Unobtrusive Sensing of Medication Intake ("USE-MI")
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- System Acceptability
研究概览
简要总结
The purpose of this study is to test the USE-MI system hardware and software to see if it can accurately measure when subjects take their HIV-related medications and help them remember to take these medications. With the use of a smartwatch and smartphone "app", investigators hope to be able to monitor medication adherence in real-time and send subjects electronic reminders when they may have forgotten to take their medication.
详细描述
Human immunodeficiency virus (HIV) treatment is most likely to be successful when patients are committed to taking their medications as prescribed (medication adherence). For maximum benefit, researchers found that patients receiving antiretroviral therapy (ART) to treat HIV infection and pre-exposure prophylaxis (PrEP) to prevent HIV infection have need consistent, high levels of adherence for maximum benefit. However, some patients struggle to take their HIV-related medications regularly and that can lead to losing on the benefits the medication can provide - either suppressing the HIV infection so people do not get sick from it or transmit it, or failing to prevent infection when someone is exposed.
Objectives: Conduct an evaluation of USE-MI to assess accuracy, robustness, acceptability of the system.
All subjects will continue to take their ART or PrEP medication as prescribed by their regular doctor. The USE-MI system is being developed as a behavioral intervention to enhance medication adherence. In the pilot phase, the investigators plan to enroll 10 subjects to use the USE-MI system for 1 month to get initial feedback about the system. In the second phase, up to 50 subjects will begin using the USE-MI for up to 6 months to assess accuracy, robustness and acceptability of the system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Either a) have an HIV infection and are taking ART, or b) risk factors for contracting HIV infection and are taking PrEP
- •Taking their medications from pill bottles, or other containers that the USE-MI system can monitor properly
- •Reasonable proficiency in English
- •Able to come to the research office for monthly follow-up visits
排除标准
- •Not responsible for taking their own HIV medications (e.g. residing in a supervised setting where their medications are administered to them)
- •Taking medications using a method that the USE-MI system cannot monitor properly
- •Lacking proficiency in English
结局指标
主要结局
System Acceptability
时间窗: 6 Months
Evaluate the use of the USE-MI system after 6 months of follow-up. At each monthly visit, subjects will complete a questionnaire about their medication-taking habits, plus the study staff will perform a manual count of their pills. Subjects will be asked for feedback about improving the system, whether they found it helpful, and whether they would be willing to continue to use such a system
次要结局
- Accuracy of Capture of Pill-Taking by USE-MI(6 Months)