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

Not Applicable

Completed

• Conditions: Tobacco Use; Smoking Cessation; Nicotine Dependence; Cigarette Smoking
• Interventions: Other: Nicotine replacement therapies (NRT); Behavioral: Social media-based education, counseling, and support; Other: Gamification

• Registration Number: NCT04461288
• Lead Sponsor: University of California, San Francisco

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-05-01
• Study First Submitted: 2020-06-29
• Study First Submitted QC: 2020-07-02
• Study First Posted: 2020-07-08
• Primary Completion: 2022-05-30
• Study Completion: 2022-05-30
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-19
• Last Update Posted: 2022-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

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

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Exclusion Criteria

• Contraindications to nicotine replacement therapy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pride Posts Plus	Gamification	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.
Usual Care Condition	Nicotine replacement therapies (NRT)	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.
Pride Posts	Nicotine replacement therapies (NRT)	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.
Pride Posts Plus	Social media-based education, counseling, and support	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.
Pride Posts	Social media-based education, counseling, and support	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.
Pride Posts Plus	Nicotine replacement therapies (NRT)	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Reported 7-day Biochemically Verified Abstinence at 3 Months	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.
Number of Participants With Reported 7-day Biochemically Verified Abstinence at 6 Months	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.

Secondary Outcome Measures

Name	Time	Method
Frequency of social media posts	3 to 6 months	Treatment engagement as measured by frequency of social media posts
Frequency of participation in live group sessions	3 to 6 months	Treatment engagement as measured by participation in live group sessions
Responses to the Thoughts About Abstinence Questionnaire Over Time	3 to 6 months	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.
Number of Participants Whom Attempted to Quit Tobacco Use During the Course of Treatment	3 to 6 months	Participants will report intentional quit attempts lasting at least 24 hours since treatment initiation or previous assessment
Duration of Active Participation	3 to 6 months	Treatment engagement as measured by duration of active participation in intervention.

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States