Pediatric, Tuberculosis
Conditions
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.
Interventions
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
Sponsors
Study design
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | December 2018-September 2021 | Among those screened the number and proportion of children presumed to have TB. |
| 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 |
| 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 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 Completing TB Preventive Therapy | December 2018-September 2021 | Number and proportion of pediatric patients on preventive treatment who completed therapy |
| Children Diagnosed With Active TB | December 2018-September 2021 | Number of pediatric cases diagnosed with active TB disease among children with presumptive TB |
| Children Initiated on TB Treatment | December 2018-September 2021 | Number and proportion of pediatric TB cases started on DS-TB treatment |
| Children Achieving Treatment Success | December 2018-September 2021 | Number and proportion of pediatric DS-TB cases who achieve treatment success |
| 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 |
| TB Contacts Eligible for Preventive Therapy | December 2018-September 2021 | Number and proportion of screened negative pediatric contacts eligible for preventive therapy |
Countries
Cameroon, Côte d’Ivoire, Democratic Republic of the Congo, India, Kenya, Lesotho, Malawi, Tanzania, Uganda, Zimbabwe
Participant flow
Pre-assignment details
This study does not have a set number of participants. The number of participants is number of children screened.
Participants by arm
| Arm | Count |
|---|---|
| CaP TB TIPPI Study No new information to report | 2,318 |
| Total | 2,318 |
Baseline characteristics
| Characteristic | CaP TB TIPPI Study | — |
|---|---|---|
| Age, Categorical <=18 years | 2318 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 0 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Cameroon | 159 participants | — |
| Region of Enrollment Congo, The Democratic Republic of the | 709 participants | — |
| Region of Enrollment Côte D'Ivoire | 247 participants | — |
| Region of Enrollment Kenya | 212 participants | — |
| Region of Enrollment Lesotho | 116 participants | — |
| Region of Enrollment Malawi | 167 participants | — |
| Region of Enrollment Tanzania | 335 participants | — |
| Region of Enrollment Uganda | 92 participants | — |
| Region of Enrollment Zimbabwe | 281 participants | — |
| Sex: Female, Male Female | 1163 Participants | — |
| Sex: Female, Male Male | 1155 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Children Achieving Treatment Success
Number and proportion of pediatric DS-TB cases who achieve treatment success
Time frame: December 2018-September 2021
Population: Please note that this measure if different than the one reported in Children initiated in DS TB treatment because this number only includes children with expected treatment outcomes (i.e completing 6 months treatment)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CaP TB TIPPI Study | Children Achieving Treatment Success | 6553 Participants |
Children Completing TB Preventive Therapy
Number and proportion of pediatric patients on preventive treatment who completed therapy
Time frame: December 2018-September 2021
Population: Please note the number this measure is different than the one indicated for Children Initiation on PT because here we report Children that were initiated on PT with expected outcomes (i.e. 6 months of preventive therapy)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CaP TB TIPPI Study | Children Completing TB Preventive Therapy | 22590 Participants |
Children Diagnosed With Active TB
Number of pediatric cases diagnosed with active TB disease among children with presumptive TB
Time frame: December 2018-September 2021
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CaP TB TIPPI Study | Children Diagnosed With Active TB | 11078 Participants |
Children Initiated on TB Preventive Therapy
Number and proportion of pediatric patients started on preventive therapy of those who are eligible for preventive therapy
Time frame: December 2018-September 2021
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CaP TB TIPPI Study | Children Initiated on TB Preventive Therapy | 28762 Participants |
Children Initiated on TB Treatment
Number and proportion of pediatric TB cases started on DS-TB treatment
Time frame: December 2018-September 2021
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CaP TB TIPPI Study | Children Initiated on TB Treatment | 10834 Participants |
Children Screened for TB
Number and proportion of children (age 0-14) screened for TB among clinic attendees
Time frame: December 2018-September 2021
Population: The number of participants analyzed, 7198865, is the clinic attendees and 4749072 is number of children screened. 4749072 is the number indicated in the participant flow because this data is generated by the study. Clinic attendees data is already available in health facilities.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CaP TB TIPPI Study | Children Screened for TB | 4749072 Participants |
Children With Presumptive TB
Among those screened the number and proportion of children presumed to have TB.
Time frame: December 2018-September 2021
Population: The number Started in the participant flow was revised and both values are equal
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CaP TB TIPPI Study | Children With Presumptive TB | 60250 Participants |
Children With Presumptive TB Referred for Lab-based TB Diagnosis
Number and proportion of presumptive TB cases referred for lab-based TB diagnosis
Time frame: December 2018-September 2021
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CaP TB TIPPI Study | Children With Presumptive TB Referred for Lab-based TB Diagnosis | 49022 Participants |
Children With Presumptive TB Tested Using GeneXpert
Number and proportion of pediatric (0-14 years) presumptive TB cases who are tested with GeneXpert
Time frame: December 2018-September 2021
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CaP TB TIPPI Study | Children With Presumptive TB Tested Using GeneXpert | 35554 Participants |
TB Contacts Eligible for Preventive Therapy
Number and proportion of screened negative pediatric contacts eligible for preventive therapy
Time frame: December 2018-September 2021
Population: Please note that these numbers will differ from the numbers reported on previous measures related to preventive therapy because these numbers only include contact tracing whereas previously reported measures included both TB contacts and people coming from HIV clinics
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CaP TB TIPPI Study | TB Contacts Eligible for Preventive Therapy | 19630 Participants |
TB Contacts Screened Negative for TB
Number and proportion of pediatric household contacts who are negative to TB screening
Time frame: December 2018-September 2021
Population: The overall number of participants analyzed here would be the number of contacts screened.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CaP TB TIPPI Study | TB Contacts Screened Negative for TB | 37774 Participants |
TB Contacts Successfully Traced
Number and proportion of all TB index cases for whom successful contact tracing has been done
Time frame: December 2018-September 2021
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CaP TB TIPPI Study | TB Contacts Successfully Traced | 20998 Participants |