Home-based AIDS Care Project, Tororo, Uganda
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Equivalence of 3 different monitoring regimens for ART
研究概览
简要总结
The Home-based AIDS care program pilot project delivers and monitors antiretroviral (ARV) and tuberculosis (TB) medications at the homes of 1,000 people with HIV living in a rural area of Uganda. This study is evaluating how well this program reduces illness and prolongs the life of participants, changes sexual behavior, influences levels of adherence to medication, affects aspects of perceived stigma by participants and their communities, and other operational components of the program including cost-effectiveness. This study is evaluating the hypothesis that frequent home visits by a trained lay person with a standard questionnaire is equivalent in terms of health outcomes to frequent viral load and CD4 cell count measurements.
详细描述
In Uganda, the high cost and complexity of administering antiretroviral therapy is an obstacle to full implementation country-wide. The Home-based AIDS care program (HBAC) pilot project was designed to deliver and monitor ARV and tuberculosis (TB) medications at the homes of 1,000 people with HIV living in a rural area of Uganda. In addition, the cost and complexity of frequent laboratory monitoring of viral load and CD4 cell counts is a major impediment to widespread use of ARV therapies in Uganda and other resource-limited settings. Nested within the Home-Based AIDS Care (HBAC) project, is a randomized study of strategies for monitoring ARV therapy that involves 3 arms: 1) Quarterly CD4 cell counts, viral loads and home visits by trained lay persons; 2) Quarterly CD4 cell counts and home visits; and 3) Home visits alone.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV infection
- •CD4 cell count <250 or symptomatic AIDS
- •Age >13 years
- •Karnofsky score >40%
- •AST or ALT < 5 times normal values
- •Creatinine clearance >25 ml/min
排除标准
- 未提供
结局指标
主要结局
Equivalence of 3 different monitoring regimens for ART
次要结局
- Sexual risk behavior
- medication adherence
- viral load
- quality of life
- depression
- cost-effectiveness
- CD4 cell count