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Completed

NCT Number: NCT05847673

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

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.

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Key information

Conditions

Cigarette Smoking-Related Carcinoma

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Online Smoking Cessation Intervention

Behavioral

Receive EQQUAL A intervention

Other names: Smoking and Tobacco Use Cessation Intervention

Questionnaire Administration

Other

Ancillary studies

Health Promotion and Education

Other

Receive motivational messages and smoking cessation information via SMS text messages

Primary outcomes

  1. Overall satisfaction

    Time frame: At 3-month follow-up

    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).

  2. Average change in Contemplation Ladder scores

    Time frame: Baseline through 3-month follow-up

    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).

  3. Reduction in cigarettes smoked per day

    Time frame: Baseline through 3-month follow-up

    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).

  4. 7-day point prevalence abstinence (PPA) from all nicotine and tobacco use

    Time frame: At 3-month follow-up

    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).

  5. Usability of the Empowered, Queer, Quitting, and Living (EQQUAL) program

    Time frame: At 3-month follow-up

    Measured by the System Usability Scale. Will be presented descriptively as an average usability score.

  6. Acceptability of the EQQUAL avatar

    Time frame: At 3-month follow-up

    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.

  7. Number of EQQUAL sessions completed

    Time frame: Up to 3 months

    Will be presented descriptively as frequencies and percentages.

Secondary outcomes

  1. Changes in the acceptance of smoking triggers

    Time frame: Baseline through 3-month follow-up

    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.

  2. Changes in psychological flexibility

    Time frame: Baseline through 3-month follow-up

    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.

  3. Changes in valued living

    Time frame: Baseline through 3-month follow-up

    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.

  4. Differences in 3-month smoking outcomes between those with high versus low baseline readiness to quit

    Time frame: Baseline through 3-month follow-up

    Will be presented descriptively as frequencies and percentages.

  5. Differences in 3-month smoking outcomes between those who identify as gender minority versus those who don't

    Time frame: Baseline through 3-month follow-up

    Will be presented descriptively as frequencies and percentages.

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Collaborators

  • The Leonard and Norma Klorfine Foundation

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 8, 2023
Registry last updated
Jul 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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