Opioid Use DisorderNCT06573476
Addressing Racial Disparities in Opioid Overdose Using Peer Recovery Coach Training and mHealth Platform
A study testing PRC supported text + AI driven CSDH-enhanced text, AI driven CSDH-enhanced text only and Treatment as Usual (TAU) in people with Opioid Use Disorder, run by Friends Research Institute, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- PRC supported text + AI driven CSDH-enhanced text, AI driven CSDH-enhanced text only and Treatment as Usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jun 2025to 15 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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
Show all 9Show fewer
- 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.
Who cannot join
- inability to comprehend text content written at a 3rd grade reading level
- physical or visual disability preventing mobile phone use
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
START Treatment and Recovery
New York, New York, 11238
Ana Ventuneac, PhD, 718-260-2931, aventuneac@startny.org
About this study
Official title: Addressing Racial Disparities in Opioid Overdose Deaths Using an Open Source Peer Recovery Coach Training and Multimodal Mobile Health Platform
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.
Read the 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
- Opioid Use Disorder
- Being tested
- PRC supported text + AI driven CSDH-enhanced text, AI driven CSDH-enhanced text only, Treatment as Usual (TAU)
- Keywords
- Opioid Use Disorder, Peer Recovery Coach, Cultural Structural Humility, mHealth, People With Opioid Use Disorder, OUD, PWOUD, mHealth Intervention
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRC supported text + AI driven CSDH-enhanced textBehavioural
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 onlyBehavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm-1: PRC supported text+ AI driven CSDH-enhanced text | Experimental | Individuals randomized to Arm-1 will receive PRC-supported text check-ins and AI-driven CSDH-enhanced text messaging. Receives: Behavioral: PRC supported text + AI driven CSDH-enhanced text |
| Intervention Arm-2: AI driven CSDH-enhanced text only | Experimental | Individuals randomized to Arm-2 will receive the AI-driven CSDH-enhanced text messaging only Receives: Behavioral: AI driven CSDH-enhanced text only |
| Control Arm 3- Treatment as Usual | Placebo comparator | Individuals randomized to the control arm will receive treatment as usual. Receives: Behavioral: Treatment as Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated Rate of PRC-PWUO Contact
The number of contacts between Peer Recovery Coaches (PRC) and People Who Use Opioids (PWUO), measured through communication logs.
Measured: 3 months
Rate of AI-Driven Texting Use Among PWUO
The frequency of AI-driven text interactions initiated by PWUO, captured through software logs.
Measured: 3 months
Change in Felt and/or Anticipated Stigma
The change in felt and/or anticipated stigma pre- and post-intervention, measured by a validated stigma assessment questionnaire.
Measured: 3 months
Amount of time to Initial Receipt of Buprenorphine (Self-Reported)
The time (in days) to the initial receipt of buprenorphine, as self-reported by participants.
Measured: 3 months
The Amount of Self-Reported Social Services Use
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.
Measured: 3 months
Cost (Amount of Money) of Implementing and Sustaining the Multimodal Intervention
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.
Measured: 3 months
Secondary outcomes (1)
The Amount of Participants That Retain in Treatment
The number of participants continuously retained in buprenorphine treatment over a 12-week period, assessed at the 12-week mark.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start25 Jun 2025
- Primary completion1 Mar 2027 (estimated)
- Study completion15 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Friends Research Institute, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Nathan Kline Institute for Psychiatric Research, NYU Langone Health
- Responsible party
- Sponsor
- Investigators
- Ana Ventuneac, Study director, START Treatment and Recovery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06573476
- Sponsor's protocol ID
- R34DA059770
- Status last verified
- May 2026
- First submitted
- 21 Aug 2024
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Racial Disparities in Opioid Overdose Deaths Using an Open Source Peer Recovery Coach Training and Multimodal Mobile Health Platform
- ClinicalTrials.gov ID
- NCT06573476
- Acronym / sponsor ID
- R34DA059770
- Conditions
- Opioid Use Disorder
- Keywords
- Opioid Use Disorder, Peer Recovery Coach, Cultural Structural Humility, mHealth, People With Opioid Use Disorder, OUD, PWOUD, mHealth Intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Friends Research Institute, Inc.University, hospital or other
- Collaborators
- Nathan Kline Institute for Psychiatric Research, NYU Langone Health
- Study start
- 25 Jun 2025 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 15 Mar 2027 (estimated)
- First posted
- 27 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm-1: PRC supported text+ AI driven CSDH-enhanced text | Experimental | Behavioral: PRC supported text + AI driven CSDH-enhanced textIndividuals randomized to Arm-1 will receive PRC-supported text check-ins and AI-driven CSDH-enhanced text messaging. |
| Intervention Arm-2: AI driven CSDH-enhanced text only | Experimental | Behavioral: AI driven CSDH-enhanced text onlyIndividuals randomized to Arm-2 will receive the AI-driven CSDH-enhanced text messaging only |
| Control Arm 3- Treatment as Usual | Placebo comparator | Behavioral: Treatment as Usual (TAU)Individuals randomized to the control arm will receive treatment as usual. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- ≥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
Key exclusion criteria (2 listed)
- inability to comprehend text content written at a 3rd grade reading level
- physical or visual disability preventing mobile phone use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRC 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. | Behavioural | Intervention Arm-1: PRC supported text+ AI driven CSDH-enhanced text |
| AI 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. | Behavioural | Intervention Arm-2: AI driven CSDH-enhanced text only |
| 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. | Behavioural | Control Arm 3- Treatment as Usual |
Primary outcome
Estimated Rate of PRC-PWUO Contact
Time frame: 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
Time frame: 3 months
The frequency of AI-driven text interactions initiated by PWUO, captured through software logs.
Change in Felt and/or Anticipated Stigma
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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.
1 secondary outcome
The Amount of Participants That Retain in Treatment
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ana Ventuneac study director
START Treatment and Recovery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRC supported text + AI driven CSDH-enhanced text, AI driven CSDH-enhanced text only and Treatment as Usual (TAU) in people with Opioid Use Disorder, run by Friends Research Institute, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ana Ventuneac, PHd (718-260-2931, aventuneac@startny.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimated Rate of PRC-PWUO Contact (time frame: 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.