The DECIDE-TB Trial; Validation of Treatment Decision Algorithms for Childhood Tuberculosis
NCT ID: NCT06593080
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30240 participants
INTERVENTIONAL
2024-06-01
2027-03-31
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
DIAGNOSTIC
NONE
Study Groups
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Standard of Care
The District Hospitals and Primary Health Centres in study districts will implement TB diagnosis for children as per the current Standard of Care (control) in both countries . In Mozambique, the SOC is based on local algorithms which include: TB symptoms screening (TB contact history), HIV testing, Xpert testing on induced sputum (and stool), and a tuberculin skin test. Urine Lipoarabinomannan (LAM) is indicated for Children Living with HIV (CLHIV). No CXR is performed.
In Zambia, the SOC is based on the Union desk guide algorithm which includes: TB symptom screening (TB contact history), HIV testing and Xpert testing on respiratory or stool samples. Urine LAM is indicated for CLHIV,Severe Acute Malnutrition, sepsis, immune-suppression; chronic kidney diseases and cancer. CXRs are performed depending on the facilities. Other tests and imaging are advised in presumed extrapulmonary TB cases. A confirmed TB diagnosis is made based on a positive Xpert or LAM test.
No interventions assigned to this group
The comprehensive TDA based approach
Children will benefit from the country SOC as described in the control arm, plus the study intervention
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 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.
Interventions
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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 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.
Eligibility Criteria
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Inclusion Criteria
* For access to TB diagnostic services and TDAs, children aged below 16 years identified with presumptive TB, i.e. those with ≥1 systematic screening criteria, among the following:
* Cough with a duration of \>2 weeks,
* Fever with a duration of \>2 weeks,
* Documented weight loss,
* History of TB contact with any duration of cough, OR identified by the site clinician irrespective of the above criteria, especially presumed extra-pulmonary TB cases.
Exclusion Criteria
* Adult patients
* Patients not in the selected district or facilities
15 Years
ALL
Yes
Sponsors
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University of Bordeaux
OTHER
Instituto Nacional de Saúde, Mozambique
OTHER_GOV
ADERA
UNKNOWN
University of Stellenbosch
OTHER
Imperial College London
OTHER
Institut de Recherche pour le Développement (IRD)
UNKNOWN
University of Sheffield
OTHER
Ludwig-Maximilians - University of Munich
OTHER
Ministry of Health, Zambia
OTHER_GOV
Ministry of Health, Mozambique
OTHER_GOV
Eduardo Mondlane University
OTHER
European and Developing Countries Clinical Trials Partnership (EDCTP)
OTHER_GOV
Chishala Chabala
OTHER
Responsible Party
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Chishala Chabala
Principal Investigator
Principal Investigators
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Olivier Marcy
Role: PRINCIPAL_INVESTIGATOR
University of Bordeaux
Chishala Chabala
Role: PRINCIPAL_INVESTIGATOR
University of Zambia
Joanna Orne-Gliemann
Role: PRINCIPAL_INVESTIGATOR
University of Bordeaux
James Seddon
Role: PRINCIPAL_INVESTIGATOR
Imperial College London
Locations
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Chawama Urban Health Centre
Chingola, Copperbelt, Zambia
Chiwempala Urban Health Centre
Chingola, Copperbelt, Zambia
Kabundi East Urban Health Clinic
Chingola, Copperbelt, Zambia
Kasompe Urban Health Centre
Chingola, Copperbelt, Zambia
Muchinshi Rural Health Centre
Chingola, Copperbelt, Zambia
Nchanga 1 Urban Health Centre
Chingola, Copperbelt, Zambia
Nchanga North Referal Hospital
Chingola, Copperbelt, Zambia
Allessandras Urban Health Centre
Luanshya, Copperbelt, Zambia
Chaisa Urban Health Centre
Luanshya, Copperbelt, Zambia
Fisenge Urban Health Centre
Luanshya, Copperbelt, Zambia
Kawama Urban Health Centre
Luanshya, Copperbelt, Zambia
Malaika Urban Health Centre
Luanshya, Copperbelt, Zambia
Mikomfwa Urban Health Centre
Luanshya, Copperbelt, Zambia
Roan Antelope General Hospital
Luanshya, Copperbelt, Zambia
Thomson District Hospital
Luanshya, Copperbelt, Zambia
Chipepo Rural Health Centre
Chirundu, Southern Province, Zambia
Hachipilika Rural Health Centre
Chirundu, Southern Province, Zambia
Jamba Rural Health Centre
Chirundu, Southern Province, Zambia
Kapululira Rural Health Centre
Chirundu, Southern Province, Zambia
Lusitu Rural Health Centre
Chirundu, Southern Province, Zambia
Mtendere Mission Referal hospital
Chirundu, Southern Province, Zambia
Sikoongo Rural Health Centre
Chirundu, Southern Province, Zambia
Habulile Rural Health Centre
Kalomo, Southern Province, Zambia
Kalomo District Hospital
Kalomo, Southern Province, Zambia
Kalomo Urban Health Centre
Kalomo, Southern Province, Zambia
Mawaya Urban Health Centre
Kalomo, Southern Province, Zambia
Namwianga Urban Health Centre
Kalomo, Southern Province, Zambia
Nkandanzovu Rural Health Centre
Kalomo, Southern Province, Zambia
Siachitema Rural Health Centre
Kalomo, Southern Province, Zambia
Countries
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Central Contacts
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Facility Contacts
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Alan Kachuka
Role: primary
Natasha Namuziya
Role: backup
Chishala Chabala
Role: backup
Other Identifiers
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DECIDE-TB
Identifier Type: -
Identifier Source: org_study_id
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