NCT03862261

Integrating Pediatric TB Services Into Child Healthcare Services in Africa

Integrating Pediatric TB Services Into Child Healthcare Services in Africa. A Cluster-randomized Stepped-wedge Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,715 (actual)
• Sponsor: Elizabeth Glaser Pediatric AIDS Foundation · Academic / Other
• Sex: All
• Age: 5 Years
• Healthy volunteers: Not accepted

Summary

Under-diagnosis of TB in children is a critical gap to address. The INPUT study is a multinational stepped-wedge cluster-randomized intervention study aiming to assess the effect of integrating TB services into child healthcare services on TB diagnosis capacities in children under 5 years of age.

Detailed description

Study clusters (district-level hospitals and their health centers) will start under standard-of-care and transition to the intervention at randomly assigned time points. In this study two strategies will be compared: i) The standard of care, offering pediatric TB services based on current routine approach; ii) The intervention, with pediatric TB services integrated into child healthcare services. The primary objective will be to assess the effect of the intervention compared to standard of care on the proportion of TB cases diagnosed among children \<5 years old (that is the number of children who are clinically or bacteriologically diagnosed with TB over the total number of children attending the child healthcare services). Secondary objectives are detailed in the protocol. Study sites will include six hospital in each participating country (Cameroon and Kenya) along with selected attached health centers. The study population will be children aged less than five years of age with a presumptive diagnosis of TB. Study enrollment will start in March 2019, last enrollments until July 2020 and follow up will be completed by August 2021.

Conditions

• Tuberculosis
• Children, Only
• Diagnosis
• Delivery of Health Care

Interventions

Type	Name	Description
OTHER	Integrated pediatric TB services	pediatric TB services will be integrated into key child healthcare services: maternal neonatal and child health (MNCH) services, under-5 clinic, pediatric outpatient services, nutrition services, pediatric antiretroviral therapy (ART) services and primary health care: * Integration of the screening into all the child health care services with introduction of a specific case detection tool and updated presumptive TB register. * Improvement of diagnosis capacities and their integration in all levels of care and all services.

Timeline

• Start date: 2019-05-10
• Primary completion: 2021-06-30
• Completion: 2021-12-31
• First posted: 2019-03-05
• Last updated: 2022-03-23

Locations

12 sites across 2 countries: Cameroon, Kenya