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

Primary Purpose

Smoking Cessation, Nicotine Dependence, Tobacco Use

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Social media-based education, counseling, and support
Nicotine replacement therapies (NRT)
Gamification
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Smoking Cessation focused on measuring smoking, social media, LGBT, sexual and gender minority, nicotine replacement therapy, digital interventions

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of California, San Francisco

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Pride Posts

Pride Posts Plus

Usual Care Condition

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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

Full Information

First Posted
June 29, 2020
Last Updated
September 19, 2022
Sponsor
University of California, San Francisco
Collaborators
Tobacco Related Disease Research Program
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1. Study Identification

Unique Protocol Identification Number
NCT04461288
Brief Title
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

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
May 30, 2022 (Actual)
Study Completion Date
May 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Tobacco Related Disease Research Program

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking Cessation, Nicotine Dependence, Tobacco Use, Cigarette Smoking
Keywords
smoking, social media, LGBT, sexual and gender minority, nicotine replacement therapy, digital interventions

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pride Posts
Arm Type
Experimental
Arm Description
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.
Arm Title
Pride Posts Plus
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care Condition
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Social media-based education, counseling, and support
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Nicotine replacement therapies (NRT)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Gamification
Intervention Description
Gaming elements designed to encourage participation in the program and behavior change.
Primary Outcome Measure Information:
Title
Number of Participants With Reported 7-day Biochemically Verified Abstinence at 3 Months
Description
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.
Time Frame
3 months
Title
Number of Participants With Reported 7-day Biochemically Verified Abstinence at 6 Months
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of Participants Whom Attempted to Quit Tobacco Use During the Course of Treatment
Description
Participants will report intentional quit attempts lasting at least 24 hours since treatment initiation or previous assessment
Time Frame
3 to 6 months
Title
Responses to the Thoughts About Abstinence Questionnaire Over Time
Description
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.
Time Frame
3 to 6 months
Title
Frequency of social media posts
Description
Treatment engagement as measured by frequency of social media posts
Time Frame
3 to 6 months
Title
Frequency of participation in live group sessions
Description
Treatment engagement as measured by participation in live group sessions
Time Frame
3 to 6 months
Title
Duration of Active Participation
Description
Treatment engagement as measured by duration of active participation in intervention.
Time Frame
3 to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary Humfleet, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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