<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/NCT03290755</url>
  </required_header>
  <id_info>
    <org_study_id>CHUBX 2017/01</org_study_id>
    <nct_id>NCT03290755</nct_id>
  </id_info>
  <brief_title>Sexual Hepatitis C in HIV Positive Men Who Have Sex With Men (MSM) in Bordeaux</brief_title>
  <acronym>HEPCSEX</acronym>
  <official_title>Sexual Hepatitis C in HIV Positive Men Who Have Sex With Men (MSM) in Bordeaux</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Bordeaux</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Bordeaux</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 study is to analyse sexual behavior of HIV + MSM in Bordeaux, who&#xD;
      have sexually contracted hepatitis C between January 1st 2013, to January 31, 2017. These&#xD;
      data will bring some improvement about prevention and maybe reduced the hepatitis C&#xD;
      incidence.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hepatitis C (HCV) is considered in part as a sexually transmitted infection (STI). A marked&#xD;
      decrease in its incidence has been observed for several years, coinciding with the&#xD;
      availability of new direct acting antiviral treatments (DAA). However, people are&#xD;
      increasingly infected with the hepatitis C virus, especially HIV-positive MSM. This increase&#xD;
      is explained by new sexual practices that are particularly at high level of risk, despite the&#xD;
      widening accessibility of new DAA. Prevention also plays an important role in implementing an&#xD;
      effective risk reduction policy. New methods of prevention must therefore be developed. For&#xD;
      this purpose, it is imperative to know the natural history of acute hepatitis C, the&#xD;
      different behaviours at risk of HCV transmission, and the demonstration of socio-sexual&#xD;
      networks (clusters) thanks to virological phylogenetic studies. In order to improve hepatitis&#xD;
      C prevention, we wish to establish a descriptive study focusing on :&#xD;
&#xD;
        -  Descriptive analysis of the natural history of hepatitis C,&#xD;
&#xD;
        -  Identification of patient clusters (phylogenetic analysis)&#xD;
&#xD;
        -  Description of the sexual behaviors of infected patients, through a semi-directed&#xD;
           interview.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 8, 2017</start_date>
  <completion_date type="Actual">March 13, 2018</completion_date>
  <primary_completion_date type="Actual">March 13, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Analyse sexual behaviours among HIV positive MSM in Bordeaux, through semi-directed interviews</measure>
    <time_frame>At inclusion (day 0)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Identifying socio-sexual networks through phylogenetic analysis</measure>
    <time_frame>At inclusion (day 0)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Describing the natural history of sexual hepatitis C in HIV positive MSM</measure>
    <time_frame>At inclusion (day 0)</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">29</enrollment>
  <condition>Human Immunodeficiency Virus (HIV)</condition>
  <condition>Hepatitis c</condition>
  <arm_group>
    <arm_group_label>MSM co-infected HIV-HCV</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>semi-directed interviews</intervention_name>
    <description>semi-directed interviews in order to collect socio-behavioral data</description>
    <arm_group_label>MSM co-infected HIV-HCV</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Men who have sex with Men co-infected HIV-HCV&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient older than 18 years&#xD;
&#xD;
          -  HIV-1 and/or HIV-2 confirmed Infection&#xD;
&#xD;
          -  Men who have sex with Men&#xD;
&#xD;
          -  Patients included in the &quot;ANRS CO3Aquitaine cohort&quot;.&#xD;
&#xD;
          -  HCV contamination documented over the period 01/01/2013 to 01/31/2017 (A positive HCV&#xD;
             serology and a HCV plasma RNA positive) AND a negative HCV serology OR a positive HCV&#xD;
             serology and a negative plasma RNA before inclusion period&#xD;
&#xD;
          -  A person who has received information about the protocol and has given oral consent&#xD;
             and that his / her non-opposition is documented in his / her medical file.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Transfusion contamination&#xD;
&#xD;
          -  Substance abuse IV out of SLAM context&#xD;
&#xD;
          -  Refusal to consent to research.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Linda WITTKOP, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Université de Bordeaux - ISPED - Inserm 2129 - CHU de Bordeaux</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Charles CAZANAVE, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Bordeaux, France</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Service des Maladies Infectieuses et Tropicales, Hôpital Pellegrin</name>
      <address>
        <city>Bordeaux</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>September 19, 2017</study_first_submitted>
  <study_first_submitted_qc>September 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>November 12, 2018</last_update_submitted>
  <last_update_submitted_qc>November 12, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 14, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hepatitis C</keyword>
  <keyword>sexual network</keyword>
  <keyword>sexual transmitted</keyword>
  <keyword>men who have sex with men</keyword>
  <keyword>HIV positive</keyword>
  <keyword>sexual behaviour</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis A</mesh_term>
    <mesh_term>Hepatitis C</mesh_term>
    <mesh_term>Acquired Immunodeficiency Syndrome</mesh_term>
    <mesh_term>HIV Infections</mesh_term>
    <mesh_term>HIV Seropositivity</mesh_term>
    <mesh_term>Hepatitis</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/NCT03290755
org study id: CHUBX 2017/01
nct id: NCT03290755
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The main objective of this study is to analyse sexual behavior of HIV + MSM in Bordeaux, who
      have sexually contracted hepatitis C between January 1st 2013, to January 31, 2017. These
      data will bring some improvement about prevention and maybe reduced the hepatitis C
      incidence.
Hepatitis C (HCV) is considered in part as a sexually transmitted infection (STI). A marked
      decrease in its incidence has been observed for several years, coinciding with the
      availability of new direct acting antiviral treatments (DAA). However, people are
      increasingly infected with the hepatitis C virus, especially HIV-positive MSM. This increase
      is explained by new sexual practices that are particularly at high level of risk, despite the
      widening accessibility of new DAA. Prevention also plays an important role in implementing an
      effective risk reduction policy. New methods of prevention must therefore be developed. For
      this purpose, it is imperative to know the natural history of acute hepatitis C, the
      different behaviours at risk of HCV transmission, and the demonstration of socio-sexual
      networks (clusters) thanks to virological phylogenetic studies. In order to improve hepatitis
      C prevention, we wish to establish a descriptive study focusing on :

        -  Descriptive analysis of the natural history of hepatitis C,

        -  Identification of patient clusters (phylogenetic analysis)

        -  Description of the sexual behaviors of infected patients, through a semi-directed
           interview.
observational model: Other
time perspective: Prospective
measure: Analyse sexual behaviours among HIV positive MSM in Bordeaux, through semi-directed interviews
time frame: At inclusion (day 0)
measure: Identifying socio-sexual networks through phylogenetic analysis
time frame: At inclusion (day 0)
measure: Describing the natural history of sexual hepatitis C in HIV positive MSM
time frame: At inclusion (day 0)
arm group label: MSM co-infected HIV-HCV
intervention type: Behavioral
intervention name: semi-directed interviews
description: semi-directed interviews in order to collect socio-behavioral data
arm group label: MSM co-infected HIV-HCV
study pop: 
sampling method: Probability Sample
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Linda WITTKOP, MD, PhD
role: Study Chair
affiliation: Université de Bordeaux - ISPED - Inserm 2129 - CHU de Bordeaux
last name: Charles CAZANAVE, Prof
role: Principal Investigator
affiliation: University Hospital Bordeaux, France
facility: 
country: France
responsible party type: Sponsor
mesh term: Hepatitis A
mesh term: Hepatitis C
mesh term: Acquired Immunodeficiency Syndrome
mesh term: HIV Infections
mesh term: HIV Seropositivity
mesh term: Hepatitis
sharing ipd: No