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临床试验/NCT02072772
NCT02072772已完成不适用

A Trial of Positively Smoke Free Group Therapy for HIV-infected Smokers

Montefiore Medical Center4 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2014年5月1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
450
试验地点
4
主要终点
6 month abstinence from cigarettes

研究概览

简要总结

The purpose of this study is to determine whether Positively Smoke Free group therapy is more effective at promoting cessation than standard care.

详细描述

There are 1.1 million persons living with HIV (PLWH) in the US, 60% of them smoke cigarettes, and 75% of these are interested in quitting. Almost none are currently accessing smoking cessation interventions designed to meet their specific needs and concerns.

Cigarette smoking is responsible for 24% of deaths among PLWH, and 30% of non-AIDS defining malignancies. It is driving the alarming rise in cardiac events and lung cancers in this highly vulnerable population. The lack of access to proven, effective, culturally appropriate tobacco cessation services represents a health disparity of the first order. The psychosocial profile of the PLWH-smoker community, characterized by high rates of psychiatric comorbidity, drug and alcohol use, and low levels of social support, suggests that achieving high cessation rates will be a great challenge.

Positively Smoke Free (PSF) is an intensive, multisession, group cessation program specifically developed for PLWH smokers. A pilot study of PSF yielded promising results. This proposal aims (1) to perform a definitive efficacy study of PSF by comparing 6-month biochemically confirmed abstinence rates in subjects randomized to PSF vs. standard care in a cohort of 450 PLWH smokers, (2) to determine the sociobehavioural moderators and mediators associated with successful cessation, and (3) to complete a careful cost analysis of PSF in order to estimate the incremental cost per quit associated program participation.

If PSF is proven to be effective it will establish a new treatment option for PLWH smokers. Determination of moderators and mediators of program success will provide insight into the mode of action of the intervention and will help guide the development of additional treatment strategies in the future. Finally, the cost analyses will provide critical information about the feasibility of program dissemination and implementation.

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 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • HIV-infection
  • Receives care at Montefiore Medical Center or Georgetown University
  • Motivated to quit
  • Willing to attend eight 90 minute group sessions

排除标准

  • Pregnancy or breastfeeding
  • Contraindication to nicotine patch use

结局指标

主要结局

6 month abstinence from cigarettes

时间窗: 6 months

Biochemically-confirmed 7-day point-prevalence abstinence from cigarettes at the 6-month timepoint

次要结局

  • Cost per incremental quit(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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