In press. Adherence to treatment for tuberculosis infection in children using a comprehensive care strategy: a prospective cohort study with a historical control group

Background: Low adherence to treatment for tuberculosis infection (TBI) in children threatens tuberculosis (TB) control goals. This research focuses on children with close contact to TB and TBI. This study evaluated adherence to treatment of TBI using a comprehensive care strategy (CCS) for close-contact children with pulmonary TB compared with standard of care (SOC). Methods: A prospective cohort study with a historical control group was conducted on children under five, who were close contacts of patients with bacteriologically confirmed pulmonary TB in three Colombian cities (study registration number: NCT04331262). The CCS comprised clinical evaluations, rifampicin for four months, multidisciplinary care, and logistical support, while the SOC followed program regulations with isoniazid for nine months. The primary outcome was the proportion of children completing 100% treatment during follow-up, and the secondary outcome was treatment-related adverse events (AEs). Findings: 213 children in the SOC group and 86 children in the CCS group were analyzed. The treatment adherence in the SOC group was 40·8% (95% CI 34%; 48%), while in the CCS group it was 76·7% (95% CI 66%; 85%). Children exposed to CCS had 87% higher probability of adherence to TBI treatment compared to SOC (RR 1·87; 95% CI 1·52; 2·31). The incidence of AEs was lower in the CCS group (n = 3) than in those receiving SOC (n = 24). Interpretation: The CCS increases adherence to treatment for TBI in children safely compared to SOC. Future cost-effectiveness studies will help implement this strategy in programmatic settings. Funding: Colombian Ministry of Science, Technology and Innovation.