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

Sponsor
University of California, San Francisco (Other)
Overall Status
Recruiting
CT.gov ID
NCT04461288
Collaborator
Tobacco Related Disease Research Program (Other)
136
1
3
28
4.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Social media-based education, counseling, and support
  • Other: Nicotine replacement therapies (NRT)
  • Other: Gamification
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
136 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Social Media-Based Treatment: Engaging Sexual and Gender Minority Smokers
Actual Study Start Date :
May 1, 2020
Anticipated Primary Completion Date :
Aug 31, 2022
Anticipated Study Completion Date :
Aug 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pride Posts

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
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.

Other: Nicotine replacement therapies (NRT)
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.

Experimental: Pride Posts Plus

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
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.

Other: Nicotine replacement therapies (NRT)
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.

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

Active Comparator: Usual Care Condition

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)
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.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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

  1. 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

  2. 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.

  3. Frequency of social media posts [3 to 6 months]

    Treatment engagement as measured by frequency of social media posts

  4. Frequency of participation in live group sessions [3 to 6 months]

    Treatment engagement as measured by participation in live group sessions

  5. Duration of Active Participation [3 to 6 months]

    Treatment engagement as measured by duration of active participation in intervention.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of California, San Francisco San Francisco California United States 94143

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Gary Humfleet, PhD, University of California, San Francisco

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT04461288
Other Study ID Numbers:
  • TRDRP - T29IP0461
First Posted:
Jul 8, 2020
Last Update Posted:
Sep 9, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Keywords provided by University of California, San Francisco
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 9, 2021