Engaging Sexual and Gender Minority Cigarette Smokers Into Social Media-based Treatment

Study Overview
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Brief Summary
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This research study will evaluate the preliminary efficacy of Pride Posts Plus, a social media-based smoking cessation treatment. A pilot randomized trial (N=120) will compare Pride Posts Plus, which includes a gamification element, to Pride Posts (without gamification) and to a usual care treatment. Participants will be 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 treatment engagement, a quit attempt (y/n), and thoughts about tobacco abstinence at 3 and 6 mos.

Detailed Description
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Participants (N=136) will be randomized to one of three conditions: (1) Pride Posts, a Facebook-delivered smoking cessation intervention (including daily posts, and weekly live group sessions, tailored to sexual and gender minority (SGM) adults; (2) Pride Posts Plus, the Facebook-delivered smoking cessation intervention plus a gamification element, or (2) a usual care condition which includes referral to smokefree.gov, a federally-developed web-based intervention which includes similar digital treatment elements. All participants will have access to up to six months of nicotine replacement therapy (NRT). 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 provide biochemical verification of smoking status using a portable carbon monoxide measurement tool. All intervention and assessment procedures will be conducted digitally.

Official Title
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Social Media-Based Treatment: Engaging Sexual and Gender Minority Smokers

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

Intervention / Treatment
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* Behavioral: Social media-based education, counseling, and support
* Other: Nicotine replacement therapies (NRT)
* Other: Gamification


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Daily smoker Self-identify as sexual and/or gender minority Interested in quitting in next 6 months 6 months of Facebook experience English-speaking Exclusion Criteria: Contraindications to nicotine replacement therapy

Ages Eligible for Study
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Minimum Age: 18 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: Pride Posts<br>This six month intervention will be conducted on the Facebook platform. Participants will receive regular social media posts tailored to the sexual and gender minority communities (LGBTQ+). Weekly live sessions with a tobacco expert will be available. Participants will also have access to up to six months of nicotine replacement therapy (patch + gum/lozenge). Dosage will be based manufacturer's recommendations which are based on self-reported smoking behaviors. | Behavioral: Social media-based education, counseling, and support<br>* This six-month intervention is culturally-tailored to sexual and gender minority cigarette smokers. The intervention is group-based and includes daily posts and weekly live sessions during the initial three months. Posts and group sessions focus on tobacco use education, developing a quit plan, as well as managing stress, negative thinking, social support, exercise, as techniques to support cessation.<br>Other: Nicotine replacement therapies (NRT)<br>* Participants will have access to up to six months of nicotine patch therapy. Participants will start on either 21, 14, or 7 mg patches based on manufacturers recommendations based on smoking behaviors. In addition to nicotine patch, participants will have access to a choice of 2 mg. nicotine lozenges or nicotine gum as an adjunct to patch treatment. Participants will be encouraged to use up to 5 pieces daily to address situational urges and cravings for a cigarette.<br>|
| Experimental: Pride Posts Plus<br>This six month intervention will include all elements of the Pride Posts arm. In addition, the intervention will include gamification, gaming elements designed to encourage participation in the program and behavior change. Participants will also have access to up to six months of nicotine replacement therapy (patch + gum/lozenge). Dosage will be based manufacturer's recommendations which are based on self-reported smoking behaviors. | Behavioral: Social media-based education, counseling, and support<br>* This six-month intervention is culturally-tailored to sexual and gender minority cigarette smokers. The intervention is group-based and includes daily posts and weekly live sessions during the initial three months. Posts and group sessions focus on tobacco use education, developing a quit plan, as well as managing stress, negative thinking, social support, exercise, as techniques to support cessation.<br>Other: Nicotine replacement therapies (NRT)<br>* Participants will have access to up to six months of nicotine patch therapy. Participants will start on either 21, 14, or 7 mg patches based on manufacturers recommendations based on smoking behaviors. In addition to nicotine patch, participants will have access to a choice of 2 mg. nicotine lozenges or nicotine gum as an adjunct to patch treatment. Participants will be encouraged to use up to 5 pieces daily to address situational urges and cravings for a cigarette.<br>Other: Gamification<br>* Gaming elements designed to encourage participation in the program and behavior change.<br>|
| Active Comparator: Usual Care Condition<br>Participants in this arm will be provided with a referral to smokefree.gov, a federally-funded website which provides support and digital-based interventions to assist in smoking cessation activities. Participants will also have access to up to six months of nicotine replacement therapy (patch + gum/lozenge). Dosage will be based manufacturer's recommendations which are based on self-reported smoking behaviors. | Other: Nicotine replacement therapies (NRT)<br>* Participants will have access to up to six months of nicotine patch therapy. Participants will start on either 21, 14, or 7 mg patches based on manufacturers recommendations based on smoking behaviors. In addition to nicotine patch, participants will have access to a choice of 2 mg. nicotine lozenges or nicotine gum as an adjunct to patch treatment. Participants will be encouraged to use up to 5 pieces daily to address situational urges and cravings for a cigarette.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Reported 7-day Biochemically Verified Abstinence at 3 Months | Abstinence is defined by all participants who report no smoking within the last 7 days will use a breathalyzer to measure carbon monoxide levels in the breath to verify smoking abstinence prior to the 3 month assessment. | 3 months | 
| Number of Participants With Reported 7-day Biochemically Verified Abstinence at 6 Months | Abstinence is defined by all participants who report no smoking within the last 7 days will use a breathalyzer to measure carbon monoxide levels in the breath to verify smoking abstinence prior to the 6 month assessment. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Whom Attempted to Quit Tobacco Use During the Course of Treatment | Participants will report intentional quit attempts lasting at least 24 hours since treatment initiation or previous assessment | 3 to 6 months | 
| Responses to the Thoughts About Abstinence Questionnaire Over Time | The Thoughts About Abstinence Questionnaire is a 5 item self-report questionnaire that measures: 1) desire to quit smoking, 2) expected success at quitting, 3) expected difficulty of quitting, and 4) confidence in ability to quit on 10-point Likert scales (e.g., 1=no desire to quit/lowest expectation/lowest level of difficulty to 10 = extreme desire to quit/highest expectation of success/highest expected difficulty. | 3 to 6 months | 
| Frequency of social media posts | Treatment engagement as measured by frequency of social media posts | 3 to 6 months | 
| Frequency of participation in live group sessions | Treatment engagement as measured by participation in live group sessions | 3 to 6 months | 
| Duration of Active Participation | Treatment engagement as measured by duration of active participation in intervention. | 3 to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smoking, social media, LGBT, sexual and gender minority, nicotine replacement therapy, digital interventions