跳至主要内容
临床试验/NCT03948698
NCT03948698已完成不适用

Evaluation of the Catalyzing Pediatric TB Innovations Project: A Pre- and Post-Implementation Assessment Across Ten Countries

Elizabeth Glaser Pediatric AIDS Foundation10 个研究点 分布在 10 个国家目标入组 4,159,533 人开始时间: 2018年12月1日最近更新:
适应症

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

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (10)

Loading locations...

相似试验