AzTrials
AzTrials

Tuberculosis in ChildrenNCT04038632

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)

A study testing Decentralization of Childhood TB Diagnosis in people with Tuberculosis in Children, run by Institut National de la Santé Et de la Recherche Médicale, France at 59 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages Up to 14 years
Conditions the study is for
Tuberculosis in Children
What is being tested?
Decentralization of Childhood TB Diagnosis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,106 participants
Where
59 sitesin 6 countries
Study dates
7 Mar 2020to 31 Mar 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 14 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

  • None

Trial locations and contacts

59 sites in 6 countries.

59 sites in 6 countries

Cambodia10 sites

  • Batheay Rh

    Batheay

  • Choeung Chnok Hc

    Batheay

  • Phaav HC

    Batheay

  • Tumnub Hc

    Batheay

  • Sambour Hc

    Kratie

  • Angrokar Rh

    Takeo

  • KUS HC

    Takeo

  • Nhaeng Nhang Hc

    Takeo

  • Taphem Hc

    Takeo

  • Tropang Andert Hc

    Takeo

Other trials in Cambodia

Cameroon10 sites

  • Cma Kiiki Bafia

    Bafia

  • Csi Messngssang

    Bafia

  • HD BAFIA

    Bafia

  • Csi Balamba Bafia

    Balamba

  • Cma Batchenga

    Batchenga

  • Cma Bokito Bafia

    Bokito

  • Cma Fomakap

    Obala

  • Csi Essong

    Obala

  • Csi Ngogo

    Obala

  • Obala Hosp

    Obala

Other trials in Cameroon

Côte d’Ivoire10 sites

  • Csu Dakpadou

    Dakpadou

  • Csr Daleu

    Daleu

  • Dr Banteapleu

    Danané

  • H G de Danane

    Danané

  • Csu Kouan-Houle

    Kouan Houlé

  • Csu Mahapleu

    Mahapleu

  • CMS SAGO

    Sago

  • Dr de Sahoua

    Sahoua

  • Csr Medon

    Sassandra

  • H G Sassandra

    Sassandra

Other trials in Côte d’Ivoire

Sierra Leone10 sites

  • Bo Govt Hosp

    Bo

  • Koribondo Chc

    Bo

  • New Police barracks

    Bo

  • Gbinti Chc

    Gbinti

  • Gerihun Chc

    Gerihun

  • Mange Chc

    Mange

  • Njala University Chc

    Njala

  • Petifu Chc

    Petifu

  • Babara Chc

    Port Loko

  • Port Loko Govt Hosp

    Port Loko

Other trials in Sierra Leone

Uganda10 sites

  • Buyamba Hc Iii

    Buyamba

  • Kambuga Hospital

    Kambuga

  • Kanungu Hciv

    Kanungu

  • Kanyantorogo Hciii

    Kanungu

  • Matanda Hciii

    Kanungu

  • Nyamirama HC III

    Kanungu

  • Lwanda Hc Iii

    Lwanda

  • St Bernards Manya Hc Iii

    Manya

  • Lwamaggwa Hc Iii

    Rakai

  • Rakai Hospital

    Rakai

Other trials in Uganda

Mozambique9 sites

  • Chibonzane

    Chibonzane

  • Chidenguele

    Chidenguele

  • Chalocuane

    Chokwé

  • Chiaquelane

    Chokwé

  • HOKWE

    Chokwé

  • Hosp Rural Chokwe

    Chokwé

  • MACUACUA

    Macuácua

  • Hospital Rural de Manjacaze

    Manjacaze

  • Laranjeira

    Manjacaze

Other trials in Mozambique

About this study

Official title: 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.

Read the 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.

Being tested
Decentralization of Childhood TB Diagnosis
Keywords
Decentralized Diagnosis approaches, Childhood TB, Case detection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Decentralization of Childhood TB DiagnosisOther

    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

Study groups in NCT04038632
Study groupRoleWhat they receive
District Hospital focused decentralization strategyExperimentalIn 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.
Receives: Other: Decentralization of Childhood TB Diagnosis
Primary Health Center focused decentralization strategyExperimentalIn this strategy, the patient care level innovative childhood TB diagnostic approach will be done at the PHC.
Receives: Other: Decentralization of Childhood TB Diagnosis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Children diagnosed with TB

    Proportion of TB cases detected among sick children routinely attending outpatient services before and after the intervention

    Measured: Day 0

Secondary outcomes (17)

  1. TB case detection

    Proportion of TB cases (confirmed and unconfirmed) detected among children identified as presumptive TB

    Measured: Month 6

  2. TB screening in outpatient children - 1

    Proportion of children screened for TB among sick children attending outpatient services

    Measured: Day 7

  3. TB screening in outpatient children - 2

    Proportion of children identified with presumptive TB among children screened

    Measured: Day 7

  4. 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)

    Measured: Day 7

  5. Feasibility of implementing the different diagnostic approach components - 2

    Time to sample test and results delivery to clinician

    Measured: Day 7

  6. Feasibility of implementing the different diagnostic approach components - 3

    Number of visits to the health facility until final diagnosis

    Measured: Day 7

  7. TB treatment uptake and time to TB treatment initiation - 1

    Proportion of children initiating TB treatment among those diagnosed as TB

    Measured: Month 6

  8. TB treatment uptake and time to TB treatment initiation - 2

    Time from positive TB screening to TB treatment initiation

    Measured: Month 6

  9. Cost-effectiveness from the health services perspective

    Incremental-Cost Effectiveness Ratio (ICER) of the diagnostic approach

    Measured: Month 22

  10. 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)

    Measured: Day 0

  11. 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

    Measured: Month 6

  12. 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

    Measured: Month 22

  13. 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

    Measured: Month 6

  14. TB treatment outcome

    TB treatment outcome as defined by WHO

    Measured: Month 6

  15. 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)

    Measured: Month 6

  16. 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

    Measured: Month 6

  17. 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

    Measured: Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2019
  2. Study start7 Mar 2020
  3. Primary completion31 Mar 2022
  4. Study completion31 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Model description
The study will comprise an observation phase, during which there will be no interference with the routine TB childhood diagnosis processes, 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 individual patient level randomisation. 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 who 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
Masking
None (open label)
Enrolment
3,106 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04038632
Sponsor's protocol ID
C18-25
Status last verified
Feb 2025
First submitted
6 Jun 2019
Last updated
29 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Joshi B, De Lima YV, Massom DM, Kaing S, Banga MF, Kamara ET, Sesay S, Borand L, Taguebue JV, Moh R, Khosa C, Breton G, Mwanga-Amumpaire J, Bonnet M, Wobudeya E, Marcy O, Orne-Gliemann J; TB-Speed Decentralization study group. Acceptability of decentralizing childhood tuberculosis diagnosis in low-income countries with high tuberculosis incidence: Experiences and perceptions from health care workers in Sub-Saharan Africa and South-East Asia. PLOS Glob Public Health. 2023 Oct 11;3(10):e0001525. doi: 10.1371/journal.pgph.0001525. eCollection 2023.

    PubMed 37819919

  • d'Elbee M, Harker M, Mafirakureva N, Nanfuka M, Huyen Ton Nu Nguyet M, Taguebue JV, Moh R, Khosa C, Mustapha A, Mwanga-Amumpere J, Borand L, Nolna SK, Komena E, Cumbe S, Mugisha J, Natukunda N, Mao TE, Wittwer J, Benard A, Bernard T, Sohn H, Bonnet M, Wobudeya E, Marcy O, Dodd PJ; TB-Speed Health Economics Study Group. Cost-effectiveness and budget impact of decentralising childhood tuberculosis diagnosis in six high tuberculosis incidence countries: a mathematical modelling study. EClinicalMedicine. 2024 Mar 21;70:102528. doi: 10.1016/j.eclinm.2024.102528. eCollection 2024 Apr.

    PubMed 38685930

  • Wobudeya E, Nanfuka M, Ton Nu Nguyet MH, Taguebue JV, Moh R, Breton G, Khosa C, Borand L, Mwanga-Amumpaire J, Mustapha A, Nolna SK, Komena E, Mugisha JR, Natukunda N, Dim B, de Lauzanne A, Cumbe S, Balestre E, Poublan J, Lounnas M, Ngu E, Joshi B, Norval PY, Terquiem EL, Turyahabwe S, Foray L, Sidibe S, Albert KK, Manhica I, Sekadde M, Detjen A, Verkuijl S, Mao TE, Orne-Gliemann J, Bonnet M, Marcy O; TB-Speed Decentralisation study group. Effect of decentralising childhood tuberculosis diagnosis to primary health centre versus district hospital levels on disease detection in children from six high tuberculosis incidence countries: an operational research, pre-post intervention study. EClinicalMedicine. 2024 Mar 21;70:102527. doi: 10.1016/j.eclinm.2024.102527. eCollection 2024 Apr.

    PubMed 38685921

Questions about this trial

What is this clinical trial studying?

A study testing Decentralization of Childhood TB Diagnosis in people with Tuberculosis in Children, run by Institut National de la Santé Et de la Recherche Médicale, France at 59 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 59 sites in Cambodia, Cameroon, Côte d’Ivoire, Sierra Leone, Uganda and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Children diagnosed with TB (time frame: Day 0). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04038632, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in