<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/NCT03259360</url>
  </required_header>
  <id_info>
    <org_study_id>PA-15-263</org_study_id>
    <secondary_id>R21MD011765</secondary_id>
    <nct_id>NCT03259360</nct_id>
  </id_info>
  <brief_title>A Facebook Intervention for Young Sexual and Gender Minority Smokers</brief_title>
  <acronym>POP</acronym>
  <official_title>A Facebook Intervention for Young 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>National Institute on Minority Health and Health Disparities (NIMHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, San Francisco</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The 2-year research plan will test the Put It Out Project (POP) in a pilot randomized trial&#xD;
      (N=120) compared to TSP and two historical control conditions. Participants will be young&#xD;
      adults who smoke, identify as sexual or gender minorities, and use Facebook. The primary&#xD;
      outcome will be biochemically verified 7-day abstinence from smoking at 3 and 6 months.&#xD;
      Secondary outcomes will be a quit attempt (y/n), stage of change, and thoughts about tobacco&#xD;
      abstinence at 3 and 6 mos.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will be randomized to one of two conditions: (1) a Facebook-delivered&#xD;
      intervention addressing tobacco use, tailored to SGM young adults; or (2) a 3-month Facebook&#xD;
      intervention targeting tobacco use. Both interventions will include 90 days of Facebook-based&#xD;
      messages and activities tailored to participants' readiness to quit smoking.&#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 give biochemical verification&#xD;
      of smoking status with saliva cotinine test kits that will be mailed to participants.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 23, 2018</start_date>
  <completion_date type="Actual">February 28, 2020</completion_date>
  <primary_completion_date type="Actual">April 20, 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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>7-day point prevalence abstinence at 3 months</measure>
    <time_frame>3 months post baseline</time_frame>
    <description>Reports of no smoking in the 7 days prior to the 3 month assessment. Biochemical verification of abstinence will also be recorded.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>7-day point prevalence abstinence at 6 months</measure>
    <time_frame>6 months post baseline</time_frame>
    <description>Reports of no smoking in the 7 days prior to the 6 month assessment. Biochemical verification of abstinence will also be recorded.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reduction in cigarettes smoked by at least 50%</measure>
    <time_frame>3 and 6 months post baseline</time_frame>
    <description>Reduction will be assessed at 3 and 6 month follow-ups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tobacco use quit attempts</measure>
    <time_frame>3 and 6 months post baseline</time_frame>
    <description>Whether a quit attempt was made during the follow-up period at 3 and 6 months post-baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Readiness to quit tobacco</measure>
    <time_frame>3 and 6 months post baseline</time_frame>
    <description>Proportion of participants ready to quit smoking in the next month assessed at 3 and 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thoughts About Tobacco Abstinence</measure>
    <time_frame>3 and 6 months post baseline</time_frame>
    <description>Desire to quit, abstinence self-efficacy, perceived difficulty of quitting and abstinence goal</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">165</enrollment>
  <condition>Tobacco Use</condition>
  <condition>Smoking</condition>
  <condition>Tobacco Dependence</condition>
  <condition>Tobacco Use Disorder</condition>
  <condition>Tobacco Use Cessation</condition>
  <condition>Tobacco Smoking</condition>
  <condition>Smoking Cessation</condition>
  <condition>Smoking, Cigarette</condition>
  <condition>Smoking, Tobacco</condition>
  <arm_group>
    <arm_group_label>The Put It Out Project (POP):</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>a culturally tailored intervention developed for SGM young adults on Facebook</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tobacco Status Project (TSP):</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>the original TSP intervention (non-tailored) delivered to groups of only SGM participants on Facebook</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>POP:</intervention_name>
    <description>90 days of Facebook messaging, weekly live sessions targeting tobacco use and tailored to sexual and gender minority young adults</description>
    <arm_group_label>The Put It Out Project (POP):</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>TSP:</intervention_name>
    <description>90 days of Facebook messaging, weekly live sessions targeting tobacco use</description>
    <arm_group_label>Tobacco Status Project (TSP):</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  read English&#xD;
&#xD;
          -  between 18 and 25 years of age&#xD;
&#xD;
          -  indicate they use Facebook &quot;most&quot; (≥ 4) days per week&#xD;
&#xD;
          -  have smoked ≥100 cigarettes in their lives and currently smoke at least 1 cigarette&#xD;
             per day on 4 or more days of the week&#xD;
&#xD;
          -  identifies as SGM&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  do not read English&#xD;
&#xD;
          -  are not between 18 and 25 years of age&#xD;
&#xD;
          -  indicate they do not use Facebook &quot;most&quot; (≥ 4) days per week&#xD;
&#xD;
          -  have not smoked ≥100 cigarettes in their lives and currently smoke at least 1&#xD;
             cigarette per day on 4 or more days of the week&#xD;
&#xD;
          -  does not identify as SGM&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gary L. 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 Department of Psychiatry</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>
  <reference>
    <citation>Ramo DE, Thrul J, Chavez K, Delucchi KL, Prochaska JJ. Feasibility and Quit Rates of the Tobacco Status Project: A Facebook Smoking Cessation Intervention for Young Adults. J Med Internet Res. 2015 Dec 31;17(12):e291. doi: 10.2196/jmir.5209.</citation>
    <PMID>26721211</PMID>
  </reference>
  <reference>
    <citation>Thrul J, Klein AB, Ramo DE. Smoking Cessation Intervention on Facebook: Which Content Generates the Best Engagement? J Med Internet Res. 2015 Nov 11;17(11):e244. doi: 10.2196/jmir.4575.</citation>
    <PMID>26561529</PMID>
  </reference>
  <reference>
    <citation>Ramo DE, Thrul J, Delucchi KL, Ling PM, Hall SM, Prochaska JJ. The Tobacco Status Project (TSP): Study protocol for a randomized controlled trial of a Facebook smoking cessation intervention for young adults. BMC Public Health. 2015 Sep 15;15:897. doi: 10.1186/s12889-015-2217-0.</citation>
    <PMID>26374203</PMID>
  </reference>
  <reference>
    <citation>Ramo DE, Rodriguez TM, Chavez K, Sommer MJ, Prochaska JJ. Facebook Recruitment of Young Adult Smokers for a Cessation Trial: Methods, Metrics, and Lessons Learned. Internet Interv. 2014 Apr;1(2):58-64. doi: 10.1016/j.invent.2014.05.001.</citation>
    <PMID>25045624</PMID>
  </reference>
  <reference>
    <citation>Ramo DE, Liu H, Prochaska JJ. A mixed-methods study of young adults' receptivity to using Facebook for smoking cessation: if you build it, will they come? Am J Health Promot. 2015 Mar-Apr;29(4):e126-35. doi: 10.4278/ajhp.130326-QUAL-128. Epub 2014 Feb 27.</citation>
    <PMID>24575728</PMID>
  </reference>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>August 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 23, 2017</study_first_posted>
  <last_update_submitted>May 19, 2020</last_update_submitted>
  <last_update_submitted_qc>May 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Tobacco</keyword>
  <keyword>Gender Identity Minority</keyword>
  <keyword>Sexual Identity Minority</keyword>
  <keyword>Cessation</keyword>
  <keyword>Intervention</keyword>
  <keyword>Young Adults</keyword>
  <keyword>Social Media</keyword>
  <keyword>Internet</keyword>
  <keyword>Cigarette</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tobacco Use Disorder</mesh_term>
  </condition_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/NCT03259360
org study id: PA-15-263
secondary id: R21MD011765
nct id: NCT03259360
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The 2-year research plan will test the Put It Out Project (POP) in a pilot randomized trial
      (N=120) compared to TSP and two historical control conditions. Participants will be young
      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 a quit attempt (y/n), stage of change, and thoughts about tobacco
      abstinence at 3 and 6 mos.
Participants will be randomized to one of two conditions: (1) a Facebook-delivered
      intervention addressing tobacco use, tailored to SGM young adults; or (2) a 3-month Facebook
      intervention targeting tobacco use. Both interventions will include 90 days of Facebook-based
      messages and activities tailored to participants' readiness to quit smoking.

      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 give biochemical verification
      of smoking status with saliva cotinine test kits that will be mailed to participants.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: 7-day point prevalence abstinence at 3 months
time frame: 3 months post baseline
description: Reports of no smoking in the 7 days prior to the 3 month assessment. Biochemical verification of abstinence will also be recorded.
measure: 7-day point prevalence abstinence at 6 months
time frame: 6 months post baseline
description: Reports of no smoking in the 7 days prior to the 6 month assessment. Biochemical verification of abstinence will also be recorded.
measure: Reduction in cigarettes smoked by at least 50%
time frame: 3 and 6 months post baseline
description: Reduction will be assessed at 3 and 6 month follow-ups.
measure: Tobacco use quit attempts
time frame: 3 and 6 months post baseline
description: Whether a quit attempt was made during the follow-up period at 3 and 6 months post-baseline.
measure: Readiness to quit tobacco
time frame: 3 and 6 months post baseline
description: Proportion of participants ready to quit smoking in the next month assessed at 3 and 6 months
measure: Thoughts About Tobacco Abstinence
time frame: 3 and 6 months post baseline
description: Desire to quit, abstinence self-efficacy, perceived difficulty of quitting and abstinence goal
arm group label: The Put It Out Project (POP):
arm group type: Experimental
description: a culturally tailored intervention developed for SGM young adults on Facebook
arm group label: Tobacco Status Project (TSP):
arm group type: Experimental
description: the original TSP intervention (non-tailored) delivered to groups of only SGM participants on Facebook
intervention type: Behavioral
intervention name: POP:
description: 90 days of Facebook messaging, weekly live sessions targeting tobacco use and tailored to sexual and gender minority young adults
arm group label: The Put It Out Project (POP):
intervention type: Behavioral
intervention name: TSP:
description: 90 days of Facebook messaging, weekly live sessions targeting tobacco use
arm group label: Tobacco Status Project (TSP):
criteria: 
gender: All
minimum age: 18 Years
maximum age: 25 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Gary L. Humfleet, PhD
role: Principal Investigator
affiliation: University of California, San Francisco
facility: 
country: United States
citation: Ramo DE, Thrul J, Chavez K, Delucchi KL, Prochaska JJ. Feasibility and Quit Rates of the Tobacco Status Project: A Facebook Smoking Cessation Intervention for Young Adults. J Med Internet Res. 2015 Dec 31;17(12):e291. doi: 10.2196/jmir.5209.
PMID: 26721211
citation: Thrul J, Klein AB, Ramo DE. Smoking Cessation Intervention on Facebook: Which Content Generates the Best Engagement? J Med Internet Res. 2015 Nov 11;17(11):e244. doi: 10.2196/jmir.4575.
PMID: 26561529
citation: Ramo DE, Thrul J, Delucchi KL, Ling PM, Hall SM, Prochaska JJ. The Tobacco Status Project (TSP): Study protocol for a randomized controlled trial of a Facebook smoking cessation intervention for young adults. BMC Public Health. 2015 Sep 15;15:897. doi: 10.1186/s12889-015-2217-0.
PMID: 26374203
citation: Ramo DE, Rodriguez TM, Chavez K, Sommer MJ, Prochaska JJ. Facebook Recruitment of Young Adult Smokers for a Cessation Trial: Methods, Metrics, and Lessons Learned. Internet Interv. 2014 Apr;1(2):58-64. doi: 10.1016/j.invent.2014.05.001.
PMID: 25045624
citation: Ramo DE, Liu H, Prochaska JJ. A mixed-methods study of young adults' receptivity to using Facebook for smoking cessation: if you build it, will they come? Am J Health Promot. 2015 Mar-Apr;29(4):e126-35. doi: 10.4278/ajhp.130326-QUAL-128. Epub 2014 Feb 27.
PMID: 24575728
responsible party type: Sponsor
mesh term: Tobacco Use Disorder
sharing ipd: No