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)
4,159,533
Enrollment
10
Locations
34
Actual Duration (Months)
415953.3
Patients Per Site
12244.3
Patients Per Site Per Month

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 DiseaseIntervention/TreatmentPhase
  • 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

SiteCityStateCountryPostal Code
1Sites in Centre, Littoral and West regionsDjoungoloCameroon
2Bandalungwa,Binza Meteo,Kikimi,Kingasani,Kinshasa, Lingwala, Masina II, Mont Ngafula II, NdjiliKinshasaCongo, The Democratic Republic of the
3Adjame-Plateau-Attecoube, Abobo Est,Anyama , Koumassi-Port Bouet-Vridi, Treichville-MarcoryAbidjanCôte D'Ivoire
4Sites in Maharashtra State, Telangana State, Andhra PradeshHyderabadIndia
5Turkana County and Homabay County sitesNairobiKenya
6Berea, Maseru, Mageteng, Leribe, Mohale's Hoek sitesMaseruLesotho
7Central Region, Southern region sitesDedzaMalawi
8Singida, Tabora sitesSingidaTanzania
9Mbarara sitesMbararaUganda
10Harare, Manicaland, Matabeleland SouthHarareZimbabwe

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)

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:
Dec 20, 2021
Last Verified:
Nov 1, 2021
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:

Study Results

Participant Flow

Recruitment Details
Pre-assignment DetailThis study does not have a set number of participants. The number of participants is number of children screened.
Arm/Group TitleCaP TB TIPPI Study
Arm/Group DescriptionNo new information to report
Period Title: Overall Study
STARTED4159533
COMPLETED4159533
NOT COMPLETED0

Baseline Characteristics

Arm/Group TitleCaP TB TIPPI Study
Arm/Group DescriptionNo new information to report
Overall Participants2318
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
TitleChildren Screened for TB
DescriptionNumber and proportion of children (age 0-14) screened for TB among clinic attendees
Time FrameDecember 2018-September 2021

Outcome Measure Data

Analysis Population Description
The number of participants analyzed, 6529534, is the clinic attendees and 4159533 is number of children screened. 4159533 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 TitleCaP TB TIPPI Study
Arm/Group DescriptionNo new information to report
Measure Participants6529534
Count of Participants [Participants]
4159533
179444.9%
2. Primary Outcome
TitleChildren With Presumptive TB
DescriptionAmong those screened the number and proportion of children presumed to have TB
Time FrameDecember 2018-September 2021

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleCaP TB TIPPI Study
Arm/Group DescriptionNo new information to report
Measure Participants4159533
Count of Participants [Participants]
53253
2297.4%
3. Primary Outcome
TitleChildren With Presumptive TB Referred for Lab-based TB Diagnosis
DescriptionNumber and proportion of presumptive TB cases referred for lab-based TB diagnosis
Time FrameDecember 2018-September 2021

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleCaP TB TIPPI Study
Arm/Group DescriptionNo new information to report
Measure Participants53252
Count of Participants [Participants]
34472
1487.1%
4. Primary Outcome
TitleChildren With Presumptive TB Tested Using GeneXpert
DescriptionNumber and proportion of pediatric (0-14 years) presumptive TB cases who are tested with GeneXpert
Time FrameDecember 2018-September 2021

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleCaP TB TIPPI Study
Arm/Group DescriptionNo new information to report
Measure Participants53253
Count of Participants [Participants]
30963
1335.8%
5. Primary Outcome
TitleChildren Initiated on TB Preventive Therapy
DescriptionNumber and proportion of pediatric patients started on preventive therapy of those who are eligible for preventive therapy
Time FrameDecember 2018-September 2021

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleCaP TB TIPPI Study
Arm/Group DescriptionNo new information to report
Measure Participants35346
Count of Participants [Participants]
26699
1151.8%
6. Primary Outcome
TitleChildren Completing TB Preventive Therapy
DescriptionNumber and proportion of pediatric patients on preventive treatment who completed therapy
Time FrameDecember 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 TitleCaP TB TIPPI Study
Arm/Group DescriptionNo new information to report
Measure Participants21667
Count of Participants [Participants]
19898
858.4%
7. Primary Outcome
TitleChildren Diagnosed With Active TB
DescriptionNumber of pediatric cases diagnosed with active TB disease among children with presumptive TB
Time FrameDecember 2018-September 2021

Outcome Measure Data

Analysis Population Description
Overall number of participants analyzed would be the number of children identified with presumptive TB referred for lab-based diagnosis. Number of diagnosed with TB would be 10207
Arm/Group TitleCaP TB TIPPI Study
Arm/Group DescriptionNo new information to report
Measure Participants53252
Count of Participants [Participants]
10207
440.3%
8. Primary Outcome
TitleChildren Initiated on TB Treatment
DescriptionNumber and proportion of pediatric TB cases started on DS-TB treatment
Time FrameDecember 2018-September 2021

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleCaP TB TIPPI Study
Arm/Group DescriptionNo new information to report
Measure Participants10207
Count of Participants [Participants]
9981
430.6%
9. Primary Outcome
TitleChildren Achieving Treatment Success
DescriptionNumber and proportion of pediatric DS-TB cases who achieve treatment success
Time FrameDecember 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 TitleCaP TB TIPPI Study
Arm/Group DescriptionNo new information to report
Measure Participants7221
Count of Participants [Participants]
6553
282.7%
10. Primary Outcome
TitleTB Contacts Successfully Traced
DescriptionNumber and proportion of all TB index cases for whom successful contact tracing has been done
Time FrameDecember 2018-September 2021

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleCaP TB TIPPI Study
Arm/Group DescriptionNo new information to report
Measure Participants58182
Count of Participants [Participants]
17711
764.1%
11. Primary Outcome
TitleTB Contacts Screened Negative for TB
DescriptionNumber and proportion of pediatric household contacts who are negative to TB screening
Time FrameDecember 2018-September 2021

Outcome Measure Data

Analysis Population Description
The overall number of participants analyzed here would be the number of contacts screened. Among children screened, 39990 were screened negative for TB.
Arm/Group TitleCaP TB TIPPI Study
Arm/Group DescriptionNo new information to report
Measure Participants45322
Count of Participants [Participants]
39990
1725.2%
12. Primary Outcome
TitleTB Contacts Eligible for Preventive Therapy
DescriptionNumber and proportion of screened negative pediatric contacts eligible for preventive therapy
Time FrameDecember 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 TitleCaP TB TIPPI Study
Arm/Group DescriptionNo new information to report
Measure Participants17847
Count of Participants [Participants]
15441
666.1%

Adverse Events

Time Frame
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 TitleCaP TB TIPPI Study
Arm/Group DescriptionNo arms to report
All Cause Mortality
CaP TB TIPPI Study
Affected / at Risk (%)# Events
Total0/0 (NaN)
Serious Adverse Events
CaP TB TIPPI Study
Affected / at Risk (%)# Events
Total0/0 (NaN)
Other (Not Including Serious) Adverse Events
CaP TB TIPPI Study
Affected / at Risk (%)# Events
Total0/0 (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.

Results Point of Contact

Name/TitleShirin Kakayeva
OrganizationElizabeth Glaser Pediatric AIDS Foundation
Phone2404377929
Emailskakayeva@pedaids.org
Responsible Party:
Elizabeth Glaser Pediatric AIDS Foundation
ClinicalTrials.gov Identifier:
NCT03948698
Other Study ID Numbers:
  • EG0209
First Posted:
May 14, 2019
Last Update Posted:
Dec 20, 2021
Last Verified:
Nov 1, 2021