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: 10477010
• 负责人: SETH S HIMELHOCH
• 金额: $ 62.32万
• 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 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10477010
• 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; Persons; 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，患有艾滋病毒/艾滋病（PLWH）的人几乎烟雾 一般人口的比率是三倍。生活在撒哈拉以南非洲的PLWH中的吸烟是 与性别（男性>女）有关，生活在城市贫民窟社区，也许大多数 重要的是使用非法药物使用。尽管在PLWH中使用烟草使用的精确患病率估计 肯尼亚缺乏，最新数据是从一个大型，已建立的美沙酮维护计划中收集的 内罗毕发现，鸦片使用障碍的PLWH中吸烟的流行率为100％。比较 肯尼亚一般人口为7.7-9.1％。许多干预措施有效地帮助吸烟者 一般人口退出。这些数据在多大程度上转化为中低水平收入国家的PLWH 尚不清楚健康基础设施，资源和药物访问可能面临更大的挑战。 方法：我们拟议的研究将使用阶乘设计来评估最有前途且最容易获得的 行为和药理治疗旨在实现最大疗效的戒烟 吸烟的人。我们建议将300名参与者随机化，他们吸烟和正在接受的人 在肯尼亚内罗毕的美沙酮维护计划中护理以下4个条件之一：（1） bupropioin +积极烟雾（为PLWH吸烟者量身定制的行为干预）； （2） 安非他酮 +护理标准（简短的建议退出）； （3）安慰剂 +积极烟； （4）安慰剂 + 护理标准。我们计划使用阶乘设计，因为它是评估多重的高效方法 在一次试验中的治疗可能会节省时间和资源。我们计划进行 在美沙酮维护诊所进行研究，原因有几个。首先，吸烟率令人震惊地很高 设置和有效烟草治疗的需求是巨大的。第二，提供的协同作用很大 对已经是已经已经存在的戒烟干预措施的行为和药理治疗 接受药理学干预（即美沙酮），并带有伴随物质使用咨询。第三， 美沙酮维护中的人经常接受治疗，这可能会增强吸烟 停止处理随访和完成。所有参与者将在基线，12周和36位评估 几周的主要结果是7天的禁欲（定义为过去7天的自我报告不吸烟 + CO <7 ppm）。此外，我们计划进行实施成本评估，以便严格提供 在本试验中测试的每种干预措施的总实施成本的近似值。 含义：随着肯尼亚是撒哈拉以南非洲最强大的反烟科立法之一，结果 这项研究将为决策者，社区领导人和临床医生提供最重要的证据 在美沙酮维护环境中，有效的吸烟戒烟治疗。