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Evaluatie en demonstratie van nieuwe tuberculose-diagnostiek voor Indonesië (EVIDENT)

23 september 2026 bijgewerkt door: Universitas Padjadjaran

Evaluatie en demonstratie van nieuwe tuberculose-diagnostiek voor Indonesië; Werkpakket 3: Gerandomiseerd geclusterd gecontroleerd onderzoek naar een diagnostisch pakket om het aantal gemelde tuberculosegevallen te verhogen

The goal of this cluster-randomised controlled trial (CRCT) is to learn whether the use of new non-sputum-based diagnostic tests and other intervention components for tuberculosis (TB) diagnosis in healthcare facilities (HCF) can increase TB notifications. The main questions it aims to answer are: (1) Does the diagnostic intervention package raise TB notifications by HCF?; (2) Does the diagnostic intervention package raise the proportion of patients with TB who are diagnosed with microbiological tests, lower the time needed for TB diagnosis, lower the number of visits to HCF before TB diagnosis, raise the use of TB tests by healthcare providers, and lower the costs for TB diagnosis?

Researchers will compare the diagnostic intervention package provided to HCFs and the community in the intervention arm with the standard of care in the control arm to assess the intervention's effect. Healthcare providers will be trained to provide diagnostic interventions to patients visiting their HCFs and to community residents in the areas surrounding HCFs.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

TB remains a critical public health problem worldwide. Most of the patients with TB were from low- and middle-income countries with limited resources. A large proportion of them visited HCFs without sufficient laboratory services to diagnose TB, causing a delay in TB diagnosis and treatment. In addition, while up to half of patients with presumptive TB cannot produce adequate sputum specimens, current TB diagnostics rely on sputum-based tests. Therefore, the use of near point-of-care (nPOC) or point-of-care (POC) non-sputum-based tests can potentially provide more accessible TB diagnosis and reduce delays.

This CRCT is part of a larger series of studies within the EVIDENT Research Project in Indonesia. Based on a clinical validation study (EVIDENT work package 1) and a diagnostic yield, feasibility, and cost study (EVIDENT work package 2), the CRCT (EVIDENT work package 3) will provide evidence of the effects of implementation of a multi-component public health intervention in the intervention arm, compared to the control arm. Carefully designed clinical algorithms will be employed to incorporate the new diagnostic test, using sputum and/or tongue swab specimens, into the health services. To increase patients' attendance and utilisation of the new diagnostic test, a promotional package will be provided to clinics unable to host it and to selected pharmacies. Finally, a household contact investigation will be conducted, involving community health volunteers.

Clusters are the community health centre (CHC) catchment areas, defined as geographical areas surrounding a CHC where the TB programme is expected to be implemented. The interventions will be administered in HCFs and the community in the intervention arm, while the control arm will continue standard of care with no intervention, except for refresher training on TB case notification into the National TB Information System (locally known as Sistem Informasi Tuberkulosis or SITB) before the intervention roll-out. The primary and secondary endpoints will be assessed over the 12-month post-intervention roll-out (follow-up period), with adjustment for baseline (12-month pre-randomisation period). TB case notification data will be obtained from the National TB Information System.

In addition to the main study, several sub-studies will be conducted to assess the secondary objectives: the Patient Pathway & Patient Costing Sub-study, the Standardised Patient Sub-study, and the Health System Costing Sub-study. The Patient Pathway & Patient Costing study is a cross-sectional study of patients recently diagnosed with TB at the selected HCF in the intervention and control arms. In the Standardised Patient Sub-study, trained standardised patients will visit selected HCFs to present a clinical scenario and record their experiences regarding examinations, diagnostic testing, and referrals. The health system costing study will gather information on the costs of diagnosing TB in HCFs and communities in the intervention and control arms.

Studietype

Ingrijpend

Inschrijving (Geschat)

40000

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Indonesië
    • West Java
      • Bandung, West Java, Indonesië, 40911
        • Werving
        • Bandung District Health Office
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

4 weken en ouder (Kind, Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  1. Aged between >28 days and 14 years old with the following symptoms:

    • Cough ≥2 weeks
    • Acute malnutrition
    • Weight loss or weight faltering during the past 3 months among those who had contact history with patients with TB in the past 12 months.

  2. Aged ≥15 years old who had a cough for ≥2 weeks or bloody cough, with or without the following symptoms:

    • Cough with/without sputum
    • Fever
    • Weight loss
    • Night sweat
    • Fatigue
    • Chest pain/discomfort
    • Breathlessness
    • Loss of appetite
    • Shivering

Exclusion Criteria:

  • Have started TB treatment or TB prophylaxis therapy.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Onderzoek naar gezondheidsdiensten
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Near Point-of-Care (nPOC) Testing

The intervention arm will comprise HCFs operating in the selected CHC catchment areas, including CHCs, public hospitals, private hospitals, private clinics, and private laboratories. A multi-component public health intervention package, which will incorporate nPOC testing for TB diagnosis, will be provided for these HCFs, including patients visiting the HCFs and the community residents in the selected CHC catchment areas.
Diagnostische toets: nPOC Testing Intervention Package

The intervention package will comprise:

  1. Introduction of a new-generation diagnostic test (nPOC test) into the HCFs;
  2. Optimisation of clinical algorithms with the incorporation of the new test;
  3. Promotional package to encourage patient attendance and utilisation of tests at HCFs by practitioners in the intervention areas;
  4. TB household contact investigation using the new test according to an algorithm with community health volunteers (cadres) involvement in the intervention areas.
Geen tussenkomst: Standard of Care

HCFs in the control arm will continue standard of care with no intervention, except for refresher training on reporting and notifying TB cases to the National TB Information System before the intervention package is rolled out.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in TB case notifications per population attending healthcare facilities
Tijdsspanne: The outcome is measured for the 12 months before the commencement of any study procedures and over the 12-month follow-up period, starting 6 months after the start of the intervention roll-out.

Difference in average TB notification rate per population attending healthcare facilities in intervention and control arms.
The outcome is measured for the 12 months before the commencement of any study procedures and over the 12-month follow-up period, starting 6 months after the start of the intervention roll-out.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in TB case notifications in CHC areas, who live in the area, per CHC area population
Tijdsspanne: The outcome is measured for the 12 months before the commencement of any study procedures and over the 12-month follow-up period, starting 6 months after the start of the intervention roll-out.

Difference in average TB notification rate among those who live in the CHC area, per CHC area population, in the intervention and control arms.
The outcome is measured for the 12 months before the commencement of any study procedures and over the 12-month follow-up period, starting 6 months after the start of the intervention roll-out.
Change in proportion of microbiologically confirmed TB cases over all diagnosed TB cases
Tijdsspanne: The outcome is measured over the 12 months before the commencement of any study procedures and over a 12-month follow-up period starting 6 months after the start of intervention roll-out.

The proportion of microbiologically confirmed TB cases among all diagnosed cases in healthcare facilities in the intervention and control arms.
The outcome is measured over the 12 months before the commencement of any study procedures and over a 12-month follow-up period starting 6 months after the start of intervention roll-out.
Difference in time to TB diagnosis from the beginning of symptoms (Patient Pathway and Patient Costing Sub-study)
Tijdsspanne: Up to 10 months during the follow-up period

The mean difference in days from symptom onset to TB diagnosis between the intervention and control arms.
Up to 10 months during the follow-up period
Difference in time to TB diagnosis from the first visit to a formal HCF (Patient Pathway and Patient Costing Sub-study)
Tijdsspanne: Up to 10 months during the follow-up period.

The mean difference in days from the first visit to a formal HCF to TB diagnosis between the intervention and control arms.
Up to 10 months during the follow-up period.
Number of visits to healthcare facilities before TB diagnosis (Patient Pathway and Patient Costing Sub-study)
Tijdsspanne: Up to 10 months during the follow-up period.

Ratio of the mean number of visits to HCF before TB diagnosis among patients with TB notified in the intervention arm to that in the control arm.
Up to 10 months during the follow-up period.
Propensity to test for TB (Standardised Patient Sub-study)
Tijdsspanne: Up to 6 months during the follow-up period

Odds ratio comparing the odds of a standardised patient visit correctly resulting in a test for TB in the intervention and control arms.
Up to 6 months during the follow-up period
Patient costs for TB diagnosis (Patient Pathway and Patient Cost Sub-study)
Tijdsspanne: Up to 10 months during the follow-up period.

Patient costs include medical and non-medical costs. Patient cost data will be collected from patients with TB diagnosed at CHCs, clinics, or hospitals. The patient cost data will be grouped into those diagnosed in the intervention and control arms.
Up to 10 months during the follow-up period.
TB diagnostic costs in the healthcare facilities and community settings (Health System Costing Sub-study)
Tijdsspanne: Up to 6 months during the follow-up period.

Health system costs will include building, equipment, supplies, training, and salary costs associated with TB diagnosis in the HCFs and community settings. Each cost will be grouped based on the intervention and control arms.
Up to 6 months during the follow-up period.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Universitas Padjadjaran

Medewerkers

Radboud University Medical Center
Bill and Melinda Gates Foundation
University of Otago
University of Melbourne
Universitas Sebelas Maret

Onderzoekers

  • Hoofdonderzoeker: Bachti Alisjahbana, Professor, MD, PhD, Research Center for Care and Control of Infectious Diseases Universitas Padjadjaran (RC3ID Unpad)

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 april 2026

Primaire voltooiing (Geschat)

31 maart 2027

Studie voltooiing (Geschat)

31 oktober 2027

Studieregistratiedata

Eerst ingediend

5 december 2025

Eerst ingediend dat voldeed aan de QC-criteria

5 december 2025

Eerst geplaatst (Werkelijk)

19 december 2025

Updates van studierecords

Laatste update geplaatst (Werkelijk)

25 september 2026

Laatste update ingediend die voldeed aan QC-criteria

23 september 2026

Laatst geverifieerd

1 februari 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • TBWG-202511.01

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

This CRCT aims to evaluate the effect of the diagnostic intervention package at the cluster level, including context-specific clinical algorithms that may greatly vary from those in other settings. The primary study outcomes will also be reported at the cluster level.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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