Preventing Overdose and Promoting Recovery Through Court Navigation (POPCORN)
10 luglio 2026 aggiornato da: Bradley Ray, RTI International
Hybrid Type I Trial of a Peer-Led Court Navigation Program to Improve Substance Use Disorder Treatment Receipt and Reduce Overdose and Incarceration Among People Passing Through Courthouses
This project is a hybrid type I clinical trial to assess the effectiveness and implementation determinants of a peer-led court navigation program for people who use drugs and are passing through county courthouses.
Courthouses are a common point of contact for people with behavioral health needs, but outside of specialty court models, they remain underexplored as a setting for connecting people to substance use disorder treatment and related services.
This study will test whether court navigation led by peer recovery specialists can increase receipt of substance use disorder treatment and reduce overdose and incarceration.
Peer court navigators will meet with participants in courthouse settings, assess their needs, provide information and referrals, and offer follow-up support for up to 3 months.
Peer recovery specialists, who have lived experience with substance use recovery, are increasingly being integrated into criminal legal and community-based settings; however, peer-led court navigation remains an innovative and understudied approach.
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Stimato)
600
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Bradley Ray, PhD
- Numero di telefono: 919-324-5492
- Email: bradleyray@rti.org
Backup dei contatti dello studio
- Nome: Cari Megerian, MPH
- Numero di telefono: 415-412-0830
- Email: cmegerian@rti.org
Luoghi di studio
-
-
Indiana
-
South Bend, Indiana, Stati Uniti, 46601
- St. Joseph County Courthouse 1
-
Contatto:
- Bradley Ray, PhD
- Numero di telefono: 919-324-5492
- Email: bradleyray@rti.org
-
Contatto:
- Cari Megerian, MPH
- Numero di telefono: 415-412-0830
- Email: cmegerian@rti.org
-
-
North Carolina
-
Research Triangle Park, North Carolina, Stati Uniti, 27709
- RTI International
-
Contatto:
- Bradley Ray, PhD
- Numero di telefono: 919-324-5492
- Email: bradleyray@rti.org
-
Contatto:
- Cari Megerian, MPH
- Numero di telefono: 415-412-0830
- Email: cmegerian@rti.org
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
Inclusion Criteria:
- Aged 18 years or older
- Current resident of Indiana
- Able to complete study procedures in English
- Meets at least one of the following criteria: used heroin, fentanyl, methamphetamine, or cocaine in the past 12 months; is interested in resources or treatment for a substance use disorder; or experienced an opioid-related overdose in the past 12 months
Exclusion Criteria:
- Has been sentenced to incarceration in jail or prison for the next 12 months
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Peer court navigation
CourtConnect is the intervention.
It connects individuals in courthouses with peer court navigators who provide information, referrals, and support to address substance use disorder treatment needs and related health and social needs.
Navigation begins in the courthouse and continues in the community through follow-up support for up to 3 months.
|
CourtConnect connects individuals in courthouses with peer court navigators who provide information, referrals, and support to address substance use disorder treatment needs and related health and social needs.
Navigation begins in the courthouse and continues in the community through follow-up support for up to 3 months.
|
|
Comparatore attivo: Information only
Participants assigned to the information-only group receive information about health and social services in the community from a non-peer research assistant.
They do not receive peer court navigation or follow-up support from a peer court navigator.
|
Participants assigned to the information-only group receive information about health and social services in the community from a non-peer research assistant.
They do not receive peer court navigation or follow-up support from a peer court navigator.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Administratively documented substance use disorder treatment engagement
Lasso di tempo: 90 days after baseline
|
This participant-level outcome will indicate whether a participant has any administratively documented substance use disorder treatment engagement within 90 days after baseline.
Treatment engagement will be determined from linked state administrative records, including Medicaid claims for substance use disorder treatment services and prescription drug monitoring program records showing dispensed medications used to treat substance use disorder.
For participants without administratively documented substance use disorder treatment during the 90 days before baseline, a qualifying post-baseline record will be classified as treatment initiation.
For participants with administratively documented substance use disorder treatment during the 90 days before baseline, a qualifying post-baseline record will be classified as continued treatment engagement.
The outcome will be reported as the proportion of participants in each study arm with administratively documented treatment engagement.
|
90 days after baseline
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Number of participants with a fatal or nonfatal overdose
Lasso di tempo: 12 months after baseline
|
Fatal and nonfatal overdose will be measured using statewide vital records and emergency medical records from ambulance services and hospital emergency departments.
Participants will be classified as having experienced an overdose if records show a fatal overdose or an encounter for a nonfatal overdose during the 12 months after baseline.
|
12 months after baseline
|
|
Number of participants with a jail booking or prison entry
Lasso di tempo: 12 months after baseline
|
Incarceration through jail booking or prison entry will be measured using statewide criminal legal records.
Participants will be classified as having experienced incarceration if records show a booking into a jail facility or entry into the state prison system during the 12 months after baseline.
|
12 months after baseline
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
1 ottobre 2026
Completamento primario (Stimato)
1 dicembre 2028
Completamento dello studio (Stimato)
1 maggio 2030
Date di iscrizione allo studio
Primo inviato
3 luglio 2026
Primo inviato che soddisfa i criteri di controllo qualità
10 luglio 2026
Primo Inserito (Effettivo)
14 luglio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
14 luglio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
10 luglio 2026
Ultimo verificato
1 luglio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- R01DA064492 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano IPD
The investigators will enroll 600 subjects over 24 months with 12 months of follow-up data by linking administrative records (e.g., prescription fills, emergency department/emergency medical services encounters, mortality, arrests/jail bookings) to survey contents that will include demographics, substance use disorder and treatment history, criminal legal system involvement, social constructs (self-efficacy, motivation, stigma), and harmonized measures.
The National Institutes of Health requires that the study team release study data.
The investigators will preserve and share de-identified survey datasets (with codebooks), and project documentation (protocols, instruments); derived variables from linked administrative data will be shared, while raw state administrative source files obtained under data use agreements will not be shared.
The publicly released scientific data will include only fully de-identified data.
Periodo di condivisione IPD
IPD and additional supporting information will be archived in the National Addiction & HIV Data Archive Program (NAHDAP), assigned persistent identifiers, and made available as soon as possible and no later than the earlier of the primary publication or the end of the performance period, whichever comes first.
Criteri di accesso alla condivisione IPD
After project completion, only de-identified datasets will be made available as public-use files and deposited in repositories for broader research, teaching, replication.
Shared data will be provided in open, non-proprietary formats, along with parallel Stata/R scripts and a README so that no specialized software is required to access or manipulate the data.
Publicly shared datasets will receive a DOI to facilitate sharing, citation, and version control.
Access will be controlled when there is any non-trivial re-identification risk or when required by data use agreements.
In those cases, repositories will gate access under standard data use agreements that prohibit re-identification and onward sharing, require secure storage and destruction at project end, and log requestor credentials and approved uses.
Raw state administrative source files received under data use agreements will not be shared; only de-identified, derived variables constructed from those sources will be deposited.
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- CODICE_ANALITICO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .