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

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ClinicalTrials.gov Identifier: NCT04461288
Recruitment Status : Recruiting
First Posted : July 8, 2020
Last Update Posted : July 8, 2020
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE June 29, 2020
First Posted Date  ICMJE July 8, 2020
Last Update Posted Date July 8, 2020
Actual Study Start Date  ICMJE May 1, 2020
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 2, 2020)
  • Number of Participants With Reported 7-day Biochemically Verified Abstinence at 3 Months [ Time Frame: 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 [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 2, 2020)
  • Number of Participants Whom Attempted to Quit Tobacco Use During the Course of Treatment [ Time Frame: 3 to 6 months ]
    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 [ Time Frame: 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.
  • Frequency of social media posts [ Time Frame: 3 to 6 months ]
    Treatment engagement as measured by frequency of social media posts
  • Frequency of participation in live group sessions [ Time Frame: 3 to 6 months ]
    Treatment engagement as measured by participation in live group sessions
  • Duration of Active Participation [ Time Frame: 3 to 6 months ]
    Treatment engagement as measured by duration of active participation in intervention.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Engaging Sexual and Gender Minority Cigarette Smokers Into Social Media-based Treatment
Official Title  ICMJE Social Media-Based Treatment: Engaging Sexual and Gender Minority Smokers
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=120) 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Smoking Cessation
  • Nicotine Dependence
  • Tobacco Use
  • Cigarette Smoking
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Behavioral: Social media-based education, counseling, and support
    • Other: Nicotine replacement therapies (NRT)
  • 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.
    Interventions:
    • Behavioral: Social media-based education, counseling, and support
    • Other: Nicotine replacement therapies (NRT)
    • Other: Gamification
  • 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.
    Intervention: Other: Nicotine replacement therapies (NRT)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 2, 2020)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2022
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Daily smoker
  • Self-identify as sexual and/or gender minority
  • Interested in quitting in next 30 days
  • 6 months of Facebook experience
  • English-speaking

Exclusion Criteria:

  • Contraindications to nicotine replacement therapy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Gary Humfleet, PhD 415-476-7674 gary.humfleet@ucsf.edu
Contact: John Layton 415-476-7674 john.layton@ucsf.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04461288
Other Study ID Numbers  ICMJE TRDRP - T29IP0461
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gary Humfleet, PhD University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP