Design and Testing of a mHealth App for Ambivalent Smokers Living With HIV: A Randomized Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Intervention (App) Utilization
研究概览
简要总结
This pilot study will assess the acceptability and feasibility a novel mHealth app designed for smokers who are ambivalent about quitting and have been diagnosed with HIV.
详细描述
This study will use a randomized, parallel, two-arm trial to compare outcomes between people assigned to use a "standard care" mHealth app versus a similar app with additional content targeted to people living with HIV. A total of up to 50 people will be enrolled and followed for three months to assess outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- Double (Participant, Outcomes Assessor)
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 or older;
- •Comfortable speaking and reading in English;
- •Smoked at least 100 cigarettes in their lifetime;
- •Smoked, even a puff, in the past 7 days;
- •Smoked at least 5 cigarettes a day;
- •Are interested in quitting smoking someday, but not in the next month;
- •Have an iPhone Operating System (iOS) or Android smart phone which they use at least weekly;
- •Are willing to upgrade their phone operating system, if needed;
- •Agree to download and try the app;
- •Do not use Virtual Private Network (VPN) on their smart phone;
- •Live in the United States and have a valid U.S.-based mailing address and phone number;
- •Have been diagnosed with HIV
排除标准
- •Refusing to answer all screening questions
- •History of dementia or psychosis
- •Visual impairments that preclude their ability to view content on their smart phone and lack adaptive devices to view content
- •Contraindications for nicotine replacement therapy (NRT) use (e.g., based on medical history or daily smoking level)
研究组 & 干预措施
Control
mHealth app consisting of standard, best-practice information and guidance to help people stop smoking.
干预措施: mHealth Intervention (Device)
Experimental
mHealth app consisting of standard, best-practice information and guidance to help people stop smoking + additional experimental content targeted to smokers living with HIV who are ambivalent about quitting smoking.
干预措施: mHealth Intervention (Device)
结局指标
主要结局
Intervention (App) Utilization
时间窗: 3 months post-enrollment
Number of unique app user-sessions
次要结局
- App Utilization - Cumulative Days of Use(3 month follow-up)
- Earned Nicotine Replacement Therapy (NRT)(3 month follow-up)
- Number of Cigarettes Smoked Per Day(3 month follow-up)
- App Installation and Use(3 month follow-up)
- Self-reported 24-hour Quit Attempt(3 months post-enrollment)
- Satisfaction With App Content and Advice(3 month follow-up)
- Not Smoking (Even a Puff) in the Last 7 Days(3-months post-enrollment)
- Self-efficacy for Quitting Smoking(3 month follow-up)
- Proportion Who Request Nicotine Replacement Therapy(3 month follow-up)
- Motivation for Quitting Smoking(3 month follow-up)
- Satisfaction With App Content and Advice(1 month follow-up)
- Number of Cigarettes Smoked Per Day(1 month follow-up)
- Motivation for Quitting Smoking(1 month follow-up)
- Self-efficacy for Quitting Smoking(1 month follow-up)
研究者
Jennifer McClure
Director of Research, Faculty & Development
Kaiser Permanente