A Pilot Trial of a Smoking Cessation App in People Living With HIV (PLWH)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Biochemically Verified 7-day Point Prevalence Smoking/Tobacco Abstinence
研究概览
简要总结
The overall goal of this pilot study is to evaluate the feasibility of the Lumme smartphone app for smoking cessation in people living with HIV (PLWH) and evaluate its effect on smoking cessation. Mobile health (mHealth) technology can be used for achieving health equity in vulnerable groups because it is a widely available and relatively inexpensive tool for health behavior change and can be adapted to meet the needs of its end-users. Therefore, a mHealth intervention such as the Lumme App proposed through this study is timely, relevant, scalable and likely to improve health outcomes in PLWH who smoke.
详细描述
Of the approximately one million persons living with HIV (PLWH) in the United States (U.S.), it is estimated that between 34-47% smoke cigarettes, around three times the prevalence (12.5%) observed in the general U.S. adult population. Consequently, PLWH experience substantial tobacco-related morbidity and mortality. In PLWH, after achieving and maintaining a suppressed viral load, smoking cessation is the next most important health behavior to maximize both quality of life and life expectancy. Given the high prevalence of cigarette smoking among PLWH and the benefit of smoking cessation, there is an urgent need for swift action to intervene to reduce tobacco use rates. However, evidence to improve tobacco cessation among PLWH is inadequate. Given the need for improving smoking cessation in PLWH, and the great promise of mHealth tools, this research study will assess smoking behaviors in people living with HIV and the subsequent efficacy of mHealth intervention for improving tobacco cessation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
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 old
- •own an Android smartphone
- •understand and read English
- •not pregnant or breastfeeding
- •permanent contact information
- •smokes greater than or equal to 5 cigarettes per day for the past 30 days
- •interested in quitting smoking within 30 days
- •blow ≥ 6 carbon monoxide (CO) into a breath analyzer at baseline
排除标准
- •self-report being HIV-negative or unknown status
- •pregnant, breastfeeding, or planning to become pregnant during the study period
- •planning to move within 3 months of enrollment
- •a positive history of a medical condition that precludes use of the nicotine patch
- •current use of nicotine replacement therapy or other smoking cessation medications
- •current enrollment in another smoking cessation program
- •blows ≤ 5 CO into a breath analyzer at baseline.
结局指标
主要结局
Percentage of Participants With Biochemically Verified 7-day Point Prevalence Smoking/Tobacco Abstinence
时间窗: Baseline, 12 weeks follow up
7-day point prevalence abstinence was calculated as the percentage of participants who reported no smoking/tobacco use in the 7 days prior to their 12-week follow-up visit biochemically verified by exhaled Carbon Monoxide (eCO) collected at 12 weeks. Participants with eCO levels \<6 parts per million (ppm) at 12 weeks were classified as abstinent while participants with eCO levels ≥6ppm at 12 weeks were classified as not abstinent.
次要结局
- Percentage of Participants With Self-reported 7-day Point Prevalence Abstinence at 12 Weeks(Baseline, 12 weeks follow up)
- CAGE Substance Abuse Screening Tool Score at Baseline(Baseline)
- Change in eCO in Ppm From Baseline to 12-week Follow-up(Baseline to 12-week Follow-up)
- Self-reported Number of Cigarettes Smoked Daily at Baseline(Baseline)
- Change in Center for Epidemiologic Studies Depression Scale (CES-D) Score(Baseline, 12-week Follow-up)
研究者
Rebecca Schnall, RN, MPH, PhD
Professor of Disease Prevention and Health Promotion (in Nursing)
Columbia University