A Randomised Control Trial on the Effectiveness of Three Modalities of Tuberculosis Treatment Supervision Under DOTS Strategy in Ethiopia.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 924
- 试验地点
- 2
- 主要终点
- Cured and successful completion of treatment of smear positive and smear negative pulmonary tuberculosis cases.
研究概览
简要总结
The purpose of the study is whether the provision of tuberculosis care using volunteer community health workers or self-administered treatment for 7 months is equally effective with the existing 8 months of TB care in public health facilities by health workers. Patient care by volunteer community health workers and 7 months of self-administered treatment are more patient-convenient delivery options than the ongoing TB care in health facility.
详细描述
Study setting
The study will be conducted in 10 districts which fully implemented the DOTS program in all their health facilities in order to determine whether better patient quality of care and convenience using three TB care options could improve treatment outcome. In the study districts there are 149 tabias and 1163 kushets with 1.2 million residents representing 30% of the total population of the region. All public health facilities (8 hospitals, 11 health centres and 48 health posts) in these districts will be included. District hospitals and health centres provide TB diagnostic services. The study districts comprise 2316 volunteer community health workers (CHWs) who are functional and accountable to the public health system.
Study population
Patients will be recruited from the 10 study districts of all public health institutions which serve both urban and rural population. New patients diagnosed in the study districts (8 hospitals and 10 of the health centres) and those referred for treatment will be included. Patients suspected of pulmonary tuberculosis (PTB) disease will be diagnosed based on the following case definitions:
- A patient with at least one of the following criteria will be diagnosed as smear positive PTB:
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
- Single (Investigator)
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 15 years or above
- •no previous tuberculosis treatment
- •sputum exam positive for tuberculosis (PTB+); or negative sputum results but with consistent clinical and chest x-ray features (PTB-)
排除标准
- •age less than 15 years
- •previously treated with anti-TB drugs
结局指标
主要结局
Cured and successful completion of treatment of smear positive and smear negative pulmonary tuberculosis cases.
时间窗: August 2005 to January 2007
次要结局
未报告次要终点