TuberculosisINPUTNCT03862261
Integrating Pediatric TB Services Into Child Healthcare Services in Africa
A study testing Integrated pediatric TB services in people with Tuberculosis and Children, Only, run by Elizabeth Glaser Pediatric AIDS Foundation at 12 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 5 years
- Conditions the study is for
- Tuberculosis, Children, Only, Diagnosis
- What is being tested?
- Integrated pediatric TB services
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,715 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 10 May 2019to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Children who are TB contacts but without symptoms or signs of active TB
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
Cameroon6 sites
Hopital de District Akonolinga
Akonolinga, Centre Region
Hopital de District Dschang
Dschang, West Region
Hopital de District Loum
Loum, Littoral Region
Hopital de District Foumban
Mbanga, Littoral Region
Hopital de District Mbouda
Mbouda, West Region
Hopital de District Soa
Okoa, Centre Region
Kenya6 sites
Homa Bay County Referral Hospital
Homa Bay
Kakuma Mission Hospital
Kakuma, Turkana County
Kendu Sub County Hospital
Kendu Bay, Homa Bay County
Lokitaung sub-county hospital
Lokitaung, Turkana County
Lopiding Sub County Hospital
Lopiding, Turkana County
Ndhiwa Sub county Hospital
Ndhiwa, Homa Bay County
About this study
Official title: 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.
Read the 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.
- Conditions
- Tuberculosis, Children, Only, Diagnosis, Delivery of Health Care
- Being tested
- Integrated pediatric TB services
- Medical subject headings
- Tuberculosis, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard-of-Care | No intervention | Pediatric TB services based on current routine approach (national standard of care) |
| Intervention | Experimental | Integrated pediatric TB services Receives: Other: Integrated pediatric TB services |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to two months
Secondary outcomes (9)
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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 8 to 14 months (2 months after treatment completion)
Adherence to the TB treatment
Adherence documented by seven-day recall and counting of pills
Measured: 6 to 12 months (at treatment completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start10 May 2019
- Primary completion30 Jun 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Cluster-randomized stepped-wedge model, where intervention will be randomly allocated to the different study sites at different time points.
- Masking
- None (open label)
- Enrolment
- 1,715 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elizabeth Glaser Pediatric AIDS Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- UNITAID, University of Sheffield, Kenya Ministry of Health, Ministry of Public Health, Cameroon
- Responsible party
- Sponsor
- Investigators
- Appolinaire Tiam, MBChB, MMed, Principal investigator, Elizabeth Glaser Pediatric AIDS Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03862261
- Sponsor's protocol ID
- EG0214
- Acronym
- INPUT
- Status last verified
- Mar 2022
- First submitted
- 12 Feb 2019
- Last updated
- 23 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 41221323Tchounga 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.
PubMed 40740312Katirayi 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.
PubMed 40017705Powell 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.
PubMed 37069518Denoeud-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.
PubMed 32375741
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Pediatric TB Services Into Child Healthcare Services in Africa. A Cluster-randomized Stepped-wedge Trial
- ClinicalTrials.gov ID
- NCT03862261
- Acronym / sponsor ID
- INPUT / EG0214
- Conditions
- Tuberculosis, Children, Only, Diagnosis, Delivery of Health Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,715 participants (actual)
- Lead sponsor
- Elizabeth Glaser Pediatric AIDS FoundationUniversity, hospital or other
- Collaborators
- UNITAID, University of Sheffield, Kenya Ministry of Health, Ministry of Public Health, Cameroon
- Study start
- 10 May 2019 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 5 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster-randomized stepped-wedge model, where intervention will be randomly allocated to the different study sites at different time points.
| Arm | Type | Receives |
|---|---|---|
| Standard-of-Care | No intervention | –Pediatric TB services based on current routine approach (national standard of care) |
| Intervention | Experimental | Other: Integrated pediatric TB servicesIntegrated pediatric TB services |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Children who are TB contacts but without symptoms or signs of active TB
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated pediatric TB servicespediatric 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. | Other | Intervention |
Primary outcome
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.
9 secondary outcomes
Proportion of children screened for TB
Time frame: one month
Proportion of screened children who have a sample collected
Time frame: up to three months
Proportion of children diagnosed with TB among presumptive TB cases
Time frame: up to two months
Time from screening to clinical or bacteriologic diagnosis
Time frame: up to three months
Time from diagnosis to treatment initiation
Time frame: up to three months
Proportion of cases with a bacteriologically confirmed diagnosis
Time frame: up to three months
Proportion of children who initiate TB treatment among those diagnosed
Time frame: up to two months
Treatment outcome
Time frame: 8 to 14 months (2 months after treatment completion)
Adherence to the TB treatment
Time frame: 6 to 12 months (at treatment completion)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2022.
- Derived from this study: PubMed 41221323Masaba 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.
- Derived from this study: PubMed 40740312Tchounga 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.
- Derived from this study: PubMed 40017705Katirayi 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.
- Derived from this study: PubMed 37069518Powell 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.
- Derived from this study: PubMed 32375741Denoeud-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Appolinaire Tiam, MBChB, MMed principal investigator
Elizabeth Glaser Pediatric AIDS Foundation
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated pediatric TB services in people with Tuberculosis and Children, Only, run by Elizabeth Glaser Pediatric AIDS Foundation at 12 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Cameroon, Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of children diagnosed with active TB (time frame: up to two months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03862261, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2022.