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Introduction: Malaria is still a major health problem in sub-Saharan Africa, where 98% of global malaria mortality occurs. In addition, the spread of Plasmodium falciparum with partial artemisinin resistance in East Africa and beyond is a great concern. The establishment of more effective vector control, in addition to the current long-lasting insecticide-treated net distribution programme, is an urgent task in these areas. One novel vector control candidate is the pyrethroid-PBO ceiling nets (OlysetPlus ceiling nets) which can overcome the problems of variations in net use behaviours and metabolic resistance to insecticide in vectors. Our preliminary study suggests the protective efficacy and high acceptability of this tool. With this proposed second trial, we aim to evaluate the impact of this tool in a different eco-epidemiological setting in the lake endemic region of Kenya., Methods: A cluster-randomised controlled trial is designed to evaluate the impact of pyrethroid-PBO ceiling nets in Ndhiwa Sub-County, Homa Bay County, Kenya. A total of 44 clusters will be randomly assigned in a 1:1 ratio to the intervention group (pyrethroid-PBO ceiling nets) and the control group. The assignment will be accomplished through covariate-constrained randomisation of clusters. For the primary outcome of clinical malaria incidence, 38 children from each cluster will be enrolled in a cohort and followed for 18 months. We will also evaluate the effects of the intervention on entomological indicators as well as its acceptance by communities and cost-effectiveness., Ethics and Dissemination: Ethics approvals were provided by the Mount Kenya University Institutional Scientific Ethics Review Committee and the Ethics Committee Osaka Metropolitan University. Study results will be shared with study participants and communities, the Homa Bay County government and the Kenya National Malaria Control Programme. Results will also be disseminated through publications, conferences and workshops to help the development of novel malaria control strategies in other malaria-endemic countries., Trial Registration Number: UMIN000053873., Competing Interests: Competing interests: AK and JG were partially supported by a research grant from Sumitomo Chemical Corporation. Other authors had no competing interests., (© Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group.)

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., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Tuberculosis is among the top-10 causes of mortality in children with more than 1 million children suffering from TB disease annually worldwide. The main challenge in young children is the difficulty in establishing an accurate diagnosis of active TB. The INPUT study is a stepped-wedge cluster-randomized intervention study aiming to assess the effectiveness of integrating TB services into child healthcare services on TB diagnosis capacities in children under 5 years of age., Methods: Two strategies will be compared: i) The standard of care, offering pediatric TB services based on national standard of care; ii) The intervention, with pediatric TB services integrated into child healthcare services: it consists of a package of training, supportive supervision, job aids, and logistical support to the integration of TB screening and diagnosis activities into pediatric services. The design is a cluster-randomized stepped-wedge of 12 study clusters in Cameroon and Kenya. The sites start enrolling participants under standard-of-care and will transition to the intervention at randomly assigned time points. We enroll children aged less than 5 years with a presumptive diagnosis of TB after obtaining caregiver written informed consent. The participants are followed through TB diagnosis and treatment, with clinical information prospectively abstracted from their medical records. The primary outcome is the proportion of TB cases diagnosed among children < 5 years old attending the child healthcare services. Secondary outcomes include: number of children screened for presumptive active TB; diagnosed; initiated on TB treatment; and completing treatment. We will also assess the cost-effectiveness of the intervention, its acceptability among health care providers and users, and fidelity of implementation., Discussion: Study enrolments started in May 2019, enrolments will be completed in October 2020 and follow up will be completed by June 2021. The study findings will be disseminated to national, regional and international audiences and will inform innovative approaches to integration of TB screening, diagnosis, and treatment initiation into child health care services., Trial Resistration: NCT03862261, initial release 12 February 2019.