<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/NCT03754374</url>
  </required_header>
  <id_info>
    <org_study_id>35RC16_9852_ACCEDAB</org_study_id>
    <nct_id>NCT03754374</nct_id>
  </id_info>
  <brief_title>Health Care Access for Asylum Seekers in Brittany : Description, Associated Factors and Levers of Improvement</brief_title>
  <acronym>ACCEDAB</acronym>
  <official_title>Health Care Access for Asylum Seekers in Brittany : Description, Associated Factors and Levers of Improvement</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rennes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rennes University 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>
      The main objective of this research is to study the logics and the associated factors with&#xD;
      asylum seekers use of dedicated health structures.&#xD;
&#xD;
      This objective aims to address major concerns related to the entry and continued&#xD;
      participation in the health care system of asylum seekers, including the medical and social&#xD;
      dimensions.&#xD;
&#xD;
      It aims to produce, then analyze and disseminate data on the factors associated with seeking&#xD;
      asylum seekers to optimize the care of migrants in the French health system&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 22, 2018</start_date>
  <completion_date type="Anticipated">November 22, 2019</completion_date>
  <primary_completion_date type="Actual">May 22, 2018</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>Use of health care structure</measure>
    <time_frame>6 months</time_frame>
    <description>Factors associated with the use or non-use of dedicated health facilities will be the individual (sociodemographic, migration), organizational (access to rights, characteristics of the organization of dedicated structures) and the environment characteristics reported by asylum seekers having or not having recourse to the dedicated health structures.</description>
  </primary_outcome>
  <enrollment type="Anticipated">1500</enrollment>
  <condition>Adult Asylum Seekers Who Have Applied for Asylum at the Regional Prefecture in Rennes</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>access to healthcare</intervention_name>
    <description>use or non-use of dedicated health facilities</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult asylum seekers who have applied for asylum in the prefecture of Brittany&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Adult asylum seekers who have applied for asylum in the prefecture of Brittany from May&#xD;
        22, 2018 to May 21, 2019 (or one year after obtaining authorization from the CCTIRS and the&#xD;
        CNIL).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Migrants not asylum seekers (with tourist visa, migrants of the European Union&#xD;
             (foreign nationality and not membership in the Schengen area), migrants arriving in a&#xD;
             family reunification, migrant in irregular situation).&#xD;
&#xD;
          -  Minor : unaccompanied foreign minor or with their family&#xD;
&#xD;
          -  Incapacity of a person to consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Pascal Jarno, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rennes University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>kristell COAT</last_name>
    <phone>2 99 28 25 55</phone>
    <phone_ext>33</phone_ext>
    <email>kristell.coat@chu-rennes.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Direction de la Recherche</last_name>
    <phone>2 99 28 25 55</phone>
    <phone_ext>33</phone_ext>
    <email>drc@chu-rennes.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>COALLIA - Plateforme d'accueil des demandeurs d'asile</name>
      <address>
        <city>Rennes</city>
        <zip>35000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sandra Silver</last_name>
      <phone>2 99 51 86 28</phone>
      <phone_ext>+33</phone_ext>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU de Rennes</name>
      <address>
        <city>Rennes</city>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 22, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>November 26, 2018</last_update_submitted>
  <last_update_submitted_qc>November 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Primary health</keyword>
  <keyword>migrants</keyword>
  <keyword>health care utilization</keyword>
  <keyword>access to healthcare</keyword>
  <!-- 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/NCT03754374
org study id: 35RC16_9852_ACCEDAB
nct id: NCT03754374
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The main objective of this research is to study the logics and the associated factors with
      asylum seekers use of dedicated health structures.

      This objective aims to address major concerns related to the entry and continued
      participation in the health care system of asylum seekers, including the medical and social
      dimensions.

      It aims to produce, then analyze and disseminate data on the factors associated with seeking
      asylum seekers to optimize the care of migrants in the French health system
observational model: Cohort
time perspective: Prospective
measure: Use of health care structure
time frame: 6 months
description: Factors associated with the use or non-use of dedicated health facilities will be the individual (sociodemographic, migration), organizational (access to rights, characteristics of the organization of dedicated structures) and the environment characteristics reported by asylum seekers having or not having recourse to the dedicated health structures.
intervention type: Other
intervention name: access to healthcare
description: use or non-use of dedicated health facilities
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Pascal Jarno, MD
role: Principal Investigator
affiliation: Rennes University Hospital
last name: kristell COAT
phone: 2 99 28 25 55
phone ext: 33
email: kristell.coat@chu-rennes.fr
last name: Direction de la Recherche
phone: 2 99 28 25 55
phone ext: 33
email: drc@chu-rennes.fr
facility: 
status: Recruiting
contact: 
facility: 
status: Active, not recruiting
country: France
responsible party type: Sponsor