<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/NCT04404907</url>
  </required_header>
  <id_info>
    <org_study_id>STU00206314</org_study_id>
    <nct_id>NCT04404907</nct_id>
  </id_info>
  <brief_title>Deliberate Ultraviolet Light Exposure to Get a Tan by Young Adult Sexual Minority Males</brief_title>
  <official_title>Analysis of Tanning Attitudes and Behaviors by Young Adult Sexual Minority Males in the Greater Chicago Area</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Northwestern University</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 of this study is to: a) identify enablers and barriers to deliberate ultraviolet&#xD;
      light exposure by young sexual minority men (SMM), and b) quantify the extent of their&#xD;
      deliberate ultraviolet light exposure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aim 1: To develop survey items to assess tanning attitudes and behaviors Nine survey items&#xD;
      used by the PI in previous deliberate tanning research were adapted with the expert consensus&#xD;
      of members of Northwestern's Institute for Sexual and Gender Minority Health and Wellbeing.&#xD;
      Discussions with the PI, research personnel and members of the institute developed the&#xD;
      hypothesis that in addition to the previously reported appearance motivations young SMM may&#xD;
      be engaging in tanning (indoors or outdoors) as a social activity. A tenth survey item was&#xD;
      developed to assess deliberate tanning as a social activity.&#xD;
&#xD;
      Aim 2: Analyze the tanning attitudes and behavior data acquired in an online survey of young&#xD;
      adult sexual minority males, who regularly participate in the RADAR study.&#xD;
&#xD;
      RADAR is a longitudinal study with cohorts from the greater Chicago region recruited between&#xD;
      2008 and 2015. The 10 survey items about tanning attitudes and behaviors were added to the&#xD;
      online survey that examines SMMs' behavior in the prior 6 months. This is a secondary&#xD;
      analysis of registry data acquired by the RADAR study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 15, 2019</start_date>
  <completion_date type="Actual">September 5, 2020</completion_date>
  <primary_completion_date type="Actual">September 5, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Outdoor Tanning Motives</measure>
    <time_frame>14 days</time_frame>
    <description>The 95 participants who self-reported deliberate tanning responded to 7 online survey items reported in the analysis population description.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">537</enrollment>
  <condition>Sun Sensitivity</condition>
  <arm_group>
    <arm_group_label>Males who never deliberately tan</arm_group_label>
    <description>Males responded to an anonymous online survey that they never deliberately tan</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Males who ever deliberately tan</arm_group_label>
    <description>Males responded to an anonymous online survey that they had ever deliberately tan</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>no intervention</intervention_name>
    <description>This is a secondary analysis of registry data.</description>
    <arm_group_label>Males who ever deliberately tan</arm_group_label>
    <arm_group_label>Males who never deliberately tan</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        RADAR is a longitudinal study with cohorts from the greater Chicago region recruited&#xD;
        between 2008 and 2015. Participants respond to online surveys every 6 months.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Young adult SMM (age 18-39)&#xD;
&#xD;
          -  Able to read English&#xD;
&#xD;
          -  Have internet access&#xD;
&#xD;
          -  Willing to complete the online survey&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Participants self-identify as sexual minority males</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>39 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>June K Robinson, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwestern University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Northwestern University Feinberg School of Medicine Department of Dermatology</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Robinson JK, Wahood S, Stapleton JL. Motives for intentional sunlight exposure among young adult sexual minority men: appearance, relaxation and socialization in a cohort study. Br J Dermatol. 2021 Mar;184(3):563-564. doi: 10.1111/bjd.19609. Epub 2020 Nov 18. No abstract available.</citation>
    <PMID>33067803</PMID>
  </results_reference>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <results_first_submitted>October 25, 2020</results_first_submitted>
  <results_first_submitted_qc>November 16, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">December 10, 2020</results_first_posted>
  <last_update_submitted>December 10, 2020</last_update_submitted>
  <last_update_submitted_qc>December 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwestern University</investigator_affiliation>
    <investigator_full_name>June Robinson</investigator_full_name>
    <investigator_title>Research Professor of Dermatology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypersensitivity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Since all data is deidentified, the results cannot be shared individually; however, the results may be provided to the entire cohort in a newsletter.</ipd_description>
  </patient_data>
  <study_docs>
    <study_doc>
      <doc_type>Clinical Study Report</doc_type>
      <doc_url>http://doi.org/10.3886/ICPSR37603.v1</doc_url>
      <doc_comment>Mustanski, Brian. Multilevel Influences on HIV and Substance Use in a YMSM Cohort (RADAR) - Visit #1, Chicago Metropolitan Area, 2015-2018. Inter-university Consortium for Political and Social Research [distributor], 2020-03-19.</doc_comment>
    </study_doc>
  </study_docs>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 6, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/07/NCT04404907/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Males Who Never Deliberately Tan</title>
          <description>Registry survey of males responded with a history of never deliberately (intentionallly) tanned</description>
        </group>
        <group group_id="P2">
          <title>Males Who Ever Deliberately Tanned</title>
          <description>Registry survey of males responded with a history of ever deliberately (intentionallly) tanned to make their skin appear darker</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="442"/>
                <participants group_id="P2" count="95"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Occasional Tan</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="88"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Frequent Tan</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="442"/>
                <participants group_id="P2" count="95"/>
              </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>Males Who Never Deliberately Tan</title>
          <description>Registry survey of males responded with a history of never deliberately (intentionallly) tanned</description>
        </group>
        <group group_id="B2">
          <title>Males Who Ever Deliberately Tanned</title>
          <description>Registry survey of males responded with a history of ever deliberately (intentionallly) tanned to make their skin appear darker</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="442"/>
            <count group_id="B2" value="95"/>
            <count group_id="B3" value="537"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <description>REDCap survey online</description>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24.71" spread="3.2"/>
                    <measurement group_id="B2" value="24.14" spread="2.8"/>
                    <measurement group_id="B3" value="24.42" spread="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="442"/>
                    <measurement group_id="B2" value="95"/>
                    <measurement group_id="B3" value="537"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="136"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="177"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="306"/>
                    <measurement group_id="B2" value="54"/>
                    <measurement group_id="B3" value="360"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="17"/>
                  </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="171"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="180"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="221"/>
                    <measurement group_id="B2" value="75"/>
                    <measurement group_id="B3" value="296"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                  </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="442"/>
                    <measurement group_id="B2" value="95"/>
                    <measurement group_id="B3" value="537"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Highest level of education</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>high school or less</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="108"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="122"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>trade school</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>some college</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="189"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="221"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>college graduate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="94"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="132"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>some graduate school</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>graduate degree</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Outdoor Tanning Motives</title>
        <description>The 95 participants who self-reported deliberate tanning responded to 7 online survey items reported in the analysis population description.</description>
        <time_frame>14 days</time_frame>
        <population>Responses to 7 survey items using Likert scale [1= strongly disagree (not at all concerned), 3= neither agree nor disagree, 5= strongly agree (extremely concerned)] were entered online</population>
        <group_list>
          <group group_id="O1">
            <title>Occasional Tanning</title>
            <description>Males who deliberately (intentionally tanned) 2-10 times in 3 months</description>
          </group>
          <group group_id="O2">
            <title>Frequent Tanning</title>
            <description>Males who intentionally tanned 10 or more times in 3 months</description>
          </group>
        </group_list>
        <measure>
          <title>Outdoor Tanning Motives</title>
          <description>The 95 participants who self-reported deliberate tanning responded to 7 online survey items reported in the analysis population description.</description>
          <population>Responses to 7 survey items using Likert scale [1= strongly disagree (not at all concerned), 3= neither agree nor disagree, 5= strongly agree (extremely concerned)] were entered online</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="88"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Most other gay and bisexual guys like me feel more attractive with a tan</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.64" spread="1.01"/>
                    <measurement group_id="O2" value="3.81" spread="1.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tanning helps me relax</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.10" spread="0.78"/>
                    <measurement group_id="O2" value="4.29" spread="0.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Feel more confident with a tan</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.09" spread="0.80"/>
                    <measurement group_id="O2" value="3.03" spread="1.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Go tanning with others as a social activity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.09" spread="0.80"/>
                    <measurement group_id="O2" value="4.55" spread="0.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Important to protect skin from the sun</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.07" spread="0.73"/>
                    <measurement group_id="O2" value="3.00" spread="1.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Concern about skin cancer</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.86" spread="0.86"/>
                    <measurement group_id="O2" value="3.00" spread="1.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chance of getting skin cancer is high</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.01" spread="0.88"/>
                    <measurement group_id="O2" value="3.07" spread="1.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>feel more attractive</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>ANOVA</non_inferiority_desc>
            <p_value>0.02</p_value>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>tanning helps relax</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>ANOVA</non_inferiority_desc>
            <p_value>0.001</p_value>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>confident with a tan</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.34</p_value>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Social activity</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0004</p_value>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Important to protect skin from the sun</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.66</p_value>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Concern about develop skin cancer</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.16</p_value>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Chances of getting skin cancer are high</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.29</p_value>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Males Who Never Deliberately Tan</title>
          <description>No adverse events reported in the online survey of this group</description>
        </group>
        <group group_id="E2">
          <title>Males Who Ever Deliberately Tanned</title>
          <description>No adverse events reported in the online survey of this group</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="442"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="442"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </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="442"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. June Robinson</name_or_title>
      <organization>Northwestern University</organization>
      <phone>312-503-5941</phone>
      <email>june-robinson@northwestern.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/NCT04404907
org study id: STU00206314
nct id: NCT04404907
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to: a) identify enablers and barriers to deliberate ultraviolet
      light exposure by young sexual minority men (SMM), and b) quantify the extent of their
      deliberate ultraviolet light exposure.
Aim 1: To develop survey items to assess tanning attitudes and behaviors Nine survey items
      used by the PI in previous deliberate tanning research were adapted with the expert consensus
      of members of Northwestern's Institute for Sexual and Gender Minority Health and Wellbeing.
      Discussions with the PI, research personnel and members of the institute developed the
      hypothesis that in addition to the previously reported appearance motivations young SMM may
      be engaging in tanning (indoors or outdoors) as a social activity. A tenth survey item was
      developed to assess deliberate tanning as a social activity.

      Aim 2: Analyze the tanning attitudes and behavior data acquired in an online survey of young
      adult sexual minority males, who regularly participate in the RADAR study.

      RADAR is a longitudinal study with cohorts from the greater Chicago region recruited between
      2008 and 2015. The 10 survey items about tanning attitudes and behaviors were added to the
      online survey that examines SMMs' behavior in the prior 6 months. This is a secondary
      analysis of registry data acquired by the RADAR study.
observational model: Cohort
time perspective: Other
measure: Outdoor Tanning Motives
time frame: 14 days
description: The 95 participants who self-reported deliberate tanning responded to 7 online survey items reported in the analysis population description.
arm group label: Males who never deliberately tan
description: Males responded to an anonymous online survey that they never deliberately tan
arm group label: Males who ever deliberately tan
description: Males responded to an anonymous online survey that they had ever deliberately tan
intervention type: Other
intervention name: no intervention
description: This is a secondary analysis of registry data.
arm group label: Males who ever deliberately tan
arm group label: Males who never deliberately tan
study pop: 
sampling method: Probability Sample
criteria: 
gender: Male
gender based: Yes
gender description: Participants self-identify as sexual minority males
minimum age: 18 Years
maximum age: 39 Years
last name: June K Robinson, MD
role: Principal Investigator
affiliation: Northwestern University
facility: 
country: United States
citation: Robinson JK, Wahood S, Stapleton JL. Motives for intentional sunlight exposure among young adult sexual minority men: appearance, relaxation and socialization in a cohort study. Br J Dermatol. 2021 Mar;184(3):563-564. doi: 10.1111/bjd.19609. Epub 2020 Nov 18. No abstract available.
PMID: 33067803
responsible party type: Principal Investigator
investigator affiliation: Northwestern University
investigator full name: June Robinson
investigator title: Research Professor of Dermatology
mesh term: Hypersensitivity
sharing ipd: No
ipd description: Since all data is deidentified, the results cannot be shared individually; however, the results may be provided to the entire cohort in a newsletter.
study doc: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 