Avatar-Led Digital Therapeutic for Aiding Smoking Cessation in Sexual and Gender Minority Young Adults

Study Overview
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Brief Summary
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This trial assesses the acceptability and preliminary efficacy of Empowered, Queer, Quitting, and Living (EQQUAL) smoking-cessation intervention for sexual and gender minority young adult smokers. The prevalence of tobacco use among sexual and gender minority (SGM) young adults is more than twice as high as non-SGM young adults, suggesting that existing SGM-related disparities in tobacco use will persist well into the foreseeable future unless sustained efforts are undertaken to address them. EQQUAL is an online smoking cessation intervention designed specifically for SGM young adult smokers, and may help them quit smoking.

Detailed Description
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OUTLINE: Participants are randomized to 1 of 2 arms. ARM I: Participants receive self-guided, online quit smoking program, called EQQUAL Program A. ARM II: Participants receive self-guided online quit smoking program, EQQUAL Program B.

Official Title
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Avatar-Led Digital Therapeutic to Aid Smoking Cessation Among Sexual and Gender Minority Young Adults

Conditions
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Cigarette Smoking-Related Carcinoma

Intervention / Treatment
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* Behavioral: Online Smoking Cessation Intervention
* Behavioral: Online Smoking Cessation Intervention
* Other: Questionnaire Administration
* Other: Health Promotion and Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: DEMOGRAPHIC CRITERIA: Participants must self-identify being between 18 and 30 years of age 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, with a United States (US) mailing address, and anticipate remaining in the US for the duration of the study (3 months) SMOKING CRITERIA: Participants must self-report smoking at least 1 cigarette per day in the 30 days prior to screening TREATMENT ACCESSIBILITY: Participants must self-report having at least weekly Internet access for the next three months Participants must self-report being willing and able to stream audio and 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 OTHER CRITERIA: 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 have not participated in one of our prior smoking cessation studies 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 Participants must be willing to use the assigned intervention program, complete the study assessments, and consent to participate in this study Participants must be willing to upload a photo of themselves (face visible) Exclusion Criteria: Participants must not be currently using other tobacco cessation treatments at the time of screening, including pharmacotherapy or behavioral support (but initiating these treatments during the study is allowed) Participants must not be a member of the same household as another research participant Having a Google voice number as their sole phone number

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (EQQUAL A)<br>Participants receive self-guided online EQQUAL A program on study. Participants also receive motivational messages and smoking cessation information via text messages. | Behavioral: Online Smoking Cessation Intervention<br>* Receive EQQUAL A intervention<br>* Other names: Smoking and Tobacco Use Cessation Intervention;Other: Questionnaire Administration<br>* Ancillary studies<br>Other: Health Promotion and Education<br>* Receive motivational messages and smoking cessation information via SMS text messages<br>|
| Active Comparator: Arm II (EQQUAL B)<br>Participants receive self-guided online EQQUAL B program on study. Participants also receive motivational messages and smoking cessation information via text messages. | Behavioral: Online Smoking Cessation Intervention<br>* Receive EQQUAL B intervention<br>* Other names: Smoking and Tobacco Use Cessation Intervention;Other: Questionnaire Administration<br>* Ancillary studies<br>Other: Health Promotion and Education<br>* Receive motivational messages and smoking cessation information via SMS text messages<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall satisfaction | Will be assessed with a 5-point Likert-type item on the 3-month survey. Responses will be recorded into a binary variable representing responses of mostly satisfied or very satisfied versus all other responses (i.e., not at all, a little, and somewhat). Will test for statistical differences between arms using a logistic regression, with adjustment for the stratification variables, as well as adjustment for any baseline variables that had a statistically significant difference by study arm and were associated with the outcome (i.e., potential confounders). | At 3-month follow-up | 
| Average change in Contemplation Ladder scores | Contemplation Ladder scores will be used to assess readiness to quit using cigarettes. Will test for statistical differences between arms using linear regression, with adjustment for the stratification variables, as well as adjustment for any baseline variables that had a statistically significant difference by study arm and were associated with the outcome (i.e., potential confounders). | Baseline through 3-month follow-up | 
| Reduction in cigarettes smoked per day | Change in cigarette smoked per day will be assessed as the difference between average number of cigarettes smoked per day over the past 7 days at baseline and at 3-month follow-up. Will test for statistical differences between arms using a negative binomial regression with adjustment for the stratification variables, as well as adjustment for any baseline variables that had a statistically significant difference by study arm and were associated with the outcome (i.e., potential confounders). | Baseline through 3-month follow-up | 
| 7-day point prevalence abstinence (PPA) from all nicotine and tobacco use | Self-report of no nicotine and tobacco use over the past 7 days, biochemically confirmed via saliva cotinine. Will test for statistical differences between arms using a logistic regression, with adjustment for the stratification variables, as well as adjustment for any baseline variables that had a statistically significant difference by study arm and were associated with the outcome (i.e., potential confounders). | At 3-month follow-up | 
| Usability of the Empowered, Queer, Quitting, and Living (EQQUAL) program | Measured by the System Usability Scale. Will be presented descriptively as an average usability score. | At 3-month follow-up | 
| Acceptability of the EQQUAL avatar | Will be assessed using the Agent Persona Instrument, an adapted version of the Robotics Social Attribute Scale, and 4 open-ended, study specific questions. Will be presented descriptively as frequencies and percentages. | At 3-month follow-up | 
| Number of EQQUAL sessions completed | Will be presented descriptively as frequencies and percentages. | Up to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the acceptance of smoking triggers | Assessed by the emotional and physical subscales of the Avoidance and Inflexibility Scale (AIS). Will calculate the change score as 3-month follow-up minus baseline score and use a linear regression model with adjustment for the baseline value of the measure of interest and for the stratification variables, as well as adjustment for any baseline variables that had a statistically significant difference by study arm and were associated with the outcome. | Baseline through 3-month follow-up | 
| Changes in psychological flexibility | Assessed by the short version of the Multidimensional Psychological Flexibility Inventory (MPFI). Will calculate the change score as 3-month follow-up minus baseline score and use a linear regression model with adjustment for the baseline value of the measure of interest and for the stratification variables, as well as adjustment for any baseline variables that had a statistically significant difference by study arm and were associated with the outcome. | Baseline through 3-month follow-up | 
| Changes in valued living | Assessed by the Valuing Questionnaire. Will calculate the change score as 3-month follow-up minus baseline score and use a linear regression model with adjustment for the baseline value of the measure of interest and for the stratification variables, as well as adjustment for any baseline variables that had a statistically significant difference by study arm and were associated with the outcome. | Baseline through 3-month follow-up | 
| Differences in 3-month smoking outcomes between those with high versus low baseline readiness to quit | Will be presented descriptively as frequencies and percentages. | Baseline through 3-month follow-up | 
| Differences in 3-month smoking outcomes between those who identify as gender minority versus those who don't | Will be presented descriptively as frequencies and percentages. | Baseline through 3-month follow-up |