Pilot RCT to Test the Integrated mHealth App Intervention (SiS-H) for Smoking Cessation for People With HIV
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- App usage
研究概览
简要总结
The present study is a pilot randomized controlled trial (RCT) that seeks to test the feasibility, acceptability, process outcomes, and exploratory outcomes of a newly integrated, app-based smoking cessation treatment (SiS-H, which stands for "Smiling instead of Smoking for people with HIV") for people with HIV who smoke. This treatment will be compared to onboarding to the National Cancer Institute's smartphone app "QuitGuide" (QG). Persons with HIV who smoke and are engaged in HIV clinical care (n=64) will be randomized (1:1) to smoking cessation support via SiS-H vs. "QuitGuide".
详细描述
The team recently developed an mHealth intervention that integrates (1) the "Smiling instead of Smoking" (SiS) app, a conceptually-grounded, iteratively developed smoking cessation smartphone app, (2) a successful face-to-face smoking cessation treatment for smokers with HIV, called QUIT, and (3) Life Steps, an efficacious brief intervention to promote adaptive engagement in HIV care. The new integrated treatment emphasizes protecting the experience of positive emotions among smokers with HIV as they navigate the process of quitting smoking and supports smoking self-efficacy by engaging participants in app-based activities. Guidance and support for engaging with the app are provided through two face-to-face sessions.
The present study is a pilot randomized controlled trial (RCT) that seeks to test the feasibility, acceptability, process outcomes and exploratory outcomes of this new treatment, called SiS-H, compared to onboarding to the National Cancer Institute's smartphone app "QuitGuide" (QG). Smokers with HIV engaged in HIV clinical care (n=64) will be randomized (1:1) to smoking cessation support via SiS-H vs. the National Cancer Institute's smartphone app "QuitGuide" (QG).
Smoking cessation support will last 8 weeks and will consist of face-to-face interactions with study staff about navigating their assigned smoking cessation app and brief smoking cessation information. Participants will be offered nicotine replacement patches but will not be required to use them.
Study assessments will consist of online surveys (baseline, 2, 6, and 12 weeks post-quit), and biochemical tests of smoking status (baseline, 12 weeks post-quit). Data will be extracted from the medical record, with participants' permission.
The aims of the study are:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •18+ years of age
- •current smoker, who has smoked at least 100 cigarettes lifetime, and smokes at least weekly
- •HIV positive, by self-report
- •currently engaged in HIV clinical care (i.e., saw an HIV care provider within the last year)
- •willing to let study staff look at medical record to extract HIV-relevant information (e.g., CD4 T cell count)
- •willing to make a quit attempt as part of this study
- •willing to give permission to study staff to look at app usage for the assigned smoking cessation app
- •willing and able to comply with study procedures
排除标准
- •does not own a smartphone
- •does not have daily access to the owned smartphone
研究组 & 干预措施
QuitGuide
Participants will be onboarded to the smartphone app "QuitGuide" (QG), and will be asked to use it for 8 weeks while they quit smoking.
干预措施: QuitGuide (Behavioral)
Smiling instead of Smoking - HIV
Participants will be onboarded to the smartphone app "Smiling instead of Smoking - HIV" (SiS-H), and will be asked to use it for 8 weeks while they quit smoking.
干预措施: Smiling instead of Smoking - HIV (Behavioral)
结局指标
主要结局
App usage
时间窗: Continuously logged in the app from baseline (2 weeks pre-quit) to end of treatment (6 weeks post-quit).
Number of days participants used the assigned app during the prescribed period of app use (i.e., 8 weeks for both apps). App usage is passively recorded by the app, which time-stamps every interaction with the app.
App Usage
时间窗: Continuously logged in the app from baseline (2 weeks pre-quit) to end of treatment (6 weeks post-quit).
Number of days participants used the assigned app during the prescribed period of app use (i.e., 8 weeks for both apps). App usage is passively recorded by the app, which time-stamps every interaction with the app.
次要结局
- Smoking Self-Efficacy Questionnaire (SEQ-12)(Measured at baseline, week 4 (2 weeks post-quit), week 8 (6-weeks post-quit))
- Brief Questionnaire of Smoking Urges (QSU)(Measured at baseline, week 4 (2 weeks post-quit), week 8 (6-weeks post-quit))
- Time Spent Applying Content(Measured at week 4 (2 weeks post-quit) and week 8 (6-weeks post-quit))
- Expected App Usage(Assessed at end of treatment (6 weeks post-quit))
- Use of Smoking Cessation Strategies(Assessed at end of treatment (6 weeks post-quit))
- Satisfaction With Smoking Cessation Support(Assessed at end of treatment (6 weeks post-quit))
- App Usability Rating, System Usability Scale (SUS)(Assessed at end of treatment (6 weeks post-quit))
- User Mobile Application Rating (uMARS)(Assessed at end of treatment (6 weeks post-quit))
- Positive Affect - Positive and Negative Affect Schedule (PANAS)(Measured at baseline, week 4 (2 weeks post-quit), week 8 (6-weeks post-quit))
- Negative Affect - Positive and Negative Affect Schedule (PANAS)(Measured at baseline, week 4 (2 weeks post-quit), week 8 (6-weeks post-quit))
- Attitudes Towards Smoking Scale (ATS) - Adverse Effects of Smoking Sub-scale(Measured at baseline, week 4 (2 weeks post-quit), week 8 (6-weeks post-quit))
- Attitudes Towards Smoking Scale (ATS) - Psychoactive Benefits of Smoking Sub-scale(Measured at baseline, week 4 (2 weeks post-quit), week 8 (6-weeks post-quit))
- Attitudes Towards Smoking Scale (ATS) - Pleasure of Smoking Sub-scale(Measured at baseline, week 4 (2 weeks post-quit), week 8 (6-weeks post-quit))
- Decisional Balance Inventory (DBI) for Smoking - Negative Expectancies Sub-scale(Measured at baseline, week 4 (2 weeks post-quit), week 8 (6-weeks post-quit))
- Decisional Balance Inventory (DBI) for Smoking - Positive Expectancies Subscale(Measured at baseline, week 4 (2 weeks post-quit), week 8 (6-weeks post-quit))
- Modified Version of the Twenty Statements Test(Measured at baseline, week 4 (2 weeks post-quit), week 8 (6-weeks post-quit))
- Satisfaction with smoking cessation support(Assessed at end of treatment (6 weeks post-quit))
- App usability rating, System Usability Scale (SUS)(Assessed at end of treatment (6 weeks post-quit))
- User mobile application rating (uMARS)(Assessed at end of treatment (6 weeks post-quit))
- Smoking Self-Efficacy Questionnaire (SEQ-12)(Measured at baseline, week 4 (2 weeks post-quit), week 8 (6-weeks post-quit))
- Time spent applying content(Measured at week 4 (2 weeks post-quit) and week 8 (6-weeks post-quit))
- Expected app usage(Assessed at end of treatment (6 weeks post-quit))
- Use of smoking cessation strategies(Assessed at end of treatment (6 weeks post-quit))
- Positive affect - Positive and Negative Affect Schedule (PANAS)(Measured at baseline, week 4 (2 weeks post-quit), week 8 (6-weeks post-quit))
- Negative affect - Positive and Negative Affect Schedule (PANAS)(Measured at baseline, week 4 (2 weeks post-quit), week 8 (6-weeks post-quit))
- Attitudes Towards Smoking Scale (ATS) - pleasure of smoking sub-scale(Measured at baseline, week 4 (2 weeks post-quit), week 8 (6-weeks post-quit))
- Brief Questionnaire of Smoking Urges (QSU)(Measured at baseline, week 4 (2 weeks post-quit), week 8 (6-weeks post-quit))
- Modified version of the Twenty Statements Test(Measured at baseline, week 4 (2 weeks post-quit), week 8 (6-weeks post-quit))
- Attitudes Towards Smoking Scale (ATS) - adverse effects of smoking sub-scale(Measured at baseline, week 4 (2 weeks post-quit), week 8 (6-weeks post-quit))
- Attitudes Towards Smoking Scale (ATS) - psychoactive benefits of smoking sub-scale(Measured at baseline, week 4 (2 weeks post-quit), week 8 (6-weeks post-quit))
- Decisional Balance Inventory (DBI) for Smoking - negative expectancies sub-scale(Measured at baseline, week 4 (2 weeks post-quit), week 8 (6-weeks post-quit))
- Decisional Balance Inventory (DBI) for Smoking - positive expectancies subscale(Measured at baseline, week 4 (2 weeks post-quit), week 8 (6-weeks post-quit))
研究者
Bettina B. Hoeppner
Associate Professor
Massachusetts General Hospital