The DECIDE-TB Trial; Validation of Treatment Decision Algorithms for Childhood Tuberculosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: The comprehensive TDA based approach.
- Who it may be relevant to
- Registry conditions: Tuberculosis, Child Health, HIV, Severe Acute Malnutrition. Basic parameters: up to 14 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Zambia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Validation of Treatment Decision Algorithms for Childhood Tuberculosis at District Health Care Levels in Mozambique and Zambia - the Decide-TB Cluster-randomized Pragmatic Trial
Overview
The Decide-TB project aims to generate evidence for the implementation of a comprehensive Treatment Decision Algorithms (TDA) based approach for TB in children living in high TB burden and resource-limited countries, at District Hospital (DH) and Primary Health Centre (PHC) levels, and to facilitate the integration of this evidence within practices and policies. This programmatic pilot led by the National TB Programs (NTP) will test a TDA-based approach integrating TB screening, diagnosis, treatment decision-making, and disease severity assessment for shorter treatment eligibility, for use at a lower level of healthcare. This TDA-based approach will be evaluated in a hybrid effectiveness implementation study based on a pragmatic stepped wedge cluster-randomized trial. The Decide TB project will be implemented at the district level, targeting five districts in each country. Each cluster in a district will be made up of one district hospital and six primary health centers. The study will develop a Clinical Decision Support System (CDSS) to operationalize the use of TDAs, and strengthen District Health Information Systems (DHIS2) to collect individual data, which will contribute to monitoring and evaluation, clinical mentoring, and supervision by the country's NTPs.
Detailed description
The Decide-TB trial is a pragmatic cluster-randomized study utilizing a stepped wedge design to provide scientific evidence on a comprehensive TDA-based approach for TB screening, diagnosis, and treatment in children under 15 years at low healthcare levels in Zambia and Mozambique.
The trial's primary objective is to evaluate the effectiveness, feasibility, implementation, acceptability, costs, cost-effectiveness, and adoption of a TDA-based approach for childhood TB screening, diagnosis, and treatment decision-making under programmatic conditions at District Hospitals (DH) and Primary Health Centres (PHC) levels in these countries.
There are five specific objectives corresponding to the trial's research components:
1. To assess the effectiveness of the comprehensive TDA-based approach in increasing TB case detection in children as compared to the Standard of Care (SOC), and in providing good quality TB diagnosis and treatment decision (diagnostic accuracy and reliability of treatment decision for TB and shorter treatment). 2. To describe the implementation and the feasibility of using the comprehensive TDA-based approach, including associated digital tools, and to identify contextual determinants influencing implementation and contribute to improved implementation/adaptations throughout intervention delivery. 3. To assess preferences, acceptability, and perceived feasibility of using the comprehensive TDA-based approach, including associated digital tools, among end-users, beneficiaries, and key stakeholders. 4. To assess the costs from the health system and the beneficiary (parents/caregivers of children) perspective, the cost-effectiveness of using the comprehensive TDA-based approach, including associated digital tools, and the budget impact of scaling up the intervention. 5. To assess the factors and stakeholders that support or constrain the adoption of the comprehensive TDA-based approach as health policy at district level.
The intervention will be implemented as a programmatic pilot, following the National TB Programs' decision in Mozambique and Zambia to adopt a TDA-based approach in line with World Health Organisation's (WHO) conditional recommendations. Additionally, both the standard of care and the intervention will be implemented in a non-randomized district to document diagnostic accuracy throughout the trial. The Decide-TB trial is a hybrid effectiveness-implementation trial (type 2), assessing both the clinical intervention's effectiveness and the feasibility and utility of the implementation strategy.
Diagnostic accuracy of both the standard of care and the intervention will be evaluated in an additional district, which will transition to the intervention phase alongside the last district selected per the stepped wedge design. Aggregated data will be retrospectively collected over 12 months from all participating districts and health facilities.
The Decide-TB trial endpoints include effectiveness, acceptability, implementation, health economics, and health policy. Effectiveness endpoints include the proportion of children who started TB treatment, the time it takes to make a treatment decision, and the consistency of TDA results with final treatment decisions, among other factors. Acceptability endpoints consider user preferences and local social value, whereas implementation endpoints evaluate the practicality, fidelity, contextual aspects, and sustainability of the TDA-based method. Health economics endpoints include cost assessments, cost-effectiveness, and budget impact of scaling up the TDA-based approach vs the standard of care, while health policy endpoints look at key stakeholders' roles, practices, and policy translation processes.
Interventions
- Other The comprehensive TDA based approach
The intervention consists of implementing a comprehensive TDA-based approach for TB diagnosis and treatment decision-making, including shorter treatment for non-severe TB in children identified as TB presumptive cases through a CDSS. It will also include the management of high-risk groups. In practice, all sick children will be assessed using the WHO-suggested TDAs A with CXR (DH) and B without CXR (PHC). CLHIV and those hospitalised with SAM at DH will have further assessment and treatment deci
Primary outcome measures
- Effectiveness endpoints: Children initiated on TB treatment [Time frame: Throughout the study, an average of 24 months]
Secondary outcome measures (12)
- Effectiveness endpoints: Children treated for TB among those with presumptive TB [Time frame: Throughout the study, an average of 24 months]
- Effectiveness endpoints: TB treatment proportion in high-risk pediatric groups [Time frame: Throughout the study, an average of 24 months]
- Effectiveness endpoints: Microbiologically confirmed TB cases [Time frame: Throughout the study, an average of 24 months]
- Effectiveness endpoints: Time to TDA assessment completion [Time frame: From the start of intervention to the end of the project, an average of 21 months]
- Effectiveness endpoints: Concordance of TDA results and TB treatment decisions [Time frame: From the start of intervention to the end of the intervention, an average of 21 months]
- Effectiveness endpoints: Missed and over-diagnosed TB cases [Time frame: From the start of intervention to the end of the intervention, an average of 21 months]
- Effectiveness endpoints: Concordance of TB severity evaluation and treatment regimen decision [Time frame: From the start of intervention to the end of the intervention, an average of 21 months]
- Effectiveness endpoints: False positive and negative TB severity assessments [Time frame: From the start of intervention to the end of the intervention, an average of 21 months]
- Effectiveness endpoints: Non-severe TB cases initiated on shorter treatment [Time frame: From the start of intervention to the end of the intervention, an average of 21 months]
- Effectiveness endpoints: TB treatment outcomes stratified by severity and regimen duration. [Time frame: From the start of intervention to the end of the intervention, an average of 21 months]
- Effectiveness endpoints: Deaths averted [Time frame: From the start of intervention to the end of the intervention, an average of 21 months]
- Effectiveness endpoints: Child TB among all diagnosed TB cases, including adults [Time frame: Throughout the study, an average of 24 months]
Eligibility criteria
Inclusion criteria
The effectiveness assessment will be conducted using aggregated or individual data from direct beneficiaries of the intervention:
- 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.
The WHO definition of presumptive TB will be used, as defined in the 2022 WHO Operational Handbook, namely: children are classified as having presumptive TB if they have unremitting symptoms lasting more than 2 weeks (any one of cough, fever, not eating well or anorexia, weight loss or failure to thrive, fatigue, reduced playfulness or decreased activity) .
The definitions of presumptive TB have been adapted locally for the programmatic pilot. All children with presumptive TB as defined locally will be considered in the intervention and in secondary effectiveness and sub-group analyses.
High-risk group will be defined using the definition in WHO-suggested TDAs A\&B as children younger than 2 years, CLHIV or children with SAM. CLHIV will be defined per national testing strategy including positive PCR test for children below the age of 18 months. Children will be considered to have SAM (and thereby be eligible for the TB-Speed SAM algorithm) using WHO criteria. These include being <5 years with a weight-for-height Z score (WHZ) < -3 SDs or mid-upper arm circumference (MUAC) < 115 mm (in children over 6 months) or clinical signs of bilateral pitting oedema, and being aged ≥5 years with a body mass index (BMI) for age Z-score < -3SD.
Exclusion criteria
There will be no exclusion criteria for the programmatic pilot: all children will be offered the intervention.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Zambia · 29 centers
- Chawama Urban Health Centre — Chingola
- Chiwempala Urban Health Centre — Chingola
- Kabundi East Urban Health Clinic — Chingola
- Kasompe Urban Health Centre — Chingola
- Muchinshi Rural Health Centre — Chingola
- Nchanga 1 Urban Health Centre — Chingola
- Nchanga North Referal Hospital — Chingola
- Allessandras Urban Health Centre — Luanshya
- … and 21 more centers
Publications
- Orne-Gliemann J, Roucher C, Khosa C, Hoddinott G, d'Elbee M, Huyen Ton Nu Nguyet M, Banze D, Bonnet M, Cossa K, Desselas E, Dodd PJ, Etoa C, Kachuka A, Lebrun N, Lungu P, Jose B, Manguele S, Monin C, Mubanga A, Mutemba C, Namuziya N, Olbrich L, Palmer M, van der Zalm MM, Seddon JA, Chabala C, Marcy O; Decide TB study group. Validation of treatment decision algorithms for childhood tuberculosis at PMID 42152442
Identifiers
NCT: NCT06593080 · DECIDE-TB