TuberculosisTIPPINCT03948698
TB Innovation Project: A Pre- and Post- Implementation Assessment (TIPPI)
An observational study of Tuberculosis and Pediatric, run by Elizabeth Glaser Pediatric AIDS Foundation at 10 sites in 10 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 14 years
- Conditions the study is for
- Tuberculosis, Pediatric
- What is being tested?
- Innovative approached to pediatric TB care
- How many people
- 4,159,533 participants
- Where
- 10 sitesin 10 countries
- Study dates
- 1 Dec 2018to 30 Sep 2021
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 14 years
- All sexes
- Child
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).
Who may be able to join
- 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
Who cannot join
- All pediatric TB patients who enter CaP TB project site in any of the 10 countries and who are above 15 years old
Trial locations and contacts
10 sites in 10 countries.
10 sites in 10 countries
Côte d’Ivoire1 site
Adjame-Plateau-Attecoube, Abobo Est,Anyama , Koumassi-Port Bouet-Vridi, Treichville-Marcory
Abidjan
Democratic Republic of the Congo1 site
Bandalungwa,Binza Meteo,Kikimi,Kingasani,Kinshasa, Lingwala, Masina II, Mont Ngafula II, Ndjili
Kinshasa
India1 site
Sites in Maharashtra State, Telangana State, Andhra Pradesh
Hyderabad
About this study
Official title: Evaluation of the Catalyzing Pediatric TB Innovations Project: A Pre- and Post-Implementation Assessment Across Ten Countries
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.
Read the 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.
- Conditions
- Tuberculosis, Pediatric
- Being tested
- Innovative approached to pediatric TB care
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Innovative approached to pediatric TB careOther
Also called Integration and decentralization
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Children Screened for TB
Number and proportion of children (age 0-14) screened for TB among clinic attendees
Measured: December 2018-September 2021
Children With Presumptive TB
Among those screened the number and proportion of children presumed to have TB.
Measured: December 2018-September 2021
Children With Presumptive TB Referred for Lab-based TB Diagnosis
Number and proportion of presumptive TB cases referred for lab-based TB diagnosis
Measured: December 2018-September 2021
Children With Presumptive TB Tested Using GeneXpert
Number and proportion of pediatric (0-14 years) presumptive TB cases who are tested with GeneXpert
Measured: December 2018-September 2021
Children Initiated on TB Preventive Therapy
Number and proportion of pediatric patients started on preventive therapy of those who are eligible for preventive therapy
Measured: December 2018-September 2021
Children Completing TB Preventive Therapy
Number and proportion of pediatric patients on preventive treatment who completed therapy
Measured: December 2018-September 2021
Children Diagnosed With Active TB
Number of pediatric cases diagnosed with active TB disease among children with presumptive TB
Measured: December 2018-September 2021
Children Initiated on TB Treatment
Number and proportion of pediatric TB cases started on DS-TB treatment
Measured: December 2018-September 2021
Children Achieving Treatment Success
Number and proportion of pediatric DS-TB cases who achieve treatment success
Measured: December 2018-September 2021
TB Contacts Successfully Traced
Number and proportion of all TB index cases for whom successful contact tracing has been done
Measured: December 2018-September 2021
TB Contacts Screened Negative for TB
Number and proportion of pediatric household contacts who are negative to TB screening
Measured: December 2018-September 2021
TB Contacts Eligible for Preventive Therapy
Number and proportion of screened negative pediatric contacts eligible for preventive therapy
Measured: December 2018-September 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2019
- Study start1 Dec 2018
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 4,159,533 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Elizabeth Glaser Pediatric AIDS Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Cohn, MD, Principal investigator, Elizabeth Glaser Pediatric AIDS FoundationMartina Casenghi, PhD, Principal investigator, Elizabeth Glaser Pediatric AIDS Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03948698
- Sponsor's protocol ID
- EG0209
- Acronym
- TIPPI
- Status last verified
- Apr 2023
- First submitted
- 10 May 2019
- Last updated
- 18 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lemaire JF, Cohn J, Kakayeva S, Tchounga B, Ekouevi PF, Ilunga VK, Ochieng Yara D, Lanje S, Bhamu Y, Haule L, Namubiru M, Nyamundaya T, Berset M, de Souza M, Machekano R, Casenghi M; CaP-TB Study team. Improving TB detection among children in routine clinical care through intensified case finding in facility-based child health entry points and decentralized management: A before-and-after study in Nine Sub-Saharan African Countries. PLOS Glob Public Health. 2024 Feb 5;4(2):e0002865. doi: 10.1371/journal.pgph.0002865. eCollection 2024.
PubMed 38315700Mafirakureva N, Mukherjee S, de Souza M, Kelly-Cirino C, Songane MJP, Cohn J, Lemaire JF, Casenghi M, Dodd PJ. Cost-effectiveness analysis of interventions to improve diagnosis and preventive therapy for paediatric tuberculosis in 9 sub-Saharan African countries: A modelling study. PLoS Med. 2023 Sep 6;20(9):e1004285. doi: 10.1371/journal.pmed.1004285. eCollection 2023 Sep.
PubMed 37672524
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Catalyzing Pediatric TB Innovations Project: A Pre- and Post-Implementation Assessment Across Ten Countries
- ClinicalTrials.gov ID
- NCT03948698
- Acronym / sponsor ID
- TIPPI / EG0209
- Conditions
- Tuberculosis, Pediatric
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,159,533 participants (actual)
- Lead sponsor
- Elizabeth Glaser Pediatric AIDS FoundationUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 14 May 2019 (actual)
- Results
- Posted 20 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 12 Months
Who may qualify
- Ages
- Up to 14 years
- Sex
- All
- Age groups
- Child
- 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).
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- All pediatric TB patients who enter CaP TB project site in any of the 10 countries and who are above 15 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Innovative approached to pediatric TB careAlso: Integration and decentralizationIncludes 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 | Other | – |
Primary outcome
Children Screened for TB
Time frame: December 2018-September 2021
Number and proportion of children (age 0-14) screened for TB among clinic attendees
Children With Presumptive TB
Time frame: 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
Time frame: December 2018-September 2021
Number and proportion of presumptive TB cases referred for lab-based TB diagnosis
Children With Presumptive TB Tested Using GeneXpert
Time frame: 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
Time frame: 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
Time frame: December 2018-September 2021
Number and proportion of pediatric patients on preventive treatment who completed therapy
Children Diagnosed With Active TB
Time frame: December 2018-September 2021
Number of pediatric cases diagnosed with active TB disease among children with presumptive TB
Children Initiated on TB Treatment
Time frame: December 2018-September 2021
Number and proportion of pediatric TB cases started on DS-TB treatment
Children Achieving Treatment Success
Time frame: December 2018-September 2021
Number and proportion of pediatric DS-TB cases who achieve treatment success
TB Contacts Successfully Traced
Time frame: 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
Time frame: December 2018-September 2021
Number and proportion of pediatric household contacts who are negative to TB screening
TB Contacts Eligible for Preventive Therapy
Time frame: December 2018-September 2021
Number and proportion of screened negative pediatric contacts eligible for preventive therapy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38315700Lemaire JF, Cohn J, Kakayeva S, Tchounga B, Ekouevi PF, Ilunga VK, Ochieng Yara D, Lanje S, Bhamu Y, Haule L, Namubiru M, Nyamundaya T, Berset M, de Souza M, Machekano R, Casenghi M; CaP-TB Study team. Improving TB detection among children in routine clinical care through intensified case finding in facility-based child health entry points and decentralized management: A before-and-after study in Nine Sub-Saharan African Countries. PLOS Glob Public Health. 2024 Feb 5;4(2):e0002865. doi: 10.1371/journal.pgph.0002865. eCollection 2024.
- Derived from this study: PubMed 37672524Mafirakureva N, Mukherjee S, de Souza M, Kelly-Cirino C, Songane MJP, Cohn J, Lemaire JF, Casenghi M, Dodd PJ. Cost-effectiveness analysis of interventions to improve diagnosis and preventive therapy for paediatric tuberculosis in 9 sub-Saharan African countries: A modelling study. PLoS Med. 2023 Sep 6;20(9):e1004285. doi: 10.1371/journal.pmed.1004285. eCollection 2023 Sep.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Cohn, MD principal investigator
Elizabeth Glaser Pediatric AIDS Foundation
Martina Casenghi, PhD principal investigator
Elizabeth Glaser Pediatric AIDS Foundation
10 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis and Pediatric, run by Elizabeth Glaser Pediatric AIDS Foundation at 10 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Cameroon, Côte d’Ivoire, Democratic Republic of the Congo, India, Kenya and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children Screened for TB (time frame: December 2018-September 2021). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03948698, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.