Clinical trial NCT06386432: EQQUAL-NM for the Promotion of Smoking Cessation in Sexual and Gender Minority Young Adults in New Mexico
Official title: Culturally-Tailored, Avatar-Led MHealth Intervention to Aid Smoking Cessation Among Sexual and Gender Minority Young Adults in New Mexico
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cigarette Smoking-Related Carcinoma
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: National Cancer Institute Center to Reduce Cancer Health Disparities
name: New Mexico State University
First posted: 2024-04-26
Enrollment: 120
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 clinical trial assesses the acceptability and efficacy of Empowered, Queer, Quitting, and Living--New Mexico (EQQUAL-NM), a smoking cessation intervention for sexual and gender minority young adults in New Mexico. Smoking prevalence among sexual and gender minority (SGM) adults in New Mexico is more than twice as high as non-SGM adults. Helping young adult tobacco users to quit is critical, yet there have been few efforts to develop tailored treatments specifically for this population. EQQUAL-NM is a digital smoking cessation intervention designed specifically for SGM young adult smokers in New Mexico and may help them quit smoking.

Detailed description: OUTLINE:

Participants are randomized to 1 of 2 groups.

GROUP I: Participants receive access to a self-guided, smartphone app-delivered quit smoking program, called EQQUAL-NM (Program A) that helps explore personal values and teaches participants about smoking triggers and skills to help them manage cravings and accept thoughts and feelings related to smoking. Participants receive text message reminders and prompts on study. Some participants also undergo collection of a saliva sample during follow-up.

GROUP II: Participants receive access to a self-guided, smartphone app-delivered quit smoking program, called EQQUAL-NM (Program B) that is based on current clinical practice guidelines for tobacco cessation to help them quit smoking. This program helps with quit advice, tracking progress on quitting smoking, and managing cravings. Participants receive text message reminders and prompts on study. Some participants also undergo collection of a saliva sample during follow-up.

After completion of study intervention, patients are followed up at 3 months.

Eligibility criteria: Inclusion Criteria:

* Self-identify being between 18 and 30 years of age
* 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)
* Currently reside in New Mexico, with a New Mexico mailing address, and anticipate remaining in New Mexico for the duration of the study (3 months)
* Self-report smoking at least 1 cigarette per week in the 30 days prior to screening
* Own an Android phone or iPhone
* Have at least weekly internet access for the next three months
* Willing and able to stream audio and video for this study
* Current use of a personal email account
* Current use of text messaging
* Interested in participating in the study for themselves (versus \[vs\] someone else)
* Self-report that they have not participated in one of Fred Hutch's/NMSU's prior smoking cessation studies
* Understand and agree to the conditions of compensation
* Currently not incarcerated
* Participants must be willing to use the assigned intervention program, complete the study assessments, and agree to the online consent form in English

Exclusion Criteria:

* Current use of other tobacco cessation treatments at the time of screening, including pharmacotherapy or behavioral support (but initiating these treatments during the study is allowed)
* Member of the same household as another research participant
* Previous use of the National Cancer Institute (NCI) QuitGuide app
* Google voice number as sole phone number
* Does not pass study fraud prevention protocol

Primary outcomes:
measure: Participant satisfaction
timeFrame: At 3-month follow-up
measure: Number of logins to the assigned application
timeFrame: Up to 3-month follow-up
Secondary outcomes:
measure: Self-reported 7-day point prevalence abstinence (PPA) from all nicotine and tobacco products
timeFrame: At 3 months
measure: Biochemically confirmed 7-day point prevalence abstinence (PPA) from all nicotine/tobacco products
timeFrame: At 3 months
measure: Self-reported 30-day PPA from all nicotine/tobacco products
timeFrame: At 3 months
measure: Biochemically confirmed 30-day PPA from all nicotine/tobacco products
timeFrame: At 3 months
measure: Self-reported 7-day PPA from cigarette smoking
timeFrame: At 3 months
measure: Self-reported 30-day PPA from cigarette smoking
timeFrame: At 3 months
measure: Change in Contemplation Ladder scores
timeFrame: At baseline and at 3-month follow-up
measure: Change in acceptance of tobacco-use triggers
timeFrame: At baseline and at 3-month follow-up
measure: Change in values-guided action
timeFrame: At baseline and at 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: