OPTIC-TB – MLI

Optimizing Childhood TB Treatment Decision Algorithms in sub-Saharan Africa

Background

Despite being preventable and treatable, TB remains a top killer in children. Most of the children who die due to TB are those who were not initiated on treatment majorly due to challenges related to diagnosis.

In 2022, the World Health Organization (WHO) recommended the use of Treatment Decision Algorithms (TDAs) to address these diagnostic challenges, although these have not been validated externally.

The Optimizing Childhood TB Treatment Decision Algorithms in sub-Saharan Africa (OPTIC-TB) project will therefore evaluate the effectiveness, cost-effectiveness, feasibility, and acceptability of implementing the WHO-recommended TDAs for pulmonary TB in children under 10 years old to increase case detection, reduce TB treatment delay, and improve TB treatment outcomes in Tanzania, Uganda, and DR Congo.

Specific Objectives:

To compare the effectiveness of TDA versus the Standard of Care strategies in routine non-research programmatic conditions.
To identify processes and contextual factors that influence the effectiveness and fidelity in the implementation of TDA.
To compare the costs, cost-effectiveness, and population-level impact of the TDA strategies on the burden of TB.
To estimate/validate the diagnostic performance (sensitivity, specificity, negative and positive predictive values) of the TDAs for TB in children under 10 years old in various healthcare system settings and clinical contexts.

Study period: 2024 – 2027

Design: Multi-country (Uganda, DRC, and Tanzania) four-year sequential stepped wedge randomizing 120 health facilities (40 per country) in a 1:1 ratio to either implement the new WHO-recommended integrated TDAs or continue with Standard of care.

A minimum of 500 children under ten years of age with presumptive TB will be screened at each health facility, aiming for a total of 60,000 participants across all 120 facilities.

Impact

The project aims to generate scientific evidence on addressing low paediatric TB case detection through implementing TDAs in TB high burden settings as well as the cost of bringing TDAs into paediatric TB care its epidemiological impact over a primary time.

Funding: The study is funded by the Global Health EDCTP3 Training Networks under Horizon Europe (Project: 101145735)