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

HEART to HAART：智能手机干预可提高吸毒者对 HAART 的依从性

基本信息

批准号：
8209493
负责人：
SETH S HIMELHOCH
金额：
$ 24.24万
依托单位：
UNIVERSITY OF MARYLAND BALTIMORE
依托单位国家：
美国
项目类别：
财政年份：
2011
资助国家：
美国
起止时间：
2011-09-15 至 2014-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8209493
关键词：
Address Adherence Adverse effects Behavior Therapy Biological CD4 Lymphocyte Count Cellular Phone Clinic Communication Computers Counseling Data Devices Dose Drug usage Drug user Education Frequencies Goals HIV Highly Active Antiretroviral Therapy Intervention Laboratories Learning Link Maintenance Marketing Measures Mental Health Methods Mission Modeling Monitor Morbidity - disease rate National Institute of Drug Abuse Outcome Outpatients Participant Penetration Persons Pharmaceutical Preparations Population Positioning Attribute Professional counselor Randomized Recommendation Self Management Shapes Staging Substance abuse problem System Technology Telephone Testing Text Therapeutic Studies Time Viral Viral Load result base chronic care model clinical practice cost depressive symptoms design digital improved innovation medication compliance methadone maintenance mortality non-drug novel outreach pill pilot trial primary outcome response shared decision making treatment as usual treatment strategy usability user centered design wireless network

项目摘要

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.

描述（由申请人提供）：意义：与非吸毒者相比，感染 HIV 的吸毒者更难以坚持 HAART。由于持续坚持对于降低艾滋病毒相关发病率和死亡率至关重要，因此迫切需要创新且可能可持续的治疗策略，以优化吸毒者中坚持增强干预措施的持久性。使用通信技术（例如智能手机）来评估和加强治疗的干预措施越来越多地用于治疗各种躯体、心理健康和药物滥用状况。创新/方法：与 NIDA 开发基于新技术的干预措施以促进遵守 HAART 的使命相一致，R-34 应用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、完成初步可用性和试点测试基于智能手机的 HAART 干预措施，称为 HEART（使用技术帮助增强对逆转录病毒治疗的依从性），以增强、促进和改善 HIV 感染吸毒者在非美沙酮维持治疗中对 HAART 的长期依从性环境。根据瓦格纳的慢性护理模型，HEART 到 HAART 干预旨在通过提供 (1) 有关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、抑郁症状和吸毒频率（因为这些与吸毒者依从性差有关），以及 (3) 基于评估的定制教育、推荐和鼓励。参与者（使用手机）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潜力。该提案具有与行为治疗研究阶段 1A 和 1B 阶段一致的三个目标。目标 1 和 2 寻求将 HEART 适应并进一步发展（第 1A 阶段）HAART。目标 1 和 2 将使用以用户为中心的迭代设计，允许系统的最终用户影响设计的形成方式，以提高系统学习和使用的便利性。目标 3 将测试最终形式的 HEART 转 HAART 的初步功效（第 1B 阶段）。在目标 3 中，共有 50 名艾滋病毒感染者、吸毒者在城市艾滋病毒门诊门诊接受依从性咨询，他们将被随机分配接受 HEART 转 HAART 治疗或接受常规护理（加上智能手机控制）。干预将持续 24 周，主要结果将是依从性的变化（通过未通知的电话随机药丸计数来衡量）。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。启示：如果 HEART 转 HAART 被证明是可接受且有效的，可能会引入一种全新的 HAART 药物自我管理方法，并提供量身定制的、潜在可持续的且成本较低的干预措施，从长远来看，可以提高 HIV 感染吸毒者的依从性。公共卫生相关性：与非吸毒者相比，感染艾滋病毒的吸毒者更难以坚持高效抗逆转录病毒治疗。由于持续坚持高效抗逆转录病毒治疗对于降低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，因此迫切需要创新和潜在可持续的治疗策略，以优化吸毒者中坚持增强干预措施的持久性。该 R-34 应用程序的目标是进一步开发和试点测试基于智能手机的 HAART 干预措施，称为 HEART（使用技术帮助增强对逆转录病毒治疗的依从性），以提高 HIV 感染吸毒者对 HAART 的依从性。