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

为患有艾滋病毒的矛盾吸烟者设计和测试移动医疗应用程序：一项随机试点研究

基本信息

批准号：
10250713
负责人：
JENNIFER B MCCLURE
金额：
$ 45.1万
依托单位：
KAISER FOUNDATION RESEARCH INSTITUTE
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-05-01 至 2025-04-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10250713
关键词：
Abstinence Acquired Immunodeficiency Syndrome Address Adoption Android Anti-Retroviral Agents Apple Back Bacterial Pneumonia Behavioral Caring Categories Cause of Death Collaborations Counseling Data Disease Effectiveness Elements Enrollment Ensure Equilibrium Evidence based treatment Feedback Future General Population Goals HIV Health Health Personnel Health Promotion Home Incidence Intervention Malignant Neoplasms Measures Mediating Methodology Methods Mobile Health Application Motivation Nicotine Dependence Outcome Participant Patient Self-Report Pharmaceutical Preparations Pilot Projects Population Prevalence Proxy Public Health Randomized Research Research Design Research Proposals Rewards Risk Sampling Self Efficacy Series Smoker Smoking Smoking Behavior Smoking Cessation Intervention Social Distance Surveys Testing Time Tobacco Treatment Failure Visit Work acceptability and feasibility antiretroviral therapy arm base cardiovascular risk factor comparative efficacy cost design digital health efficacy outcomes efficacy trial evidence base expectation experimental study falls health plan high risk high risk population innovation interest mortality risk motivational intervention nicotine replacement novel patient population preference programs public health priorities quitline recruit satisfaction self help service organization skills smoking cessation smoking prevalence sound standard care theories therapy design treatment guidelines

项目摘要

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.

项目摘要减少艾滋病毒携带者吸烟是公认的公共卫生优先事项。吸烟率高达2-3倍艾滋病毒携带者中的患病率高于一般人群，并且随着抗逆转录病毒治疗的广泛采用，现在，死于烟草相关疾病的艾滋病毒感染者人数多于艾滋病毒感染者。然而，可用科学证据表明，标准的、循证的戒烟治疗可能不足以 SLWH。需要新的干预策略。因此，NCI的研究提案呼吁（RFA-CA-20- 036)“在生活在吸烟区的人们中开发和测试基于证据的戒烟干预措施的适应性，艾滋病毒（PLWH）。这项建议是响应这一呼吁，并将测试两个适应标准，证据- 基础护理。首先，标准护理将增加针对SLWH的信息和设计元素，更好地解决他们的独特需求和关切，并增加干预的吸引力。第二，干预将针对那些有一天想戒烟但还没有准备好戒烟的SLWH。这些“矛盾的吸烟者”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，有健全的理论和经验支持干预，这些吸烟者，特别是使用低成本和广泛覆盖的可传播策略，如mHealth应用程序。拟议的研究将建立在我们的计划工作，开发动机干预，数字健康计划，并与SLWH合作。拟议的实验性干预措施结合了基于证据的美国PHS尼古丁依赖治疗指南推荐的治疗（例如，建议你戒烟，转介咨询，自助指导和尼古丁替代疗法），为矛盾的SLWH量身定制的基于经验的内容。这包括有关风险的艾滋病毒特定信息吸烟和戒烟的好处，量身定制的叙述性证明，以及一系列离散的行为旨在帮助矛盾的吸烟者明确他们减少吸烟/戒烟的目标的实验; 加强他们戒烟的动机、信心和结果预期;并教授他们基本技能必须减少和戒烟。使用以用户为中心（UX）的设计方法，与SLWH（n~20）合作，完善建议的内容和干预设计，关于辞职然后，我们将与Kaiser Permanente开发人员合作，构建实验性应用程序（用于 Android和iOS），并评估其可行性、可接受性和与标准循证戒烟治疗也通过mHealth应用程序提供了一个严格的，平行的，双臂，随机初步研究（n=50）。试点参与者将在全国范围内招募，并随访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与获得矛盾 SLWH，将干预范围扩大到这一高风险和经常被忽视的吸烟人群。