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)
NCT ID: NCT04038632
Last Updated: 2025-03-26
Study Results
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Basic Information
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COMPLETED
NA
3106 participants
INTERVENTIONAL
2020-03-07
2022-03-31
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
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
DIAGNOSTIC
NONE
Study Groups
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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.
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
Primary Health Center focused decentralization strategy
In this strategy, the patient care level innovative childhood TB diagnostic approach will be done at the PHC.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Age \<15 years
Exclusion Criteria
14 Years
ALL
No
Sponsors
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Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
UNITAID
OTHER
Responsible Party
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Principal Investigators
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Olivier Marcy, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Bordeaux
Maryline Bonnet, PhD
Role: PRINCIPAL_INVESTIGATOR
Institut de Recherche pour le Developpement
Eric Wobudeya, PhD
Role: PRINCIPAL_INVESTIGATOR
MU-JHU Care Ltd
Locations
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Angroka Rh
Angroka, , Cambodia
Taphem Hc
Angroka, , Cambodia
Tropang Andert Hc
Angroka, , Cambodia
Batheay Rh
Batheay, , Cambodia
Choeung Chnok Hc
Batheay, , Cambodia
Tumnub Hc
Batheay, , Cambodia
Nhaeng Nhang Hc
Nhaeng Nhang, , Cambodia
KUS HC
Phumĭ Kŭs, , Cambodia
Phaav HC
Ph’av, , Cambodia
Sambour Hc
Sambour, , Cambodia
Csi Messngssang
Bafia, , Cameroon
HD BAFIA
Bafia, , Cameroon
Csi Balamba Bafia
Balamba, , Cameroon
Cma Batchenga
Batchenga, , Cameroon
Cma Bokito Bafia
Bokito, , Cameroon
Csi Essong
Essong, , Cameroon
Cma Kiiki Bafia
Kiiki, , Cameroon
Cma Fomakap
Obala, , Cameroon
Csi Ngogo
Obala, , Cameroon
Obala Hosp
Obala, , Cameroon
Dr Banteapleu
Banteapleu, , Côte d’Ivoire
Csu Dakpadou
Dakpadou, , Côte d’Ivoire
Csr Daleu
Daleu, , Côte d’Ivoire
H G de Danane
Danané, , Côte d’Ivoire
Csu Kouan-Houle
Kouan Houlé, , Côte d’Ivoire
Csu Mahapleu
Mahapleu, , Côte d’Ivoire
Csr Medon
Médon, , Côte d’Ivoire
CMS SAGO
Sago, , Côte d’Ivoire
Dr de Sahoua
Sahoua, , Côte d’Ivoire
H G Sassandra
Sassandra, , Côte d’Ivoire
Chiaquelane
Chiaquelane, , Mozambique
Chibonzane
Chibonzane, , Mozambique
Chidenguele
Chidenguele, , Mozambique
Chalocuane
Chokwé, , Mozambique
HOKWE
Chokwé, , Mozambique
Hosp Rural Chokwe
Chokwé, , Mozambique
MACUACUA
Macuácua, , Mozambique
Hospital Rural de Manjacaze
Manjacaze, , Mozambique
Laranjeira
Manjacaze, , Mozambique
Babara Chc
Babara, , Sierra Leone
Bo Govt Hosp
Bo, , Sierra Leone
New Police barracks
Bo, , Sierra Leone
Gbinti Chc
Gbinti, , Sierra Leone
Gerihun Chc
Gerihun, , Sierra Leone
Koribondo Chc
Koribondo, , Sierra Leone
Mange Chc
Mange, , Sierra Leone
Njala University Chc
Njala, , Sierra Leone
Petifu Chc
Petifu, , Sierra Leone
Port Loko Govt Hosp
Port Loko, , Sierra Leone
Buyamba Hc Iii
Buyamba, , Uganda
Kambuga Hospital
Kambuga, , Uganda
Kanungu Hciv
Kanungu, , Uganda
Kanyantorogo Hciii
Kanyantorogo, , Uganda
Lwamaggwa Hc Iii
Lwamaggwa, , Uganda
Lwanda Hc Iii
Lwanda, , Uganda
St Bernards Manya Hc Iii
Manya, , Uganda
Matanda Hciii
Matanda, , Uganda
Nyamirama HC III
Nyamirama, , Uganda
Rakai Hospital
Rakai, , Uganda
Countries
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References
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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.
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.
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.
Related Links
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TB-Speed project official website
Other Identifiers
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C18-25
Identifier Type: -
Identifier Source: org_study_id
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