BACKGROUND
Recommended by the World Health Organization in 2022, a 4 month regimen is an alternative to the standard 6 month treatment for children with non severe, drug susceptible tuberculosis. Despite potential patient and programmatic benefits, implementation remains limited, with little evidence on eligibility, feasibility and acceptability, particularly in routine settings where diagnostic resources are constrained.
METHODS
A prospective observational and mixed-methods multi-site study included children with pulmonary tuberculosis in Tondo, Philippines (<16 years) and Mbarara, Uganda (<10 years). Eligibility was assessed at initiation with 6 month follow-up. Feasibility and acceptability were assessed using focus groups and in-depth interviews with healthcare workers before and during implementation.
RESULTS
Among 214 children in the Philippines (n=142, 66.4%) and Uganda (n=72, 33.6%), 73.8% were initially eligible for the 4 month regimen: 85.9% in the Philippines and 50.0% in Uganda. Reasons for 6 month treatment included hospitalization (11.7%), severe malnutrition (10.7%), and severe CXR findings (8.2%). CXR was available in all cases in the Philippines and 55.6% in Uganda. CXR reclassified 3.3% as severe. Seven children (4.4%) were extended from 4 to 6 months, all in the Philippines. In
the two countries, the implementation of the 4-month TB treatment guidance was documented across primary and referral facilities at differing stages of national
adoption. Feasibility was supported by clear eligibility criteria, training, and structured case-report tools, alongside CXR availability in the Philippines. Constraints included unequal X-ray access, staff turnover, and in Uganda, limited CXR availability. Initial concerns focused on safety, severity assessment, and effectiveness. Confidence increased with experience, observed outcomes, and regimen flexibility. Providers perceived benefits including reduced caregiver and health system burden, and improved adherence and child quality of life.
CONCLUSION
The 4 month regimen for drug-susceptible TB in children is feasible, with high eligibility in primary health care settings. Implementation without chest X-ray is achievable. Broader adoption will improve patient and program outcomes and optimize resource use.