NCT03862261

Brief Summary

Under-diagnosis of TB in children is a critical gap to address. The INPUT study is a multinational stepped-wedge cluster-randomized intervention study aiming to assess the effect of integrating TB services into child healthcare services on TB diagnosis capacities in children under 5 years of age.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,715

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2019

Typical duration for not_applicable

Geographic Reach
2 countries

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2019

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 5, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

May 10, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

March 23, 2022

Status Verified

March 1, 2022

Enrollment Period

2.1 years

First QC Date

February 12, 2019

Last Update Submit

March 22, 2022

Conditions

TuberculosisChildren, OnlyDiagnosisDelivery of Health Care

Outcome Measures

Primary Outcomes (1)

  • Proportion of children diagnosed with active TB

    Number of pediatric TB cases diagnosed (bacteriologically confirmed and/or clinically diagnosed) over the number of children attending the child healthcare services during the study period.

    up to two months

Secondary Outcomes (9)

  • Proportion of children screened for TB

    one month

  • Proportion of screened children who have a sample collected

    up to three months

  • Proportion of children diagnosed with TB among presumptive TB cases

    up to two months

  • Time from screening to clinical or bacteriologic diagnosis

    up to three months

  • Time from diagnosis to treatment initiation

    up to three months

  • +4 more secondary outcomes

Study Arms (2)

Standard-of-Care

NO INTERVENTION

Pediatric TB services based on current routine approach (national standard of care)

Intervention

EXPERIMENTAL

Integrated pediatric TB services

Other: Integrated pediatric TB services

Interventions

Integrated pediatric TB servicesOTHER

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.

Intervention

Eligibility Criteria

AgeUp to 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children \< 5 years old.
  • 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.

You may not qualify if:

  • Children who are TB contacts but without symptoms or signs of active TB

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Hopital de District Akonolinga

Akonolinga, Centre Region, Cameroon

Location

Hopital de District Soa

Okoa, Centre Region, Cameroon

Location

Hopital de District Loum

Loum, Littoral Region, Cameroon

Location

Hopital de District Foumban

Mbanga, Littoral Region, Cameroon

Location

Hopital de District Dschang

Dschang, West Region, Cameroon

Location

Hopital de District Mbouda

Mbouda, West Region, Cameroon

Location

Kendu Sub County Hospital

Kendu Bay, Homa Bay County, Kenya

Location

Ndhiwa Sub county Hospital

Ndhiwa, Homa Bay County, Kenya

Location

Kakuma Mission Hospital

Kakuma, Turkana County, Kenya

Location

Lokitaung sub-county hospital

Lokitaung, Turkana County, Kenya

Location

Lopiding Sub County Hospital

Lopiding, Turkana County, Kenya

Location

Homa Bay County Referral Hospital

Homa Bay, Kenya

Location

Related Publications (5)

  • Masaba R, Herrera N, Tchounga B, Siamba S, Ouma M, Okomo G, Tchendjou P, Ditekemena J, Zoung-Kanyi Bissek AC, Casenghi M, Machekano R, Tiam A, Denoeud-Ndam L. Decentralisation and integration of paediatric tuberculosis services to primary healthcare facilities as an approach to optimise management in Cameroon and Kenya: a descriptive cohort study. BMJ Public Health. 2024 Jul 29;2(Suppl 1):e001005. doi: 10.1136/bmjph-2024-001005. eCollection 2024 Jul.

    PMID: 41221323DERIVED

  • 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.

    PMID: 40740312DERIVED

  • 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.

    PMID: 40017705DERIVED

  • 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.

    PMID: 37069518DERIVED

  • 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.

    PMID: 32375741DERIVED

MeSH Terms

Conditions

TuberculosisDisease

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Appolinaire Tiam, MBChB, MMed

    Elizabeth Glaser Pediatric AIDS Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SEQUENTIAL
Model Details: Cluster-randomized stepped-wedge model, where intervention will be randomly allocated to the different study sites at different time points.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2019

First Posted

March 5, 2019

Study Start

May 10, 2019

Primary Completion

June 30, 2021

Study Completion

December 31, 2021

Last Updated

March 23, 2022

Record last verified: 2022-03

Locations

CA(6)KE(6)