Optimizing smoking cessation interventions for PLWH in Nairobi, Kenya

背景：世界范围内的估计表明，艾滋病毒/艾滋病(PLWH)患者吸烟的比例接近 是普通人口的三倍。生活在撒哈拉以南非洲的PLWH中吸烟的人数 与性别有关(男性和女性)，与生活在城市贫民窟社区有关，也许大多数 重要的是与非法药物的使用有关。尽管#年PLWH中烟草使用的准确流行率估计 肯尼亚缺乏从一个大型的、完善的美沙酮维护计划中收集的最新数据 内罗毕发现，在患有阿片类药物使用障碍的PLWH中，吸烟率为100%。这与之相比 到肯尼亚总人口的7.7%-9.1%。许多干预措施在帮助吸烟者方面是有效的 普通民众辞职了。这些数据在多大程度上转化为中低收入国家的PLWH 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：我们建议的研究将使用析因设计来评估最有希望和最容易获得的 旨在实现最大戒烟效果的行为和药物治疗 吸烟的人。我们建议将300名吸烟者和吸烟者随机分成三组 在肯尼亚内罗毕的美沙酮维持计划中接受以下4种情况之一的护理：(1) Bupropioin+积极戒烟(为PLWH吸烟者量身定做的8次行为干预)；(2) 安非他酮+护理标准(简单的戒烟建议)；(3)安慰剂+积极无烟；以及(4)安慰剂+ 护理标准。我们计划使用析因设计，因为它是评估多个 在一次试验中进行治疗，可能既节省时间又节省资源。我们计划进行 在美沙酮维持诊所学习有几个原因。首先，这里的吸烟率高得令人震惊 在这一背景下，对有效的烟草治疗的需求是巨大的。第二，在提供服务方面存在巨大的协同效应 对已经戒烟的患者进行戒烟干预的行为和药物治疗 接受药物干预(即美沙酮)，同时进行物质使用咨询。第三, 美沙酮维持者定期来接受治疗，这可能会增加吸烟 停药后随访并完成治疗。所有参与者将在基线、12周和36周进行评估 几周，主要结果是7天戒烟(自我报告在过去7天内不吸烟 +CO&lt；7ppm)。此外，我们计划进行实施成本评估，以严格提供 获得了在本试验中测试的每个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，结果 这项研究将为政策制定者、社区领袖和临床医生提供关于 在美沙酮维持环境下，PLWH吸烟者的有效戒烟治疗。

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.