What is the Decide-TB study evaluating for childhood tuberculosis?

The Decide-TB study is evaluating a comprehensive Treatment Decision Algorithms-based approach for TB screening, diagnosis, and treatment decision-making in children under 15 years in Mozambique and Zambia. Researchers aim to understand how this approach works in real healthcare settings, its feasibility, costs, acceptability, and how it can be integrated into local health policies.

Who may be eligible for this childhood tuberculosis clinical trial?

Children under 15 years old who are sick and attend selected district hospitals or primary health centers, especially those with symptoms lasting more than two weeks or who belong to high-risk groups such as children living with HIV or those with severe acute malnutrition. The study includes both outpatient and inpatient children. Please review eligibility criteria for more details.

Is there any cost to participate in this childhood tuberculosis clinical trial?

Study-related care, including the procedures and all trial visits, is provided at no cost. However, personal travel expenses to the health facilities may vary and are not guaranteed to be covered. Participants can expect to receive all study procedures free of charge.

Actively Recruiting

Phase Not Applicable

Age: 0 - 14Years

All Genders

Healthy Volunteers

ID06593080

Validation of Treatment Decision Algorithms for Childhood Tuberculosis at District Health Care Levels in Mozambique and Zambia - the Decide-TB Cluster-randomized Pragmatic Trial

Led by Chishala Chabala · Updated on 2026-03-24

30240

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

The trial investigates a comprehensive Treatment Decision Algorithms (TDA)-based approach for tuberculosis (TB) screening, diagnosis, and treatment decision-making in children under 15 years old living in high TB burden and resource-limited settings in Mozambique and Zambia. This pragmatic cluster-randomized stepped wedge study aims to provide evidence on the effectiveness, feasibility, acceptability, costs, and adoption of this approach at district hospitals and primary health centers. It also seeks to support integration of findings into local health policies and practices. The intervention involves implementing a comprehensive TDA-based approach supported by a Clinical Decision Support System (CDSS) and strengthened health information systems. This approach integrates TB screening, diagnosis, treatment decisions, and severity assessment to identify eligibility for shorter treatment regimens, especially in high-risk groups such as children living with HIV and those with severe acute malnutrition. The study compares this intervention to the current Standard of Care (SOC) used in each country, which includes symptom screening, HIV testing, Xpert testing, and other diagnostic procedures. Participants include all sick children under 15 years attending selected district hospitals and primary health centers who have presumptive TB or belong to high-risk groups. Data on TB diagnosis, treatment decisions, time to treatment, and treatment outcomes will be collected over about 24 months. Researchers will assess effectiveness, acceptability, implementation feasibility, health economics, and policy impact. The study also monitors diagnostic accuracy, user preferences, and cost-effectiveness, with follow-up extending through intervention delivery and six months post-intervention for sustained delivery.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 0 - 14Years

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

Children under 15 years old attending selected district hospitals or primary health centers
Children with symptoms lasting more than 2 weeks such as cough, fever, poor appetite, weight loss, fatigue, or decreased activity
Children identified as presumptive TB cases based on WHO and local definitions
Children from high-risk groups including those younger than 2 years, living with HIV, or with severe acute malnutrition
Children identified through community or facility-based TB contact tracing

You will not qualify if you...

None; all children meeting inclusion criteria will be offered the intervention

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 24 months throughout the study

Participants undergo TB screening and diagnosis using the comprehensive TDA-based approach including clinical assessments, microbiological tests, and digital decision support systems to confirm TB and determine treatment decisions.

Visits as needed for TB assessment and diagnosis

Treatment

Duration - Up to 24 months throughout the study

Participants diagnosed with TB receive treatment based on the TDA-guided decision, including shorter treatment regimens for non-severe cases and management of high-risk groups.

Visits according to treatment schedule and clinical monitoring

Long-term Monitoring

Duration - Up to 24 months with extended budget impact monitoring up to 5 years

Participants are monitored for treatment outcomes, acceptability, implementation feasibility, and health economic impacts during and after intervention delivery.

Follow-up visits throughout and after treatment as per study protocol

Trial Site Locations

Total: 29 locations

Chawama Urban Health Centre

Chingola, Copperbelt, Zambia

Actively Recruiting

Chiwempala Urban Health Centre

Chingola, Copperbelt, Zambia

Actively Recruiting

Kabundi East Urban Health Clinic

Chingola, Copperbelt, Zambia

Actively Recruiting

Kasompe Urban Health Centre

Chingola, Copperbelt, Zambia

Actively Recruiting

Muchinshi Rural Health Centre

Chingola, Copperbelt, Zambia

Actively Recruiting

Nchanga 1 Urban Health Centre

Chingola, Copperbelt, Zambia

Actively Recruiting

Nchanga North Referal Hospital

Chingola, Copperbelt, Zambia

Actively Recruiting

Allessandras Urban Health Centre

Luanshya, Copperbelt, Zambia

Actively Recruiting

Chaisa Urban Health Centre

Luanshya, Copperbelt, Zambia

Actively Recruiting

Fisenge Urban Health Centre

Luanshya, Copperbelt, Zambia

Actively Recruiting

Kawama Urban Health Centre

Luanshya, Copperbelt, Zambia

Actively Recruiting

Malaika Urban Health Centre

Luanshya, Copperbelt, Zambia

Actively Recruiting

Mikomfwa Urban Health Centre

Luanshya, Copperbelt, Zambia

Actively Recruiting

Roan Antelope General Hospital

Luanshya, Copperbelt, Zambia

Actively Recruiting

Thomson District Hospital

Luanshya, Copperbelt, Zambia

Actively Recruiting

Chipepo Rural Health Centre

Chirundu, Southern Province, Zambia

Actively Recruiting

Hachipilika Rural Health Centre

Chirundu, Southern Province, Zambia

Actively Recruiting

Jamba Rural Health Centre

Chirundu, Southern Province, Zambia

Actively Recruiting

Kapululira Rural Health Centre

Chirundu, Southern Province, Zambia

Actively Recruiting

Lusitu Rural Health Centre

Chirundu, Southern Province, Zambia

Actively Recruiting

Mtendere Mission Referal hospital

Chirundu, Southern Province, Zambia

Actively Recruiting

Sikoongo Rural Health Centre

Chirundu, Southern Province, Zambia

Actively Recruiting

Habulile Rural Health Centre