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Objectives

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Background

In 2022, the World Health Organization (WHO) recommended the use treatment decision algorithms (TDAs) to improve pulmonary TB diagnosis in children <10 years. This recommendation is conditional, meaning that it is temporary until stronger evidence is made available. And WHO called for gathering more information and scientific evidence to validate two suggested TDAs for children with presumptive TB.

The Decide-TB project aims to evaluate a comprehensive TDA-based approach, that is adapted to the risk profile of children, for use at lower levels of healthcare. This comprehensive TDA-based approach will combine the WHO suggested TDAs, other TDAs for children living with HIV and those with malnutrition, and the severity assessment and shorter treatment option (4 months) for children with less severe TB.

GENERAL OBJECTIVE

The general objective of Decide-TB B is to assess the effectiveness, feasibility and implementation, acceptability, costs and cost-effectiveness, and adoption of a comprehensive TDA-based approach for childhood TB screening, diagnosis, and treatment decision-making piloted and implemented under programmatic conditions at District Hospital and Primary Health Clinic level in Mozambique and Zambia.

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SPECIFIC OBJECTIVES
The Decide TB project has 5 specific objectives:

1

To assess the effectiveness of the comprehensive TDA-based approach in increasing TB case detection in children and providing good quality TB diagnosis and shorter treatment decision making (diagnostic accuracy and reliability of treatment decision for TB and shorter treatment), as compared to the standard of care (SOC).

2

To describe the implementation and the feasibility of using the comprehensive TDA-based approach, and to identify contextual determinants influencing implementation and contribute to improved implementation/adaptations throughout intervention delivery.

3

To assess preferences, acceptability, and perceived feasibility of using the comprehensive TDA-based approach among end-users, beneficiaries, and key stakeholders.

4

To assess the costs from the health system and the beneficiary (parents/caregivers of children) perspective, the cost-effectiveness of using the comprehensive TDA-based approach and the budget impact of scaling up the intervention.

5

To assess the factors and stakeholders that support or constrain the adoption of the comprehensive TDA-based approach as health policy at district level.