NCT07293455

Brief Summary

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40,000

participants targeted

Target at P75+ for not_applicable

Timeline
17mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress12%
Mar 2026Oct 2027

First Submitted

Initial submission to the registry

December 5, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 19, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

February 10, 2026

Status Verified

February 1, 2026

Enrollment Period

11 months

First QC Date

December 5, 2025

Last Update Submit

February 6, 2026

Conditions

Tuberculosis

Keywords

TuberculosisDiagnosisTongue swabNear point-of-care testCluster randomised controlled trial

Outcome Measures

Primary Outcomes (1)

  • Change in TB case notifications per population attending healthcare facilities

    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.

Secondary Outcomes (8)

  • Change in TB case notifications in CHC areas, who live in the area, per CHC area population

    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

    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)

    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)

    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)

    Up to 10 months during the follow-up period.

  • +3 more secondary outcomes

Study Arms (2)

Near Point-of-Care (nPOC) Testing

ACTIVE COMPARATOR

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.

Diagnostic Test: nPOC Testing Intervention Package

Standard of Care

NO INTERVENTION

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.

Interventions

nPOC Testing Intervention PackageDIAGNOSTIC_TEST

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.

Near Point-of-Care (nPOC) Testing

Eligibility Criteria

Age29 Days+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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

You may not qualify if:

  • Have started TB treatment or TB prophylaxis therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bandung District Health Office

Bandung, West Java, 40911, Indonesia

Location

Related Publications (5)

  • Lestari BW, McAllister S, Hadisoemarto PF, Afifah N, Jani ID, Murray M, van Crevel R, Hill PC, Alisjahbana B. Patient pathways and delays to diagnosis and treatment of tuberculosis in an urban setting in Indonesia. Lancet Reg Health West Pac. 2020 Nov 28;5:100059. doi: 10.1016/j.lanwpc.2020.100059. eCollection 2020 Dec.

    PMID: 34327397BACKGROUND

  • Sakundarno M, Nurjazuli N, Jati SP, Sariningdyah R, Purwadi S, Alisjahbana B, van der Werf MJ. Insufficient quality of sputum submitted for tuberculosis diagnosis and associated factors, in Klaten district, Indonesia. BMC Pulm Med. 2009 May 8;9:16. doi: 10.1186/1471-2466-9-16.

    PMID: 19426477BACKGROUND

  • Pai M, Dewan PK, Swaminathan S. Transforming tuberculosis diagnosis. Nat Microbiol. 2023 May;8(5):756-759. doi: 10.1038/s41564-023-01365-3. No abstract available.

    PMID: 37127703BACKGROUND

  • Church EC, Steingart KR, Cangelosi GA, Ruhwald M, Kohli M, Shapiro AE. Oral swabs with a rapid molecular diagnostic test for pulmonary tuberculosis in adults and children: a systematic review. Lancet Glob Health. 2024 Jan;12(1):e45-e54. doi: 10.1016/S2214-109X(23)00469-2.

    PMID: 38097297BACKGROUND

  • Steadman A, Andama A, Ball A, Mukwatamundu J, Khimani K, Mochizuki T, Asege L, Bukirwa A, Kato JB, Katumba D, Kisakye E, Mangeni W, Mwebe S, Nakaye M, Nassuna I, Nyawere J, Nakaweesa A, Cook C, Phillips P, Nalugwa T, Bachman CM, Semitala FC, Weigl BH, Connelly J, Worodria W, Cattamanchi A. New Manual Quantitative Polymerase Chain Reaction Assay Validated on Tongue Swabs Collected and Processed in Uganda Shows Sensitivity That Rivals Sputum-based Molecular Tuberculosis Diagnostics. Clin Infect Dis. 2024 May 15;78(5):1313-1320. doi: 10.1093/cid/ciae041.

    PMID: 38306491BACKGROUND

Related Links

MeSH Terms

Conditions

TuberculosisDisease

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Bachti Alisjahbana, Professor, MD, PhD

    Research Center for Care and Control of Infectious Diseases Universitas Padjadjaran

    PRINCIPAL INVESTIGATOR

Central Study Contacts

EVIDENT Study Contact Centre

CONTACT

+6281324285417evident.pokja3@gmail.com

Nur Afifah, MD, MSc

CONTACT

nurafifah3393@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Statisticians and investigators who will conduct the primary data analysis.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2025

First Posted

December 19, 2025

Study Start

March 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

February 10, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

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.

Locations

ID(1)