NCT07181551

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
67mo left

Started Oct 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress11%
Oct 2025Dec 2031

First Submitted

Initial submission to the registry

September 11, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 18, 2025

Completed
26 days until next milestone

Study Start

First participant enrolled

October 14, 2025

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2030

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2031

Last Updated

March 20, 2026

Status Verified

March 1, 2026

Enrollment Period

5.1 years

First QC Date

September 11, 2025

Last Update Submit

March 19, 2026

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (4)

  • 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.

    3 months post-baseline

  • Intervention feasibility

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

    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.

    3 month post-baseline

  • Remote biochemical data collection feasibility

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

    3 months post-baseline

Secondary Outcomes (2)

  • Smoking cessation

    3 month post-baseline

  • Conceptual model covariates

    3 months post-baseline

Study Arms (1)

F2Q Intervention

EXPERIMENTAL

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

Behavioral: Forward to Quit (F2Q)

Interventions

Forward to Quit (F2Q)BEHAVIORAL

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

F2Q Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Identify with a gender different from sex assigned at birth
  • + 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Christina Sun, PhD

    Universtiy of Colorado Anschutz Medical Campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2025

First Posted

September 18, 2025

Study Start

October 14, 2025

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2031

Last Updated

March 20, 2026

Record last verified: 2026-03

Locations

US(1)