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)

NCT04038632 | Completed

• 1 other identifier: C18-25
• Study Type: interventional
• Target: 3,106
• Locations: 5 countries
• Sites: 49

Brief 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). 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.

Conditions

Tuberculosis in Children

Keywords

Decentralized Diagnosis approaches; Childhood TB; Case detection

Outcome Measures

Primary Outcomes (1)

• Children diagnosed with TB

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

  Day 0

Secondary Outcomes (17)

• TB case detection

  Month 6

• TB screening in outpatient children - 1

  Day 7

• TB screening in outpatient children - 2

  Day 7

• Feasibility of implementing the different diagnostic approach components - 1

  Day 7

• Feasibility of implementing the different diagnostic approach components - 2

  Day 7

Study Arms (2)

District Hospital focused decentralization strategy

EXPERIMENTAL

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

Primary Health Center focused decentralization strategy

EXPERIMENTAL

In this strategy, the patient care level innovative childhood TB diagnostic approach will be done at the PHC.

Other: Decentralization of Childhood TB Diagnosis

Interventions

Decentralization of Childhood TB Diagnosis OTHER

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

District Hospital focused decentralization strategy; Primary Health Center focused decentralization strategy

Eligibility Criteria

• Age: Up to 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• \- None

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead
• UNITAID: collaborator

Study Sites (59)

Angroka Rh

Angroka, Cambodia

Location

Taphem Hc

Angroka, Cambodia

Location

Tropang Andert Hc

Angroka, Cambodia

Location

Batheay Rh

Batheay, Cambodia

Location

Choeung Chnok Hc

Batheay, Cambodia

Location

Tumnub Hc

Batheay, Cambodia

Location

Nhaeng Nhang Hc

Nhaeng Nhang, Cambodia

Location

KUS HC

Phumĭ Kŭs, Cambodia

Location

Phaav HC

Ph’av, Cambodia

Location

Sambour Hc

Sambour, Cambodia

Location

Csi Messngssang

Bafia, Cameroon

Location

HD BAFIA

Bafia, Cameroon

Location

Csi Balamba Bafia

Balamba, Cameroon

Location

Cma Batchenga

Batchenga, Cameroon

Location

Cma Bokito Bafia

Bokito, Cameroon

Location

Csi Essong

Essong, Cameroon

Location

Cma Kiiki Bafia

Kiiki, Cameroon

Location

Cma Fomakap

Obala, Cameroon

Location

Csi Ngogo

Obala, Cameroon

Location

Obala Hosp

Obala, Cameroon

Location

Dr Banteapleu

Banteapleu, Côte d’Ivoire

Location

Csu Dakpadou

Dakpadou, Côte d’Ivoire

Location

Csr Daleu

Daleu, Côte d’Ivoire

Location

H G de Danane

Danané, Côte d’Ivoire

Location

Csu Kouan-Houle

Kouan Houlé, Côte d’Ivoire

Location

Csu Mahapleu

Mahapleu, Côte d’Ivoire

Location

Csr Medon

Médon, Côte d’Ivoire

Location

CMS SAGO

Sago, Côte d’Ivoire

Location

Dr de Sahoua

Sahoua, Côte d’Ivoire

Location

H G Sassandra

Sassandra, Côte d’Ivoire

Location

Chiaquelane

Chiaquelane, Mozambique

Location

Chibonzane

Chibonzane, Mozambique

Location

Chidenguele

Chidenguele, Mozambique

Location

Chalocuane

Chokwé, Mozambique

Location

HOKWE

Chokwé, Mozambique

Location

Hosp Rural Chokwe

Chokwé, Mozambique

Location

MACUACUA

Macuácua, Mozambique

Location

Hospital Rural de Manjacaze

Manjacaze, Mozambique

Location

Laranjeira

Manjacaze, Mozambique

Location

Babara Chc

Babara, Sierra Leone

Location

Bo Govt Hosp

Bo, Sierra Leone

Location

New Police barracks

Bo, Sierra Leone

Location

Gbinti Chc

Gbinti, Sierra Leone

Location

Gerihun Chc

Gerihun, Sierra Leone

Location

Koribondo Chc

Koribondo, Sierra Leone

Location

Mange Chc

Mange, Sierra Leone

Location

Njala University Chc

Njala, Sierra Leone

Location

Petifu Chc

Petifu, Sierra Leone

Location

Port Loko Govt Hosp

Port Loko, Sierra Leone

Location

Buyamba Hc Iii

Buyamba, Uganda

Location

Kambuga Hospital

Kambuga, Uganda

Location

Kanungu Hciv

Kanungu, Uganda

Location

Kanyantorogo Hciii

Kanyantorogo, Uganda

Location

Lwamaggwa Hc Iii

Lwamaggwa, Uganda

Location

Lwanda Hc Iii

Lwanda, Uganda

Location

St Bernards Manya Hc Iii

Manya, Uganda

Location

Matanda Hciii

Matanda, Uganda

Location

Nyamirama HC III

Nyamirama, Uganda

Location

Rakai Hospital

Rakai, Uganda

Location

Related Publications (3)

• 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.

  PMID: 37819919 BACKGROUND

• 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.

  PMID: 38685930 DERIVED

• 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.

  PMID: 38685921 DERIVED

Related Links

• TB-Speed project official website

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: June 6, 2019
• First Posted: July 31, 2019
• Study Start: March 7, 2020
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: March 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

SI (10); CA (10); UG (10); CÔ (10); MO (9)