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

NCT04461288 | Completed DMC

• 1 other identifier: TRDRP - T29IP0461
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation; Nicotine Dependence; Tobacco Use; Cigarette Smoking

Keywords

smoking; social media; LGBT; sexual and gender minority; nicotine replacement therapy; digital interventions

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Number of Participants Whom Attempted to Quit Tobacco Use During the Course of Treatment

  3 to 6 months

• Responses to the Thoughts About Abstinence Questionnaire Over Time

  3 to 6 months

• Frequency of social media posts

  3 to 6 months

• Frequency of participation in live group sessions

  3 to 6 months

• Duration of Active Participation

  3 to 6 months

Study Arms (3)

Pride Posts

EXPERIMENTAL

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; Other: Nicotine replacement therapies (NRT)

Pride Posts Plus

EXPERIMENTAL

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; Other: Nicotine replacement therapies (NRT); Other: Gamification

Usual Care Condition

ACTIVE COMPARATOR

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)

Interventions

Social media-based education, counseling, and support BEHAVIORAL

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.

Pride Posts; Pride Posts Plus

Nicotine replacement therapies (NRT) OTHER

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.

Pride Posts; Pride Posts Plus; Usual Care Condition

Gamification OTHER

Gaming elements designed to encourage participation in the program and behavior change.

Pride Posts Plus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Daily smoker
• Self-identify as sexual and/or gender minority
• Interested in quitting in next 6 months
• months of Facebook experience
• English-speaking

You may not qualify if:

• Contraindications to nicotine replacement therapy

Sponsors & Collaborators

• University of California, San Francisco: lead
• Tobacco Related Disease Research Program: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Smoking Cessation; Tobacco Use Disorder; Tobacco Use; Cigarette Smoking; Smoking; Coitus

Interventions

Counseling; Palliative Care; Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Tobacco Smoking; Sexual Behavior

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Patient Care; Therapeutics; Drug Therapy

Study Officials

• Gary Humfleet, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: July 8, 2020
• Study Start: May 1, 2020
• Primary Completion: May 30, 2022
• Study Completion: May 30, 2022
• Last Updated: September 21, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)