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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03948698
Recruitment Status : Active, not recruiting
First Posted : May 14, 2019
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
Elizabeth Glaser Pediatric AIDS Foundation

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
Tuberculosis Pediatric Other: Innovative approached to pediatric TB care

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 3000 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 12 Months
Official Title: Evaluation of the Catalyzing Pediatric TB Innovations Project: A Pre- and Post-Implementation Assessment Across Ten Countries
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Innovative 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
    Other Name: Integration and decentralization


Primary Outcome Measures :
  1. Children screened for TB [ Time Frame: January 2019-September 2021 ]
    Number and proportion of children (age 0-14) screened for TB among clinic attendees

  2. Children with presumptive TB [ Time Frame: January 2019-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 [ Time Frame: January 2019-September 2021 ]
    Number and proportion of presumptive TB cases referred for lab-based TB diagnosis

  4. Children with presumptive TB tested using GeneXpert [ Time Frame: January 2019-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 [ Time Frame: January 2019-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 [ Time Frame: January 2019-September 2021 ]
    Number and proportion of pediatric patients on preventive treatment who completed therapy

  7. Children diagnosed with active TB [ Time Frame: January 2019-September 2021 ]
    Number of pediatric cases diagnosed with active TB disease

  8. Time to TB diagnosis [ Time Frame: January 2019-September 2021 ]
    Time between when a child is identified as a presumptive TB case and when the child is diagnosed with TB

  9. Children initiated on TB treatment [ Time Frame: January 2019-September 2021 ]
    Number and proportion of pediatric TB cases started on DS-TB treatment

  10. Time to initiation of TB treatment [ Time Frame: January 2019-September 2021 ]
    Time between when a child is identified as a presumptive TB case and when the child is initiated on TB treatment

  11. Children achieving treatment success [ Time Frame: January 2019-September 2021 ]
    Number and proportion of pediatric DS-TB cases who achieve treatment success

  12. TB contacts successfully traced [ Time Frame: January 2019-September 2021 ]
    Number and proportion of all TB index cases for whom successful contact tracing has been done

  13. TB contacts screened negative for TB [ Time Frame: January 2019-September 2021 ]
    Number and proportion of pediatric household contacts who are negative to TB screening

  14. TB contacts eligible for preventive therapy [ Time Frame: January 2019-September 2021 ]
    Number and proportion of screened negative pediatric contacts eligible for preventive therapy



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Ages Eligible for Study:   Child, Adult, Older Adult
Sampling Method:   Non-Probability Sample
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).
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03948698


Locations
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Cameroon
Sites in Centre, Littoral and West regions
Djoungolo, Cameroon
Congo, The Democratic Republic of the
Bandalungwa,Binza Meteo,Kikimi,Kingasani,Kinshasa, Lingwala, Masina II, Mont Ngafula II, Ndjili
Kinshasa, Congo, The Democratic Republic of the
Côte D'Ivoire
Adjame-Plateau-Attecoube, Abobo Est,Anyama , Koumassi-Port Bouet-Vridi, Treichville-Marcory
Abidjan, Côte D'Ivoire
India
Sites in Maharashtra State, Telangana State, Andhra Pradesh
Hyderabad, India
Kenya
Turkana County and Homabay County sites
Nairobi, Kenya
Lesotho
Berea, Maseru, Mageteng, Leribe, Mohale's Hoek sites
Maseru, Lesotho
Malawi
Central Region, Southern region sites
Dedza, Malawi
Tanzania
Singida, Tabora sites
Singida, Tanzania
Uganda
Mbarara sites
Mbarara, Uganda
Zimbabwe
Harare, Manicaland, Matabeleland South
Harare, Zimbabwe
Sponsors and Collaborators
Elizabeth Glaser Pediatric AIDS Foundation
Investigators
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Principal Investigator: Jennifer Cohn, MD Elizabeth Glaser Pediatric AIDS Foundation
Principal Investigator: Martina Casenghi, PhD Elizabeth Glaser Pediatric AIDS Foundation

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Responsible Party: Elizabeth Glaser Pediatric AIDS Foundation
ClinicalTrials.gov Identifier: NCT03948698     History of Changes
Other Study ID Numbers: TIPPI
First Posted: May 14, 2019    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections