Randomized Trial of Automated Video-Assisted Smoking Treatment for People Living with HIV

对艾滋病毒感染者进行自动视频辅助吸烟治疗的随机试验

• 批准号: 10020988
• 负责人: Damon J. Vidrine
• 金额: $ 47.19万
• 依托单位: H. LEE MOFFITT CANCER CTR & RES INST
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-19 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10020988
• 关键词: AIDS/HIV problem; Abstinence; Address; Adopted; Biochemical; Cancer Center; Car Phone; Cardiovascular Diseases; Cellular Phone; Clinic; Communities; Coronary heart disease; Cost Analysis; Counseling; Data; Data Management Resources; Development; Disease; Disease Progression; Enrollment; Evaluation; Foundations; General Population; Goals; HIV; HIV Seropositivity; Health; Health Resources; Health system; Human; Individual; Intervention; Life Expectancy; Literature; Lung; Malignant Neoplasms; Mediating; Mediator of activation protein; Mind; Mobile Health Application; Modernization; Motivation; Mouth Diseases; Outcome; Participant; Persons; Pilot Projects; Population; Prevalence; Public Health; Publishing; Randomized; Randomized Controlled Trials; Research; Resource Sharing; Resources; Risk; Series; Site; Smoker; Smoking; Smoking Cessation Intervention; Stress; Sum; Symptoms; Telephone; Text; Tobacco smoke; Treatment Efficacy; Treatment Failure; Work; antiretroviral therapy; base; behavioral pharmacology; cigarette smoking; cost; cost effective; cost effectiveness; design; disadvantaged population; economic evaluation; evidence base; experience; improved; mHealth; mobile application; mortality; negative affect; nicotine replacement; non-smoker; prevent; public health priorities; quitline; randomized trial; recruit; resilience; safety net; smoking abstinence; smoking cessation; smoking relapse; social disadvantage; social stigma; standard care; tobacco cessation intervention; tobacco control; treatment group; treatment program

SUMMARY Modern antiretroviral therapy has brought about significantly increased life expectancies for persons living with HIV/AIDS (PLWH). However, the effort to reduce the occurrence of cardiovascular disease and various malignancies in this population remains an important public health priority. Arguably, the most effective way to prevent these diseases in PLWH would be to reduce the prevalence of cigarette smoking. Despite the significant need, relatively few smoking cessation trials with PLWH appear in the literature. Thus, efforts to develop and evaluate sustainable, low cost evidence-based cessation interventions for smokers with HIV are needed. Given the widespread proliferation of mobile phones, the potential of using mHealth applications to improve the reach and efficacy of cessation interventions is promising, but evidence of efficacy is lacking, particularly among PLWH. With these needs in mind, the overarching purpose of the proposed project is to evaluate a fully automated smartphone intervention for HIV+ smokers. Participants (n=500) will be randomized to one of two treatment conditions: 1) Standard Treatment (ST, n=250) or Automated Video-Assisted Smoking Treatment (AVAST, n=250). ST participants will be electronically connected to state quitline- delivered cessation treatment, consisting of proactive phone counseling plus nicotine replacement therapy (NRT) in the form of transdermal patches. This approach, frequently referred to as Ask Advise Connect (AAC), was developed by our team and has been successfully implemented in numerous health systems. ST will be compared to AVAST, a fully automated treatment delivery approach. In the AVAST condition, participants will receive NRT plus an interactive smartphone-based intervention that comprises individually tailored audio/video and text content. Foundational programming and developmental work for AVAST has already been completed by the Stephenson Cancer Center's mHealth Shared Resource, and results from a series of pilot studies (including extensive work conducted at both proposed HIV clinic recruitment sites) with beta versions of the mobile application and data management system are extremely encouraging. The major goal of this project is to determine if AVAST performs better, in terms of facilitating long-term smoking abstinence (i.e., biochemically verified abstinence 12 months post-enrollment), than the more resource-intensive ST approach. If efficacy is established, the AVAST approach will be readily adoptable by various HIV clinic and community-based organizations, and offer an efficient way to allocate limited public health resources to tobacco control interventions. The primary aim is to evaluate the efficacy of AVAST for facilitating smoking cessation among PLWH. Secondary aims include: 1) exploring potential mediators and moderators, and 2) conducting economic evaluations to assess the cost and cost-effectiveness of AVAST. In sum, there is a critical need for efficacious, cost-effective, and sustainable cessation treatments for PLWH who smoke tobacco. The proposed AVAST intervention has been designed to help fill this need.

总结 现代抗逆转录病毒疗法大大延长了艾滋病毒感染者的预期寿命， 艾滋病毒/艾滋病（PLWH）。然而，减少心血管疾病和各种疾病发生的努力， 这一人群中的恶性肿瘤仍然是重要的公共卫生优先事项。可以说，最有效的方法， 在艾滋病毒携带者中预防这些疾病的方法是减少吸烟的流行。尽管 由于存在显著的需求，文献中出现的PLWH戒烟试验相对较少。因此，努力 为感染艾滋病毒的吸烟者制定和评估可持续的、低成本的循证戒烟干预措施， needed.鉴于移动的电话的广泛普及，使用移动健康应用程序 提高戒烟干预措施的覆盖面和有效性是有希望的，但缺乏有效性的证据， 尤其是在艾滋病毒携带者中。考虑到这些需求，拟议项目的总体目标是 评估针对HIV+吸烟者的全自动智能手机干预。将对受试者（n=500）进行随机分组 两种治疗条件之一：1）标准治疗（ST，n=250）或自动视频辅助 吸烟治疗（AVAST，n=250）。ST参与者将通过电子方式连接到州退出热线- 提供戒烟治疗，包括主动电话咨询和尼古丁替代疗法 (NRT)以透皮贴剂的形式。这种方法，通常被称为咨询建议连接（AAC）， 由我们的团队开发，并已在许多卫生系统中成功实施。ST将是 与AVAST相比，AVAST是一种完全自动化的治疗方法。在AVAST条件下，参与者将 接受NRT加上基于智能手机的交互式干预，包括个性化定制的音频/视频 和文本内容。AVAST的基础编程和开发工作已经完成 由斯蒂芬森癌症中心的移动健康共享资源，并从一系列试点研究的结果 （包括在两个拟议的艾滋病毒诊所招募地点开展的广泛工作）， 移动的应用程序和数据管理系统非常令人鼓舞。该项目的主要目标是 为了确定AVAST在促进长期戒烟方面是否表现更好（即，生物化学 入组后12个月经验证的禁欲），而不是更资源密集型的ST方法。如果功效是 一旦建立，AVAST方法将很容易被各种艾滋病毒诊所和社区所采用。 这是一个有效的方法，可以将有限的公共卫生资源分配给烟草控制。 干预措施。主要目的是评估AVAST促进戒烟的有效性， PLWH。次要目标包括：1）探索潜在的调解人和主持人，2）进行经济 评估AVAST的成本和成本效益。总之，迫切需要有效的， 为吸烟的艾滋病病毒携带者提供具有成本效益和可持续的戒烟治疗。建议的AVAST 已经设计了干预措施来帮助满足这一需求。