Quit For Life (QFL): Smoking Cessation Among Chinese Smokers Living With HIV
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 4
- 主要终点
- Number of Participants With Biochemically Verified Smoking Cessation
研究概览
简要总结
The purpose of this two arm randomized clinical trial (RCT) is to test if a smoking cessation program called Quit for Life (QFL) which was developed by the investigators is effective for patients in China with HIV who smoke. This program is designed to suit the needs of people with HIV who smoke in China.
Eligible participants who provide consent will be randomized into either the QFL or the Control group.
The QFL group will receive a quit smoking program that lasts for 8 weeks with two parts-
- 4 sessions with a trained counselor who will discuss the participants' smoking habits and strategies to help them quit.
- Messages sent to the participants' cell phone using WeChat.
The Control group will not have sessions with a trained counselor or receive messages sent to their cell phone.
Both groups will be offered nicotine replacement therapy and a self-help guide with information about quitting smoking.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •HIV seropositive (by being at the HIV clinic and receiving care)
- •Receiving ART treatment from the clinic (by being at the HIV clinic and receiving care)
- •Smokes ≥ 5 cigarettes per day
- •Able to speak and read in Mandarin Chinese
- •Self-reported anticipate to receive ART treatment from the clinic for at least 9 months
- •Own a cell phone
- •Be willing to set a quit date within 1 month after baseline assessment
排除标准
- •Self-reported using other smoking cessation program or medication
- •Having a serious health problem that may make them unsuitable to stay in the study
结局指标
主要结局
Number of Participants With Biochemically Verified Smoking Cessation
时间窗: 12 weeks
Defined as not smoking during the previous 7 days, not even a puff, validated by measuring CO level (\<8ppm) in the exhaled air
次要结局
- Change in Number of Cigarettes Smoked in the Previous 30 Days at 8 Weeks(baseline, 8 weeks)
- Number of Quit Attempts at 8 Weeks(8 weeks)
- Change in Number of Cigarettes Smoked in the Previous 30 Days at 12 Weeks(baseline, 12 weeks)
- Adherence to Antiretroviral Treatments (ART) at 8 Weeks(8 weeks)
- Quality of Life (QOL) in the Dimensions of Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at 12 Weeks(12 weeks)
- Number of Quit Attempts at 12 Weeks(12 weeks)
- Number of Participants That Self Reported Smoking Cessation at 8 Weeks(8 weeks)
- Number of Participants That Self Reported Smoking Cessation at 12 Weeks(12 weeks)
- Adherence to Antiretroviral Treatments (ART) at 12 Weeks(12 weeks)