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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

30,240

participants targeted

Target at P75+ for not_applicable

Timeline

16mo left

Started Jun 2024

Longer than P75 for not_applicable

Geographic Reach

1 country

29 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.2 years study duration

Study Progress59%

Jun 2024Aug 2027

Study Start

First participant enrolled

June 1, 2024

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2024

Completed

2 months until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed

2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2027

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2027

Last Updated

March 24, 2026

Status Verified

March 1, 2026

Enrollment Period

3.2 years

First QC Date

August 1, 2024

Last Update Submit

March 19, 2026

Conditions

Tuberculosis Child Health HIV Severe Acute Malnutrition

Outcome Measures

Primary Outcomes (1)

Effectiveness endpoints: Children initiated on TB treatment
Proportion of children started on treatment for TB among sick children attending care at participant health facilities for any health complaints
Throughout the study, an average of 24 months

Secondary Outcomes (35)

Effectiveness endpoints: Children treated for TB among those with presumptive TB
Throughout the study, an average of 24 months
Effectiveness endpoints: TB treatment proportion in high-risk pediatric groups
Throughout the study, an average of 24 months
Effectiveness endpoints: Microbiologically confirmed TB cases
Throughout the study, an average of 24 months
Effectiveness endpoints: Time to TDA assessment completion
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
From the start of intervention to the end of the intervention, an average of 21 months
+30 more secondary outcomes

Study Arms (2)

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

Other: The comprehensive TDA based approach

Interventions

The comprehensive TDA based approachOTHER

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.

The comprehensive TDA based approach

Eligibility Criteria

AgeUp to 14 Years

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17)

You may qualify if:

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Chishala Chabalalead
University of Bordeauxcollaborator
Instituto Nacional de Saúde, Mozambiquecollaborator
ADERAcollaborator
University of Stellenboschcollaborator
Imperial College Londoncollaborator
Institut de Recherche pour le Développement (IRD)collaborator
University of Sheffieldcollaborator
Ludwig-Maximilians - University of Munichcollaborator
Ministry of Health, Zambiacollaborator
Ministry of Health, Mozambiquecollaborator
Eduardo Mondlane Universitycollaborator
European and Developing Countries Clinical Trials Partnership (EDCTP)collaborator

Study Sites (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