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

Not Applicable

Completed

• Conditions: Tobacco Use; Smoking Cessation; Nicotine Dependence; Cigarette Smoking

• 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.

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

Exclusion Criteria

• Contraindications to nicotine replacement therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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