xml: <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/NCT05972941</url>
    </required_header>
    <id_info>
      <org_study_id>OSU-23020</org_study_id>
      <secondary_id>4R00CA260718-02</secondary_id>
      <nct_id>NCT05972941</nct_id>
    </id_info>
    <brief_title>Nicotine and Tobacco Message Framing Among LGBT Young Adults</brief_title>
    <official_title>The Effect of Nicotine and Tobacco Message Framing on Use Among Diverse Groups of Young Adults</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ohio State University Comprehensive Cancer Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institutes of Health (NIH)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
      <collaborator>
        <agency>National Cancer Institute (NCI)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Ohio State University Comprehensive Cancer Center</source>
    <oversight_info>
      <has_dmc>Yes</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>
        This trial refines and evaluates how cultural targeting influences the effectiveness of&#xD;
        anti-tobacco messages among lesbian, gay, bisexual, and transgender (LGBT) young adults at&#xD;
        risk for the use of more than one tobacco product (polytobacco use). Polytobacco use is&#xD;
        associated with nicotine dependence and tobacco use into adulthood, and is disproportionately&#xD;
        high among LGBT young adults. This trial seeks to determine how cultural targeting can be&#xD;
        applied to communicate polytobacco use risk to at-risk LGBT young adults.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The goal of this study is to identify if culturally targeted (CT) or non-targeted (NT)&#xD;
        anti-polytobacco messages are most effective for engaging LGBT consumers. Using the most&#xD;
        effective NT messages from Aim 1, investigators will create a set of CT messages. Message&#xD;
        framing will remain consistent between CT and NT messages; however, CT messages will include&#xD;
        language and graphics representing LGBT values formative research and the existing&#xD;
        peer-reviewed literature. Participants will be randomized to view CT or NT messages in a&#xD;
        virtual lab where investigators will assess eye-tracking, self-reported perceived&#xD;
        effectiveness, risk perceptions, and behavioral intentions. Participants will also complete a&#xD;
        1-week follow-up. The study aims to determine the effects of cultural targeting on attention&#xD;
        to anti-polytobacco messages and perceived effectiveness among LGBT young adults susceptible&#xD;
        to polytobacco use.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 19, 2023</start_date>
    <completion_date type="Anticipated">August 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">August 31, 2023</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>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Visual attention - dwell time</measure>
      <time_frame>During intervention</time_frame>
      <description>Visual attention measured by dwell time (milliseconds) on areas of interest (text, graphic) measured via eye-tracking</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Visual attention - time to first fixation</measure>
      <time_frame>During intervention</time_frame>
      <description>Time (milliseconds) to first fixation on areas of interest (text, graphic) measured via eye-tracking</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Perceived message effectiveness - message perceptions</measure>
      <time_frame>Immediately post-exposure to intervention</time_frame>
      <description>6-items on a 5-point scale where 1 = Not at all and 5 = Very much.&#xD;
  Please rate each statement from 1 (not at all) to 5 (very much). These message are worth remembering. These messages grabbed my attention. These messages are powerful. These messages are convincing. These messages are meaningful. These messages are informative.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Perceived message effectiveness - effects perceptions</measure>
      <time_frame>Immediately post-exposure to intervention</time_frame>
      <description>6-items. 5-point scale where 1 = Strongly disagree to 5 = Strongly agree&#xD;
  These messages discourage me from smoking cigarettes. These messages make me concerned about the negative effects of smoking cigarettes These messages make smoking cigarettes seem unpleasant to me. These messages discourage me from vaping nicotine. These messages make me concerned about the negative effects of vaping nicotine. These messages make vaping nicotine seem unpleasant to me.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in harm perceptions</measure>
      <time_frame>Change from Baseline in harm perceptions immediately post-exposure to intervention</time_frame>
      <description>3-items; 4-point scale 1=No harm to 4 = A lot of harm How harmful are nicotine vapes to your health? Compared to combustible cigarettes, how harmful are nicotine vapes to your health? How harmful are combustible cigarettes to your health?</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in harm perceptions</measure>
      <time_frame>Change from Baseline in harm perceptions at 1-week follow-up after intervention exposure</time_frame>
      <description>3-items; 4-point scale 1=No harm to 4 = A lot of harm How harmful are nicotine vapes to your health? Compared to combustible cigarettes, how harmful are nicotine vapes to your health? How harmful are combustible cigarettes to your health?</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in behavioral intentions</measure>
      <time_frame>Change from Baseline in behavioral intentions immediately post-exposure to intervention</time_frame>
      <description>8 items total. 4-point scale 1 = Definitely not to 4 = Definitely will.&#xD;
  How likely is it that in the next 3 months, you will refrain from vaping nicotine....&#xD;
  completely and permanently?&#xD;
  when you get lonely?&#xD;
  when you are with your friends who use them?&#xD;
  when someone hands you a vape?&#xD;
  How likely is it that in the next 3 months, you will refrain from smoking cigarettes...&#xD;
  completely and permanently?&#xD;
  when you get lonely?&#xD;
  when you are with your friends who use them?&#xD;
  when someone hands you a vape?</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in behavioral intentions</measure>
      <time_frame>Change from Baseline in behavioral intentions at 1-week follow-up after intervention exposure</time_frame>
      <description>Do you plan to quit smoking cigarettes in the next 30 days (Yes/No) Do you plan to quit vaping in the next 30 days (Yes/No)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Reactance</measure>
      <time_frame>Immediately post-exposure to intervention</time_frame>
      <description>3-items; 5-point Likert scale where 1 = Strongly disagree and 5 = Strongly agree&#xD;
  These messages are trying to manipulate me. These messages annoy me. The health effects of these messages are overblown.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Ad relevance</measure>
      <time_frame>Immediately post-exposure to intervention</time_frame>
      <description>5 items; 7-point Likert scale where 1 = Strongly Disagree and 7 = Strongly agree These ads were created just for me. These ads were created for people like me. These ads were relevant to me. These ads were of value to me. These ads were important to me.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Liking</measure>
      <time_frame>Immediately post-exposure to intervention</time_frame>
      <description>Single item; 5-point Likert scale where 1 = Strongly disagree and 5 = Strongly agree&#xD;
  I like these messages.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Attitudes</measure>
      <time_frame>Immediately post-exposure to intervention</time_frame>
      <description>Two items; 7-point Likert scale where 1 = These message made me feel much worse and 7 = These message made me feel much better.&#xD;
  Did these messages change how you feel about smoking combustible cigarettes? Did these messages change how you feel about vaping nicotine?</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Response efficacy</measure>
      <time_frame>Immediately post-exposure to intervention</time_frame>
      <description>6-items; 5 point Likert scale where 1 = Strongly disagree and 5 = Strongly agree&#xD;
  These messages will motivate CIGARETTE SMOKERS to switch to vaping. These messages will motivate people to quit ALL smoking and vaping. These messages will motivate NON-USERS to start vaping. These messages will motivate NON-USERS to start smoking cigarettes. These messages will motivate CIGARETTE SMOKERS to quit. These messages will motivate VAPERS to quit.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Qualitative recall of health messages</measure>
      <time_frame>1-week follow-up after intervention exposure</time_frame>
      <description>Participants will be asked the following question: &quot;The images that you viewed included health messages. What do you remember about the health messages?&quot;</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Tobacco-Related Carcinoma</condition>
    <arm_group>
      <arm_group_label>Culturally targeted messages</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will view 8 nicotine and tobacco health messages with LGBT culturally targeted messages and imagery</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Non-targeted messages</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Participants will view 8 nicotine and tobacco health messages with universal messages and imagery</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Health communications</intervention_name>
      <description>Participants will view eight culturally targeted or non-targeted health communications about the health risks of nicotine and tobacco use.</description>
      <arm_group_label>Culturally targeted messages</arm_group_label>
      <arm_group_label>Non-targeted messages</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Speaks English fluently&#xD;
  &#xD;
            -  Self-identifies as lesbian, gay, bisexual, transgender, queer, or another non-&#xD;
               heterosexual orientation or non-binary gender identity&#xD;
  &#xD;
            -  Ever used e-cigarettes AND combustible cigarettes&#xD;
  &#xD;
            -  Currently uses e-cigarettes, combustible cigarettes, or both e-cigarettes and&#xD;
               combustible cigarettes&#xD;
  &#xD;
            -  Resides in the United States&#xD;
  &#xD;
            -  Access to a laptop or desktop computer with a camera for virtual eye-tracking&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Glaucoma&#xD;
  &#xD;
            -  Cataracts&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>35 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Joanne G Patterson, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>The Ohio State University College of Public Health</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>The Ohio State University Comprehensive Cancer Center</last_name>
      <phone>800-293-5066</phone>
      <email>OSUCCCClinicaltrials@osumc.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>The Ohio State University</name>
        <address>
          <city>Columbus</city>
          <state>Ohio</state>
          <zip>43210</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>The Ohio State University Comprehensive Cancer Center</last_name>
        <phone>800-293-5066</phone>
        <email>OSUCCCClinicaltrials@osumc.edu</email>
      </contact>
      <investigator>
        <last_name>Joanne Patterson, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>http://cancer.osu.edu</url>
      <description>The Jamesline</description>
    </link>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 26, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Ohio State University Comprehensive Cancer Center</investigator_affiliation>
      <investigator_full_name>Joanne Patterson</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>health communication</keyword>
    <keyword>LGBT</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05972941
  org study id: OSU-23020
  secondary id: 4R00CA260718-02
  nct id: NCT05972941
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This trial refines and evaluates how cultural targeting influences the effectiveness of
        anti-tobacco messages among lesbian, gay, bisexual, and transgender (LGBT) young adults at
        risk for the use of more than one tobacco product (polytobacco use). Polytobacco use is
        associated with nicotine dependence and tobacco use into adulthood, and is disproportionately
        high among LGBT young adults. This trial seeks to determine how cultural targeting can be
        applied to communicate polytobacco use risk to at-risk LGBT young adults.
  The goal of this study is to identify if culturally targeted (CT) or non-targeted (NT)
        anti-polytobacco messages are most effective for engaging LGBT consumers. Using the most
        effective NT messages from Aim 1, investigators will create a set of CT messages. Message
        framing will remain consistent between CT and NT messages; however, CT messages will include
        language and graphics representing LGBT values formative research and the existing
        peer-reviewed literature. Participants will be randomized to view CT or NT messages in a
        virtual lab where investigators will assess eye-tracking, self-reported perceived
        effectiveness, risk perceptions, and behavioral intentions. Participants will also complete a
        1-week follow-up. The study aims to determine the effects of cultural targeting on attention
        to anti-polytobacco messages and perceived effectiveness among LGBT young adults susceptible
        to polytobacco use.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Single (Participant)
  measure: Visual attention - dwell time
  time frame: During intervention
  description: Visual attention measured by dwell time (milliseconds) on areas of interest (text, graphic) measured via eye-tracking
  measure: Visual attention - time to first fixation
  time frame: During intervention
  description: Time (milliseconds) to first fixation on areas of interest (text, graphic) measured via eye-tracking
  measure: Perceived message effectiveness - message perceptions
  time frame: Immediately post-exposure to intervention
  description: 6-items on a 5-point scale where 1 = Not at all and 5 = Very much.
  Please rate each statement from 1 (not at all) to 5 (very much). These message are worth remembering. These messages grabbed my attention. These messages are powerful. These messages are convincing. These messages are meaningful. These messages are informative.
  measure: Perceived message effectiveness - effects perceptions
  time frame: Immediately post-exposure to intervention
  description: 6-items. 5-point scale where 1 = Strongly disagree to 5 = Strongly agree
  These messages discourage me from smoking cigarettes. These messages make me concerned about the negative effects of smoking cigarettes These messages make smoking cigarettes seem unpleasant to me. These messages discourage me from vaping nicotine. These messages make me concerned about the negative effects of vaping nicotine. These messages make vaping nicotine seem unpleasant to me.
  measure: Change in harm perceptions
  time frame: Change from Baseline in harm perceptions immediately post-exposure to intervention
  description: 3-items; 4-point scale 1=No harm to 4 = A lot of harm How harmful are nicotine vapes to your health? Compared to combustible cigarettes, how harmful are nicotine vapes to your health? How harmful are combustible cigarettes to your health?
  measure: Change in harm perceptions
  time frame: Change from Baseline in harm perceptions at 1-week follow-up after intervention exposure
  description: 3-items; 4-point scale 1=No harm to 4 = A lot of harm How harmful are nicotine vapes to your health? Compared to combustible cigarettes, how harmful are nicotine vapes to your health? How harmful are combustible cigarettes to your health?
  measure: Change in behavioral intentions
  time frame: Change from Baseline in behavioral intentions immediately post-exposure to intervention
  description: 8 items total. 4-point scale 1 = Definitely not to 4 = Definitely will.
  How likely is it that in the next 3 months, you will refrain from vaping nicotine....
  completely and permanently?
  when you get lonely?
  when you are with your friends who use them?
  when someone hands you a vape?
  How likely is it that in the next 3 months, you will refrain from smoking cigarettes...
  completely and permanently?
  when you get lonely?
  when you are with your friends who use them?
  when someone hands you a vape?
  measure: Change in behavioral intentions
  time frame: Change from Baseline in behavioral intentions at 1-week follow-up after intervention exposure
  description: Do you plan to quit smoking cigarettes in the next 30 days (Yes/No) Do you plan to quit vaping in the next 30 days (Yes/No)
  measure: Reactance
  time frame: Immediately post-exposure to intervention
  description: 3-items; 5-point Likert scale where 1 = Strongly disagree and 5 = Strongly agree
  These messages are trying to manipulate me. These messages annoy me. The health effects of these messages are overblown.
  measure: Ad relevance
  time frame: Immediately post-exposure to intervention
  description: 5 items; 7-point Likert scale where 1 = Strongly Disagree and 7 = Strongly agree These ads were created just for me. These ads were created for people like me. These ads were relevant to me. These ads were of value to me. These ads were important to me.
  measure: Liking
  time frame: Immediately post-exposure to intervention
  description: Single item; 5-point Likert scale where 1 = Strongly disagree and 5 = Strongly agree
  I like these messages.
  measure: Attitudes
  time frame: Immediately post-exposure to intervention
  description: Two items; 7-point Likert scale where 1 = These message made me feel much worse and 7 = These message made me feel much better.
  Did these messages change how you feel about smoking combustible cigarettes? Did these messages change how you feel about vaping nicotine?
  measure: Response efficacy
  time frame: Immediately post-exposure to intervention
  description: 6-items; 5 point Likert scale where 1 = Strongly disagree and 5 = Strongly agree
  These messages will motivate CIGARETTE SMOKERS to switch to vaping. These messages will motivate people to quit ALL smoking and vaping. These messages will motivate NON-USERS to start vaping. These messages will motivate NON-USERS to start smoking cigarettes. These messages will motivate CIGARETTE SMOKERS to quit. These messages will motivate VAPERS to quit.
  measure: Qualitative recall of health messages
  time frame: 1-week follow-up after intervention exposure
  description: Participants will be asked the following question: "The images that you viewed included health messages. What do you remember about the health messages?"
  arm group label: Culturally targeted messages
  arm group type: Experimental
  description: Participants will view 8 nicotine and tobacco health messages with LGBT culturally targeted messages and imagery
  arm group label: Non-targeted messages
  arm group type: Other
  description: Participants will view 8 nicotine and tobacco health messages with universal messages and imagery
  intervention type: Behavioral
  intervention name: Health communications
  description: Participants will view eight culturally targeted or non-targeted health communications about the health risks of nicotine and tobacco use.
  arm group label: Culturally targeted messages
  arm group label: Non-targeted messages
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 35 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Joanne G Patterson, PhD
  role: Principal Investigator
  affiliation: The Ohio State University College of Public Health
  last name: The Ohio State University Comprehensive Cancer Center
  phone: 800-293-5066
  email: OSUCCCClinicaltrials@osumc.edu
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: United States
  url: http://cancer.osu.edu
  description: The Jamesline
  responsible party type: Principal Investigator
  investigator affiliation: Ohio State University Comprehensive Cancer Center
  investigator full name: Joanne Patterson
  investigator title: Principal Investigator
  sharing ipd: No