Implementing Computerized Clinical Assessment of HIV Patient Adherence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 371
- 试验地点
- 6
- 主要终点
- Patient adherence to HIV medications, as measured by MEMS data, and by self-report questionnaires.
研究概览
简要总结
This study will examine whether a computerized, self-administered assessment of patient medication adherence and health behaviors, plus support for adherence, improves the ability of clinicians to identify adherence problems and leads to better adherence.
详细描述
Antiretroviral medications are highly effective in controlling HIV, if patients adhere to the regimen. However, HIV medication adherence problems are very common, and evidence is clear that providers have great difficulty 'diagnosing' poor adherence accurately. If healthcare providers can identify patients with adherence problems, they can intervene to help patients overcome these problems and take their medications as prescribed, which can improve symptoms and quality and length of life. Both clinicians and HIV positive patients will be recruited to this study. Before each clinic visit, patients randomized to the intervention will be asked to answer questions about their medications, medication-taking behavior, and risk-factors for non-adherence on MedCHEC, a tablet touch-screen computer that generates provider and patient reports. We will give these reports to the provider and patient to assist with the clinical visit. Based on the MedCHEC-generated report, the patient may be referred to an Adherence Care Manager (ACM). The ACM will assist the patient in overcoming adherence barriers by telephone and in-clinic counseling. The study will evaluate the effects of this system on adherence and clinical care using both quantitative methods (randomized controlled trials of effects on adherence and providers' adherence estimates), and qualitative methods.
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
- •Over 18 years of age
- •Confirmed HIV-positive
- •On or newly starting antiretroviral medication for HIV
- •Under treatment at one of the study sites
- •Available by telephone
排除标准
- •Clinically diagnosed by provider with significant cognitive impairment, or Mini-Mental Status Exam score less than or equal to 22
- •Inability to read English
- •Inability or refusal to use MedCHEC touch-screen computer
- •Inability or refusal to use any form of electronic drug monitoring device (MEMS)
- •Never available by telephone
研究组 & 干预措施
MedCHEC Tablet Computer & Adherence Care
Patients assigned to the intervention answer questions about their medication, medication-taking behavior and risks for non-adherence on the MedCHEC tablet touch-screen computer, which generates provider and patient reports. Patients may be referred to an Adherence Care Manager on the basis of the reports. In addition, patients will receive standard information about adherence.
干预措施: MedCHEC Tablet Computer & Adherence Care (Behavioral)
Adherence Information Only
Patients assigned to the active comparator arm will receive standard information about adherence.
结局指标
主要结局
Patient adherence to HIV medications, as measured by MEMS data, and by self-report questionnaires.
时间窗: 1 year
次要结局
未报告次要终点
研究者
Allen L. Gifford
Professor of Public Health and Medicine
Boston University
