Integrating Pediatric TB Services Into Child Healthcare Services in Africa

Tuberculosis Clinical Trial

— INPUT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03862261
• Other study ID #: EG0214
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

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

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)