Tuberculosis Paediatrics
Conditions
Interventions
Standard of care
Sponsors
University of Zambia School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All sick children aged below 15 years entering the selected health facilities (DH and PHC) at either outpatient (OPD) or inpatient (IPD) departments, including children from high-risk groups, as well as children identified as contact of TB cases through community- or facility-based household contact tracing. Children with presumptive TB including children from high-risk groups with informed consent provided for data sharing for research within the NTP DHIS2 data collection tool.
Exclusion criteria
Exclusion criteria: There will be no exclusion criteria for the programmatic pilot: all children will be offered the intervention.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of children started on treatment for TB among sick children attending care at participant health facilities for any health complaints | — |
Secondary
| Measure | Time frame |
|---|---|
| Concordance of the TDA result and the final TB treatment decision using the proportion of children wrongly initiated or not initiated on TB treatment defined as: i) children not started on TB treatment despite positive score; ii) children initiated on TB treatment despite negative score. Reasons for both decisions will be collected4. ;Proportion of missed TB cases (false negative) and over-diagnosed TB cases (unlikely TB with a positive score, i.e. false positive). ;Concordance of the severity evaluation and decision for short TB treatment regimen using the proportion of i) children with 4-month TB treatment regimen used despite severe disease as assessed by the clinical/CXR evaluation; ii) children with 6-month TB treatment regimen despite non-severe disease as assessed by the clinical/CXR evaluation. ;Proportion of false positive and false negative TB severity assessments at low level of health care: i) children with non-severe disease according to clinical criteria despite severe disease as evaluated by expert CXR read; ii) children with clinically assessed severe disease despite non-severe disease as evaluated by expert CXR read. ;Proportion of children with presumptive TB and with non-severe TB disease initiated on shorter TB treatment. ;TB treatment outcomes as defined per WHO (treatment success, cured, treatment completion, loss to follow-up, death, treatment failure) overall and stratified by severity and regimen duration. ;Deaths averted assessed through modelling. ;Number of adult with TB, including microbiologically confirmed TB, and proportion of all TB diagnosed that is child TB. ;Preferences of users (healthcare providers) in delivering childhood TB screening, diagnosis, and treatment decision-making comparing the comprehensive TDA-based approach vs. the SOC approach. ;Local social value (i.e., alignment with values / preferences and perceived potential to impact on lived experience) of the comprehensive TDA-based approach, including asso | — |
Countries
Zambia
Contacts
Public ContactNatasha ;Clementine Namuziya;Roucher
Paediatrician and Honorary Lecturer;Clinical Project Manager
Outcome results
None listed