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

Completed

Conditions: Pediatric
Tuberculosis

Registration Number: NCT03948698

Lead Sponsor: Elizabeth Glaser Pediatric AIDS Foundation

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 4159533

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Children Diagnosed With Active TB	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	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	December 2018-September 2021	Number and proportion of pediatric patients on preventive treatment who completed therapy
Children Initiated on TB Treatment	December 2018-September 2021	Number and proportion of pediatric TB cases started on DS-TB treatment
Children With Presumptive TB	December 2018-September 2021	Among those screened the number and proportion of children presumed to have TB.
Children Initiated on TB Preventive Therapy	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	December 2018-September 2021	Number and proportion of pediatric DS-TB cases who achieve treatment success
Children Screened for TB	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	December 2018-September 2021	Number and proportion of presumptive TB cases referred for lab-based TB diagnosis
TB Contacts Eligible for Preventive Therapy	December 2018-September 2021	Number and proportion of screened negative pediatric contacts eligible for preventive therapy
TB Contacts Successfully Traced	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	December 2018-September 2021	Number and proportion of pediatric household contacts who are negative to TB screening

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (10): Mbarara sites
🇺🇬
Mbarara, Uganda
Central Region, Southern region sites
🇲🇼
Dedza, Malawi
Berea, Maseru, Mageteng, Leribe, Mohale's Hoek sites
🇱🇸
Maseru, Lesotho
Singida, Tabora sites
🇹🇿
Singida, Tanzania
Bandalungwa,Binza Meteo,Kikimi,Kingasani,Kinshasa, Lingwala, Masina II, Mont Ngafula II, Ndjili
🇨🇩
Kinshasa, Congo, The Democratic Republic of the
Adjame-Plateau-Attecoube, Abobo Est,Anyama , Koumassi-Port Bouet-Vridi, Treichville-Marcory
🇨🇮
Abidjan, Côte D'Ivoire
Sites in Centre, Littoral and West regions
🇨🇲
Djoungolo, Cameroon
Sites in Maharashtra State, Telangana State, Andhra Pradesh
🇮🇳
Hyderabad, India
Harare, Manicaland, Matabeleland South
🇿🇼
Harare, Zimbabwe
Turkana County and Homabay County sites
🇰🇪
Nairobi, Kenya