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- Ensayo clínico NCT02440256
Expanded HIV Care in Opioid Substitution Treatment (EHOST) Trial (EHOST)
24 de abril de 2017 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
49
Fase
- No aplica
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Otro: 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.
|
|
Otro: 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.
|
|
Otro: 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
The HIV testing rate among those not known to be HIV positive
Periodo de tiempo: 24 months
|
24 months
|
|
The rate of Highly Active Antiretroviral (HAART) initiation among those not on HAART
Periodo de tiempo: 24 months
|
24 months
|
|
The rate of HAART adherence among those on HAART
Periodo de tiempo: 24 months
|
24 months
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Bohdan Nosyk, PhD, Simon Fraser University
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de septiembre de 2015
Finalización primaria (Actual)
1 de marzo de 2017
Finalización del estudio (Actual)
1 de marzo de 2017
Fechas de registro del estudio
Enviado por primera vez
24 de marzo de 2015
Primero enviado que cumplió con los criterios de control de calidad
6 de mayo de 2015
Publicado por primera vez (Estimar)
12 de mayo de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
25 de abril de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
24 de abril de 2017
Última verificación
1 de abril de 2017
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Desordenes mentales
- Trastornos inducidos químicamente
- Trastornos relacionados con sustancias
- Trastornos relacionados con narcóticos
- Trastornos relacionados con opioides
- Efectos fisiológicos de las drogas
- Depresores del sistema nervioso central
- Agentes del sistema nervioso periférico
- Analgésicos
- Agentes del sistema sensorial
- Estupefacientes
- Analgésicos Opiáceos
Otros números de identificación del estudio
- MOP313184
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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