TB Innovation Project: A Pre- and Post- Implementation Assessment (TIPPI)

Tuberculosis Clinical Trial

— TIPPI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03948698
• Other study ID #: EG0209
• Status: Completed
• Start date: December 1, 2018
• Est. completion date: September 30, 2021

Study information

• Verified date: April 2023
• Source: Elizabeth Glaser Pediatric AIDS Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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 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

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 and/or 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4159533
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Gender: All
• Age group: N/A to 14 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• All pediatric TB patients who enter CaP TB project site in any of the 10 countries and who are above 15 years old

Related Conditions & MeSH terms

• Pediatric
• Tuberculosis

Intervention

Other:
• Innovative approached to pediatric TB care
Includes integration of TB care in non-TB entry points in facilities, decentralization from higher level clinics to lower levels, strengthening screening activities and building diagnosis and treatment capacity among healthcare workers

Locations

Country	Name	City	State
Cameroon	Sites in Centre, Littoral and West regions	Djoungolo
Congo, The Democratic Republic of the	Bandalungwa,Binza Meteo,Kikimi,Kingasani,Kinshasa, Lingwala, Masina II, Mont Ngafula II, Ndjili	Kinshasa
Côte D'Ivoire	Adjame-Plateau-Attecoube, Abobo Est,Anyama , Koumassi-Port Bouet-Vridi, Treichville-Marcory	Abidjan
India	Sites in Maharashtra State, Telangana State, Andhra Pradesh	Hyderabad
Kenya	Turkana County and Homabay County sites	Nairobi
Lesotho	Berea, Maseru, Mageteng, Leribe, Mohale's Hoek sites	Maseru
Malawi	Central Region, Southern region sites	Dedza
Tanzania	Singida, Tabora sites	Singida
Uganda	Mbarara sites	Mbarara
Zimbabwe	Harare, Manicaland, Matabeleland South	Harare

Sponsors (1)

Lead Sponsor	Collaborator
Elizabeth Glaser Pediatric AIDS Foundation

Countries where clinical trial is conducted

Cameroon,  Congo, The Democratic Republic of the,  Côte D'Ivoire,  India,  Kenya,  Lesotho,  Malawi,  Tanzania,  Uganda,  Zimbabwe, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Children Screened for TB	Number and proportion of children (age 0-14) screened for TB among clinic attendees	December 2018-September 2021
Primary	Children With Presumptive TB	Among those screened the number and proportion of children presumed to have TB.	December 2018-September 2021
Primary	Children With Presumptive TB Referred for Lab-based TB Diagnosis	Number and proportion of presumptive TB cases referred for lab-based TB diagnosis	December 2018-September 2021
Primary	Children With Presumptive TB Tested Using GeneXpert	Number and proportion of pediatric (0-14 years) presumptive TB cases who are tested with GeneXpert	December 2018-September 2021
Primary	Children Initiated on TB Preventive Therapy	Number and proportion of pediatric patients started on preventive therapy of those who are eligible for preventive therapy	December 2018-September 2021
Primary	Children Completing TB Preventive Therapy	Number and proportion of pediatric patients on preventive treatment who completed therapy	December 2018-September 2021
Primary	Children Diagnosed With Active TB	Number of pediatric cases diagnosed with active TB disease among children with presumptive TB	December 2018-September 2021
Primary	Children Initiated on TB Treatment	Number and proportion of pediatric TB cases started on DS-TB treatment	December 2018-September 2021
Primary	Children Achieving Treatment Success	Number and proportion of pediatric DS-TB cases who achieve treatment success	December 2018-September 2021
Primary	TB Contacts Successfully Traced	Number and proportion of all TB index cases for whom successful contact tracing has been done	December 2018-September 2021
Primary	TB Contacts Screened Negative for TB	Number and proportion of pediatric household contacts who are negative to TB screening	December 2018-September 2021
Primary	TB Contacts Eligible for Preventive Therapy	Number and proportion of screened negative pediatric contacts eligible for preventive therapy	December 2018-September 2021