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02 — Tools & research

Three tools, one decision.

A blood test, an AI-assisted X-ray reader and a clinical decision app, built to work together at the point of care.

Tool 01 — Clinical decision support

The CDM-app

The Clinical Decision-Making app (CDM-app) is an open-access digital tool used at the bedside. It supports health care workers, from community level to specialists, in making a TB diagnosis in children. It is compared with the WHO Treatment Decision Algorithms and will incorporate the results of Actiphage® and CAD, giving frontline health care workers a single, evidence-based tool for the “treat, test or reassure” decision, informed by the clinical action threshold(s).

in days

Tool 02 — Blood-based test

Actiphage®

Actiphage® is a blood-based test that confirms the presence and viability of Mycobacterium tuberculosis directly, without needing a respiratory sample. ACT4KIDS-TB is measuring what it adds to current confirmatory microbiological tests (culture and/or nucleic acid amplification tests) in children aged 0 to 10, including high-risk groups such as children under 2, those with severe acute malnutrition, extrapulmonary TB, or living with HIV.

The project is also adapting the test to bring it closer to the point of care, for example by exploring fingerstick sampling and transport methods that would allow testing outside centralised laboratories.

Tool 03 — Imaging

Computer-aided chest X-ray reading

The CAD component brings existing computer-aided chest X-ray reading software to children for the first time at scale. ACT4KIDS-TB is building an online chest X-ray repository from more than 200 children in Benin and South Africa, externally validating CAD performance against clinical, microbiological and radiological reference standards, and co-designing with Delft Imaging a point-of-care CAD app, able to read phone-based chest X-ray images, that can be integrated directly into the CDM-app.

Why it matters. CAD already helps screen adults for TB; ACT4KIDS-TB brings it to young children, who are the hardest to diagnose.

Work packages

Five work packages carry the research.

WP1

ACT4KIDS-AP — the Actiphage® trial

Runs the clinical trial that establishes what Actiphage® adds to current confirmatory microbiological tests in children with presumptive TB, and explores adaptations that bring the test closer to the point of care.

Led by

Desmond Tutu TB Centre, Stellenbosch University (DTTC/SU)

WP2

ACT4KIDS-CDM — the decision app

Develops and validates the paediatric CDM-app, compares it with the WHO Treatment Decision Algorithms, and builds a tool that combines symptoms, chest X-ray, Actiphage® and standard microbiological test results into one clinical recommendation, informed by the clinical action threshold(s).

Led by

The Aga Khan University (AKU)

WP3

ACT4KIDS-CEAF — cost-effectiveness, acceptability and feasibility

Evaluates whether the innovations are worth scaling up: cost-effectiveness of Actiphage® and CAD compared with current care, and how well the tools fit into real clinical workflows for caregivers, children and health care workers.

Led by

Health economic analyses: University of Cape Town (UCT); acceptability and feasibility: Institute of Tropical Medicine (ITM)

WP4

ACT4KIDS-CAD — chest X-ray reading

Builds a paediatric chest X-ray repository, externally validates existing CAD software for children, and co-designs with Delft Imaging a point-of-care CAD app, able to read phone-based chest X-ray images, that can be integrated into the CDM-app.

Led by

Desmond Tutu TB Centre, Stellenbosch University (DTTC/SU)

WP5

ACT4KIDS-CDE — communication, dissemination and exploitation

Drives communication and dissemination, builds a three-level (national, regional, international) training programme on paediatric TB diagnosis for health care workers, and coordinates doctoral-level capacity strengthening.

Led by

CNHU-PPC, Cotonou

Two further work packages cover scientific coordination (DTTC/SU) and project management (ITM).

Explore the results as they arrive.