An Extended Facebook Intervention for Young Sexual and Gender Minority Smokers (POP-6)

The 2-year research plan will test the Extended Put It Out Project (POP-6) in a pilot randomized trial (N=168) compared to TSP-6, as well as comparing POP-6 and TSP-6 to the POP-3 and TSP-3 interventions from a previously-conducted trial. Participants will be young adults who smoke, identify as sexual or gender minorities (SGM), and use Facebook. 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 months.

Study Overview

• Status: Completed
• Conditions: Smoking; Smoking Cessation; Tobacco Use; Tobacco Smoking; Tobacco Use Disorder; Tobacco Use Cessation; Tobacco Dependence; Smoking, Tobacco; Smoking, Cigarette
• Intervention / Treatment: Behavioral: POP-6:; Behavioral: TSP-6:

Detailed Description

Participants will be randomized to one of two conditions: (1) a 6-month Facebook-delivered intervention addressing tobacco use, tailored to SGM young adults; or (2) a 6-month Facebook intervention targeting tobacco use. Both interventions will include 180 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 nicotine test kits that will be mailed to participants.

• Study Type: Interventional
• Enrollment (Actual): 173
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California San Francisco Department of Psychiatry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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
• lives in California

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
• does not live in California

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The Put It Out Project (POP-6): a culturally tailored intervention developed for sexual and gender minority (SGM) young adults on Facebook	Behavioral: POP-6: 90 days of Facebook messaging, weekly live sessions targeting tobacco use and tailored to SGM young adults Drug: nicotine patch 14-day supply of nicotine patch
Experimental: Tobacco Status Project (TSP-6): the original TSP intervention (non-tailored) delivered to groups of only SGM participants on Facebook	Behavioral: TSP-6: 90 days of Facebook messaging, weekly live sessions targeting tobacco use Drug: nicotine patch 14-day supply of nicotine patch

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
7-day point prevalence abstinence at 3 months	Reports of no smoking in the 7 days prior to the 3 month assessment. Biochemical verification of abstinence will also be recorded.	3 months post baseline
7-day point prevalence abstinence at 6 months	Reports of no smoking in the 7 days prior to the 6 month assessment. Biochemical verification of abstinence will also be recorded.	6 months post baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in cigarettes smoked by at least 50%	Reduction will be assessed at 3 and 6 month follow-ups	3 and 6 months post baseline
Tobacco use quit attempts	A Smoking Questionnaire will assess the presence and number of 24 hr quit attempts since the last assessment, used to calculate presence of at least one quit attempt (y/n) in the assessment time period. This questionnaire has good internal consistency and construct validity, and is routinely used in smoking treatment research.	3 and 6 months post baseline
Readiness to quit tobacco	Proportion of participants ready to quit smoking in the next month assessed at 3 and 6 months.	3 and 6 months post baseline
Thoughts About Tobacco Abstinence	The 4-item Thoughts About Abstinence Form, will measure thoughts about abstinence (desire to quit, abstinence self-efficacy, and perceived difficulty of quitting) on a scale from 1 ("least") to 10("most"), and abstinence goal as no goal, intermediary goal (e.g., reduced smoking), or total abstinence.	3 and 6 months post baseline

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Tobacco Related Disease Research Program
• Investigators: Principal Investigator: Gary L. Humfleet, PhD, University of California, San Francisco

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2018
• Primary Completion (Actual): July 7, 2019
• Study Completion (Actual): July 7, 2019

Study Registration Dates

• First Submitted: May 30, 2018
• First Submitted That Met QC Criteria: May 30, 2018
• First Posted (Actual): June 12, 2018

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 14, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Tobacco; Intervention; Young Adults; Cigarette; Internet; Cessation; Social Media; Gender Identity Minority; Sexual Identity Minority
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder
• Other Study ID Numbers: P0520362; 26IR-0004 (Other Grant/Funding Number: UC Tobacco-Related Disease Research Pgm)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No