An Innovative Telephone Intervention for HIV-Positive Smokers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 706
- 试验地点
- 4
- 主要终点
- Proportion of participants in the two intervention groups who are abstinent as measured by point prevalence
研究概览
简要总结
The goal of this research study is to look at treatments that may help individuals who have HIV/AIDS to stop smoking.
详细描述
If you agree to take part in this study, researchers will first do a test to learn what the CO level of your blood is. To do this test, you will be asked to blow into a cardboard tube. If the test finds that you are ineligible, you will not be able to continue on this study.
If you are found to be eligible, you will be enrolled in this study and asked to complete an interview that should last about 1 hour. During this interview, you will be asked basic questions, such as your age, education level, and smoking history. You will also be asked questions about your mood, quality of life, and stress. You will then be asked to complete a short test that involves completing some basic tasks, such as remembering several words and drawing a simple shape. This test, which will take about 2-5 minutes to complete, is used to measure attention and concentration.
You will then be randomly assigned (as in the toss of a coin) to one of two treatment groups. There is an equal chance of being assigned to either group.
If you are assigned to Group 1, you will receive advice from your physician/provider to stop smoking and written materials designed to help you quit smoking.
If you are assigned to Group 2, you will receive the advice from your physician/provider to quit smoking and the written materials, but you also be given a cell phone and be called 11 times over the course of an 12 to 13 week period. During these calls, which will last about 10 minutes, you will be asked to talk about smoking and quitting smoking. Access to a hotline number that you can call to speak with a counselor about quitting smoking will also be given to you if you are assigned to group 2. Participants in Group 1 will not get the number to the hotline. There is a limited number of prepaid minutes on the phone, so participants who receive a cell phone should make an effort to save enough minutes to complete this study.
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-positive
- •18 years of age or older
- •Current, regular smoker (> 5 cigarettes per day for the past 30 days, breath CO of > 7ppm)
- •English or Spanish speaking
- •Able to provide written informed consent to participate
- •Willing to set a quit date within 1 week of baseline assessment
排除标准
- •Physician deemed ineligibility based on medical (HIV related or other condition) or psychiatric condition
- •Current participation in another smoking cessation program
结局指标
主要结局
Proportion of participants in the two intervention groups who are abstinent as measured by point prevalence
时间窗: 1 year after quit date
次要结局
未报告次要终点
