<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/NCT02970136</url>
  </required_header>
  <id_info>
    <org_study_id>20160023</org_study_id>
    <secondary_id>1U01MD010614-01</secondary_id>
    <nct_id>NCT02970136</nct_id>
  </id_info>
  <brief_title>Increasing Uptake of Evidence-Based Screening Services Through CHW-led Multi-modality Intervention</brief_title>
  <official_title>Increasing Uptake of Evidence-Based Screening Services Through CHW-led Multi-modality Intervention: South Florida Center for Reducing Health Disparities</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Miami</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Minority Health and Health Disparities (NIMHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Miami</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>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research study is to determine the best way to increase screening for&#xD;
      cervical cancer, colorectal cancer, HIV, and Hepatitis C among under screened Hispanic,&#xD;
      Haitian and African-American individuals in Hialeah, South Dade, and Little Haiti. The&#xD;
      investigator will compare home testing led by a community health worker (CHW) versus clinic&#xD;
      testing guided by a CHW. Community Health Workers are people who have undergone several weeks&#xD;
      of community outreach and health education training. During the study period the participant&#xD;
      will continue to receive all of their regular medical care from their regular health care&#xD;
      providers. If the participant does not have a health care provider, the Community Health&#xD;
      Workers would be able to help in referring the participant for care at a local health care&#xD;
      clinic located in their community.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 11, 2017</start_date>
  <completion_date type="Actual">October 30, 2020</completion_date>
  <primary_completion_date type="Actual">October 30, 2020</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>Percentage of Participants Who Are Screened for All Conditions</measure>
    <time_frame>Baseline</time_frame>
    <description>As evaluated by participant self report and completed sampling kits. Female participants are to be screened on 4 conditions: HIV, HCV, Human Papilloma Virus (HPV) and Fecal Immunochemical Testing (FIT). Male participants are to be screened on 3 conditions: HIV, Hepatitis C Virus (HCV) and FIT.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Percentage of Participants Completing Screening Test From Baseline to 6 Months</measure>
    <time_frame>Baseline, Up to 6 months</time_frame>
    <description>As evaluated by participant self report and completed sampling kits. Female participants are to be screened on 4 conditions: HIV, HCV, HPV and FIT. Male participants are to be screened on 3 conditions: HIV, HCV and FIT.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median Number of Screenings Completed</measure>
    <time_frame>At baseline and at 6 months</time_frame>
    <description>As evaluated by participant self report and completed sampling kits. Female participants are to be screened on 4 conditions: HIV, HCV, HPV and FIT. Male participants are to be screened on 3 conditions: HIV, HCV and FIT.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">754</enrollment>
  <condition>Human Papillomavirus</condition>
  <condition>Human Immunodeficiency Virus</condition>
  <condition>Hepatitis C</condition>
  <condition>ColoRectal Cancer</condition>
  <arm_group>
    <arm_group_label>Home Based Screening</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The participant will be receiving home-based screening tests (OraQuick Swab, OraQuick Fingerstick, Human Papillomavirus (HPV) Self-Sampling Test, Fecal Immunochemical Test) delivered by the community health worker</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Clinic Based Screening</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The participant will meet the Community Health Worker and will be navigated to a clinic appointment for standard screening tests</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>OraQuick Swab</intervention_name>
    <description>OraQuick for oral fluid HIV antibody testing</description>
    <arm_group_label>Home Based Screening</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Fecal Immunochemical Test</intervention_name>
    <description>Fecal Immunochemical stool test specific for human hemoglobin</description>
    <arm_group_label>Home Based Screening</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>OraQuick Fingerstick</intervention_name>
    <description>Patients will be tested for Hepatitis C infection using a fingerstick</description>
    <arm_group_label>Home Based Screening</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard Screening Tests</intervention_name>
    <description>Patients will be navigated to a local health center for standard screening tests</description>
    <arm_group_label>Clinic Based Screening</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>HPV Self-Sampling Test</intervention_name>
    <description>Patients will be using swab to check for HPV infection</description>
    <arm_group_label>Home Based Screening</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Home Based Screening Tests</intervention_name>
    <description>Patients will provided screening tests and instructed by Community Health Worker on how to perform home screening tests</description>
    <arm_group_label>Home Based Screening</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. live in one of the three target communities&#xD;
&#xD;
          2. self-identify as Haitian, Hispanic and/or Black.&#xD;
&#xD;
          3. be 50-64 years old&#xD;
&#xD;
          4. need at least one of the four recommended screening services as per US Preventive&#xD;
             Service Task Force 121 guidelines as follows: never having had a HIV test b) never&#xD;
             having had a Hepatitis C Virus (HCV) test c) not having a Pap smear in the last three&#xD;
             years d) not having had a colonoscopy in last 10 years and/or stool-based test in the&#xD;
             last year.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. plan to move out of the community during the next six months;&#xD;
&#xD;
          2. current or prior enrollment (5 five years) in any research study that involved&#xD;
             screening for these conditions.&#xD;
&#xD;
          3. Are adults unable to consent&#xD;
&#xD;
          4. Are individuals who are not yet adults (infants, children, teenagers)&#xD;
&#xD;
          5. Pregnant women&#xD;
&#xD;
          6. Prisoners&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Olveen Carrasquillo, MD</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>November 2021</verification_date>
  <study_first_submitted>November 18, 2016</study_first_submitted>
  <study_first_submitted_qc>November 18, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <results_first_submitted>October 29, 2021</results_first_submitted>
  <results_first_submitted_qc>November 29, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">December 28, 2021</results_first_posted>
  <last_update_submitted>November 29, 2021</last_update_submitted>
  <last_update_submitted_qc>November 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Miami</investigator_affiliation>
    <investigator_full_name>Olveen Carrasquillo</investigator_full_name>
    <investigator_title>Professor of Medicine and Public Health Sciences</investigator_title>
  </responsible_party>
  <keyword>Increased Screening Uptake</keyword>
  <keyword>Community Health Worker</keyword>
  <keyword>Medically Underserved</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis C</mesh_term>
    <mesh_term>Acquired Immunodeficiency Syndrome</mesh_term>
    <mesh_term>HIV Infections</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>February 11, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/36/NCT02970136/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Home Based Screening</title>
          <description>The participant will be receiving home-based screening tests (OraQuick Swab, OraQuick Fingerstick, Human Papillomavirus (HPV) Self-Sampling Test, Fecal Immunochemical Test) delivered by the community health worker&#xD;
OraQuick Swab: OraQuick for oral fluid HIV antibody testing&#xD;
Fecal Immunochemical Test: Fecal Immunochemical stool test specific for human hemoglobin&#xD;
OraQuick Fingerstick: Patients will be tested for Hepatitis C infection using a fingerstick&#xD;
HPV Self-Sampling Test: Patients will be using swab to check for HPV infection&#xD;
Home Based Screening Tests: Patients will provided screening tests and instructed by Community Health Worker on how to perform home screening tests</description>
        </group>
        <group group_id="P2">
          <title>Clinic Based Screening</title>
          <description>The participant will meet the Community Health Worker and will be navigated to a clinic appointment for standard screening tests&#xD;
Standard Screening Tests: Patients will be navigated to a local health center for standard screening tests</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="377"/>
                <participants group_id="P2" count="377"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="297"/>
                <participants group_id="P2" count="282"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="80"/>
                <participants group_id="P2" count="95"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Home Based Screening</title>
          <description>The participant will be receiving home-based screening tests (OraQuick Swab, OraQuick Fingerstick, Human Papillomavirus (HPV) Self-Sampling Test, Fecal Immunochemical Test) delivered by the community health worker&#xD;
OraQuick Swab: OraQuick for oral fluid HIV antibody testing&#xD;
Fecal Immunochemical Test: Fecal Immunochemical stool test specific for human hemoglobin&#xD;
OraQuick Fingerstick: Patients will be tested for Hepatitis C infection using a fingerstick&#xD;
HPV Self-Sampling Test: Patients will be using swab to check for HPV infection&#xD;
Home Based Screening Tests: Patients will provided screening tests and instructed by Community Health Worker on how to perform home screening tests</description>
        </group>
        <group group_id="B2">
          <title>Clinic Based Screening</title>
          <description>The participant will meet the Community Health Worker and will be navigated to a clinic appointment for standard screening tests&#xD;
Standard Screening Tests: Patients will be navigated to a local health center for standard screening tests</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="377"/>
            <count group_id="B2" value="377"/>
            <count group_id="B3" value="754"/>
          </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="57.33" spread="4.54"/>
                    <measurement group_id="B2" value="57.40" spread="4.49"/>
                    <measurement group_id="B3" value="57.37" spread="4.51"/>
                  </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="282"/>
                    <measurement group_id="B2" value="282"/>
                    <measurement group_id="B3" value="564"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="95"/>
                    <measurement group_id="B2" value="95"/>
                    <measurement group_id="B3" value="190"/>
                  </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="239"/>
                    <measurement group_id="B2" value="241"/>
                    <measurement group_id="B3" value="480"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="138"/>
                    <measurement group_id="B2" value="136"/>
                    <measurement group_id="B3" value="274"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</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>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="142"/>
                    <measurement group_id="B2" value="143"/>
                    <measurement group_id="B3" value="285"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="205"/>
                    <measurement group_id="B2" value="214"/>
                    <measurement group_id="B3" value="419"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="47"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <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>Percentage of Participants Who Are Screened for All Conditions</title>
        <description>As evaluated by participant self report and completed sampling kits. Female participants are to be screened on 4 conditions: HIV, HCV, Human Papilloma Virus (HPV) and Fecal Immunochemical Testing (FIT). Male participants are to be screened on 3 conditions: HIV, Hepatitis C Virus (HCV) and FIT.</description>
        <time_frame>Baseline</time_frame>
        <population>There were 282 female participants and 95 male participants enrolled for each arm for a total of 377 total enrolled participants per arm. Female participants are to be screened on 4 conditions: HIV, HCV, Human Papilloma Virus (HPV) and Fecal Immunochemical Testing (FIT). Male participants are to be screened on 3 conditions: HIV, Hepatitis C Virus (HCV) and FIT.</population>
        <group_list>
          <group group_id="O1">
            <title>Home Based Screening</title>
            <description>The participant will be receiving home-based screening tests (OraQuick Swab, OraQuick Fingerstick, Human Papillomavirus (HPV) Self-Sampling Test, Fecal Immunochemical Test) delivered by the community health worker&#xD;
OraQuick Swab: OraQuick for oral fluid HIV antibody testing&#xD;
Fecal Immunochemical Test: Fecal Immunochemical stool test specific for human hemoglobin&#xD;
OraQuick Fingerstick: Patients will be tested for Hepatitis C infection using a fingerstick&#xD;
HPV Self-Sampling Test: Patients will be using swab to check for HPV infection&#xD;
Home Based Screening Tests: Patients will provided screening tests and instructed by Community Health Worker on how to perform home screening tests</description>
          </group>
          <group group_id="O2">
            <title>Clinic Based Screening</title>
            <description>The participant will meet the Community Health Worker and will be navigated to a clinic appointment for standard screening tests&#xD;
Standard Screening Tests: Patients will be navigated to a local health center for standard screening tests</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Are Screened for All Conditions</title>
          <description>As evaluated by participant self report and completed sampling kits. Female participants are to be screened on 4 conditions: HIV, HCV, Human Papilloma Virus (HPV) and Fecal Immunochemical Testing (FIT). Male participants are to be screened on 3 conditions: HIV, Hepatitis C Virus (HCV) and FIT.</description>
          <population>There were 282 female participants and 95 male participants enrolled for each arm for a total of 377 total enrolled participants per arm. Female participants are to be screened on 4 conditions: HIV, HCV, Human Papilloma Virus (HPV) and Fecal Immunochemical Testing (FIT). Male participants are to be screened on 3 conditions: HIV, Hepatitis C Virus (HCV) and FIT.</population>
          <units>Percentage 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="377"/>
                <count group_id="O2" value="377"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Female Participants</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="282"/>
                    <count group_id="O2" value="282"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.18" lower_limit="20.22" upper_limit="30.24"/>
                    <measurement group_id="O2" value="8.16" lower_limit="5.24" upper_limit="11.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Male Participants</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="95"/>
                    <count group_id="O2" value="95"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.63" lower_limit="23.36" upper_limit="43.02"/>
                    <measurement group_id="O2" value="15.79" lower_limit="9.02" upper_limit="24.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Percentage of Participants Completing Screening Test From Baseline to 6 Months</title>
        <description>As evaluated by participant self report and completed sampling kits. Female participants are to be screened on 4 conditions: HIV, HCV, HPV and FIT. Male participants are to be screened on 3 conditions: HIV, HCV and FIT.</description>
        <time_frame>Baseline, Up to 6 months</time_frame>
        <population>There were 282 female participants and 95 male participants enrolled for each arm for a total of 377 total enrolled participants per arm. Female participants are to be screened on 4 conditions: HIV, HCV, Human Papilloma Virus (HPV) and Fecal Immunochemical Testing (FIT). Male participants are to be screened on 3 conditions: HIV, Hepatitis C Virus (HCV) and FIT.</population>
        <group_list>
          <group group_id="O1">
            <title>Home Based Screening</title>
            <description>The participant will be receiving home-based screening tests (OraQuick Swab, OraQuick Fingerstick, Human Papillomavirus (HPV) Self-Sampling Test, Fecal Immunochemical Test) delivered by the community health worker&#xD;
OraQuick Swab: OraQuick for oral fluid HIV antibody testing&#xD;
Fecal Immunochemical Test: Fecal Immunochemical stool test specific for human hemoglobin&#xD;
OraQuick Fingerstick: Patients will be tested for Hepatitis C infection using a fingerstick&#xD;
HPV Self-Sampling Test: Patients will be using swab to check for HPV infection&#xD;
Home Based Screening Tests: Patients will provided screening tests and instructed by Community Health Worker on how to perform home screening tests</description>
          </group>
          <group group_id="O2">
            <title>Clinic Based Screening</title>
            <description>The participant will meet the Community Health Worker and will be navigated to a clinic appointment for standard screening tests&#xD;
Standard Screening Tests: Patients will be navigated to a local health center for standard screening tests</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Percentage of Participants Completing Screening Test From Baseline to 6 Months</title>
          <description>As evaluated by participant self report and completed sampling kits. Female participants are to be screened on 4 conditions: HIV, HCV, HPV and FIT. Male participants are to be screened on 3 conditions: HIV, HCV and FIT.</description>
          <population>There were 282 female participants and 95 male participants enrolled for each arm for a total of 377 total enrolled participants per arm. Female participants are to be screened on 4 conditions: HIV, HCV, Human Papilloma Virus (HPV) and Fecal Immunochemical Testing (FIT). Male participants are to be screened on 3 conditions: HIV, Hepatitis C Virus (HCV) and FIT.</population>
          <units>percentage 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="377"/>
                <count group_id="O2" value="377"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>HCV Screening Test</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="377"/>
                    <count group_id="O2" value="377"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.88" lower_limit="67.35" upper_limit="76.42"/>
                    <measurement group_id="O2" value="31.56" lower_limit="26.87" upper_limit="36.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HIV Screening Test</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="377"/>
                    <count group_id="O2" value="377"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.15" lower_limit="41.12" upper_limit="51.19"/>
                    <measurement group_id="O2" value="20.95" lower_limit="16.85" upper_limit="25.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HPV Screening Test</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="282"/>
                    <count group_id="O2" value="282"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.47" lower_limit="19.45" upper_limit="29.49"/>
                    <measurement group_id="O2" value="12.06" lower_limit="8.26" upper_limit="15.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FIT Screening Test</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="377"/>
                    <count group_id="O2" value="377"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.26" lower_limit="34.33" upper_limit="44.19"/>
                    <measurement group_id="O2" value="18.57" lower_limit="14.64" upper_limit="22.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median Number of Screenings Completed</title>
        <description>As evaluated by participant self report and completed sampling kits. Female participants are to be screened on 4 conditions: HIV, HCV, HPV and FIT. Male participants are to be screened on 3 conditions: HIV, HCV and FIT.</description>
        <time_frame>At baseline and at 6 months</time_frame>
        <population>There were 282 female participants and 95 male participants enrolled for each arm for a total of 377 total enrolled participants per arm. Female participants are to be screened on 4 conditions: HIV, HCV, Human Papilloma Virus (HPV) and Fecal Immunochemical Testing (FIT). Male participants are to be screened on 3 conditions: HIV, Hepatitis C Virus (HCV) and FIT.</population>
        <group_list>
          <group group_id="O1">
            <title>Home Based Screening</title>
            <description>The participant will be receiving home-based screening tests (OraQuick Swab, OraQuick Fingerstick, Human Papillomavirus (HPV) Self-Sampling Test, Fecal Immunochemical Test) delivered by the community health worker&#xD;
OraQuick Swab: OraQuick for oral fluid HIV antibody testing&#xD;
Fecal Immunochemical Test: Fecal Immunochemical stool test specific for human hemoglobin&#xD;
OraQuick Fingerstick: Patients will be tested for Hepatitis C infection using a fingerstick&#xD;
HPV Self-Sampling Test: Patients will be using swab to check for HPV infection&#xD;
Home Based Screening Tests: Patients will provided screening tests and instructed by Community Health Worker on how to perform home screening tests</description>
          </group>
          <group group_id="O2">
            <title>Clinic Based Screening</title>
            <description>The participant will meet the Community Health Worker and will be navigated to a clinic appointment for standard screening tests&#xD;
Standard Screening Tests: Patients will be navigated to a local health center for standard screening tests</description>
          </group>
        </group_list>
        <measure>
          <title>Median Number of Screenings Completed</title>
          <description>As evaluated by participant self report and completed sampling kits. Female participants are to be screened on 4 conditions: HIV, HCV, HPV and FIT. Male participants are to be screened on 3 conditions: HIV, HCV and FIT.</description>
          <population>There were 282 female participants and 95 male participants enrolled for each arm for a total of 377 total enrolled participants per arm. Female participants are to be screened on 4 conditions: HIV, HCV, Human Papilloma Virus (HPV) and Fecal Immunochemical Testing (FIT). Male participants are to be screened on 3 conditions: HIV, Hepatitis C Virus (HCV) and FIT.</population>
          <units>screenings completed</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="377"/>
                <count group_id="O2" value="377"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Female Participants at Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="282"/>
                    <count group_id="O2" value="282"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" lower_limit="1" upper_limit="2"/>
                    <measurement group_id="O2" value="1" lower_limit="0" upper_limit="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Female Participants at 6 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="282"/>
                    <count group_id="O2" value="282"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4" lower_limit="2" upper_limit="4"/>
                    <measurement group_id="O2" value="2" lower_limit="1" upper_limit="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Male participants at Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="95"/>
                    <count group_id="O2" value="95"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" lower_limit="0" upper_limit="1"/>
                    <measurement group_id="O2" value="1" lower_limit="0" upper_limit="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Male Participants at 6 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="95"/>
                    <count group_id="O2" value="95"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" lower_limit="2" upper_limit="3"/>
                    <measurement group_id="O2" value="2" lower_limit="1" upper_limit="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 6 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Home Based Screening</title>
          <description>The participant will be receiving home-based screening tests (OraQuick Swab, OraQuick Fingerstick, Human Papillomavirus (HPV) Self-Sampling Test, Fecal Immunochemical Test) delivered by the community health worker&#xD;
OraQuick Swab: OraQuick for oral fluid HIV antibody testing&#xD;
Fecal Immunochemical Test: Fecal Immunochemical stool test specific for human hemoglobin&#xD;
OraQuick Fingerstick: Patients will be tested for Hepatitis C infection using a fingerstick&#xD;
HPV Self-Sampling Test: Patients will be using swab to check for HPV infection&#xD;
Home Based Screening Tests: Patients will provided screening tests and instructed by Community Health Worker on how to perform home screening tests</description>
        </group>
        <group group_id="E2">
          <title>Clinic Based Screening</title>
          <description>The participant will meet the Community Health Worker and will be navigated to a clinic appointment for standard screening tests&#xD;
Standard Screening Tests: Patients will be navigated to a local health center for standard screening tests</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="377"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="377"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="377"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="377"/>
              </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="377"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="377"/>
              </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>Olveen Carrasquillo</name_or_title>
      <organization>University of Miami</organization>
      <phone>305-243-5505</phone>
      <email>ocarrasquillo@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/NCT02970136
org study id: 20160023
secondary id: 1U01MD010614-01
nct id: NCT02970136
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The purpose of this research study is to determine the best way to increase screening for
      cervical cancer, colorectal cancer, HIV, and Hepatitis C among under screened Hispanic,
      Haitian and African-American individuals in Hialeah, South Dade, and Little Haiti. The
      investigator will compare home testing led by a community health worker (CHW) versus clinic
      testing guided by a CHW. Community Health Workers are people who have undergone several weeks
      of community outreach and health education training. During the study period the participant
      will continue to receive all of their regular medical care from their regular health care
      providers. If the participant does not have a health care provider, the Community Health
      Workers would be able to help in referring the participant for care at a local health care
      clinic located in their community.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: Single (Outcomes Assessor)
measure: Percentage of Participants Who Are Screened for All Conditions
time frame: Baseline
description: As evaluated by participant self report and completed sampling kits. Female participants are to be screened on 4 conditions: HIV, HCV, Human Papilloma Virus (HPV) and Fecal Immunochemical Testing (FIT). Male participants are to be screened on 3 conditions: HIV, Hepatitis C Virus (HCV) and FIT.
measure: Change in Percentage of Participants Completing Screening Test From Baseline to 6 Months
time frame: Baseline, Up to 6 months
description: As evaluated by participant self report and completed sampling kits. Female participants are to be screened on 4 conditions: HIV, HCV, HPV and FIT. Male participants are to be screened on 3 conditions: HIV, HCV and FIT.
measure: Median Number of Screenings Completed
time frame: At baseline and at 6 months
description: As evaluated by participant self report and completed sampling kits. Female participants are to be screened on 4 conditions: HIV, HCV, HPV and FIT. Male participants are to be screened on 3 conditions: HIV, HCV and FIT.
arm group label: Home Based Screening
arm group type: Experimental
description: The participant will be receiving home-based screening tests (OraQuick Swab, OraQuick Fingerstick, Human Papillomavirus (HPV) Self-Sampling Test, Fecal Immunochemical Test) delivered by the community health worker
arm group label: Clinic Based Screening
arm group type: Active Comparator
description: The participant will meet the Community Health Worker and will be navigated to a clinic appointment for standard screening tests
intervention type: Device
intervention name: OraQuick Swab
description: OraQuick for oral fluid HIV antibody testing
arm group label: Home Based Screening
intervention type: Device
intervention name: Fecal Immunochemical Test
description: Fecal Immunochemical stool test specific for human hemoglobin
arm group label: Home Based Screening
intervention type: Device
intervention name: OraQuick Fingerstick
description: Patients will be tested for Hepatitis C infection using a fingerstick
arm group label: Home Based Screening
intervention type: Other
intervention name: Standard Screening Tests
description: Patients will be navigated to a local health center for standard screening tests
arm group label: Clinic Based Screening
intervention type: Device
intervention name: HPV Self-Sampling Test
description: Patients will be using swab to check for HPV infection
arm group label: Home Based Screening
intervention type: Other
intervention name: Home Based Screening Tests
description: Patients will provided screening tests and instructed by Community Health Worker on how to perform home screening tests
arm group label: Home Based Screening
criteria: 
gender: All
minimum age: 50 Years
maximum age: 64 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Olveen Carrasquillo, MD
role: Principal Investigator
affiliation: University of Miami
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Miami
investigator full name: Olveen Carrasquillo
investigator title: Professor of Medicine and Public Health Sciences
mesh term: Hepatitis C
mesh term: Acquired Immunodeficiency Syndrome
mesh term: HIV Infections
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 