<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/NCT04402684</url>
  </required_header>
  <id_info>
    <org_study_id>RIPH_2020_5</org_study_id>
    <nct_id>NCT04402684</nct_id>
  </id_info>
  <brief_title>Influenza Vaccination in Patients Living With HIV in the Northern Region</brief_title>
  <acronym>VACCIGRIPPE</acronym>
  <official_title>Influenza Vaccination in Patients Living With HIV in the Northern Region: An Observational Monocentre Study of Blankets, Modalities, Drivers and Brakes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tourcoing Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tourcoing Hospital</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>
      Anyone living with the Human Immunodeficiency Virus (HIV) has an indication for annual&#xD;
      influenza vaccination. (Vaccination schedule and vaccination recommendations 2019). Influenza&#xD;
      is a viral infection that has a significant impact on the health care system. However,&#xD;
      vaccination coverage in France is still insufficient with regard to the objectives set at 75%&#xD;
      by the WHO and the European Commission. For the 2019-2020 seasonal influenza vaccination&#xD;
      campaign, flu vaccination by volunteer pharmacists has become possible throughout the&#xD;
      country. Studies that have estimated vaccination coverage among HIV-positive populations are&#xD;
      rare and show very low rates.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cross-sectional study via a self-questionnaire given to all HIV-infected patients coming for&#xD;
      a scheduled consultation as part of their HIV follow-up in the spring of 2020. Non-opposition&#xD;
      letter given to the patient. Collection of data a posteriori from the medical file recorded&#xD;
      in the eNadis patient file.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 10, 2020</start_date>
  <completion_date type="Actual">December 30, 2020</completion_date>
  <primary_completion_date type="Actual">September 30, 2020</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>questionnaire influenza vaccine coverage</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>The objective of this questionnaire is to estimate the influenza vaccine coverage among PVVIH followed at the Tourcoing Hospital Center.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>modalities of influenza vaccination</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>To identify the modalities of influenza vaccination when it is carried out</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the drivers and disincentives to influenza vaccination</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Estimate from patient reports the drivers and disincentives to influenza vaccination in a specific risk population.</description>
  </secondary_outcome>
  <enrollment type="Actual">124</enrollment>
  <condition>HIV</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Any adult person living with HIV presenting for a follow-up consultation in the spring of&#xD;
        2020&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any adult person living with HIV presenting for a follow-up consultation in the spring&#xD;
             of 2020&#xD;
&#xD;
          -  People who do not read French may participate if they wish with the help of a medical&#xD;
             or paramedical staff member.&#xD;
&#xD;
          -  Patient did not object&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Minor patients&#xD;
&#xD;
          -  Major under guardianship, curatorship, protected person&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Macha TETART, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CH Tourcoing</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CH Tourcoing</name>
      <address>
        <city>Tourcoing</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>April 17, 2020</study_first_submitted>
  <study_first_submitted_qc>May 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>January 25, 2021</last_update_submitted>
  <last_update_submitted_qc>January 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 26, 2021</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>Influenza, Human</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/NCT04402684
org study id: RIPH_2020_5
nct id: NCT04402684
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Anyone living with the Human Immunodeficiency Virus (HIV) has an indication for annual
      influenza vaccination. (Vaccination schedule and vaccination recommendations 2019). Influenza
      is a viral infection that has a significant impact on the health care system. However,
      vaccination coverage in France is still insufficient with regard to the objectives set at 75%
      by the WHO and the European Commission. For the 2019-2020 seasonal influenza vaccination
      campaign, flu vaccination by volunteer pharmacists has become possible throughout the
      country. Studies that have estimated vaccination coverage among HIV-positive populations are
      rare and show very low rates.
Cross-sectional study via a self-questionnaire given to all HIV-infected patients coming for
      a scheduled consultation as part of their HIV follow-up in the spring of 2020. Non-opposition
      letter given to the patient. Collection of data a posteriori from the medical file recorded
      in the eNadis patient file.
observational model: Cohort
time perspective: Prospective
measure: questionnaire influenza vaccine coverage
time frame: through study completion, an average of 1 year
description: The objective of this questionnaire is to estimate the influenza vaccine coverage among PVVIH followed at the Tourcoing Hospital Center.
measure: modalities of influenza vaccination
time frame: through study completion, an average of 1 year
description: To identify the modalities of influenza vaccination when it is carried out
measure: the drivers and disincentives to influenza vaccination
time frame: through study completion, an average of 1 year
description: Estimate from patient reports the drivers and disincentives to influenza vaccination in a specific risk population.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Macha TETART, MD
role: Principal Investigator
affiliation: CH Tourcoing
facility: 
country: France
responsible party type: Sponsor
mesh term: Influenza, Human
sharing ipd: No