Evaluation and Demonstration of New Tuberculosis Diagnostics for Indonesia

NCT ID: NCT07293455

Last Updated: 2025-12-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-03-31
• Study Completion Date: 2027-10-31

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.

Detailed Description

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.

Conditions

Tuberculosis

Keywords

Tuberculosis; Diagnosis; Tongue swab; Near point-of-care test; Cluster randomised controlled trial

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Intervention Arm

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 will be provided for these HCFs, including patients visiting the HCFs and the community residents in the selected CHC catchment areas.

Group Type: ACTIVE_COMPARATOR

Multi-component public health intervention

Intervention Type: OTHER

The intervention will comprise:

1. Introduction of a new-generation diagnostic 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.

Control Arm

HCFs in the control arm will receive no intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Multi-component public health intervention

The intervention will comprise:

1. Introduction of a new-generation diagnostic 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 29 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bill and Melinda Gates Foundation

OTHER

Sponsor Role: collaborator

Universitas Padjadjaran

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bachti Alisjahbana, Professor, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Research Center for Care and Control of Infectious Diseases Universitas Padjadjaran

Locations

Bandung District Health Office

Bandung, West Java, Indonesia

Countries

Indonesia

Central Contacts

EVIDENT Study Contact Centre

Role: CONTACT

Phone: +6281324285417

Email: evident.pokja3@gmail.com

Nur Afifah, MD

Role: CONTACT

Email: nurafifah3393@gmail.com

Facility Contacts

Bandung District Health Office

Role: primary

References

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.

Reference Type: RESULT

PMID: 34327397 (View on PubMed)

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.

Reference Type: RESULT

PMID: 19426477 (View on PubMed)

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.

Reference Type: RESULT

PMID: 37127703 (View on PubMed)

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.

Reference Type: RESULT

PMID: 38097297 (View on PubMed)

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.

Reference Type: RESULT

PMID: 38306491 (View on PubMed)

Related Links

https://evident.rc3id.unpad.ac.id/

EVIDENT Indonesia Official Website

Other Identifiers

TBWG-202511.01

Identifier Type: -

Identifier Source: org_study_id