Evaluation of the Catalyzing Pediatric TB Innovations Project: A Pre- and Post-Implementation Assessment Across Ten Countries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,159,533
- 试验地点
- 10
- 主要终点
- Children Diagnosed With Active TB
研究概览
简要总结
This evaluation will be conducted in ten countries involved in the Catalyzing Pediatric TB Innovation (CaP-TB) project: Cameroon, Cote D'Ivoire, Democratic Republic of Congo, Kenya, Lesotho, Malawi, Tanzania, Uganda, Zimbabwe and India. The CaP-TB project is a project designed to use innovative methods and capacity building to strengthen the health systems of developing countries in terms of pediatric TB case detection, early accurate diagnosis and effective treatment. This project is funded by Unitaid and is implemented by Elizabeth Glaser Pediatric AIDS Foundation.
EGPAF proposes to evaluate the implementation of CaP-TB in up to 450 sites in ten participating countries. This evaluation will assess the effects of CaP-TB innovative interventions on selected service delivery outcomes as compared to routine TB program in a sub-set of project sites in the ten countries.
详细描述
This pre-post quasi-experimental evaluation study will be conducted in ten countries involved in the Catalyzing Pediatric TB Innovation (CaP-TB) project: Cameroon, Cote D'Ivoire, Democratic Republic of Congo, Kenya, Lesotho, Malawi, Tanzania, Uganda, Zimbabwe and India. The CaP-TB project is a project designed to use innovative methods and capacity building to strengthen the health systems of developing countries in terms of pediatric TB case detection, early accurate diagnosis and effective treatment. This project is funded by Unitaid headquartered in Geneva, Switzerland and is implemented by Elizabeth Glaser Pediatric AIDS Foundation (EGPAF) with headquarters in Washington, D.C. and Geneva and 10 country offices. This study will assess the effects of CaP-TB innovative interventions on selected service delivery outcomes as compared to routine TB program in a sub-set of project sites in ten countries.
The CaP TB project is a 4-year (October 1, 2017-September 30, 2021) Unitaid-funded project to improve pediatric TB outcomes by introducing integrated and decentralized models of pediatric TB care and strengthening access to WHO-recommended drugs and diagnostics. Integration refers to supporting TB activities, such as screening and TB sample collection for children, into non-TB health care services, such as general pediatric outpatient clinics. Decentralization refers to moving pediatric TB services from higher levels of health clinics to lower levels.
Objectives of the study
To evaluate the CaP TB project on the below TB service indicators and clinical outcomes for children 0-14 in facilities implementing the CaP TB project:
- Number and proportion of children screened for TB among clinic attendees
- Number and proportion of presumptive TB cases referred for lab-based TB diagnosis
- Number and proportion of pediatric presumptive TB cases who are tested with Xpert
- Number and proportion (out of all children screened) of pediatric cases diagnosed with active TB disease
- Time between when a child is identified as a presumptive TB case and when the child is diagnosed with TB
- Number and proportion of pediatric TB cases started on DS-TB treatment
- Time between when a child is identified as a presumptive TB case and when the child is initiated on TB treatment
- Number and proportion of pediatric DS-TB cases or cases treated with first-line TB treatment who achieve treatment success
- Number and proportion of all TB index cases for whom successful contact tracing has been done
- Number and proportion of pediatric household contacts who are negative to TB screening
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
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
- •All pediatric TB patients (0-14 years of age) in CaP TB project sites in any of the 10 countries and receive TB screening (including screening, diagnosis and treatment for active TB, and provision of TB preventive therapy).
- •All pediatric TB patients (0-14 years of age) in CaP TB project sites in any of the 10 countries and receive TB diagnosis
- •All pediatric TB patients (0-14 years of age) in CaP TB project sites in any of the 10 countries and receive TB treatment for active TB
- •All pediatric TB patients (0-14 years of age) in CaP TB project sites in any of the 10 countries and receive TB preventive therapy
排除标准
- •All pediatric TB patients who enter CaP TB project site in any of the 10 countries and who are above 15 years old
结局指标
主要结局
Children Diagnosed With Active TB
时间窗: December 2018-September 2021
Number of pediatric cases diagnosed with active TB disease among children with presumptive TB
Children With Presumptive TB Tested Using GeneXpert
时间窗: December 2018-September 2021
Number and proportion of pediatric (0-14 years) presumptive TB cases who are tested with GeneXpert
Children Completing TB Preventive Therapy
时间窗: December 2018-September 2021
Number and proportion of pediatric patients on preventive treatment who completed therapy
Children Initiated on TB Treatment
时间窗: December 2018-September 2021
Number and proportion of pediatric TB cases started on DS-TB treatment
Children With Presumptive TB
时间窗: December 2018-September 2021
Among those screened the number and proportion of children presumed to have TB.
Children Initiated on TB Preventive Therapy
时间窗: December 2018-September 2021
Number and proportion of pediatric patients started on preventive therapy of those who are eligible for preventive therapy
Children Achieving Treatment Success
时间窗: December 2018-September 2021
Number and proportion of pediatric DS-TB cases who achieve treatment success
Children Screened for TB
时间窗: December 2018-September 2021
Number and proportion of children (age 0-14) screened for TB among clinic attendees
Children With Presumptive TB Referred for Lab-based TB Diagnosis
时间窗: December 2018-September 2021
Number and proportion of presumptive TB cases referred for lab-based TB diagnosis
TB Contacts Eligible for Preventive Therapy
时间窗: December 2018-September 2021
Number and proportion of screened negative pediatric contacts eligible for preventive therapy
TB Contacts Successfully Traced
时间窗: December 2018-September 2021
Number and proportion of all TB index cases for whom successful contact tracing has been done
TB Contacts Screened Negative for TB
时间窗: December 2018-September 2021
Number and proportion of pediatric household contacts who are negative to TB screening
次要结局
未报告次要终点
