Integrating Pediatric TB Services Into Child Healthcare Services in Africa

Elizabeth Glaser Pediatric AIDS Foundation1,715 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

1,715

Conditions

Tuberculosis Children, Only Diagnosis Delivery of Health Care

Interventions

Integrated pediatric TB servicesOTHER

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.

Eligibility

Sex: ALLMax age: 5 Years

Medical Language ↔ Plain English

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

Locations (12)

Hopital de District Akonolinga

Akonolinga, Centre Region, Cameroon

Hopital de District Soa

Okoa, Centre Region, Cameroon

Hopital de District Loum

Loum, Littoral Region, Cameroon

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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