A Smoking Cessation Trial in HIV-infected patients in South Africa

描述(申请人提供)：据估计，烟草使用每年导致全球500多万人死亡，全球200万人死于艾滋病毒/艾滋病，生活在发展中国家的人面临的风险尤其大。然而，烟草使用和艾滋病毒之间的联系并不清楚。在发达国家，高效抗逆转录病毒疗法(HAART)的引入延长了艾滋病毒感染后的存活率，现在HAART正在发展中国家推广，这些高度流行的地区的存活率也将增加。鉴于存活率的增加，将有更多的人死于与艾滋病毒无关的疾病，吸烟对这些疾病起着重要的因果作用。美国已经对HIV感染者的戒烟进行了研究，尽管这些研究的人数很少，后续研究也很有限。美国的研究表明，结合尼古丁替代疗法(NRT)和咨询干预的方法是最成功的。在资源有限的情况下，尚未确定最佳方法。这项建议的总体目标是在南非艾滋病毒感染患者中进行一项强化禁烟咨询加尼古丁替代疗法(NRT)与单独强化反吸烟咨询的随机对照试验(RCT)，并同时测量南非艾滋病毒感染患者的吸烟流行率。我们将比较NRT加强化戒烟咨询和单独戒烟咨询，比较2、6和12个月时戒烟的情况。6个月后，接受禁烟咨询的患者将可以选择接受另一轮小组分配的干预。我们将通过免疫学和病毒标志物、呼吸道感染(包括结核病)和艾滋病相关恶性肿瘤的风险来衡量吸烟和戒烟与艾滋病毒进展之间的关系。随机对照试验将在南非克勒克斯多普的Tshepong HIV健康诊所进行，该诊所与南非威特沃特斯兰德大学有关联。每月有4000多名艾滋病毒感染者在这个乡村诊所就诊。该地区艾滋病毒流行率很高(19%)，估计有50%的艾滋病毒男性人口吸烟。这一人群是发起HAART的南非艾滋病毒人群的代表，研究结果将具有高度普适性。我们的主要重点是比较两种戒烟策略，这两种策略在南非可供PWLHA使用，但由于获得机会有限而很少使用，这将为理解这些策略的有效性提供全面的数据。这些发现将指导在艾滋病毒/艾滋病和烟草暴露率较高的地区制定有效的戒烟战略。

DESCRIPTION (provided by applicant): Tobacco use is estimated to be responsible for over 5 million deaths globally every year and HIV/AIDS kills 2 million worldwide, with persons living in the developing world especially at risk. However, the association between tobacco use and HIV is not clearly understood. The introduction of highly active antiretroviral therapy (HAART) has led to longer duration of survival following HIV-infection in the developed world, and now that HAART is being rolled out in the developing world, survival will increase in these highly endemic regions as well. Given this increase in survival, more people will die of non-HIV related illnesses for which smoking plays an important causal role. Smoking cessation for HIV-infected persons has been studied in the US though these studies have had small numbers and limited follow-up. US based studies suggest that approaches that combine nicotine replacement therapy (NRT) and counseling interventions are most successful. Optimal approaches in resource-limited settings have not been determined. The overall objective of this proposal is to conduct a randomized controlled trial (RCT) of intensive anti-smoking counseling plus nicotine replacement therapy (NRT) versus intensive anti-smoking counseling alone among HIV-infected patients in South Africa, and to concurrently measure the prevalence of smoking among HIV-infected patients in South Africa. We will compare NRT plus intensive anti-smoking counseling versus anti-smoking counseling alone, comparing smoking cessation at 2, 6 and 12 months. At 6 months, patients in the anti-smoking counseling arm will have the option to receive another round of their group assigned intervention. We will relate smoking exposure and cessation to HIV progression as measured by immunologic and viral markers, risk of respiratory infections, including tuberculosis (TB), and AIDS-related malignancies. The RCT will be performed at the Tshepong HIV Wellness Clinic in Klerksdorp, South Africa, associated with the University of the Witwatersrand, South Africa. Over 4,000 HIV- infected patients are seen monthly at this rural clinic. HIV prevalence in this region is high (19%) and an estimated 50% of the male HIV population smokes tobacco. This population is representative of the South African HIV population initiating HAART, and findings will be highly generalizable. Our primary focus on comparing two cessation strategies that are available to PWLHA in South Africa, but rarely utilized due to limited access, will provide comprehensive data towards understanding the effectiveness of these strategies. These findings will guide development of effective smoking cessation strategies in a region with high prevalences of HIV/AIDS and tobacco exposure.