Non-vaccination Factors Against Hepatitis B Virus in Drug Users

NCT03817697 | Completed

• 2 other identifiers: 69HCL18_09922019-A00114-53
• Study Type: observational
• Target: 137
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Adult Patients Drug Users; Substituted / Weaned or Not

Outcome Measures

Primary Outcomes (1)

• comparison of the characteristics of patients vaccinated and unvaccinated against hepatitis B

  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.

  One day

Study Arms (1)

Drug users

The cohort will be constituted of adult patients drug users, substituted/weaned or not, consulting at the Croix-Rousse CSAPA

Other: Questionnaire

Interventions

Questionnaire OTHER

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.

Drug users

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients drug users, substituted / weaned or not, consulting at the Croix-Rousse CSAPA

You may qualify if:

• Adults (age ≥ 18 years)
• Patients with an addiction with product, substituted / weaned or not
• Patients consulting at the CSAPA of the Croix-Rousse hospital

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital de la Croix-Rousse, 103 grande rue de la Croix-Rousse

Lyon, 69004, France

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2019
• First Posted: January 25, 2019
• Study Start: April 10, 2019
• Primary Completion: September 4, 2019
• Study Completion: September 4, 2019
• Last Updated: September 17, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)