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

摘要 迫切需要在艾滋病毒护理项目中实施有效的戒烟干预措施， 和中等收入国家（LMIC），大多数烟草使用者和艾滋病毒感染者生活在这些国家。印度是一个 一个重要的环境，在其中测试戒烟干预措施，估计有2.75亿烟草使用者 200万艾滋病毒感染者（PWH）。有效的药物和行为干预措施尚未得到 在中低收入国家的艾滋病毒护理环境中得到了良好的检验。在高收入环境中，积极无烟（PSF），一个理论- 基于行为干预，已在PWH中证明有效性，并适用于移动的电话 交付（PSF-M）。移动的健康干预措施提供了可扩展性，在PWH中可能比 面对面伐尼克兰是对PWH有效的最有力证据， 实现足够的坚持以维持长期成功是一项挑战。我们建议将两者联合收割机 在PWH、伐尼克兰和PSF-M中，最有希望的戒烟干预措施，用伐尼克兰加强 坚持支持。他们将在志愿卫生服务（VHS）传染病医疗中心接受检测。 中心，钦奈抗病毒研究和治疗临床研究网站，其中24%的患者新艾滋病毒 护理是目前吸烟者或吸烟和无烟烟草的双重用户，83%拥有移动的手机。在 在此背景下，我们提出了以下具体目标：（1）展示综合的有效性 联合伐尼克兰和移动的行为治疗对烟草使用者艾滋病护理的干预 与标准护理对照相比，24周时经生化验证的戒烟率;（2）：评价 在低收入国家艾滋病实践中实施综合干预的过程;（3）： 伐尼克兰和PSF-M综合干预的成本和成本效益。完成这些 PSF-M将适应VHS背景和有关无烟烟草和药物的新内容 将添加依从性自我效能。一项随机的两组试验将比较伐尼克兰和 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， 如果扩大规模，综合干预的临床影响和价值。拟议的工作是响应 通过测试戒烟干预措施的有效性， 在其他环境中证明了有效性，并适用于LMIC环境，评估实施情况 从多个利益相关者的角度在艾滋病毒护理实践过程中，并评估临床影响， 如果大规模实施，综合干预措施的价值。这项工作的顺利完成将推动 通过提高我们对综合戒烟有效性的认识， 艾滋病毒护理环境中的干预措施，并预测实施综合干预措施对人口的影响。 为印度或其他低收入国家的威尔斯亲王医院进行干预。

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.