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）感染导致了过去二十年中最昂贵和最具破坏性的流行病之一。未经治疗，病毒会慢慢破坏免疫系统，导致严重的发病率，并在初次感染后的2至20年内几乎100%死亡。幸运的是，抗逆转录病毒疗法的最新进展已经允许几乎完全抑制感染个体中的病毒复制。不幸的是，病毒快速突变并对治疗产生抗性的能力需要使用复杂的给药方案给予多种药物，以维持病毒抑制。尽管遵守这些复杂的治疗方案至关重要，但即使是最警惕的人也很难长时间维持这些方案。该项目的目的是改造和测试一个计算机化药盒，以便为艾滋病毒感染者储存和运输抗逆转录病毒药物。该设备旨在通过在给药时间和使用报告功能时引入提醒信号来进一步帮助依从性。该器械在第一阶段进行了测试，并证明了高度积极的可用性评级，以及与增加服药时间依从性的显著相关性（通过打开药丸盖观察到）。在第一次测试中提出的修改将被实施，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，以确定其在提高药物依从性方面的有效性、可用性和有效性。