Clinical trial NCT03862261: Integrating Pediatric TB Services Into Child Healthcare Services in Africa
Official title: Integrating Pediatric TB Services Into Child Healthcare Services in Africa. A Cluster-randomized Stepped-wedge Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tuberculosis
Children, Only
Diagnosis
Delivery of Health Care
Lead sponsor: Elizabeth Glaser Pediatric AIDS Foundation
Sponsor class: OTHER
Collaborators: name: UNITAID
name: University of Sheffield
name: Kenya Ministry of Health
name: Cameroon Ministry of Public Health
First posted: 2019-03-05
Enrollment: 1715
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Cluster-randomized stepped-wedge model, where intervention will be randomly allocated to the different study sites at different time points.
Primary purpose: DIAGNOSTIC

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.

Detailed description: Study clusters (district-level hospitals and their health centers) will start under standard-of-care and transition to the intervention at randomly assigned time points.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Proportion of children diagnosed with active TB
timeFrame: up to two months
Secondary outcomes:
measure: Proportion of children screened for TB
timeFrame: one month
measure: Proportion of screened children who have a sample collected
timeFrame: up to three months
measure: Proportion of children diagnosed with TB among presumptive TB cases
timeFrame: up to two months
measure: Time from screening to clinical or bacteriologic diagnosis
timeFrame: up to three months
measure: Time from diagnosis to treatment initiation
timeFrame: up to three months
measure: Proportion of cases with a bacteriologically confirmed diagnosis
timeFrame: up to three months
measure: Proportion of children who initiate TB treatment among those diagnosed
timeFrame: up to two months
measure: Treatment outcome
timeFrame: 8 to 14 months (2 months after treatment completion)
measure: Adherence to the TB treatment
timeFrame: 6 to 12 months (at treatment completion)
Other outcomes:
Locations:
city: Akonolinga
country: Cameroon
facility: Hopital de District Akonolinga
state: Centre
city: Soa
country: Cameroon
facility: Hopital de District Soa
state: Centre
city: Loum
country: Cameroon
facility: Hopital de District Loum
state: Littoral
city: Mbanga
country: Cameroon
facility: Hopital de District Foumban
state: Littoral
city: Dschang
country: Cameroon
facility: Hopital de District Dschang
state: West
city: Mbouda
country: Cameroon
facility: Hopital de District Mbouda
state: West
city: Kendu Bay
country: Kenya
facility: Kendu Sub County Hospital
state: Homa Bay
city: Ndhiwa
country: Kenya
facility: Ndhiwa Sub county Hospital
state: Homa Bay
city: Kakuma
country: Kenya
facility: Kakuma Mission Hospital
state: Turkana
city: Lokitaung
country: Kenya
facility: Lokitaung sub-county hospital
state: Turkana
city: Lopiding
country: Kenya
facility: Lopiding Sub County Hospital
state: Turkana
city: Homa Bay
country: Kenya
facility: Homa Bay County Referral Hospital
Study officials:
affiliation: Elizabeth Glaser Pediatric AIDS Foundation
name: Appolinaire Tiam, MBChB, MMed
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.