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

• Sponsor: Elizabeth Glaser Pediatric AIDS Foundation (Other)
• Overall Status: Completed
• CT.gov ID: NCT03948698
• Collaborator: (none)
• Enrollment: 4,159,533
• Locations: 10
• Actual Duration (Months): 34
• Patients Per Site: 415953.3
• Patients Per Site Per Month: 12244.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tuberculosis; Pediatric	Other: Innovative approached to pediatric TB care

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

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 4159533 participants
• Observational Model: Other
• Time Perspective: Cross-Sectional
• Official Title: Evaluation of the Catalyzing Pediatric TB Innovations Project: A Pre- and Post-Implementation Assessment Across Ten Countries
• Actual Study Start Date: Dec 1, 2018
• Actual Primary Completion Date: Sep 30, 2021
• Actual Study Completion Date: Sep 30, 2021

Outcome Measures

Primary Outcome Measures

1. Children Screened for TB [December 2018-September 2021]

   Number and proportion of children (age 0-14) screened for TB among clinic attendees

2. Children With Presumptive TB [December 2018-September 2021]

   Among those screened the number and proportion of children presumed to have TB.

3. 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

4. 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

5. 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

6. Children Completing TB Preventive Therapy [December 2018-September 2021]

   Number and proportion of pediatric patients on preventive treatment who completed therapy

7. Children Diagnosed With Active TB [December 2018-September 2021]

   Number of pediatric cases diagnosed with active TB disease among children with presumptive TB

8. Children Initiated on TB Treatment [December 2018-September 2021]

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

9. Children Achieving Treatment Success [December 2018-September 2021]

   Number and proportion of pediatric DS-TB cases who achieve treatment success

10. TB Contacts Successfully Traced [December 2018-September 2021]

    Number and proportion of all TB index cases for whom successful contact tracing has been done

11. TB Contacts Screened Negative for TB [December 2018-September 2021]

    Number and proportion of pediatric household contacts who are negative to TB screening

12. TB Contacts Eligible for Preventive Therapy [December 2018-September 2021]

    Number and proportion of screened negative pediatric contacts eligible for preventive therapy

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sites in Centre, Littoral and West regions	Djoungolo		Cameroon
2	Bandalungwa,Binza Meteo,Kikimi,Kingasani,Kinshasa, Lingwala, Masina II, Mont Ngafula II, Ndjili	Kinshasa		Congo, The Democratic Republic of the
3	Adjame-Plateau-Attecoube, Abobo Est,Anyama , Koumassi-Port Bouet-Vridi, Treichville-Marcory	Abidjan		Côte D'Ivoire
4	Sites in Maharashtra State, Telangana State, Andhra Pradesh	Hyderabad		India
5	Turkana County and Homabay County sites	Nairobi		Kenya
6	Berea, Maseru, Mageteng, Leribe, Mohale's Hoek sites	Maseru		Lesotho
7	Central Region, Southern region sites	Dedza		Malawi
8	Singida, Tabora sites	Singida		Tanzania
9	Mbarara sites	Mbarara		Uganda
10	Harare, Manicaland, Matabeleland South	Harare		Zimbabwe

Sponsors and Collaborators

• Elizabeth Glaser Pediatric AIDS Foundation

Investigators

• Principal Investigator: Jennifer Cohn, MD, Elizabeth Glaser Pediatric AIDS Foundation
• Principal Investigator: Martina Casenghi, PhD, Elizabeth Glaser Pediatric AIDS Foundation

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 8, 2021

More Information

Publications

None provided.

• Responsible Party: Elizabeth Glaser Pediatric AIDS Foundation
• ClinicalTrials.gov Identifier: NCT03948698
• Other Study ID Numbers: EG0209
• First Posted: May 14, 2019
• Last Update Posted: Jul 29, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Tuberculosis

Study Results

Participant Flow

Pre-assignment Detail	This study does not have a set number of participants. The number of participants is number of children screened.

Arm/Group Title	CaP TB TIPPI Study
Arm/Group Description	No new information to report
Period Title: Overall Study
STARTED	4749072
COMPLETED	4749072
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	CaP TB TIPPI Study
Arm/Group Description	No new information to report
Overall Participants	2318
Age (Count of Participants)
<=18 years	2318 100%
Between 18 and 65 years	0 0%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	1163 50.2%
Male	1155 49.8%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
Cameroon	159 6.9%
Malawi	167 7.2%
Côte D'Ivoire	247 10.7%
Congo, The Democratic Republic of the	709 30.6%
Tanzania	335 14.5%
Uganda	92 4%
Zimbabwe	281 12.1%
Kenya	212 9.1%
Lesotho	116 5%

Outcome Measures

1. Primary Outcome

Title	Children Screened for TB
Description	Number and proportion of children (age 0-14) screened for TB among clinic attendees
Time Frame	December 2018-September 2021

Outcome Measure Data

Analysis Population Description

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/Group Title	CaP TB TIPPI Study
Arm/Group Description	No new information to report
Measure Participants	7198865
Count of Participants [Participants]	4749072 204878%

2. Primary Outcome

Title	Children With Presumptive TB
Description	Among those screened the number and proportion of children presumed to have TB.
Time Frame	December 2018-September 2021

Outcome Measure Data

Analysis Population Description

The number Started in the participant flow was revised and both values are equal

Arm/Group Title	CaP TB TIPPI Study
Arm/Group Description	No new information to report
Measure Participants	4749072
Count of Participants [Participants]	60250 2599.2%

3. Primary Outcome

Title	Children With Presumptive TB Referred for Lab-based TB Diagnosis
Description	Number and proportion of presumptive TB cases referred for lab-based TB diagnosis
Time Frame	December 2018-September 2021

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CaP TB TIPPI Study
Arm/Group Description	No new information to report
Measure Participants	60250
Count of Participants [Participants]	49022 2114.8%

4. Primary Outcome

Title	Children With Presumptive TB Tested Using GeneXpert
Description	Number and proportion of pediatric (0-14 years) presumptive TB cases who are tested with GeneXpert
Time Frame	December 2018-September 2021

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CaP TB TIPPI Study
Arm/Group Description	No new information to report
Measure Participants	60250
Count of Participants [Participants]	35554 1533.8%

5. Primary Outcome

Title	Children Initiated on TB Preventive Therapy
Description	Number and proportion of pediatric patients started on preventive therapy of those who are eligible for preventive therapy
Time Frame	December 2018-September 2021

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CaP TB TIPPI Study
Arm/Group Description	No new information to report
Measure Participants	36026
Count of Participants [Participants]	28762 1240.8%

6. Primary Outcome

Title	Children Completing TB Preventive Therapy
Description	Number and proportion of pediatric patients on preventive treatment who completed therapy
Time Frame	December 2018-September 2021

Outcome Measure Data

Analysis Population Description

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/Group Title	CaP TB TIPPI Study
Arm/Group Description	No new information to report
Measure Participants	28762
Count of Participants [Participants]	22590 974.5%

7. Primary Outcome

Title	Children Diagnosed With Active TB
Description	Number of pediatric cases diagnosed with active TB disease among children with presumptive TB
Time Frame	December 2018-September 2021

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CaP TB TIPPI Study
Arm/Group Description	No new information to report
Measure Participants	60250
Count of Participants [Participants]	11078 477.9%

8. Primary Outcome

Title	Children Initiated on TB Treatment
Description	Number and proportion of pediatric TB cases started on DS-TB treatment
Time Frame	December 2018-September 2021

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CaP TB TIPPI Study
Arm/Group Description	No new information to report
Measure Participants	11078
Count of Participants [Participants]	10834 467.4%

9. Primary Outcome

Title	Children Achieving Treatment Success
Description	Number and proportion of pediatric DS-TB cases who achieve treatment success
Time Frame	December 2018-September 2021

Outcome Measure Data

Analysis Population Description

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/Group Title	CaP TB TIPPI Study
Arm/Group Description	No new information to report
Measure Participants	7221
Count of Participants [Participants]	6553 282.7%

10. Primary Outcome

Title	TB Contacts Successfully Traced
Description	Number and proportion of all TB index cases for whom successful contact tracing has been done
Time Frame	December 2018-September 2021

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CaP TB TIPPI Study
Arm/Group Description	No new information to report
Measure Participants	63314
Count of Participants [Participants]	20998 905.9%

11. Primary Outcome

Title	TB Contacts Screened Negative for TB
Description	Number and proportion of pediatric household contacts who are negative to TB screening
Time Frame	December 2018-September 2021

Outcome Measure Data

Analysis Population Description

The overall number of participants analyzed here would be the number of contacts screened.

Arm/Group Title	CaP TB TIPPI Study
Arm/Group Description	No new information to report
Measure Participants	48907
Count of Participants [Participants]	37774 1629.6%

12. Primary Outcome

Title	TB Contacts Eligible for Preventive Therapy
Description	Number and proportion of screened negative pediatric contacts eligible for preventive therapy
Time Frame	December 2018-September 2021

Outcome Measure Data

Analysis Population Description

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/Group Title	CaP TB TIPPI Study
Arm/Group Description	No new information to report
Measure Participants	37774
Count of Participants [Participants]	19630 846.9%

Adverse Events

Adverse Event Reporting Description	Please note that that this study does not monitor for adverse events because it does not introduce new treatment, etc. It is introducing a more intensified screening for TB and then monitors routine clinical screening procedures.
Arm/Group Title	CaP TB TIPPI Study
Arm/Group Description	No arms to report
All Cause Mortality
	CaP TB TIPPI Study
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Serious Adverse Events
	CaP TB TIPPI Study
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	CaP TB TIPPI Study
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.