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

描述（由申请人提供）：据估计，烟草使用每年造成全球500多万人死亡，艾滋病毒/艾滋病在全世界造成200万人死亡，发展中国家的人尤其面临风险。然而，烟草使用与艾滋病毒之间的关系尚不清楚。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生存时间，现在HAART正在发展中国家推广，这些高流行地区的生存率也将提高。鉴于这种生存率的增加，更多的人将死于非艾滋病毒相关的疾病，而吸烟在这些疾病中起着重要的因果作用。美国已经对艾滋病毒感染者的戒烟进行了研究，尽管这些研究的数量很少，随访也很有限。基于美国的研究表明，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，最佳方法尚未确定。本提案的总体目标是在南非艾滋病毒感染患者中进行强化戒烟咨询加尼古丁替代疗法（NRT）与单独强化戒烟咨询的随机对照试验（RCT），同时测量南非艾滋病毒感染患者中吸烟的流行程度。我们将比较NRT加强化反吸烟咨询与单独反吸烟咨询，比较2、6和12个月的戒烟情况。在6个月时，反吸烟咨询组的患者可以选择接受另一轮小组指定的干预。我们将通过免疫和病毒标志物、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暴露和戒烟与艾滋病毒进展的关系。这项随机对照试验将在南非克勒克斯多普的Tshepong艾滋病毒健康诊所进行，该诊所与南非威特沃特斯兰德大学有联系。这个农村诊所每月接待4000多名艾滋病毒感染者。该区域的艾滋病毒流行率很高（19%），估计50%的男性艾滋病毒感染者吸烟。这一人群是南非艾滋病毒感染者开始HAART的代表性人群，研究结果将具有高度的普遍性。我们的主要重点是比较南非PWLHA可用的两种戒烟策略，但由于获取途径有限，很少使用，将为了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/艾滋病和烟草接触高发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.