<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/NCT03243071</url>
  </required_header>
  <id_info>
    <org_study_id>17-00170</org_study_id>
    <nct_id>NCT03243071</nct_id>
  </id_info>
  <brief_title>Advancing People of Color in Clinical Trials Now: Involvement in Trials Using a Patient-Centered Website: A Community-Engaged Approach</brief_title>
  <acronym>ACT Now</acronym>
  <official_title>Advancing People of Color in Clinical Trials Now: Involvement in Trials Using a Patient-Centered Website: A Community-Engaged Approach</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NYU Langone Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose pf this study is to evaluate the comparative effectiveness of a culturally and&#xD;
      linguistically tailored clinical trial literacy website in increasing likelihood of&#xD;
      participating in clinical trials. To achieve this objective,a randomized group design will&#xD;
      address the following patient-centered outcomes: willingness to enroll in clinical trials and&#xD;
      behavioral intent as well as likelihood of referring others to enroll in such trials) before&#xD;
      and after exposure to a culturally-tailored clinical trial literacy website. Health literacy&#xD;
      will be measured both before and post exposure to tailored messages. Participants will be&#xD;
      randomized into two groups. The intervention group (n=50) will have access to culturally&#xD;
      tailored website. Participants in the control group (n=50) will have access to NYU 's&#xD;
      standard trial participation website.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Compelling evidence demonstrates racial/ethnic disparities in health and healthcare in the&#xD;
      United States. These disparities arise from various factors including unequal access to&#xD;
      adequate medical care, perceived racial discrimination, and poor health literacy.The Center&#xD;
      for Healthful Behavior Change (CHBC) has been involved in numerous initiatives to eradicate&#xD;
      health disparities and have implemented NIH-funded interventions to address inequities in&#xD;
      health. Interventions targeting patient-centered outcomes have been suboptimal because of&#xD;
      inadequate infrastructure to support equitable contributions from stakeholders (patients,&#xD;
      providers, and community leaders) in all aspects of the research process. This is crucial to&#xD;
      promote sustainable effects regarding minority patients' ability to make informed decisions&#xD;
      about participating in existing clinical trials. This study will address this gap, bringing&#xD;
      together academic investigators and important stakeholders to develop a website providing&#xD;
      access to culturally tailored videos to enhance awareness of clinical trial, health literacy,&#xD;
      thus promoting participation in existing clinical trials.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 14, 2017</start_date>
  <completion_date type="Actual">April 28, 2019</completion_date>
  <primary_completion_date type="Actual">January 28, 2019</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>ACTNOW! Clinical Trial Knowledge Assessment Score</measure>
    <time_frame>Baseline</time_frame>
    <description>26 statements involved in assessing the participants' knowledge of clinical trials. The total range of score is 0-104; the higher the score, the higher the level of knowledge.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical Trial Knowledge Assessment Score</measure>
    <time_frame>Month 1</time_frame>
    <description>26 statements involved in assessing the participants' knowledge of clinical trials. The total range of score is 0-104; the higher the score, the higher the level of knowledge.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical Trial Knowledge Assessment Score</measure>
    <time_frame>Month 3</time_frame>
    <description>26 statements involved in assessing the participants' knowledge of clinical trials. The total range of score is 0-104; the higher the score, the higher the level of knowledge.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ACTNOW! Self-Efficacy Score</measure>
    <time_frame>Baseline</time_frame>
    <description>A 4-item perceived effectiveness scale was used to assess the perceived persuasiveness of the message. The total range of score is 0-16; the higher the score, the higher the level of self-efficacy.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Self-Efficacy Score</measure>
    <time_frame>Month 1</time_frame>
    <description>A 4-item perceived effectiveness scale, adapted from Fishbein et al. (2002) was used to assess the perceived persuasiveness of the message. The total range of score is 0-16; the higher the score, the higher the level of self-efficacy.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Self-Efficacy Score</measure>
    <time_frame>Month 3</time_frame>
    <description>A 4-item perceived effectiveness scale, adapted from Fishbein et al. (2002) was used to assess the perceived persuasiveness of the message. The total range of score is 0-16; the higher the score, the higher the level of self-efficacy.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">112</enrollment>
  <condition>Recruitment</condition>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention group will have access to culturally tailored website.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in the control group will have access to NYU 's standard trial participation website.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Tailored Website</intervention_name>
    <description>Participants randomized to the intervention arm will have free access to a password protected interactive culturally and linguistically tailored website via a tablet device. No private identifiable data about you will be collected. Participants will receive a brief 10-minute tutorial by a trained research assistant on login procedures and use of the website.</description>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard Website</intervention_name>
    <description>Participants randomized to the control condition will have free access to the NYU standard clinical trials website. Participants in the control condition will have access to the tailored website at the date of study completion (no later than 6 months' post-date of enrollment).</description>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Self-reported race/ethnicity as African American, African, Caribbean American or black&#xD;
             men and women&#xD;
&#xD;
          -  accessible by telephone&#xD;
&#xD;
          -  no plans to move away from the region within the year following enrollment; consent to&#xD;
             participate.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Progressive medical illness in which disability or death is expected within one year&#xD;
&#xD;
          -  impaired cognitive or functional ability, which would preclude meaningful&#xD;
             participation in the study&#xD;
&#xD;
          -  stated intention to move within the same year of enrollment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Girardin Jean-Louis, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>NYU Langone Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>New York University School of Medicine</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>August 2, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <results_first_submitted>September 27, 2021</results_first_submitted>
  <results_first_submitted_qc>January 28, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">February 1, 2022</results_first_posted>
  <last_update_submitted>January 28, 2022</last_update_submitted>
  <last_update_submitted_qc>January 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Medical Care</keyword>
  <keyword>Racial Discrimination</keyword>
  <keyword>Poor Health Literacy</keyword>
  <keyword>Medical Care Disparities</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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>November 5, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/71/NCT03243071/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Intervention Group</title>
          <description>The intervention group will have access to culturally tailored website.&#xD;
Tailored Website: Participants randomized to the intervention arm will have free access to a password protected interactive culturally and linguistically tailored website via a tablet device. No private identifiable data about you will be collected. Participants will receive a brief 10-minute tutorial by a trained research assistant on login procedures and use of the website.</description>
        </group>
        <group group_id="P2">
          <title>Control Group</title>
          <description>Participants in the control group will have access to NYU 's standard trial participation website.&#xD;
Standard Website: Participants randomized to the control condition will have free access to the NYU standard clinical trials website. Participants in the control condition will have access to the tailored website at the date of study completion (no later than 6 months' post-date of 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="59"/>
                <participants group_id="P2" count="53"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="59"/>
                <participants group_id="P2" count="53"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Intervention Group</title>
          <description>The intervention group (n=50) will have access to culturally tailored website.&#xD;
Tailored Website: Participants randomized to the intervention arm will have free access to a password protected interactive culturally and linguistically tailored website via a tablet device. No private identifiable data about you will be collected. Participants will receive a brief 10-minute tutorial by a trained research assistant on login procedures and use of the website.</description>
        </group>
        <group group_id="B2">
          <title>Control Group</title>
          <description>Participants in the control group (n=50) will have access to NYU 's standard trial participation website.&#xD;
Standard Website: Participants randomized to the control condition will have free access to the NYU standard clinical trials website. Participants in the control condition will have access to the tailored website at the date of study completion (no later than 6 months' post-date of 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="59"/>
            <count group_id="B2" value="53"/>
            <count group_id="B3" value="112"/>
          </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="43" spread="15.98"/>
                    <measurement group_id="B2" value="43" spread="15.03"/>
                    <measurement group_id="B3" value="43" spread="15.74"/>
                  </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="46"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="73"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="39"/>
                  </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="2"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="9"/>
                  </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="47"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="83"/>
                  </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="10"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="59"/>
                    <measurement group_id="B2" value="53"/>
                    <measurement group_id="B3" value="112"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>ACTNOW! Clinical Trial Knowledge Assessment Score</title>
        <description>26 statements involved in assessing the participants' knowledge of clinical trials. The total range of score is 0-104; the higher the score, the higher the level of knowledge.</description>
        <time_frame>Baseline</time_frame>
        <population>The discrepancy in overall number of participants analyzed with numbers provided in the participant flow module lies with over enrollment of study subjects to account for attrition loss and analysis only being done for those participants who had complete data.&#xD;
The two arms (intervention and control groups) are further divided into pairs for statistical analysis purposes (paired t-tests).</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group (Pair 1)</title>
            <description>The intervention group will have access to culturally tailored website.&#xD;
Tailored Website: Participants randomized to the intervention arm will have free access to a password protected interactive culturally and linguistically tailored website via a tablet device. No private identifiable data about you will be collected. Participants will receive a brief 10-minute tutorial by a trained research assistant on login procedures and use of the website.</description>
          </group>
          <group group_id="O2">
            <title>Intervention Group (Pair 2)</title>
            <description>The intervention group will have access to culturally tailored website.&#xD;
Tailored Website: Participants randomized to the intervention arm will have free access to a password protected interactive culturally and linguistically tailored website via a tablet device. No private identifiable data about you will be collected. Participants will receive a brief 10-minute tutorial by a trained research assistant on login procedures and use of the website.</description>
          </group>
          <group group_id="O3">
            <title>Control Group (Pair 3)</title>
            <description>Participants in the control group will have access to NYU 's standard trial participation website.&#xD;
Standard Website: Participants randomized to the control condition will have free access to the NYU standard clinical trials website. Participants in the control condition will have access to the tailored website at the date of study completion (no later than 6 months' post-date of enrollment).</description>
          </group>
          <group group_id="O4">
            <title>Control Group (Pair 4)</title>
            <description>Participants in the control group will have access to NYU 's standard trial participation website.&#xD;
Standard Website: Participants randomized to the control condition will have free access to the NYU standard clinical trials website. Participants in the control condition will have access to the tailored website at the date of study completion (no later than 6 months' post-date of enrollment).</description>
          </group>
        </group_list>
        <measure>
          <title>ACTNOW! Clinical Trial Knowledge Assessment Score</title>
          <description>26 statements involved in assessing the participants' knowledge of clinical trials. The total range of score is 0-104; the higher the score, the higher the level of knowledge.</description>
          <population>The discrepancy in overall number of participants analyzed with numbers provided in the participant flow module lies with over enrollment of study subjects to account for attrition loss and analysis only being done for those participants who had complete data.&#xD;
The two arms (intervention and control groups) are further divided into pairs for statistical analysis purposes (paired t-tests).</population>
          <units>score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="49"/>
                <count group_id="O4" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93.89" spread="9.98"/>
                    <measurement group_id="O2" value="93.58" spread="9.69"/>
                    <measurement group_id="O3" value="94.88" spread="11.80"/>
                    <measurement group_id="O4" value="97.88" spread="11.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Clinical Trial Knowledge Assessment Score</title>
        <description>26 statements involved in assessing the participants' knowledge of clinical trials. The total range of score is 0-104; the higher the score, the higher the level of knowledge.</description>
        <time_frame>Month 1</time_frame>
        <population>The discrepancy in overall number of participants analyzed with numbers provided in the participant flow module lies with over enrollment of study subjects to account for attrition loss and analysis only being done for those participants who had complete data.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group (Pair 1)</title>
            <description>The intervention group will have access to culturally tailored website.&#xD;
Tailored Website: Participants randomized to the intervention arm will have free access to a password protected interactive culturally and linguistically tailored website via a tablet device. No private identifiable data about you will be collected. Participants will receive a brief 10-minute tutorial by a trained research assistant on login procedures and use of the website.</description>
          </group>
          <group group_id="O2">
            <title>Control Group (Pair 3)</title>
            <description>Participants in the control group will have access to NYU 's standard trial participation website.&#xD;
Standard Website: Participants randomized to the control condition will have free access to the NYU standard clinical trials website. Participants in the control condition will have access to the tailored website at the date of study completion (no later than 6 months' post-date of enrollment).</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Trial Knowledge Assessment Score</title>
          <description>26 statements involved in assessing the participants' knowledge of clinical trials. The total range of score is 0-104; the higher the score, the higher the level of knowledge.</description>
          <population>The discrepancy in overall number of participants analyzed with numbers provided in the participant flow module lies with over enrollment of study subjects to account for attrition loss and analysis only being done for those participants who had complete data.</population>
          <units>score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="101.89" spread="10.37"/>
                    <measurement group_id="O2" value="99.67" spread="10.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Clinical Trial Knowledge Assessment Score</title>
        <description>26 statements involved in assessing the participants' knowledge of clinical trials. The total range of score is 0-104; the higher the score, the higher the level of knowledge.</description>
        <time_frame>Month 3</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group (Pair 2)</title>
            <description>The intervention group will have access to culturally tailored website.&#xD;
Tailored Website: Participants randomized to the intervention arm will have free access to a password protected interactive culturally and linguistically tailored website via a tablet device. No private identifiable data about you will be collected. Participants will receive a brief 10-minute tutorial by a trained research assistant on login procedures and use of the website.</description>
          </group>
          <group group_id="O2">
            <title>Control Group (Pair 4)</title>
            <description>Participants in the control group will have access to NYU 's standard trial participation website.&#xD;
Standard Website: Participants randomized to the control condition will have free access to the NYU standard clinical trials website. Participants in the control condition will have access to the tailored website at the date of study completion (no later than 6 months' post-date of enrollment).</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Trial Knowledge Assessment Score</title>
          <description>26 statements involved in assessing the participants' knowledge of clinical trials. The total range of score is 0-104; the higher the score, the higher the level of knowledge.</description>
          <units>score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.00" spread="11.99"/>
                    <measurement group_id="O2" value="98.32" spread="8.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>ACTNOW! Self-Efficacy Score</title>
        <description>A 4-item perceived effectiveness scale was used to assess the perceived persuasiveness of the message. The total range of score is 0-16; the higher the score, the higher the level of self-efficacy.</description>
        <time_frame>Baseline</time_frame>
        <population>The two arms (intervention and control groups) are further divided into pairs for statistical analysis purposes (paired t-tests).</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group (Pair 1)</title>
            <description>The intervention group will have access to culturally tailored website.&#xD;
Tailored Website: Participants randomized to the intervention arm will have free access to a password protected interactive culturally and linguistically tailored website via a tablet device. No private identifiable data about you will be collected. Participants will receive a brief 10-minute tutorial by a trained research assistant on login procedures and use of the website.</description>
          </group>
          <group group_id="O2">
            <title>Intervention Group (Pair 2)</title>
            <description>The intervention group will have access to culturally tailored website.&#xD;
Tailored Website: Participants randomized to the intervention arm will have free access to a password protected interactive culturally and linguistically tailored website via a tablet device. No private identifiable data about you will be collected. Participants will receive a brief 10-minute tutorial by a trained research assistant on login procedures and use of the website.</description>
          </group>
          <group group_id="O3">
            <title>Control Group (Pair 3)</title>
            <description>Participants in the control group (n=50) will have access to NYU 's standard trial participation website.&#xD;
Standard Website: Participants randomized to the control condition will have free access to the NYU standard clinical trials website. Participants in the control condition will have access to the tailored website at the date of study completion (no later than 6 months' post-date of enrollment).</description>
          </group>
          <group group_id="O4">
            <title>Control Group (Pair 4)</title>
            <description>Participants in the control group will have access to NYU 's standard trial participation website.&#xD;
Standard Website: Participants randomized to the control condition will have free access to the NYU standard clinical trials website. Participants in the control condition will have access to the tailored website at the date of study completion (no later than 6 months' post-date of enrollment).</description>
          </group>
        </group_list>
        <measure>
          <title>ACTNOW! Self-Efficacy Score</title>
          <description>A 4-item perceived effectiveness scale was used to assess the perceived persuasiveness of the message. The total range of score is 0-16; the higher the score, the higher the level of self-efficacy.</description>
          <population>The two arms (intervention and control groups) are further divided into pairs for statistical analysis purposes (paired t-tests).</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="49"/>
                <count group_id="O4" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.13" spread="4.19"/>
                    <measurement group_id="O2" value="10.06" spread="4.49"/>
                    <measurement group_id="O3" value="11.16" spread="3.08"/>
                    <measurement group_id="O4" value="11.04" spread="3.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Self-Efficacy Score</title>
        <description>A 4-item perceived effectiveness scale, adapted from Fishbein et al. (2002) was used to assess the perceived persuasiveness of the message. The total range of score is 0-16; the higher the score, the higher the level of self-efficacy.</description>
        <time_frame>Month 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group (Pair 1)</title>
            <description>The intervention group will have access to culturally tailored website.&#xD;
Tailored Website: Participants randomized to the intervention arm will have free access to a password protected interactive culturally and linguistically tailored website via a tablet device. No private identifiable data about you will be collected. Participants will receive a brief 10-minute tutorial by a trained research assistant on login procedures and use of the website.</description>
          </group>
          <group group_id="O2">
            <title>Control Group (Pair 3)</title>
            <description>Participants in the control group will have access to NYU 's standard trial participation website.&#xD;
Standard Website: Participants randomized to the control condition will have free access to the NYU standard clinical trials website. Participants in the control condition will have access to the tailored website at the date of study completion (no later than 6 months' post-date of enrollment).</description>
          </group>
        </group_list>
        <measure>
          <title>Self-Efficacy Score</title>
          <description>A 4-item perceived effectiveness scale, adapted from Fishbein et al. (2002) was used to assess the perceived persuasiveness of the message. The total range of score is 0-16; the higher the score, the higher the level of self-efficacy.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.06" spread="3.35"/>
                    <measurement group_id="O2" value="12.02" spread="3.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Self-Efficacy Score</title>
        <description>A 4-item perceived effectiveness scale, adapted from Fishbein et al. (2002) was used to assess the perceived persuasiveness of the message. The total range of score is 0-16; the higher the score, the higher the level of self-efficacy.</description>
        <time_frame>Month 3</time_frame>
        <population>The discrepancy in overall number of participants analyzed with numbers provided in the participant flow module lies with over enrollment of study subjects to account for attrition loss and analysis only being done for those participants who had complete data.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group (Pair 2)</title>
            <description>The intervention group will have access to culturally tailored website.&#xD;
Tailored Website: Participants randomized to the intervention arm will have free access to a password protected interactive culturally and linguistically tailored website via a tablet device. No private identifiable data about you will be collected. Participants will receive a brief 10-minute tutorial by a trained research assistant on login procedures and use of the website.</description>
          </group>
          <group group_id="O2">
            <title>Control Group (Pair 4)</title>
            <description>Participants in the control group will have access to NYU 's standard trial participation website.&#xD;
Standard Website: Participants randomized to the control condition will have free access to the NYU standard clinical trials website. Participants in the control condition will have access to the tailored website at the date of study completion (no later than 6 months' post-date of enrollment).</description>
          </group>
        </group_list>
        <measure>
          <title>Self-Efficacy Score</title>
          <description>A 4-item perceived effectiveness scale, adapted from Fishbein et al. (2002) was used to assess the perceived persuasiveness of the message. The total range of score is 0-16; the higher the score, the higher the level of self-efficacy.</description>
          <population>The discrepancy in overall number of participants analyzed with numbers provided in the participant flow module lies with over enrollment of study subjects to account for attrition loss and analysis only being done for those participants who had complete data.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.42" spread="3.40"/>
                    <measurement group_id="O2" value="11.88" spread="3.10"/>
                  </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>Intervention Group</title>
          <description>The intervention group will have access to culturally tailored website.&#xD;
Tailored Website: Participants randomized to the intervention arm will have free access to a password protected interactive culturally and linguistically tailored website via a tablet device. No private identifiable data about you will be collected. Participants will receive a brief 10-minute tutorial by a trained research assistant on login procedures and use of the website.</description>
        </group>
        <group group_id="E2">
          <title>Control Group</title>
          <description>Participants in the control group will have access to NYU 's standard trial participation website.&#xD;
Standard Website: Participants randomized to the control condition will have free access to the NYU standard clinical trials website. Participants in the control condition will have access to the tailored website at the date of study completion (no later than 6 months' post-date of 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="59"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="53"/>
              </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="59"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="53"/>
              </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>Girardin Jean-Louis, PhD</name_or_title>
      <organization>NYU Langoen Health</organization>
      <phone>646-501-3431</phone>
      <email>Girardin.Jean-Louis@nyulangone.org</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/NCT03243071
org study id: 17-00170
nct id: NCT03243071
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose pf this study is to evaluate the comparative effectiveness of a culturally and
      linguistically tailored clinical trial literacy website in increasing likelihood of
      participating in clinical trials. To achieve this objective,a randomized group design will
      address the following patient-centered outcomes: willingness to enroll in clinical trials and
      behavioral intent as well as likelihood of referring others to enroll in such trials) before
      and after exposure to a culturally-tailored clinical trial literacy website. Health literacy
      will be measured both before and post exposure to tailored messages. Participants will be
      randomized into two groups. The intervention group (n=50) will have access to culturally
      tailored website. Participants in the control group (n=50) will have access to NYU 's
      standard trial participation website.
Compelling evidence demonstrates racial/ethnic disparities in health and healthcare in the
      United States. These disparities arise from various factors including unequal access to
      adequate medical care, perceived racial discrimination, and poor health literacy.The Center
      for Healthful Behavior Change (CHBC) has been involved in numerous initiatives to eradicate
      health disparities and have implemented NIH-funded interventions to address inequities in
      health. Interventions targeting patient-centered outcomes have been suboptimal because of
      inadequate infrastructure to support equitable contributions from stakeholders (patients,
      providers, and community leaders) in all aspects of the research process. This is crucial to
      promote sustainable effects regarding minority patients' ability to make informed decisions
      about participating in existing clinical trials. This study will address this gap, bringing
      together academic investigators and important stakeholders to develop a website providing
      access to culturally tailored videos to enhance awareness of clinical trial, health literacy,
      thus promoting participation in existing clinical trials.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: ACTNOW! Clinical Trial Knowledge Assessment Score
time frame: Baseline
description: 26 statements involved in assessing the participants' knowledge of clinical trials. The total range of score is 0-104; the higher the score, the higher the level of knowledge.
measure: Clinical Trial Knowledge Assessment Score
time frame: Month 1
description: 26 statements involved in assessing the participants' knowledge of clinical trials. The total range of score is 0-104; the higher the score, the higher the level of knowledge.
measure: Clinical Trial Knowledge Assessment Score
time frame: Month 3
description: 26 statements involved in assessing the participants' knowledge of clinical trials. The total range of score is 0-104; the higher the score, the higher the level of knowledge.
measure: ACTNOW! Self-Efficacy Score
time frame: Baseline
description: A 4-item perceived effectiveness scale was used to assess the perceived persuasiveness of the message. The total range of score is 0-16; the higher the score, the higher the level of self-efficacy.
measure: Self-Efficacy Score
time frame: Month 1
description: A 4-item perceived effectiveness scale, adapted from Fishbein et al. (2002) was used to assess the perceived persuasiveness of the message. The total range of score is 0-16; the higher the score, the higher the level of self-efficacy.
measure: Self-Efficacy Score
time frame: Month 3
description: A 4-item perceived effectiveness scale, adapted from Fishbein et al. (2002) was used to assess the perceived persuasiveness of the message. The total range of score is 0-16; the higher the score, the higher the level of self-efficacy.
arm group label: Intervention Group
arm group type: Experimental
description: The intervention group will have access to culturally tailored website.
arm group label: Control Group
arm group type: Active Comparator
description: Participants in the control group will have access to NYU 's standard trial participation website.
intervention type: Behavioral
intervention name: Tailored Website
description: Participants randomized to the intervention arm will have free access to a password protected interactive culturally and linguistically tailored website via a tablet device. No private identifiable data about you will be collected. Participants will receive a brief 10-minute tutorial by a trained research assistant on login procedures and use of the website.
arm group label: Intervention Group
intervention type: Behavioral
intervention name: Standard Website
description: Participants randomized to the control condition will have free access to the NYU standard clinical trials website. Participants in the control condition will have access to the tailored website at the date of study completion (no later than 6 months' post-date of enrollment).
arm group label: Control Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Girardin Jean-Louis, Ph.D.
role: Principal Investigator
affiliation: NYU Langone Health
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: Undecided
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 