Skip to main content
OpenTrials
Completed

NCT Number: NCT03862261

Integrating Pediatric TB Services Into Child Healthcare Services in Africa

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Children, Only Delivery of Health Care Diagnosis Disease Gram-Positive Bacterial Infections Infections Mycobacterium Infections Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

Up to 5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital de District Akonolinga, Akonolinga, Centre Region, Cameroon

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Integrated pediatric TB services

Other

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.

Primary outcomes

  1. Proportion of children diagnosed with active TB

    Time frame: up to two months

    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.

Secondary outcomes

  1. Proportion of children screened for TB

    Time frame: one month

    Number of children screened for TB over the number of children attending the child healthcare services during the study period

  2. Proportion of screened children who have a sample collected

    Time frame: up to three months

    Proportion of children who have a sample collected for microbiologic diagnosis among those screened positive for TB (i.e. presumptive TB cases)

  3. Proportion of children diagnosed with TB among presumptive TB cases

    Time frame: up to two months

    Proportion of children diagnosed with TB (bacteriologically or clinically) among presumptive TB cases, overall and disaggregated by HIV status and nutrition status

  4. Time from screening to clinical or bacteriologic diagnosis

    Time frame: up to three months

    For children finally diagnosed with TB, time elapsed from presumptive to confirmed TB case

  5. Time from diagnosis to treatment initiation

    Time frame: up to three months

    For children diagnosed with TB, time elapsed to initiate treatment after active TB is confirmed

  6. Proportion of cases with a bacteriologically confirmed diagnosis

    Time frame: up to three months

    Proportion of cases with a bacteriologically confirmed diagnosis among children diagnosed with TB

  7. Proportion of children who initiate TB treatment among those diagnosed

    Time frame: up to two months

    Proportion of children who initiate TB treatment among those diagnosed will give treatment coverage

  8. Treatment outcome

    Time frame: 8 to 14 months (2 months after treatment completion)

    Treatment outcomes for patients initiated on treatment according to WHO categories: treatment success, treatment failed, died, lost to follow-up, and not evaluated.

  9. Adherence to the TB treatment

    Time frame: 6 to 12 months (at treatment completion)

    Adherence documented by seven-day recall and counting of pills

Sponsors and collaborators

Lead sponsor

Elizabeth Glaser Pediatric AIDS Foundation

Other

Collaborators

  • Cameroon Ministry of Public Health
  • Kenya Ministry of Health
  • UNITAID
  • University of Sheffield

Registry information

Official study title

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

Acronym: INPUT

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 5, 2019
Registry last updated
Mar 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.