The DECIDE-TB Trial; Validation of Treatment Decision Algorithms for Childhood Tuberculosis

Summary

The Decide-TB project aims to generate evidence for the implementation of a comprehensive Treatment Decision Algorithms (TDA) based approach for TB in children living in high TB burden and resource-limited countries, at District Hospital (DH) and Primary Health Centre (PHC) levels, and to facilitate the integration of this evidence within practices and policies.

This programmatic pilot led by the National TB Programs (NTP) will test a TDA-based approach integrating TB screening, diagnosis, treatment decision-making, and disease severity assessment for shorter treatment eligibility, for use at a lower level of healthcare. This TDA-based approach will be evaluated in a hybrid effectiveness implementation study based on a pragmatic stepped wedge cluster-randomized trial. The Decide TB project will be implemented at the district level, targeting five districts in each country. Each cluster in a district will be made up of one district hospital and six primary health centers. The study will develop a Clinical Decision Support System (CDSS) to operationalize the use of TDAs, and strengthen District Health Information Systems (DHIS2) to collect individual data, which will contribute to monitoring and evaluation, clinical mentoring, and supervision by the country's NTPs.

Conditions

• Tuberculosis
• Child Health
• HIV
• Severe Acute Malnutrition

Interventions

OTHER

The comprehensive TDA based approach

The intervention consists of implementing a comprehensive TDA-based approach for TB diagnosis and treatment decision-making, including shorter treatment for non-severe TB in children identified as TB presumptive cases through a CDSS. It will also include the management of high-risk groups. In practice, all sick children will be assessed using the WHO-suggested TDAs A with CXR (DH) and B without CXR (PHC). CLHIV and those hospitalised with SAM at DH will have further assessment and treatment decisions based on the PAANTHER and TB-Speed SAM TDAs, respectively. Clinical and microbiological assessment data will be incorporated into a CDSS to help with the clinical decision to initiate TB treatment. The CDSS will incorporate specific features and test results for high-risk group children based on the PAANTHER TDA and the TB-Speed SAM TDA and will incorporate the results of the severity assessment to guide the choice of TB treatment duration once children are diagnosed with TB.

Sponsors & Collaborators

• University of Bordeaux

  collaborator OTHER

• Instituto Nacional de Saúde, Mozambique

  collaborator OTHER_GOV

• ADERA

  collaborator UNKNOWN

• University of Stellenbosch

  collaborator OTHER

• Imperial College London

  collaborator OTHER

• Institut de Recherche pour le Développement (IRD)

  collaborator UNKNOWN

• University of Sheffield

  collaborator OTHER

• Ludwig-Maximilians - University of Munich

  collaborator OTHER

• Ministry of Health, Zambia

  collaborator OTHER_GOV

• Ministry of Health, Mozambique

  collaborator OTHER_GOV

• Eduardo Mondlane University

  collaborator OTHER

• European and Developing Countries Clinical Trials Partnership (EDCTP)

  collaborator OTHER_GOV

• Chishala Chabala

  lead OTHER

Principal Investigators

• James Seddon · Imperial College London

• Olivier Marcy · University of Bordeaux

• Chishala Chabala · University of Zambia

• Joanna Orne-Gliemann · University of Bordeaux

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

SEQUENTIAL

Eligibility

Max Age

14 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-06-01

Primary Completion

2027-08-31

Completion

2027-08-31

Countries

• Zambia

Study Locations