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A Facebook Intervention for Young Sexual and Gender Minority Smokers (POP)

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ClinicalTrials.gov Identifier: NCT03259360
Recruitment Status : Active, not recruiting
First Posted : August 23, 2017
Last Update Posted : August 29, 2018
Sponsor:
Collaborator:
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Tobacco Use Smoking Tobacco Dependence Tobacco Use Disorder Tobacco Use Cessation Tobacco Smoking Smoking Cessation Smoking, Cigarette Smoking, Tobacco Behavioral: POP: Behavioral: TSP: Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 165 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Facebook Intervention for Young Sexual and Gender Minority Smokers
Actual Study Start Date : April 23, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: The Put It Out Project (POP):
a culturally tailored intervention developed for SGM young adults on Facebook
Behavioral: POP:
90 days of Facebook messaging, weekly live sessions targeting tobacco use and tailored to sexual and gender minority young adults

Experimental: Tobacco Status Project (TSP):
the original TSP intervention (non-tailored) delivered to groups of only SGM participants on Facebook
Behavioral: TSP:
90 days of Facebook messaging, weekly live sessions targeting tobacco use




Primary Outcome Measures :
  1. 7-day point prevalence abstinence at 3 months [ Time Frame: 3 months post baseline ]
    Reports of no smoking in the 7 days prior to the 3 month assessment. Biochemical verification of abstinence will also be recorded.

  2. 7-day point prevalence abstinence at 6 months [ Time Frame: 6 months post baseline ]
    Reports of no smoking in the 7 days prior to the 6 month assessment. Biochemical verification of abstinence will also be recorded.


Secondary Outcome Measures :
  1. Reduction in cigarettes smoked by at least 50% [ Time Frame: 3 and 6 months post baseline ]
    Reduction will be assessed at 3 and 6 month follow-ups.

  2. Tobacco use quit attempts [ Time Frame: 3 and 6 months post baseline ]
    Whether a quit attempt was made during the follow-up period at 3 and 6 months post-baseline.

  3. Readiness to quit tobacco [ Time Frame: 3 and 6 months post baseline ]
    Proportion of participants ready to quit smoking in the next month assessed at 3 and 6 months

  4. Thoughts About Tobacco Abstinence [ Time Frame: 3 and 6 months post baseline ]
    Desire to quit, abstinence self-efficacy, perceived difficulty of quitting and abstinence goal



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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • read English
  • between 18 and 25 years of age
  • indicate they use Facebook "most" (≥ 4) days per week
  • have smoked ≥100 cigarettes in their lives and currently smoke at least 1 cigarette per day on 4 or more days of the week
  • identifies as SGM

Exclusion Criteria:

  • do not read English
  • are not between 18 and 25 years of age
  • indicate they do not use Facebook "most" (≥ 4) days per week
  • have not smoked ≥100 cigarettes in their lives and currently smoke at least 1 cigarette per day on 4 or more days of the week
  • does not identify as SGM

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03259360


Locations
United States, California
University of California San Francisco Department of Psychiatry
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
National Institute on Minority Health and Health Disparities (NIMHD)
Investigators
Principal Investigator: Gary L. Humfleet, PhD University of California, San Francisco

Publications:
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03259360     History of Changes
Other Study ID Numbers: PA-15-263
R21MD011765 ( U.S. NIH Grant/Contract )
First Posted: August 23, 2017    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of California, San Francisco:
Tobacco
Gender Identity Minority
Sexual Identity Minority
Cessation
Intervention
Young Adults
Social Media
Internet
Cigarette

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders