OPTIC-TB
Every year, about a million children under 15 years are diagnosed with Tuberculosis (TB) worldwide, and about a quarter die. However, over 60% of children with TB remain undiagnosed, particularly in sub-Saharan Africa, which accounts for about 20% of the global burden of paediatric TB cases. Challenges in specimen collection in young children, which often require trained and experienced staff, difficulty in diagnosis, the perceived low risk of transmission and the lack of laboratory infrastructure contribute to low TB detection in children in this region.
About the research project
Full project title: Optimizing Childhood TB Treatment Decision Algorithms in sub-Saharan Africa - OPTIC-TB.
Summary of the project
In 2022, the World Health Organization (WHO) issued an interim recommendation to use integrated Treatment-Decision Algorithms (TDAs) to diagnose TB in children under ten years. However, this recommendation was based on very low certainty of evidence. Therefore, our project, which will be conducted in Tanzania, Uganda and DR. Congo aims to address four objectives:
- To compare the effectiveness of TDAs and the Standard of Care in routine clinical settings
- To identify processes and contextual factors that influence the effectiveness and fidelity in the implementation of TDAs
- To compare the costs, cost-effectiveness and the population-level impact of TDA strategies on the burden of TB
- To validate the diagnostic performance (sensitivity, specificity, negative and positive predictive values) of the TDAs in various health system settings and clinical context
Partners and project leaders
University of Bergen (UiB), Norway (coordinator)
National Institute for Medical Research (external link), (NIMR), Tanzania
Universite Catholique De Bukavu (external link) (UCB), Democratic Republic of Congo
Kampala International University Tanzania (external link) (KIUT), Tanzania
Makerere University Lung Institute (external link), (MULI), Uganda
Kampala International University (external link) (KIU), Uganda
Dr. Amani Thomas Mori (UiB) (project coordinator)
Prof Sayoki Mfinanga (NIMR)
Prof Patrick de marie Katoto (UCB)
Prof Bruce Kirenga (MULI)
Prof Angwara Kiwara (KIUT)
Prof Andrew Kitua (KIU)
Design, hypothesis and outcomes, Impact
Design
A four-year pragmatic open-label cluster randomized controlled trial will be conducted in 120 primary health facilities in the three countries. About 60,000 children with presumptive TB visiting the health facilities will be screened and those fulfilling the criteria will be enrolled in the study.
Hypothesis and outcomes
We hypothesize that the WHO-recommended TDA strategy is superior to the standard of care (SOC) in (i) increasing by at least 20%, the proportion of children below 10 years with pulmonary TB detected and initiated on TB treatment and (ii) improve the proportion of children with pulmonary TB with good TB treatment outcome in the intervention facilities compared to the Standard of Care.
Impact
We anticipate that this project will yield results that address the issue of low detection of paediatric TB in sub-Saharan Africa and beyond, build research capacity in conducting implementation research in low- and middle-income countries and foster networking and collaboration between the partner institutions.
Work packages
- WP1 Project Management & Coordination - UiB
- WP2 Effectiveness assessment, costing/cost effectiveness and impact evaluation - NIMR
- WP3 Performance validation, feasibility and accetability studies - MULI
- WP4 Dissemination, Communication and networking - UCB
- WP5 Data Management, economic and statistical analysis - NIMR
- WP6 Mentorship and Capacity Building - KIUT
- WP7 Ethics requirements - UiB
- WP8 Scientific project leadership - NIMR
Upcoming events
The Second OPTIC TB Annual General Meeting
The OPTIC-TB 2nd Annual General Meeting will take place in Zanzibar (Tanzania) on 29–30 April 2026 at Medinat Al Bahr hotel bringing together consortium countries (Tanzania, Uganda, DR Congo, and Norway) to review trial milestones, share progress, and plan the next phase of the project.
Link to the hotel website : https://www.madinatalbahr.com/ (external link)
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Featured
People
Project manager
Amani Mori Project coordinator, senior researcher
Funding
The project is supported by the EDCTP3 and its members. Funded by the European Union. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or Horizon Europe/EDCTP3. Neither the European Union nor the granting authority can be held responsible for them.