<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/NCT03824093</url>
  </required_header>
  <id_info>
    <org_study_id>ChildrensMHC</org_study_id>
    <nct_id>NCT03824093</nct_id>
  </id_info>
  <brief_title>High and Low Resource Interventions to Promote HPV Vaccines</brief_title>
  <official_title>High and Low Resource Interventions to Promote HPV Vaccines</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Mercy Hospital Kansas City</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Kansas Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Midwest Cancer Alliance</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Children's Mercy Hospital Kansas City</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Human Papillomavirus (HPV) is a significant public health issue affecting nearly 14 million&#xD;
      people in the United States. HPV can lead to cervical, oropharyngeal, anal, and penile&#xD;
      cancers as well as genital warts.The purpose of this study is to test the comparative&#xD;
      effectiveness of two interventions, AFIX only vs. AFIX + communication training, to increase&#xD;
      Human Papillomavirus (HPV) vaccination rates among adolescent patients in outpatient clinic&#xD;
      settings. Providers and staff at four pediatric practices will be randomized to receive an&#xD;
      in-person AFIX consultation or an AFIX consultation combined with communication training and&#xD;
      commitment poster displays. Provider and parent data will be collected via a tablet computer&#xD;
      RedCap survey. Additional practice and provider level HPV vaccination rates will be collected&#xD;
      via patient de-identified claims data. The results of this study could contribute to the&#xD;
      existing body of literature that suggests provider recommendations and routine vaccination&#xD;
      assessments are key to increasing HPV vaccination uptake. This project has the potential to&#xD;
      lead to the implementation and dissemination of low resource interventions to increase HPV&#xD;
      vaccination rates among children and adolescents.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Significance: Human Papillomavirus (HPV) is the most common sexually transmitted infection in&#xD;
      the United States with an estimated 14 million new infections each year. While most HPV&#xD;
      infections resolve without any symptoms or signs of infection, some HPV infections can lead&#xD;
      to genital warts and cancer. Every year, more than 30,000 people are affected by an&#xD;
      HPV-related cancer, including cervical, oropharyngeal, vaginal and anal cancers. Because most&#xD;
      adults will become infected with HPV at some point in their lives, the CDC recommends routine&#xD;
      vaccination for girls aged 11-26 and boys aged 11-21. While vaccines to prevent HPV infection&#xD;
      have been widely available for more than a decade nearly 38% of eligible girls and 50% of&#xD;
      eligible boys have not initiated the HPV vaccine series and more than 70% of boys and 50% of&#xD;
      girls have not completed the full vaccine series. Rates of HPV vaccination are significantly&#xD;
      lower than rates for other adolescent recommended vaccines including, tetanus, diptheria, and&#xD;
      acellular pertussis (Tdap), and meningococcal conjugate (MenACWY), which range from 81 to 86&#xD;
      percent. There are many factors that contribute to less than optimal HPV vaccination rates&#xD;
      but chief among them is lack of a strong provider recommendation to initiate and complete the&#xD;
      HPV vaccine series.&#xD;
&#xD;
      Innovation: This study will be the first randomized controlled trial comparing the&#xD;
      effectiveness of an AFIX intervention vs. an AFIX intervention combined with a provider&#xD;
      &quot;nudge&quot; that includes a brief communication skills training and commitment messaging displays&#xD;
      to increase HPV vaccination rates in pediatric outpatient settings.&#xD;
&#xD;
      Approach: 200 eligible parents (or caregivers) of adolescents between the ages of 11 and 18&#xD;
      will be enrolled and exposed to one of the interventions based on their clinic location.&#xD;
      Parents will be recruited from the Children's Mercy Hospital Primary Care Clinic (CMH PCC)&#xD;
      and Cradle Thru College Care Pediatrics in Kansas City, MO, Preferred Pediatrics in Lee's&#xD;
      Summit, MO, and Cass County Pediatrics in Belton,MO. Practices will be randomized to receive&#xD;
      either an in-person AFIX assessment or an in-person AFIX assessment combined with a brief,&#xD;
      provider communication training and adolescent vaccine commitment poster displays. The&#xD;
      primary outcome of this study is HPV vaccination rates. A secondary outcome is parent ratings&#xD;
      of satisfaction with their child's visit with the health care provider. Data will be&#xD;
      collected via a tablet computer administered RedCap survey in the exam room immediately&#xD;
      following the child's visit.&#xD;
&#xD;
      Public Health Impact: This study could have a significant public health impact and contribute&#xD;
      to meeting the Healthy People 2020 goals to reduce vaccine preventable infections by&#xD;
      increasing vaccination rates in the pediatric population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2018</start_date>
  <completion_date type="Actual">May 6, 2020</completion_date>
  <primary_completion_date type="Actual">May 6, 2020</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>Health Services Research</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Practices will be randomly assigned to the AFIX only or AFIX+ communication training study arms. Both groups will receive identical AFIX consultations, but only practices assigned to the AFIX+ communication training arm will receive brief, provider communication training and commitment poster displays. Once practices have been randomized, parents of adolescent patients will be exposed to one of the interventions based on their practice location. Participants will not be informed of their practice's study arm.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>HPV vaccination rates</measure>
    <time_frame>18 months</time_frame>
    <description>Practice and provider level HPV vaccination rates will be collected from patient de-identified claims data.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Parent Satisfaction</measure>
    <time_frame>18 months</time_frame>
    <description>Parent satisfaction with visit will be collected using validated measures on tablet computers</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">225</enrollment>
  <condition>Human Papilloma Virus</condition>
  <condition>Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination</condition>
  <condition>Meningitis, Meningococcal</condition>
  <condition>Communication</condition>
  <condition>Satisfaction</condition>
  <arm_group>
    <arm_group_label>AFIX Only</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Practices enrolled in the AFIX only arm will receive an in-person AFIX consultation that includes assessment of current HPV vaccination rates and feedback on strategies to increase vaccination rates.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AFIX+ Provider Communication Training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Practices enrolled in the AFIX+ Provider Training arm will receive an in-person AFIX consultation along with a brief communication training for providers and poster and brochure displays in clinic waiting and exam rooms.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>AFIX Only</intervention_name>
    <description>The intervention will include an in-person AFIX assessment of the practice's adolescent vaccination rates.</description>
    <arm_group_label>AFIX Only</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>AFIX+ Provider Communication Training</intervention_name>
    <description>The intervention will include an in-person AFIX assessment of the practice's adolescent vaccination rates along with communication training for providers and poster and brochure displays.</description>
    <arm_group_label>AFIX+ Provider Communication Training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Parent or legal guardian of a child 11-18 years of age or a pediatric health care&#xD;
             provider&#xD;
&#xD;
          -  Parent or legal guardian of a child being seen for a well-child visit&#xD;
&#xD;
          -  Ability to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior participation in the study&#xD;
&#xD;
          -  Unable to read or understand English&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Children's Mercy Hospital Kansas City</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>January 29, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>January 19, 2021</last_update_submitted>
  <last_update_submitted_qc>January 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Adolescent Vaccines</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diphtheria</mesh_term>
    <mesh_term>Meningitis, Meningococcal</mesh_term>
    <mesh_term>Papilloma</mesh_term>
    <mesh_term>Meningitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>We will create a clean, de-identified copy of our final dataset that will be available to other researcher groups, upon request, within 9 months of the end of the study period. Prior to data sharing, we will remove all identifying information. We will make data and associated documentation available to users under a data-sharing agreement.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Data will be made available 9 months after the conclusion of the study upon request and completion of a data sharing agreement.</ipd_time_frame>
  </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/NCT03824093
org study id: ChildrensMHC
nct id: NCT03824093
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Human Papillomavirus (HPV) is a significant public health issue affecting nearly 14 million
      people in the United States. HPV can lead to cervical, oropharyngeal, anal, and penile
      cancers as well as genital warts.The purpose of this study is to test the comparative
      effectiveness of two interventions, AFIX only vs. AFIX + communication training, to increase
      Human Papillomavirus (HPV) vaccination rates among adolescent patients in outpatient clinic
      settings. Providers and staff at four pediatric practices will be randomized to receive an
      in-person AFIX consultation or an AFIX consultation combined with communication training and
      commitment poster displays. Provider and parent data will be collected via a tablet computer
      RedCap survey. Additional practice and provider level HPV vaccination rates will be collected
      via patient de-identified claims data. The results of this study could contribute to the
      existing body of literature that suggests provider recommendations and routine vaccination
      assessments are key to increasing HPV vaccination uptake. This project has the potential to
      lead to the implementation and dissemination of low resource interventions to increase HPV
      vaccination rates among children and adolescents.
Significance: Human Papillomavirus (HPV) is the most common sexually transmitted infection in
      the United States with an estimated 14 million new infections each year. While most HPV
      infections resolve without any symptoms or signs of infection, some HPV infections can lead
      to genital warts and cancer. Every year, more than 30,000 people are affected by an
      HPV-related cancer, including cervical, oropharyngeal, vaginal and anal cancers. Because most
      adults will become infected with HPV at some point in their lives, the CDC recommends routine
      vaccination for girls aged 11-26 and boys aged 11-21. While vaccines to prevent HPV infection
      have been widely available for more than a decade nearly 38% of eligible girls and 50% of
      eligible boys have not initiated the HPV vaccine series and more than 70% of boys and 50% of
      girls have not completed the full vaccine series. Rates of HPV vaccination are significantly
      lower than rates for other adolescent recommended vaccines including, tetanus, diptheria, and
      acellular pertussis (Tdap), and meningococcal conjugate (MenACWY), which range from 81 to 86
      percent. There are many factors that contribute to less than optimal HPV vaccination rates
      but chief among them is lack of a strong provider recommendation to initiate and complete the
      HPV vaccine series.

      Innovation: This study will be the first randomized controlled trial comparing the
      effectiveness of an AFIX intervention vs. an AFIX intervention combined with a provider
      "nudge" that includes a brief communication skills training and commitment messaging displays
      to increase HPV vaccination rates in pediatric outpatient settings.

      Approach: 200 eligible parents (or caregivers) of adolescents between the ages of 11 and 18
      will be enrolled and exposed to one of the interventions based on their clinic location.
      Parents will be recruited from the Children's Mercy Hospital Primary Care Clinic (CMH PCC)
      and Cradle Thru College Care Pediatrics in Kansas City, MO, Preferred Pediatrics in Lee's
      Summit, MO, and Cass County Pediatrics in Belton,MO. Practices will be randomized to receive
      either an in-person AFIX assessment or an in-person AFIX assessment combined with a brief,
      provider communication training and adolescent vaccine commitment poster displays. The
      primary outcome of this study is HPV vaccination rates. A secondary outcome is parent ratings
      of satisfaction with their child's visit with the health care provider. Data will be
      collected via a tablet computer administered RedCap survey in the exam room immediately
      following the child's visit.

      Public Health Impact: This study could have a significant public health impact and contribute
      to meeting the Healthy People 2020 goals to reduce vaccine preventable infections by
      increasing vaccination rates in the pediatric population.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Participant)
masking description: Practices will be randomly assigned to the AFIX only or AFIX+ communication training study arms. Both groups will receive identical AFIX consultations, but only practices assigned to the AFIX+ communication training arm will receive brief, provider communication training and commitment poster displays. Once practices have been randomized, parents of adolescent patients will be exposed to one of the interventions based on their practice location. Participants will not be informed of their practice's study arm.
measure: HPV vaccination rates
time frame: 18 months
description: Practice and provider level HPV vaccination rates will be collected from patient de-identified claims data.
measure: Parent Satisfaction
time frame: 18 months
description: Parent satisfaction with visit will be collected using validated measures on tablet computers
arm group label: AFIX Only
arm group type: Active Comparator
description: Practices enrolled in the AFIX only arm will receive an in-person AFIX consultation that includes assessment of current HPV vaccination rates and feedback on strategies to increase vaccination rates.
arm group label: AFIX+ Provider Communication Training
arm group type: Active Comparator
description: Practices enrolled in the AFIX+ Provider Training arm will receive an in-person AFIX consultation along with a brief communication training for providers and poster and brochure displays in clinic waiting and exam rooms.
intervention type: Behavioral
intervention name: AFIX Only
description: The intervention will include an in-person AFIX assessment of the practice's adolescent vaccination rates.
arm group label: AFIX Only
intervention type: Behavioral
intervention name: AFIX+ Provider Communication Training
description: The intervention will include an in-person AFIX assessment of the practice's adolescent vaccination rates along with communication training for providers and poster and brochure displays.
arm group label: AFIX+ Provider Communication Training
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diphtheria
mesh term: Meningitis, Meningococcal
mesh term: Papilloma
mesh term: Meningitis
sharing ipd: Yes
ipd description: We will create a clean, de-identified copy of our final dataset that will be available to other researcher groups, upon request, within 9 months of the end of the study period. Prior to data sharing, we will remove all identifying information. We will make data and associated documentation available to users under a data-sharing agreement.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: Data will be made available 9 months after the conclusion of the study upon request and completion of a data sharing agreement.