<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/NCT02196454</url>
  </required_header>
  <id_info>
    <org_study_id>IRB 14-011091</org_study_id>
    <nct_id>NCT02196454</nct_id>
  </id_info>
  <brief_title>Video to Promote HPV Vaccination</brief_title>
  <official_title>Educating Pre/Teens and Their Parents on the Importance of HPV Vaccination</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital of Philadelphia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Noble Medical, LLC</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Children's Hospital of Philadelphia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research study is to determine if video-based education will increase HPV&#xD;
      vaccination rates among 11 - 17 year olds.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Human Papillomavirus (HPV) is a common sexually transmitted infection that has the potential&#xD;
      to cause cancer. The vaccine is recommended because it prevents the HPV infections that most&#xD;
      commonly cause cancer. HPV vaccines offer the best protection to girls and boys who receive&#xD;
      the complete, three-vaccine series and have time to develop an immune response before being&#xD;
      exposed to HPV. However, vaccination rates are low compared to other vaccines for teens.&#xD;
&#xD;
      Results from this study will help us learn why participants do or do not get the HPV&#xD;
      vaccination and whether video-based education can help improve vaccination rates&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">May 31, 2018</completion_date>
  <primary_completion_date type="Actual">December 2016</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>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>HPV Vaccination Series Initiation</measure>
    <time_frame>90 days</time_frame>
    <description>Number of HPV vaccine doses received among study participants</description>
  </primary_outcome>
  <primary_outcome>
    <measure>HPV Vaccine Series Initiation</measure>
    <time_frame>0 days</time_frame>
    <description>HPV Vaccine Receipt among study participants</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>HPV Vaccine Series Initiation (depending on male versus female narrator)</measure>
    <time_frame>0 days</time_frame>
    <description>Difference in rate of HPV vaccine receipt between study participants who viewed a video narrated by a male versus a female</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HPV Vaccine Series Initiation (depending on male versus female narrator)</measure>
    <time_frame>90 days</time_frame>
    <description>Difference in number of HPV vaccine doses between study participants who viewed a video narrated by a male versus a female</description>
  </secondary_outcome>
  <other_outcome>
    <measure>HPV Vaccine Awareness</measure>
    <time_frame>0 days</time_frame>
    <description>Reported reason for HPV vaccine receipt or deferral</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">110</enrollment>
  <condition>Vaccine Acceptance</condition>
  <condition>Social Acceptance</condition>
  <condition>Acceptance Processes</condition>
  <condition>Health Behavior</condition>
  <condition>Human Papillomavirus</condition>
  <arm_group>
    <arm_group_label>Vaccine Information Statement</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Study participants will receive the HPV Vaccine Information Statement (VIS) which is part of routine care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Video &amp; Vaccine Information Statement</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will view an educational video about the HPV vaccine with a male or female narrator. Participants will also receive the HPV Vaccine Information Statement (VIS) which is part of routine care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Educational Video with Male or Female Narrator</intervention_name>
    <description>Participants will watch an educational video about the quadrivalent HPV vaccine (Gardasil) narrated by either a male or female.</description>
    <arm_group_label>Video &amp; Vaccine Information Statement</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Parent-child dyads in which the child is a male or female age 11 to 17 years who has&#xD;
             not received the HPV vaccine&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Parent-child dyads in which the child has received the HPV vaccine&#xD;
&#xD;
          -  Parent-child dyads in which the child is older than 18 at the time of enrollment&#xD;
&#xD;
          -  Non-English speakers&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>11 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kristen A. Feemster, MD MPH MSHP</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Hospital of Philadephia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Primary Care, Flourtown, Children's Hospital of Philadelphia</name>
      <address>
        <city>Flourtown</city>
        <state>Pennsylvania</state>
        <zip>19031</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nicholas and Athena Karabots Pediatric Care Center</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19139</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>July 16, 2014</study_first_submitted>
  <study_first_submitted_qc>July 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</study_first_posted>
  <last_update_submitted>May 31, 2018</last_update_submitted>
  <last_update_submitted_qc>May 31, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HPV vaccine</keyword>
  <keyword>vaccination</keyword>
  <keyword>immunization</keyword>
  <keyword>video</keyword>
  <keyword>health education</keyword>
  <keyword>communication</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/NCT02196454
org study id: IRB 14-011091
nct id: NCT02196454
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this research study is to determine if video-based education will increase HPV
      vaccination rates among 11 - 17 year olds.
Human Papillomavirus (HPV) is a common sexually transmitted infection that has the potential
      to cause cancer. The vaccine is recommended because it prevents the HPV infections that most
      commonly cause cancer. HPV vaccines offer the best protection to girls and boys who receive
      the complete, three-vaccine series and have time to develop an immune response before being
      exposed to HPV. However, vaccination rates are low compared to other vaccines for teens.

      Results from this study will help us learn why participants do or do not get the HPV
      vaccination and whether video-based education can help improve vaccination rates
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: HPV Vaccination Series Initiation
time frame: 90 days
description: Number of HPV vaccine doses received among study participants
measure: HPV Vaccine Series Initiation
time frame: 0 days
description: HPV Vaccine Receipt among study participants
measure: HPV Vaccine Series Initiation (depending on male versus female narrator)
time frame: 0 days
description: Difference in rate of HPV vaccine receipt between study participants who viewed a video narrated by a male versus a female
measure: HPV Vaccine Series Initiation (depending on male versus female narrator)
time frame: 90 days
description: Difference in number of HPV vaccine doses between study participants who viewed a video narrated by a male versus a female
measure: HPV Vaccine Awareness
time frame: 0 days
description: Reported reason for HPV vaccine receipt or deferral
arm group label: Vaccine Information Statement
arm group type: No Intervention
description: Study participants will receive the HPV Vaccine Information Statement (VIS) which is part of routine care.
arm group label: Video & Vaccine Information Statement
arm group type: Experimental
description: Participants will view an educational video about the HPV vaccine with a male or female narrator. Participants will also receive the HPV Vaccine Information Statement (VIS) which is part of routine care.
intervention type: Other
intervention name: Educational Video with Male or Female Narrator
description: Participants will watch an educational video about the quadrivalent HPV vaccine (Gardasil) narrated by either a male or female.
arm group label: Video & Vaccine Information Statement
criteria: 
gender: All
minimum age: 11 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Kristen A. Feemster, MD MPH MSHP
role: Principal Investigator
affiliation: Children's Hospital of Philadephia
facility: 
facility: 
country: United States
responsible party type: Sponsor