx people who use opioids.

Study Overview

• Status: Recruiting
• Conditions: Opioid Use Disorder
• Intervention / Treatment: Behavioral: PRC supported text + AI driven SDH-enhanced text; Behavioral: AI driven SDH-enhanced text only; Behavioral: Treatment as Usual (TAU)

Detailed Description

The investigators have validated a theory-driven, artificial intelligence (AI)-driven texting tool using natural language processing to facilitate real-time text responses to patient queries combined with automated texts facilitating receipt of buprenorphine in office-based opioid treatment (OBOT) and social services that address social determinants of health (SDH). This open-source texting tool offers passive reminders, informational content, and interactive two-way response algorithms without personal staff contact. In addition, the investigators have adapted an efficacious cultural and structural humility training for PRCs that goes beyond SDH to also address stigma reduction, discrimination, health habitus, and patient navigation to enhance uptake of primary care and social services for PWUO.

Using a three-arm, comparative effectiveness trial design, the specific aims are to: (1) Assess the efficacy of PRC supported text-based care/services coordination with PWUO + AI-driven SDH-enhanced text messaging (intervention arm-1) vs. AI-driven SDH-enhanced text messaging only (intervention arm-2) vs. Treatment as Usual (TAU) or printed social/medical services referrals (control) to enhance the receipt of buprenorphine in OBOT among community and ED-enrolled Black / Latinx PWUO (N=252); (2) Evaluate the implementation of the multimodal intervention (arm-1) guided by the RE-AIM and CFIR frameworks using in-depth interviews among 3 stakeholder groups: (a) frontline providers (n=10); (b) administrators (n=10); and (c) a subset of the Black and Latinx PWUO from the multimodal intervention arm-1 (n=30); and (3) Identify the resources and estimate the associated cost of implementing and sustaining the multimodal intervention and incorporate this information into a customizable budget-impact tool and conduct a comprehensive economic evaluation to calculate the relative economic value (e.g., cost-per quality-adjusted life years, cost-per OUD treatment days) of each study arm from the healthcare sector, state policymaker, and societal perspectives which will also inform implementation framed by RE-AIM.

• Study Type: Interventional
• Enrollment (Estimated): 292
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Babak Tofighi, MSc, MD; Phone Number: 4102947477; Email: babak.tofighi@nki.rfmh.org

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10451
      • Recruiting
      • NYC Health + Hospitals
      • Contact: Babak Tofighi, MSc, MD; Phone Number: 410-294-7477; Email: btofighi@friendsresearch.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. ≥18 years of age;
2. fluent in English and/or Spanish;
3. self-reported non-prescription opioid use <30 days prior to consent;
4. provision of informed consent;
5. planned stay in NYC ≥12 month;
6. self-identified Black and/or Latinx race/ethnicity;
7. positive urine toxicology for opioids per EMR records;
8. diagnosis of OUD per the Diagnostic and Statistical Manual of Mental Disorders-5
9. self-reported interest in initiating buprenorphine in primary care
10. must have a mobile phone data plan.

Exclusion Criteria:

1. inability to comprehend text content written at a 3rd grade reading level;
2. physical or visual disability preventing mobile phone use;
3. self-reported receipt of medications for OUD in past 30 days.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Arm-1: PRC supported text+ AI driven SDH-enhanced text; Participants in this arm will receive a combination of Peer Recovery Coaches (PRCs) supported text-based care/services coordination alongside AI-driven SDH-enhanced text messages to enhance the receipt of buprenorphine in Black/ Latin people who use opioids.	Behavioral: PRC supported text + AI driven SDH-enhanced text; This interventional study evaluates an AI-driven texting tool combined with peer recovery coach support to deliver social services, reduce stigma, and provide patient navigation content. The goal is to enhance the receipt of buprenorphine in primary care among emergency department-enrolled Black and Latinx individuals who use opioids, addressing the disproportionate impact of opioid overdose deaths on these communities.
Experimental: Intervention Arm-2: AI driven SDH-enhanced text only; Participants in this arm will receive AI-driven SDH-enhanced text messages to enhance the receipt of buprenorphine in Black/ Latin people who use opioids. Unlike Arm-1, this intervention does not include the additional support and coordination provided by Peer Recovery Coaches.	Behavioral: AI driven SDH-enhanced text only; This interventional study evaluates an AI-driven SDH-enhanced texting tool to deliver social services, reduce stigma, and provide patient navigation content. The goal is to enhance the receipt of buprenorphine in primary care among emergency department-enrolled Black and Latinx individuals who use opioids, addressing the disproportionate impact of opioid overdose deaths on these communities.
Placebo Comparator: Control Arm 3- Treatment as Usual; Control Arm-3 will receive treatment as usual (i.e., verbal instructions, NYC Dept of Health pamphlets detailing access to OUD and social services, health system smartphone application EMR patient portal).	Behavioral: Treatment as Usual (TAU); Control Arm-3 will receive treatment as usual (i.e., verbal instructions, NYC Dept of Health pamphlets detailing access to OUD and social services, health system smartphone application EMR patient portal).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of self-reported linkage to OUD services	The primary outcome for this efficacy study is self-reported linkage to OUD services (i.e., time to initial buprenorphine prescription that is prescribed in OBOT programs or other OUD treatment providers per the Non-study Medical and Other Services form.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Office-Based Opioid Treatment with buprenorphine.	Durability of treatment effect at 52 weeks. For example, continuous retention in Office-Based Opioid Treatment with buprenorphine.	1 year
Number of social services received	Total number of social services received and documented over 52 weeks.	1 year
Number of interactions and time spent (in minutes) engaged with the intervention	Total number of interactions and time spent (in minutes) engaged with the intervention over 26 weeks	26 weeks

Collaborators and Investigators

• Sponsor: Friends Research Institute, Inc.
• Collaborators: NYU Langone Health; Weill Medical College of Cornell University; Nathan Kline Institute for Psychiatric Research
• Investigators: Principal Investigator: Babak Tofighi, MSc, MD, Friends Research Institute, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2025
• Primary Completion (Estimated): August 31, 2025
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: August 12, 2024
• First Submitted That Met QC Criteria: August 21, 2024
• First Posted (Actual): August 26, 2024

Study Record Updates

• Last Update Posted (Actual): August 12, 2025
• Last Update Submitted That Met QC Criteria: August 6, 2025
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Opioid Use Disorder; mobile health (mHealth); Peer Recovery Coach; AI-driven text tool
• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Opioid-Related Disorders
• Other Study ID Numbers: R18HS029783 (U.S. AHRQ Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No