Achieving TB Control In Zambia Through Scale Up Of Innovative Tools And Proven Active TB Case Finding Interventions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18,194
- 试验地点
- 2
- 主要终点
- increase TB case detection
研究概览
简要总结
To achieve TB control, innovative case finding interventions are needed that will reach the broader affected population including those that do not access the health facilities. Systematic community case finding with highly sensitive screening and diagnostic tools are needed. At the facility level, the index of suspicion for TB by health care workers needs to be raised to ensure that all those that need TB screening are appropriately screened.
详细描述
The purpose of this study is to initiate sustained, active health facility and community-based case finding interventions to achieve improved TB case detection in high burden settings (Zambia) and contribute to TB control.
The interventions are expected to increase the impact of Xpert on TB case finding, thus increase TB case detection through scaling up of a combination of community level and facility level TB case finding interventions. The study will generate evidence on the added value of using Chest X-ray (CXR) screening at community level, whilst also comparing the performance of CXR with computer assisted diagnosis (CAD) and C-reactive protein (CRP) and symptoms as screening tools in terms sensitivity, specificity and cost effectiveness. Symptom screen alone has been shown to be suboptimal for screening as it misses a significant percentage of TB due to atypical presentation of TB in HIV-infected populations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 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
- 是
入选标准
- •Program Implementation:
- •Inclusion criteria:
- •Any adult or child with TB symptoms (weight loss, chest pain, shortness of breath, fever, cough, hemoptysis, night sweats)
- •Ability to produce sputum
- •Verbal consent of parent or guardian if < 18 years old
- •Operations Research:
- •Inclusion criteria
- •Adults (18 years and older)
- •TB symptoms (weight loss, chest pain, shortness of breath, fever, cough, hemoptysis, night sweats)
- •Ability to provide a sputum sample
- •Willing to provide written informed consent
- •Willing to undergo full clinical evaluation
- •Willing to undergo a CXR
排除标准
- 未提供
研究组 & 干预措施
Community level screening; Arm 1
use of chest X-ray plus Xpert Ultra for community level TB screening
干预措施: Screening at community level (Diagnostic Test)
Community level screening: Arm 2
use of C-reactive Protein and Xpert Ultra for community level TB screening
干预措施: Screening at community level (Diagnostic Test)
结局指标
主要结局
increase TB case detection
时间窗: 6 months
comparison of two diagnostic tools (Chest Xray with CAD versus CRP) and Xpert Ultra for active community based TB case detection
次要结局
未报告次要终点
研究者
Stewart Reid
Primary Investigator
University of Alabama at Birmingham