Forward to Quit: A Person-centered Mobile Technology Intervention for Smoking Cessation Among Transgender Adults

N/AActive Not RecruitingNCT07181551

University of Colorado, Denver47 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Smoking Cessation

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Intervention Acceptability

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.

Time frame: 3 months post-baseline

Intervention feasibility

Feasibility will be met if retention rates are at least 80%.

Time frame: 3 months post-baseline

Remote biochemical data collection acceptability

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.

Time frame: 3 month post-baseline

Remote biochemical data collection feasibility

Completion rate (percentage of eligible participants who submit biochemical samples for verification of tobacco abstinence)

Time frame: 3 months post-baseline

Secondary Outcomes

Smoking cessation

Participants will be categorized as abstinent or not abstinent based on self-report.

Time frame: 3 month post-baseline

Conceptual model covariates

Nicotine dependence and other conceptual model covariates will be assessed with validated survey items.

Time frame: 3 months post-baseline

Forward to Quit: A Person-centered Mobile Technology Intervention for Smoking Cessation Among Transgender Adults

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes