Pilot Study of Care4Today v.2.0 Application for Improving Adherence to HIV Medications
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Average Minutes From Antiretroviral Medication Dose Time Based on MEMS Cap Openings
研究概览
简要总结
Although poor antiretroviral (ART) adherence in HIV does not mean a complete lack of therapeutic results, the benefit of ART increases as adherence improves. Consequences of suboptimal ART adherence are viral rebound, development of drug-resistant HIV strains, and more rapid progression to AIDS. Moreover, HIV-infected persons tend to have numerous co-occurring conditions and therefore take many medications making adherence to multiple drug regimens more difficult. A mobile application capable of improving medication adherence among HIV-infected persons would be highly useful.
The investigators propose an intervention study designed to address these potential mechanisms of nonadherence by utilizing the Care4Today v2.0 smartphone application (app). The current study is a small pilot Randomized Controlled Trial (RCT) comparing the smart phone application titled "Care4Today v2.0" versus standard of care to improve medication adherence to ART over a 4-week period with 60 HIV-infected participants.
The pilot RCT consists of 60 HIV-infected persons who are at risk for ART medication nonadherence. Using random assignment, 30 HIV-infected participants will be assigned to medication adherence improvement via "Care4Today" app as compared to 30 HIV-infected participants assigned standard of care.
The investigators will assess the effectiveness and acceptability of the app in improving objectively measured ART adherence (i.e., via medication event monitoring system caps) over a 4-week period via a pilot RCT with 30 HIV-infected persons assigned to the Care4Today intervention and 30 HIV-infected persons assigned to standard of care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Ability to provide informed consent
- •18 years or older at the time of enrollment
- •HIV-infected
- •Taking at least one medication to treat HIV illness
- •Indication of medication nonadherence, or having a condition (e.g., active substance use, depression) that puts the individual at risk for medication non adherence
- •Willingness to use electronic monitoring caps to track ART medication
- •Willingness to respond to application alert messages
排除标准
- •Axis I psychiatric diagnosis of psychotic disorder or mood disorder with psychotic features
- •Presence of a neurological condition (beyond HIV infection) known to impact cognitive functioning (e.g., Huntington's Disease, Stroke)
- •Unwillingness or inability to use electronic medication monitoring technology
- •Unwillingness or inability to use daily alert messages
结局指标
主要结局
Average Minutes From Antiretroviral Medication Dose Time Based on MEMS Cap Openings
时间窗: Completion of 30-day intervention
The absolute value (in minutes) from the time a participant was scheduled to take an antiretroviral medication dose to when the participant opened the MEMS cap
Number of Participants ≥90% Adherent to Antiretroviral Medication Based on MEMS Cap Openings
时间窗: Completion of 30-day intervention
Adherence will be measured using Medication Event Monitoring Systems (MEMS). Adherence defined as % MEMS adherence (doses taken/doses prescribed) within 2 hours of the indicated dose time. Adherence was dichotomized into 2 groups: \<90% and ≥90% using MEMS caps.
Percentage of Doses Taken in Dose Time Window
时间窗: Completion of 30-day intervention
次要结局
未报告次要终点
研究者
David J. Moore, Ph.D.
Professor of Psychiatry
University of California, San Diego