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Optimizing the implementation and scale-up of the WHO treatment-decision algorithms for children with pulmonary tuberculosis in sub-Saharan Africa.

Optimizing the implementation and scale-up of the WHO treatment-decision algorithms for children with pulmonary tuberculosis in sub-Saharan Africa

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
PACTR
Registry ID
PACTR202501677523721
Enrollment
60000
Registered
2025-01-20
Start date
2024-04-01
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tuberculosis

Interventions

Standard of Care for Pediatric TB Diagnosis
WHO Recommended Treatment Decision Algorithms

Sponsors

Global Health EDCTP3 Training Networks
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: • Children: A child will be eligible for inclusion if all the criteria listed below are satisfied. 1. Under ten years old on the day of assessment 2. Fulfills the criteria of presumptive TB according to definition 11.3.1 in the standard protocol 3. The parent or guardian allows the child to participate in the study or accepts to sign the Informed Consent Form (ICF) (Annex 3). 4. The child wishes to participate in the study or accepts to sign the Assent Form (where applicable). • Health workers: Healthcare providers involved in TB pediatric care for children in the selected health facilities. These may include medical officers, clinical officers and nurses • Stakeholders: Stakeholders and policy makers involved in decision making in regards to pediatric TB care at the selected facilities. These will be healthcare administrators and leaders in child health in Uganda. Examples include medical in-charges at each health facility, administrators at the District Health Office and Ministry of Health, and members of the Uganda Paediatrics Association. • Caregivers: parents or caregivers whose children have been assessed for TB using the recommended WHO treatment decision algorithm for pulmonary TB among children less than 10 years. Examples include parents and grandparents

Exclusion criteria

Exclusion criteria: A child or caregiver or stakeholder or healthcare worker who declines to participate in the study.

Design outcomes

Primary

MeasureTime frame
1.The proportion of children detected with pulmonary TB 2.The proportion of children detected with pulmonary TB and initiated on treatment

Secondary

MeasureTime frame
1) The proportion of children detected and initiated on TB treatment and with good treatment outcomes. 2) The incremental cost of introducing and maintaining the TDAs strategy from the providers' perspective. 3) The incremental patient costs associated with the use of TDAs. 4) The incremental cost-effectiveness ratio of the TDAs strategy from a societal perspective, measured as the cost per child diagnosed and initiated on treatment and disability-adjusted life year (DALY) averted. 5) The incidence of catastrophic health expenditures. 6) The reasons for variability in uptake and effectiveness of TDAs strategy. 7) The number and cumulative fraction of healthcare professionals and researchers who are trained stratified by type and level of training and gender. 8) The impact of TDA on the burden of pulmonary TB in children.

Countries

Congo, Uganda, United Republic of Tanzania

Contacts

Public ContactPatrick De Marie Katoto

Professor

katotopatrick@gmail.com+243854893440

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026