Smoking Cessation
Conditions
Brief summary
This study evaluates the feasibility, acceptability, and preliminary efficacy of "Forward to Quit" (F2Q), a person-centered mobile health (mHealth) smoking cessation intervention designed specifically for transgender adults. The intervention was developed in collaboration with transgender individuals and gender-affirming healthcare providers. The study includes usability testing and a remote single-arm pilot trial. Primary outcomes include feasibility and acceptability of both the intervention and remote biochemical verification of smoking cessation. Secondary outcomes include self-reported and biochemically verified smoking cessation, as well as changes in psychosocial factors such as social support and gender affirmation. The goal is to inform a future large-scale trial and address tobacco-related health disparities in transgender populations.
Interventions
BEHAVIORALForward to Quit (F2Q)
A mobile health (mHealth) smoking cessation intervention designed specifically for transgender adults. Delivered via a secure website accessible by smartphone or tablet.
Sponsors
University of Colorado, Denver
National Institute on Drug Abuse (NIDA)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Identify with a gender different from sex assigned at birth * 18+ years of age * Report smoking at least 5 cigarettes per day * Have smoked 100+ cigarettes in their lifetime * Own a device that can access the Internet (e.g., tablet, smartphone) * Speak English * Be willing to submit biochemical samples to verify cessation * Be willing to use a website-based intervention to help with quit attempt * Be willing to set a quit date within 1 month of baseline assessment * Be willing to complete 3 months post-baseline and 6 months post-baseline assessments
Exclusion criteria
* Do not meet inclusion criteria * Medical conditions precluding use of the carbon monoxide (CO) monitor or salivary cotinine testing * Current use of pharmacotherapies for nicotine dependence * Enrollment in another tobacco cessation program
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intervention Acceptability | 3 months post-baseline | We will assess participants' perceptions of information quality and usefulness as well as overall satisfaction with the intervention. If the average score across all items is \>=6 on a 7-point scale for 90% of participants after using intervention for 3 months, we will consider intervention to be acceptable. |
| Intervention feasibility | 3 months post-baseline | Feasibility will be met if retention rates are at least 80%. |
| Remote biochemical data collection acceptability | 3 month post-baseline | We will measure participants' perceived difficulty, satisfaction, and comfort with remote biochemical verification. If scores are \>=6 on a 7-point scale for 90% of participants, we will consider remote biochemical verification to be acceptable. |
| Remote biochemical data collection feasibility | 3 months post-baseline | Completion rate (percentage of eligible participants who submit biochemical samples for verification of tobacco abstinence) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Smoking cessation | 3 month post-baseline | Participants will be categorized as abstinent or not abstinent based on self-report. |
| Conceptual model covariates | 3 months post-baseline | Nicotine dependence and other conceptual model covariates will be assessed with validated survey items. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORChristina Sun, PhD
Universtiy of Colorado Anschutz Medical Campus
Outcome results
None listed