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Preventing Overdose and Promoting Recovery Through Court Navigation (POPCORN)

10 juillet 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

600

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

  • Nom: Cari Megerian, MPH
  • Numéro de téléphone: 415-412-0830
  • E-mail: cmegerian@rti.org

Lieux d'étude

  • États-Unis
    • Indiana
      • South Bend, Indiana, États-Unis, 46601
        • St. Joseph County Courthouse 1
        • Contact:
        • Contact:
    • North Carolina
      • Research Triangle Park, North Carolina, États-Unis, 27709
        • RTI International
        • Contact:
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Recherche sur les services de santé
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Comportemental: CourtConnect
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.
Comparateur actif: 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.
Autre: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Administratively documented substance use disorder treatment engagement
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Number of participants with a fatal or nonfatal overdose
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

RTI International

Collaborateurs

National Institute on Drug Abuse (NIDA)

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 octobre 2026

Achèvement primaire (Estimé)

1 décembre 2028

Achèvement de l'étude (Estimé)

1 mai 2030

Dates d'inscription aux études

Première soumission

3 juillet 2026

Première soumission répondant aux critères de contrôle qualité

10 juillet 2026

Première publication (Réel)

14 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

14 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

10 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • R01DA064492 (Subvention/contrat des NIH des États-Unis)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime 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.

Délai de partage 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.

Critères d'accès au partage 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.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • ANALYTIC_CODE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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