<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/NCT03000998</url>
  </required_header>
  <id_info>
    <org_study_id>0310</org_study_id>
    <secondary_id>1R01CA210125-01A1</secondary_id>
    <nct_id>NCT03000998</nct_id>
  </id_info>
  <brief_title>Web App Technology for Boys and Parents: Improving HPV Vaccine Uptake</brief_title>
  <official_title>Web App Technology for Boys and Parents: Improving HPV Vaccine Uptake</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Klein Buendel, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of New Mexico</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Indiana University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Klein Buendel, Inc.</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>
      The uptake of vaccines for Human Papillomavirus (HPV) in the U.S. is far below recommended&#xD;
      levels, particularly for adolescent boys and especially among minority families. Proposed&#xD;
      here is a mobile web application (&quot;mobile web app&quot;) for personal computers, smart phones, and&#xD;
      tablet computers that will accurately inform parents and adolescent boys about the HPV&#xD;
      vaccination and address unique concerns about its safety and effectiveness for boys. The&#xD;
      BoyVac mobile web app will be evaluated for its ability to improve vaccine outcomes in a&#xD;
      randomized efficacy trial with parents and adolescent boys aged 11-13 years.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The President's Cancer Advisory Board and the Centers for Disease Control have called for&#xD;
      renewed efforts in promoting vaccination for Human Papillomavirus (HPV), including&#xD;
      vaccination for adolescent boys, because the uptake of this new vaccine remains alarmingly&#xD;
      low. Currently, less than 15% of adolescent boys have received the HPV vaccine; thus, most of&#xD;
      this population remains at risk for oropharyngeal, anal, and penile cancers. Many parents&#xD;
      remain unconvinced of the safety and effectiveness of HPV vaccines, so effective and&#xD;
      accessible messaging to improve decision-making on this vaccine is needed. Parents of&#xD;
      adolescent boys also have different concerns about HPV vaccination than for adolescent girls,&#xD;
      creating a need for unique health communication interventions to promote vaccine uptake among&#xD;
      boys. Interventions also need to address the unique challenges of minority populations and&#xD;
      populations for whom English is not the first language. A novel digital intervention will be&#xD;
      produced and evaluated for its ability to improve HPV vaccine outcomes. Specifically, a&#xD;
      mobile responsive web application (&quot;mobile web app&quot;) will be created that performs similar to&#xD;
      a mobile app but runs on a variety of computing platforms from personal desktop and laptop&#xD;
      computers to the latest smart phones and tablet computers. Mobile web app content will be&#xD;
      targeted to parents and adolescent boys aged 11-13 years. The specific aims are to: 1)&#xD;
      carefully and systematically develop a mobile web app (BoyVac) for smart phones, tablet&#xD;
      computers, and personal computers that will utilize Diffusion of Innovations principles to&#xD;
      provide targeted information concerning HPV vaccine adoption to adolescent males and their&#xD;
      parents, particularly minority adolescents and parents; 2) implement a comprehensive and&#xD;
      rigorous test of the impact of the BoyVac mobile web app intervention on HPV vaccine adoption&#xD;
      outcomes via a randomized efficacy trial (BoyVac v. usual and customary care); and 3) examine&#xD;
      the dose-response relationships between mobile web app usage and vaccine outcomes within a&#xD;
      components analysis. A group-randomized pretest-posttest controlled design will be&#xD;
      implemented, recruiting 1800 pairs of parents and adolescent boys from 30 pediatric clinics&#xD;
      (n=60 parents and boys per clinic). Parents will be surveyed at baseline, a 3-month&#xD;
      follow-up, and a 9-month follow-up and records HPV vaccination adoption for the boys will be&#xD;
      obtained from the clinics' medical records at the 9-month follow-up. Analyses will test the&#xD;
      hypotheses that 1) more 11-13 year old boys in the intervention group (BoyVac mobile web app)&#xD;
      will adopt the HPV vaccine than boys in the usual and customary care comparison group and 2)&#xD;
      adoption of HPV vaccine will be mediated by improvements in theoretical mediators among&#xD;
      parents in the intervention compared to the usual and customary care comparison group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 31, 2017</start_date>
  <completion_date type="Actual">June 30, 2022</completion_date>
  <primary_completion_date type="Actual">June 30, 2022</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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Vaccine Initiation</measure>
    <time_frame>1 Month</time_frame>
    <description>Vaccine initiation - whether or not each boy received the HPV vaccine and the date of administration. Number of participants who received at least 1 dose.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Vaccine Adherence</measure>
    <time_frame>2 Months</time_frame>
    <description>Vaccine Adherence - whether participants adhered to the three-dose course of the HPV vaccination or not. 2nd dose and date received. Number of participants who received at least 2 doses.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Vaccine Adherence</measure>
    <time_frame>4 months</time_frame>
    <description>Vaccine Adherence - whether participants adhered to the three-dose course of the HPV vaccination or not. 3rd dose and date received. Number of participants who received the 3 doses.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Attitudes towards vaccination in general</measure>
    <time_frame>Baseline, 3-month follow-up, and 9-month follow-up</time_frame>
    <description>Quantitative research in the form of an online survey will be conducted to examine attitudes towards vaccinations in general</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Attitudes towards the HPV vaccine</measure>
    <time_frame>Baseline, 3-month follow-up, and 9-month follow-up</time_frame>
    <description>Quantitative research in the form of an online survey will be conducted to examine attitudes towards the HPV vaccine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perception of risk due to HPV and not being vaccinated</measure>
    <time_frame>Baseline, 3-month follow-up, and 9-month follow-up</time_frame>
    <description>Quantitative research in the form of an online survey will be conducted to examine the perception of risk due to HPV and not being vaccinated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perception of negative and positive consequences associated with HPV vaccination</measure>
    <time_frame>Baseline, 3-month follow-up, and 9-month follow-up</time_frame>
    <description>Quantitative research in the form of an online survey will be conducted to examine the perception of negative and positive consequences associated with HPV vaccination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-efficacy to make informed decisions about HPV vaccination</measure>
    <time_frame>Baseline, 3-month follow-up, and 9-month follow-up</time_frame>
    <description>Quantitative research in the form of an online survey will be conducted to examine the self-efficacy to make informed decisions about HPV vaccination</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HPV knowledge</measure>
    <time_frame>Baseline, 3-month follow-up, and 9-month follow-up</time_frame>
    <description>Quantitative research in the form of an online survey will be conducted to examine the participant's knowledge about HPV</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Spousal support and social normative and cultural perceptions of receiving the HPV vaccination</measure>
    <time_frame>Baseline, 3-month follow-up, and 9-month follow-up</time_frame>
    <description>Quantitative research in the form of an online survey will be conducted to examine the spousal support and social normative and cultural perceptions of receiving the HPV vaccination.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">432</enrollment>
  <condition>Human Papillomavirus Virus</condition>
  <condition>HPV</condition>
  <arm_group>
    <arm_group_label>Web App Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The BoyVac mobile web app will be evaluated in a pair-matched group-randomized pretest-posttest controlled design. In Year 2, 30 clinics in New Mexico will be pair-matched and one member of each pair will be randomized to the intervention (mobile web app) or a usual and customary (UC) HPV vaccine adoption procedures comparison group. Clinics will be paired based on similarities in patient demographic (ethnicity and % Medicaid patients) and location (urban and rural).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Customary Care Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Currently in pediatric clinics in New Mexico, the HPV vaccines are offered to parents and adolescents as part of annual well-child checkups. Typically for boys aged 11-13, parents initiate this checkup as part of a back-to-school activity. As part of the well-child checkup, clinic staff (physician, physician assistant and/or nurse) talk with parents and adolescents about the recommendation that their sons or daughters receive the HPV vaccination. Well-child pediatric visits to promote good health and development are recommended for all children from infancy through adolescence by the American Academy of Pediatrics.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Web App Intervention Group</intervention_name>
    <description>All baseline and follow-up data collection will be conducted via online surveys and a customized web portal and include parent self-reports and clinic records of vaccination of boys</description>
    <arm_group_label>Web App Intervention Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Usual Customary Care Group</intervention_name>
    <description>Participants randomized to the usual and customary care (UC) group will receive a website with a pamphlet on HPV vaccination from the Centers for Disease Control and Prevention (CDC) in Portable Document Format (PDF) format.</description>
    <arm_group_label>Usual Customary Care Group</arm_group_label>
    <other_name>UC</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Adolescent boys:&#xD;
&#xD;
          1. being male&#xD;
&#xD;
          2. being 11-13 years old&#xD;
&#xD;
          3. being a patient at a participating University of New Mexico (UNM) Hospital's Envision&#xD;
             pediatric practice&#xD;
&#xD;
          4. parental consent for testing, and&#xD;
&#xD;
          5. child assent for testing&#xD;
&#xD;
        Parents/Guardians:&#xD;
&#xD;
          1. being a parent/guardian of an eligible and participating 11-13 year old boy&#xD;
&#xD;
          2. demonstrated ability to comprehend study requirements, and&#xD;
&#xD;
          3. providing informed consent for oneself and assent for their youth's participation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Adolescent boys:&#xD;
&#xD;
          1. another immediate family member is participating in the project (i.e., a sibling)&#xD;
&#xD;
          2. the participant has already received any or all doses for the HPV vaccine, or&#xD;
&#xD;
          3. the participant refuses to assent.&#xD;
&#xD;
        Parents/Guardians:&#xD;
&#xD;
          1. under the age of 18, or&#xD;
&#xD;
          2. another immediate family member is participating in the project (i.e., another&#xD;
             parent).&#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>Gill Woodall, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Klein Buendel, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Klein Buendel, Inc.</name>
      <address>
        <city>Golden</city>
        <state>Colorado</state>
        <zip>80401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Indiana University</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202-2915</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of New Mexico</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87131-0001</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>November 21, 2016</study_first_submitted>
  <study_first_submitted_qc>December 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 22, 2016</study_first_posted>
  <last_update_submitted>February 2, 2023</last_update_submitted>
  <last_update_submitted_qc>February 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HPV</keyword>
  <keyword>Cancer</keyword>
  <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/NCT03000998
org study id: 0310
secondary id: 1R01CA210125-01A1
nct id: NCT03000998
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The uptake of vaccines for Human Papillomavirus (HPV) in the U.S. is far below recommended
      levels, particularly for adolescent boys and especially among minority families. Proposed
      here is a mobile web application ("mobile web app") for personal computers, smart phones, and
      tablet computers that will accurately inform parents and adolescent boys about the HPV
      vaccination and address unique concerns about its safety and effectiveness for boys. The
      BoyVac mobile web app will be evaluated for its ability to improve vaccine outcomes in a
      randomized efficacy trial with parents and adolescent boys aged 11-13 years.
The President's Cancer Advisory Board and the Centers for Disease Control have called for
      renewed efforts in promoting vaccination for Human Papillomavirus (HPV), including
      vaccination for adolescent boys, because the uptake of this new vaccine remains alarmingly
      low. Currently, less than 15% of adolescent boys have received the HPV vaccine; thus, most of
      this population remains at risk for oropharyngeal, anal, and penile cancers. Many parents
      remain unconvinced of the safety and effectiveness of HPV vaccines, so effective and
      accessible messaging to improve decision-making on this vaccine is needed. Parents of
      adolescent boys also have different concerns about HPV vaccination than for adolescent girls,
      creating a need for unique health communication interventions to promote vaccine uptake among
      boys. Interventions also need to address the unique challenges of minority populations and
      populations for whom English is not the first language. A novel digital intervention will be
      produced and evaluated for its ability to improve HPV vaccine outcomes. Specifically, a
      mobile responsive web application ("mobile web app") will be created that performs similar to
      a mobile app but runs on a variety of computing platforms from personal desktop and laptop
      computers to the latest smart phones and tablet computers. Mobile web app content will be
      targeted to parents and adolescent boys aged 11-13 years. The specific aims are to: 1)
      carefully and systematically develop a mobile web app (BoyVac) for smart phones, tablet
      computers, and personal computers that will utilize Diffusion of Innovations principles to
      provide targeted information concerning HPV vaccine adoption to adolescent males and their
      parents, particularly minority adolescents and parents; 2) implement a comprehensive and
      rigorous test of the impact of the BoyVac mobile web app intervention on HPV vaccine adoption
      outcomes via a randomized efficacy trial (BoyVac v. usual and customary care); and 3) examine
      the dose-response relationships between mobile web app usage and vaccine outcomes within a
      components analysis. A group-randomized pretest-posttest controlled design will be
      implemented, recruiting 1800 pairs of parents and adolescent boys from 30 pediatric clinics
      (n=60 parents and boys per clinic). Parents will be surveyed at baseline, a 3-month
      follow-up, and a 9-month follow-up and records HPV vaccination adoption for the boys will be
      obtained from the clinics' medical records at the 9-month follow-up. Analyses will test the
      hypotheses that 1) more 11-13 year old boys in the intervention group (BoyVac mobile web app)
      will adopt the HPV vaccine than boys in the usual and customary care comparison group and 2)
      adoption of HPV vaccine will be mediated by improvements in theoretical mediators among
      parents in the intervention compared to the usual and customary care comparison group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Vaccine Initiation
time frame: 1 Month
description: Vaccine initiation - whether or not each boy received the HPV vaccine and the date of administration. Number of participants who received at least 1 dose.
measure: Vaccine Adherence
time frame: 2 Months
description: Vaccine Adherence - whether participants adhered to the three-dose course of the HPV vaccination or not. 2nd dose and date received. Number of participants who received at least 2 doses.
measure: Vaccine Adherence
time frame: 4 months
description: Vaccine Adherence - whether participants adhered to the three-dose course of the HPV vaccination or not. 3rd dose and date received. Number of participants who received the 3 doses.
measure: Attitudes towards vaccination in general
time frame: Baseline, 3-month follow-up, and 9-month follow-up
description: Quantitative research in the form of an online survey will be conducted to examine attitudes towards vaccinations in general
measure: Attitudes towards the HPV vaccine
time frame: Baseline, 3-month follow-up, and 9-month follow-up
description: Quantitative research in the form of an online survey will be conducted to examine attitudes towards the HPV vaccine
measure: Perception of risk due to HPV and not being vaccinated
time frame: Baseline, 3-month follow-up, and 9-month follow-up
description: Quantitative research in the form of an online survey will be conducted to examine the perception of risk due to HPV and not being vaccinated.
measure: Perception of negative and positive consequences associated with HPV vaccination
time frame: Baseline, 3-month follow-up, and 9-month follow-up
description: Quantitative research in the form of an online survey will be conducted to examine the perception of negative and positive consequences associated with HPV vaccination.
measure: Self-efficacy to make informed decisions about HPV vaccination
time frame: Baseline, 3-month follow-up, and 9-month follow-up
description: Quantitative research in the form of an online survey will be conducted to examine the self-efficacy to make informed decisions about HPV vaccination
measure: HPV knowledge
time frame: Baseline, 3-month follow-up, and 9-month follow-up
description: Quantitative research in the form of an online survey will be conducted to examine the participant's knowledge about HPV
measure: Spousal support and social normative and cultural perceptions of receiving the HPV vaccination
time frame: Baseline, 3-month follow-up, and 9-month follow-up
description: Quantitative research in the form of an online survey will be conducted to examine the spousal support and social normative and cultural perceptions of receiving the HPV vaccination.
arm group label: Web App Intervention Group
arm group type: Experimental
description: The BoyVac mobile web app will be evaluated in a pair-matched group-randomized pretest-posttest controlled design. In Year 2, 30 clinics in New Mexico will be pair-matched and one member of each pair will be randomized to the intervention (mobile web app) or a usual and customary (UC) HPV vaccine adoption procedures comparison group. Clinics will be paired based on similarities in patient demographic (ethnicity and % Medicaid patients) and location (urban and rural).
arm group label: Usual Customary Care Group
arm group type: Active Comparator
description: Currently in pediatric clinics in New Mexico, the HPV vaccines are offered to parents and adolescents as part of annual well-child checkups. Typically for boys aged 11-13, parents initiate this checkup as part of a back-to-school activity. As part of the well-child checkup, clinic staff (physician, physician assistant and/or nurse) talk with parents and adolescents about the recommendation that their sons or daughters receive the HPV vaccination. Well-child pediatric visits to promote good health and development are recommended for all children from infancy through adolescence by the American Academy of Pediatrics.
intervention type: Behavioral
intervention name: Web App Intervention Group
description: All baseline and follow-up data collection will be conducted via online surveys and a customized web portal and include parent self-reports and clinic records of vaccination of boys
arm group label: Web App Intervention Group
intervention type: Behavioral
intervention name: Usual Customary Care Group
description: Participants randomized to the usual and customary care (UC) group will receive a website with a pamphlet on HPV vaccination from the Centers for Disease Control and Prevention (CDC) in Portable Document Format (PDF) format.
arm group label: Usual Customary Care Group
other name: UC
criteria: 
gender: All
minimum age: 11 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Gill Woodall, PhD
role: Principal Investigator
affiliation: Klein Buendel, Inc.
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No