<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/NCT04421131</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00100618</org_study_id>
    <secondary_id>R21TW011223-02</secondary_id>
    <nct_id>NCT04421131</nct_id>
  </id_info>
  <brief_title>mHealth-supported Telecolposcopy for Cervical Cancer Programs in Low-resource Settings: Evaluation (mIVAA)</brief_title>
  <official_title>mHealth-supported Telecolposcopy for Cervical Cancer Programs in Low-resource Settings: Evaluation (mIVAA)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fogarty International Center of the National Institute of Health</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The central hypothesis is that use of mIVAA (mobile Inspección Visual con Ácido Acético -&#xD;
      Spanish for Visual Inspection with Acetic Acid (VIA)) will increase the proportion of VIA&#xD;
      positive women who complete follow-up clinical evaluation compared to VIA positive women in&#xD;
      situations in which mIVAA was not used, thus potentially improving cervical cancer treatment&#xD;
      and survival rates. The study will collect qualitative and quantitative data to examine the&#xD;
      feasibility and preliminary impact of mIVAA on reducing attrition for follow-up clinical&#xD;
      evaluations.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will be conducted in Lima, Peru in the context of mobile units operated by La Liga&#xD;
      for promoting cancer screening. mIVAA comprises two components: a digital imaging device and&#xD;
      a telemedicine platform.&#xD;
&#xD;
        1. The digital imaging device is either a mobile phone camera or the pocket colposcope&#xD;
           plugged into a mobile phone.&#xD;
&#xD;
        2. The telemedicine platform is mobile phone-based, with an interface for midwives in the&#xD;
           mobile units to enter patient information and acquire and upload cervical images, and an&#xD;
           interface for the colposcopists based remotely to review the cervical images and patient&#xD;
           information and return feedback.&#xD;
&#xD;
      The specific aim is to pilot test mIVAA in a community-based setting in Peru.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 8, 2021</start_date>
  <completion_date type="Actual">June 30, 2021</completion_date>
  <primary_completion_date type="Actual">June 30, 2021</primary_completion_date>
  <phase>N/A</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>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Women Referred to a Follow up Screening Appointment With a Colposcopist Who Did Not Attend the Appointment</measure>
    <time_frame>up to 142 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Women Approached Who Consented to Participate in Study</measure>
    <time_frame>up to 142 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Women Approached Who Refused to Participate in Study</measure>
    <time_frame>up to 142 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Visual Inspection With Acetic Acid (VIA) Screened Women Who Are VIA+</measure>
    <time_frame>up to 142 days</time_frame>
    <description>Women who screened positive (i.e., suspicious) for cervical cancer/pre-cancer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average Number of Days From Screening to When a Follow up Appointment is Scheduled</measure>
    <time_frame>up to 142 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median Number of Days From Screening to When a Follow up Appointment is Scheduled</measure>
    <time_frame>up to 142 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Women Who Were Screened Using mIVAA</measure>
    <time_frame>up to 142 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average Number of Hours From Screening to When Expert Enters Feedback Using mIVAA</measure>
    <time_frame>up to 142 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of mIVAA Screened Women With Expert Feedback Within 0-7 Days of mIVAA Screening Date</measure>
    <time_frame>up to 7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Women Screened Positive (i.e., Suspicious) for Cervical Cancer/Pre-cancer by Midwife</measure>
    <time_frame>up to 142 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Women Screened Positive (i.e., Suspicious) for Cervical Cancer/Pre-cancer by Expert Colposcopist</measure>
    <time_frame>up to 142 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average Number of Attempts Per Woman Before a Readable Image is Obtained by Midwife</measure>
    <time_frame>up to 142 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of mIVAA Screened Women With at Least 1 Image Rated as Readable by Expert</measure>
    <time_frame>up to 142 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Instances of Network Failure</measure>
    <time_frame>up to 142 days</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">112</enrollment>
  <condition>Cervical Cancer</condition>
  <arm_group>
    <arm_group_label>mIVAA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Screened for cervical cancer with mIVAA in mobile units</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pocket colposcope/Mobile phone camera</intervention_name>
    <description>The Pocket colposcope or mobile phone camera will be used to capture magnified digital images of the cervix</description>
    <arm_group_label>mIVAA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>mIVAA</intervention_name>
    <description>A mobile-phone-based telemedicine platform that enables remote consultation with an expert colposcopist</description>
    <arm_group_label>mIVAA</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 or older&#xD;
&#xD;
          -  Patients coming to the mobile unit for cervical cancer screening&#xD;
&#xD;
          -  Willing to allow use of mIVAA during screening with VIA.&#xD;
&#xD;
          -  Agree to be audio recorded&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently pregnant&#xD;
&#xD;
          -  History of hysterectomy&#xD;
&#xD;
          -  Does not understand the study purpose and details&#xD;
&#xD;
          -  Is not willing to sign an informed consent&#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>
  <overall_official>
    <last_name>Lavanya Vasudevan, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>La Liga Contra el Cancer-Peru</name>
      <address>
        <city>Lima</city>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Peru</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <results_first_submitted>June 29, 2022</results_first_submitted>
  <results_first_submitted_qc>September 20, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">October 17, 2022</results_first_posted>
  <last_update_submitted>September 20, 2022</last_update_submitted>
  <last_update_submitted_qc>September 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 17, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cervical cancer screening</keyword>
  <keyword>colposcopy</keyword>
  <keyword>digital health</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Uterine Cervical Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 21, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/31/NCT04421131/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Informed consent was obtained prior to establishing eligibility. One consented participant was deemed ineligible and one was ineligible due to not completing screening.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>mIVAA (Mobile Inspección Visual Con Ácido Acético - Spanish for Visual Inspection With Acetic Acid)</title>
          <description>Screened for cervical cancer with mIVAA in mobile units&#xD;
Pocket colposcope/Mobile phone camera: The Pocket colposcope or mobile phone camera will be used to capture magnified digital images of the cervix&#xD;
mIVAA: A mobile-phone-based telemedicine platform that enables remote consultation with an expert colposcopist</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="110"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Referred to a Follow up Screening</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="102"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>App crashed</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Participants who completed the study.</population>
      <group_list>
        <group group_id="B1">
          <title>mIVAA (Mobile Inspección Visual Con Ácido Acético - Spanish for Visual Inspection With Acetic Acid)</title>
          <description>Screened for cervical cancer with mIVAA in mobile units&#xD;
Pocket colposcope/Mobile phone camera: The Pocket colposcope or mobile phone camera will be used to capture magnified digital images of the cervix&#xD;
mIVAA: A mobile-phone-based telemedicine platform that enables remote consultation with an expert colposcopist</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="102"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="39.5" spread="9.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="102"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="102"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="78"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Peru</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="102"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Women Referred to a Follow up Screening Appointment With a Colposcopist Who Did Not Attend the Appointment</title>
        <time_frame>up to 142 days</time_frame>
        <population>Participants who were referred.</population>
        <group_list>
          <group group_id="O1">
            <title>mIVAA (Mobile Inspección Visual Con Ácido Acético - Spanish for Visual Inspection With Acetic Acid)</title>
            <description>Screened for cervical cancer with mIVAA in mobile units&#xD;
Pocket colposcope/Mobile phone camera: The Pocket colposcope or mobile phone camera will be used to capture magnified digital images of the cervix&#xD;
mIVAA: A mobile-phone-based telemedicine platform that enables remote consultation with an expert colposcopist</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Women Referred to a Follow up Screening Appointment With a Colposcopist Who Did Not Attend the Appointment</title>
          <population>Participants who were referred.</population>
          <units>percentage of women</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Women Approached Who Consented to Participate in Study</title>
        <time_frame>up to 142 days</time_frame>
        <population>Women who were approached to participate in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>mIVAA (Mobile Inspección Visual Con Ácido Acético - Spanish for Visual Inspection With Acetic Acid)</title>
            <description>Screened for cervical cancer with mIVAA in mobile units&#xD;
Pocket colposcope/Mobile phone camera: The Pocket colposcope or mobile phone camera will be used to capture magnified digital images of the cervix&#xD;
mIVAA: A mobile-phone-based telemedicine platform that enables remote consultation with an expert colposcopist</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Women Approached Who Consented to Participate in Study</title>
          <population>Women who were approached to participate in the study.</population>
          <units>percentage of women</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="112"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Women Approached Who Refused to Participate in Study</title>
        <time_frame>up to 142 days</time_frame>
        <population>Women who were approached to participate in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>mIVAA (Mobile Inspección Visual Con Ácido Acético - Spanish for Visual Inspection With Acetic Acid)</title>
            <description>Screened for cervical cancer with mIVAA in mobile units&#xD;
Pocket colposcope/Mobile phone camera: The Pocket colposcope or mobile phone camera will be used to capture magnified digital images of the cervix&#xD;
mIVAA: A mobile-phone-based telemedicine platform that enables remote consultation with an expert colposcopist</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Women Approached Who Refused to Participate in Study</title>
          <population>Women who were approached to participate in the study.</population>
          <units>percentage of women</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="112"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Visual Inspection With Acetic Acid (VIA) Screened Women Who Are VIA+</title>
        <description>Women who screened positive (i.e., suspicious) for cervical cancer/pre-cancer.</description>
        <time_frame>up to 142 days</time_frame>
        <population>Participants who completed the study.</population>
        <group_list>
          <group group_id="O1">
            <title>mIVAA (Mobile Inspección Visual Con Ácido Acético - Spanish for Visual Inspection With Acetic Acid)</title>
            <description>Screened for cervical cancer with mIVAA in mobile units&#xD;
Pocket colposcope/Mobile phone camera: The Pocket colposcope or mobile phone camera will be used to capture magnified digital images of the cervix&#xD;
mIVAA: A mobile-phone-based telemedicine platform that enables remote consultation with an expert colposcopist</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Visual Inspection With Acetic Acid (VIA) Screened Women Who Are VIA+</title>
          <description>Women who screened positive (i.e., suspicious) for cervical cancer/pre-cancer.</description>
          <population>Participants who completed the study.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Average Number of Days From Screening to When a Follow up Appointment is Scheduled</title>
        <time_frame>up to 142 days</time_frame>
        <population>Participants who completed the study.</population>
        <group_list>
          <group group_id="O1">
            <title>mIVAA (Mobile Inspección Visual Con Ácido Acético - Spanish for Visual Inspection With Acetic Acid)</title>
            <description>Screened for cervical cancer with mIVAA in mobile units&#xD;
Pocket colposcope/Mobile phone camera: The Pocket colposcope or mobile phone camera will be used to capture magnified digital images of the cervix&#xD;
mIVAA: A mobile-phone-based telemedicine platform that enables remote consultation with an expert colposcopist</description>
          </group>
        </group_list>
        <measure>
          <title>Average Number of Days From Screening to When a Follow up Appointment is Scheduled</title>
          <population>Participants who completed the study.</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.6" spread="41.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median Number of Days From Screening to When a Follow up Appointment is Scheduled</title>
        <time_frame>up to 142 days</time_frame>
        <population>Participants who completed the study.</population>
        <group_list>
          <group group_id="O1">
            <title>mIVAA (Mobile Inspección Visual Con Ácido Acético - Spanish for Visual Inspection With Acetic Acid)</title>
            <description>Screened for cervical cancer with mIVAA in mobile units&#xD;
Pocket colposcope/Mobile phone camera: The Pocket colposcope or mobile phone camera will be used to capture magnified digital images of the cervix&#xD;
mIVAA: A mobile-phone-based telemedicine platform that enables remote consultation with an expert colposcopist</description>
          </group>
        </group_list>
        <measure>
          <title>Median Number of Days From Screening to When a Follow up Appointment is Scheduled</title>
          <population>Participants who completed the study.</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6" lower_limit="3" upper_limit="116"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Women Who Were Screened Using mIVAA</title>
        <time_frame>up to 142 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>mIVAA (Mobile Inspección Visual Con Ácido Acético - Spanish for Visual Inspection With Acetic Acid)</title>
            <description>Screened for cervical cancer with mIVAA in mobile units&#xD;
Pocket colposcope/Mobile phone camera: The Pocket colposcope or mobile phone camera will be used to capture magnified digital images of the cervix&#xD;
mIVAA: A mobile-phone-based telemedicine platform that enables remote consultation with an expert colposcopist</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Women Who Were Screened Using mIVAA</title>
          <units>percentage of women</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Average Number of Hours From Screening to When Expert Enters Feedback Using mIVAA</title>
        <time_frame>up to 142 days</time_frame>
        <population>Participants who completed the study.</population>
        <group_list>
          <group group_id="O1">
            <title>mIVAA (Mobile Inspección Visual Con Ácido Acético - Spanish for Visual Inspection With Acetic Acid)</title>
            <description>Screened for cervical cancer with mIVAA in mobile units&#xD;
Pocket colposcope/Mobile phone camera: The Pocket colposcope or mobile phone camera will be used to capture magnified digital images of the cervix&#xD;
mIVAA: A mobile-phone-based telemedicine platform that enables remote consultation with an expert colposcopist</description>
          </group>
        </group_list>
        <measure>
          <title>Average Number of Hours From Screening to When Expert Enters Feedback Using mIVAA</title>
          <population>Participants who completed the study.</population>
          <units>hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" spread="5.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of mIVAA Screened Women With Expert Feedback Within 0-7 Days of mIVAA Screening Date</title>
        <time_frame>up to 7 days</time_frame>
        <population>Participants who completed the study.</population>
        <group_list>
          <group group_id="O1">
            <title>mIVAA (Mobile Inspección Visual Con Ácido Acético - Spanish for Visual Inspection With Acetic Acid)</title>
            <description>Screened for cervical cancer with mIVAA in mobile units&#xD;
Pocket colposcope/Mobile phone camera: The Pocket colposcope or mobile phone camera will be used to capture magnified digital images of the cervix&#xD;
mIVAA: A mobile-phone-based telemedicine platform that enables remote consultation with an expert colposcopist</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of mIVAA Screened Women With Expert Feedback Within 0-7 Days of mIVAA Screening Date</title>
          <population>Participants who completed the study.</population>
          <units>percentage of women</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Women Screened Positive (i.e., Suspicious) for Cervical Cancer/Pre-cancer by Midwife</title>
        <time_frame>up to 142 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>mIVAA (Mobile Inspección Visual Con Ácido Acético - Spanish for Visual Inspection With Acetic Acid)</title>
            <description>Screened for cervical cancer with mIVAA in mobile units&#xD;
Pocket colposcope/Mobile phone camera: The Pocket colposcope or mobile phone camera will be used to capture magnified digital images of the cervix&#xD;
mIVAA: A mobile-phone-based telemedicine platform that enables remote consultation with an expert colposcopist</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Women Screened Positive (i.e., Suspicious) for Cervical Cancer/Pre-cancer by Midwife</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Women Screened Positive (i.e., Suspicious) for Cervical Cancer/Pre-cancer by Expert Colposcopist</title>
        <time_frame>up to 142 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>mIVAA (Mobile Inspección Visual Con Ácido Acético - Spanish for Visual Inspection With Acetic Acid)</title>
            <description>Screened for cervical cancer with mIVAA in mobile units&#xD;
Pocket colposcope/Mobile phone camera: The Pocket colposcope or mobile phone camera will be used to capture magnified digital images of the cervix&#xD;
mIVAA: A mobile-phone-based telemedicine platform that enables remote consultation with an expert colposcopist</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Women Screened Positive (i.e., Suspicious) for Cervical Cancer/Pre-cancer by Expert Colposcopist</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Average Number of Attempts Per Woman Before a Readable Image is Obtained by Midwife</title>
        <time_frame>up to 142 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>mIVAA (Mobile Inspección Visual Con Ácido Acético - Spanish for Visual Inspection With Acetic Acid)</title>
            <description>Screened for cervical cancer with mIVAA in mobile units&#xD;
Pocket colposcope/Mobile phone camera: The Pocket colposcope or mobile phone camera will be used to capture magnified digital images of the cervix&#xD;
mIVAA: A mobile-phone-based telemedicine platform that enables remote consultation with an expert colposcopist</description>
          </group>
        </group_list>
        <measure>
          <title>Average Number of Attempts Per Woman Before a Readable Image is Obtained by Midwife</title>
          <units>attempts</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.35" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of mIVAA Screened Women With at Least 1 Image Rated as Readable by Expert</title>
        <time_frame>up to 142 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>mIVAA (Mobile Inspección Visual Con Ácido Acético - Spanish for Visual Inspection With Acetic Acid)</title>
            <description>Screened for cervical cancer with mIVAA in mobile units&#xD;
Pocket colposcope/Mobile phone camera: The Pocket colposcope or mobile phone camera will be used to capture magnified digital images of the cervix&#xD;
mIVAA: A mobile-phone-based telemedicine platform that enables remote consultation with an expert colposcopist</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of mIVAA Screened Women With at Least 1 Image Rated as Readable by Expert</title>
          <units>percentage of women</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Instances of Network Failure</title>
        <time_frame>up to 142 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>mIVAA (Mobile Inspección Visual Con Ácido Acético - Spanish for Visual Inspection With Acetic Acid)</title>
            <description>Screened for cervical cancer with mIVAA in mobile units&#xD;
Pocket colposcope/Mobile phone camera: The Pocket colposcope or mobile phone camera will be used to capture magnified digital images of the cervix&#xD;
mIVAA: A mobile-phone-based telemedicine platform that enables remote consultation with an expert colposcopist</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Instances of Network Failure</title>
          <units>network failures</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 142 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>mIVAA (Mobile Inspección Visual Con Ácido Acético - Spanish for Visual Inspection With Acetic Acid)</title>
          <description>Screened for cervical cancer with mIVAA in mobile units&#xD;
Pocket colposcope/Mobile phone camera: The Pocket colposcope or mobile phone camera will be used to capture magnified digital images of the cervix&#xD;
mIVAA: A mobile-phone-based telemedicine platform that enables remote consultation with an expert colposcopist</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>In March of 2021, NIH agreed to reduce the scope of the study. Therefore, the investigators did not conduct any Aim 2 study activities indicated in the Study Protocol.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Lavanya Vasudevan, Ph.D.</name_or_title>
      <organization>Duke University</organization>
      <phone>919-613-1423</phone>
      <email>lavanya.vasudevan@duke.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT04421131
org study id: Pro00100618
secondary id: R21TW011223-02
nct id: NCT04421131
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The central hypothesis is that use of mIVAA (mobile Inspección Visual con Ácido Acético -
      Spanish for Visual Inspection with Acetic Acid (VIA)) will increase the proportion of VIA
      positive women who complete follow-up clinical evaluation compared to VIA positive women in
      situations in which mIVAA was not used, thus potentially improving cervical cancer treatment
      and survival rates. The study will collect qualitative and quantitative data to examine the
      feasibility and preliminary impact of mIVAA on reducing attrition for follow-up clinical
      evaluations.
The study will be conducted in Lima, Peru in the context of mobile units operated by La Liga
      for promoting cancer screening. mIVAA comprises two components: a digital imaging device and
      a telemedicine platform.

        1. The digital imaging device is either a mobile phone camera or the pocket colposcope
           plugged into a mobile phone.

        2. The telemedicine platform is mobile phone-based, with an interface for midwives in the
           mobile units to enter patient information and acquire and upload cervical images, and an
           interface for the colposcopists based remotely to review the cervical images and patient
           information and return feedback.

      The specific aim is to pilot test mIVAA in a community-based setting in Peru.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Percentage of Women Referred to a Follow up Screening Appointment With a Colposcopist Who Did Not Attend the Appointment
time frame: up to 142 days
measure: Percentage of Women Approached Who Consented to Participate in Study
time frame: up to 142 days
measure: Percentage of Women Approached Who Refused to Participate in Study
time frame: up to 142 days
measure: Number of Visual Inspection With Acetic Acid (VIA) Screened Women Who Are VIA+
time frame: up to 142 days
description: Women who screened positive (i.e., suspicious) for cervical cancer/pre-cancer.
measure: Average Number of Days From Screening to When a Follow up Appointment is Scheduled
time frame: up to 142 days
measure: Median Number of Days From Screening to When a Follow up Appointment is Scheduled
time frame: up to 142 days
measure: Percentage of Women Who Were Screened Using mIVAA
time frame: up to 142 days
measure: Average Number of Hours From Screening to When Expert Enters Feedback Using mIVAA
time frame: up to 142 days
measure: Percentage of mIVAA Screened Women With Expert Feedback Within 0-7 Days of mIVAA Screening Date
time frame: up to 7 days
measure: Number of Women Screened Positive (i.e., Suspicious) for Cervical Cancer/Pre-cancer by Midwife
time frame: up to 142 days
measure: Number of Women Screened Positive (i.e., Suspicious) for Cervical Cancer/Pre-cancer by Expert Colposcopist
time frame: up to 142 days
measure: Average Number of Attempts Per Woman Before a Readable Image is Obtained by Midwife
time frame: up to 142 days
measure: Percentage of mIVAA Screened Women With at Least 1 Image Rated as Readable by Expert
time frame: up to 142 days
measure: Number of Instances of Network Failure
time frame: up to 142 days
arm group label: mIVAA
arm group type: Experimental
description: Screened for cervical cancer with mIVAA in mobile units
intervention type: Device
intervention name: Pocket colposcope/Mobile phone camera
description: The Pocket colposcope or mobile phone camera will be used to capture magnified digital images of the cervix
arm group label: mIVAA
intervention type: Other
intervention name: mIVAA
description: A mobile-phone-based telemedicine platform that enables remote consultation with an expert colposcopist
arm group label: mIVAA
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Lavanya Vasudevan, PhD
role: Principal Investigator
affiliation: Duke University
facility: 
country: Peru
responsible party type: Sponsor
mesh term: Uterine Cervical Neoplasms
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: In March of 2021, NIH agreed to reduce the scope of the study. Therefore, the investigators did not conduct any Aim 2 study activities indicated in the Study Protocol.
point of contact: 