Optimizing smoking cessation interventions for PLWH in Nairobi, Kenya

优化肯尼亚内罗毕艾滋病病毒感染者的戒烟干预措施

• 批准号: 10242725
• 负责人: SETH S HIMELHOCH
• 金额: $ 62.93万
• 依托单位: UNIVERSITY OF MARYLAND BALTIMORE
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-05 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10242725
• 关键词: AIDS/HIV problem; Abstinence; Africa South of the Sahara; Behavior Therapy; Behavioral; Bupropion; Caring; Client; Clinic; Communities; Cost Analysis; Counseling; Country; Data; Female; Gender; General Population; HIV; Health; Income; Individual; Infrastructure; Intervention; Kenya; Mental disorders; Meta-Analysis; Methadone; Methods; Morbidity - disease rate; Nature; Outcome; Participant; Patient Self-Report; Pharmaceutical Preparations; Pharmacological Treatment; Pharmacology; Pharmacotherapy; Placebos; Prevalence; Price; Randomized; Research; Resources; Savings; Services; Site; Slum; Smoke; Smoker; Smoking; Smoking Cessation Intervention; Statutes and Laws; Substance abuse problem; Testing; Time; Tobacco; Tobacco use; Training; Translating; World Bank; brief advice; cost; cost estimate; design; effective intervention; evidence base; follow-up; implementation cost; low and middle-income countries; male; methadone treatment; mortality; opioid use disorder; smoking abstinence; smoking cessation; smoking prevalence; standard of care; substance use; synergism; varenicline

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.

背景：全球估计表明，艾滋病毒/艾滋病患者 (PLWH) 的吸烟率接近 是一般人口比率的三倍。生活在撒哈拉以南非洲地区的艾滋病病毒感染者和艾滋病病毒感染者中吸烟的情况 与性别（男>女）、生活在城市贫民窟社区有关，也许大多数 重要的是非法药物的使用。尽管对 PLWH 中烟草使用率的精确估计 肯尼亚缺乏从一个大型、完善的美沙酮维持计划收集的最新数据 内罗毕发现患有阿片类药物使用障碍的艾滋病毒感染者和艾滋病病毒感染者中吸烟率为 100%。这比较 肯尼亚总人口的这一比例为 7.7-9.1%。许多干预措施可以有效帮助吸烟者 普通民众退出。这些数据在多大程度上转化为中低收入国家的 PLWH 目前尚不清楚卫生基础设施、资源和药物获取方面可能面临更大的挑战。 方法：我们提出的研究将使用因子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功效 吸烟的艾滋病病毒感染者。我们建议对 300 名吸烟且正在接受治疗的艾滋病毒感染者和艾滋病患者参与者进行随机分组 肯尼亚内罗毕美沙酮维持计划中的护理符合以下 4 种情况之一：(1) 安非他酮 + Positively Smoke（针对 PLWH 吸烟者的 8 次定制行为干预）； (2) 安非他酮 + 标准护理（简短的戒烟建议）； (3)安慰剂+积极无烟； (4) 安慰剂 + 护理标准。我们计划使用因子设计，因为它是评估多重因素的高效方法 在一次试验中进行治疗，可以节省时间和资源。我们计划进行 由于多种原因，在美沙酮维持诊所进行研究。首先，这个地区的吸烟率高得惊人 环境，对有效烟草治疗的需求是巨大的。其次，在提供服务方面具有巨大的协同作用。 对已经戒烟的客户进行行为和药物治疗 接受药物干预（即美沙酮）并同时进行药物使用咨询。第三， 接受美沙酮维持治疗的人定期接受治疗可能会加剧吸烟 戒烟治疗的随访和完成。所有参与者都将在基线、12 周和 36 周进行评估 主要结果是 7 天戒烟（定义为自我报告在过去 7 天内没有吸烟） + CO<7 ppm）。此外，我们计划进行实施成本评估，以严格提供 获得了本次试验中测试的每项干预措施的总实施成本的近似值。 影响：由于肯尼亚是撒哈拉以南非洲地区反烟草立法最强有力的国家之一，因此 这项研究将为政策制定者、社区领袖和临床医生提供最重要的证据 在美沙酮维持环境中对 PLWH 吸烟者进行有效的戒烟治疗。