<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/NCT01731496</url>
  </required_header>
  <id_info>
    <org_study_id>5K08HS017951-03</org_study_id>
    <nct_id>NCT01731496</nct_id>
  </id_info>
  <brief_title>The Efficacy of Reminders to Complete HPV Series</brief_title>
  <acronym>ICHAT</acronym>
  <official_title>Improving Communication and Health for Adolescents With Technology - Implementation of Immunization Strategy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Rochester</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Agency for Healthcare Research and Quality (AHRQ)</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Rochester</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The human papillomavirus (HPV) vaccine is routinely recommended for both adolescent girls and&#xD;
      boys starting at age 11, although it can be offered as young as 9 years of age. This is a&#xD;
      3-dose series and many adolescents do not complete it after getting the first dose. This&#xD;
      study will study how effective it will be to send reminders to parents to schedule an&#xD;
      appointment when their child is due for the next dose of HPV. Parents can chose whether they&#xD;
      would like a phone call or text message reminder. This study will determine if the reminders&#xD;
      work, and if one method is better than another (phone message vs. text message).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2012</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">May 2014</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>Factorial Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>HPV completion rate</measure>
    <time_frame>One Year</time_frame>
    <description>Post intervention HPV vaccination rates will be summarized by intervention group with frequencies and proportions, and will be compared between groups using chi square or Fisher's exact test as appropriate</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>HPV Dosing Intervals</measure>
    <time_frame>One Year</time_frame>
    <description>Dosing intervals will be summarized by group with mean, median, standard deviation and will be compared between groups using a two sample t-test.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">749</enrollment>
  <condition>Completion of Three Dose Series of HPV</condition>
  <condition>Improvement in Vaccine Intervals Between HPV Doses</condition>
  <arm_group>
    <arm_group_label>Telephone reminder</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Telephone message reminder to parents of adolescents whose child is due for a 2nd or 3rd dose of HPV vaccine.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Text Message reminder</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Text message reminder to parents of adolescents whose child is due for a 2nd or 3rd dose of HPV vaccine.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control: Telephone</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control: Text Message</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Telephone reminder</intervention_name>
    <description>One week prior to when a child is due for either their 2nd or 3rd HPV vaccine, their parent will receive a telephone reminder to call to make an appointment to receive their next dose. A total of 3 reminders will be sent.</description>
    <arm_group_label>Telephone reminder</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Text Message reminder</intervention_name>
    <description>One week prior to when a child is due for either their 2nd or 3rd HPV vaccine, their parent will receive a text message reminder to call to make an appointment to receive their next dose. A total of 3 reminders will be sent.</description>
    <arm_group_label>Text Message reminder</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Parents of adolescents aged 10 - 17 who have had at least 1 dose of HPV&#xD;
&#xD;
          -  Patients aged 18 - 21 who have had at least 1 dose of HPV&#xD;
&#xD;
        Exclusion Criteria:&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cynthia Rand, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Rochester</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Culver Medical Group</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14609</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Highland Family Medicine</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14620</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Strong Pediatric Practice</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>February 2015</verification_date>
  <study_first_submitted>November 15, 2012</study_first_submitted>
  <study_first_submitted_qc>November 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <last_update_submitted>February 5, 2015</last_update_submitted>
  <last_update_submitted_qc>February 5, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 6, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Rochester</investigator_affiliation>
    <investigator_full_name>Cynthia Rand</investigator_full_name>
    <investigator_title>Associate Professor, Pediatrics</investigator_title>
  </responsible_party>
  <keyword>Human Papillomavirus</keyword>
  <!-- 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/NCT01731496
org study id: 5K08HS017951-03
nct id: NCT01731496
lead sponsor: 
collaborator: 
has dmc: No
The human papillomavirus (HPV) vaccine is routinely recommended for both adolescent girls and
      boys starting at age 11, although it can be offered as young as 9 years of age. This is a
      3-dose series and many adolescents do not complete it after getting the first dose. This
      study will study how effective it will be to send reminders to parents to schedule an
      appointment when their child is due for the next dose of HPV. Parents can chose whether they
      would like a phone call or text message reminder. This study will determine if the reminders
      work, and if one method is better than another (phone message vs. text message).
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Health Services Research
masking: Single (Participant)
measure: HPV completion rate
time frame: One Year
description: Post intervention HPV vaccination rates will be summarized by intervention group with frequencies and proportions, and will be compared between groups using chi square or Fisher's exact test as appropriate
measure: HPV Dosing Intervals
time frame: One Year
description: Dosing intervals will be summarized by group with mean, median, standard deviation and will be compared between groups using a two sample t-test.
arm group label: Telephone reminder
arm group type: Experimental
description: Telephone message reminder to parents of adolescents whose child is due for a 2nd or 3rd dose of HPV vaccine.
arm group label: Text Message reminder
arm group type: Experimental
description: Text message reminder to parents of adolescents whose child is due for a 2nd or 3rd dose of HPV vaccine.
arm group label: Control: Telephone
arm group type: No Intervention
arm group label: Control: Text Message
arm group type: No Intervention
intervention type: Other
intervention name: Telephone reminder
description: One week prior to when a child is due for either their 2nd or 3rd HPV vaccine, their parent will receive a telephone reminder to call to make an appointment to receive their next dose. A total of 3 reminders will be sent.
arm group label: Telephone reminder
intervention type: Other
intervention name: Text Message reminder
description: One week prior to when a child is due for either their 2nd or 3rd HPV vaccine, their parent will receive a text message reminder to call to make an appointment to receive their next dose. A total of 3 reminders will be sent.
arm group label: Text Message reminder
criteria: 
gender: All
minimum age: 10 Years
maximum age: 21 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Cynthia Rand, MD, MPH
role: Principal Investigator
affiliation: University of Rochester
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Rochester
investigator full name: Cynthia Rand
investigator title: Associate Professor, Pediatrics