<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/NCT03801603</url>
  </required_header>
  <id_info>
    <org_study_id>1330087</org_study_id>
    <nct_id>NCT03801603</nct_id>
  </id_info>
  <brief_title>Improving HPV Vaccination Rates Among Rural and Native American Adolescents</brief_title>
  <official_title>Accelerating Uptake of the HPV Vaccine Among Rural and Native American Adolescents</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Davis</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, Davis</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>
      This study will develop and implement a multi-level intervention aimed at improving human&#xD;
      papillomavirus (HPV) vaccination rates at an Indian rural health clinic.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The focus of this study is to develop, implement, and evaluate a human papillomavirus (HPV)&#xD;
      vaccination program aimed at accelerating vaccine uptake among rural and Native American&#xD;
      adolescents ages 11-17. HPV vaccination coverage with at least one dose remains&#xD;
      disproportionately lower among rural adolescent compared to adolescents residing in urban&#xD;
      areas and the rate of series completion is lower among Native American adolescent girls&#xD;
      compared to non-Hispanic White adolescent girls.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 30, 2018</start_date>
  <completion_date type="Actual">June 30, 2020</completion_date>
  <primary_completion_date type="Actual">June 30, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinic HPV Vaccination Rates</measure>
    <time_frame>One year</time_frame>
    <description>HPV vaccine uptake rates (initiation and completion of the 2-dose series) among clinic patients aged 11-17 as measured by the HPV ICD code from baseline to post.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">263</enrollment>
  <condition>HPV Vaccinations</condition>
  <arm_group>
    <arm_group_label>HPV Vaccination Training and Education</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be educated on the importance of HPV vaccination.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>HPV vaccination training and education</intervention_name>
    <description>1) Training of providers and clinic staff on the importance of providing a strong HPV vaccination program and 2) HPV vaccination education for parents and the community.</description>
    <arm_group_label>HPV Vaccination Training and Education</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinic patients between the ages of 11-17 who are eligible for the HPV vaccine&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>11 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of California, Davis Comprehensive Cancer Center</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>March 15, 2021</last_update_submitted>
  <last_update_submitted_qc>March 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03801603
org study id: 1330087
nct id: NCT03801603
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will develop and implement a multi-level intervention aimed at improving human
      papillomavirus (HPV) vaccination rates at an Indian rural health clinic.
The focus of this study is to develop, implement, and evaluate a human papillomavirus (HPV)
      vaccination program aimed at accelerating vaccine uptake among rural and Native American
      adolescents ages 11-17. HPV vaccination coverage with at least one dose remains
      disproportionately lower among rural adolescent compared to adolescents residing in urban
      areas and the rate of series completion is lower among Native American adolescent girls
      compared to non-Hispanic White adolescent girls.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Clinic HPV Vaccination Rates
time frame: One year
description: HPV vaccine uptake rates (initiation and completion of the 2-dose series) among clinic patients aged 11-17 as measured by the HPV ICD code from baseline to post.
arm group label: HPV Vaccination Training and Education
arm group type: Experimental
description: Participants will be educated on the importance of HPV vaccination.
intervention type: Behavioral
intervention name: HPV vaccination training and education
description: 1) Training of providers and clinic staff on the importance of providing a strong HPV vaccination program and 2) HPV vaccination education for parents and the community.
arm group label: HPV Vaccination Training and Education
criteria: 
gender: All
minimum age: 11 Years
maximum age: 17 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No