HEART to HAART: Smartphone Intervention to Improve HAART Adherence for Drug Users

说明（由申请人提供）：意义：与非吸毒者相比，感染艾滋病毒的吸毒者坚持HAART治疗的难度更大。由于持续坚持治疗对于降低与艾滋病毒相关的发病率和死亡率至关重要，因此迫切需要能够优化吸毒者坚持治疗持久性的创新和潜在可持续治疗战略。利用通信技术（如智能手机）评估和加强治疗的干预措施正越来越多地用于各种躯体、精神健康和药物滥用状况。创新/方法:NIDA的使命是开发基于新技术的干预措施以促进对HAART的坚持这项R-34申请的目标是使用行为治疗研究的阶段模型来适应，进一步开发，完成一种基于智能手机的干预措施的初步可用性和试点测试称为HEART（利用技术帮助提高抗逆转录病毒治疗的依从性），以增强，促进，提高非美沙酮维持环境中艾滋病毒感染吸毒者对HAART的长期依从性。根据Wagner的慢性护理模型，HEART到HAART干预旨在通过提供(1)关于药物依从性的实时信息（使用Wisepill设备）来增强持续的依从性咨询；(2)使用生态瞬时评估定期评估药物副作用、抑郁症状和药物使用频率（因为这些与吸毒者依从性差有关）；(3)根据评估进行有针对性的教育、推荐和鼓励。参与者（使用他们的手机）和他们的依从性团队（使用临床医生界面）可以共同跟踪依从性的实时变化，从而增加共同决策的可能性。本建议有三个目标，与行为治疗研究阶段1A和1B相一致。目标1和2寻求适应和进一步发展（1A阶段）心脏到HAART。目标1和2将使用迭代的以用户为中心的设计，允许系统的最终用户影响设计的形成方式，以增加系统的学习和使用的便利性。目的3将测试最终形式的HEART对HAART的初步疗效（1B期）。在目标3中，共有50名艾滋病毒感染者和吸毒者在一个城市的艾滋病毒门诊诊所接受依从性咨询，将被随机分配接受心脏疗法或HAART疗法与常规治疗，并增加智能手机控制。干预将持续24周，主要结果将是依从性的变化，这是由未经通知的电话随机药丸计数来衡量的。还将评估包括HIV病毒载量和CD4计数在内的生物学结果的变化。意义：如果HEART to HAART被证明是可接受和有效的，可能会引入一种全新的HAART药物自我管理方法，并提供一种量身定制的、潜在可持续的、成本较低的干预措施，可以提高感染艾滋病毒的吸毒者的长期依从性。

DESCRIPTION (provided by applicant): Significance: HIV infected drug users have greater difficulty adhering to HAART compared to non-drug users. As sustained adherence is critical to reducing HIV related morbidity and mortality, innovative and potentially sustainable treatment strategies that can optimize the durability of adherence enhancing interventions among drug users are urgently needed. Increasingly, interventions using communication technologies (e.g.,smartphones) to assess and enhance treatments are being used for a variety of somatic, mental health and substance abuse conditions. Innovation/Approach: Consistent with NIDA's mission to develop novel technological based interventions to promote adherence to HAART the goal of this R-34 application is to use the stage model of behavioral therapy research to adapt, further develop, complete preliminary usability and pilot testing of a smart phone based intervention called HEART (Helping Enhance Adherence to Retroviral therapy using Technology) to HAART, to enhance, promote, and improve long-term adherence to HAART among HIV infected drug users in the non- methadone maintenance setting. Informed by Wagner's Chronic Care Model, the HEART to HAART intervention is designed to enhance ongoing adherence counseling by providing (1) real time information about medication adherence (using Wisepill device); (2) periodic assessment of medication side effects, depressive symptoms and drug use frequency (as these are linked to poor adherence among drug users) using ecological momentary assessment and (3) tailored education, recommendation and encouragement based on assessments. The participant (using their phone) and their adherence team (using a clinician interface) can jointly track real time changes in adherence increasing the potential for shared decision-making. This proposal has three aims consistent with stage 1A and 1B of the stage of behavioral therapy research. Aims 1 and 2 seek to adapt and further develop (Stage 1A) HEART to HAART. Aims 1 and 2 will use an iterative user-centered design that allows end users of a system to influence how a design takes shape to increase the ease with which a system can be learned and used. Aim 3 will test the preliminary efficacy (Stage 1B) of the finalized form of HEART to HAART. In aim 3, a total of 50 HIV infected, drug users receiving adherence counseling at an urban, outpatient HIV clinic will be randomly assigned to receive either HEART to HAART versus usual care with the addition of a smart phone control. The intervention will last 24 weeks and the primary outcome will be change in adherence as measured by unannounced telephone based random pill counts. Changes in biological outcomes including HIV viral load and CD4 count will also be evaluated. Implication: If shown to be acceptable and efficacious HEART to HAART may introduce a fundamentally new method of HAART medication self-management and provide a tailored, potentially sustainable and less cost intensive intervention that can increase adherence among HIV infected drug users over the long term.