<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/NCT02202109</url>
  </required_header>
  <id_info>
    <org_study_id>20140249</org_study_id>
    <secondary_id>1R01CA183612-01</secondary_id>
    <nct_id>NCT02202109</nct_id>
  </id_info>
  <brief_title>Using CHWs or Mailing Self Sampling Home Tests to Increase Cervical Cancer Screening in South Florida</brief_title>
  <official_title>Addressing Cervical Cancer Disparity in South Florida: CBPR in Action</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Miami</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Health Choice Network</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Center for Haitian Studies</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Miami</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study will test the significance of community health worker (CHW) participation by&#xD;
      comparing self-sampling provided by a community health worker and self-sampling provided by&#xD;
      mail. The study will enroll 700 participants in communities that lack access to medical care&#xD;
      in South Florida.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2015</start_date>
  <completion_date type="Actual">August 2017</completion_date>
  <primary_completion_date type="Actual">August 2017</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Completing a Self-sampling Test</measure>
    <time_frame>2 to 6 months</time_frame>
    <description>The primary outcome is having had a self-sampling done since the initial evaluation. Participants who test negative will be encouraged to rescreen while Participants who test positive for HPV will be navigated to appropriate follow-up care. The CHWs will follow up with participants who do not return the kit within 60 days.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of Change in Cervical Cancer Knowledge Among Participants</measure>
    <time_frame>Baseline, 6 months</time_frame>
    <description>Cervical cancer knowledge was measured with a series of questions asked at both pre(baseline) and post (exit). The questions were designed to measure participant's knowledge of cervical cancer prior to the study intervention and following the intervention. Cervical cancer knowledge is defined by participants answering 3 out 5 questions correctly.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants With a Change in Access to Care</measure>
    <time_frame>Baseline, 6 months</time_frame>
    <description>Access to care was defined as having a routine source of care and measured at both pre(baseline) and post (exit).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">602</enrollment>
  <condition>Cervical Cancer</condition>
  <arm_group>
    <arm_group_label>CHWs facilitated Self-Sampling</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>CHW and Self-sampling for Cervical Cancer. Home visit, self-sampler, collection of test</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mailed Self-Sampler</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Mailed Self Sampler. Self sampler is mailed to participant; follow up by phone</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CHW and Self-sampling for Cervical Cancer</intervention_name>
    <description>Behavioral: CHW and Self-sampling for Cervical Cancer The intervention strategies will involve one home visit: 1) provide brief health education on cervical cancer screening, 2) provide and collect self-sampler test. We envision visits lasting no more than 60 minutes.</description>
    <arm_group_label>CHWs facilitated Self-Sampling</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mailed Self Sampler</intervention_name>
    <description>Mailed Self Sampler. Women randomized to this intervention arm will receive a self-sampling kit via mail. This kit will include: 1) the self-sampler; 2) the vial for collecting and storing the specimen; 3) a pre-addressed, stamped envelope for returning the vial; 4) a brief introductory letter/postcard which includes a picture of the CHE and the CHW and serves to re-orient the participant to the focus of the study; 5) instructional guide that visually depicts the steps for self-sampling;</description>
    <arm_group_label>Mailed Self-Sampler</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women&#xD;
&#xD;
          -  Haitian, Hispanic, or African American&#xD;
&#xD;
          -  Ages 30-65 years&#xD;
&#xD;
          -  Report not having had a pap smear in the last three years live in the cities of&#xD;
             Miami/Little Haiti, Hialeah or unincorporated Southern Miami-Dade&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women who report having had a hysterectomy&#xD;
&#xD;
          -  Women who have a history of cervical cancer&#xD;
&#xD;
          -  Women who plan to move outside of Miami-Dade county during the next six months&#xD;
&#xD;
          -  Women who are enrolled in any other cancer prevention/outreach related study&#xD;
&#xD;
          -  Adults unable to consent&#xD;
&#xD;
          -  Individuals who are not yet adults (infants, children, teenagers)&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Prisoners&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Erin Kobetz, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Miami</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Miami</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>July 9, 2014</study_first_submitted>
  <study_first_submitted_qc>July 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 28, 2014</study_first_posted>
  <results_first_submitted>July 3, 2018</results_first_submitted>
  <results_first_submitted_qc>December 13, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">December 19, 2018</results_first_posted>
  <last_update_submitted>December 13, 2018</last_update_submitted>
  <last_update_submitted_qc>December 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Miami</investigator_affiliation>
    <investigator_full_name>Erin Kobetz-Kerman</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Screen</keyword>
  <keyword>self-sampler</keyword>
  <keyword>cervical, cancer</keyword>
  <keyword>women</keyword>
  <keyword>community health workers</keyword>
  <keyword>Hispanic/ Latinas</keyword>
  <keyword>Haitian</keyword>
  <keyword>Focus of study is cervical cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Uterine Cervical Neoplasms</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 4, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/09/NCT02202109/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 2, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/09/NCT02202109/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>CHWs Facilited Self-Sampling</title>
          <description>CHW and Self-sampling for Cervical Cancer. Home visit, self-sampler, collection of test&#xD;
CHW and Self-sampling for Cervical Cancer: Behavioral: CHW and Self-sampling for Cervical Cancer The intervention strategies will involve one home visit: 1) provide brief health education on cervical cancer screening, 2) provide and collect self-sampler test. We envision visits lasting no more than 60 minutes.</description>
        </group>
        <group group_id="P2">
          <title>Mailed Self-Sampler</title>
          <description>Mailed Self Sampler. Self sampler is mailed to participant; follow up by phone&#xD;
Mailed Self Sampler: Mailed Self Sampler. Women randomized to this intervention arm will receive a self-sampling kit via mail. This kit will include: 1) the self-sampler; 2) the vial for collecting and storing the specimen; 3) a pre-addressed, stamped envelope for returning the vial; 4) a brief introductory letter/postcard which includes a picture of the CHE and the CHW and serves to re-orient the participant to the focus of the study; 5) instructional guide that visually depicts the steps for self-sampling;</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="302"/>
                <participants group_id="P2" count="300"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="212"/>
                <participants group_id="P2" count="213"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="90"/>
                <participants group_id="P2" count="87"/>
              </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="88"/>
                <participants group_id="P2" count="87"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>CHWs Facilited Self-Sampling</title>
          <description>CHW and Self-sampling for Cervical Cancer. Home visit, self-sampler, collection of test&#xD;
CHW and Self-sampling for Cervical Cancer: Behavioral: CHW and Self-sampling for Cervical Cancer The intervention strategies will involve one home visit: 1) provide brief health education on cervical cancer screening, 2) provide and collect self-sampler test. We envision visits lasting no more than 60 minutes.</description>
        </group>
        <group group_id="B2">
          <title>Mailed Self-Sampler</title>
          <description>Mailed Self Sampler. Self sampler is mailed to participant; follow up by phone&#xD;
Mailed Self Sampler: Mailed Self Sampler. Women randomized to this intervention arm will receive a self-sampling kit via mail. This kit will include: 1) the self-sampler; 2) the vial for collecting and storing the specimen; 3) a pre-addressed, stamped envelope for returning the vial; 4) a brief introductory letter/postcard which includes a picture of the CHE and the CHW and serves to re-orient the participant to the focus of the study; 5) instructional guide that visually depicts the steps for self-sampling;</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="302"/>
            <count group_id="B2" value="300"/>
            <count group_id="B3" value="602"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="302"/>
                    <measurement group_id="B2" value="300"/>
                    <measurement group_id="B3" value="602"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </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="302"/>
                    <measurement group_id="B2" value="300"/>
                    <measurement group_id="B3" value="602"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" 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="198"/>
                    <measurement group_id="B2" value="197"/>
                    <measurement group_id="B3" value="395"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="103"/>
                    <measurement group_id="B2" value="103"/>
                    <measurement group_id="B3" value="206"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </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 group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="106"/>
                    <measurement group_id="B2" value="113"/>
                    <measurement group_id="B3" value="219"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="141"/>
                    <measurement group_id="B2" value="138"/>
                    <measurement group_id="B3" value="279"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="54"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="101"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Completing a Self-sampling Test</title>
        <description>The primary outcome is having had a self-sampling done since the initial evaluation. Participants who test negative will be encouraged to rescreen while Participants who test positive for HPV will be navigated to appropriate follow-up care. The CHWs will follow up with participants who do not return the kit within 60 days.</description>
        <time_frame>2 to 6 months</time_frame>
        <population>Participants were given up to 6 months to complete HPV self-sampling.</population>
        <group_list>
          <group group_id="O1">
            <title>CHWs Facilited Self-Sampling</title>
            <description>CHW and Self-sampling for Cervical Cancer. Home visit, self-sampler, collection of test&#xD;
CHW and Self-sampling for Cervical Cancer: Behavioral: CHW and Self-sampling for Cervical Cancer The intervention strategies will involve one home visit: 1) provide brief health education on cervical cancer screening, 2) provide and collect self-sampler test. We envision visits lasting no more than 60 minutes.</description>
          </group>
          <group group_id="O2">
            <title>Mailed Self-Sampler</title>
            <description>Mailed Self Sampler. Self sampler is mailed to participant; follow up by phone&#xD;
Mailed Self Sampler: Mailed Self Sampler. Women randomized to this intervention arm will receive a self-sampling kit via mail. This kit will include: 1) the self-sampler; 2) the vial for collecting and storing the specimen; 3) a pre-addressed, stamped envelope for returning the vial; 4) a brief introductory letter/postcard which includes a picture of the CHE and the CHW and serves to re-orient the participant to the focus of the study; 5) instructional guide that visually depicts the steps for self-sampling;</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Completing a Self-sampling Test</title>
          <description>The primary outcome is having had a self-sampling done since the initial evaluation. Participants who test negative will be encouraged to rescreen while Participants who test positive for HPV will be navigated to appropriate follow-up care. The CHWs will follow up with participants who do not return the kit within 60 days.</description>
          <population>Participants were given up to 6 months to complete HPV self-sampling.</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="272"/>
                <count group_id="O2" value="257"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="272"/>
                    <measurement group_id="O2" value="257"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Change in Cervical Cancer Knowledge Among Participants</title>
        <description>Cervical cancer knowledge was measured with a series of questions asked at both pre(baseline) and post (exit). The questions were designed to measure participant's knowledge of cervical cancer prior to the study intervention and following the intervention. Cervical cancer knowledge is defined by participants answering 3 out 5 questions correctly.</description>
        <time_frame>Baseline, 6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>CHWs Facilited Self-Sampling</title>
            <description>CHW and Self-sampling for Cervical Cancer. Home visit, self-sampler, collection of test&#xD;
CHW and Self-sampling for Cervical Cancer: Behavioral: CHW and Self-sampling for Cervical Cancer The intervention strategies will involve one home visit: 1) provide brief health education on cervical cancer screening, 2) provide and collect self-sampler test. We envision visits lasting no more than 60 minutes.</description>
          </group>
          <group group_id="O2">
            <title>Mailed Self-Sampler</title>
            <description>Mailed Self Sampler. Self sampler is mailed to participant; follow up by phone&#xD;
Mailed Self Sampler: Mailed Self Sampler. Women randomized to this intervention arm will receive a self-sampling kit via mail. This kit will include: 1) the self-sampler; 2) the vial for collecting and storing the specimen; 3) a pre-addressed, stamped envelope for returning the vial; 4) a brief introductory letter/postcard which includes a picture of the CHE and the CHW and serves to re-orient the participant to the focus of the study; 5) instructional guide that visually depicts the steps for self-sampling;</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Change in Cervical Cancer Knowledge Among Participants</title>
          <description>Cervical cancer knowledge was measured with a series of questions asked at both pre(baseline) and post (exit). The questions were designed to measure participant's knowledge of cervical cancer prior to the study intervention and following the intervention. Cervical cancer knowledge is defined by participants answering 3 out 5 questions correctly.</description>
          <units>proportion of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="212"/>
                <count group_id="O2" value="213"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.033" lower_limit="-0.038" upper_limit="0.104"/>
                    <measurement group_id="O2" value="0.089" lower_limit="0.017" upper_limit="0.162"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Participants With a Change in Access to Care</title>
        <description>Access to care was defined as having a routine source of care and measured at both pre(baseline) and post (exit).</description>
        <time_frame>Baseline, 6 months</time_frame>
        <population>Only participants with complete information on access to care were included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>CHWs Facilited Self-Sampling</title>
            <description>CHW and Self-sampling for Cervical Cancer. Home visit, self-sampler, collection of test&#xD;
CHW and Self-sampling for Cervical Cancer: Behavioral: CHW and Self-sampling for Cervical Cancer The intervention strategies will involve one home visit: 1) provide brief health education on cervical cancer screening, 2) provide and collect self-sampler test. We envision visits lasting no more than 60 minutes.</description>
          </group>
          <group group_id="O2">
            <title>Mailed Self-Sampler</title>
            <description>Mailed Self Sampler. Self sampler is mailed to participant; follow up by phone&#xD;
Mailed Self Sampler: Mailed Self Sampler. Women randomized to this intervention arm will receive a self-sampling kit via mail. This kit will include: 1) the self-sampler; 2) the vial for collecting and storing the specimen; 3) a pre-addressed, stamped envelope for returning the vial; 4) a brief introductory letter/postcard which includes a picture of the CHE and the CHW and serves to re-orient the participant to the focus of the study; 5) instructional guide that visually depicts the steps for self-sampling;</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Participants With a Change in Access to Care</title>
          <description>Access to care was defined as having a routine source of care and measured at both pre(baseline) and post (exit).</description>
          <population>Only participants with complete information on access to care were included in the analysis.</population>
          <units>proportion of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="212"/>
                <count group_id="O2" value="211"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.160" lower_limit="0.092" upper_limit="0.230"/>
                    <measurement group_id="O2" value="0.166" lower_limit="0.088" upper_limit="0.244"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Data for adverse events was collected for a period of one year.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>CHWs Facilited Self-Sampling</title>
          <description>CHW and Self-sampling for Cervical Cancer. Home visit, self-sampler, collection of test&#xD;
CHW and Self-sampling for Cervical Cancer: Behavioral: CHW and Self-sampling for Cervical Cancer The intervention strategies will involve one home visit: 1) provide brief health education on cervical cancer screening, 2) provide and collect self-sampler test. We envision visits lasting no more than 60 minutes.</description>
        </group>
        <group group_id="E2">
          <title>Mailed Self-Sampler</title>
          <description>Mailed Self Sampler. Self sampler is mailed to participant; follow up by phone&#xD;
Mailed Self Sampler: Mailed Self Sampler. Women randomized to this intervention arm will receive a self-sampling kit via mail. This kit will include: 1) the self-sampler; 2) the vial for collecting and storing the specimen; 3) a pre-addressed, stamped envelope for returning the vial; 4) a brief introductory letter/postcard which includes a picture of the CHE and the CHW and serves to re-orient the participant to the focus of the study; 5) instructional guide that visually depicts the steps for self-sampling;</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="302"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="300"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="302"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="300"/>
              </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="302"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="300"/>
              </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>
    <point_of_contact>
      <name_or_title>Dr. Erin Kobetz</name_or_title>
      <organization>University of Miami</organization>
      <phone>3052436185</phone>
      <email>ekobetz@med.miami.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/NCT02202109
org study id: 20140249
secondary id: 1R01CA183612-01
nct id: NCT02202109
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The study will test the significance of community health worker (CHW) participation by
      comparing self-sampling provided by a community health worker and self-sampling provided by
      mail. The study will enroll 700 participants in communities that lack access to medical care
      in South Florida.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: Single (Outcomes Assessor)
measure: Number of Participants Completing a Self-sampling Test
time frame: 2 to 6 months
description: The primary outcome is having had a self-sampling done since the initial evaluation. Participants who test negative will be encouraged to rescreen while Participants who test positive for HPV will be navigated to appropriate follow-up care. The CHWs will follow up with participants who do not return the kit within 60 days.
measure: Proportion of Change in Cervical Cancer Knowledge Among Participants
time frame: Baseline, 6 months
description: Cervical cancer knowledge was measured with a series of questions asked at both pre(baseline) and post (exit). The questions were designed to measure participant's knowledge of cervical cancer prior to the study intervention and following the intervention. Cervical cancer knowledge is defined by participants answering 3 out 5 questions correctly.
measure: Proportion of Participants With a Change in Access to Care
time frame: Baseline, 6 months
description: Access to care was defined as having a routine source of care and measured at both pre(baseline) and post (exit).
arm group label: CHWs facilitated Self-Sampling
arm group type: Active Comparator
description: CHW and Self-sampling for Cervical Cancer. Home visit, self-sampler, collection of test
arm group label: Mailed Self-Sampler
arm group type: Active Comparator
description: Mailed Self Sampler. Self sampler is mailed to participant; follow up by phone
intervention type: Behavioral
intervention name: CHW and Self-sampling for Cervical Cancer
description: Behavioral: CHW and Self-sampling for Cervical Cancer The intervention strategies will involve one home visit: 1) provide brief health education on cervical cancer screening, 2) provide and collect self-sampler test. We envision visits lasting no more than 60 minutes.
arm group label: CHWs facilitated Self-Sampling
intervention type: Behavioral
intervention name: Mailed Self Sampler
description: Mailed Self Sampler. Women randomized to this intervention arm will receive a self-sampling kit via mail. This kit will include: 1) the self-sampler; 2) the vial for collecting and storing the specimen; 3) a pre-addressed, stamped envelope for returning the vial; 4) a brief introductory letter/postcard which includes a picture of the CHE and the CHW and serves to re-orient the participant to the focus of the study; 5) instructional guide that visually depicts the steps for self-sampling;
arm group label: Mailed Self-Sampler
criteria: 
gender: Female
minimum age: 30 Years
maximum age: 65 Years
healthy volunteers: No
last name: Erin Kobetz, PhD
role: Principal Investigator
affiliation: University of Miami
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Miami
investigator full name: Erin Kobetz-Kerman
investigator title: Associate Professor
mesh term: Uterine Cervical Neoplasms
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 