Integrating Pediatric TB Services Into Child Healthcare Services in Africa. A Cluster-randomized Stepped-wedge Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 1,715
- Locations
- 12
- Primary Endpoint
- Proportion of children diagnosed with active TB
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- — to 5 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Proportion of children diagnosed with active TB
Time Frame: 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 Outcomes
- Proportion of children screened for TB(one month)
- Proportion of screened children who have a sample collected(up to three months)
- Time from screening to clinical or bacteriologic diagnosis(up to three months)
- Proportion of children diagnosed with TB among presumptive TB cases(up to two months)
- Time from diagnosis to treatment initiation(up to three months)
- Proportion of cases with a bacteriologically confirmed diagnosis(up to three months)
- Proportion of children who initiate TB treatment among those diagnosed(up to two months)
- Treatment outcome(8 to 14 months (2 months after treatment completion))
- Adherence to the TB treatment(6 to 12 months (at treatment completion))