Integrating Pediatric TB Services Into Child Healthcare Services in Africa
NCT ID: NCT03862261
Last Updated: 2022-03-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1715 participants
INTERVENTIONAL
2019-05-10
2021-12-31
Brief Summary
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Detailed Description
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In this study two strategies will be compared: i) The standard of care, offering pediatric TB services based on current routine approach; ii) The intervention, with pediatric TB services integrated into child healthcare services.
The primary objective will be to assess the effect of the intervention compared to standard of care on the proportion of TB cases diagnosed among children \<5 years old (that is the number of children who are clinically or bacteriologically diagnosed with TB over the total number of children attending the child healthcare services). Secondary objectives are detailed in the protocol.
Study sites will include six hospital in each participating country (Cameroon and Kenya) along with selected attached health centers.
The study population will be children aged less than five years of age with a presumptive diagnosis of TB.
Study enrollment will start in March 2019, last enrollments until July 2020 and follow up will be completed by August 2021.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
DIAGNOSTIC
NONE
Study Groups
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Standard-of-Care
Pediatric TB services based on current routine approach (national standard of care)
No interventions assigned to this group
Intervention
Integrated pediatric TB services
Integrated pediatric TB services
pediatric TB services will be integrated into key child healthcare services: maternal neonatal and child health (MNCH) services, under-5 clinic, pediatric outpatient services, nutrition services, pediatric antiretroviral therapy (ART) services and primary health care:
* Integration of the screening into all the child health care services with introduction of a specific case detection tool and updated presumptive TB register.
* Improvement of diagnosis capacities and their integration in all levels of care and all services.
Interventions
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Integrated pediatric TB services
pediatric TB services will be integrated into key child healthcare services: maternal neonatal and child health (MNCH) services, under-5 clinic, pediatric outpatient services, nutrition services, pediatric antiretroviral therapy (ART) services and primary health care:
* Integration of the screening into all the child health care services with introduction of a specific case detection tool and updated presumptive TB register.
* Improvement of diagnosis capacities and their integration in all levels of care and all services.
Eligibility Criteria
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Inclusion Criteria
* TB diagnosis investigations initiated.
* Other infectious diseases are not suspected or have already been ruled out.
* Commitment to take treatment in the clinic of enrolment or another INPUT study site.
* Parental/caregiver consent for the child to participate in the study.
Exclusion Criteria
5 Years
ALL
No
Sponsors
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UNITAID
OTHER
University of Sheffield
OTHER
Kenya Ministry of Health
OTHER_GOV
Cameroon Ministry of Public Health
UNKNOWN
Elizabeth Glaser Pediatric AIDS Foundation
OTHER
Responsible Party
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Principal Investigators
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Appolinaire Tiam, MBChB, MMed
Role: PRINCIPAL_INVESTIGATOR
Elizabeth Glaser Pediatric AIDS Foundation
Locations
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Hopital de District Akonolinga
Akonolinga, Centre Region, Cameroon
Hopital de District Soa
Okoa, Centre Region, Cameroon
Hopital de District Loum
Loum, Littoral Region, Cameroon
Hopital de District Foumban
Mbanga, Littoral Region, Cameroon
Hopital de District Dschang
Dschang, West Region, Cameroon
Hopital de District Mbouda
Mbouda, West Region, Cameroon
Kendu Sub County Hospital
Kendu Bay, Homa Bay County, Kenya
Ndhiwa Sub county Hospital
Ndhiwa, Homa Bay County, Kenya
Kakuma Mission Hospital
Kakuma, Turkana County, Kenya
Lokitaung sub-county hospital
Lokitaung, Turkana County, Kenya
Lopiding Sub County Hospital
Lopiding, Turkana County, Kenya
Homa Bay County Referral Hospital
Homa Bay, , Kenya
Countries
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References
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Tchounga B, Tiam A, Masaba RO, Herrera N, Mbunka M, Siamba S, Goura AP, Ouma M, Petnga SJ, Tchakounte Youngui B, Zemsi A, Zoung-Kanyi Bissek AC, Okomo G, Simo L, Casenghi M, Tchendjou P, Ditekemena J, Rakhmanina N, Denoeud-Ndam L. Assessing tuberculosis clinical presentation, diagnosis and treatment outcomes among children under 5 years old: results from a cohort of children with presumptive TB in Cameroon and Kenya. BMJ Public Health. 2025 Jun 26;2(Suppl 1):e001566. doi: 10.1136/bmjph-2024-001566. eCollection 2024 Jul.
Katirayi L, Masaba R, Tchounga B, Ndimbii J, Mbunka M, Ouma M, Olughu K, Siehien J, Petnga SJ, Casenghi M, Okomo G, Zoung-Kanyi Bissek AC, Tiam A, Denoeud-Ndam L; INPUT study team. 'We did not even know it was tuberculosis': a qualitative evaluation of integrating tuberculosis services into paediatric entry points in the CaP-TB programme in Cameroon and Kenya. BMJ Public Health. 2024 Jul 2;2(Suppl 1):e001001. doi: 10.1136/bmjph-2024-001001. eCollection 2024 Jul.
Powell L, Denoeud-Ndam L, Herrera N, Masaba R, Tchounga B, Siamba S, Ouma M, Petnga SJ, Machekano R, Pamen B, Okomo G, Simo L, Casenghi M, Rakhmanina N, Tiam A. HIV matters when diagnosing TB in young children: an ancillary analysis in children enrolled in the INPUT stepped wedge cluster randomized study. BMC Infect Dis. 2023 Apr 17;23(1):234. doi: 10.1186/s12879-023-08216-w.
Denoeud-Ndam L, Otieno-Masaba R, Tchounga B, Machekano R, Simo L, Mboya JP, Kose J, Tchendjou P, Bissek AZ, Okomo GO, Casenghi M, Cohn J, Tiam A; INPUT Study Group. Integrating pediatric TB services into child healthcare services in Africa: study protocol for the INPUT cluster-randomized stepped wedge trial. BMC Public Health. 2020 May 6;20(1):623. doi: 10.1186/s12889-020-08741-2.
Other Identifiers
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EG0214
Identifier Type: -
Identifier Source: org_study_id
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