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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04038632
Other study ID # C18-25
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 7, 2020
Est. completion date March 2022

Study information

Verified date August 2021
Source Institut National de la Santé Et de la Recherche Médicale, France
Contact Mastula Nanfuka
Phone +256704158338
Email nmastula@mujhu.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The TB-Speed Decentralisation study aims to increase childhood Tuberculosis (TB) case detection at district hospital (DH) and Primary health Care (PHC) levels using adapted and child-friendly specimen collection methods, i.e. Nasopharyngeal Aspirate (NPA) and stool samples, sensitive microbiological detection tests (Ultra) close to the point-of-care (Omni/G1(Edge)), reinforced training on clinical diagnosis, and standardized CXR quality and interpretation using digital radiography. The TB-Speed Decentralisation study will evaluate the impact of an innovative patient care level diagnostic approach deployed at DH and PHC levels, namely the DH focused and the PHC focused decentralization strategies. This is aimed at, improving case detection in 6 high TB incidence in low/moderate resource countries: Cambodia, Cameroon, Côte d'Ivoire, Mozambique, Sierra Leone, and Uganda, and compare effectiveness and cost-effectiveness of the two different decentralization approaches. The hypothesis is that, in countries with high and very high TB incidence (100-299 and ≥300 cases/100,000 population/year, respectively), a systematic approach to the screening for and diagnosis of TB in sick children presenting to the health system will increase childhood TB case detection, especially PTB, which represents the majority of the disease burden (>75% of case)(40). The study also hypothesizes that sputum collection using battery-operated suction machines and microbiological TB diagnosis using Omni/G1 (Edge) can be decentralized to PHC level, thus enabling TB diagnosis and treatment in children at PHC level.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Other:
Decentralization of Childhood TB Diagnosis
The patient care level TB diagnostic approach consists of systematic TB screening, clinical evaluation, NPA and stool or sputum testing using Xpert Ultra, and optimised CXR reading will be implemented at DH and PHC levels

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Sponsors (2)

Lead Sponsor Collaborator
Institut National de la Santé Et de la Recherche Médicale, France UNITAID

Countries where clinical trial is conducted

Cambodia,  Cameroon,  Côte D'Ivoire,  Mozambique,  Sierra Leone,  Uganda, 

Outcome

Type Measure Description Time frame Safety issue
Primary Children diagnosed with TB Proportion of TB cases detected among sick children routinely attending outpatient services before and after the intervention Month 6
Secondary TB case detection Proportion of TB cases (confirmed and unconfirmed) detected among children identified as presumptive TB Month 6
Secondary TB screening in outpatient children - 1 Proportion of children screened for TB among sick children attending outpatient services Day 0
Secondary TB screening in outpatient children - 2 Proportion of children identified with presumptive TB among children screened Month 6
Secondary Feasibility of implementing the different diagnostic approach components - 1 Proportion of children with presumptive TB enrolled in the study receiving the different components of the innovative childhood TB diagnostic approach (NPA and stool or sputum sampling attempt and success, sample testing with Ultra and results, clinical evaluation, CXR and interpretation, full diagnostic package) Month 6
Secondary Feasibility of implementing the different diagnostic approach components - 2 Time to sample test and results delivery to clinician Month 6
Secondary Feasibility of implementing the different diagnostic approach components - 3 Number of visits to the health facility until final diagnosis Month 6
Secondary TB treatment uptake and time to TB treatment initiation - 1 Proportion of children initiating TB treatment among those diagnosed as TB Month 6
Secondary TB treatment uptake and time to TB treatment initiation - 2 Time from positive TB screening to TB treatment initiation Month 6
Secondary Cost-effectiveness from the health services perspective Incremental-Cost Effectiveness Ratio (ICER) of the diagnostic approach Month 22
Secondary Acceptability by health care providers, NTPs and health authorities, and beneficiaries Perceptions and experience of the intervention by healthcare workers (HCWs), the NTP and health authorities, and the beneficiaries (parents/guardians) Day 0
Secondary Fidelity of the implementation of the diagnostic approach as compared to the protocol and study procedures - 1 Changes in the intervention implementation as compared to 1) study standard implementation procedures and 2) country implementation procedures.
These changes could be related to NTP guidelines dispositions, adaptation to local context and constraints not initially planned per standard and country implementation procedures
Month 6
Secondary Fidelity of the implementation of the diagnostic approach as compared to the protocol and study procedures - 2 Proportion of clinical mentoring visits performed per study procedures; proportion of health facilities implementing NPA and stool sample collection and performing sample processing and Ultra testing per study procedures Month 22
Secondary Performance of the diagnostic approach at patient level Sensitivity and specificity of the diagnostic approach as compared to the reference diagnosis based on the Case Definitions for Classification of Intrathoracic Tuberculosis in Children for clinical research Month 6
Secondary TB treatment outcome TB treatment outcome as defined by WHO Month 6
Secondary Diagnostic performance of CXR reading by clinicians at DH and PHC levels Sensitivity and specificity of CXR reading by clinicians at DH and PHC to detect lesions suggestive of TB as compared to the reference reading (independent reading by external radiologist experts) Month 6
Secondary Added value of CXR in the diagnosis of TB in children as compared to microbiology and clinical evaluation only Proportion of children diagnosed with TB based on CXR and incremental yield of TB detection with CXR results as compared to microbiological (Ultra on NPA and stool or sputum) and clinical evaluation, respectively Month 6
Secondary Uptake of the quality control of the CXR reading Proportion of CXR selected for quality review assessed by the reference reviewer and time to results of the quality control to the clinic Month 6