<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/NCT02234063</url>
  </required_header>
  <id_info>
    <org_study_id>GCO 12-1143</org_study_id>
    <nct_id>NCT02234063</nct_id>
  </id_info>
  <brief_title>Genetic Testing to Understand and Address Renal Disease Disparities</brief_title>
  <acronym>GUARDD</acronym>
  <official_title>Genomic Medicine Pilot for Hypertension and Kidney Disease in Primary Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Icahn School of Medicine at Mount Sinai</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Icahn School of Medicine at Mount Sinai</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this genomic medicine implementation pilot project, the investigators aim to conduct a&#xD;
      randomized trial in a network of community health centers and primary care facilities to&#xD;
      study processes, effects and challenges of incorporating information for apolipoprotein L1&#xD;
      (APOL1)-attributable genetic risk for end stage kidney disease in patients of African&#xD;
      ancestry with hypertension .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      CKD is most commonly associated with diabetes (40%) and hypertension (28%), and affects 26&#xD;
      million American adults. African ancestry populations with hypertension (HTN) have 2- to&#xD;
      3-fold higher risk of developing CKD, and a 5-fold increased risk to progress to end stage&#xD;
      renal disease (ESRD) when compared with whites. HTN is a risk factor for progression of CKD&#xD;
      and for increased cardiovascular risk with CKD. Thus targeting blood pressure control as a&#xD;
      modifiable risk factor may both reduce CVD in people with CKD and reduce progression of CKD&#xD;
      to end stage disease. Recent discoveries demonstrate that testable alleles of the APOL1 locus&#xD;
      on chromosome 22 have a major effect on and explain almost all of the excess risk for&#xD;
      hypertension-associated CKD and its progression to ESRD in African ancestry populations.&#xD;
&#xD;
      We will use community-engaged approaches to enroll patients of African Ancestry with HTN from&#xD;
      a network of community health centers and primary care facilities in Harlem and the Bronx and&#xD;
      randomize them on a 7 to 1 ratio to receive APOL1 genetic testing and EMR-enabled provider&#xD;
      clinical decision support incorporating APOL1 genomic risk information.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2014</start_date>
  <completion_date type="Actual">January 12, 2018</completion_date>
  <primary_completion_date type="Actual">January 12, 2018</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>Prevention</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Urine Protein Excretion</measure>
    <time_frame>Baseline and 12 months</time_frame>
    <description>Number of participants with urine protein excretion in urine tests to assess kidney function at 12 months as compared to baseline</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Systolic Blood Pressure</measure>
    <time_frame>Baseline and 3 months</time_frame>
    <description>Change in systolic blood pressure at 3 months as compared to baseline</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Change in Medication Adherence</measure>
    <time_frame>3 months</time_frame>
    <description>Participant surveys (self-report) regarding medication adherence behaviors 3 months after randomization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients With Changes in Psychosocial Behaviors</measure>
    <time_frame>3 months</time_frame>
    <description>Number of patients with changes in psychosocial behaviors 3 months after randomization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Attitude Towards Genetic Testing</measure>
    <time_frame>3 months</time_frame>
    <description>Patient attitude towards genetic testing 3 months after randomization</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2052</enrollment>
  <condition>Hypertension</condition>
  <condition>Chronic Kidney Disease</condition>
  <condition>Genomics</condition>
  <arm_group>
    <arm_group_label>Immediate Genetic Testing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants randomized to intervention will receive the APOL1 genetic test upon study enrollment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control- Delayed Testing</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants randomized to control will not receive the APOL1 genetic test upon study enrollment. They will be offered the option to take the test during their final follow-up study visit (12 months post enrollment).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Immediate Genetic Testing</intervention_name>
    <description>Participants will receive the APOL1 genetic test. Trained research staff will meet with participants to communicate results and lifetime ESRD risk attributable to variations in the APOL1 gene. Primary care providers will receive APOL1 genetic risk information via a best practice alert in the participant's EMR upon commencement of a patient encounter and through results filed in the participant's genetics results section of their EMR.</description>
    <arm_group_label>Immediate Genetic Testing</arm_group_label>
    <other_name>Genetic Risk Communication</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ages18-65&#xD;
&#xD;
          -  Self-identifies as Black/African American&#xD;
&#xD;
          -  History of hypertension&#xD;
&#xD;
          -  Patient at a participating site&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of Chronic Kidney Disease&#xD;
&#xD;
          -  History of Diabetes&#xD;
&#xD;
          -  Pregnant&#xD;
&#xD;
          -  Cognitively impaired/unable to provide consent&#xD;
&#xD;
          -  Terminally ill&#xD;
&#xD;
          -  Planning to leave area of study permanently during the one year study period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Erwin Bottinger, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Icahn School of Medicine at Mount Sinai</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Carol R Horowitz, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Icahn School of Medicine at Mount Sinai</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institute for Family Health</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Icahn School of Medicine at Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://ignite-genomics.org/</url>
    <description>Implementing GeNomics In PracTicE (IGNITE) Network Website</description>
  </link>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>September 4, 2014</study_first_submitted>
  <study_first_submitted_qc>September 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <results_first_submitted>July 31, 2020</results_first_submitted>
  <results_first_submitted_qc>September 10, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">October 5, 2020</results_first_posted>
  <last_update_submitted>September 10, 2020</last_update_submitted>
  <last_update_submitted_qc>September 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Icahn School of Medicine at Mount Sinai</investigator_affiliation>
    <investigator_full_name>Carol R Horowitz</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Hypertension</keyword>
  <keyword>Chronic Kidney Disease</keyword>
  <keyword>End Stage Renal Disease</keyword>
  <keyword>APOL1</keyword>
  <keyword>Genomics</keyword>
  <keyword>Genetics</keyword>
  <keyword>Community-engaged</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <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>March 16, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/63/NCT02234063/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Patients were recruited from 15 academic, community and safety-net practices in New York City. 2052 participants were enrolled. however 2 participants were not randomized.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Immediate Genetic Testing</title>
          <description>Participants randomized to intervention will receive the APOL1 genetic test immediately upon study enrollment.</description>
        </group>
        <group group_id="P2">
          <title>Control- Delayed Testing</title>
          <description>Participants randomized to control will not receive the APOL1 genetic test upon study enrollment. They will be offered the option to take the test during their final follow-up study visit (12 months post enrollment).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1795"/>
                <participants group_id="P2" count="255"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1540"/>
                <participants group_id="P2" count="212"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="255"/>
                <participants group_id="P2" count="43"/>
              </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="235"/>
                <participants group_id="P2" count="42"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Control- Delayed Testing</title>
          <description>Participants randomized to control will not receive the APOL1 genetic test upon study enrollment. They will be offered the option to take the test during their final follow-up study visit (12 months post enrollment).</description>
        </group>
        <group group_id="B2">
          <title>Immediate Genetic Testing</title>
          <description>Participants randomized to intervention will receive the APOL1 genetic test immediately upon study enrollment.</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="255"/>
            <count group_id="B2" value="1795"/>
            <count group_id="B3" value="2050"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="255"/>
                    <count group_id="B2" value="1795"/>
                    <count group_id="B3" value="2050"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53" spread="10"/>
                    <measurement group_id="B2" value="53" spread="10"/>
                    <measurement group_id="B3" value="53" spread="10"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="255"/>
                    <count group_id="B2" value="1795"/>
                    <count group_id="B3" value="2050"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="172"/>
                    <measurement group_id="B2" value="1187"/>
                    <measurement group_id="B3" value="1359"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="83"/>
                    <measurement group_id="B2" value="608"/>
                    <measurement group_id="B3" value="691"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="255"/>
                    <count group_id="B2" value="1795"/>
                    <count group_id="B3" value="2050"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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="255"/>
                    <measurement group_id="B2" value="1795"/>
                    <measurement group_id="B3" value="2050"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</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>More than one race</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>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>Household income &lt;$30,000/year</title>
          <population>Results available for those participants who chose to provide data for this measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="232"/>
                    <count group_id="B2" value="1588"/>
                    <count group_id="B3" value="1820"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="126"/>
                    <measurement group_id="B2" value="888"/>
                    <measurement group_id="B3" value="1014"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Education more than some college</title>
          <population>Results available for those participants who chose to provide data for this measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="255"/>
                    <count group_id="B2" value="1791"/>
                    <count group_id="B3" value="2046"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="162"/>
                    <measurement group_id="B2" value="1008"/>
                    <measurement group_id="B3" value="1170"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Married/Partner</title>
          <population>Results available for those participants who chose to provide data for this measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="253"/>
                    <count group_id="B2" value="1791"/>
                    <count group_id="B3" value="2044"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="72"/>
                    <measurement group_id="B2" value="540"/>
                    <measurement group_id="B3" value="612"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Type of Insurance</title>
          <population>Results available for those participants who chose to provide data for this measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Private</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="255"/>
                    <count group_id="B2" value="1793"/>
                    <count group_id="B3" value="2048"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="118"/>
                    <measurement group_id="B2" value="745"/>
                    <measurement group_id="B3" value="863"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Medicaid</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="255"/>
                    <count group_id="B2" value="1795"/>
                    <count group_id="B3" value="2050"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="109"/>
                    <measurement group_id="B2" value="821"/>
                    <measurement group_id="B3" value="930"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Medicare</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="255"/>
                    <count group_id="B2" value="1795"/>
                    <count group_id="B3" value="2050"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="126"/>
                    <measurement group_id="B3" value="140"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="255"/>
                    <count group_id="B2" value="1795"/>
                    <count group_id="B3" value="2050"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="51"/>
                    <measurement group_id="B3" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>None</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="255"/>
                    <count group_id="B2" value="1795"/>
                    <count group_id="B3" value="2050"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Charlson Comorbidity Index</title>
          <description>Charlson Comorbidity Index (CCI) predicts 10-year survival in patients with multiple comorbidities. A score of zero indicates that no comorbidities were found. The higher the score, the more likely the predicted outcome will result in mortality or higher resource use.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="255"/>
                    <count group_id="B2" value="1795"/>
                    <count group_id="B3" value="2050"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="141"/>
                    <measurement group_id="B2" value="924"/>
                    <measurement group_id="B3" value="1065"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="255"/>
                    <count group_id="B2" value="1795"/>
                    <count group_id="B3" value="2050"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61"/>
                    <measurement group_id="B2" value="481"/>
                    <measurement group_id="B3" value="542"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="255"/>
                    <count group_id="B2" value="1795"/>
                    <count group_id="B3" value="2050"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                    <measurement group_id="B2" value="390"/>
                    <measurement group_id="B3" value="443"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline mean Systolic Blood Pressure</title>
          <population>Results available for those participants who chose to provide data for this measure.</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="254"/>
                    <count group_id="B2" value="1795"/>
                    <count group_id="B3" value="2049"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="133.8" spread="19.4"/>
                    <measurement group_id="B2" value="134.2" spread="19.6"/>
                    <measurement group_id="B3" value="134.1" spread="19.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body mass index</title>
          <population>Results available for those participants who chose to provide data for this measure.</population>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="254"/>
                    <count group_id="B2" value="1795"/>
                    <count group_id="B3" value="2049"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33.9" spread="7.7"/>
                    <measurement group_id="B2" value="32.4" spread="7.7"/>
                    <measurement group_id="B3" value="32.5" spread="7.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Participants with High health literacy</title>
          <description>Number of participants who responded with (5) very much confident filling out medical forms.&#xD;
Health literacy was assessed at baseline using a single item - &quot;How confident are you filling out medical forms by yourself?&quot; Responses were recorded using a five-point Likert scale of: Not at all confident (1), A little bit confident (2), Somewhat confident (3), Quite a bit confident (4), Very much confident (5).</description>
          <population>Results available for those participants who chose to provide data for this measure</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="255"/>
                    <count group_id="B2" value="1793"/>
                    <count group_id="B3" value="2048"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="169"/>
                    <measurement group_id="B2" value="1110"/>
                    <measurement group_id="B3" value="1279"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Excellent/Very good self-reported Health</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="255"/>
                    <count group_id="B2" value="1795"/>
                    <count group_id="B3" value="2050"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="64"/>
                    <measurement group_id="B2" value="465"/>
                    <measurement group_id="B3" value="529"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Urine Protein Excretion</title>
        <description>Number of participants with urine protein excretion in urine tests to assess kidney function at 12 months as compared to baseline</description>
        <time_frame>Baseline and 12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control- Delayed Testing</title>
            <description>Participants randomized to control did not receive the APOL1 genetic test upon study enrollment. They were offered the option to take the test during their final follow-up study visit (12 months post enrollment).</description>
          </group>
          <group group_id="O2">
            <title>Immediate Genetic Testing for APOL1 Negative</title>
            <description>Participants with low-risk APOL1 alleles (APOL1 negatives) randomized to intervention who received the APOL1 genetic test immediately upon study enrollment.</description>
          </group>
          <group group_id="O3">
            <title>Immediate Genetic Testing for APOL1 Positive</title>
            <description>Participants with high-risk APOL1 alleles (APOL1 positives) randomized to intervention who received the APOL1 genetic test immediately upon study enrollment.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Urine Protein Excretion</title>
          <description>Number of participants with urine protein excretion in urine tests to assess kidney function at 12 months as compared to baseline</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="255"/>
                <count group_id="O2" value="1561"/>
                <count group_id="O3" value="234"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Kidney function urine test before randomization</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33"/>
                    <measurement group_id="O2" value="278"/>
                    <measurement group_id="O3" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Kidney function urine test after randomization</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50"/>
                    <measurement group_id="O2" value="377"/>
                    <measurement group_id="O3" value="68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Systolic Blood Pressure</title>
        <description>Change in systolic blood pressure at 3 months as compared to baseline</description>
        <time_frame>Baseline and 3 months</time_frame>
        <population>Results available for those participants who returned for 3 month visit and had both timepoint data.</population>
        <group_list>
          <group group_id="O1">
            <title>Control- Delayed Testing</title>
            <description>Participants randomized to control did not receive the APOL1 genetic test upon study enrollment. They were offered the option to take the test during their final follow-up study visit (12 months post enrollment).</description>
          </group>
          <group group_id="O2">
            <title>Immediate Genetic Testing for APOL1 Negative</title>
            <description>Participants with low-risk APOL1 alleles (APOL1 negatives) randomized to intervention who received the APOL1 genetic test immediately upon study enrollment.</description>
          </group>
          <group group_id="O3">
            <title>Immediate Genetic Testing for APOL1 Positive</title>
            <description>Participants with high-risk APOL1 alleles (APOL1 positives) randomized to intervention who received the APOL1 genetic test immediately upon study enrollment.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Systolic Blood Pressure</title>
          <description>Change in systolic blood pressure at 3 months as compared to baseline</description>
          <population>Results available for those participants who returned for 3 month visit and had both timepoint data.</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="232"/>
                <count group_id="O2" value="1468"/>
                <count group_id="O3" value="218"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3" spread="18"/>
                    <measurement group_id="O2" value="-3" spread="16"/>
                    <measurement group_id="O3" value="-6" spread="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Change in Medication Adherence</title>
        <description>Participant surveys (self-report) regarding medication adherence behaviors 3 months after randomization</description>
        <time_frame>3 months</time_frame>
        <population>Survey only for participants who received genetic testing.</population>
        <group_list>
          <group group_id="O1">
            <title>Immediate Genetic Testing for APOL1 Negative</title>
            <description>Participants with low-risk APOL1 alleles (APOL1 negatives) randomized to intervention who received the APOL1 genetic test immediately upon study enrollment.</description>
          </group>
          <group group_id="O2">
            <title>Immediate Genetic Testing for APOL1 Positive</title>
            <description>Participants with high-risk APOL1 alleles (APOL1 positives) randomized to intervention who received the APOL1 genetic test immediately upon study enrollment.</description>
          </group>
          <group group_id="O3">
            <title>Control- Delayed Testing</title>
            <description>Participants randomized to control did not receive the APOL1 genetic test upon study enrollment. They were offered the option to take the test during their final follow-up study visit (12 months post enrollment).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Change in Medication Adherence</title>
          <description>Participant surveys (self-report) regarding medication adherence behaviors 3 months after randomization</description>
          <population>Survey only for participants who received genetic testing.</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="1468"/>
                <count group_id="O2" value="218"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Changed how you take BP meds</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="146"/>
                    <measurement group_id="O2" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Take BP meds more often</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68"/>
                    <measurement group_id="O2" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients With Changes in Psychosocial Behaviors</title>
        <description>Number of patients with changes in psychosocial behaviors 3 months after randomization</description>
        <time_frame>3 months</time_frame>
        <population>Survey only for participants who received genetic testing.</population>
        <group_list>
          <group group_id="O1">
            <title>Immediate Genetic Testing for APOL1 Negative</title>
            <description>Participants with low-risk APOL1 alleles (APOL1 negatives) randomized to intervention who received the APOL1 genetic test immediately upon study enrollment.</description>
          </group>
          <group group_id="O2">
            <title>Immediate Genetic Testing for APOL1 Positive</title>
            <description>Participants with high-risk APOL1 alleles (APOL1 positives) randomized to intervention who received the APOL1 genetic test immediately upon study enrollment.</description>
          </group>
          <group group_id="O3">
            <title>Control- Delayed Testing</title>
            <description>Participants randomized to control did not receive the APOL1 genetic test upon study enrollment. They were offered the option to take the test during their final follow-up study visit (12 months post enrollment).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients With Changes in Psychosocial Behaviors</title>
          <description>Number of patients with changes in psychosocial behaviors 3 months after randomization</description>
          <population>Survey only for participants who received genetic testing.</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="1468"/>
                <count group_id="O2" value="218"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="547"/>
                    <measurement group_id="O2" value="129"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Attitude Towards Genetic Testing</title>
        <description>Patient attitude towards genetic testing 3 months after randomization</description>
        <time_frame>3 months</time_frame>
        <population>Survey only for participants who received genetic testing.</population>
        <group_list>
          <group group_id="O1">
            <title>Immediate Genetic Testing for APOL1 Negative</title>
            <description>Participants with low-risk APOL1 alleles (APOL1 negatives) randomized to intervention who received the APOL1 genetic test immediately upon study enrollment.</description>
          </group>
          <group group_id="O2">
            <title>Immediate Genetic Testing for APOL1 Positive</title>
            <description>Participants with high-risk APOL1 alleles (APOL1 positives) randomized to intervention who received the APOL1 genetic test immediately upon study enrollment.</description>
          </group>
          <group group_id="O3">
            <title>Control- Delayed Testing</title>
            <description>Participants randomized to control did not receive the APOL1 genetic test upon study enrollment. They were offered the option to take the test during their final follow-up study visit (12 months post enrollment).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Attitude Towards Genetic Testing</title>
          <description>Patient attitude towards genetic testing 3 months after randomization</description>
          <population>Survey only for participants who received genetic testing.</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="1468"/>
                <count group_id="O2" value="218"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Had enough information on getting the test</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1425"/>
                    <measurement group_id="O2" value="208"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Information for test was easy to understand</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1391"/>
                    <measurement group_id="O2" value="203"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Would get tested again</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1420"/>
                    <measurement group_id="O2" value="211"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>3 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Control- Delayed Testing</title>
          <description>Participants randomized to control did not receive the APOL1 genetic test upon study enrollment. They were offered the option to take the test during their final follow-up study visit (12 months post enrollment).</description>
        </group>
        <group group_id="E2">
          <title>Immediate Genetic Testing for APOL1 Negative</title>
          <description>Participants with low-risk APOL1 alleles (APOL1 negatives) randomized to intervention who received the APOL1 genetic test immediately upon study enrollment.</description>
        </group>
        <group group_id="E3">
          <title>Immediate Genetic Testing for APOL1 Positive</title>
          <description>Participants with high-risk APOL1 alleles (APOL1 positives) randomized to intervention who received the APOL1 genetic test immediately upon study enrollment.</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="255"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1561"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="234"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="255"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1561"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="234"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</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="255"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1561"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="234"/>
              </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 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>Primary analysis was conducted on the Genotype level and not on the randomization level.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Carol R. Horowitz</name_or_title>
      <organization>Icahn School of Medicine at Mount Sinai</organization>
      <phone>212-659-9564</phone>
      <email>carol.horowitz@mssm.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/NCT02234063
org study id: GCO 12-1143
nct id: NCT02234063
lead sponsor: 
has dmc: No
In this genomic medicine implementation pilot project, the investigators aim to conduct a
      randomized trial in a network of community health centers and primary care facilities to
      study processes, effects and challenges of incorporating information for apolipoprotein L1
      (APOL1)-attributable genetic risk for end stage kidney disease in patients of African
      ancestry with hypertension .
CKD is most commonly associated with diabetes (40%) and hypertension (28%), and affects 26
      million American adults. African ancestry populations with hypertension (HTN) have 2- to
      3-fold higher risk of developing CKD, and a 5-fold increased risk to progress to end stage
      renal disease (ESRD) when compared with whites. HTN is a risk factor for progression of CKD
      and for increased cardiovascular risk with CKD. Thus targeting blood pressure control as a
      modifiable risk factor may both reduce CVD in people with CKD and reduce progression of CKD
      to end stage disease. Recent discoveries demonstrate that testable alleles of the APOL1 locus
      on chromosome 22 have a major effect on and explain almost all of the excess risk for
      hypertension-associated CKD and its progression to ESRD in African ancestry populations.

      We will use community-engaged approaches to enroll patients of African Ancestry with HTN from
      a network of community health centers and primary care facilities in Harlem and the Bronx and
      randomize them on a 7 to 1 ratio to receive APOL1 genetic testing and EMR-enabled provider
      clinical decision support incorporating APOL1 genomic risk information.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Investigator, Outcomes Assessor)
measure: Number of Participants With Urine Protein Excretion
time frame: Baseline and 12 months
description: Number of participants with urine protein excretion in urine tests to assess kidney function at 12 months as compared to baseline
measure: Change in Systolic Blood Pressure
time frame: Baseline and 3 months
description: Change in systolic blood pressure at 3 months as compared to baseline
measure: Number of Participants With Change in Medication Adherence
time frame: 3 months
description: Participant surveys (self-report) regarding medication adherence behaviors 3 months after randomization
measure: Number of Patients With Changes in Psychosocial Behaviors
time frame: 3 months
description: Number of patients with changes in psychosocial behaviors 3 months after randomization
measure: Number of Participants With Attitude Towards Genetic Testing
time frame: 3 months
description: Patient attitude towards genetic testing 3 months after randomization
arm group label: Immediate Genetic Testing
arm group type: Experimental
description: Participants randomized to intervention will receive the APOL1 genetic test upon study enrollment.
arm group label: Control- Delayed Testing
arm group type: No Intervention
description: Participants randomized to control will not receive the APOL1 genetic test upon study enrollment. They will be offered the option to take the test during their final follow-up study visit (12 months post enrollment).
intervention type: Other
intervention name: Immediate Genetic Testing
description: Participants will receive the APOL1 genetic test. Trained research staff will meet with participants to communicate results and lifetime ESRD risk attributable to variations in the APOL1 gene. Primary care providers will receive APOL1 genetic risk information via a best practice alert in the participant's EMR upon commencement of a patient encounter and through results filed in the participant's genetics results section of their EMR.
arm group label: Immediate Genetic Testing
other name: Genetic Risk Communication
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Erwin Bottinger, MD, MPH
role: Principal Investigator
affiliation: Icahn School of Medicine at Mount Sinai
last name: Carol R Horowitz, MD, MPH
role: Principal Investigator
affiliation: Icahn School of Medicine at Mount Sinai
facility: 
facility: 
country: United States
url: https://ignite-genomics.org/
description: Implementing GeNomics In PracTicE (IGNITE) Network Website
responsible party type: Principal Investigator
investigator affiliation: Icahn School of Medicine at Mount Sinai
investigator full name: Carol R Horowitz
investigator title: Professor
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
mesh term: Hypertension
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Primary analysis was conducted on the Genotype level and not on the randomization level.
point of contact: 