Optimizing Smoking Cessation interventions for PLWH in Nairobi, Kenya

背景：全球范围内的估计表明，艾滋病毒/艾滋病（PLWH）感染者吸烟的人数几乎 是普通人群的三倍。生活在撒哈拉以南非洲的艾滋病毒携带者吸烟是 与性别（男性>女性），与生活在城市贫民窟社区， 尤其是非法使用药物。虽然对艾滋病毒/艾滋病感染者烟草使用的精确流行率估计， 肯尼亚缺乏从一个大型的，完善的美沙酮维持计划中收集的最新数据， 内罗毕发现，患有阿片类药物使用障碍的艾滋病毒携带者和艾滋病患者的吸烟率为100%。相比之 肯尼亚总人口的7.7 - 9.1%。许多干预措施可以有效地帮助吸烟者 一般人都不干了这些数据在多大程度上转化为中低收入国家的艾滋病毒携带者， 在卫生基础设施、资源和药物获取方面可能面临更大的挑战，目前尚不清楚。 方法：我们提出的研究将使用析因设计来评估最有前途和最容易获得的 行为和药物治疗，旨在实现戒烟的最大疗效， 抽烟的人。我们建议随机抽取300名吸烟和接受 在肯尼亚内罗毕的美沙酮维持治疗计划中接受以下4种情况之一：（1） 安非他酮+积极无烟（为PLWH吸烟者量身定制的8次行为干预）;（2） 安非他酮+标准治疗（戒烟的简短建议）;（3）安慰剂+积极无烟;和（4）安慰剂+ 护理标准。我们计划使用析因设计，因为它是一种高效的评估多重 在一个单一的试验治疗与节省时间和资源的可能性。我们计划进行 在美沙酮维持诊所进行的研究有几个原因。首先，吸烟率高得惊人， 因此，对有效的烟草治疗的需求是巨大的。第二，在提供方面有很大的协同作用 行为和药物治疗戒烟干预的客户谁已经 接受药物干预（即，美沙酮），并提供伴随药物使用咨询。第三、 接受美沙酮维持治疗的人士定期来港接受治疗， 停止治疗随访和完成。所有参与者将在基线、12周和36周时进行评估 主要结局为7天戒烟（定义为自我报告在过去7天内不吸烟 + CO <7ppm）。此外，我们计划进行实施成本评估， 获得了在本试验中测试的每种干预措施的总实施成本的近似值。 影响：由于肯尼亚拥有撒哈拉以南非洲最强有力的反烟草立法之一， 这项研究将为决策者、社区领导人和临床医生提供关键证据， 在美沙酮维持治疗环境中为艾滋病毒携带者和高血压患者吸烟者提供有效的戒烟治疗。

Background: Worldwide estimates suggest that people living with HIV/AIDS (PLWH) smoke at nearly three times the rate of the general population. Smoking among PLWH living in sub-Saharan Africa is associated with gender (male>female), with living in an urban slum community, and perhaps most importantly with illicit substance use. Although precise prevalence estimates of tobacco use among PLWH in Kenya are lacking, recent data collected from a large, well established methadone maintenance program in Nairobi found the prevalence of smoking among PLWH with opiate use disorders was 100%. This compares to 7.7-9.1% in the Kenyan general population. Many interventions are effective in helping smokers in the general population quit. To what degree these data translate to PLWH in lower-middle income countries that may have greater challenges with health infrastructure, resources and medication access, is not clear. Approach: Our proposed study will use a factorial design to evaluate the most promising and accessible behavioral and pharmacologic treatments aimed at achieving maximal efficacy for smoking cessation among PLWH who smoke. We propose to randomize 300 participants PLWH, who smoke and who are receiving care in a methadone maintenance program in Nairobi, Kenya to one of the following 4 conditions: (1) bupropioin + Positively Smoke Free (an 8 session tailored behavioral intervention for PLWH smokers); (2) bupropion + Standard of Care (brief advice to quit); (3) Placebo + Positively Smoke Free; and (4) Placebo + Standard of Care. We plan to use a factorial design as it is a highly efficient method of assessing multiple treatments in a single trial with the possibility of saving both time and resources. We plan to conduct the study in a methadone maintenance clinic for several reasons. First, smoking rates are shockingly high in this setting, and the need for effective tobacco treatment is enormous. Second, there is great synergy in providing behavioral and pharmacological treatment for smoking cessation interventions to clients who are already receiving a pharmacological intervention (i.e., methadone) with concomitant substance use counseling. Third, people in methadone maintenance come regularly to receive treatment which is likely to enhance smoking cessation treatment follow-up and completion. All participants will be assessed at baseline,12 weeks and 36 weeks with the main outcome being 7-day abstinence (defined as self-reported no smoking in the past 7 days + CO<7 ppm). Additionally, we plan to conduct an implementation costs assessment to provide rigorously obtained approximations of total implementation costs of each intervention tested in this trial. Implications: As Kenya has one of the strongest anti-tobacco legislations in sub-Saharan Africa, results of this study will provide policymakers, community leaders and clinicians with critical evidence of the most effective smoking cessation treatments for PLWH smokers in the methadone maintenance setting.