A Targeted Cell Phone Intervention to Improve Patient Access to Care and Drug Adherence in Patients Taking Antiretroviral (ARV) Medications in Kenya
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 536
- 试验地点
- 1
- 主要终点
- Adherence to ART and HIV RNA suppression
研究概览
简要总结
A clinical study to evaluate the use of cell phones to support drug adherence and follow-up of patients taking antiretroviral therapy (ART) for treatment of HIV. The intervention involves health-care providers sending regular short-message-service (SMS) text messages to patients and following up their responses. The hypothesis is that the cell phone intervention will improve ART adherence and health outcomes compared with the current standard of care.
详细描述
This RCT study focuses on enrolling and following patients initiating ART. Note, a second parallel prospective cohort study enrolls and follows ART experienced patients who have already been taking ART for at least one year before and after the same intervention.
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
- •HIV infected and starting antiretroviral therapy
- •Adequate (daily) access to a cell phone
- •Intending to attend the enrollment clinic for 2 years
- •Consent to participate
排除标准
- •Not meeting inclusion criteria
结局指标
主要结局
Adherence to ART and HIV RNA suppression
时间窗: 6,12 months
Although many patients are seen every 3 months, study visits with questionnaires and viral load are completed at 0, 6, and 12 month scheduled follow-up visits.
次要结局
- Retention(6, 12 months)
- Quality of Life (SF-12)(3, 6, 9, 12 months)
- Health (CD4, weight, progression to AIDS, all cause mortality)(6, 12 months)