Integrating Pediatric TB Services Into Child Healthcare Services in Africa (INPUT)

Elizabeth Glaser Pediatric AIDS Foundation

Status: Completed

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

Treatments: Other: Integrated pediatric TB services

Study type: Interventional

Funder types: Other

Identifiers

NCT03862261

EG0214

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,715 patients

Sex: All

Ages: Under 5 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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1,715 participants in 2 patient groups

Standard-of-Care

No Intervention group

Description:

Pediatric TB services based on current routine approach (national standard of care)

Intervention

Experimental group

Description:

Integrated pediatric TB services

Treatment:

Other: Integrated pediatric TB services