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

NCT ID: NCT07181551

Last Updated: 2025-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-12-31

Study Completion Date

2031-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Smoking Cessation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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F2Q Intervention

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

Group Type EXPERIMENTAL

Forward to Quit (F2Q)

Intervention Type BEHAVIORAL

A mobile health (mHealth) smoking cessation intervention designed specifically for transgender adults. Delivered via a secure website accessible by smartphone or tablet.

Interventions

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Forward 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christina Sun, PhD

Role: PRINCIPAL_INVESTIGATOR

Universtiy of Colorado Anschutz Medical Campus

Central Contacts

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Christina Sun, PhD

Role: CONTACT

303-724-3601

Other Identifiers

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5R34DA058191-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

22-2296

Identifier Type: -

Identifier Source: org_study_id

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