<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03817697</url>
  </required_header>
  <id_info>
    <org_study_id>69HCL18_0992</org_study_id>
    <secondary_id>2019-A00114-53</secondary_id>
    <nct_id>NCT03817697</nct_id>
  </id_info>
  <brief_title>Non-vaccination Factors Against Hepatitis B Virus in Drug Users</brief_title>
  <acronym>ANOVAC B</acronym>
  <official_title>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))</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hepatitis B is one of the major public health problems in the world. According to World&#xD;
      Health Organization (WHO) data, about 2 billion people have been in contact with the&#xD;
      hepatitis B virus (HBV), and 257 million have chronic HBV infection.&#xD;
&#xD;
      Although France is a low endemic country, with just over 280,000 people with chronic&#xD;
      infection, hepatitis B remains a public health problem due to its morbidity and mortality.&#xD;
&#xD;
      Drug users are a population at risk by their consumption practices (injection or sniffing),&#xD;
      but also by other high-risk behaviours, particularly sexual behaviours.&#xD;
&#xD;
      Prevention therefore involves securing consumption practices (sterile and single-use&#xD;
      equipment) and protection of sexual intercourse, but also by vaccination (protecting more&#xD;
      than 90%).&#xD;
&#xD;
      Since 1982, HAS has recommended to systematically vaccinate drug users. However, according to&#xD;
      the Marmottan study published in 2003, immunization coverage among drug addicts was already&#xD;
      insufficient in 1999 (45.3%) and decreased again in 2000 and 2001 (15.6 and 21.7%).&#xD;
&#xD;
      This decrease can be explained by the controversy around the potential link, now refuted,&#xD;
      between vaccine against HBV and demyelination, which has stopped the mass vaccination&#xD;
      campaign launched by the French health authorities in 1995.&#xD;
&#xD;
      A study conducted between 2009 and 2012 on injecting drug users in Alsace, estimated&#xD;
      vaccination coverage at 28%.&#xD;
&#xD;
      The hypothesize is that despite the recommendations in a population at high risk of&#xD;
      contamination, and a balance of benefits and risks in favor of vaccination, vaccination&#xD;
      coverage against the hepatitis B virus remains insufficient among drug users because of poor&#xD;
      vaccination acquaintance, and hepatitis B in general, in this population.&#xD;
&#xD;
      Principal objective of this study is to identify non-vaccination factors against hepatitis B&#xD;
      virus among drug users consulting at the Croix-Rousse CSAPA.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 10, 2019</start_date>
  <completion_date type="Actual">September 4, 2019</completion_date>
  <primary_completion_date type="Actual">September 4, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>comparison of the characteristics of patients vaccinated and unvaccinated against hepatitis B</measure>
    <time_frame>One day</time_frame>
    <description>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.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">137</enrollment>
  <condition>Adult Patients Drug Users</condition>
  <condition>Substituted / Weaned or Not</condition>
  <arm_group>
    <arm_group_label>Drug users</arm_group_label>
    <description>The cohort will be constituted of adult patients drug users, substituted/weaned or not, consulting at the Croix-Rousse CSAPA</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire</intervention_name>
    <description>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.</description>
    <arm_group_label>Drug users</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients drug users, substituted / weaned or not, consulting at the Croix-Rousse&#xD;
        CSAPA&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults (age ≥ 18 years)&#xD;
&#xD;
          -  Patients with an addiction with product, substituted / weaned or not&#xD;
&#xD;
          -  Patients consulting at the CSAPA of the Croix-Rousse hospital&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with an addiction without a product&#xD;
&#xD;
          -  Patients who have never snorted or injected psychoactive product&#xD;
&#xD;
          -  Patients protected by the law&#xD;
&#xD;
          -  Patient refusing to participate to the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hôpital de la Croix-Rousse, 103 grande rue de la Croix-Rousse</name>
      <address>
        <city>Lyon</city>
        <zip>69004</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>January 23, 2019</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>September 16, 2019</last_update_submitted>
  <last_update_submitted_qc>September 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis B</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03817697
org study id: 69HCL18_0992
secondary id: 2019-A00114-53
nct id: NCT03817697
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Cohort
time perspective: Prospective
measure: comparison of the characteristics of patients vaccinated and unvaccinated against hepatitis B
time frame: One day
description: 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.
arm group label: Drug users
description: The cohort will be constituted of adult patients drug users, substituted/weaned or not, consulting at the Croix-Rousse CSAPA
intervention type: Other
intervention name: Questionnaire
description: 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.
arm group label: Drug users
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Hepatitis B
sharing ipd: No