Integrating Pediatric TB Services Into Child Healthcare Services in Africa

Not Applicable

Completed

• Conditions: Tuberculosis; Diagnosis; Delivery of Health Care; Children, Only
• Interventions: Other: Integrated pediatric TB services

• Registration Number: NCT03862261
• Lead Sponsor: Elizabeth Glaser Pediatric AIDS Foundation

Brief 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.

Study Timeline

• Study First Submitted: 2019-02-12
• Study First Submitted QC: 2019-03-01
• Study First Posted: 2019-03-05
• Study Start: 2019-05-10
• Primary Completion: 2021-06-30
• Study Completion: 2021-12-31
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-22
• Last Update Posted: 2022-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1715

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

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Intervention	Integrated pediatric TB services	Integrated pediatric TB services

Primary Outcome Measures

Name	Time	Method
Proportion of children diagnosed with active TB	up to two months	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.

Secondary Outcome Measures

Name	Time	Method
Proportion of children screened for TB	one month	Number of children screened for TB over the number of children attending the child healthcare services during the study period
Proportion of screened children who have a sample collected	up to three months	Proportion of children who have a sample collected for microbiologic diagnosis among those screened positive for TB (i.e. presumptive TB cases)
Time from screening to clinical or bacteriologic diagnosis	up to three months	For children finally diagnosed with TB, time elapsed from presumptive to confirmed TB case
Proportion of children diagnosed with TB among presumptive TB cases	up to two months	Proportion of children diagnosed with TB (bacteriologically or clinically) among presumptive TB cases, overall and disaggregated by HIV status and nutrition status
Time from diagnosis to treatment initiation	up to three months	For children diagnosed with TB, time elapsed to initiate treatment after active TB is confirmed
Proportion of cases with a bacteriologically confirmed diagnosis	up to three months	Proportion of cases with a bacteriologically confirmed diagnosis among children diagnosed with TB
Proportion of children who initiate TB treatment among those diagnosed	up to two months	Proportion of children who initiate TB treatment among those diagnosed will give treatment coverage
Treatment outcome	8 to 14 months (2 months after treatment completion)	Treatment outcomes for patients initiated on treatment according to WHO categories: treatment success, treatment failed, died, lost to follow-up, and not evaluated.
Adherence to the TB treatment	6 to 12 months (at treatment completion)	Adherence documented by seven-day recall and counting of pills

Trial Locations

Locations (12)

Hopital de District Akonolinga; 🇨🇲 Akonolinga, Centre, Cameroon

Hopital de District Soa; 🇨🇲 Soa, Centre, Cameroon

Hopital de District Foumban; 🇨🇲 Mbanga, Littoral, Cameroon

Lopiding Sub County Hospital; 🇰🇪 Lopiding, Turkana, Kenya

Kakuma Mission Hospital; 🇰🇪 Kakuma, Turkana, Kenya

Hopital de District Loum; 🇨🇲 Loum, Littoral, Cameroon

Kendu Sub County Hospital; 🇰🇪 Kendu Bay, Homa Bay, Kenya

Ndhiwa Sub county Hospital; 🇰🇪 Ndhiwa, Homa Bay, Kenya

Hopital de District Dschang; 🇨🇲 Dschang, West, Cameroon

Hopital de District Mbouda; 🇨🇲 Mbouda, West, Cameroon

Lokitaung sub-county hospital; 🇰🇪 Lokitaung, Turkana, Kenya

Homa Bay County Referral Hospital; 🇰🇪 Homa Bay, Kenya