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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

August 21, 2017
August 23, 2017
August 29, 2018
April 23, 2018
December 31, 2018   (Final data collection date for primary outcome measure)
  • 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.
  • 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.
  • 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. Biochemical verification of abstinence will also be recorded.
  • 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. Biochemical verification of abstinence will also be recorded
Complete list of historical versions of study NCT03259360 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
  • 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
  • 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
Same as current
Not Provided
Not Provided
 
A Facebook Intervention for Young Sexual and Gender Minority Smokers
A Facebook Intervention for Young Sexual and Gender Minority Smokers
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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Tobacco Use
  • Smoking
  • Tobacco Dependence
  • Tobacco Use Disorder
  • Tobacco Use Cessation
  • Tobacco Smoking
  • Smoking Cessation
  • Smoking, Cigarette
  • Smoking, Tobacco
  • Behavioral: POP:
    90 days of Facebook messaging, weekly live sessions targeting tobacco use and tailored to sexual and gender minority young adults
  • Behavioral: TSP:
    90 days of Facebook messaging, weekly live sessions targeting tobacco use
  • Experimental: The Put It Out Project (POP):
    a culturally tailored intervention developed for SGM young adults on Facebook
    Intervention: Behavioral: POP:
  • Experimental: Tobacco Status Project (TSP):
    the original TSP intervention (non-tailored) delivered to groups of only SGM participants on Facebook
    Intervention: Behavioral: TSP:

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
165
120
June 2019
December 31, 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 25 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT03259360
PA-15-263
R21MD011765 ( U.S. NIH Grant/Contract )
Not Provided
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
University of California, San Francisco
University of California, San Francisco
National Institute on Minority Health and Health Disparities (NIMHD)
Principal Investigator: Gary L. Humfleet, PhD University of California, San Francisco
University of California, San Francisco
August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP