Design and Testing of a mHealth App for Ambivalent Smokers Living with HIV: A Randomized Pilot Study

项目总结 在公共卫生部门中减少吸烟是公认的公共卫生优先事项。吸烟率高达2-3倍 PLWH的发病率高于普通人群，而且随着抗逆转录病毒疗法的广泛采用， 现在死于与烟草有关的疾病的吸烟者比死于艾滋病毒的吸烟者更多。然而，可用 科学证据表明，标准的、基于证据的戒烟治疗可能不足以 什么都不是。似乎需要新的干预策略。因此，NCI呼吁研究建议(RFA-CA-20- 036)“开发和测试循证戒烟干预措施在生活人群中的适应性 艾滋病病毒携带者(PLWH)。这项提案是对这一呼吁的回应，并将测试对标准证据的两种适应- 以医疗为基础的。首先，标准护理将增加针对SLWH的信息和设计元素，以 更好地解决他们的独特需求和关切，增加干预号召力。第二，干预 将针对有一天想戒烟，但还没有准备好戒烟的SLWH。这些“矛盾情绪” 吸烟者占所有吸烟者的70%，但他们通常被排除在治疗之外，因为他们不是 准备好辞职了。然而，干预有可靠的理论和经验支持。 这些吸烟者，特别是使用低成本和广泛覆盖的可传播战略，如mHealth应用程序。 拟议的研究将建立在我们开发激励性干预措施、数字 健康计划，并与SLWH合作。拟议的实验干预结合了循证的 由美国PHS尼古丁依赖治疗指南推荐的治疗(例如，戒烟建议， 转诊至咨询、自助指导和尼古丁替代疗法) 基于经验的内容，为矛盾的SLWH量身定做。这包括艾滋病毒特有的有关风险的信息 吸烟和戒烟的好处，量身定做的叙事性证词，以及一系列独立的行为 旨在帮助矛盾的吸烟者阐明他们减少/戒烟的目标的实验；建立和 增强他们戒烟的动力、信心和结果预期；并教他们基本技能 有必要减少吸烟和戒烟。使用以用户为中心(UX)的设计方法，我们将反复 与持矛盾态度的SLWH(n~20)合作，完善建议的内容和干预设计 关于辞职的事。然后，我们将与Kaiser Permanente开发人员合作构建这款实验性应用程序(用于 Android和iOS)，并对照标准评估其可行性、可接受性和潜在功效 基于证据的戒烟治疗也通过mHealth应用程序以严格、平行、双臂、 随机先导研究(n=50)。试点参与者将在全国范围内招募，并跟踪3个月。如果 这种新的干预措施最终是有效的，可以通过卫生计划广泛传播和推广， 戒烟热线、艾滋病服务组织和其他公共卫生机构有权获得矛盾 SLWH，将干预范围扩大到这一高危且经常被忽视的吸烟人群。

PROJECT SUMMARY Reducing smoking among PLWH is a recognized public health priority. Smoking rates are up to 2-3 times higher among PLWH than in the general population and with the widespread adoption of antiretroviral therapy, more smokers living with HIV (SLWH) now die from tobacco-related diseases than HIV. However, available scientific evidence suggests that standard, evidence-based cessation treatments may not be adequate for SLWH. Novel intervention strategies appear needed. Hence, NCI’s call for research proposals (RFA-CA-20- 036) “to develop and test adaptations of evidence-based smoking cessation interventions among people living with HIV (PLWH).” This proposal is responsive to this call and will test two adaptions to standard, evidence- based care. First, standard care will be augmented with information and design elements targeted to SLWH, to better address their unique needs and concerns and increase the intervention appeal. Second, the intervention will target SLWH who want to quit smoking someday, but who are not yet ready to quit. These “ambivalent smokers” make up ~ 70% of all smokers, but they are typically excluded from treatment because they are not ready to commit to quitting. However, there is sound theoretical and empirical support for intervening with these smokers, particularly using disseminable strategies with low cost and wide-reach, such as mHealth apps. The proposed study will build on our programmatic work developing motivational interventions, digital health programs, and working with SLWH. The proposed experimental intervention combines evidence-based treatment recommended by the US PHS Nicotine Dependence Treatment Guidelines (e.g., advice to quit, referral to counseling, self-help guidance and nicotine replacement therapy) with theoretically-grounded and empirically-based content tailored to ambivalent SLWH. This includes HIV-specific information about the risks of smoking and benefits of quitting, tailored narrative testimonials, and a series of discrete behavioral experiments designed to help ambivalent smokers clarify their goals for smoking reduction/quitting; build and strengthen their motivation, confidence, and outcome expectations for quitting; and teach them the basic skills necessary to cut back and quit smoking. Using user-centered (UX) design methodologies, we will iteratively refine the proposed content and intervention design in collaboration with SLWH (n~20) who are ambivalent about quitting. We will then partner with Kaiser Permanente developers to build the experimental app (for Android and iOS) and assess its feasibility, acceptability, and potential efficacy compared to standard evidence-based cessation treatment also delivered via mHealth app in a rigorous, parallel, two-arm, randomized pilot study (n=50). Pilot participants will be recruited nationwide and followed for 3 months. If ultimately effective, this novel intervention could be widely disseminated and promoted through health plans, tobacco quitlines, AIDS service organizations and other public health agencies with access to ambivalent SLWH, expanding intervention reach to this high-risk and often overlooked smoking population.