Integrating Pediatric TB Services Into Child Healthcare Services in Africa

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Other: Integrated pediatric TB services


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Cluster-randomized stepped-wedge model, where intervention will be randomly allocated to the different study sites at different time points.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard-of-Care<br>Pediatric TB services based on current routine approach (national standard of care) | |
| Experimental: Intervention<br>Integrated pediatric TB services | Other: Integrated pediatric TB services<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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) | 
| Adherence to the TB treatment | Adherence documented by seven-day recall and counting of pills | 6 to 12 months (at treatment completion) |