--- title: The DECIDE-TB Trial; Validation of Treatment Decision Algorithms for Childhood Tuberculosis nct_id: NCT06593080 overall_status: RECRUITING phase: NA sponsor: Chishala Chabala study_type: INTERVENTIONAL primary_condition: Tuberculosis countries: Zambia canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06593080.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06593080" ct_last_update_post_date: 2026-03-24 last_seen_at: "2026-05-12T06:12:40.885Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # The DECIDE-TB Trial; Validation of Treatment Decision Algorithms for Childhood Tuberculosis **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 **NCT ID:** [NCT06593080](https://clinicaltrials.gov/study/NCT06593080) ## Key Facts - **Status:** RECRUITING - **Phase:** NA - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 30240 - **Lead Sponsor:** Chishala Chabala - **Collaborators:** University of Bordeaux, Instituto Nacional de Saúde, Mozambique, ADERA, University of Stellenbosch, Imperial College London, Institut de Recherche pour le Développement (IRD), University of Sheffield, Ludwig-Maximilians - University of Munich, Ministry of Health, Zambia, Ministry of Health, Mozambique, Eduardo Mondlane University, European and Developing Countries Clinical Trials Partnership (EDCTP) - **Conditions:** Tuberculosis, Child Health, HIV, Severe Acute Malnutrition - **Start Date:** 2024-06-01 - **Completion Date:** 2027-08-31 - **CT.gov Last Update:** 2026-03-24 ## Brief Summary 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. ## Eligibility - **Maximum age:** 14 Years - **Sex:** ALL - **Healthy Volunteers:** Yes ``` 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. ``` ## Arms - **Standard of Care** (NO_INTERVENTION) — 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. - **The comprehensive TDA based approach** (EXPERIMENTAL) — Children will benefit from the country SOC as described in the control arm, plus the study intervention ## Interventions - **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 - **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 - **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)_ - **Acceptability endpoints: Preferences** _(time frame: Throughout the study, an average of 24 months)_ - **Acceptability endpoints: Local social value (users)** _(time frame: Throughout the study, an average of 24 months)_ - **Acceptability endpoints: Local social value (beneficiaries)** _(time frame: Throughout the study, an average of 24 months)_ - **Acceptability endpoints:Health systems and socioeconomic factors** _(time frame: Throughout the study, an average of 24 months)_ - **Implementation endpoints: Feasibility** _(time frame: From the start of intervention to the end of the intervention, an average of 21 months)_ - **Implementation endpoints: Fidelity** _(time frame: From the start of intervention to the end of the intervention, an average of 21 months)_ - **Implementation endpoints: Contextual factors** _(time frame: From the start of intervention to the end of the intervention, an average of 21 months)_ - **Implementation endpoints: Sustained intervention delivery** _(time frame: 6 months post intervention)_ - **Health economics endpoints: Cost analysis 1** _(time frame: Throughout the study, an average of 24 months)_ - **Health economics endpoints: Cost analysis 2** _(time frame: Throughout the study, an average of 24 months)_ - **Health economics endpoints: Cost analysis 3** _(time frame: From the start of intervention to the end of the intervention, an average of 21 months)_ - **Health economics endpoints: Cost analysis 4** _(time frame: Throughout the study, an average of 24 months)_ - **Health economics endpoints: Cost effectiveness; Modelled health impact measure 1** _(time frame: Throughout the study, an average of 24 months)_ - **Health economics endpoints: Cost effectiveness; Modelled health impact measure 2** _(time frame: Throughout the study, an average of 24 months)_ - **Health economics endpoints: Cost effectiveness; Modelled health impact measure 3** _(time frame: Throughout the study, an average of 24 months)_ - **Health economics endpoints: Cost effectiveness; Modelled health impact measure 4** _(time frame: Throughout the study, an average of 24 months)_ - **Health economics endpoints: Cost effectiveness- Incremental cost 1** _(time frame: Throughout the study, an average of 24 months)_ - **Health economics endpoints: Cost effectiveness- Incremental cost 2** _(time frame: Throughout the study, an average of 24 months)_ - **Health economics endpoints: Cost effectiveness- Incremental cost 3** _(time frame: Throughout the study, an average of 24 months)_ - **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.)_ - **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.)_ - **Health Policy endpoints: Roles, practices and processes** _(time frame: Throughout the study, an average of 24 months)_ - **Health policy endpoints: Translation mechanism** _(time frame: At the end of the project, after 24 months since the start of the project)_ ## Locations (29) - Chawama Urban Health Centre, Chingola, Copperbelt, Zambia — _RECRUITING_ - Chiwempala Urban Health Centre, Chingola, Copperbelt, Zambia — _RECRUITING_ - Kabundi East Urban Health Clinic, Chingola, Copperbelt, Zambia — _RECRUITING_ - Kasompe Urban Health Centre, Chingola, Copperbelt, Zambia — _RECRUITING_ - Muchinshi Rural Health Centre, Chingola, Copperbelt, Zambia — _RECRUITING_ - Nchanga 1 Urban Health Centre, Chingola, Copperbelt, Zambia — _RECRUITING_ - Nchanga North Referal Hospital, Chingola, Copperbelt, Zambia — _RECRUITING_ - Allessandras Urban Health Centre, Luanshya, Copperbelt, Zambia — _RECRUITING_ - Chaisa Urban Health Centre, Luanshya, Copperbelt, Zambia — _RECRUITING_ - Fisenge Urban Health Centre, Luanshya, Copperbelt, Zambia — _RECRUITING_ - Kawama Urban Health Centre, Luanshya, Copperbelt, Zambia — _RECRUITING_ - Malaika Urban Health Centre, Luanshya, Copperbelt, Zambia — _RECRUITING_ - Mikomfwa Urban Health Centre, Luanshya, Copperbelt, Zambia — _RECRUITING_ - Roan Antelope General Hospital, Luanshya, Copperbelt, Zambia — _RECRUITING_ - Thomson District Hospital, Luanshya, Copperbelt, Zambia — _RECRUITING_ - Chipepo Rural Health Centre, Chirundu, Southern Province, Zambia — _RECRUITING_ - Hachipilika Rural Health Centre, Chirundu, Southern Province, Zambia — _RECRUITING_ - Jamba Rural Health Centre, Chirundu, Southern Province, Zambia — _RECRUITING_ - Kapululira Rural Health Centre, Chirundu, Southern Province, Zambia — _RECRUITING_ - Lusitu Rural Health Centre, Chirundu, Southern Province, Zambia — _RECRUITING_ - Mtendere Mission Referal hospital, Chirundu, Southern Province, Zambia — _RECRUITING_ - Sikoongo Rural Health Centre, Chirundu, Southern Province, Zambia — _RECRUITING_ - Habulile Rural Health Centre, Kalomo, Southern Province, Zambia — _RECRUITING_ - Kalomo District Hospital, Kalomo, Southern Province, Zambia — _RECRUITING_ - Kalomo Urban Health Centre, Kalomo, Southern Province, Zambia — _RECRUITING_ - Mawaya Urban Health Centre, Kalomo, Southern Province, Zambia — _RECRUITING_ - Namwianga Urban Health Centre, Kalomo, Southern Province, Zambia — _RECRUITING_ - Nkandanzovu Rural Health Centre, Kalomo, Southern Province, Zambia — _RECRUITING_ - Siachitema Rural Health Centre, Kalomo, Southern Province, Zambia — _RECRUITING_ ## Recent Field Changes (last 30 days) - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `sponsor.collaborators` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.chawama urban health centre|chingola|copperbelt|zambia` — added _(2026-05-12)_ - `locations.chiwempala urban health centre|chingola|copperbelt|zambia` — added _(2026-05-12)_ - `locations.kabundi east urban health clinic|chingola|copperbelt|zambia` — added _(2026-05-12)_ - `locations.kasompe urban health centre|chingola|copperbelt|zambia` — added _(2026-05-12)_ - `locations.muchinshi rural health centre|chingola|copperbelt|zambia` — added _(2026-05-12)_ - `locations.nchanga 1 urban health centre|chingola|copperbelt|zambia` — added _(2026-05-12)_ - `locations.nchanga north referal hospital|chingola|copperbelt|zambia` — added _(2026-05-12)_ - `locations.allessandras urban health centre|luanshya|copperbelt|zambia` — added _(2026-05-12)_ - `locations.chaisa urban health centre|luanshya|copperbelt|zambia` — added _(2026-05-12)_ - `locations.fisenge urban health centre|luanshya|copperbelt|zambia` — added _(2026-05-12)_ - `locations.kawama urban health centre|luanshya|copperbelt|zambia` — added _(2026-05-12)_ - `locations.malaika urban health centre|luanshya|copperbelt|zambia` — added _(2026-05-12)_ - `locations.mikomfwa urban health centre|luanshya|copperbelt|zambia` — added _(2026-05-12)_ - `locations.roan antelope general hospital|luanshya|copperbelt|zambia` — added _(2026-05-12)_ - `locations.thomson district hospital|luanshya|copperbelt|zambia` — added _(2026-05-12)_ - `locations.chipepo rural health centre|chirundu|southern province|zambia` — added _(2026-05-12)_ - `locations.hachipilika rural health centre|chirundu|southern province|zambia` — added _(2026-05-12)_ - `locations.jamba rural health centre|chirundu|southern province|zambia` — added _(2026-05-12)_ - `locations.kapululira rural health centre|chirundu|southern province|zambia` — added _(2026-05-12)_ - `locations.lusitu rural health centre|chirundu|southern province|zambia` — added _(2026-05-12)_ - `locations.mtendere mission referal hospital|chirundu|southern province|zambia` — added _(2026-05-12)_ - `locations.sikoongo rural health centre|chirundu|southern province|zambia` — added _(2026-05-12)_ - `locations.habulile rural health centre|kalomo|southern province|zambia` — added _(2026-05-12)_ - `locations.kalomo district hospital|kalomo|southern province|zambia` — added _(2026-05-12)_ - `locations.kalomo urban health centre|kalomo|southern province|zambia` — added _(2026-05-12)_ - `locations.mawaya urban health centre|kalomo|southern province|zambia` — added _(2026-05-12)_ - `locations.namwianga urban health centre|kalomo|southern province|zambia` — added _(2026-05-12)_ - `locations.nkandanzovu rural health centre|kalomo|southern province|zambia` — added _(2026-05-12)_ - `locations.siachitema rural health centre|kalomo|southern province|zambia` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT06593080.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT06593080* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*