Integrating Pediatric TB Services Into Child Healthcare Services in Africa (INPUT)

Integrating Pediatric TB Services Into Child Healthcare Services in Africa. A Cluster-randomized Stepped-wedge Trial

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.

Study Overview

• Status: Completed
• Conditions: Tuberculosis; Children, Only; Diagnosis; Delivery of Health Care
• Intervention / Treatment: Other: Integrated pediatric TB services

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.

• Study Type: Interventional
• Enrollment (Actual): 1715
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Cameroon
  • Centre
    • Akonolinga, Centre, Cameroon
      • Hopital de District Akonolinga
    • Soa, Centre, Cameroon
      • Hopital de District Soa
  • Littoral
    • Loum, Littoral, Cameroon
      • Hopital de District Loum
    • Mbanga, Littoral, Cameroon
      • Hopital de District Foumban
  • West
    • Dschang, West, Cameroon
      • Hopital de District Dschang
    • Mbouda, West, Cameroon
      • Hopital de District Mbouda
• Kenya
  • Homa Bay, Kenya
    • Homa Bay County Referral Hospital
  • Homa Bay
    • Kendu Bay, Homa Bay, Kenya
      • Kendu Sub County Hospital
    • Ndhiwa, Homa Bay, Kenya
      • Ndhiwa Sub county Hospital
  • Turkana
    • Kakuma, Turkana, Kenya
      • Kakuma Mission Hospital
    • Lokitaung, Turkana, Kenya
      • Lokitaung sub-county hospital
    • Lopiding, Turkana, Kenya
      • Lopiding Sub County Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 5 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Standard-of-Care; Pediatric TB services based on current routine approach (national standard of care)
EXPERIMENTAL: Intervention; Integrated pediatric TB services	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of children screened for TB	Number of children screened for TB over the number of children attending the child healthcare services during the study period	one month
Proportion of screened children who have a sample collected	Proportion of children who have a sample collected for microbiologic diagnosis among those screened positive for TB (i.e. presumptive TB cases)	up to three months
Proportion of children diagnosed with TB among presumptive TB cases	Proportion of children diagnosed with TB (bacteriologically or clinically) among presumptive TB cases, overall and disaggregated by HIV status and nutrition status	up to two months
Time from screening to clinical or bacteriologic diagnosis	For children finally diagnosed with TB, time elapsed from presumptive to confirmed TB case	up to three months
Time from diagnosis to treatment initiation	For children diagnosed with TB, time elapsed to initiate treatment after active TB is confirmed	up to three months
Proportion of cases with a bacteriologically confirmed diagnosis	Proportion of cases with a bacteriologically confirmed diagnosis among children diagnosed with TB	up to three months
Proportion of children who initiate TB treatment among those diagnosed	Proportion of children who initiate TB treatment among those diagnosed will give treatment coverage	up to two months
Treatment outcome	Treatment outcomes for patients initiated on treatment according to WHO categories: treatment success, treatment failed, died, lost to follow-up, and not evaluated.	8 to 14 months (2 months after treatment completion)
Adherence to the TB treatment	Adherence documented by seven-day recall and counting of pills	6 to 12 months (at treatment completion)

Collaborators and Investigators

• Sponsor: Elizabeth Glaser Pediatric AIDS Foundation
• Collaborators: University of Sheffield; UNITAID; Kenya Ministry of Health; Cameroon Ministry of Public Health

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 10, 2019
• Primary Completion (ACTUAL): June 30, 2021
• Study Completion (ACTUAL): December 31, 2021

Study Registration Dates

• First Submitted: February 12, 2019
• First Submitted That Met QC Criteria: March 1, 2019
• First Posted (ACTUAL): March 5, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 23, 2022
• Last Update Submitted That Met QC Criteria: March 22, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis
• Other Study ID Numbers: EG0214

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No