退出问题是人类免疫缺陷病毒混合试验 (QMH)
艾滋病毒患者中戒烟的数字治疗方法的混合试验
The purpose of this study is to compare the advantages and disadvantages of two approaches for quitting smoking among people living with HIV (PWH). Participants will complete a 24- week (~6-month) study where the Participants will be assigned to one of two smartphone apps to help with quitting smoking. Regardless of the group participants are assigned to, they will also receive a combination of nicotine replacement therapy (patches and gums) that have been shown to help people quit smoking. The main questions this study aims to answer are:
Participants will complete 6 video call visits over about 6 months. Participants will install their assigned smoking cessation app onto their phone and will be asked to use the app for the duration of the study along with their provided Nicotine Replacement Therapy (NRT) products. During the study visits, participants will meet with study staff to complete questionnaires and interviews. Participants may be asked to provide breath and saliva samples to measure the level of carbon monoxide and nicotine.
研究概览
地位
详细说明
Tobacco use has alarmingly high rates among people with Human Immunodeficiency Virus (HIV) (PWH), 43% compared with 15% in the general population. Due to the development of highly effective treatments for HIV and the resulting increased longevity among PWH, this population now loses more life years to smoking than to HIV infection itself. Novel and effective models to deliver wider reaching smoking cessation interventions for PWH are highly needed and indicated as a priority for National Institute of Health. Digital therapeutics (DTx) may be a novel, scalable, and highly available approach for engaging and treating smoking in this population. However, although DTx for smoking cessation have been shown effective in the general population, no large trial to date has examined the effectiveness of a tailored DTx for smoking cessation in PWH, and no implementation science work has examined barriers and facilitators of implementation of DTx for smoking cessation in this population.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Clinical Studies Coordinator
- 电话号码：(984) 377-4306
- 邮箱：caitlyn.arnold@advocatehealth.org
研究联系人备份
- 姓名：Roger Vilardaga Vierra, Ph.D.
- 电话号码：336-716-1495
- 邮箱：Roger.Vilardaga@wfusm.edu
学习地点
-
-
North Carolina
-
Winston-Salem、North Carolina、美国、27101
- 招聘中
- Wake Forest University, Implementation Science
-
接触：
- Principal Investigator
- 电话号码：919-439-3498
- 邮箱：Roger.Vilardagaviera@advocatehealth.org
-
接触：
- Clinical Studies Coordinator
- 电话号码：(984)377-4306
- 邮箱：caitlyn.arnold@advocatehealth.org
-
首席研究员：
- Roger Vilardaga
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Self-reported daily cigarette smoking over the past 30 days
- Self-reported HIV status
- Age 18 or older
- Desire to quit smoking
- Willing and medically eligible to use NRT
- Currently receiving HIV care
- Currently owning an Android or iOS smartphone
Exclusion Criteria:
- Current acute psychotic episode or unsafe to participate in the study
- Pregnant or intending to become pregnant in the next 6 months
- Currently receiving any pharmacological and/or behavioral intervention or counseling for smoking cessation
- Any medical condition or medication that could compromise subject safety, as determined by the PIs and/or study physician
- Not able to fluently speak and write in English
- Hearing, comprehension, visual, speech, or motor limitations that preclude study participation
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Learn to Quit - HIV (LTQ-H) App
a smoking cessation Digital Therapeutic (DTx) for people with HIV (PWH) |
LTQ-H consists of 319 screens divided into: (a) HIV-tailored smoking cessation ACT skills, (b) education about tobacco dependence and treatment (USCPG), and (c) NRT psychoeducation and adherence. Content is gradually presented across 28 modules (14 education and 14 skills) that can be completed in 14 days.
其他名称：
|
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有源比较器：QuitStart App
an evidence-based DTx designed for the general population |
This DTx, QuitGuide was adapted from the National Cancer Institute Smokefree.gov Initiative's QuitGuide's 5 modules have the following intervention components: (a) psychoeducation about the impact of smoking on health, (b) setting up a quit date and a quit plan, (c) selecting reasons for quitting, (d) tracking triggers and smoking habits, and (e) tips for quitting.
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Biochemically verified 7-day point prevalence abstinence at 6, 12, 18, and 24-weeks
大体时间：Weeks 6, 12, 18, and 24
|
Abstinence is determined by a self-report of not smoking any cigarettes for greater than or equal to 7 days prior to Weeks 6, 12, 18, and 24 and biochemically verified by an expired carbon monoxide breath test or a cotinine level saliva test at Weeks 6, 12, 18, and 24. Criteria for the bioverification tests to be considered abstinent includes a reading of <6 parts per million using an iCOquit Smokerlyzer carbon monoxide breath test OR a cotinine level of 30 or less ng/ml using an iScreen saliva test. If the participant does not meet both criteria of the self report of 7 or more days of abstinence plus a bioverification test below the thresholds listed above, they are not considered abstinent. As per convention, participants are assumed to be smoking if they report smoking at the time-point, cannot be reached to provide data at the time-point, fail to provide a breath sample at the time-point, or provide a breath sample at the time-point that is greater than or equal to 6 ppm. |
Weeks 6, 12, 18, and 24
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Self-reported 7-day point prevalence abstinence at 6 weeks - the percentage of participants who are abstinent from cigarettes at a given point in time
大体时间：6 weeks
|
Percent of subjects in each group self-reporting no smoking at all for greater or equal to 7 days prior to the timepoint. |
6 weeks
|
|
Self-reported 7-day point prevalence abstinence at 12 weeks - the percentage of participants who are abstinent from cigarettes at a given point in time
大体时间：12 weeks
|
Percent of subjects in each group self-reporting no smoking at all for greater or equal to 7 days prior to the timepoint. |
12 weeks
|
|
Self-reported 7-day point prevalence abstinence at 18 weeks - the percentage of participants who are abstinent from cigarettes at a given point in time
大体时间：18 weeks
|
Percent of subjects in each group self-reporting no smoking at all for greater or equal to 7 days prior to the timepoint. |
18 weeks
|
|
Self-reported 7-day point prevalence abstinence at 24 weeks - the percentage of participants who are abstinent from cigarettes at a given point in time
大体时间：24 weeks
|
Percent of subjects in each group self-reporting no smoking at all for greater or equal to 7 days prior to the timepoint. |
24 weeks
|
|
Self-reported 30-day point prevalence abstinence at 6 weeks - the percentage of participants who are abstinent from cigarettes at a given point in time
大体时间：6 weeks
|
Percent of subjects in each group self-reporting no smoking at all for greater or equal to 30 days but < 30 days prior to the timepoint. |
6 weeks
|
|
Self-reported 30-day point prevalence abstinence at 12 weeks - the percentage of participants who are abstinent from cigarettes at a given point in time
大体时间：12 weeks
|
Percent of subjects in each group self-reporting no smoking at all for greater or equal to 30 days prior to the timepoint. |
12 weeks
|
|
Self-reported 30-day point prevalence abstinence at 18 weeks - the percentage of participants who are abstinent from cigarettes at a given point in time
大体时间：18 weeks
|
Percent of subjects in each group self-reporting no smoking at all for greater or equal to 30 days prior to the timepoint. |
18 weeks
|
|
Self-reported 30-day point prevalence abstinence at 24 weeks - the percentage of participants who are abstinent from cigarettes at a given point in time
大体时间：24 weeks
|
Percent of subjects in each group self-reporting no smoking at all for greater or equal to 30 days prior to the timepoint. |
24 weeks
|
|
Change in average number of cigarettes smoked per day
大体时间：6 weeks
|
Change in self-reported number of cigarettes smoked per day, averaged within groups. |
6 weeks
|
|
Change in average number of cigarettes smoked per day
大体时间：12 weeks
|
Change in self-reported number of cigarettes smoked per day, averaged within groups. |
12 weeks
|
|
Change in average number of cigarettes smoked per day
大体时间：18 weeks
|
Change in self-reported number of cigarettes smoked per day, averaged within groups. |
18 weeks
|
|
Change in average number of cigarettes smoked per day
大体时间：24 weeks
|
Change in self-reported number of cigarettes smoked per day, averaged within groups. |
24 weeks
|
|
Average number of quit attempts
大体时间：6 weeks
|
Average number of quit attempts self-reported per group at the specified time point. Quit attempts are defined by no smoking cigarettes at all for 24 hours or more. |
6 weeks
|
|
Average number of quit attempts
大体时间：12 weeks
|
Average number of quit attempts self-reported per group at the specified time point. Quit attempts are defined by no smoking cigarettes at all for 24 hours or more. |
12 weeks
|
|
Average number of quit attempts
大体时间：18 weeks
|
Average number of quit attempts self-reported per group at the specified time point. Quit attempts are defined by no smoking cigarettes at all for 24 hours or more. |
18 weeks
|
|
Average number of quit attempts
大体时间：24 weeks
|
Average number of quit attempts self-reported per group at the specified time point. Quit attempts are defined by no smoking cigarettes at all for 24 hours or more. |
24 weeks
|
|
Average acceptance of physical smoking cravings
大体时间：6 weeks
|
Average self-reported scores of acceptance of cravings on the physical sensations subscale of the Avoidance and Inflexibility Scale. Scores range from 4-20 with lower scores indicating more acceptance of smoking cravings. |
6 weeks
|
|
Average acceptance of physical smoking cravings
大体时间：12 weeks
|
Average self-reported scores of acceptance of cravings on the physical sensations subscale of the Avoidance and Inflexibility Scale. Scores range from 4-20 with lower scores indicating more acceptance of smoking cravings. |
12 weeks
|
|
Average acceptance of physical smoking cravings
大体时间：18 weeks
|
Average self-reported scores of acceptance of cravings on the physical sensations subscale of the Avoidance and Inflexibility Scale. Scores range from 4-20 with lower scores indicating more acceptance of smoking cravings. |
18 weeks
|
|
Average acceptance of physical smoking cravings
大体时间：24 weeks
|
Average self-reported scores of acceptance of cravings on the physical sensations subscale of the Avoidance and Inflexibility Scale. Scores range from 4-20 with lower scores indicating more acceptance of smoking cravings. |
24 weeks
|
|
Average frequency of app use
大体时间：Weeks 0-24
|
Average frequency of app use over the 24-week study period. Measured by average number of app openings. |
Weeks 0-24
|
|
Average duration of app use
大体时间：Weeks 0-24
|
Average duration of app use over the 24-week study period. |
Weeks 0-24
|
|
Average number of app modules completed
大体时间：Weeks 0-24
|
Average number of app modules completed over the 24-week study period. |
Weeks 0-24
|
合作者和调查者
调查人员
- 首席研究员：Roger Vilardaga Viera, Ph.D.、Wake Forest University Health Sciences
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- IRB00112958
- 7R01CA285331-02 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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