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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03948698
Acronym
TIPPI
Enrollment
4159533
Registered
2019-05-14
Start date
2018-12-01
Completion date
2021-09-30
Last updated
2023-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric, Tuberculosis

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

OTHERInnovative 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

Sponsors

Elizabeth Glaser Pediatric AIDS Foundation
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
No minimum to 14 Years

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

MeasureTime frameDescription
Children Screened for TBDecember 2018-September 2021Number and proportion of children (age 0-14) screened for TB among clinic attendees
Children With Presumptive TBDecember 2018-September 2021Among those screened the number and proportion of children presumed to have TB.
Children With Presumptive TB Referred for Lab-based TB DiagnosisDecember 2018-September 2021Number and proportion of presumptive TB cases referred for lab-based TB diagnosis
Children With Presumptive TB Tested Using GeneXpertDecember 2018-September 2021Number and proportion of pediatric (0-14 years) presumptive TB cases who are tested with GeneXpert
Children Initiated on TB Preventive TherapyDecember 2018-September 2021Number and proportion of pediatric patients started on preventive therapy of those who are eligible for preventive therapy
Children Completing TB Preventive TherapyDecember 2018-September 2021Number and proportion of pediatric patients on preventive treatment who completed therapy
Children Diagnosed With Active TBDecember 2018-September 2021Number of pediatric cases diagnosed with active TB disease among children with presumptive TB
Children Initiated on TB TreatmentDecember 2018-September 2021Number and proportion of pediatric TB cases started on DS-TB treatment
Children Achieving Treatment SuccessDecember 2018-September 2021Number and proportion of pediatric DS-TB cases who achieve treatment success
TB Contacts Successfully TracedDecember 2018-September 2021Number and proportion of all TB index cases for whom successful contact tracing has been done
TB Contacts Screened Negative for TBDecember 2018-September 2021Number and proportion of pediatric household contacts who are negative to TB screening
TB Contacts Eligible for Preventive TherapyDecember 2018-September 2021Number 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

ArmCount
CaP TB TIPPI Study
No new information to report
2,318
Total2,318

Baseline characteristics

CharacteristicCaP 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 typeEG000
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

Primary

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)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
CaP TB TIPPI StudyChildren Achieving Treatment Success6553 Participants
Primary

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)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
CaP TB TIPPI StudyChildren Completing TB Preventive Therapy22590 Participants
Primary

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
CaP TB TIPPI StudyChildren Diagnosed With Active TB11078 Participants
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

Time frame: December 2018-September 2021

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
CaP TB TIPPI StudyChildren Initiated on TB Preventive Therapy28762 Participants
Primary

Children Initiated on TB Treatment

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

Time frame: December 2018-September 2021

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
CaP TB TIPPI StudyChildren Initiated on TB Treatment10834 Participants
Primary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
CaP TB TIPPI StudyChildren Screened for TB4749072 Participants
Primary

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
CaP TB TIPPI StudyChildren With Presumptive TB60250 Participants
Primary

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
CaP TB TIPPI StudyChildren With Presumptive TB Referred for Lab-based TB Diagnosis49022 Participants
Primary

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
CaP TB TIPPI StudyChildren With Presumptive TB Tested Using GeneXpert35554 Participants
Primary

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
CaP TB TIPPI StudyTB Contacts Eligible for Preventive Therapy19630 Participants
Primary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
CaP TB TIPPI StudyTB Contacts Screened Negative for TB37774 Participants
Primary

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
CaP TB TIPPI StudyTB Contacts Successfully Traced20998 Participants

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026