Flexiquit+: Web Program to Promote Smoking Cessation in Sexual and Gender Minority Young Adult Smokers

Study Overview
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Brief Summary
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This phase I trial studies how well Flexiquit+ helps young adult smokers who identify as a sexual and/or gender minority to quit or cut down on smoking. Flexiquit+ is an avatar-led, web-based intervention that can help smokers quit or cut back on how much they smoke cigarettes and/or vape, reducing their chances of developing tobacco-related health conditions.

Detailed Description
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OUTLINE: Individuals will be recruited to use the Flexiquit+ program consisting of 6 sessions, each lasting approximately 25 minutes. Participants will also receive text messages providing motivational messages and review information discussed in the program. At the end of the intervention, participants will receive an email with all of the session handouts. Participants are followed up with at 2 months.

Official Title
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A Scalable E-Health Smoking Cessation Intervention for Sexual and Gender Minority Young Adults

Conditions
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Tobacco Use Disorder

Intervention / Treatment
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* Behavioral: Computer-Assisted Smoking Cessation Intervention
* Other: Text Message
* Other: Handout
* Other: Questionnaire Administration
* Other: Quality-of-Life Assessment
* Other: Survey Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must self-identify as a sexual and/or gender minority (i.e., a sexual orientation other than straight and/or gender that doesn't match sex assigned at birth) Participants must currently reside in the United States and anticipate remaining in the United States for the duration of the study (2 months) Participants must self-report smoking at least 1 cigarette per day in the 30 days prior to screening Participants must self-report having at least weekly internet access for the next two months Participants must self-report being willing and able to stream video online for this study Participants must self-report current use of a personal email account Participants must self-report current use of text messaging Participants must self-report that they are interested in participating in the study for themselves (versus [vs] someone else) Participants must self-report that they are not currently taking part in any other smoking cessation treatment such as the nicotine patch, nicotine gum, Zyban, in-person counseling, telephone counseling, using a web-based or app-based cessation program Participants must self-report that they have not participated in one of our prior smoking cessation studies, including the user-centered research conducted in the development of Flexiquit+ Participants must self-report that they are comfortable reading, writing, and speaking English Participants must self-report that they understand and agree to the conditions of compensation Participants must self-report that they are not currently incarcerated in a prison Participants must be willing to use the Flexiquit+ program, complete the study assessments, and sign an online consent form

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prevention (Flexiquit+, text message, handout)<br>Individuals will be recruited to use the Flexiquit+ program consisting of 6 sessions, each lasting approximately 25 minutes. Participants will also receive text messages providing motivational messages and review information discussed in the program. At the end of the intervention, participants will receive an email with all of the session handouts. | Behavioral: Computer-Assisted Smoking Cessation Intervention<br>* Use the Flexiquit+ program<br>Other: Text Message<br>* Receive text messages<br>* Other names: Text;Other: Handout<br>* Receive handouts via email<br>Other: Questionnaire Administration<br>* Ancillary studies<br>Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Survey Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment utilization | Will be determined by the server-recorded number of logins and the number of sessions completed. Frequencies (for categorical variables) or means and standard deviations (for continuous variables) will be reported for treatment utilization and satisfaction. Tables with N (%) or mean (standard deviation) by treatment arm will be provided. | Enrollment up to 2 months | 
| Treatment satisfaction: survey | Will be determined using 12 items on the 2-month outcome survey. Frequencies (for categorical variables) or means and standard deviations (for continuous variables) will be reported for treatment utilization and satisfaction. Categorical ratings for treatment satisfaction questions will be dichotomized as somewhat, mostly, or very useful versus (vs.) lower ratings. Tables with N (%) or mean (standard deviation) by treatment arm will be provided. | Enrollment up to 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking cessation rate | Will be assessed using the self-reported 7-day point prevalence abstinence at 2-month follow-up survey, biochemically confirmed with saliva cotinine. | At 2 months post-enrollment | 
| Change in motivation to quit smoking | Will be assessed using the Contemplation Ladder. | From baseline to 2-month follow-up |