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

• 批准号: 8512690
• 负责人: SETH S HIMELHOCH
• 金额: $ 22.4万
• 依托单位: UNIVERSITY OF MARYLAND BALTIMORE
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-15 至 2015-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8512690
• 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; 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

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.

描述（由申请人提供）：意义：与非药物使用者相比，艾滋病毒感染的吸毒者对HAART的粘附更大。由于持续的依从性对于降低艾滋病毒相关的发病率和死亡率至关重要，因此迫切需要优化依从性增强药物使用干预措施的耐用性的创新性和潜在的可持续治疗策略。越来越多地，使用通信技术（例如，智能手机）评估和增强治疗方法的干预措施已用于各种体细胞，心理健康和药物滥用条件。 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在非美沙酮维护环境中，艾滋病毒感染了吸毒者。由瓦格纳（Wagner）的慢性护理模型告知，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）使用生态瞬时评估的药物副作用，抑郁症状和药物使用频率的定期评估（因为这些与吸毒者之间的依从性差有关），以及（3）基于评估的量身定制的教育，建议和鼓励。参与者（使用手机）和他们的依从团队（使用临床医生界面）可以共同跟踪依从性的实时变化，从而增加了共享决策的潜力。该提议的目标与行为疗法研究的阶段的1A和1B相一致。目标1和2试图适应并进一步发展（第1A阶段）心脏。 AIMS 1和2将使用以用户为中心的迭代设计，该设计使系统的最终用户能够影响设计的形状，从而提高了可以学习和使用系统的易度性。 AIM 3将测试HAART最终确定形式的初步功效（第1B期）。在AIM 3中，总共感染了50名艾滋病毒的吸毒者，在城市中接受依从性咨询，门诊艾滋病毒诊所将被随机分配，以接受Haart的心脏，而添加智能手机控制。干预将持续24周，主要结果将是通过未通知的基于电话的随机药丸计数来衡量的依从性。还将评估包括HIV病毒负荷和CD4计数在内的生物学结果的变化。含义：如果证明是可以接受和有效的心脏，Haart可能会引入一种从根本上引入HAART药物自我管理的新方法，并提供量身定制的，潜在的可持续性和成本较低的强化干预措施，从而可以长期增加HIV感染的药物使用者的依从性。