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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03817697
Non-vaccination Factors Against Hepatitis B Virus in Drug Users (ANOVAC B)
Analysis of Non-vaccination Factors Against Hepatitis B Virus (HBV) in Drug Users Consulting at the Croix-rousse Drug Addict Care Center (Annuaire Centres de Soins, d'Accompagnement et de prévention en Addictologie (CSAPA))
Hepatitis B is one of the major public health problems in the world. According to World Health Organization (WHO) data, about 2 billion people have been in contact with the hepatitis B virus (HBV), and 257 million have chronic HBV infection.
Although France is a low endemic country, with just over 280,000 people with chronic infection, hepatitis B remains a public health problem due to its morbidity and mortality.
Drug users are a population at risk by their consumption practices (injection or sniffing), but also by other high-risk behaviours, particularly sexual behaviours.
Prevention therefore involves securing consumption practices (sterile and single-use equipment) and protection of sexual intercourse, but also by vaccination (protecting more than 90%).
Since 1982, HAS has recommended to systematically vaccinate drug users. However, according to the Marmottan study published in 2003, immunization coverage among drug addicts was already insufficient in 1999 (45.3%) and decreased again in 2000 and 2001 (15.6 and 21.7%).
This decrease can be explained by the controversy around the potential link, now refuted, between vaccine against HBV and demyelination, which has stopped the mass vaccination campaign launched by the French health authorities in 1995.
A study conducted between 2009 and 2012 on injecting drug users in Alsace, estimated vaccination coverage at 28%.
The hypothesize is that despite the recommendations in a population at high risk of contamination, and a balance of benefits and risks in favor of vaccination, vaccination coverage against the hepatitis B virus remains insufficient among drug users because of poor vaccination acquaintance, and hepatitis B in general, in this population.
Principal objective of this study is to identify non-vaccination factors against hepatitis B virus among drug users consulting at the Croix-Rousse CSAPA.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Lyon, Francia, 69004
- Hôpital de la Croix-Rousse, 103 grande rue de la Croix-Rousse
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Adults (age ≥ 18 years)
- Patients with an addiction with product, substituted / weaned or not
- Patients consulting at the CSAPA of the Croix-Rousse hospital
Exclusion Criteria:
- Patients with an addiction without a product
- Patients who have never snorted or injected psychoactive product
- Patients protected by the law
- Patient refusing to participate to the study
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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Drug users
The cohort will be constituted of adult patients drug users, substituted/weaned or not, consulting at the Croix-Rousse CSAPA
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The socio-demographic characteristics of patients, their current and past drug use as well as their knowledge of hepatitis B and vaccination, will be collected via a questionnaire, conducted by the service's addictologists at the beginning of the consultation.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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comparison of the characteristics of patients vaccinated and unvaccinated against hepatitis B
Periodo de tiempo: One day
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These data will be collected via a questionnaire with questions of patient socio-demographic characteristics, as well as their knowledge of hepatitis B and vaccination.
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One day
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 69HCL18_0992
- 2019-A00114-53 (Otro identificador: ID-RCB)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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