<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/NCT04505930</url>
  </required_header>
  <id_info>
    <org_study_id>Pilot HPV Vaccination</org_study_id>
    <secondary_id>U54CA153513</secondary_id>
    <nct_id>NCT04505930</nct_id>
  </id_info>
  <brief_title>Pilot HPV Vaccination in Chinese American Community</brief_title>
  <official_title>Developing and Pilot Testing a Multilevel HPV Vaccination Intervention in Chinese American Community</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Temple University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Temple University</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>
      This study provides a pioneer model in increasing knowledge of HPV vaccination among Chinese&#xD;
      American families through culturally tailored interventions, and eventually increase the HPV&#xD;
      vaccine uptake among Chinese American adolescents.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 27, 2015</start_date>
  <completion_date type="Actual">August 31, 2017</completion_date>
  <primary_completion_date type="Actual">August 31, 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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>changes from baseline HPV vaccine uptake rate at 6-month follow up</measure>
    <time_frame>baseline, and 6-month follow up</time_frame>
    <description>the rate of getting HPV vaccination uptake 6 months post intervention</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>change of HPV knowledge from baseline to 6-month follow up</measure>
    <time_frame>baseline, and 6-month</time_frame>
    <description>Knowledge scores ranged from 0 to 7, computed by taking the total number of correct answers to the questions with a higher numeric value indicating better knowledge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in adolescents engagement percentage</measure>
    <time_frame>baseline, and 6-month</time_frame>
    <description>change in the percents of engaging adolescents in decision-making at post intervention</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">170</enrollment>
  <condition>HPV</condition>
  <arm_group>
    <arm_group_label>Intervention Group with active education</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The study team provides participants in the intervention group with interventional education, using interactive video watch and dynamic discussion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group with handouts</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The study team provides the participants in the control group with education, using only handouts of vaccinations including HPV, but not using interactive video watch and dynamic discussion</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Interventional HPV vaccination video modules</intervention_name>
    <description>The study team provide participants in the intervention group with interventional education, using interactive video watch and dynamic discussion. The educational videos were aiming to reinforcement and improvement the awareness, knowledge, attitude, intention and actual uptake of HPV vaccination shots among Chinese parents.</description>
    <arm_group_label>Intervention Group with active education</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>General Vaccination Education</intervention_name>
    <description>Education session conducted using only handouts of vaccinations including HPV</description>
    <arm_group_label>Control Group with handouts</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Self-identified Chinese Parents or legal guardian with children aged 11-18 years old;&#xD;
&#xD;
          2. The children have not received any does of HPV vaccination&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>110 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Grace X Ma, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Temple University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Center for Asian Health, Lewis Katz School of Medicine, Temple University</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19140</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>July 23, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>April 11, 2023</last_update_submitted>
  <last_update_submitted_qc>April 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT04505930
org study id: Pilot HPV Vaccination
secondary id: U54CA153513
nct id: NCT04505930
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This study provides a pioneer model in increasing knowledge of HPV vaccination among Chinese
      American families through culturally tailored interventions, and eventually increase the HPV
      vaccine uptake among Chinese American adolescents.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: changes from baseline HPV vaccine uptake rate at 6-month follow up
time frame: baseline, and 6-month follow up
description: the rate of getting HPV vaccination uptake 6 months post intervention
measure: change of HPV knowledge from baseline to 6-month follow up
time frame: baseline, and 6-month
description: Knowledge scores ranged from 0 to 7, computed by taking the total number of correct answers to the questions with a higher numeric value indicating better knowledge
measure: change in adolescents engagement percentage
time frame: baseline, and 6-month
description: change in the percents of engaging adolescents in decision-making at post intervention
arm group label: Intervention Group with active education
arm group type: Experimental
description: The study team provides participants in the intervention group with interventional education, using interactive video watch and dynamic discussion.
arm group label: Control Group with handouts
arm group type: Active Comparator
description: The study team provides the participants in the control group with education, using only handouts of vaccinations including HPV, but not using interactive video watch and dynamic discussion
intervention type: Behavioral
intervention name: Interventional HPV vaccination video modules
description: The study team provide participants in the intervention group with interventional education, using interactive video watch and dynamic discussion. The educational videos were aiming to reinforcement and improvement the awareness, knowledge, attitude, intention and actual uptake of HPV vaccination shots among Chinese parents.
arm group label: Intervention Group with active education
intervention type: Behavioral
intervention name: General Vaccination Education
description: Education session conducted using only handouts of vaccinations including HPV
arm group label: Control Group with handouts
criteria: 
gender: All
minimum age: 18 Years
maximum age: 110 Years
healthy volunteers: No
last name: Grace X Ma, PhD
role: Principal Investigator
affiliation: Temple University
facility: 
country: United States
responsible party type: Sponsor