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

NCT03948698 | Completed Results DMC

• 1 other identifier: EG0209
• Study Type: observational
• Target: 4,159,533
• Locations: 10 countries
• Sites: 10

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.

Conditions

Tuberculosis; Pediatric

Outcome Measures

Primary Outcomes (12)

• Children Screened for TB

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

  December 2018-September 2021

• Children With Presumptive TB

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

  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

  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

  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

  December 2018-September 2021

• Children Completing TB Preventive Therapy

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

  December 2018-September 2021

• Children Diagnosed With Active TB

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

  December 2018-September 2021

• Children Initiated on TB Treatment

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

  December 2018-September 2021

• Children Achieving Treatment Success

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

  December 2018-September 2021

• TB Contacts Successfully Traced

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

  December 2018-September 2021

• TB Contacts Screened Negative for TB

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

  December 2018-September 2021

• TB Contacts Eligible for Preventive Therapy

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

  December 2018-September 2021

Interventions

Innovative approached to pediatric TB care OTHER

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

Also known as: Integration and decentralization

Eligibility Criteria

• Age: Up to 14 Years
• Sex: all
• Age Groups: Child (0-17)
• 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).

You may qualify if:

• 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

You may not qualify if:

• All pediatric TB patients who enter CaP TB project site in any of the 10 countries and who are above 15 years old

Sponsors & Collaborators

• Elizabeth Glaser Pediatric AIDS Foundation: lead

Study Sites (10)

Sites in Centre, Littoral and West regions

Djoungolo, Cameroon

Location

Adjame-Plateau-Attecoube, Abobo Est,Anyama , Koumassi-Port Bouet-Vridi, Treichville-Marcory

Abidjan, Côte d’Ivoire

Location

Bandalungwa,Binza Meteo,Kikimi,Kingasani,Kinshasa, Lingwala, Masina II, Mont Ngafula II, Ndjili

Kinshasa, Democratic Republic of the Congo

Location

Sites in Maharashtra State, Telangana State, Andhra Pradesh

Hyderabad, India

Location

Turkana County and Homabay County sites

Nairobi, Kenya

Location

Berea, Maseru, Mageteng, Leribe, Mohale's Hoek sites

Maseru, Lesotho

Location

Central Region, Southern region sites

Dedza, Malawi

Location

Singida, Tabora sites

Singida, Tanzania

Location

Mbarara sites

Mbarara, Uganda

Location

Harare, Manicaland, Matabeleland South

Harare, Zimbabwe

Location

Related Publications (2)

• 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.

  PMID: 38315700 DERIVED

• Mafirakureva 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.

  PMID: 37672524 DERIVED

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Shirin Kakayeva
• Organization: Elizabeth Glaser Pediatric AIDS Foundation

skakayeva@pedaids.org

2404377929

Study Officials

• Jennifer Cohn, MD

  Elizabeth Glaser Pediatric AIDS Foundation

  PRINCIPAL INVESTIGATOR

• Martina Casenghi, PhD

  Elizabeth Glaser Pediatric AIDS Foundation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2019
• First Posted: May 14, 2019
• Study Start: December 1, 2018
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: April 18, 2023
• Results First Posted: December 20, 2021

Record last verified: 2023-04

Locations

DE (1); IN (1); ZI (1); KE (1); LE (1); CA (1); UG (1); CÔ (1); MA (1); TA (1)