Ignite Creation Date:
2024-05-06 @ 1:09 PM
Last Modification Date:
2024-10-26 @ 1:09 PM
Study NCT ID:
NCT03948698
Status:
COMPLETED
Last Update Posted:
2023-04-18
First Post:
2019-05-10
Brief Title:
TB Innovation Project A Pre- and Post- Implementation Assessment TIPPI
Sponsor:
Elizabeth Glaser Pediatric AIDS Foundation
Organization:
Elizabeth Glaser Pediatric AIDS Foundation
Study Overview
Official Title:
Evaluation of the Catalyzing Pediatric TB Innovations Project A Pre- and Post-Implementation Assessment Across Ten Countries
Status:
COMPLETED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TIPPI
Brief Summary:
This evaluation will be conducted in ten countries involved in the Catalyzing Pediatric TB Innovation CaP-TB project Cameroon Cote DIvoire 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
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
Detailed Description:
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 DIvoire 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 DC 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
Study data
Pre-intervention retrospective data collection
Under the standard of care condition baseline the investigators will
Capture data that will answer the TB service indicators and clinical outcomes listed in the primary objectives
Capture key data points that will be needed to estimate project targets In each site trained data collectors will retrospectively extract data from appropriate registers logs and in some cases patient files for a period of 12 months starting 6 months before the start date of data extraction
After the implementation of the CaP TB project prospective data will be collected by project-specific data collection tools andor from existing registers Whenever possible the CaP TB data collection will use existing site level data collection tools to gather the data for the project
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
Study data
Pre-intervention retrospective data collection
Under the standard of care condition baseline the investigators will
Capture data that will answer the TB service indicators and clinical outcomes listed in the primary objectives
Capture key data points that will be needed to estimate project targets In each site trained data collectors will retrospectively extract data from appropriate registers logs and in some cases patient files for a period of 12 months starting 6 months before the start date of data extraction
After the implementation of the CaP TB project prospective data will be collected by project-specific data collection tools andor from existing registers Whenever possible the CaP TB data collection will use existing site level data collection tools to gather the data for the project
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None