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- Essai clinique NCT02440256
Expanded HIV Care in Opioid Substitution Treatment (EHOST) Trial (EHOST)
24 avril 2017 mis à jour par: Bohdan Nosyk, Simon Fraser University
The Expanded HIV Care in Opioid Substitution Treatment (EHOST) Stepped-wedge, Cluster-randomized Trial
Opioid Substitution Treatment (OST) provides a critical opportunity for HIV testing and linkage to antiretroviral treatment.
The EHOST study will evaluate a prescriber-focused intervention to increase HIV testing rates, and optimize antiretroviral treatment, re-engagement and retention outcomes among individuals engaged in OST.
46 OST sites in British Columbia will be randomly allocated into three clusters.
Clusters will initiative the intervention at different time points, or steps, with every cluster receiving the intervention.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
The public health response to the HIV/AIDS epidemic has turned its focus on means of optimizing health care delivery, and re-engineering delivery systems to maximize case identification, as well as access and sustained engagement in antiretroviral treatment.
Opioid Substitution Treatment (OST) provides a critical opportunity for HIV testing and linkage to antiretroviral treatment.
The EHOST study is a cluster-randomized, stepped-wedge trial to evaluate a prescriber-focused intervention to increase HIV testing rates, and optimize antiretroviral treatment re-engagement and retention outcomes among individuals engaged in OST.
The study will encompass all drug treatment clinics currently admitting patients for the treatment of opioid dependence across the province of British Columbia, which are thought to treat 90% of the OST caseload.
The trial will be executed over a 24-month period, with groups of clinics receiving the intervention in 6-month intervals.
Evaluation of the effectiveness of the proposed intervention will be conducted entirely through existing data collection mechanisms, and focuses on three primary outcomes: (i) the HIV testing rate among those not known to be HIV positive; (ii) the rate of Highly Active Antiretroviral (HAART) initiation among those not on HAART; and (iii) the rate of HAART continuation among those on HAART.
Despite the randomized delivery of the intervention, a difference-in-differences analytical framework will be applied to adjust for potential residual heterogeneity in patient case mix, volume, and quality of care across OST clinics.
Facilitated by established collaborations between key stakeholders across the province, we hypothesize that the EHOST intervention will optimize HIV testing and care within this marginalized and hard-to-reach population.
Type d'étude
Interventionnel
Inscription (Réel)
49
Phase
- N'est pas applicable
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
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Drug treatment clinic currently admitting patients for the treatment of opioid dependence across the province of British Columbia
Exclusion Criteria:
- Private office-based setting
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 croisée
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Autre: Cluster 1
Cluster 1 is the first OST cluster (with an estimated 15-16 OST sites) to receive the 'Expanded HIV care in Opioid Substitution Treatment' intervention, to be administered during the sixth month of the trial.
Cluster 1 will be a 'no intervention' arm in the first 6 months of the study, and will cross-over to an experimental arm for months 6-24.
|
The EHOST intervention entails in-person presentations and consultation sessions with individual OST sites that will: (i) provide rationale for the study (ii) outline action items of the intervention; and (iii) describe guidelines around HIV testing and care.
The EHOST intervention will be delivered at three distinct times: (i) at point of OST entry; (ii) following 7 days non-adherence; and (iii) at bi-annual intervals.
The interventions are comprised of HIV test offers for individuals of unknown HIV status; offers of HIV-related care, including cluster of differentiation 4 (CD4), plasma viral load (pVL) and resistance tests, along with HAART initiation for those known to be HIV-positive, not on HAART; and regular monitoring for those known to be HIV positive, on HAART.
|
|
Autre: Cluster 2
Cluster 2 is the second OST cluster (with an estimated 15-16 OST sites) to receive the 'Expanded HIV care in Opioid Substitution Treatment' intervention, to be administered during the twelfth month of the trial.
Cluster 2 will be a 'no intervention' arm in the first 12 months of the study, and will cross-over to a experimental arm for month 12-24.
|
The EHOST intervention entails in-person presentations and consultation sessions with individual OST sites that will: (i) provide rationale for the study (ii) outline action items of the intervention; and (iii) describe guidelines around HIV testing and care.
The EHOST intervention will be delivered at three distinct times: (i) at point of OST entry; (ii) following 7 days non-adherence; and (iii) at bi-annual intervals.
The interventions are comprised of HIV test offers for individuals of unknown HIV status; offers of HIV-related care, including cluster of differentiation 4 (CD4), plasma viral load (pVL) and resistance tests, along with HAART initiation for those known to be HIV-positive, not on HAART; and regular monitoring for those known to be HIV positive, on HAART.
|
|
Autre: Cluster 3
Cluster 3 is the final OST cluster (with an estimated 15-16 OST sites) to receive the 'Expanded HIV care in Opioid Substitution Treatment' intervention, to be administered during the 18th month of the trial.
As such, Cluster 3 will be a 'no intervention' arm in the first 18 months of the study, and will cross-over to an experimental arm for months 18-24.
|
The EHOST intervention entails in-person presentations and consultation sessions with individual OST sites that will: (i) provide rationale for the study (ii) outline action items of the intervention; and (iii) describe guidelines around HIV testing and care.
The EHOST intervention will be delivered at three distinct times: (i) at point of OST entry; (ii) following 7 days non-adherence; and (iii) at bi-annual intervals.
The interventions are comprised of HIV test offers for individuals of unknown HIV status; offers of HIV-related care, including cluster of differentiation 4 (CD4), plasma viral load (pVL) and resistance tests, along with HAART initiation for those known to be HIV-positive, not on HAART; and regular monitoring for those known to be HIV positive, on HAART.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
The HIV testing rate among those not known to be HIV positive
Délai: 24 months
|
24 months
|
|
The rate of Highly Active Antiretroviral (HAART) initiation among those not on HAART
Délai: 24 months
|
24 months
|
|
The rate of HAART adherence among those on HAART
Délai: 24 months
|
24 months
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Bohdan Nosyk, PhD, Simon Fraser University
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 (Réel)
1 septembre 2015
Achèvement primaire (Réel)
1 mars 2017
Achèvement de l'étude (Réel)
1 mars 2017
Dates d'inscription aux études
Première soumission
24 mars 2015
Première soumission répondant aux critères de contrôle qualité
6 mai 2015
Première publication (Estimation)
12 mai 2015
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
25 avril 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
24 avril 2017
Dernière vérification
1 avril 2017
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Les troubles mentaux
- Troubles induits chimiquement
- Troubles liés à une substance
- Troubles liés aux stupéfiants
- Troubles liés aux opioïdes
- Effets physiologiques des médicaments
- Dépresseurs du système nerveux central
- Agents du système nerveux périphérique
- Analgésiques
- Agents du système sensoriel
- Stupéfiants
- Analgésiques, Opioïdes
Autres numéros d'identification d'étude
- MOP313184
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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