<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/NCT04461288</url>
  </required_header>
  <id_info>
    <org_study_id>TRDRP - T29IP0461</org_study_id>
    <nct_id>NCT04461288</nct_id>
  </id_info>
  <brief_title>Engaging Sexual and Gender Minority Cigarette Smokers Into Social Media-based Treatment</brief_title>
  <official_title>Social Media-Based Treatment: Engaging Sexual and Gender Minority Smokers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Tobacco Related Disease Research Program</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, San Francisco</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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research study will evaluate the preliminary efficacy of Pride Posts Plus, a social&#xD;
      media-based smoking cessation treatment. A pilot randomized trial (N=120) will compare Pride&#xD;
      Posts Plus, which includes a gamification element, to Pride Posts (without gamification) and&#xD;
      to a usual care treatment. Participants will be adults who smoke, identify as sexual or&#xD;
      gender minorities, and use Facebook. The primary outcome will be biochemically verified 7-day&#xD;
      abstinence from smoking at 3 and 6 months. Secondary outcomes will be treatment engagement, a&#xD;
      quit attempt (y/n), and thoughts about tobacco abstinence at 3 and 6 mos.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants (N=136) will be randomized to one of three conditions: (1) Pride Posts, a&#xD;
      Facebook-delivered smoking cessation intervention (including daily posts, and weekly live&#xD;
      group sessions, tailored to sexual and gender minority (SGM) adults; (2) Pride Posts Plus,&#xD;
      the Facebook-delivered smoking cessation intervention plus a gamification element, or (2) a&#xD;
      usual care condition which includes referral to smokefree.gov, a federally-developed&#xD;
      web-based intervention which includes similar digital treatment elements. All participants&#xD;
      will have access to up to six months of nicotine replacement therapy (NRT).&#xD;
&#xD;
      Assessments will occur at baseline, 3, and 6 months follow-up. Assessments will include&#xD;
      measures on smoking, thoughts about abstinence, and SGM identity experiences. All&#xD;
      participants who report no past 7-day smoking will be asked to provide biochemical&#xD;
      verification of smoking status using a portable carbon monoxide measurement tool. All&#xD;
      intervention and assessment procedures will be conducted digitally.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2020</start_date>
  <completion_date type="Actual">May 30, 2022</completion_date>
  <primary_completion_date type="Actual">May 30, 2022</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Reported 7-day Biochemically Verified Abstinence at 3 Months</measure>
    <time_frame>3 months</time_frame>
    <description>Abstinence is defined by all participants who report no smoking within the last 7 days will use a breathalyzer to measure carbon monoxide levels in the breath to verify smoking abstinence prior to the 3 month assessment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Reported 7-day Biochemically Verified Abstinence at 6 Months</measure>
    <time_frame>6 months</time_frame>
    <description>Abstinence is defined by all participants who report no smoking within the last 7 days will use a breathalyzer to measure carbon monoxide levels in the breath to verify smoking abstinence prior to the 6 month assessment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Whom Attempted to Quit Tobacco Use During the Course of Treatment</measure>
    <time_frame>3 to 6 months</time_frame>
    <description>Participants will report intentional quit attempts lasting at least 24 hours since treatment initiation or previous assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Responses to the Thoughts About Abstinence Questionnaire Over Time</measure>
    <time_frame>3 to 6 months</time_frame>
    <description>The Thoughts About Abstinence Questionnaire is a 5 item self-report questionnaire that measures: 1) desire to quit smoking, 2) expected success at quitting, 3) expected difficulty of quitting, and 4) confidence in ability to quit on 10-point Likert scales (e.g., 1=no desire to quit/lowest expectation/lowest level of difficulty to 10 = extreme desire to quit/highest expectation of success/highest expected difficulty.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of social media posts</measure>
    <time_frame>3 to 6 months</time_frame>
    <description>Treatment engagement as measured by frequency of social media posts</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of participation in live group sessions</measure>
    <time_frame>3 to 6 months</time_frame>
    <description>Treatment engagement as measured by participation in live group sessions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Active Participation</measure>
    <time_frame>3 to 6 months</time_frame>
    <description>Treatment engagement as measured by duration of active participation in intervention.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">121</enrollment>
  <condition>Smoking Cessation</condition>
  <condition>Nicotine Dependence</condition>
  <condition>Tobacco Use</condition>
  <condition>Cigarette Smoking</condition>
  <arm_group>
    <arm_group_label>Pride Posts</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This six month intervention will be conducted on the Facebook platform. Participants will receive regular social media posts tailored to the sexual and gender minority communities (LGBTQ+). Weekly live sessions with a tobacco expert will be available. Participants will also have access to up to six months of nicotine replacement therapy (patch + gum/lozenge). Dosage will be based manufacturer's recommendations which are based on self-reported smoking behaviors.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pride Posts Plus</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This six month intervention will include all elements of the Pride Posts arm. In addition, the intervention will include gamification, gaming elements designed to encourage participation in the program and behavior change. Participants will also have access to up to six months of nicotine replacement therapy (patch + gum/lozenge). Dosage will be based manufacturer's recommendations which are based on self-reported smoking behaviors.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care Condition</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in this arm will be provided with a referral to smokefree.gov, a federally-funded website which provides support and digital-based interventions to assist in smoking cessation activities. Participants will also have access to up to six months of nicotine replacement therapy (patch + gum/lozenge). Dosage will be based manufacturer's recommendations which are based on self-reported smoking behaviors.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Social media-based education, counseling, and support</intervention_name>
    <description>This six-month intervention is culturally-tailored to sexual and gender minority cigarette smokers. The intervention is group-based and includes daily posts and weekly live sessions during the initial three months. Posts and group sessions focus on tobacco use education, developing a quit plan, as well as managing stress, negative thinking, social support, exercise, as techniques to support cessation.</description>
    <arm_group_label>Pride Posts</arm_group_label>
    <arm_group_label>Pride Posts Plus</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Nicotine replacement therapies (NRT)</intervention_name>
    <description>Participants will have access to up to six months of nicotine patch therapy. Participants will start on either 21, 14, or 7 mg patches based on manufacturers recommendations based on smoking behaviors.&#xD;
In addition to nicotine patch, participants will have access to a choice of 2 mg. nicotine lozenges or nicotine gum as an adjunct to patch treatment. Participants will be encouraged to use up to 5 pieces daily to address situational urges and cravings for a cigarette.</description>
    <arm_group_label>Pride Posts</arm_group_label>
    <arm_group_label>Pride Posts Plus</arm_group_label>
    <arm_group_label>Usual Care Condition</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Gamification</intervention_name>
    <description>Gaming elements designed to encourage participation in the program and behavior change.</description>
    <arm_group_label>Pride Posts Plus</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Daily smoker&#xD;
&#xD;
          -  Self-identify as sexual and/or gender minority&#xD;
&#xD;
          -  Interested in quitting in next 6 months&#xD;
&#xD;
          -  6 months of Facebook experience&#xD;
&#xD;
          -  English-speaking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindications to nicotine replacement therapy&#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>Gary Humfleet, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California, San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>September 19, 2022</last_update_submitted>
  <last_update_submitted_qc>September 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>smoking</keyword>
  <keyword>social media</keyword>
  <keyword>LGBT</keyword>
  <keyword>sexual and gender minority</keyword>
  <keyword>nicotine replacement therapy</keyword>
  <keyword>digital interventions</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tobacco Use Disorder</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nicotine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT04461288
org study id: TRDRP - T29IP0461
nct id: NCT04461288
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
This research study will evaluate the preliminary efficacy of Pride Posts Plus, a social
      media-based smoking cessation treatment. A pilot randomized trial (N=120) will compare Pride
      Posts Plus, which includes a gamification element, to Pride Posts (without gamification) and
      to a usual care treatment. Participants will be adults who smoke, identify as sexual or
      gender minorities, and use Facebook. The primary outcome will be biochemically verified 7-day
      abstinence from smoking at 3 and 6 months. Secondary outcomes will be treatment engagement, a
      quit attempt (y/n), and thoughts about tobacco abstinence at 3 and 6 mos.
Participants (N=136) will be randomized to one of three conditions: (1) Pride Posts, a
      Facebook-delivered smoking cessation intervention (including daily posts, and weekly live
      group sessions, tailored to sexual and gender minority (SGM) adults; (2) Pride Posts Plus,
      the Facebook-delivered smoking cessation intervention plus a gamification element, or (2) a
      usual care condition which includes referral to smokefree.gov, a federally-developed
      web-based intervention which includes similar digital treatment elements. All participants
      will have access to up to six months of nicotine replacement therapy (NRT).

      Assessments will occur at baseline, 3, and 6 months follow-up. Assessments will include
      measures on smoking, thoughts about abstinence, and SGM identity experiences. All
      participants who report no past 7-day smoking will be asked to provide biochemical
      verification of smoking status using a portable carbon monoxide measurement tool. All
      intervention and assessment procedures will be conducted digitally.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants With Reported 7-day Biochemically Verified Abstinence at 3 Months
time frame: 3 months
description: Abstinence is defined by all participants who report no smoking within the last 7 days will use a breathalyzer to measure carbon monoxide levels in the breath to verify smoking abstinence prior to the 3 month assessment.
measure: Number of Participants With Reported 7-day Biochemically Verified Abstinence at 6 Months
time frame: 6 months
description: Abstinence is defined by all participants who report no smoking within the last 7 days will use a breathalyzer to measure carbon monoxide levels in the breath to verify smoking abstinence prior to the 6 month assessment.
measure: Number of Participants Whom Attempted to Quit Tobacco Use During the Course of Treatment
time frame: 3 to 6 months
description: Participants will report intentional quit attempts lasting at least 24 hours since treatment initiation or previous assessment
measure: Responses to the Thoughts About Abstinence Questionnaire Over Time
time frame: 3 to 6 months
description: The Thoughts About Abstinence Questionnaire is a 5 item self-report questionnaire that measures: 1) desire to quit smoking, 2) expected success at quitting, 3) expected difficulty of quitting, and 4) confidence in ability to quit on 10-point Likert scales (e.g., 1=no desire to quit/lowest expectation/lowest level of difficulty to 10 = extreme desire to quit/highest expectation of success/highest expected difficulty.
measure: Frequency of social media posts
time frame: 3 to 6 months
description: Treatment engagement as measured by frequency of social media posts
measure: Frequency of participation in live group sessions
time frame: 3 to 6 months
description: Treatment engagement as measured by participation in live group sessions
measure: Duration of Active Participation
time frame: 3 to 6 months
description: Treatment engagement as measured by duration of active participation in intervention.
arm group label: Pride Posts
arm group type: Experimental
description: This six month intervention will be conducted on the Facebook platform. Participants will receive regular social media posts tailored to the sexual and gender minority communities (LGBTQ+). Weekly live sessions with a tobacco expert will be available. Participants will also have access to up to six months of nicotine replacement therapy (patch + gum/lozenge). Dosage will be based manufacturer's recommendations which are based on self-reported smoking behaviors.
arm group label: Pride Posts Plus
arm group type: Experimental
description: This six month intervention will include all elements of the Pride Posts arm. In addition, the intervention will include gamification, gaming elements designed to encourage participation in the program and behavior change. Participants will also have access to up to six months of nicotine replacement therapy (patch + gum/lozenge). Dosage will be based manufacturer's recommendations which are based on self-reported smoking behaviors.
arm group label: Usual Care Condition
arm group type: Active Comparator
description: Participants in this arm will be provided with a referral to smokefree.gov, a federally-funded website which provides support and digital-based interventions to assist in smoking cessation activities. Participants will also have access to up to six months of nicotine replacement therapy (patch + gum/lozenge). Dosage will be based manufacturer's recommendations which are based on self-reported smoking behaviors.
intervention type: Behavioral
intervention name: Social media-based education, counseling, and support
description: This six-month intervention is culturally-tailored to sexual and gender minority cigarette smokers. The intervention is group-based and includes daily posts and weekly live sessions during the initial three months. Posts and group sessions focus on tobacco use education, developing a quit plan, as well as managing stress, negative thinking, social support, exercise, as techniques to support cessation.
arm group label: Pride Posts
arm group label: Pride Posts Plus
intervention type: Other
intervention name: Nicotine replacement therapies (NRT)
description: Participants will have access to up to six months of nicotine patch therapy. Participants will start on either 21, 14, or 7 mg patches based on manufacturers recommendations based on smoking behaviors.
In addition to nicotine patch, participants will have access to a choice of 2 mg. nicotine lozenges or nicotine gum as an adjunct to patch treatment. Participants will be encouraged to use up to 5 pieces daily to address situational urges and cravings for a cigarette.
arm group label: Pride Posts
arm group label: Pride Posts Plus
arm group label: Usual Care Condition
intervention type: Other
intervention name: Gamification
description: Gaming elements designed to encourage participation in the program and behavior change.
arm group label: Pride Posts Plus
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Gary Humfleet, PhD
role: Principal Investigator
affiliation: University of California, San Francisco
facility: 
country: United States
responsible party type: Sponsor
mesh term: Tobacco Use Disorder
mesh term: Nicotine
sharing ipd: No