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

RecruitingNA

Sponsor: Chishala Chabala

Conditions: Tuberculosis, Child Health, HIV, Severe Acute Malnutrition

Interventions: The comprehensive TDA based approach

Countries: Zambia

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.

Eligibility overview

Sex: ALL

Age: — to 14 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (29)

Chingola, Copperbelt, Zambia
Chingola, Copperbelt, Zambia
Chingola, Copperbelt, Zambia
Chingola, Copperbelt, Zambia
Chingola, Copperbelt, Zambia
Chingola, Copperbelt, Zambia
Chingola, Copperbelt, Zambia
Luanshya, Copperbelt, Zambia
Luanshya, Copperbelt, Zambia
Luanshya, Copperbelt, Zambia
Luanshya, Copperbelt, Zambia
Luanshya, Copperbelt, Zambia
Luanshya, Copperbelt, Zambia
Luanshya, Copperbelt, Zambia
Luanshya, Copperbelt, Zambia
Chirundu, Southern Province, Zambia
Chirundu, Southern Province, Zambia
Chirundu, Southern Province, Zambia
Chirundu, Southern Province, Zambia
Chirundu, Southern Province, Zambia
Chirundu, Southern Province, Zambia
Chirundu, Southern Province, Zambia
Kalomo, Southern Province, Zambia
Kalomo, Southern Province, Zambia
Kalomo, Southern Province, Zambia
Kalomo, Southern Province, Zambia
Kalomo, Southern Province, Zambia
Kalomo, Southern Province, Zambia
Kalomo, Southern Province, Zambia