Forward to Quit: A Person-centered Mobile Technology Intervention for Smoking Cessation Among Transgender Adults
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Intervention Acceptability
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
F2Q Intervention
Participants will receive access to the Forward to Quit (F2Q) mHealth smoking cessation intervention tailored for transgender adults
干预措施: Forward to Quit (F2Q) (Behavioral)
结局指标
主要结局
Intervention Acceptability
时间窗: 3 months post-baseline
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.
Intervention feasibility
时间窗: 3 months post-baseline
Feasibility will be met if retention rates are at least 80%.
Remote biochemical data collection acceptability
时间窗: 3 month post-baseline
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.
Remote biochemical data collection feasibility
时间窗: 3 months post-baseline
Completion rate (percentage of eligible participants who submit biochemical samples for verification of tobacco abstinence)
次要结局
- Conceptual model covariates(3 months post-baseline)
- Smoking cessation(3 month post-baseline)