Impact of an Innovative Childhood TB Diagnostic Approach Decentralized to District Hospital and Primary Health Care Levels on Childhood Tuberculosis Case Detection and Management in High Tuberculosis Incidence Countries (TB-Speed Decentralisation)

March 25, 2025 updated by: Institut National de la Santé Et de la Recherche Médicale, France

Impact of an Innovative Childhood TB Diagnostic Approach Decentralized to District Hospital and Primary Health Care Levels on Childhood Tuberculosis Case Detection and Management in High Tuberculosis Incidence Countries

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). 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This will be an operational research study using:

  • a before and after cross-sectional design to assess the impact of decentralizing an innovative childhood TB diagnostic approach
  • a cross-sectional and nested cohort design to compare two different decentralization strategies at DH and PHC levels.
  • quantitative and qualitative methods The intervention will be at two levels: at patient care level where an innovative childhood TB diagnostic approach will be implemented, and at health systems level where two distinct decentralization strategies will be implemented. 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. The two decentralization strategies are the DH-focused and the PHC-focused implementation of the innovative childhood TB diagnostic approach. Two districts per participating countries will be randomly assigned to implement the DH or PHC-focused strategies.

The study will also include a nested cohort at both the DH and PHC during the intervention phase for a selected sub-set of children with presumptive TB and all children with a diagnosis of TB that consent to participate. This prospective cohort will enable to further document study endpoints related to follow up (TB treatment outcome) and to document TB diagnosis by assessing spontaneous resolution or resolution under TB treatment.

The study will comprise an observation phase followed by an intervention phase in participating districts. During the last month of the observation phase, each district will be randomly assigned to implement either DH or PHC-focused decentralisation. There will be no patient level randomisation.

During this 3-month observation phase, the study will 1) describe the childhood TB diagnosis data and practices; 2) describe the referral processes and outcomes of referrals for TB diagnosis and treatment where feasible and 3) assess existing challenges in childhood TB diagnosis and treatment, as well as readiness (including potential challenges) for the study intervention implementation. There will be no interference with the routine TB childhood diagnosis processes.

Mixed-methods (quantitative and qualitative) will be used including the collection of retrospective and prospective aggregated data by study nurses from facility registers, the implementation of a self-administered questionnaire among all healthcare workers (HCWs), the observation of consultations and care provided, and the conduct of individual interviews with HCWs and key informants.

At the beginning of the intervention phase, a 3-months preparation period will set up the health facilities for decentralization by providing equipment, materials, and reagents, training health workers in childhood TB care, in NPA and stool collection and testing on Ultra, setting up G1 (Edge) at PHC or G4 at DH if not already available and digital CXR and CXR quality control. Existing health care workers will be trained in childhood TB care according to the National Tuberculosis Program (NTP) guidelines, and also in NPA and stool collection and testing on Ultra for study purposes.

Implementation of the innovative childhood TB diagnostic approach at the selected DH and PHC will start as soon as sites are equipped and HCWs trained in childhood TB care and NPA and stool collection, and will implement continued capacity building at sites, regular clinical mentoring visits with NTP or their representative, and continued CXR quality control.

The 6-month prospective cohort follow-up study will be initiated immediately and will consecutively include every tenth child with presumptive TB and all children diagnosed with TB.

Individual data collection will be initiated as soon as the innovative childhood TB diagnostic approach including NPA and stool sample collection and Ultra testing is implemented in the site and will be conducted throughout the intervention phase to document secondary endpoints. Aggregated data for TB screening will be collected throughout the study.

Feasibility, acceptability, and compliance to the intervention protocol will be assessed by mixed methods including a repeat self-administered questionnaire among all HCWs, observations of consultations and care provided, and individual interviews with HCWs, National TB program & local health authorities representatives, and beneficiaries. i.e. parents/guardians.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3106

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Cambodia
      • Angroka, Cambodia
        • Angroka Rh
      • Angroka, Cambodia
        • Taphem Hc
      • Angroka, Cambodia
        • Tropang Andert Hc
      • Batheay, Cambodia
        • Batheay Rh
      • Batheay, Cambodia
        • Choeung Chnok Hc
      • Batheay, Cambodia
        • Tumnub Hc
      • KUS, Cambodia
        • KUS HC
      • Nhaeng Nhang, Cambodia
        • Nhaeng Nhang Hc
      • Phaav, Cambodia
        • Phaav HC
      • Sambour, Cambodia
        • Sambour Hc
  • Cameroon
      • Bafia, Cameroon
        • Csi Messngssang
      • Bafia, Cameroon
        • HD BAFIA
      • Balamba, Cameroon
        • Csi Balamba Bafia
      • Batchenga, Cameroon
        • Cma Batchenga
      • Bokito, Cameroon
        • Cma Bokito Bafia
      • Essong, Cameroon
        • Csi Essong
      • Kiiki, Cameroon
        • Cma Kiiki Bafia
      • Obala, Cameroon
        • Cma Fomakap
      • Obala, Cameroon
        • Csi Ngogo
      • Obala, Cameroon
        • Obala Hosp
  • Côte D'Ivoire
      • Banteapleu, Côte D'Ivoire
        • Dr Banteapleu
      • Dakpadou, Côte D'Ivoire
        • Csu Dakpadou
      • Daleu, Côte D'Ivoire
        • Csr Daleu
      • Danane, Côte D'Ivoire
        • H G de Danane
      • Kouan-houle, Côte D'Ivoire
        • Csu Kouan-Houle
      • Mahapleu, Côte D'Ivoire
        • Csu Mahapleu
      • Medon, Côte D'Ivoire
        • Csr Medon
      • Sago, Côte D'Ivoire
        • CMS SAGO
      • Sahoua, Côte D'Ivoire
        • Dr de Sahoua
      • Sassandra, Côte D'Ivoire
        • H G Sassandra
  • Mozambique
      • Chiaquelane, Mozambique
        • Chiaquelane
      • Chibonzane, Mozambique
        • Chibonzane
      • Chidenguele, Mozambique
        • Chidenguele
      • Chokwe, Mozambique
        • Chalocuane
      • Chokwe, Mozambique
        • HOKWE
      • Chokwe, Mozambique
        • Hosp Rural Chokwe
      • Macuacua, Mozambique
        • MACUACUA
      • Manjacaze, Mozambique
        • Hospital Rural de Manjacaze
      • Manjacaze, Mozambique
        • Laranjeira
  • Sierra Leone
      • BO, Sierra Leone
        • Bo Govt Hosp
      • BO, Sierra Leone
        • New Police barracks
      • Babara, Sierra Leone
        • Babara Chc
      • Gbinti, Sierra Leone
        • Gbinti Chc
      • Gerihun, Sierra Leone
        • Gerihun Chc
      • Koribondo, Sierra Leone
        • Koribondo Chc
      • Mange, Sierra Leone
        • Mange Chc
      • Njala, Sierra Leone
        • Njala University Chc
      • Petifu, Sierra Leone
        • Petifu Chc
      • Port Loko, Sierra Leone
        • Port Loko Govt Hosp
  • Uganda
      • Buyamba, Uganda
        • Buyamba Hc Iii
      • Kambuga, Uganda
        • Kambuga Hospital
      • Kanungu, Uganda
        • Kanungu Hciv
      • Kanyantorogo, Uganda
        • Kanyantorogo Hciii
      • Lwamaggwa, Uganda
        • Lwamaggwa Hc Iii
      • Lwanda, Uganda
        • Lwanda Hc Iii
      • Manya, Uganda
        • St Bernards Manya Hc Iii
      • Matanda, Uganda
        • Matanda Hciii
      • Nyamirama, Uganda
        • Nyamirama HC III
      • Rakai, Uganda
        • Rakai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 14 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Sick children seeking care at Oupatient Department of District Hospital or Primary Health Center
  • Age <15 years

Exclusion Criteria:

- None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: District Hospital focused decentralization strategy
In this strategy, the patient care level innovative childhood TB diagnostic approach will be implemented at the DH level. PHCs in this district, will only conduct systematic TB screening.
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
Experimental: Primary Health Center focused decentralization strategy
In this strategy, the patient care level innovative childhood TB diagnostic approach will be done at the PHC.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Children diagnosed with TB
Time Frame: Day 0
Proportion of TB cases detected among sick children routinely attending outpatient services before and after the intervention
Day 0

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
TB case detection
Time Frame: Month 6
Proportion of TB cases (confirmed and unconfirmed) detected among children identified as presumptive TB
Month 6
TB treatment uptake and time to TB treatment initiation - 1
Time Frame: Month 6
Proportion of children initiating TB treatment among those diagnosed as TB
Month 6
TB treatment uptake and time to TB treatment initiation - 2
Time Frame: Month 6
Time from positive TB screening to TB treatment initiation
Month 6
Cost-effectiveness from the health services perspective
Time Frame: Month 22
Incremental-Cost Effectiveness Ratio (ICER) of the diagnostic approach
Month 22
Acceptability by health care providers, NTPs and health authorities, and beneficiaries
Time Frame: Day 0
Perceptions and experience of the intervention by healthcare workers (HCWs), the NTP and health authorities, and the beneficiaries (parents/guardians)
Day 0
Fidelity of the implementation of the diagnostic approach as compared to the protocol and study procedures - 1
Time Frame: Month 6

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
Fidelity of the implementation of the diagnostic approach as compared to the protocol and study procedures - 2
Time Frame: Month 22
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
Performance of the diagnostic approach at patient level
Time Frame: Month 6
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
TB treatment outcome
Time Frame: Month 6
TB treatment outcome as defined by WHO
Month 6
Diagnostic performance of CXR reading by clinicians at DH and PHC levels
Time Frame: Month 6
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
Added value of CXR in the diagnosis of TB in children as compared to microbiology and clinical evaluation only
Time Frame: Month 6
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
Uptake of the quality control of the CXR reading
Time Frame: Month 6
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
TB screening in outpatient children - 1
Time Frame: Day 7
Proportion of children screened for TB among sick children attending outpatient services
Day 7
TB screening in outpatient children - 2
Time Frame: Day 7
Proportion of children identified with presumptive TB among children screened
Day 7
Feasibility of implementing the different diagnostic approach components - 1
Time Frame: Day 7
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)
Day 7
Feasibility of implementing the different diagnostic approach components - 2
Time Frame: Day 7
Time to sample test and results delivery to clinician
Day 7
Feasibility of implementing the different diagnostic approach components - 3
Time Frame: Day 7
Number of visits to the health facility until final diagnosis
Day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institut National de la Santé Et de la Recherche Médicale, France

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
UNITAID

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Olivier Marcy, PhD, University of Bordeaux
  • Principal Investigator: Maryline Bonnet, PhD, Institut de Recherche pour le Developpement
  • Principal Investigator: Eric Wobudeya, PhD, MU-JHU Care Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 7, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 6, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 31, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 26, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • C18-25

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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