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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03862261
Other study ID # EG0214
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 10, 2019
Est. completion date December 31, 2021

Study information

Verified date March 2022
Source Elizabeth Glaser Pediatric AIDS Foundation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1715
Est. completion date December 31, 2021
Est. primary completion date June 30, 2021
Accepts healthy volunteers No
Gender All
Age group N/A to 5 Years
Eligibility Inclusion Criteria: - Children < 5 years old. - TB diagnosis investigations initiated. - Other infectious diseases are not suspected or have already been ruled out. - Commitment to take treatment in the clinic of enrolment or another INPUT study site. - Parental/caregiver consent for the child to participate in the study. Exclusion Criteria: - Children who are TB contacts but without symptoms or signs of active TB

Study Design


Intervention

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.

Locations

Country Name City State
Cameroon Hopital de District Akonolinga Akonolinga Centre
Cameroon Hopital de District Dschang Dschang West
Cameroon Hopital de District Loum Loum Littoral
Cameroon Hopital de District Foumban Mbanga Littoral
Cameroon Hopital de District Mbouda Mbouda West
Cameroon Hopital de District Soa Soa Centre
Kenya Homa Bay County Referral Hospital Homa Bay
Kenya Kakuma Mission Hospital Kakuma Turkana
Kenya Kendu Sub County Hospital Kendu Bay Homa Bay
Kenya Lokitaung sub-county hospital Lokitaung Turkana
Kenya Lopiding Sub County Hospital Lopiding Turkana
Kenya Ndhiwa Sub county Hospital Ndhiwa Homa Bay

Sponsors (5)

Lead Sponsor Collaborator
Elizabeth Glaser Pediatric AIDS Foundation Cameroon Ministry of Public Health, Kenya Ministry of Health, UNITAID, University of Sheffield

Countries where clinical trial is conducted

Cameroon,  Kenya, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. up to two months
Secondary 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 one month
Secondary 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) up to three months
Secondary 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 up to two months
Secondary Time from screening to clinical or bacteriologic diagnosis For children finally diagnosed with TB, time elapsed from presumptive to confirmed TB case up to three months
Secondary Time from diagnosis to treatment initiation For children diagnosed with TB, time elapsed to initiate treatment after active TB is confirmed up to three months
Secondary Proportion of cases with a bacteriologically confirmed diagnosis Proportion of cases with a bacteriologically confirmed diagnosis among children diagnosed with TB up to three months
Secondary Proportion of children who initiate TB treatment among those diagnosed Proportion of children who initiate TB treatment among those diagnosed will give treatment coverage up to two months
Secondary 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. 8 to 14 months (2 months after treatment completion)
Secondary Adherence to the TB treatment Adherence documented by seven-day recall and counting of pills 6 to 12 months (at treatment completion)
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