Clinical trial NCT05847673: Avatar-Led Digital Therapeutic for Aiding Smoking Cessation in Sexual and Gender Minority Young Adults
Official title: Avatar-Led Digital Therapeutic to Aid Smoking Cessation Among Sexual and Gender Minority Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cigarette Smoking-Related Carcinoma
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: The Leonard and Norma Klorfine Foundation
First posted: 2023-05-08
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall satisfaction
timeFrame: At 3-month follow-up
measure: Average change in Contemplation Ladder scores
timeFrame: Baseline through 3-month follow-up
measure: Reduction in cigarettes smoked per day
timeFrame: Baseline through 3-month follow-up
measure: 7-day point prevalence abstinence (PPA) from all nicotine and tobacco use
timeFrame: At 3-month follow-up
measure: Usability of the Empowered, Queer, Quitting, and Living (EQQUAL) program
timeFrame: At 3-month follow-up
measure: Acceptability of the EQQUAL avatar
timeFrame: At 3-month follow-up
measure: Number of EQQUAL sessions completed
timeFrame: Up to 3 months
Secondary outcomes:
measure: Changes in the acceptance of smoking triggers
timeFrame: Baseline through 3-month follow-up
measure: Changes in psychological flexibility
timeFrame: Baseline through 3-month follow-up
measure: Changes in valued living
timeFrame: Baseline through 3-month follow-up
measure: Differences in 3-month smoking outcomes between those with high versus low baseline readiness to quit
timeFrame: Baseline through 3-month follow-up
measure: Differences in 3-month smoking outcomes between those who identify as gender minority versus those who don't
timeFrame: Baseline through 3-month follow-up
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Jaimee Heffner
role: PRINCIPAL_INVESTIGATOR
References: