A Novel Technology to Improve HIV Medication Compliance

提高艾滋病毒药物依从性的新技术

• 批准号: 7248661
• 负责人: Vesta Brue
• 金额: $ 106.55万
• 依托单位: LIFETECHNIQUES, INC.
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-08-15 至 2009-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7248661
• 关键词: Adherence; Anti-Retroviral Agents; Clinical; Complex; Daily; Data; Device Designs; Devices; Dose; Effectiveness; Epidemic; Feedback; Focus Groups; HIV; Health Status; Housing; Immune system; Individual; Infection; Measures; Modems; Modification; Morbidity - disease rate; Mutate; Opportunistic Infections; Participant; Patients; Pattern; Performance; Persons; Pharmaceutical Preparations; Phase; Phase II Clinical Trials; Plasma; Population; Population Study; Production; Prophylactic treatment; Protocols documentation; Provider; Purpose; Randomized Controlled Clinical Trials; Rate; Recommendation; Reporting; Research Infrastructure; Research Personnel; Resistance; Schedule; Signal Transduction; Small Business Funding Mechanisms; Small Business Innovation Research Grant; Telephone; Testing; Time; Treatment Protocols; Treatment outcome; Upper arm; Validity and Reliability; Viral; Viral Load result; Virus; antiretroviral therapy; base; computerized; design; improved; medication compliance; mortality; new technology; novel; pill; preference; programs; usability

DESCRIPTION (provided by applicant): Infection with the human immunodeficiency virus (HIV) has led to one of the most costly and devastating epidemics of the last two decades. Untreated, the virus slowly destroys the immune system, leading to significant morbidity and virtually 100% mortality within two to twenty years after initial infection. Fortunately, recent advances in antiretroviral therapy have allowed for almost complete inhibition of viral replication in infected individuals. Unfortunately, the ability of the virus to rapidly mutate and become resistant to treatments necessitates the administration of multiple medications, using complex dosing schedules, in order to maintain viral suppression. Although adherence to these complicated treatment regimens is paramount, even the most vigilant persons have difficulty maintaining these protocols for extended periods of time. The purpose of this project is to retool and test a computerized pillbox that will allow convenient storage and transport of antiretroviral medications for persons infected with HIV. The device is designed to further aid adherence by incorporating reminding signals at dosing times and usage reporting functions. The device was tested in Phase I and demonstrated highly positive usability ratings and significant association with increased medication taking timing compliance (as observed via pill lid openings). Modifications that were suggested in the first test will be implemented, and the beta unit will be tested in focus groups before production units are built and beta tested. When finalized, the device and its infrastructure will be tested in a study population of HIV patients in order to determine its effectiveness, usability, and validity in increasing medication compliance.

描述（由申请人提供）：人类免疫缺陷病毒（HIV）的感染导致了过去二十年来最昂贵和最具破坏性的流行病之一。如果不加以治疗，这种病毒会慢慢破坏免疫系统，在初次感染后的2至20年内导致严重的发病率和几乎100%的死亡率。幸运的是，抗逆转录病毒疗法的最新进展已使感染者体内的病毒复制几乎完全被抑制。不幸的是，这种病毒能够迅速变异并对治疗产生抗药性，因此必须使用多种药物，使用复杂的给药方案，以维持病毒抑制。尽管坚持这些复杂的治疗方案是至关重要的，但即使是最警惕的人也很难长时间维持这些方案。这个项目的目的是改造和测试一个电脑化药箱，以便为艾滋病毒感染者方便地储存和运输抗逆转录病毒药物。该设备的设计通过在给药时间和使用报告功能结合提醒信号来进一步帮助依从性。该设备在第一阶段进行了测试，显示出高度积极的可用性评级，并与增加服药时间依从性显著相关（通过药盖开口观察）。在第一次测试中提出的修改将被执行，在生产单元构建和测试之前，测试单元将在焦点小组中进行测试。最终确定后，该设备及其基础设施将在HIV患者的研究人群中进行测试，以确定其有效性，可用性和有效性，以提高药物依从性。