Impact of an Innovative Childhood TB Diagnostic Approach Decentralized to District Hospital and Primary Health Care Levels on Childhood Tuberculosis Case Detection and Management in High Tuberculosis Incidence Countries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,106
- 试验地点
- 77
- 主要终点
- Children diagnosed with TB
研究概览
简要总结
The TB-Speed Decentralisation study aims to increase childhood Tuberculosis (TB) case detection at district hospital (DH) and Primary health Care (PHC) levels using adapted and child-friendly specimen collection methods, i.e. Nasopharyngeal Aspirate (NPA) and stool samples, sensitive microbiological detection tests (Ultra) close to the point-of-care (Omni/G1(Edge)), reinforced training on clinical diagnosis, and standardized CXR quality and interpretation using digital radiography.
The TB-Speed Decentralisation study will evaluate the impact of an innovative patient care level diagnostic approach deployed at DH and PHC levels, namely the DH focused and the PHC focused decentralization strategies. This is aimed at, improving case detection in 6 high TB incidence in low/moderate resource countries: Cambodia, Cameroon, Côte d'Ivoire, Mozambique, Sierra Leone, and Uganda, and compare effectiveness and cost-effectiveness of the two different decentralization approaches.
The hypothesis is that, in countries with high and very high TB incidence (100-299 and ≥300 cases/100,000 population/year, respectively), a systematic approach to the screening for and diagnosis of TB in sick children presenting to the health system will increase childhood TB case detection, especially PTB, which represents the majority of the disease burden (>75% of case). The study also hypothesizes that sputum collection using battery-operated suction machines and microbiological TB diagnosis using Omni/G1 (Edge) can be decentralized to PHC level, thus enabling TB diagnosis and treatment in children at PHC level.
详细描述
This will be an operational research study using:
- a before and after cross-sectional design to assess the impact of decentralizing an innovative childhood TB diagnostic approach
- a cross-sectional and nested cohort design to compare two different decentralization strategies at DH and PHC levels.
- quantitative and qualitative methods The intervention will be at two levels: at patient care level where an innovative childhood TB diagnostic approach will be implemented, and at health systems level where two distinct decentralization strategies will be implemented. The patient care level TB diagnostic approach consists of systematic TB screening, clinical evaluation, NPA and stool or sputum testing using Xpert Ultra, and optimised CXR reading. The two decentralization strategies are the DH-focused and the PHC-focused implementation of the innovative childhood TB diagnostic approach. Two districts per participating countries will be randomly assigned to implement the DH or PHC-focused strategies.
The study will also include a nested cohort at both the DH and PHC during the intervention phase for a selected sub-set of children with presumptive TB and all children with a diagnosis of TB that consent to participate. This prospective cohort will enable to further document study endpoints related to follow up (TB treatment outcome) and to document TB diagnosis by assessing spontaneous resolution or resolution under TB treatment.
The study will comprise an observation phase followed by an intervention phase in participating districts. During the last month of the observation phase, each district will be randomly assigned to implement either DH or PHC-focused decentralisation. There will be no patient level randomisation.
During this 3-month observation phase, the study will 1) describe the childhood TB diagnosis data and practices; 2) describe the referral processes and outcomes of referrals for TB diagnosis and treatment where feasible and 3) assess existing challenges in childhood TB diagnosis and treatment, as well as readiness (including potential challenges) for the study intervention implementation. There will be no interference with the routine TB childhood diagnosis processes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- — 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sick children seeking care at Oupatient Department of District Hospital or Primary Health Center
- •Age <15 years
排除标准
- 未提供
结局指标
主要结局
Children diagnosed with TB
时间窗: Day 0
Proportion of TB cases detected among sick children routinely attending outpatient services before and after the intervention
次要结局
- TB case detection(Month 6)
- TB screening in outpatient children - 1(Day 7)
- TB screening in outpatient children - 2(Day 7)
- Feasibility of implementing the different diagnostic approach components - 1(Day 7)
- Feasibility of implementing the different diagnostic approach components - 2(Day 7)
- Feasibility of implementing the different diagnostic approach components - 3(Day 7)
- TB treatment uptake and time to TB treatment initiation - 1(Month 6)
- TB treatment uptake and time to TB treatment initiation - 2(Month 6)
- Cost-effectiveness from the health services perspective(Month 22)
- Acceptability by health care providers, NTPs and health authorities, and beneficiaries(Day 0)
- Fidelity of the implementation of the diagnostic approach as compared to the protocol and study procedures - 1(Month 6)
- Fidelity of the implementation of the diagnostic approach as compared to the protocol and study procedures - 2(Month 22)
- Performance of the diagnostic approach at patient level(Month 6)
- TB treatment outcome(Month 6)
- Diagnostic performance of CXR reading by clinicians at DH and PHC levels(Month 6)
- Added value of CXR in the diagnosis of TB in children as compared to microbiology and clinical evaluation only(Month 6)
- Uptake of the quality control of the CXR reading(Month 6)