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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.

项目概要减少艾滋病病毒感染者和艾滋病病毒感染者吸烟是公认的公共卫生优先事项。吸烟率高达2-3倍 PLWH 中的感染率高于一般人群，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吸烟者感染艾滋病毒 (SLWH) 的数量比死于艾滋病毒的吸烟者还要多。不过，可用科学证据表明，基于证据的标准戒烟治疗可能不足以 SLWH。看来需要新的干预策略。因此，NCI 呼吁研究提案 (RFA-CA-20- 036）“开发和测试基于证据的戒烟干预措施在生活中的人们的适应性感染艾滋病毒（艾滋病病毒感染者）。”该提案是对这一呼吁的响应，并将测试对标准、证据的两项调整：基础护理。首先，将通过针对 SLWH 的信息和设计元素来增强标准护理，以更好地解决他们的独特需求和关切，并增加干预吸引力。二、干预将针对那些希望有一天戒烟但尚未准备好戒烟的 SLWH。这些“矛盾的吸烟者”约占所有吸烟者的 70%，但他们通常被排除在治疗之外，因为他们不准备承诺戒烟。然而，干预有充分的理论和经验支持。这些吸烟者，特别是使用低成本和广泛传播的策略，例如移动医疗应用程序。拟议的研究将建立在我们开发激励干预措施、数字化干预措施的规划工作的基础上健康计划，并与 SLWH 合作。拟议的实验干预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（例如戒烟建议、转介咨询、自助指导和尼古丁替代疗法）具有理论依据和针对矛盾的 SLWH 量身定制基于经验的内容。这包括有关艾滋病毒风险的特定信息吸烟和戒烟的好处、量身定制的叙述感言以及一系列离散的行为旨在帮助矛盾吸烟者明确减少吸烟/戒烟目标的实验；构建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和戒烟。使用以用户为中心（UX）的设计方法，我们将迭代与矛盾的 SLWH (n~20) 合作完善提议的内容和干预设计关于戒烟。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）并与标准相比评估其可行性、可接受性和潜在功效基于证据的戒烟治疗还通过 mHealth 应用程序以严格、并行、双臂、随机试点研究（n=50）。试点参与者将在全国范围内招募并跟踪3个月。如果最终有效的是，这种新颖的干预措施可以通过健康计划广泛传播和推广，戒烟热线、艾滋病服务组织和其他能够获得矛盾信息的公共卫生机构 SLWH，将干预措施扩大到这一高风险且经常被忽视的吸烟人群。