<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/NCT03235011</url>
  </required_header>
  <id_info>
    <org_study_id>SEXODREP</org_study_id>
    <nct_id>NCT03235011</nct_id>
  </id_info>
  <brief_title>Evaluation of Knowledge Among Adolescents With Sickle Cell Disease.</brief_title>
  <acronym>SEXODREP</acronym>
  <official_title>Evaluation of Knowledge and Practices About Contraception, Sexuality and Transmission Among Adolescents With Sickle Cell Disease.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Adele CARLIER-GONOD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Intercommunal Creteil</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>
      Evaluation of knowledge about contraception in sickle cell adolescents.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sickle cell teenagers receive regular hospital medical care.&#xD;
&#xD;
      Adolescence is the time when the pathophysiology of the disease is re-explained and when&#xD;
      questions around puberty (possibly delayed), sexuality and contraception are discussed.&#xD;
&#xD;
      Sickle cell disease, like any chronic disease, can have repercussion on the development and&#xD;
      behavior of young patients.&#xD;
&#xD;
      Knowledge and understanding of young patients with sickle cell disease around these issues&#xD;
      may be insufficient.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 10, 2017</start_date>
  <completion_date type="Actual">January 31, 2018</completion_date>
  <primary_completion_date type="Actual">January 31, 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>Score value of the questionnaire on general knowledge on contraception</measure>
    <time_frame>at inclusion</time_frame>
    <description>questionnaire on general knowledge on contraception rated by 4 questions</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Score value of the questionnaire on specific knowledge on the transmission of the disease</measure>
    <time_frame>at inclusion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Score value of the questionnaire on the transmission of the disease knowledge</measure>
    <time_frame>at inclusion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Score value of the questionnaire on specific knowledge about the impact of sickle cell disease on the course of puberty</measure>
    <time_frame>at inclusion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Score value of the questionnaire onspecific knowledge about the impact of sickle cell disease on the course of sexuality</measure>
    <time_frame>at inclusion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>age of the patient with sickle cell disease</measure>
    <time_frame>at inclusion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>gender of the patient with sickle cell disease</measure>
    <time_frame>at inclusion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of hospitalizations of the patient with sickle cell disease</measure>
    <time_frame>at inclusion</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">99</enrollment>
  <condition>Sickle Cell Disease</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The teenagers from 14 to 19 years old followed in the STYLE for a sickle cell disease.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with sickle cell disease followed at the CHIC&#xD;
&#xD;
          -  Aged 14 to 19&#xD;
&#xD;
          -  Both sexes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Neurological disorders that can impede understanding of the questionnaire.&#xD;
&#xD;
          -  Refusal to participate.&#xD;
&#xD;
          -  Not affiliated to social security.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>19 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Centre Hospitalier Intercommunal de Créteil</name>
      <address>
        <city>Créteil</city>
        <state>Creteil</state>
        <zip>77500</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>July 27, 2017</study_first_submitted>
  <study_first_submitted_qc>July 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <last_update_submitted>February 5, 2019</last_update_submitted>
  <last_update_submitted_qc>February 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Centre Hospitalier Intercommunal Creteil</investigator_affiliation>
    <investigator_full_name>Adele CARLIER-GONOD</investigator_full_name>
    <investigator_title>Peadiatrician</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anemia, Sickle Cell</mesh_term>
  </condition_browse>
  <!-- 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/NCT03235011
org study id: SEXODREP
nct id: NCT03235011
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Evaluation of knowledge about contraception in sickle cell adolescents.
Sickle cell teenagers receive regular hospital medical care.

      Adolescence is the time when the pathophysiology of the disease is re-explained and when
      questions around puberty (possibly delayed), sexuality and contraception are discussed.

      Sickle cell disease, like any chronic disease, can have repercussion on the development and
      behavior of young patients.

      Knowledge and understanding of young patients with sickle cell disease around these issues
      may be insufficient.
observational model: Cohort
time perspective: Prospective
measure: Score value of the questionnaire on general knowledge on contraception
time frame: at inclusion
description: questionnaire on general knowledge on contraception rated by 4 questions
measure: Score value of the questionnaire on specific knowledge on the transmission of the disease
time frame: at inclusion
measure: Score value of the questionnaire on the transmission of the disease knowledge
time frame: at inclusion
measure: Score value of the questionnaire on specific knowledge about the impact of sickle cell disease on the course of puberty
time frame: at inclusion
measure: Score value of the questionnaire onspecific knowledge about the impact of sickle cell disease on the course of sexuality
time frame: at inclusion
measure: age of the patient with sickle cell disease
time frame: at inclusion
measure: gender of the patient with sickle cell disease
time frame: at inclusion
measure: number of hospitalizations of the patient with sickle cell disease
time frame: at inclusion
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 14 Years
maximum age: 19 Years
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor-Investigator
investigator affiliation: Centre Hospitalier Intercommunal Creteil
investigator full name: Adele CARLIER-GONOD
investigator title: Peadiatrician
mesh term: Anemia, Sickle Cell