Novel Methods for Intensive Longitudinal Data in SMART Studies of Drug Abuse and HIV

摘要 吸毒和艾滋病毒的治疗往往需要就吸毒和艾滋病毒感染者的健康状况作出连续的、个性化的决策。 治疗的类型或提供。适应性干预是一种使用来自以下方面的持续信息的治疗设计 患者指导是否以及如何随着时间的推移修改治疗。通过提供适当的 治疗那些需要它的人，当他们需要它的时候，适应性干预有希望改善长期的- * 为更多的人取得长期成果，从而扩大吸毒和艾滋病毒的影响范围和影响 在现实世界中的治疗。序贯多分配随机试验（SMART）是一项强有力的 用于构建有效AI的实验设计。为了使智能 最大限度地有用的药物使用和艾滋病毒干预科学家，方法学工作，需要扩大 用于分析SMART产生的数据的选项，并扩展当前 在设计中，它在重要方面受到限制。此提案是以下内容的竞争性续期申请： R 01（DA 039901;结束于20年7月31日），其中我们的行为干预和数据多学科团队 科学家们已经成功地开发和测试了一套设计和纵向分析的方法， 聪明人。在这次更新中，我们开始了与使用新的治疗方法有关的新的方法学方向。 技术和由此产生的密集的纵向数据（ILD），为有效的AI的发展提供信息。一 越来越多的药物滥用和艾滋病毒干预措施利用现代技术，如移动的和 基于网络的应用程序和可穿戴设备，以提供和增强治疗。这些技术使 对个人行为和经历的频繁测量的集合。这样的数据有很大的潜力 解决适应性干预的动态影响的新的研究问题， 更复杂，但负担更轻的剪裁变量。然而，现有的纵向方法， SMART分析目前不适用于ILD。此外，现有的SMART设计目前不 在如何将ILD用作定制变量方面，充分利用ILD的临床潜力。 我们的目标是通过开发和评估新的方法来弥合这些关键差距， 使用/HIV科学家在SMART中分析多种类型的ILD;开发和评估新方法， 分析现有ILD，以设计更有效的SMART;使用 来自三项SMART研究和两项药物滥用和HIV观察性研究的数据， 收集协议;开发免费的、用户友好的资源来实现这些方法。的方法 该项目开发的药物将通过使药物使用和艾滋病毒感染能够改善临床和公共卫生结果。 科学家开发更有效的适应性干预措施，以指导药物使用和艾滋病毒的个体化 治疗。

ABSTRACT The treatment of drug use and HIV often requires sequential, individualized decision-making concerning the type or delivery of treatment. An adaptive intervention is a treatment design that uses ongoing information from the patient to guide whether, and how to modify the treatment over time. By providing the appropriate treatment to those who need it, when they need it, adaptive interventions hold the promise of improving long- term outcomes for greater numbers of people, thereby increasing the reach and impact of drug use and HIV treatments in real-world settings. The sequential multiple assignment randomized trial (SMART) is a powerful experimental design that is used for constructing efficacious AIs. However, in order to make the SMART maximally useful to drug use and HIV intervention scientists, methodological work is needed to expand the options for analyzing data that arise from a SMART and to expand the kinds of SMARTs that are currently being designed, which are limited in important ways. This proposal is a competing renewal application of R01(DA039901; ending 07/31/20), in which our multidisciplinary team of behavior intervention and data scientists has successfully developed and tested a suite of methods for the design and longitudinal analysis of SMARTs. In this renewal we embark in new methodological directions related to use of novel treatment technologies and resulting intensive longitudinal data (ILD) to inform the development of effective AIs. A growing number of drug abuse and HIV interventions capitalize on modern technologies such as mobile and web-based applications, and wearable devices to deliver and augment treatments. These technologies enable the collection of frequent measures of an individual’s behavior and experiences. Such data have great potential for addressing new research questions about the dynamic effects of adaptive interventions and for constructing more sophisticated, yet less burdensome tailoring variables. However, existing longitudinal methods for the analysis of SMARTs do not currently accommodate ILD. Further, existing SMART designs do not currently take full advantage of the clinical potential of ILD in terms of how ILD can be employed as tailoring variables. Our objective is to bridge these critical gaps by developing and evaluating new methods to enable drug use/HIV scientists to analyze multiple types of ILD in a SMART; developing and evaluating new methods to analyze existing ILD in order to design more effective SMARTs; applying and illustrating these methods using data from three SMART studies and two observational studies in drug abuse and HIV that employ an ILD collection protocol; and developing free, user-friendly resources to implement these methods. The methods developed in this project will improve clinical and public health outcomes by enabling drug use and HIV scientists to develop more potent adaptive interventions to guide the individualization of drug use and HIV treatments.