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NCT Number: NCT06593080

The DECIDE-TB Trial; Validation of Treatment Decision Algorithms for Childhood Tuberculosis

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.

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Key information

Conditions

Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Child Health Gram-Positive Bacterial Infections HIV Infections Malnutrition Mycobacterium Infections Nutrition Disorders Nutritional and Metabolic Diseases Severe Acute Malnutrition

Age range

Up to 14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chawama Urban Health Centre, Chingola, Copperbelt, Zambia

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About this study

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:

  • 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).
  • 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.
  • 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.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

The comprehensive TDA based approach

Other

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 decisions based on the PAANTHER and TB-Speed SAM TDAs, respectively.

Clinical and microbiological assessment data will be incorporated into a CDSS to help with the clinical decision to initiate TB treatment. The CDSS will incorporate specific features and test results for high-risk group children based on the PAANTHER TDA and the TB-Speed SAM TDA and will incorporate the results of the severity assessment to guide the choice of TB treatment duration once children are diagnosed with TB.

Primary outcomes

  1. Effectiveness endpoints: Children initiated on TB treatment

    Time frame: Throughout the study, an average of 24 months

    Proportion of children started on treatment for TB among sick children attending care at participant health facilities for any health complaints

Secondary outcomes

  1. Effectiveness endpoints: Children treated for TB among those with presumptive TB

    Time frame: Throughout the study, an average of 24 months

    Proportion of children treated for TB among those with presumptive TB, including children with microbiologically confirmed TB.

  2. Effectiveness endpoints: TB treatment proportion in high-risk pediatric groups

    Time frame: Throughout the study, an average of 24 months

    Proportion of children from high-risk groups treated for TB (age <2 years, CLHIV, children with SAM) i) among all children from high-risk groups attending care, ii) among children from high-risk groups with presumptive TB.

  3. Effectiveness endpoints: Microbiologically confirmed TB cases

    Time frame: Throughout the study, an average of 24 months

    Proportion of children with TB that are microbiologically confirmed (i.e. smear or Xpert or LAM positive), ratio of <5 to 5-14 years among children with TB, ratio of pulmonary TB to extrapulmonary TB (EPTB).

  4. 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

    Time from presumptive TB identification to final TB treatment decision and access to TB diagnostic assessment defined as the proportion of children with presumptive TB having completed assessment with the TDAs and CDSS, including in high-risk groups.

  5. 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

    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 collected.

  6. 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

    Proportion of missed TB cases (false negative) and over-diagnosed TB cases (unlikely TB with a positive score, i.e. false positive).

  7. 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

    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.

  8. 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

    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.

  9. 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

    Proportion of children with presumptive TB and with non-severe TB disease initiated on shorter TB treatment.

  10. 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

    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.

  11. Effectiveness endpoints: Deaths averted

    Time frame: From the start of intervention to the end of the intervention, an average of 21 months

    Number of deaths averted assessed through modelling.

  12. Effectiveness endpoints: Child TB among all diagnosed TB cases, including adults

    Time frame: Throughout the study, an average of 24 months

    Number of adults with TB, including microbiologically confirmed TB, and proportion of all TB diagnosed that is child TB.

  13. Acceptability endpoints: Preferences

    Time frame: Throughout the study, an average of 24 months

    Proportion of healthcare providers' preferences in delivering childhood TB screening, diagnosis, and treatment decision-making, comparing the comprehensive TDA-based approach vs. the Standard of Care (SOC) approach, as assessed by TB diagnosis questionnaire, a self-administered questionnaire, completed every 3months in both arms, by all healthcare providers involved in child care.

  14. Acceptability endpoints: Local social value (users)

    Time frame: Throughout the study, an average of 24 months

    Proportion of healthcare providers' preferences/ alignment with values and perceived potential to impact on lived experience) of the comprehensive TDA-based approach, including associated digital tools, to users (healthcare providers) as part of their work duties in childhood TB care, assessed by questionnaires.

  15. Acceptability endpoints: Local social value (beneficiaries)

    Time frame: Throughout the study, an average of 24 months

    Proportion of beneficiaries' (children and their caregivers receiving a diagnosis of TB) local social value of the comprehensive TDA-based approach, including associated digital tools, as assessed by interviews and group discussions

  16. Acceptability endpoints:Health systems and socioeconomic factors

    Time frame: Throughout the study, an average of 24 months

    Number of health systems and socioeconomic factors influencing preferences and local social value of the comprehensive TDA-based approach, including associated digital tools, for users and beneficiaries, as assessed by questionnaires, interviews and group discussions

  17. Implementation endpoints: Feasibility

    Time frame: From the start of intervention to the end of the intervention, an average of 21 months

    Feasibility of implementing and delivering the comprehensive TDA-based approach, including associated digital tools: health systems, logistical, managerial, challenges faced during implementation, and solutions found as assessed by the TB diagnosis questionnaire.

  18. Implementation endpoints: Fidelity

    Time frame: From the start of intervention to the end of the intervention, an average of 21 months

    Fidelity to intervention delivery and to implementation strategies: adherence to intervention procedures and implementation guide/manuals, adaptations, quality of implementation and intervention delivery.Assessed based on project process data (for example number and regularity of support supervision visits achieved compared to what was planned); fidelity of intervention delivery will based on the TB diagnosis questionnaire (number of health care worker reporting using TDAs to diagnose TB in children).

  19. Implementation endpoints: Contextual factors

    Time frame: From the start of intervention to the end of the intervention, an average of 21 months

    Number of contextual factors influencing intervention delivery and implementation (at Individual, facility, health systems and community-level): barriers and facilitators as assessed by questionnaires, interviews and group discussions.

  20. Implementation endpoints: Sustained intervention delivery

    Time frame: 6 months post intervention

    Number of facilities reporting using TDAs for childhood TB diagnosis 6 months post intervention period as assessed by sustainability questionaries.

  21. Health economics endpoints: Cost analysis 1

    Time frame: Throughout the study, an average of 24 months

    Total TB care costs from the health system perspective.

  22. Health economics endpoints: Cost analysis 2

    Time frame: Throughout the study, an average of 24 months

    Unit cost per TB care activity (e.g. clinical assessment, CXR).

  23. Health economics endpoints: Cost analysis 3

    Time frame: From the start of intervention to the end of the intervention, an average of 21 months

    Total TB care costs of overdiagnosis (false positive)

  24. Health economics endpoints: Cost analysis 4

    Time frame: Throughout the study, an average of 24 months

    Total costs incurred by parents/caregivers for receiving child TB care

  25. Health economics endpoints: Cost effectiveness; Modelled health impact measure 1

    Time frame: Throughout the study, an average of 24 months

    Number of children treated for TB.

  26. Health economics endpoints: Cost effectiveness; Modelled health impact measure 2

    Time frame: Throughout the study, an average of 24 months

    Number of adults treated for TB.

  27. Health economics endpoints: Cost effectiveness; Modelled health impact measure 3

    Time frame: Throughout the study, an average of 24 months

    Number of deaths.

  28. Health economics endpoints: Cost effectiveness; Modelled health impact measure 4

    Time frame: Throughout the study, an average of 24 months

    Measure of healthy life lost, either through premature death or living with disability due to illness; Disability-Adjusted Life Years (DALYs)

  29. Health economics endpoints: Cost effectiveness- Incremental cost 1

    Time frame: Throughout the study, an average of 24 months

    Incremental number of children treated for TB.

  30. Health economics endpoints: Cost effectiveness- Incremental cost 2

    Time frame: Throughout the study, an average of 24 months

    Incremental cost per Death averted.

  31. Health economics endpoints: Cost effectiveness- Incremental cost 3

    Time frame: Throughout the study, an average of 24 months

    Incremental cost per DALY averted.

  32. Health economics endpoints: Budget impact 1

    Time frame: Throughout the study; an average duration of 24 months and extending up to 5 years after its conclusion.

    Cost of scaling up the comprehensive TDA-based approach nationally.

  33. Health economics endpoints: Budget impact 2

    Time frame: Throughout the study; an average duration of 24 months and extending up to 5 years after its conclusion.

    Cumulative number of children and adults treated for TB, lives saved, and DALYs averted during a 5-year scale-up.

  34. Health Policy endpoints: Roles, practices and processes

    Time frame: Throughout the study, an average of 24 months

    Roles, practices and processes among implementers and decision-makers of the comprehensive TDA-based approach, including associated digital tools, at district-level.

  35. Health policy endpoints: Translation mechanism

    Time frame: At the end of the project, after 24 months since the start of the project

    Mechanism of translation of the research results and evidence on the comprehensive TDA-based approach, including associated digital tools, into public policies and practices: experience and perceptions of key stakeholders at regional, national and district-level.

Study contacts

Contact information is provided by the study sponsor or research team.

Clementine Roucher

CONTACT

[email protected]

+330557574723 ext. 330

Natasha Namuziya

CONTACT

[email protected]

+26021250753 ext. 260

Sponsors and collaborators

Lead sponsor

Chishala Chabala

Other

Collaborators

  • ADERA
  • Eduardo Mondlane University
  • European and Developing Countries Clinical Trials Partnership (EDCTP)
  • Imperial College London
  • Institut de Recherche pour le Développement (IRD)
  • Instituto Nacional de Saúde, Mozambique
  • Ludwig-Maximilians - University of Munich
  • Ministry of Health, Mozambique
  • Ministry of Health, Zambia
  • University of Bordeaux
  • University of Sheffield
  • University of Stellenbosch

Registry information

Official study 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

Acronym: DTB

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Sep 19, 2024
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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