<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/NCT03795376</url>
  </required_header>
  <id_info>
    <org_study_id>DAT_002</org_study_id>
    <nct_id>NCT03795376</nct_id>
  </id_info>
  <brief_title>Dat'Aids Prevention</brief_title>
  <official_title>HIV Prevention in France : &quot;Dat'AIDS Prevention&quot;</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>DatAids</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>DatAids</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      DatAIDS prevention is a cohort study of HIV prevention in over 23 HIV sites in France&#xD;
      including overseas, aiming to describe HIV prevention in every aspect including HIV&#xD;
      screening, STI and hepatitis screening, post-exposure prophylaxis and pre-exposure&#xD;
      prophylaxis&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Anticipated">January 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2024</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>Number of patients enrolled for HIV prevention in the cohort</measure>
    <time_frame>From date of enrollment, through study completion, an average of 1 year</time_frame>
    <description>Demographics, risk factors clinical and biological characteristics, treatment of patients enrolled for HIV prevention in the cohort</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of persons enrolled for pre-exposure prophylaxis in the cohort</measure>
    <time_frame>From date of enrollment, through study completion, an average of 1 year</time_frame>
    <description>Demographics, risk factors clinical and biological characteristics, treatment of patients attending for pre-exposure prophylaxis in the cohort</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of persons enrolled for post-exposure prophylaxis in the cohort</measure>
    <time_frame>From date of enrollment, through study completion, an average of 1 year</time_frame>
    <description>Demographics, risk factors clinical and biological characteristics, treatment of patients attending for post-exposure prophylaxis in the cohort</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of persons enrolled for hepatitis screening in the cohort</measure>
    <time_frame>From date of enrollment, through study completion, an average of 1 year</time_frame>
    <description>Demographics, risk factors clinical and biological characteristics, treatment of patients attending for hepatitis screening in the cohort</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of persons enrolled for pre-exposure prophylaxis in the cohort according to national French guidelines</measure>
    <time_frame>From date of enrollment, through study completion, an average of 1 year</time_frame>
    <description>Adequation between prevention practices and guidelines</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of persons enrolled for post-exposure prophylaxis in the cohort according to national French guidelines</measure>
    <time_frame>From date of enrollment, through study completion, an average of 1 year</time_frame>
    <description>Adequation between prevention practices and guidelines</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of STIs</measure>
    <time_frame>From date of enrollment, through study completion, an average of 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of hepatitis</measure>
    <time_frame>From date of enrollment, through study completion, an average of 1 year</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">6500</enrollment>
  <condition>HIV Prevention</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All persons attending for HIV prevention and seeking care at 23 centers using NADIS are&#xD;
        included in the Dataids Prevention cohort after receiving oral information and giving&#xD;
        written consent. NADIS is an electronic medical record (EMR) for HIV infection (and&#xD;
        Hepatitis B virus (HBV), Hepatitis C virus (HCV), STI) and HIV prevention in French public&#xD;
        hospitals.&#xD;
&#xD;
        The Dataids Prevention study recruits persons HIV- and above the age of 18 years.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female over 18 years old,&#xD;
&#xD;
          -  HIV negative&#xD;
&#xD;
          -  Attending for :&#xD;
&#xD;
          -  HIV screening&#xD;
&#xD;
          -  Hepatitis screening&#xD;
&#xD;
          -  STI screening / treatment&#xD;
&#xD;
          -  Blood, body fluid or sexual exposure&#xD;
&#xD;
          -  Post-exposure prophylaxis&#xD;
&#xD;
          -  Pre-exposure prophylaxis&#xD;
&#xD;
          -  Signed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  HIV-infection&#xD;
&#xD;
          -  Refusal to participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pascal PUGLIESE, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Hospitalier Universitaire de Nice</affiliation>
  </overall_official>
  <overall_official>
    <last_name>André CABIE, MD-PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Hospitalier Universitaire de Martinique</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Pascal Pugliese, MD</last_name>
    <phone>0033492035802</phone>
    <email>pugliese.p@chu-nice.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Solène Secher</last_name>
    <email>dpo@dataids.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>CHU Besançon - Hôpital Jean Minjoz</name>
      <address>
        <city>Besançon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Catherine CHIROUZE</last_name>
    </contact>
    <investigator>
      <last_name>Catherine CHIROUZE</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHRU Brest</name>
      <address>
        <city>Brest</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sylvain JAFFUEL</last_name>
    </contact>
    <investigator>
      <last_name>Sylvain JAFFUEL</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU Clermont-Ferrand - Hôpital Gabriel-Montpied</name>
      <address>
        <city>Clermont-Ferrand</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christine JACOMET</last_name>
    </contact>
    <investigator>
      <last_name>Christine JACOMET</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHD Vendée</name>
      <address>
        <city>La Roche-sur-Yon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dominique MERRIEN</last_name>
    </contact>
    <investigator>
      <last_name>Dominique MERRIEN</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital Bicêtre - Assistance Publique des Hôpitaux de Paris</name>
      <address>
        <city>Le Kremlin-Bicêtre</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Antoine CHERET</last_name>
    </contact>
    <investigator>
      <last_name>Antoine CHERET</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital de la Croix-Rousse - Hospices Civils de Lyon</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Laurent COTTE</last_name>
    </contact>
    <investigator>
      <last_name>Laurent COTTE</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital de la Conception - Assistance Publique des Hôpitaux de Marseille</name>
      <address>
        <city>Marseille</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Isabelle RAVAUX</last_name>
    </contact>
    <investigator>
      <last_name>Isabelle RAVAUX</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital Sainte Marguerite - Assistance Publique des Hôpitaux de Marseille</name>
      <address>
        <city>Marseille</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sylvie BREGIGEON-RONOT</last_name>
    </contact>
    <investigator>
      <last_name>Sylvie BREGIGEON-RONOT</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHR Metz-Thionville</name>
      <address>
        <city>Metz</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Céline ROBERT</last_name>
    </contact>
    <investigator>
      <last_name>Céline ROBERT</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital Gui de Chauliac</name>
      <address>
        <city>Montpellier</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alain MAKINSON</last_name>
    </contact>
    <investigator>
      <last_name>Alain MAKINSON</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU Nancy - Hôpital Brabois</name>
      <address>
        <city>Nancy</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Benjamin LEFEVRE</last_name>
    </contact>
    <investigator>
      <last_name>Benjamin LEFEVRE</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU Nantes - Hôtel-Dieu</name>
      <address>
        <city>Nantes</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>François RAFFI</last_name>
    </contact>
    <investigator>
      <last_name>François RAFFI</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU Nice - Hôpital l'Archet</name>
      <address>
        <city>Nice</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pascal PUGLIESE</last_name>
    </contact>
    <investigator>
      <last_name>Pascal PUGLIESE</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CH Niort</name>
      <address>
        <city>Niort</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Simon SUNDER</last_name>
    </contact>
    <investigator>
      <last_name>Simon SUNDER</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Groupe Hospitalier Pitié Salpêtrière - Assistance Publique des Hôpitaux de Paris</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christine KATLAMA</last_name>
    </contact>
    <investigator>
      <last_name>Christine KATLAMA</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital Bichat - Assistance Publique des Hôpitaux de Paris</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yazdan YAZDANPANAH</last_name>
    </contact>
    <investigator>
      <last_name>Yazdan YAZDANPANAH</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital Necker-Pasteur - Assistance Publique des Hôpitaux de Paris</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Claudine DUVIVIER</last_name>
    </contact>
    <investigator>
      <last_name>Claudine DUVIVIER</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de Cornouaille</name>
      <address>
        <city>Quimper</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nolwenn HALL</last_name>
    </contact>
    <investigator>
      <last_name>Nolwenn HALL</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU Reims - Hôpital Robert Debré</name>
      <address>
        <city>Reims</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Firouze BANISADR</last_name>
    </contact>
    <investigator>
      <last_name>Firouze BANISADR</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU Rennes - Hôpital Pontchaillou</name>
      <address>
        <city>Rennes</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pierre TATTEVIN</last_name>
    </contact>
    <investigator>
      <last_name>Pierre TATTEVIN</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU St Etienne - Hôpital Nord</name>
      <address>
        <city>Saint-Étienne</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amandine GAGNEUX-BRUNON</last_name>
    </contact>
    <investigator>
      <last_name>Amandine GAGNEUX-BRUNON</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU Strasbourg - Hôpital Civil</name>
      <address>
        <city>Strasbourg</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>David REY</last_name>
    </contact>
    <investigator>
      <last_name>David REY</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU Toulouse - Hôpital Purpan</name>
      <address>
        <city>Toulouse</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pierre DELOBEL</last_name>
    </contact>
    <investigator>
      <last_name>Pierre DELOBEL</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU Tourcoing - Hôpital Guy Chatiliez</name>
      <address>
        <city>Tourcoing</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Olivier ROBINEAU</last_name>
    </contact>
    <investigator>
      <last_name>Olivier ROBINEAU</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CH Bretagne-Atlantique</name>
      <address>
        <city>Vannes</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Grégory CORVAISIER</last_name>
    </contact>
    <investigator>
      <last_name>Grégory CORVAISIER</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU de Guadeloupe</name>
      <address>
        <city>Pointe-à-Pitre</city>
        <country>Guadeloupe</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Isabelle LAMAURY</last_name>
    </contact>
    <investigator>
      <last_name>Isabelle LAMAURY</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU de Martinique</name>
      <address>
        <city>Fort-de-France</city>
        <country>Martinique</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>André CABIE</last_name>
    </contact>
    <investigator>
      <last_name>André CABIE</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
    <country>Guadeloupe</country>
    <country>Martinique</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>December 21, 2018</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 7, 2019</study_first_posted>
  <last_update_submitted>February 15, 2023</last_update_submitted>
  <last_update_submitted_qc>February 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 16, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03795376
org study id: DAT_002
nct id: NCT03795376
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
DatAIDS prevention is a cohort study of HIV prevention in over 23 HIV sites in France
      including overseas, aiming to describe HIV prevention in every aspect including HIV
      screening, STI and hepatitis screening, post-exposure prophylaxis and pre-exposure
      prophylaxis
observational model: Cohort
time perspective: Prospective
measure: Number of patients enrolled for HIV prevention in the cohort
time frame: From date of enrollment, through study completion, an average of 1 year
description: Demographics, risk factors clinical and biological characteristics, treatment of patients enrolled for HIV prevention in the cohort
measure: Proportion of persons enrolled for pre-exposure prophylaxis in the cohort
time frame: From date of enrollment, through study completion, an average of 1 year
description: Demographics, risk factors clinical and biological characteristics, treatment of patients attending for pre-exposure prophylaxis in the cohort
measure: Proportion of persons enrolled for post-exposure prophylaxis in the cohort
time frame: From date of enrollment, through study completion, an average of 1 year
description: Demographics, risk factors clinical and biological characteristics, treatment of patients attending for post-exposure prophylaxis in the cohort
measure: Proportion of persons enrolled for hepatitis screening in the cohort
time frame: From date of enrollment, through study completion, an average of 1 year
description: Demographics, risk factors clinical and biological characteristics, treatment of patients attending for hepatitis screening in the cohort
measure: Proportion of persons enrolled for pre-exposure prophylaxis in the cohort according to national French guidelines
time frame: From date of enrollment, through study completion, an average of 1 year
description: Adequation between prevention practices and guidelines
measure: Proportion of persons enrolled for post-exposure prophylaxis in the cohort according to national French guidelines
time frame: From date of enrollment, through study completion, an average of 1 year
description: Adequation between prevention practices and guidelines
measure: Incidence of STIs
time frame: From date of enrollment, through study completion, an average of 1 year
measure: Incidence of hepatitis
time frame: From date of enrollment, through study completion, an average of 1 year
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Pascal PUGLIESE, MD
role: Principal Investigator
affiliation: Centre Hospitalier Universitaire de Nice
last name: André CABIE, MD-PhD
role: Principal Investigator
affiliation: Centre Hospitalier Universitaire de Martinique
last name: Pascal Pugliese, MD
phone: 0033492035802
email: pugliese.p@chu-nice.fr
last name: Solène Secher
email: dpo@dataids.org
facility: 
status: Recruiting
contact: 
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status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: France
country: Guadeloupe
country: Martinique
responsible party type: Sponsor
sharing ipd: No