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Background In 2021, over one million children developed tuberculosis, resulting in 214 000 deaths, largely due to inadequate diagnosis and treatment. The diagnosis and treatment of tuberculosis is limited in most high-burden countries because services are highly centralised at secondary/tertiary levels and are managed in a vertical, non-integrated way. To improve case detection and treatment among children, the World Health Organisation (WHO) recommends decentralised and integrated tuberculosis care models. The Integrating Paediatric TB Services Into Child Healthcare Services in Africa (INPUT) stepped-wedge cluster-randomised trial evaluated the impact of integrating tuberculosis services into healthcare for children under five in Cameroon and Kenya, compared with usual care, finding a 10-fold increase in tuberculosis case detection in Cameroon but no effect in Kenya.Methods We estimated intervention impact on healthcare outcomes, resource use, health system costs and cost-effectiveness relative to the standard of care (SoC) using a decision tree analytical approach and data from the INPUT trial. INPUT trial data on cascades, resource use and intervention diagnostic rate ratios were used to parametrise the decision tree model. Health outcomes following tuberculosis treatment were modelled in terms of mortality and disability-adjusted life-years (DALYs).Findings For every 100 children starting antituberculosis treatment under SoC, an additional 876 (95% uncertainty interval (UI) −76 to 5518) in Cameroon and −6 (95% UI −61 to 96) in Kenya would start treatment under the intervention. Treatment success would increase by 5% in Cameroon and 9% in Kenya under the intervention compared with SoC. An estimated 350 (95% UI −31 to 2204) and 3 (95% UI −22 to 48) deaths would be prevented in Cameroon and Kenya, respectively. The incremental cost-effectiveness ratio for the intervention compared with SoC was US$506 and US$1299 per DALY averted in Cameroon and Kenya, respectively.Interpretation Although likely to be effective, the cost-effectiveness of integrating tuberculosis services into child healthcare services depends on baseline service coverage, tuberculosis detection and treatment outcomes.

Introduction Paediatric tuberculosis (TB) underdiagnosis is a critical concern. The INPUT stepped-wedge cluster-randomised trial assessed the impact of integrating child TB services into child healthcare on TB case detection among children under age 5 years.Methods We compared the standard of care, providing TB care in specific TB clinics (control phase), with the Catalysing Paediatric TB Innovations (CaP-TB) intervention, integrating TB services across all child health services (intervention phase). 12 clusters in Cameroon and Kenya transitioned from the standard of care to the intervention at randomly assigned times. Children with presumptive TB were enrolled after obtaining their parents’ consent and were followed throughout TB diagnostic procedures and treatment. Study outcomes included the rate of children with presumptive TB receiving TB investigations and that of children diagnosed with TB (the primary outcome was case detection), per thousand children under 5 years attending facilities. Generalised linear mixed Poisson models estimated the intervention’s effect as adjusted rate ratios (aRR) and associated 95% CIs. Ad hoc country-stratified analyses were conducted.Results During control and intervention phases, respectively, 121 909 and 109 614 children under 5 years attended paediatric entry points, 133 (1.1 per thousand) and 610 (5.6 per thousand) children with presumptive TB received TB investigations, and 79 and 74 were diagnosed with TB, corresponding to a case detection rate of 0.64 and 0.68 per thousand, respectively. CaP-TB significantly increased TB investigations in both countries overall (aRR=3.9, 95% CI 2.4 to 5.4), and in each. Overall, TB case detection was not statistically different between intervention and control (aRR 1.32, 95% CI 0.66 to 2.61, p=0.43). Country-stratified analysis revealed a 10-fold increase (aRR 9.75, 95% CI 1.04 to 91.84, p=0.046) in case detection with CaP-TB in Cameroon and no significant effect in Kenya (aRR 0.94, 95% CI 0.44 to 2.01, p=0.88).Conclusion CaP-TB increased TB investigations in both study countries and markedly enhanced TB case detection in one, underlining integrated TB services' potential to address paediatric TB underdiagnosis.