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

说明(申请人提供)：意义：艾滋病毒感染的吸毒者比非吸毒者更难坚持HAART。由于持续坚持对于减少艾滋病毒相关发病率和死亡率至关重要，迫切需要创新的和潜在的可持续的治疗战略，以优化坚持的持久性，以加强吸毒者的干预措施。使用通信技术(如智能手机)评估和加强治疗的干预措施越来越多地用于各种躯体、心理健康和药物滥用情况。创新/方法：与NIDA开发新型技术干预措施以促进坚持HAART的使命一致，这项R-34应用程序的目标是利用行为治疗研究的阶段模型来适应、进一步开发、完成一种名为心脏的智能手机干预措施的初步可用性和试点测试(利用技术帮助提高逆转录病毒治疗的依从性)，以加强、促进和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。在瓦格纳慢性护理模式的启发下，心脏到HAART干预旨在通过以下方式加强持续的依从性咨询：(1)关于服药依从性的实时信息(使用Wisepill设备)；(2)使用生态瞬时评估对药物副作用、抑郁症状和药物使用频率(因为这些与吸毒者的依从性差有关)进行定期评估；以及(3)基于评估的量身定制的教育、建议和鼓励。参与者(使用他们的手机)和他们的遵从性团队(使用临床医生界面)可以联合跟踪遵从性的实时变化，增加了共享决策的可能性。这项建议有三个目标，与行为疗法研究阶段的1A和1B阶段一致。目标1和目标2寻求适应和进一步发展(阶段1A)心脏以适应HAART。AIMS 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，以增加学习和使用系统的简易性。目标3将测试最终形式的心脏对HAART的初步疗效(阶段1B)。在AIM 3中，总共50名在城市艾滋病毒门诊诊所接受依从性咨询的艾滋病毒感染吸毒者将被随机分配到接受HAART心脏到HAART治疗和常规护理的两组中，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，通过未经宣布的电话随机药片计数来衡量。还将评估包括艾滋病毒病毒载量和CD4计数在内的生物学结果的变化。暗示：如果HAART被证明是可接受和有效的，HAART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、成本密集度较低的干预措施，可以提高HIV感染吸毒者的长期依从性。 公共卫生相关性：与非吸毒者相比，感染艾滋病毒的吸毒者接受高效抗逆转录病毒治疗的难度更大。由于持续坚持高效抗逆转录病毒疗法对于减少艾滋病毒相关发病率、死亡率和减少艾滋病毒传播至关重要，迫切需要能够优化坚持的持久性的创新和潜在可持续的治疗战略，以加强吸毒者的干预措施。这一R-34应用程序的目标是进一步开发和试点测试一种基于智能手机的干预措施，称为心脏(使用技术帮助提高对逆转录病毒疗法的依从性)，以提高感染艾滋病毒的吸毒者对HAART的依从性。

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. PUBLIC HEALTH RELEVANCE: HIV infected drug users have greater difficulty adhering to highly active antiretroviral therapy compared to non-drug users. As sustained adherence to highly active antiretroviral therapy is critical to reducing HIV related morbidity, mortality, and reducing the spread of HIV, innovative and potentially sustainable treatment strategies that can optimize the durability of adherence enhancing interventions among drug users is urgently needed. The goal of this R-34 application is to further develop and pilot test a smartphone based intervention called HEART (Helping Enhance Adherence to Retroviral therapy using Technology) to HAART, to enhance adherence to HAART among HIV infected drug users.