Med-eMonitor: A Web-Enabled HIV ART Adherence Monitoring Device and System

Med-eMonitor：一种支持网络的 HIV ART 依从性监测设备和系统

• 批准号: 7119381
• 负责人: BRUCE A KEHR
• 金额: $ 15万
• 依托单位: INFORMEDIX HOLDINGS, INC.
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-06-01 至 2007-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7119381
• 关键词: AIDS therapy; HIV infections; Internet; antiAIDS agent; antiviral agents; behavioral /social science research tag; blood tests; clinical research; computer assisted patient care; computer program /software; computer system design /evaluation; health care service evaluation; health services research tag; home health care; human immunodeficiency virus 1; human subject; interview; patient monitoring device; telemedicine; therapy compliance; virus load; AIDS therapy; HIV infections; Internet; antiAIDS agent; antiviral agents; behavioral /social science research tag; blood tests; clinical research; computer assisted patient care; computer program /software; computer system design /evaluation; health care service evaluation; health services research tag; home health care; human immunodeficiency virus 1; human subject; interview; patient monitoring device; telemedicine; therapy compliance; virus load

DESCRIPTION (provided by applicant): Adherence to HIV antiretroviral therapy (ART) is closely associated with viral suppression, drug resistance and disease progression. Although near perfect adherence is needed for reliable viral suppression, average adherence to HIV antiretroviral therapy is under 70%. Accurate assessment of adherence is the first step in improving adherence because it identifies patients in need of more intensive intervention and monitoring. Patient self-report is the least costly and most practical method for assessing adherence in routine practice, but has poor sensitivity at detecting nonadherence. On the other hand, unannounced home pill counts are accurate and sensitive to the detection of nonadherence, but are not feasible in routine clinical practice because of their high cost and labor demands. Electronic medication monitors designed for clinical practice deliver objective, real-time adherence monitoring at a reasonable cost. Data from monitors are associated with viral suppression and the development of resistance. The most commonly used device, MEMS Caps, has several limitations however, including the number of medications it holds, cumbersome reporting functions, and price. Lacking a valid, practical, and inexpensive method of adherence assessment, providers rely on informal and unsystematic assessments of adherence that are often no better than chance. Understanding these challenges, InforMedix has developed the Med-eMonitor System, an affordable and easy-to-use electronic adherence measurement device coupled with a Web-enabled device programming and reporting system. We propose a 3-month observational study to test the feasibility and validity of the Med-eMonitor in people taking ART (N=50). We will assess the feasibility of the devices using self-reported likeability and usability surveys, and device-related process measures. We will assess validity with concurrent unannounced home pill counts and viral load monitoring. Our specific aims are as follows: Specific Aim 1: Examine the feasibility of the Med-eMonitor device for use by HIV positive people living in the community. We will document the feasibility of the device's use using process variables (i.e., drop out rates, missing data), and qualitative usability and likeability data derived from one-on-one interviews. Specific Aim 2: Measure the validity of the Med-eMonitor device's measure of medication adherence using unannounced pill counts and HIV viral load. We will estimate the device's measurement validity via comparisons with viral load suppression and unannounced, home-based pill counts. If valid, Med-eMonitor may accurately measure ART adherence, thus improving HIV disease outcomes.

描述（由申请人提供）：遵守HIV抗逆转录病毒疗法（ART）与病毒抑制，耐药性和疾病进展密切相关。尽管需要几乎完美的依从性才能获得可靠的病毒抑制，但平均遵守HIV抗逆转录病毒疗法的依从性却低于70％。准确评估依从性是提高依从性的第一步，因为它确定了需要更密集的干预和监测的患者。患者的自我报告是评估常规实践中依从性的成本最低，最实用的方法，但在检测不遵守方面的敏感性较差。另一方面，未经宣布的家用药丸计数准确且敏感，但由于其高成本和劳动力需求而在常规临床实践中不可行。设计用于临床实践的电子药物监测器以合理的成本提供目标，实时依从性监测。监测器的数据与病毒抑制和抗药性发展有关。但是，最常用的设备MEMS CAPS具有多个限制，包括其持有的药物数量，繁琐的报告功能和价格。缺乏有效，实用且廉价的依从性评估方法，提供者依靠非正式和非系统性评估的依从性评估，这些评估通常不超过机会。了解这些挑战时，Informedix开发了Med-MeNitor系统，这是一种负担得起且易于使用的电子依从性测量设备，并加上支持Web的设备编程和报告系统。我们提出了一项为期3个月的观察性研究，以测试Med-MeNtor在服用ART的人（n = 50）中的可行性和有效性。我们将使用自我报告的可爱性和可用性调查以及与设备相关的过程指标评估设备的可行性。我们将通过同时进行的未经宣布的家用药丸计数和病毒负荷监测来评估有效性。我们的具体目的如下：特定目的1：检查Med-MeNter设备用于艾滋病毒阳性人士使用的可行性。我们将记录使用过程变量使用设备使用的可行性（即删除率，丢失的数据）以及从一对一的访谈中得出的定性可用性和可爱性数据。特定目标2：使用未经宣布的药丸计数和HIV病毒载荷来衡量Med-Med-Med-Med-MeNitor设备的药物依从性量度。我们将通过与病毒负荷抑制和未经通知的家庭药丸计数进行比较来估计设备的测量有效性。如果有效，则大法官可以准确地衡量艺术依从性，从而改善HIV疾病的结果。