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临床试验/NCT02898597
NCT02898597已完成不适用

Smoking Cessation Intervention for Women With HIV/AIDS

University of Massachusetts, Boston2 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2016年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
49
试验地点
2
主要终点
Number of Participants With Abstinence

研究概览

简要总结

As people with HIV/AIDS live longer, the burden of non-AIDS-related health problems such as cardiovascular diseases and cancers on these people have consistently increased. Smoking is one of the major contributing factors to these health problems and rates of cigarette smoking in this group are substantially higher than those of the general population: 40-70% vs. 17-10%. Especially, women living with HIV/AIDS seem to be more susceptible to the negative consequence of smoking than their male counterparts. They are also less likely to see tobacco dependence treatment for dual stigma associated with both conditions: HIV infection and nicotine addiction. This is a pilot study to develop smoking cessation intervention for these women.

详细描述

Women are at high risk of becoming HIV positive due to biological vulnerabilities, low socioeconomic status, dominant sexual practices of males and epidemiological factors. For example, the risk of being infected with HIV during unprotected sex is two to four times greater for women than for men. With the use of combined antiretroviral therapies, these women now live longer than ever before which now faces the healthcare community with the need for evolving understanding of HIV and aging. However, the burden of non-AIDS related health problems such as cardiovascular diseases and cancers on people living with HIV/AIDS while aging has considerably increased. Smoking is one of the major contributing factors to these health problems. Rates of current cigarette smoking are substantially higher among people living with HIV/AIDS than the general population: 40-75% versus 19%. Women smokers living with HIV have a 36% higher risk for developing AIDS and 53% higher mortality when compared to non-smoking women with HIV. This study is a pilot randomized controlled trial (RCT) testing the feasibility and acceptability of a videoconferencing smoking cessation intervention (video arm) for women with HIV in comparison with a telephone-based smoking cessation intervention (telephone arm). Both arms will receive 8, 30-minute weekly cessation counseling sessions plus 8-week nicotine replacement therapy. Participants will be followed up at 1, 3 and 6 months from the target quit day. Self-reported abstinence will be verified with a saliva cotinine test using an Nicotine Alert test strip and the testing process will be monitored via mobile-phone video call.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • English speaking
  • Diagnosis of HIV infection
  • Age 18 or older
  • Smoking at least 5 cigarettes a day
  • Having access to a mobile-phone with Internet connection
  • Willing to quit smoking within the next 4 weeks

排除标准

  • Inability to speak English
  • Involvement in another cessation program
  • Being pregnant or lactating
  • Having an active skin disease
  • History of serious mental illnesses (e.g., schizophrenia and bipolar disorder)
  • Serious alcohol use problem
  • Use of any illegal substances excluding marijuana

研究组 & 干预措施

Video

Experimental

Video-call delivered cognitive behavioral therapy

干预措施: Cognitive Behavioral Therapy (Behavioral)

Voice

Active Comparator

Voice-call delivered cognitive behavioral therapy

干预措施: Cognitive Behavioral Therapy (Behavioral)

结局指标

主要结局

Number of Participants With Abstinence

时间窗: 6-month follow-up

Self-reported abstinence since the quit day, which will be verified with a salivary cotinine test at both 3-month and 6-month follow-ups

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sun S Kim

Associate Professor

University of Massachusetts, Boston

研究点 (2)

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