<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/NCT04459221</url>
  </required_header>
  <id_info>
    <org_study_id>2020/CHU/05</org_study_id>
    <secondary_id>2020-002332-73</secondary_id>
    <nct_id>NCT04459221</nct_id>
  </id_info>
  <brief_title>Study of the Impact of a School Program Combining - Promotion of HPV Vaccination and HPV Vaccine Offer in Middle School - on Adherence to HPV Vaccination in Middle School Students</brief_title>
  <acronym>PROM SSCOL</acronym>
  <official_title>Study of the Impact of a School Program Combining - Promotion of HPV Vaccination and HPV Vaccine Offer in Middle School - on Adherence to HPV Vaccination in Middle School Students</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de la Réunion</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de la Réunion</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>
      Cervical cancer (CCU) is the fourth most common cancer in women worldwide. In Reunion island,&#xD;
      CCU is the third leading cause of cancer in women (standardized incidence rate on the world&#xD;
      population (TIS) in 2013 of 10.3 / 100,000) and is the eighth deadliest cancer with a rate&#xD;
      standardized mortality of 4.8 / 100,000, almost three times higher than in mainland France&#xD;
      where it was 1.7 / 100,000 in 2018.&#xD;
&#xD;
      CCU results from infection with the human papillomavirus (HPV), which is the most common&#xD;
      sexually transmitted viral infection.&#xD;
&#xD;
      CCU prevention is mainly based on cervical smear screening and anti HPV vaccination (VHPV)&#xD;
      which has demonstrated its effectiveness on the prevalence of HPV carriage, but also on&#xD;
      incidence of condyloma or intermediate grade dysplasia. Since HPV is mainly transmitted&#xD;
      sexually, it is important to vaccinate before the start of sex.&#xD;
&#xD;
      In Reunion island, the HPV vaccination coverage rate is the lowest in France, estimated by&#xD;
      Public Health France at 8.1% among girls aged 16 years in 2018, while the already low&#xD;
      national average was established 23.7%.&#xD;
&#xD;
      Thus, in view of the epidemiological situation in Reunion island (high incidence and&#xD;
      mortality for the CCU, very low VHPV coverage rate), we thought it would be interesting to&#xD;
      study the impact of a health promotion program sex and prevention of sexually transmitted&#xD;
      infections (STIs) including papillomavirus-related pathologies, with a program to promote HPV&#xD;
      vaccination among young students in middle school.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2020</start_date>
  <completion_date type="Actual">December 30, 2021</completion_date>
  <primary_completion_date type="Actual">June 25, 2021</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change the vaccination rate in girls</measure>
    <time_frame>9 month</time_frame>
    <description>Number of girls having completed a complete vaccination schedule. Hypothesis: the intervention under study should increase the rate of vaccinated</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>increase the vaccination rate in all student</measure>
    <time_frame>9 month</time_frame>
    <description>number of student having completed a complete vaccination schedule</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>increase the vaccination rate in all student</measure>
    <time_frame>9 month</time_frame>
    <description>number of student having completed a incomplete vaccination schedule</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">355</enrollment>
  <condition>Papilloma Viral Infection</condition>
  <arm_group>
    <arm_group_label>Facilitating access to HPV vaccination</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>promotion of HPV vaccination</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gardasil 9, 9-Valent Intramuscular Suspension</intervention_name>
    <description>access to HPV vaccination near the college in a health bus</description>
    <arm_group_label>Facilitating access to HPV vaccination</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  schooled in one of the classes drawn at random in the 2 colleges selected for the&#xD;
             study,&#xD;
&#xD;
          -  members or beneficiaries of a social security scheme,&#xD;
&#xD;
          -  having agreed to participate in the study and whose parents or holder (s) of parental&#xD;
             authority have signed a free, informed and written consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  under the age of 9, or over the age of 17 at inclusion,&#xD;
&#xD;
          -  with hypersensitivity to the active substances or to any of the excipients of the&#xD;
             vaccine (Gardasil 9®),&#xD;
&#xD;
          -  with a permanent contraindication to vaccination.&#xD;
&#xD;
          -  having already initiated the HPV vaccination (complete or incomplete scheme). Students&#xD;
             with an incomplete vaccination schedule will be referred to their attending physician&#xD;
             to complete the missing dose (s).&#xD;
&#xD;
          -  pregnancy or breastfeeding (based on the declaration)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>9 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de la Réunion</name>
      <address>
        <city>Saint-Pierre</city>
        <zip>97448</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>July 1, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>March 1, 2022</last_update_submitted>
  <last_update_submitted_qc>March 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 2, 2022</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>Virus Diseases</mesh_term>
    <mesh_term>Papillomavirus Infections</mesh_term>
    <mesh_term>Papilloma</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/NCT04459221
org study id: 2020/CHU/05
secondary id: 2020-002332-73
nct id: NCT04459221
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Cervical cancer (CCU) is the fourth most common cancer in women worldwide. In Reunion island,
      CCU is the third leading cause of cancer in women (standardized incidence rate on the world
      population (TIS) in 2013 of 10.3 / 100,000) and is the eighth deadliest cancer with a rate
      standardized mortality of 4.8 / 100,000, almost three times higher than in mainland France
      where it was 1.7 / 100,000 in 2018.

      CCU results from infection with the human papillomavirus (HPV), which is the most common
      sexually transmitted viral infection.

      CCU prevention is mainly based on cervical smear screening and anti HPV vaccination (VHPV)
      which has demonstrated its effectiveness on the prevalence of HPV carriage, but also on
      incidence of condyloma or intermediate grade dysplasia. Since HPV is mainly transmitted
      sexually, it is important to vaccinate before the start of sex.

      In Reunion island, the HPV vaccination coverage rate is the lowest in France, estimated by
      Public Health France at 8.1% among girls aged 16 years in 2018, while the already low
      national average was established 23.7%.

      Thus, in view of the epidemiological situation in Reunion island (high incidence and
      mortality for the CCU, very low VHPV coverage rate), we thought it would be interesting to
      study the impact of a health promotion program sex and prevention of sexually transmitted
      infections (STIs) including papillomavirus-related pathologies, with a program to promote HPV
      vaccination among young students in middle school.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change the vaccination rate in girls
time frame: 9 month
description: Number of girls having completed a complete vaccination schedule. Hypothesis: the intervention under study should increase the rate of vaccinated
measure: increase the vaccination rate in all student
time frame: 9 month
description: number of student having completed a complete vaccination schedule
measure: increase the vaccination rate in all student
time frame: 9 month
description: number of student having completed a incomplete vaccination schedule
arm group label: Facilitating access to HPV vaccination
arm group type: Experimental
arm group label: promotion of HPV vaccination
arm group type: No Intervention
intervention type: Drug
intervention name: Gardasil 9, 9-Valent Intramuscular Suspension
description: access to HPV vaccination near the college in a health bus
arm group label: Facilitating access to HPV vaccination
criteria: 
gender: All
minimum age: 9 Years
maximum age: 17 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: France
responsible party type: Sponsor
mesh term: Virus Diseases
mesh term: Papillomavirus Infections
mesh term: Papilloma
sharing ipd: No