An Extended Facebook Intervention for Young Sexual and Gender Minority Smokers

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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An Extended Facebook Intervention for Young Sexual and Gender Minority Smokers

Conditions
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Tobacco Use, Smoking, Tobacco Dependence, Tobacco Use Disorder, Tobacco Use Cessation, Tobacco Smoking, Smoking Cessation, Smoking, Cigarette, Smoking, Tobacco

Intervention / Treatment
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* Behavioral: POP-6:
* Behavioral: TSP-6:


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tobacco, Gender Identity Minority, Sexual Identity Minority, Cessation, Intervention, Young Adults, Social Media, Internet, Cigarette