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

NCT ID: NCT03948698

Last Updated: 2023-04-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 4159533 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-12-01
• Study Completion Date: 2021-09-30

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.

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Interventions

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

Intervention Type: OTHER

Other Intervention Names

Integration and decentralization

Eligibility 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

• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Elizabeth Glaser Pediatric AIDS Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer Cohn, MD

Role: PRINCIPAL_INVESTIGATOR

Elizabeth Glaser Pediatric AIDS Foundation

Martina Casenghi, PhD

Role: PRINCIPAL_INVESTIGATOR

Elizabeth Glaser Pediatric AIDS Foundation

Locations

Sites in Centre, Littoral and West regions

Djoungolo, , Cameroon

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

Abidjan, , Côte d’Ivoire

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

Kinshasa, , Democratic Republic of the Congo

Sites in Maharashtra State, Telangana State, Andhra Pradesh

Hyderabad, , India

Turkana County and Homabay County sites

Nairobi, , Kenya

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

Maseru, , Lesotho

Central Region, Southern region sites

Dedza, , Malawi

Singida, Tabora sites

Singida, , Tanzania

Mbarara sites

Mbarara, , Uganda

Harare, Manicaland, Matabeleland South

Harare, , Zimbabwe

Countries

Cameroon; Côte d’Ivoire; Democratic Republic of the Congo; India; Kenya; Lesotho; Malawi; Tanzania; Uganda; Zimbabwe

References

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.

Reference Type: DERIVED

PMID: 38315700 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37672524 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

EG0209

Identifier Type: -

Identifier Source: org_study_id