Development and Pilot Testing of the Sense2Quit App
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Biochemically Verified 7-day Point Prevalence Smoking/Tobacco Abstinence at 12 Weeks
研究概览
简要总结
This is a pilot randomized controlled trial to examine the feasibility, acceptability and preliminary efficacy of the Sense2Quit App in a sample of 60 PLWH who smoke.
详细描述
The estimated 40-70% of persons living with HIV (PLWH) who smoke cigarettes experience substantial tobacco-related morbidity and mortality. For PLWH, apart from achieving and maintaining a suppressed viral load, tobacco cessation is the most important health behavior they can undertake to maximize both quality of life and life expectancy. However, the currently available evidence for improving tobacco cessation among PLWH is inadequate. Few tobacco cessation interventions have been tested among PLWH, and of those which have, there is 'very low' quality evidence that they were effective in the short-term and 'moderate' quality evidence indicating similar outcomes to controls in the long-term. Thus, it is critical to develop evidence-based tobacco cessation interventions to address the complex and unique needs of PLWH. In response to this need, the investigators propose to develop a mobile intervention for PLWH who smoke building on Sense2Quit, a multi-component intervention that links a smartphone app to a smartwatch to provide real-time quit reminders to curtail relapses and avoid potential trigger. This real-time feedback is critical especially in the first few weeks of a quit attempt.
The proposed Sense2Quit intervention for PLWH who smoke cigarettes is a novel and evidence-driven intervention using mobile technology to improve tobacco cessation. This will be the first study to develop and pilot test an innovative tobacco cessation intervention for PLWH. The final product of this study will be the basis for an R01 application to conduct a large-scale efficacy study for this population.
The investigators are confident that the proposed intervention will be a high impact intervention for improving tobacco cessation among PLWH and have long-term implications for overall improvement in the public's health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
Intervention assignment will be masked to participants only
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
- •PLWH confirmed through medical records or pill bottles for antiretroviral therapy (ART)medications.
- •≥ 18 years of age;
- •Own an Android smartphone;
- •Understand and read English;
- •Not pregnant or breastfeeding (due to contraindications for Nicotine Replacement Therapy [NRT]);
- •Permanent contact information;
- •Smokes ≥5 cigarettes per day for the past 30 days;
- •Interested in quitting smoking within 30 days;
- •Blows ≥5 ppm eCO into a breath analyzer at baseline.
排除标准
- •Use of tobacco products other than cigarettes (i.e. cigars, piped tobacco, chew, snuff)
- •Planning to move within 3 months of enrollment;
- •Positive history of a medical condition that precludes nicotine patch use;
- •Current use of NRT or other smoking cessation medications (e.g., Chantix or Zyban);
- •Current enrollment in another smoking cessation program.
- •Alcohol dependence measured through the AUDIT-C
- •A household member is also participating in the Sense2Quit study (due to study contamination).
研究组 & 干预措施
Intervention (App Arm)
Participants randomized to the intervention arm will receive access to the Sense2Quit App (A multi-component intervention that links a smartphone app to a smartwatch to provide real-time quit reminders to curtail relapses and avoid potential triggers), standard smoking cessation counseling, and nicotine replacement therapy.
干预措施: Sense2Quit App (Behavioral)
Control
Participants randomized to the control arm will receive standard smoking cessation counseling and referral to quitline.
结局指标
主要结局
Percentage of Participants With Biochemically Verified 7-day Point Prevalence Smoking/Tobacco Abstinence at 12 Weeks
时间窗: 12 weeks after baseline (or quit date if later than baseline visit)
7-day point prevalence abstinence is calculated as the percentage of participants who reported no smoking/tobacco use in the 7 days prior to their 12-week follow-up visits biochemically verified by exhaled Carbon Monoxide (eCO) collected at 4 and 12 weeks via breathalyzer (Micro+TM basic Smokerlyzer®). At each of the 2 follow-up timepoints, participants with eCO levels \<5 parts per million (ppm) will be classified as abstinent while participants with eCO levels ≥5ppm will be classified as not abstinent.
次要结局
未报告次要终点
研究者
Rebecca Schnall, RN, MPH, PhD
Mary Dickey Lindsay Professor of Disease Prevention and Health Promotion
Columbia University