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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
125
Receive EQQUAL A intervention
Receive EQQUAL B intervention
Ancillary studies
Receive motivational messages and smoking cessation information via SMS text messages
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: At 3-month follow-up
Number of EQQUAL sessions completed
Will be presented descriptively as frequencies and percentages.
Time frame: Up to 3 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline through 3-month follow-up
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