Varenicline and mobile behavioral assistance for tobacco cessation in HIV care in India.

摘要 迫切需要在低收入人群的艾滋病毒护理方案中实施有效的戒烟干预措施。 以及大多数烟草使用者和艾滋病毒携带者生活的中等收入国家(LMIC)。印度是一个 在约2.75亿吸烟者中测试戒烟干预措施的重要环境 以及200万艾滋病毒携带者(PWH)。有效的药物和行为干预一直没有得到 在LMIC的艾滋病毒护理环境中进行了良好的测试。在高收入环境中，积极无烟(PSF)是一种理论-- 基于行为干预，已在PWH中证明有效，并适用于移动电话 交付(PSF-M)。移动卫生干预提供了可伸缩性，在PWH中可能比 面对面的。Varenicline是治疗PWH疗效最强的戒断药物，但 实现足够的坚持以维持长期的成功是一项挑战。我们建议将两者结合起来 在PWH、varenicline和PSF-M之间最有希望的戒断干预措施，与varenicline一起强化 坚持支持。他们将在自愿医疗服务(VHS)传染病医疗中心接受测试 中心，金奈抗病毒研究和治疗临床研究网站，24%的患者新接触艾滋病毒 CARE是目前吸烟者或吸烟和无烟烟草的双重使用者，83%的人拥有移动电话。在……里面 在这一背景下，我们提出了以下具体目标：(1)展示一体化的有效性 瓦伦尼克林联合移动行为疗法在吸烟者艾滋病护理中的应用 生物化学验证的戒烟24周与标准护理对照的比较；(2)：评估 在LMIC艾滋病毒实践中实施综合干预的过程；和(3)：衡量 用伐伦克林和PSF-M进行综合干预的成本和成本-效果要实现这些目标 AIMS，PSF-M将适应VHS的背景和关于无烟烟草和药物的新内容 坚持自我效能感将会被增加。一项随机的双臂试验将比较伐伦克林的组合 和PSF-M进行标准护理对照。我们将评估艾滋病毒护理工作流程中的实施过程 包括可接受性、适当性、可行性和成本，并进行成本效益分析，以评估 如果扩大，综合干预的临床影响和价值。拟议的工作是对 通过测试戒烟干预的有效性对RFA-CA-20-037的具体兴趣 在其他环境中展示了效力，并根据LMIC的情况进行了调整，评估了实施情况 在艾滋病毒护理实践中从多个利益相关者的角度进行流程，并评估临床影响和 如果大规模实施，综合干预的价值。这项工作的圆满完成将推动 通过促进我们对综合戒烟有效性的理解，这一领域向前迈进 干预艾滋病毒护理环境，并预测实施综合方案对人口的影响 对印度威尔斯亲王医院或其他低收入国家的干预。

Abstract There is an urgent need to implement effective tobacco cessation interventions in HIV care programs in low- and middle-income countries (LMICs) where most tobacco users and people with HIV live. India is an important setting in which to test tobacco cessation interventions with an estimated 275 million tobacco users and 2 million people living with HIV (PWH). Effective medications and behavioral interventions have not been well tested in HIV care settings in LMICs. In high income settings, Positively Smoke Free (PSF), a theory- based behavioral intervention, has demonstrated efficacy among PWH and been adapted for mobile phone delivery (PSF-M). Mobile health interventions offer scalability and may be more effective among PWH than face-to-face. Varenicline is the cessation medication with the strongest evidence of efficacy in PWH but achieving sufficient adherence to sustain long-term success is a challenge. We propose to combine the two most promising cessation interventions among PWH, varenicline and PSF-M, enhanced with varenicline adherence support. They will be tested at the Voluntary Health Services (VHS) Infectious Disease Medical Center, Chennai Antiviral Research and Treatment Clinical Research Site, where 24% of patients new to HIV care are current smokers or dual users of smoked and smokeless tobacco and 83% own mobile phones. In this setting we propose the following specific aims: (1) To demonstrate the effectiveness of an integrated intervention combining varenicline plus mobile behavioral treatment among tobacco users in HIV care on biochemically verified tobacco abstinence at 24 weeks compared to a standard care control; (2): To evaluate the implementation processes of the integrated intervention in an LMIC HIV practice; and (3): To measure the costs and cost-effectiveness of an integrated intervention with varenicline and PSF-M. To accomplish these aims, PSF-M will be adapted to the VHS context and novel content about smokeless tobacco and medication adherence self-efficacy will be added. A randomized two-arm trial will compare the combination of varenicline and PSF-M to a standard care control. We will evaluate implementation processes within HIV care workflows including acceptability, appropriateness, feasibility and costs and conduct cost-effectiveness analysis to assess the clinical impact and value of the integrated intervention if scaled-up. The work proposed is responsive to the specific interests in RFA-CA-20-037 by testing the effectiveness of tobacco cessation interventions with demonstrated efficacy in other settings and adapted for an LMIC context, evaluating the implementation process from multiple stakeholder perspectives in an HIV care practice, and assessing the clinical impact and value of the integrated intervention if implemented at scale. The successful completion of this work will move the field forward by advancing our understanding of the effectiveness of an integrated tobacco cessation intervention in HIV care settings and projecting the population level impacts of implementing the integrated intervention for PWH in India or other LMICs.