N/A
Completed N=4,749,072
TB Innovation Project: A Pre- and Post- Implementation Assessment (TIPPI)
Tuberculosis · Pediatric
Source: ClinicalTrials.gov NCT03948698 ↗
Enrolled (actual)
4,749,072
Serious AEs
—
Results posted
Dec 2021
Primary outcomePrimary: Children Screened for TB — 4749072 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Children Screened for TB |
4749072 | — |
| PRIMARY Children With Presumptive TB |
60250 | — |
| PRIMARY Children With Presumptive TB Referred for Lab-based TB Diagnosis |
49022 | — |
| PRIMARY Children With Presumptive TB Tested Using GeneXpert |
35554 | — |
| PRIMARY Children Initiated on TB Preventive Therapy |
28762 | — |
| PRIMARY Children Completing TB Preventive Therapy |
22590 | — |
| PRIMARY Children Diagnosed With Active TB |
11078 | — |
| PRIMARY Children Initiated on TB Treatment |
10834 | — |
| PRIMARY Children Achieving Treatment Success |
6553 | — |
| PRIMARY TB Contacts Successfully Traced |
20998 | — |
| PRIMARY TB Contacts Screened Negative for TB |
37774 | — |
| PRIMARY TB Contacts Eligible for Preventive Therapy |
19630 | — |
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
Data sourced from ClinicalTrials.gov (NCT03948698). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.