Effectiveness of a Social-Psychological Intervention to Improve Adherence to Antiretroviral Drug Regimens for AIDS: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- Adherence to HAART
研究概览
简要总结
All eligible patients will be invited to use electronic monitoring of medication (MEMS) during the next six months. After two months with MEMS the enrolled patients will be randomized to intervention group or to control group. The intervention group will be submitted to four social-psycho sessions with a pre-trained health professional. The control group will receive the usual care of the health service.
The study will compare the rate of adherence to antiretroviral therapy between the intervention group and the control group. The duration of the study will be of six months. The analysis will be based on "intention-to-treat.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Patients aged more than 18 years old, with detectable viral load and more than six months under HAART
排除标准
- •Pregnant women
- •Patients participating in other trials
- •Patients in treatment for hepatitis and for active opportunistic infection
- •Patients with mental or physical condition which do not allow their attendance to the health service
研究组 & 干预措施
Intervention
The intervention group will be submitted to four social-psychological individual sessions with a pre-trained health professional.
干预措施: Social-psycho intervention to improve adherence to HAART (Behavioral)
Control
The control group will be submitted to the usual care of the health service.
干预措施: Usual care (Other)
结局指标
主要结局
Adherence to HAART
时间窗: 24 weeks
次要结局
- Viral Load(12 and 24 weeks)