Forward to Quit: A Person-centered Mobile Technology Intervention for Smoking Cessation Among Transgender Adults (F2Q)

University of Colorado Denver (CU Denver)

Status: Active, not recruiting

Conditions: Smoking Cessation

Treatments: Behavioral: Forward to Quit (F2Q)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07181551

5R34DA058191 (U.S. NIH Grant/Contract)

22-2296

Details and patient eligibility

About

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.

Enrollment: 44 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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44 participants in 1 patient group

F2Q Intervention

Experimental group

Description:

Participants will receive access to the Forward to Quit (F2Q) mHealth smoking cessation intervention tailored for transgender adults

Treatment:

Behavioral: Forward to Quit (F2Q)