<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/NCT04411849</url>
  </required_header>
  <id_info>
    <org_study_id>OSU-20055</org_study_id>
    <secondary_id>NCI-2020-01228</secondary_id>
    <secondary_id>P01CA229143</secondary_id>
    <nct_id>NCT04411849</nct_id>
  </id_info>
  <brief_title>Multilevel HPV Self-Testing Intervention for the Increase of Cervical Cancer Screening Among Women in Appalachia</brief_title>
  <official_title>A Multilevel HPV Self-Testing Intervention to Increase Cervical Cancer Screening Among Women in Appalachia</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial studies how well a multilevel human papillomavirus (HPV) self-testing intervention&#xD;
      works in increasing cervical cancer screening among women in Appalachia. Most cases of&#xD;
      cervical cancer occur among unscreened and underscreened women. A multilevel HPV self-testing&#xD;
      intervention may help to improve cervical cancer screening rates.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. Determine the effectiveness of the intervention in increasing cervical cancer screening.&#xD;
&#xD;
      II. Assess the fidelity, sustainability, and cost-effectiveness of the intervention.&#xD;
&#xD;
      III. Determine satisfaction with the intervention at the patient- and provider-levels.&#xD;
&#xD;
      OUTLINE: Participants are randomized to 1 of 2 groups.&#xD;
&#xD;
      GROUP I: During year 2, participants receive the HPV self-testing intervention consisting of&#xD;
      mailed HPV self-test devices. Participants also receive an information about cervical cancer.&#xD;
      Participants who do not return their self-test within a few weeks receive telephone-based&#xD;
      patient navigation. Participants then complete a satisfaction survey and have their medical&#xD;
      record reviewed. During years 3-5, this intervention is repeated among women who remain&#xD;
      unscreened/underscreened.&#xD;
&#xD;
      GROUP II: During year 2, participants receive usual care consisting of a reminder letter to&#xD;
      get a clinic-based cervical cancer screening test and information about cervical cancer.&#xD;
      During years 3-5, participants receive the HPV self-testing intervention described for Group&#xD;
      I.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 27, 2021</start_date>
  <completion_date type="Anticipated">March 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">March 31, 2024</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>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Effectiveness of human papillomavirus (HPV) intervention</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>The patient-level effectiveness will be whether or not women get &quot;screened&quot; during the project. Will examine the proportion of women from year 2 screened, and use an intent-to-treat approach. To compare treatment groups (Group 1 versus Group 2), will use generalized linear mixed models (GLMMs) to account for the correlation between women from the same clinic. Will examine the proportion of HPV self-test returners who returned their self-test following receipt of patient navigation (PN). Will use GLMMs with a logit link to examine potential differences in the proportion of women screened across project years within each treatment group (i.e., comparing years 2, 3, 4, and 5 for Group 1).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Equitableness of HPV intervention</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>To assess if the intervention is equitable, will examine patient characteristics. Will use GLMMs with a logit link to examine if patient characteristics are associated with women being categorized as &quot;screened&quot;. Participant characteristics will primarily be demographic characteristics (e.g., age).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of HPV intervention</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Will descriptively examine data from the patient satisfaction survey to see if women report any issues about using their HPV self-test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fidelity of HPV intervention</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Will develop an electronic tracking system to track all mailings (e.g., self-test distribution) and other data collection activities.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sustainability of HPV intervention</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Will examine the screening rates during the Sustainability phase(s) for both Groups 1 and 2 to determine sustainability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost-effectiveness of HPV intervention</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Cost-effectiveness analyses will be conducted from a payer perspective.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with HPV self-testing and PN</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Patient-level satisfaction data will come from the patient satisfaction surveys sent to women. Will examine satisfaction with both the HPV self-test device (appearance, usability, return process, etc.) and its instructions (appearance, readability, etc.).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with provider education sessions</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Provider-level satisfaction data will come from the post-test surveys from provider education sessions. All satisfaction items will use 5-point Likert response scales.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">2000</enrollment>
  <condition>Cervical Carcinoma</condition>
  <condition>Human Papillomavirus Infection</condition>
  <arm_group>
    <arm_group_label>Group I (early intervention)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>During year 2, participants receive the HPV self-testing intervention consisting of mailed HPV self-test devices. Participants also receive an information about cervical cancer. Participants who do not return their self-test within a few weeks receive telephone-based patient navigation. Participants then complete a satisfaction survey and have their medical record reviewed. During years 3-5, this intervention is repeated among women who remain unscreened/underscreened.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group II (delayed intervention)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>During year 2, participants receive usual care consisting of a reminder letter to get a clinic-based cervical cancer screening test and information about cervical cancer. During years 3-5, participants receive the HPV self-testing intervention described for Group I.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Best Practice</intervention_name>
    <description>Receive usual care</description>
    <arm_group_label>Group II (delayed intervention)</arm_group_label>
    <other_name>standard of care</other_name>
    <other_name>standard therapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>HPV Self-Collection</intervention_name>
    <description>Receive HPV self-testing intervention</description>
    <arm_group_label>Group I (early intervention)</arm_group_label>
    <arm_group_label>Group II (delayed intervention)</arm_group_label>
    <other_name>At-home HPV Self Collection</other_name>
    <other_name>HPV Self Collection</other_name>
    <other_name>Human Papillomavirus Self-Collection</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Informational Intervention</intervention_name>
    <description>Receive information about cervical cancer</description>
    <arm_group_label>Group I (early intervention)</arm_group_label>
    <arm_group_label>Group II (delayed intervention)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Medical Chart Review</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Group I (early intervention)</arm_group_label>
    <arm_group_label>Group II (delayed intervention)</arm_group_label>
    <other_name>Chart Review</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Patient Navigation Program</intervention_name>
    <description>Receive telephone-based patient navigation</description>
    <arm_group_label>Group I (early intervention)</arm_group_label>
    <arm_group_label>Group II (delayed intervention)</arm_group_label>
    <other_name>Patient Navigator Program</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Survey Administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Group I (early intervention)</arm_group_label>
    <arm_group_label>Group II (delayed intervention)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Not within recommended cervical cancer screening guidelines for women in this age&#xD;
             range (i.e., no Papanicolaou [Pap] test in last 3 years or no Pap test plus&#xD;
             clinic-based HPV test in last 5 years)&#xD;
&#xD;
          -  Resident of an Appalachian county&#xD;
&#xD;
          -  Not currently pregnant&#xD;
&#xD;
          -  Intact cervix&#xD;
&#xD;
          -  No history of invasive cervical cancer&#xD;
&#xD;
          -  Seen in a participating clinic/health system in last 2 years (i.e., active patient)&#xD;
&#xD;
          -  Have a working telephone&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Paul Reiter</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@uky.edu</email>
    </contact>
    <contact_backup>
      <last_name>Mark Cromo</last_name>
      <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>Paul Reiter</last_name>
      <phone>614-292-4803</phone>
      <email>reiter.36@osu.edu</email>
    </contact>
    <investigator>
      <last_name>Paul Reiter</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>Emma McKim Mitchell, PhD, MSN, RN</last_name>
      <phone>434-243-3962</phone>
      <email>emm6z@virginia.edu</email>
    </contact>
    <investigator>
      <last_name>Melissa Little, PhD, MPH</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>West Virginia University</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26506</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amie Ashcraft, PhD, MPH</last_name>
      <phone>304-581-1646</phone>
      <email>amashcraft@hsc.wvu.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://cancer.osu.edu</url>
    <description>The Jamesline</description>
  </link>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>November 4, 2022</last_update_submitted>
  <last_update_submitted_qc>November 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 7, 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>Paul Reiter</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>Papillomavirus Infections</mesh_term>
  </condition_browse>
  <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/NCT04411849
org study id: OSU-20055
secondary id: NCI-2020-01228
secondary id: P01CA229143
nct id: NCT04411849
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This trial studies how well a multilevel human papillomavirus (HPV) self-testing intervention
      works in increasing cervical cancer screening among women in Appalachia. Most cases of
      cervical cancer occur among unscreened and underscreened women. A multilevel HPV self-testing
      intervention may help to improve cervical cancer screening rates.
PRIMARY OBJECTIVES:

      I. Determine the effectiveness of the intervention in increasing cervical cancer screening.

      II. Assess the fidelity, sustainability, and cost-effectiveness of the intervention.

      III. Determine satisfaction with the intervention at the patient- and provider-levels.

      OUTLINE: Participants are randomized to 1 of 2 groups.

      GROUP I: During year 2, participants receive the HPV self-testing intervention consisting of
      mailed HPV self-test devices. Participants also receive an information about cervical cancer.
      Participants who do not return their self-test within a few weeks receive telephone-based
      patient navigation. Participants then complete a satisfaction survey and have their medical
      record reviewed. During years 3-5, this intervention is repeated among women who remain
      unscreened/underscreened.

      GROUP II: During year 2, participants receive usual care consisting of a reminder letter to
      get a clinic-based cervical cancer screening test and information about cervical cancer.
      During years 3-5, participants receive the HPV self-testing intervention described for Group
      I.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Effectiveness of human papillomavirus (HPV) intervention
time frame: Up to 5 years
description: The patient-level effectiveness will be whether or not women get "screened" during the project. Will examine the proportion of women from year 2 screened, and use an intent-to-treat approach. To compare treatment groups (Group 1 versus Group 2), will use generalized linear mixed models (GLMMs) to account for the correlation between women from the same clinic. Will examine the proportion of HPV self-test returners who returned their self-test following receipt of patient navigation (PN). Will use GLMMs with a logit link to examine potential differences in the proportion of women screened across project years within each treatment group (i.e., comparing years 2, 3, 4, and 5 for Group 1).
measure: Equitableness of HPV intervention
time frame: Up to 5 years
description: To assess if the intervention is equitable, will examine patient characteristics. Will use GLMMs with a logit link to examine if patient characteristics are associated with women being categorized as "screened". Participant characteristics will primarily be demographic characteristics (e.g., age).
measure: Safety of HPV intervention
time frame: Up to 5 years
description: Will descriptively examine data from the patient satisfaction survey to see if women report any issues about using their HPV self-test.
measure: Fidelity of HPV intervention
time frame: Up to 5 years
description: Will develop an electronic tracking system to track all mailings (e.g., self-test distribution) and other data collection activities.
measure: Sustainability of HPV intervention
time frame: Up to 5 years
description: Will examine the screening rates during the Sustainability phase(s) for both Groups 1 and 2 to determine sustainability.
measure: Cost-effectiveness of HPV intervention
time frame: Up to 5 years
description: Cost-effectiveness analyses will be conducted from a payer perspective.
measure: Satisfaction with HPV self-testing and PN
time frame: Up to 5 years
description: Patient-level satisfaction data will come from the patient satisfaction surveys sent to women. Will examine satisfaction with both the HPV self-test device (appearance, usability, return process, etc.) and its instructions (appearance, readability, etc.).
measure: Satisfaction with provider education sessions
time frame: Up to 5 years
description: Provider-level satisfaction data will come from the post-test surveys from provider education sessions. All satisfaction items will use 5-point Likert response scales.
arm group label: Group I (early intervention)
arm group type: Experimental
description: During year 2, participants receive the HPV self-testing intervention consisting of mailed HPV self-test devices. Participants also receive an information about cervical cancer. Participants who do not return their self-test within a few weeks receive telephone-based patient navigation. Participants then complete a satisfaction survey and have their medical record reviewed. During years 3-5, this intervention is repeated among women who remain unscreened/underscreened.
arm group label: Group II (delayed intervention)
arm group type: Active Comparator
description: During year 2, participants receive usual care consisting of a reminder letter to get a clinic-based cervical cancer screening test and information about cervical cancer. During years 3-5, participants receive the HPV self-testing intervention described for Group I.
intervention type: Other
intervention name: Best Practice
description: Receive usual care
arm group label: Group II (delayed intervention)
other name: standard of care
other name: standard therapy
intervention type: Procedure
intervention name: HPV Self-Collection
description: Receive HPV self-testing intervention
arm group label: Group I (early intervention)
arm group label: Group II (delayed intervention)
other name: At-home HPV Self Collection
other name: HPV Self Collection
other name: Human Papillomavirus Self-Collection
intervention type: Other
intervention name: Informational Intervention
description: Receive information about cervical cancer
arm group label: Group I (early intervention)
arm group label: Group II (delayed intervention)
intervention type: Other
intervention name: Medical Chart Review
description: Ancillary studies
arm group label: Group I (early intervention)
arm group label: Group II (delayed intervention)
other name: Chart Review
intervention type: Behavioral
intervention name: Patient Navigation Program
description: Receive telephone-based patient navigation
arm group label: Group I (early intervention)
arm group label: Group II (delayed intervention)
other name: Patient Navigator Program
intervention type: Other
intervention name: Survey Administration
description: Ancillary studies
arm group label: Group I (early intervention)
arm group label: Group II (delayed intervention)
criteria: 
gender: Female
minimum age: 30 Years
maximum age: 64 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Paul Reiter
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: 
facility: 
status: Recruiting
contact: 
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: Paul Reiter
investigator title: Principal Investigator
mesh term: Papillomavirus Infections
sharing ipd: No