Integrating Pediatric TB Services Into Child Healthcare Services in Africa. A Cluster-randomized Stepped-wedge Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,715
- 试验地点
- 12
- 主要终点
- Proportion of children diagnosed with active TB
研究概览
简要总结
Under-diagnosis of TB in children is a critical gap to address. The INPUT study is a multinational stepped-wedge cluster-randomized intervention study aiming to assess the effect of integrating TB services into child healthcare services on TB diagnosis capacities in children under 5 years of age.
详细描述
Study clusters (district-level hospitals and their health centers) will start under standard-of-care and transition to the intervention at randomly assigned time points.
In this study two strategies will be compared: i) The standard of care, offering pediatric TB services based on current routine approach; ii) The intervention, with pediatric TB services integrated into child healthcare services.
The primary objective will be to assess the effect of the intervention compared to standard of care on the proportion of TB cases diagnosed among children <5 years old (that is the number of children who are clinically or bacteriologically diagnosed with TB over the total number of children attending the child healthcare services). Secondary objectives are detailed in the protocol.
Study sites will include six hospital in each participating country (Cameroon and Kenya) along with selected attached health centers.
The study population will be children aged less than five years of age with a presumptive diagnosis of TB.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- — 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children < 5 years old.
- •TB diagnosis investigations initiated.
- •Other infectious diseases are not suspected or have already been ruled out.
- •Commitment to take treatment in the clinic of enrolment or another INPUT study site.
- •Parental/caregiver consent for the child to participate in the study.
排除标准
- •Children who are TB contacts but without symptoms or signs of active TB
结局指标
主要结局
Proportion of children diagnosed with active TB
时间窗: up to two months
Number of pediatric TB cases diagnosed (bacteriologically confirmed and/or clinically diagnosed) over the number of children attending the child healthcare services during the study period.
次要结局
- Proportion of children screened for TB(one month)
- Proportion of screened children who have a sample collected(up to three months)
- Time from screening to clinical or bacteriologic diagnosis(up to three months)
- Proportion of children diagnosed with TB among presumptive TB cases(up to two months)
- Time from diagnosis to treatment initiation(up to three months)
- Proportion of cases with a bacteriologically confirmed diagnosis(up to three months)
- Proportion of children who initiate TB treatment among those diagnosed(up to two months)
- Treatment outcome(8 to 14 months (2 months after treatment completion))
- Adherence to the TB treatment(6 to 12 months (at treatment completion))