Evaluation of an Intervention (Consisting of an Electronic Reminder Device, Pillboxes, and Monthly Telephone Calls) on Adherence to Highly Active Antiretroviral Therapy (HAART) in HIV Infected Adults
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- The primary outcome is to determine if the intervention has any effect on adherance with HAART by noting the HIV viral loads of both groups.
研究概览
简要总结
It is known successful HIV therapy depends on the patients' ability to take their medicine regularly. This study is designed to find out if an intervention designed to help patients remember to take their medication is effective. The intervention consists of a wristwatch that has an alarm to remind patients when to take their medication, a pillbox and three monthly phone calls by a physician. All these experimental measures are meant to improve the ability of patients to take their medicines.
详细描述
--Background--
The management of HIV has changed dramatically since the introduction of highly active antiretroviral therapy (HAART). HAART consists of a drug regimen that targets the virus at various points in its life cycle and is thus more effective than monotherapy. The drugs that comprise this regimen usually belong to different classes of antiretrovirals.
HAART regimens can be complex and difficult to tolerate. They usually consist of multiple pills that have to be taken two to three times a day and may also need to be taken with food, on an empty stomach or with plenty of fluids (depending on the particular drug). In addition, they have multiple side effects that may limit the patient's willingness to take them.
Adherance to HAART is of paramount importance. Paterson et al showed that patients should take 95% of their prescribed doses in order to achieve a high likelihood of success and maintaining an undetectable viral load. Poor adherence can lead to serious consequences including failure to prevent viral replication, shortened survival and development of viral resistance.
Various methods have been used to measure adherence to HAART. All these methods have their limitations and no gold standard exists with which they can be compared.
研究设计
- 研究类型
- Interventional
- 干预模型
- Factorial
- 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
- •patient must have HIV to participate
- •patient must be at least 18 years of age or older
- •must have been on HAART for six weeks
- •must have a working telephone number
排除标准
- •patient is HIV negative
- •patient is younger than 18 years of age
- •patient has been on HAART for less than 6 weeks
- •if patient does not have a working telephone number, he/she cannot participate in the study
结局指标
主要结局
The primary outcome is to determine if the intervention has any effect on adherance with HAART by noting the HIV viral loads of both groups.
次要结局
- To determine if the study's simple and cost effective intervention has a benefit to subjects and if it would stand to benefit other centers that take care of patients with HIV.