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| ID | Type | Description | Link |
|---|---|---|---|
| 5R34DA058191 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| F2Q Intervention | Experimental | Participants will receive access to the Forward to Quit (F2Q) mHealth smoking cessation intervention tailored for transgender adults |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Smoking cessation | Participants will be categorized as abstinent or not abstinent based on self-report. | 3 month post-baseline |
| Conceptual model covariates | Nicotine dependence and other conceptual model covariates will be assessed with validated survey items. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christina Sun, PhD | Universtiy of Colorado Anschutz Medical Campus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | 80045 | United States |
Unsure of where or how IPD would be shared
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| 3 months post-baseline |