<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/NCT04474821</url>
  </required_header>
  <id_info>
    <org_study_id>18-010455</org_study_id>
    <secondary_id>NCI-2020-04723</secondary_id>
    <secondary_id>18-010455</secondary_id>
    <nct_id>NCT04474821</nct_id>
  </id_info>
  <brief_title>HPV Educational Intervention to Increase Acceptance and Completion Rate of Free HPV Vaccination Among Underserved Adult Patients</brief_title>
  <official_title>Acceptance and Completion Rate of Free HPV Vaccination Among Underserved Adult Patients (Age 18-45)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</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 phase IV trial examines the impact of an education program on the human papilloma virus&#xD;
      (HPV) and its effects on the acceptance and completion rates of a free HPV vaccination&#xD;
      program in underserved adult patients. Participating in the HPV educational program may&#xD;
      increase the HPV vaccination rates among low income uninsured adult patients and ultimately&#xD;
      prevent HPV related cancers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. Determine the acceptability and completion rates of free HPV vaccination among the&#xD;
      underserved adult patients at the Volunteer in Medicine Clinic (VIM) in Jacksonville,&#xD;
      Florida.&#xD;
&#xD;
      II. Determine if an education program on HPV vaccination increases the acceptability of free&#xD;
      HPV vaccination among the underserved adult patients at the Volunteer in Medicine Clinic&#xD;
      (VIM) in Jacksonville, Florida.&#xD;
&#xD;
      III. Determine the baseline prevalence of HPV vaccination completion rates among VIM patients&#xD;
      age 18-45.&#xD;
&#xD;
      IV. Determine if there are differences in acceptance and completion rates of HPV vaccination,&#xD;
      among VIM patients of different sex, age (18-26 versus [vs] 27-45), ethnicity or race,&#xD;
      following an education program on HPV as part of this protocol participation.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients receive educational materials on HPV and are asked of their willingness to proceed&#xD;
      with the first HPV vaccination. Patients who express interest in receiving the HPV&#xD;
      vaccination, then receive the first dose of the HPV vaccine and the next 2 doses&#xD;
      approximately 2 months and 6 months following the initial vaccine.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 19, 2020</start_date>
  <completion_date type="Anticipated">December 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2023</primary_completion_date>
  <phase>Phase 4</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Acceptance and completion rates of free HPV vaccination</measure>
    <time_frame>Up to 2 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Differences in acceptance and completion rates of HPV vaccination, among patients of different sex, ethnic or race</measure>
    <time_frame>Up to 2 years</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Human Papillomavirus Infection</condition>
  <condition>Human Papillomavirus-Related Carcinoma</condition>
  <arm_group>
    <arm_group_label>Prevention (HPV educational program)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive educational materials on HPV and are asked of their willingness to proceed with the first HPV vaccination. Patients who express interest in receiving the HPV vaccination, then receive the first dose of the HPV vaccine and the next 2 doses approximately 2 months and 6 months following the initial vaccine.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Educational Intervention</intervention_name>
    <description>Receive educational materials on HPV</description>
    <arm_group_label>Prevention (HPV educational program)</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>Survey Administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Prevention (HPV educational program)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient of VIM clinic&#xD;
&#xD;
          -  No history of HPV vaccination&#xD;
&#xD;
          -  No history of allergy to HPV vaccination contents&#xD;
&#xD;
          -  Willingness to participate in clinical trial&#xD;
&#xD;
          -  For female patients, no history of positive HPV testing or abnormal Papanicolaou (Pap)&#xD;
             smears&#xD;
&#xD;
          -  Patients who read and understand English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals who had previously received the HPV vaccine&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gerardo Colon-Otero</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Florida</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32224-9980</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Clinical Trials Referral Office</last_name>
      <phone>855-776-0015</phone>
      <email>mayocliniccancerstudies@mayo.edu</email>
    </contact>
    <investigator>
      <last_name>Gerardo Colon-Otero</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>July 17, 2023</last_update_submitted>
  <last_update_submitted_qc>July 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 19, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Papillomavirus Infections</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/NCT04474821
org study id: 18-010455
secondary id: NCI-2020-04723
secondary id: 18-010455
nct id: NCT04474821
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This phase IV trial examines the impact of an education program on the human papilloma virus
      (HPV) and its effects on the acceptance and completion rates of a free HPV vaccination
      program in underserved adult patients. Participating in the HPV educational program may
      increase the HPV vaccination rates among low income uninsured adult patients and ultimately
      prevent HPV related cancers.
PRIMARY OBJECTIVES:

      I. Determine the acceptability and completion rates of free HPV vaccination among the
      underserved adult patients at the Volunteer in Medicine Clinic (VIM) in Jacksonville,
      Florida.

      II. Determine if an education program on HPV vaccination increases the acceptability of free
      HPV vaccination among the underserved adult patients at the Volunteer in Medicine Clinic
      (VIM) in Jacksonville, Florida.

      III. Determine the baseline prevalence of HPV vaccination completion rates among VIM patients
      age 18-45.

      IV. Determine if there are differences in acceptance and completion rates of HPV vaccination,
      among VIM patients of different sex, age (18-26 versus [vs] 27-45), ethnicity or race,
      following an education program on HPV as part of this protocol participation.

      OUTLINE:

      Patients receive educational materials on HPV and are asked of their willingness to proceed
      with the first HPV vaccination. Patients who express interest in receiving the HPV
      vaccination, then receive the first dose of the HPV vaccine and the next 2 doses
      approximately 2 months and 6 months following the initial vaccine.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Acceptance and completion rates of free HPV vaccination
time frame: Up to 2 years
measure: Differences in acceptance and completion rates of HPV vaccination, among patients of different sex, ethnic or race
time frame: Up to 2 years
arm group label: Prevention (HPV educational program)
arm group type: Experimental
description: Patients receive educational materials on HPV and are asked of their willingness to proceed with the first HPV vaccination. Patients who express interest in receiving the HPV vaccination, then receive the first dose of the HPV vaccine and the next 2 doses approximately 2 months and 6 months following the initial vaccine.
intervention type: Other
intervention name: Educational Intervention
description: Receive educational materials on HPV
arm group label: Prevention (HPV educational program)
other name: Education for Intervention
other name: Intervention by Education
other name: Intervention through Education
other name: Intervention, Educational
intervention type: Other
intervention name: Survey Administration
description: Ancillary studies
arm group label: Prevention (HPV educational program)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Gerardo Colon-Otero
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Papillomavirus Infections