<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/NCT03307642</url>
  </required_header>
  <id_info>
    <org_study_id>Version 3.01</org_study_id>
    <nct_id>NCT03307642</nct_id>
  </id_info>
  <brief_title>Evaluation of the School Kids Influenza Prevention Project</brief_title>
  <acronym>SKIPP</acronym>
  <official_title>Evaluation of a Text Based Reminder Recall System to Increase Utilization of the School Kids Influenza Prevention Project and Increase Influenza Vaccination Rates in Monroe County, NY</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Rochester</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Rochester</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>
      Children whose parents receive text reminders are more likely to be consented to participate&#xD;
      in the school located influenza vaccination clinic than children whose parents do not receive&#xD;
      text reminders.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 4, 2017</start_date>
  <completion_date type="Actual">December 22, 2017</completion_date>
  <primary_completion_date type="Actual">December 22, 2017</primary_completion_date>
  <phase>N/A</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>
    <intervention_model_description>SLIV will be offered at all schools in an urban school district. Students will be randomized into either SLIV + standard communication about SLIV or SLIV + standard communication + text message reminders.</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Influenza vaccination status</measure>
    <time_frame>Through January, 2018</time_frame>
    <description>Vaccination status for the 2017/2018 influenza season will be assessed. The vaccination date will be recorded, as well as the provider name, to determine whether vaccine was received at the school-located influenza clinic</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">18540</enrollment>
  <condition>Childhood Influenza Vaccination</condition>
  <condition>School-located Influenza Vaccination</condition>
  <arm_group>
    <arm_group_label>SLIV + usual communication</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Parents receive usual communication from school (paper consent packets &amp; automated voice mails) about SLIV</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SLIV + usual communication + text</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Parents receive usual communication from school (paper consent packets &amp; automated voice mails) about SLIV plus a series of text messages informing them about the usual communication for SLIV</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Text message notification</intervention_name>
    <description>Three text messages will be sent to 50% of the parents, scheduled around the standard methods of communication</description>
    <arm_group_label>SLIV + usual communication + text</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Enrolled in the urban school district&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Attends a school in the urban district containing a school-based health center&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>19 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stanley Schaffer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Rochester</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Rochester Medical Center</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>October 5, 2017</study_first_submitted>
  <study_first_submitted_qc>October 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 12, 2017</study_first_posted>
  <last_update_submitted>March 9, 2018</last_update_submitted>
  <last_update_submitted_qc>March 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 12, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Rochester</investigator_affiliation>
    <investigator_full_name>Stanley J Schaffer, MD</investigator_full_name>
    <investigator_title>Primary Investigator</investigator_title>
  </responsible_party>
  <keyword>Influenza vaccination rates</keyword>
  <keyword>Respiratory Tract Diseases</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Influenza, Human</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/NCT03307642
org study id: Version 3.01
nct id: NCT03307642
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Children whose parents receive text reminders are more likely to be consented to participate
      in the school located influenza vaccination clinic than children whose parents do not receive
      text reminders.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: SLIV will be offered at all schools in an urban school district. Students will be randomized into either SLIV + standard communication about SLIV or SLIV + standard communication + text message reminders.
primary purpose: Health Services Research
masking: Double (Participant, Outcomes Assessor)
measure: Influenza vaccination status
time frame: Through January, 2018
description: Vaccination status for the 2017/2018 influenza season will be assessed. The vaccination date will be recorded, as well as the provider name, to determine whether vaccine was received at the school-located influenza clinic
arm group label: SLIV + usual communication
arm group type: No Intervention
description: Parents receive usual communication from school (paper consent packets & automated voice mails) about SLIV
arm group label: SLIV + usual communication + text
arm group type: Active Comparator
description: Parents receive usual communication from school (paper consent packets & automated voice mails) about SLIV plus a series of text messages informing them about the usual communication for SLIV
intervention type: Other
intervention name: Text message notification
description: Three text messages will be sent to 50% of the parents, scheduled around the standard methods of communication
arm group label: SLIV + usual communication + text
criteria: 
gender: All
minimum age: 4 Years
maximum age: 19 Years
healthy volunteers: No
last name: Stanley Schaffer, MD
role: Principal Investigator
affiliation: University of Rochester
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Rochester
investigator full name: Stanley J Schaffer, MD
investigator title: Primary Investigator
mesh term: Influenza, Human
sharing ipd: No