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临床试验/NCT00502827
NCT00502827已完成不适用

An Innovative Telephone Intervention for HIV-Positive Smokers

M.D. Anderson Cancer Center4 个研究点 分布在 1 个国家目标入组 706 人开始时间: 2004年1月最近更新:
适应症

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

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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