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

描述（由申请人提供）：意义：与非吸毒者相比，HIV感染的吸毒者更难坚持HAART。由于持续坚持对降低艾滋病毒相关发病率和死亡率至关重要，因此迫切需要创新的和可能可持续的治疗战略，以优化吸毒者中加强坚持的干预措施的持久性。越来越多地使用通信技术进行干预（例如，智能手机）评估和加强治疗的方法正被用于各种躯体、心理健康和药物滥用状况。创新/方法：与NIDA的使命一致，即开发新的基于技术的干预措施，以促进对HAART的依从性，该R-34应用程序的目标是使用行为治疗研究的阶段模型，以适应、进一步开发、完成基于智能手机的干预措施（称为HEART）的初步可用性和试点测试（帮助加强坚持使用技术逆转录病毒治疗）HAART，以加强，促进和改善长期坚持HAART艾滋病毒感染的吸毒者在非美沙酮维持设置。根据瓦格纳的慢性护理模式，HEART到HAART干预旨在通过提供（1）关于药物依从性的真实的时间信息来加强持续的依从性咨询（使用Wisepill器械）;（2）定期评估药物副作用、抑郁症状和用药频率（因为这些与吸毒者的依从性差有关）使用生态瞬时评估和（3）基于评估的有针对性的教育、建议和鼓励。参与者（使用他们的电话）和他们的依从性团队（使用临床医生界面）可以联合跟踪依从性的真实的时间变化，从而增加了共同决策的可能性。这个建议有三个目标与行为治疗研究阶段的1A和1B阶段一致。目标1和2寻求适应和进一步发展（第1A阶段）HEART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如何形成，以增加系统学习和使用的容易性。目标3将测试最终形式的HEART到HAART的初步疗效（第1B阶段）。在目标3中，在城市门诊HIV诊所接受依从性咨询的总共50名HIV感染者、吸毒者将被随机分配接受HEART到HAART或常规护理，并增加智能手机控制。干预将持续24周，主要结局将是通过电话随机药丸计数测量的依从性变化。还将评价生物学结局的变化，包括HIV病毒载量和CD 4计数。含义：如果被证明是可接受的和有效的HEART到HAART可能会引入一个全新的HAART药物自我管理的方法，并提供一个定制的，潜在的可持续的和成本较低的密集型干预，可以增加艾滋病毒感染的吸毒者之间的长期坚持。

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.