An interventional study of Integrated pediatric TB services in Tuberculosis, Children, Only and Diagnosis, sponsored by Elizabeth Glaser Pediatric AIDS Foundation. Completed at 12 sites in 2 countries. Open to participants aged Up to 5 Years. Per ClinicalTrials.gov, last updated 2022-03-23.
Sponsored by Elizabeth Glaser Pediatric AIDS Foundation · Not applicable, Interventional, and Diagnostic
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.
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.
1,417 studies on the registry are indexed under Tuberculosis; 208 are open to participants now.
This study's enrollment of 1,715 is above the median of 150 across 952 interventional studies indexed under Tuberculosis.
Browse Tuberculosis studies →Elizabeth Glaser Pediatric AIDS Foundation is the lead sponsor of 29 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Pediatric TB services based on current routine approach (national standard of care)
Integrated pediatric TB services
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.
Proportion of children diagnosed with active TB
Number of pediatric TB cases diagnosed (bacteriologically confirmed and/or clinically diagnosed) over the number of children attending the child healthcare services during the study period.
Time frame: up to two months
Proportion of children screened for TB
Number of children screened for TB over the number of children attending the child healthcare services during the study period
Time frame: one month
Proportion of screened children who have a sample collected
Proportion of children who have a sample collected for microbiologic diagnosis among those screened positive for TB (i.e. presumptive TB cases)
Time frame: up to three months
Proportion of children diagnosed with TB among presumptive TB cases
Proportion of children diagnosed with TB (bacteriologically or clinically) among presumptive TB cases, overall and disaggregated by HIV status and nutrition status
Time frame: up to two months
Time from screening to clinical or bacteriologic diagnosis
For children finally diagnosed with TB, time elapsed from presumptive to confirmed TB case
Time frame: up to three months
Time from diagnosis to treatment initiation
For children diagnosed with TB, time elapsed to initiate treatment after active TB is confirmed
Time frame: up to three months
Proportion of cases with a bacteriologically confirmed diagnosis
Proportion of cases with a bacteriologically confirmed diagnosis among children diagnosed with TB
Time frame: up to three months
Proportion of children who initiate TB treatment among those diagnosed
Proportion of children who initiate TB treatment among those diagnosed will give treatment coverage
Time frame: up to two months
Treatment outcome
Treatment outcomes for patients initiated on treatment according to WHO categories: treatment success, treatment failed, died, lost to follow-up, and not evaluated.
Time frame: 8 to 14 months (2 months after treatment completion)
Adherence to the TB treatment
Adherence documented by seven-day recall and counting of pills
Time frame: 6 to 12 months (at treatment completion)
Plan to share: Undecided
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Elizabeth Glaser Pediatric AIDS Foundation