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临床试验/NCT03580460
NCT03580460已完成不适用

Cultural Adaptation and Piloting of an Avatar Delivered Smoking Cessation Intervention for Low Income Smokers in Baltimore City Living With HIV

Johns Hopkins University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年4月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Readiness to change smoking behaviour

研究概览

简要总结

One population of tobacco users that is severely affected by the consequences of smoking is people living with HIV (PLWH). Between 40-84% of PLWH smoke, a percentage that has remained constant since the first studies of smoking in HIV were conducted in the 1990's. Overall, smoking related morbidity and mortality is also greatly increased among PLWH smokers. Compared with PLWH nonsmokers, PLWH who smoke have more than 5 times the risk of non-HIV-related mortality and almost 4 times the risk of all-cause mortality. Compared with the general population, incidence ratio of smoking related cancers (eg, lung, head, neck, bladder and esophageal) is more than 5 times higher. At a critical time when advances in HIV care are providing an opportunity for prolonged life, smoking is significantly impeding the health of PLWH.

To produce meaningful changes in smoking, however, treatment will have to be acceptable and engaging to this population as well as feasible and sustainable to implement in a busy clinic. Novel technology-based interventions that incorporate evidence-based behavioral and pharmacologic interventions for smoking and are culturally tailored offer real solutions to these implementation barriers. Research shows that internet- or computer-delivered interventions (CDI) that are tailored and interactive can be efficacious in reducing smoking and are significantly more effective than usual care or written self-help materials. CDIs can also be readily adapted to different sociodemographic characteristics of a patient population because content is modular and menu driven. Moreover, technology-based interventions appear as effective as counselor-delivered interventions in reducing smoking. This growing body of evidence strongly suggests that these interventions offer promise in reducing smoking, the potential to reach significantly more patients, and the ability to overcome barriers of cost, implementation, and cultural nonspecificity. The goal of this pilot study is test to examine feasibility, acceptability of a computer-delivered smoking cessation intervention for PLWH, and to determine if intervention participation results in increased readiness to quit smoking and increased confidence in ability to quit smoking.

详细描述

One population of tobacco users that is severely affected by the consequences of smoking is people living with HIV (PLWH). Between 40-84% of PLWH smoke, a percentage that has remained constant since the first studies of smoking in HIV were conducted in the 1990's. Overall, smoking related morbidity and mortality is also greatly increased among PLWH smokers. Compared with PLWH nonsmokers, PLWH who smoke have more than 5 times the risk of non-HIV-related mortality and almost 4 times the risk of all-cause mortality. Compared with the general population, their incidence ratio of smoking related cancers (eg, lung, head, neck, bladder and esophageal) is more than 5 times higher. At a critical time when advances in HIV care are providing an opportunity for prolonged life, smoking is significantly impeding the health of PLWH.

To produce meaningful changes in smoking, however, treatment will have to be acceptable and engaging to this population as well as feasible and sustainable to implement in a busy clinic. Novel technology-based interventions that incorporate evidence-based behavioral and pharmacologic interventions for smoking and are culturally tailored offer real solutions to these implementation barriers. Research shows that internet- or computer-delivered interventions (CDI) that are tailored and interactive can be efficacious in reducing smoking and are significantly more effective than usual care or written self-help materials. CDIs can also be readily adapted to different sociodemographic characteristics of a patient population because content is modular and menu driven. Moreover, technology-based interventions appear as effective as counselor-delivered interventions in reducing smoking. This growing body of evidence strongly suggests that these interventions offer promise in reducing smoking, the potential to reach significantly more patients, and the ability to overcome barriers of cost, implementation, and cultural nonspecificity. The goal of this pilot randomized controlled trial (RCT) is study is test to examine feasibility, acceptability of a computer-delivered smoking cessation intervention for PLWH, and to determine if intervention participation results in increased readiness to quit smoking and increased confidence in ability to quit smoking.To pilot test the computer-delivered intervention among 40 individuals with HIV receiving care in an urban HIV clinic in a small Randomized Controlled Trial 2a) To determine intervention effect on 1) readiness to quit smoking 2) increased confidence in ability to quit smoking 2) uptake of smoking cessation therapy, including a. Quit Line, b. Nicotine replacement therapy c. Pharmacotherapy (varenicline, Wellbutrin) Hypothesis: Investigators hypothesize that intervention participation will be associated with 1) increased readiness to quit and confidence in quitting smoking and 2) increased engagement with smoking cessation services.

2b) To examine feasibility and acceptability of delivering the computer-delivered smoking cessation counseling in this setting.

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 (Investigator)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age >=18
  • A patient in the Johns Hopkins University (JHU) Bartlett Clinic
  • Smoked >100 cigarettes in their lifetime
  • Current daily smoker (verified by exhaled carbon monoxide)
  • English speaking.

排除标准

  • Individuals will be excluded if they do not meet the above requirements

结局指标

主要结局

Readiness to change smoking behaviour

时间窗: immediately post-intervention

Self-report on the Alcohol and Other Drug Contemplation Ladder, 1-10 Visual Analog Scale with 0- no readiness and 10- full readiness

次要结局

  • Confidence in ability to quit smoking(immediately post-intervention)
  • Engagement in Smoking Cessation Services(8 weeks post-intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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