Development of an Integrated mHealth App-Based Intervention to Support Smoking Cessation in People Living with HIV

项目摘要/摘要 高效抗逆转录病毒疗法(HAART)的出现极大地降低了艾滋病患者的死亡率 艾滋病毒(PLWH)，以至于现在与生活方式有关的因素对长期生存的威胁比艾滋病毒更大， 他们中最主要的是吸烟。尽管公共卫生部门对戒烟的兴趣很高，但 PLWH中的吸烟率仍然是普通人群的两倍多。令人鼓舞的是， 在利用艾滋病毒初级保健环境吸引PLWH吸烟者吸烟方面取得了成功 停止努力。然而，正如过去的证据所表明的那样，扩大和扩大这一成功一直是困难的 会议次数越多，干预效果越好。高强度面对面 干预措施并不容易扩展。然而，移动医疗(MHealth)方法可以提供持续的 和更长时间的按需支持，减少了对面对面治疗的需求，同时提供 长期支持。为此，在我们以前工作的基础上，我们建议开发一种mHealth 综合(1)“微笑代替吸烟”(SIS)应用程序的干预措施，这是一款概念上扎根的、 迭代开发的戒烟智能手机应用程序(M-PI Hoeppner)，(2)成功的面对面 SLH的Face戒烟治疗，称为戒烟(M-Pi O‘Cleirigh)，以及(3)Life Steps，我们的 有效的短期干预措施，以促进艾滋病毒护理的适应性参与。这一综合治疗将 通过完成治疗开发目标而被告知和具体说明。我们预计它将会 将最初的面对面、SLH重点治疗与SLH适应的、实时的、临时定制的治疗相结合 超过8周的智能手机应用程序支持。目标1是构建集成的mHealth应用程序干预(SIS-H) 基于对吸烟者艾滋病毒携带者(SLH)进行的以用户为中心的设计研究中获得的反馈，咨询 与艾滋病戒烟科学家和临床医生合作，并与我们的软件开发合作伙伴合作。 目标2是进行概念验证随机对照试验，以测试其可行性、可接受性和 SIS-H的初步疗效，同时跟踪艾滋病毒特有的结果。要改编的应用程序是 SIS APP，基于社会认知理论，在积极的范围内实施临床实践指南 心理学框架。拟议的综合治疗将强调保护患者的经验 SLH在戒烟过程中的积极情绪，并通过以下方式支持提高自我效能 戒烟和生命步骤部分的补充性技能培训。拟议中的项目 推进使戒烟支持更容易获得这一至关重要的公共卫生目标 献给PLWH吸烟者。更务实的是，这个项目的数据可以为更大的R01资助的设计提供参考 RCT和必要的监管战略，以推动SIS-H作为处方药的批准 这在艾滋病毒初级保健和其他社区卫生临床环境中很可能是可持续的。

PROJECT SUMMARY / ABSTRACT The advent of highly active antiretroviral therapy (HAART) has greatly reduced mortality in persons living with HIV (PLWH), to the point where now lifestyle-related factors pose greater threat to long-term survival than HIV, chief among them smoking. Although interest in quitting smoking is high amongst PLWH, the prevalence of smoking among PLWH remains more than twice as high as that in the general population. Encouragingly, there have been successes in leveraging HIV primary care settings to engage PLWH smokers in smoking cessation efforts. Scaling up and expanding on this success has been difficult, however, as past evidence has indicated that interventions with more sessions produced stronger effects. High intensity face-to-face interventions are not readily scalable. Mobile health (mHealth) approaches, however, can provide continuous and as-needed support over longer periods of time, reducing the need for in-person treatment while providing prolonged support. To this end, and building on our previous work, we propose to develop an mHealth intervention that integrates (1) the “Smiling instead of Smoking” (SiS) app, a conceptually-grounded, iteratively developed smoking cessation smartphone app (M-PI Hoeppner), (2) a successful face-to- face smoking cessation treatment for SLH, called QUIT (M-PI O'Cleirigh), and (3) Life Steps, our efficacious brief intervention to promote adaptive engagement in HIV care. This integrated treatment will be informed and specified through the completion of the treatment development aims. We anticipate that it will combine initial face-to-face, SLH-focused treatment with SLH-adapted, real-time, temporally tailored smartphone app support over 8 weeks. Aim 1 is to build the integrated mHealth app intervention (SiS-H) based on feedback derived in user-centered design research with smokers living with HIV (SLH), consultation with HIV smoking cessation scientists and clinicians, and collaboration with our software development partner. Aim 2 is to conduct a proof-of-concept randomized controlled trial to test the feasibility, acceptability, and preliminary efficacy of SiS-H, while tracking HIV-specific outcomes. The app to be adapted is Version 3 of the SiS app, which is based on social cognitive theory, and implements clinical practice guidelines within a positive psychology framework. The proposed integrated treatment will emphasize protecting the experience of positive emotions among SLH as they navigate quitting smoking, and support increased self-efficacy through the complementing skills-based training of the QUIT and Life Steps components. The proposed project advances the critically important public health goal of making smoking cessation support more readily available to PLWH smokers. More pragmatically, data from this project could inform the design of a larger R01-funded RCT and the necessary regulatory strategy to advance towards approval of SiS-H as a prescription treatment that could well be sustainable in HIV primary care and other community health clinical settings.