<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/NCT04452526</url>
  </required_header>
  <id_info>
    <org_study_id>OSU-20058</org_study_id>
    <secondary_id>NCI-2020-01225</secondary_id>
    <secondary_id>P01CA229143</secondary_id>
    <nct_id>NCT04452526</nct_id>
  </id_info>
  <brief_title>I Vaccinate: Testing Multi-Level Interventions to Improve HPV Vaccination</brief_title>
  <acronym>IVaccinate</acronym>
  <official_title>Improving Uptake of Cervical Cancer Prevention Services in Appalachia; Testing Multi-Level Interventions to Improve HPV Vaccination: The &quot;I Vaccinate&quot; Program</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ohio State University Comprehensive Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Ohio State University Comprehensive Cancer Center</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial studies how well a multi-level health system-based intervention works in improving&#xD;
      human papillomavirus (HPV) vaccine initiation and completion among children in health systems&#xD;
      in four Appalachian states. Utilizing educational and promotional materials and electronic&#xD;
      health record reminders, may improve the uptake of the HPV vaccine in children and young&#xD;
      adults, ultimately preventing the development of cervical cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVE:&#xD;
&#xD;
      I. Test the effectiveness of a multi-level intervention (MLI) directed at clinics, providers,&#xD;
      and patients (parents of children aged 11-12) to improve HPV vaccine initiation and&#xD;
      completion in health systems in four Appalachian states (Kentucky [KY], Ohio [OH], West&#xD;
      Virginia [WV,] and Virginia [VA]) among children aged 11-12 and assess the effectiveness of&#xD;
      the intervention program among subgroups, e.g., females versus (vs) males.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. Assess sustainability of the intervention. II. Assess cost impacts of the intervention&#xD;
      III. Assess changes in clinic practices that occur as a result of the intervention in terms&#xD;
      of staff responsibilities for the vaccination process and reducing missed opportunities for&#xD;
      vaccination.&#xD;
&#xD;
      IV. Assess whether interventions focused on 13-26 year olds increases catch-up vaccination.&#xD;
&#xD;
      V. Examine changes in knowledge and attitudes of providers via educational session pre-post&#xD;
      surveys.&#xD;
&#xD;
      VI. Satisfaction with the intervention at the multiple levels.&#xD;
&#xD;
      OUTLINE: Health systems are randomized to 1 of 2 arms.&#xD;
&#xD;
      ARM I (EARLY INTERVENTION): Health systems receive educational materials consisting of&#xD;
      posters, brochures and table tents. Providers complete survey about HPV knowledge,&#xD;
      participate in educational session over 1 hour and receive educational handouts on the HPV&#xD;
      vaccine. Patients receive educational materials about HPV vaccine and reminder letters for&#xD;
      HPV vaccination.&#xD;
&#xD;
      ARM II (DELAYED INTERVENTION): Health systems, providers, and patients receive usual care for&#xD;
      12 months, then receive multi-level intervention as in Arm I.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 21, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in rate of human papillomavirus (HPV) vaccination initiation among 11-12 year olds</measure>
    <time_frame>Baseline up to 24 months</time_frame>
    <description>The effectiveness of the intervention will be assessed by comparing early vs delayed intervention clinics at the end of the first implementation phase adjusting for baseline rates and pre- versus (vs) post implementation rates in the delayed implementation clinics.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in rate of HPV vaccination initiation among those 13-26</measure>
    <time_frame>Baseline up to 24 months</time_frame>
    <description>The effectiveness of the intervention will be assessed by comparing early vs delayed intervention clinics at the end of the first implementation phase adjusting for baseline rates and pre- versus (vs) post implementation rates in the delayed implementation clinics.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sustainability</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Will use logistic regression models with random health systems effects to compare odds of vaccination at the end of sustainability period to odds of vaccination at the end of the implementation period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cost-effectiveness</measure>
    <time_frame>Up to 60 months</time_frame>
    <description>Will conduct the cost-effectiveness analyses of using the multi-level intervention (MLI) intervention to promote HPV vaccination in three broad steps.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in knowledge of providers</measure>
    <time_frame>Baseline up to 60 months</time_frame>
    <description>Will compare changes in knowledge of providers via educational session pre-post survey. Changes in Knowledge following the educational session will be assessed using linear mixed models containing random health system effects.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in attitudes of providers</measure>
    <time_frame>Baseline up to 60 months</time_frame>
    <description>Will compare changes in attitudes of providers via educational session pre-post survey.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1500</enrollment>
  <condition>Cervical Carcinoma</condition>
  <condition>Human Papillomavirus-Related Malignant Neoplasm</condition>
  <arm_group>
    <arm_group_label>ARM I (EARLY INTERVENTION) (educational material, reminders)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Health systems receive educational materials consisting of posters, brochures and handouts. Providers complete survey about HPV knowledge, participate in educational session over 1 hour and receive educational handouts on the HPV vaccine. Patients receive educational materials about HPV vaccine and reminder letters for HPV vaccination</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ARM II (DELAYED INTERVENTION)(education, reminder, usual care)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Health systems, providers, and patients receive usual care for 12 months, then receive multi-level intervention as in Arm I.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Best Practice</intervention_name>
    <description>Receive usual care</description>
    <arm_group_label>ARM I (EARLY INTERVENTION) (educational material, reminders)</arm_group_label>
    <arm_group_label>ARM II (DELAYED INTERVENTION)(education, reminder, usual care)</arm_group_label>
    <other_name>standard of care</other_name>
    <other_name>standard therapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Educational Intervention</intervention_name>
    <description>Receive educational materials</description>
    <arm_group_label>ARM I (EARLY INTERVENTION) (educational material, reminders)</arm_group_label>
    <arm_group_label>ARM II (DELAYED INTERVENTION)(education, reminder, usual care)</arm_group_label>
    <other_name>Education for Intervention</other_name>
    <other_name>Intervention by Education</other_name>
    <other_name>Intervention through Education</other_name>
    <other_name>Intervention, Educational</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire Administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>ARM I (EARLY INTERVENTION) (educational material, reminders)</arm_group_label>
    <arm_group_label>ARM II (DELAYED INTERVENTION)(education, reminder, usual care)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Reminder</intervention_name>
    <description>Receive reminder letter</description>
    <arm_group_label>ARM I (EARLY INTERVENTION) (educational material, reminders)</arm_group_label>
    <arm_group_label>ARM II (DELAYED INTERVENTION)(education, reminder, usual care)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  CLINIC&#xD;
&#xD;
          -  Located in one of the counties that are part of this program&#xD;
&#xD;
          -  Provides care to patients aged 11-26&#xD;
&#xD;
          -  Provides immunizations&#xD;
&#xD;
          -  HEALTH CARE PROVIDERS (PHYSICIANS, NURSES) AND OFFICE STAFF&#xD;
&#xD;
          -  Practicing in a clinic in one of the participating health systems&#xD;
&#xD;
          -  Personnel involved in the vaccine process (determined by individual clinics)&#xD;
&#xD;
          -  Able to speak, read, and write English&#xD;
&#xD;
          -  Are able to speak, read, and write English, as there are very few Spanish-speaking&#xD;
             residents in these communities&#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>Electra D Paskett</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ohio State University Comprehensive Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Kentucky/Markey Cancer Center</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40536</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mark Dingnan, PhD, MPH</last_name>
      <phone>859-323-4708</phone>
      <email>mbdign2@email.uky.edu</email>
    </contact>
    <contact_backup>
      <email>mark.cromo@uky.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Mark Dingnan, PhD, MPH</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ohio State University Comprehensive Cancer Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Electra D. Paskett</last_name>
      <phone>614-293-7520</phone>
      <email>Electra.Paskett@osumc.edu</email>
    </contact>
    <investigator>
      <last_name>Electra D. Paskett</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Virginia</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22908</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Melissa Little, PhD, MPH</last_name>
      <phone>434-964-4671</phone>
      <email>mlittle@virginia.edu</email>
    </contact>
    <investigator>
      <last_name>Melissa Little, PhD, MPH</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://cancer.osu.edu</url>
    <description>The Jamesline</description>
  </link>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>June 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>April 18, 2022</last_update_submitted>
  <last_update_submitted_qc>April 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ohio State University Comprehensive Cancer Center</investigator_affiliation>
    <investigator_full_name>Electra Paskett</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT04452526
org study id: OSU-20058
secondary id: NCI-2020-01225
secondary id: P01CA229143
nct id: NCT04452526
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
This trial studies how well a multi-level health system-based intervention works in improving
      human papillomavirus (HPV) vaccine initiation and completion among children in health systems
      in four Appalachian states. Utilizing educational and promotional materials and electronic
      health record reminders, may improve the uptake of the HPV vaccine in children and young
      adults, ultimately preventing the development of cervical cancer.
PRIMARY OBJECTIVE:

      I. Test the effectiveness of a multi-level intervention (MLI) directed at clinics, providers,
      and patients (parents of children aged 11-12) to improve HPV vaccine initiation and
      completion in health systems in four Appalachian states (Kentucky [KY], Ohio [OH], West
      Virginia [WV,] and Virginia [VA]) among children aged 11-12 and assess the effectiveness of
      the intervention program among subgroups, e.g., females versus (vs) males.

      SECONDARY OBJECTIVES:

      I. Assess sustainability of the intervention. II. Assess cost impacts of the intervention
      III. Assess changes in clinic practices that occur as a result of the intervention in terms
      of staff responsibilities for the vaccination process and reducing missed opportunities for
      vaccination.

      IV. Assess whether interventions focused on 13-26 year olds increases catch-up vaccination.

      V. Examine changes in knowledge and attitudes of providers via educational session pre-post
      surveys.

      VI. Satisfaction with the intervention at the multiple levels.

      OUTLINE: Health systems are randomized to 1 of 2 arms.

      ARM I (EARLY INTERVENTION): Health systems receive educational materials consisting of
      posters, brochures and table tents. Providers complete survey about HPV knowledge,
      participate in educational session over 1 hour and receive educational handouts on the HPV
      vaccine. Patients receive educational materials about HPV vaccine and reminder letters for
      HPV vaccination.

      ARM II (DELAYED INTERVENTION): Health systems, providers, and patients receive usual care for
      12 months, then receive multi-level intervention as in Arm I.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in rate of human papillomavirus (HPV) vaccination initiation among 11-12 year olds
time frame: Baseline up to 24 months
description: The effectiveness of the intervention will be assessed by comparing early vs delayed intervention clinics at the end of the first implementation phase adjusting for baseline rates and pre- versus (vs) post implementation rates in the delayed implementation clinics.
measure: Change in rate of HPV vaccination initiation among those 13-26
time frame: Baseline up to 24 months
description: The effectiveness of the intervention will be assessed by comparing early vs delayed intervention clinics at the end of the first implementation phase adjusting for baseline rates and pre- versus (vs) post implementation rates in the delayed implementation clinics.
measure: Sustainability
time frame: Up to 24 months
description: Will use logistic regression models with random health systems effects to compare odds of vaccination at the end of sustainability period to odds of vaccination at the end of the implementation period.
measure: Cost-effectiveness
time frame: Up to 60 months
description: Will conduct the cost-effectiveness analyses of using the multi-level intervention (MLI) intervention to promote HPV vaccination in three broad steps.
measure: Change in knowledge of providers
time frame: Baseline up to 60 months
description: Will compare changes in knowledge of providers via educational session pre-post survey. Changes in Knowledge following the educational session will be assessed using linear mixed models containing random health system effects.
measure: Change in attitudes of providers
time frame: Baseline up to 60 months
description: Will compare changes in attitudes of providers via educational session pre-post survey.
arm group label: ARM I (EARLY INTERVENTION) (educational material, reminders)
arm group type: Experimental
description: Health systems receive educational materials consisting of posters, brochures and handouts. Providers complete survey about HPV knowledge, participate in educational session over 1 hour and receive educational handouts on the HPV vaccine. Patients receive educational materials about HPV vaccine and reminder letters for HPV vaccination
arm group label: ARM II (DELAYED INTERVENTION)(education, reminder, usual care)
arm group type: Experimental
description: Health systems, providers, and patients receive usual care for 12 months, then receive multi-level intervention as in Arm I.
intervention type: Other
intervention name: Best Practice
description: Receive usual care
arm group label: ARM I (EARLY INTERVENTION) (educational material, reminders)
arm group label: ARM II (DELAYED INTERVENTION)(education, reminder, usual care)
other name: standard of care
other name: standard therapy
intervention type: Other
intervention name: Educational Intervention
description: Receive educational materials
arm group label: ARM I (EARLY INTERVENTION) (educational material, reminders)
arm group label: ARM II (DELAYED INTERVENTION)(education, reminder, usual care)
other name: Education for Intervention
other name: Intervention by Education
other name: Intervention through Education
other name: Intervention, Educational
intervention type: Other
intervention name: Questionnaire Administration
description: Ancillary studies
arm group label: ARM I (EARLY INTERVENTION) (educational material, reminders)
arm group label: ARM II (DELAYED INTERVENTION)(education, reminder, usual care)
intervention type: Other
intervention name: Reminder
description: Receive reminder letter
arm group label: ARM I (EARLY INTERVENTION) (educational material, reminders)
arm group label: ARM II (DELAYED INTERVENTION)(education, reminder, usual care)
criteria: 
gender: All
minimum age: 11 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Electra D Paskett
role: Principal Investigator
affiliation: Ohio State University Comprehensive Cancer Center
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
url: http://cancer.osu.edu
description: The Jamesline
responsible party type: Principal Investigator
investigator affiliation: Ohio State University Comprehensive Cancer Center
investigator full name: Electra Paskett
investigator title: Principal Investigator
mesh term: Neoplasms