Clinical trial NCT04461288: Engaging Sexual and Gender Minority Cigarette Smokers Into Social Media-based Treatment
Official title: Social Media-Based Treatment: Engaging Sexual and Gender Minority Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Nicotine Dependence
Tobacco Use
Cigarette Smoking
Keywords: smoking
social media
LGBT
sexual and gender minority
nicotine replacement therapy
digital interventions
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Tobacco Related Disease Research Program
First posted: 2020-07-08
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Reported 7-day Biochemically Verified Abstinence at 3 Months
timeFrame: 3 months
measure: Number of Participants With Reported 7-day Biochemically Verified Abstinence at 6 Months
timeFrame: 6 months
Secondary outcomes:
measure: Number of Participants Whom Attempted to Quit Tobacco Use During the Course of Treatment
timeFrame: 3 to 6 months
measure: Responses to the Thoughts About Abstinence Questionnaire Over Time
timeFrame: 3 to 6 months
measure: Frequency of social media posts
timeFrame: 3 to 6 months
measure: Frequency of participation in live group sessions
timeFrame: 3 to 6 months
measure: Duration of Active Participation
timeFrame: 3 to 6 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Gary Humfleet, PhD
role: PRINCIPAL_INVESTIGATOR
References: