Clinical trial NCT03948698: TB Innovation Project: A Pre- and Post- Implementation Assessment (TIPPI)
Official title: Evaluation of the Catalyzing Pediatric TB Innovations Project: A Pre- and Post-Implementation Assessment Across Ten Countries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tuberculosis
Pediatric
Lead sponsor: Elizabeth Glaser Pediatric AIDS Foundation
Sponsor class: OTHER
First posted: 2019-05-14
Enrollment: 4159533
Sex: ALL
Maximum age (years): 14
Standard ages: CHILD
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All pediatric TB patients (0-14 years of age) who present to a CaP TB project site in any of the 10 countries and receive TB services (including screening, diagnosis and treatment for active TB, and provision of TB preventive therapy).

Brief 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.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Children Screened for TB
timeFrame: December 2018-September 2021
measure: Children With Presumptive TB
timeFrame: December 2018-September 2021
measure: Children With Presumptive TB Referred for Lab-based TB Diagnosis
timeFrame: December 2018-September 2021
measure: Children With Presumptive TB Tested Using GeneXpert
timeFrame: December 2018-September 2021
measure: Children Initiated on TB Preventive Therapy
timeFrame: December 2018-September 2021
measure: Children Completing TB Preventive Therapy
timeFrame: December 2018-September 2021
measure: Children Diagnosed With Active TB
timeFrame: December 2018-September 2021
measure: Children Initiated on TB Treatment
timeFrame: December 2018-September 2021
measure: Children Achieving Treatment Success
timeFrame: December 2018-September 2021
measure: TB Contacts Successfully Traced
timeFrame: December 2018-September 2021
measure: TB Contacts Screened Negative for TB
timeFrame: December 2018-September 2021
measure: TB Contacts Eligible for Preventive Therapy
timeFrame: December 2018-September 2021
Secondary outcomes:
Other outcomes:
Locations:
city: Djoungolo
country: Cameroon
facility: Sites in Centre, Littoral and West regions
city: Kinshasa
country: Congo, The Democratic Republic of the
facility: Bandalungwa,Binza Meteo,Kikimi,Kingasani,Kinshasa, Lingwala, Masina II, Mont Ngafula II, Ndjili
city: Abidjan
country: Côte D'Ivoire
facility: Adjame-Plateau-Attecoube, Abobo Est,Anyama , Koumassi-Port Bouet-Vridi, Treichville-Marcory
city: Hyderabad
country: India
facility: Sites in Maharashtra State, Telangana State, Andhra Pradesh
city: Nairobi
country: Kenya
facility: Turkana County and Homabay County sites
city: Maseru
country: Lesotho
facility: Berea, Maseru, Mageteng, Leribe, Mohale's Hoek sites
city: Dedza
country: Malawi
facility: Central Region, Southern region sites
city: Singida
country: Tanzania
facility: Singida, Tabora sites
city: Mbarara
country: Uganda
facility: Mbarara sites
city: Harare
country: Zimbabwe
facility: Harare, Manicaland, Matabeleland South
Study officials:
affiliation: Elizabeth Glaser Pediatric AIDS Foundation
name: Jennifer Cohn, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Elizabeth Glaser Pediatric AIDS Foundation
name: Martina Casenghi, PhD
role: PRINCIPAL_INVESTIGATOR
References: