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NCT Number: NCT03948698

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

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.

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Key information

Conditions

Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Mycobacterium Infections Pediatric

Age range

Up to 14 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sites in Centre, Littoral and West regions, Djoungolo, Cameroon

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Innovative approached to pediatric TB care

Other

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

Other names: Integration and decentralization

Primary outcomes

  1. Children Screened for TB

    Time frame: December 2018-September 2021

    Number and proportion of children (age 0-14) screened for TB among clinic attendees

  2. Children With Presumptive TB

    Time frame: December 2018-September 2021

    Among those screened the number and proportion of children presumed to have TB.

  3. Children With Presumptive TB Referred for Lab-based TB Diagnosis

    Time frame: December 2018-September 2021

    Number and proportion of presumptive TB cases referred for lab-based TB diagnosis

  4. Children With Presumptive TB Tested Using GeneXpert

    Time frame: December 2018-September 2021

    Number and proportion of pediatric (0-14 years) presumptive TB cases who are tested with GeneXpert

  5. Children Initiated on TB Preventive Therapy

    Time frame: December 2018-September 2021

    Number and proportion of pediatric patients started on preventive therapy of those who are eligible for preventive therapy

  6. Children Completing TB Preventive Therapy

    Time frame: December 2018-September 2021

    Number and proportion of pediatric patients on preventive treatment who completed therapy

  7. Children Diagnosed With Active TB

    Time frame: December 2018-September 2021

    Number of pediatric cases diagnosed with active TB disease among children with presumptive TB

  8. Children Initiated on TB Treatment

    Time frame: December 2018-September 2021

    Number and proportion of pediatric TB cases started on DS-TB treatment

  9. Children Achieving Treatment Success

    Time frame: December 2018-September 2021

    Number and proportion of pediatric DS-TB cases who achieve treatment success

  10. TB Contacts Successfully Traced

    Time frame: December 2018-September 2021

    Number and proportion of all TB index cases for whom successful contact tracing has been done

  11. TB Contacts Screened Negative for TB

    Time frame: December 2018-September 2021

    Number and proportion of pediatric household contacts who are negative to TB screening

  12. TB Contacts Eligible for Preventive Therapy

    Time frame: December 2018-September 2021

    Number and proportion of screened negative pediatric contacts eligible for preventive therapy

Sponsors and collaborators

Lead sponsor

Elizabeth Glaser Pediatric AIDS Foundation

Other

Registry information

Official study title

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

Acronym: TIPPI

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
May 14, 2019
Registry last updated
Apr 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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