TuberculosisEVIDENTNCT07293455
Evaluation and Demonstration of New Tuberculosis Diagnostics for Indonesia
A study testing nPOC Testing Intervention Package in people with Tuberculosis, run by Universitas Padjadjaran at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 29 days and older
- Conditions the study is for
- Tuberculosis
- What is being tested?
- nPOC Testing Intervention Package
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40,000 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Apr 2026to 31 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 29 days and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- Fever
- Weight loss
- Night sweat
- Fatigue
- Chest pain/discomfort
- Breathlessness
- Loss of appetite
- Shivering
Who cannot join
- Have started TB treatment or TB prophylaxis therapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Nur Afifah, MD, MSc contact
Indonesia1 site, 1 recruiting
- Recruiting
Bandung District Health Office
Bandung, West Java, 40911
Bandung District Health Office, +62225897520, dinkes@bandungkab.go.id
About this study
Official title: Evaluation and Demonstration of New Tuberculosis Diagnostics for Indonesia; Work Package 3: Cluster Randomised Controlled Trial of A Diagnostic Package to Increase the Number of Tuberculosis Cases Notified
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.
Read the 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
- Being tested
- nPOC Testing Intervention Package
- Keywords
- Tuberculosis, Diagnosis, Tongue swab, Near point-of-care test, Cluster randomised controlled trial
- Medical subject headings
- Tuberculosis, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nPOC Testing Intervention PackageDiagnostic test
The intervention package will comprise:
- Introduction of a new-generation diagnostic test (nPOC test) into the HCFs;
- Optimisation of clinical algorithms with the incorporation of the new test;
- Promotional package to encourage patient attendance and utilisation of tests at HCFs by practitioners in the intervention areas;
- TB household contact investigation using the new test according to an algorithm with community health volunteers (cadres) involvement in the intervention areas.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Difference in average TB notification rate among those who live in the CHC area, per CHC area population, in the intervention and control arms.
Measured: 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 proportion of microbiologically confirmed TB cases among all diagnosed cases in healthcare facilities in the intervention and control arms.
Measured: 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)
The mean difference in days from symptom onset to TB diagnosis between the intervention and control arms.
Measured: 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)
The mean difference in days from the first visit to a formal HCF to TB diagnosis between the intervention and control arms.
Measured: 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)
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.
Measured: Up to 10 months during the follow-up period.
Propensity to test for TB (Standardised Patient Sub-study)
Odds ratio comparing the odds of a standardised patient visit correctly resulting in a test for TB in the intervention and control arms.
Measured: Up to 6 months during the follow-up period
Patient costs for TB diagnosis (Patient Pathway and Patient Cost Sub-study)
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.
Measured: Up to 10 months during the follow-up period.
TB diagnostic costs in the healthcare facilities and community settings (Health System Costing Sub-study)
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.
Measured: Up to 6 months during the follow-up period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start1 Apr 2026
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Padjadjaran
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, University of Otago, University of Melbourne, Radboud University Medical Center, Universitas Sebelas Maret
- Responsible party
- Sponsor
- Investigators
- Bachti Alisjahbana, Professor, MD, PhD, Principal investigator, Research Center for Care and Control of Infectious Diseases Universitas Padjadjaran (RC3ID Unpad)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07293455
- Sponsor's protocol ID
- TBWG-202511.01
- Acronym
- EVIDENT
- Status last verified
- Feb 2026
- First submitted
- 5 Dec 2025
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 34327397Sakundarno 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.
PubMed 19426477Pai 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.
PubMed 37127703Church 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.
PubMed 38097297Steadman 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.
PubMed 38306491
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Demonstration of New Tuberculosis Diagnostics for Indonesia; Work Package 3: Cluster Randomised Controlled Trial of A Diagnostic Package to Increase the Number of Tuberculosis Cases Notified
- ClinicalTrials.gov ID
- NCT07293455
- Acronym / sponsor ID
- EVIDENT / TBWG-202511.01
- Conditions
- Tuberculosis
- Keywords
- Tuberculosis, Diagnosis, Tongue swab, Near point-of-care test, Cluster randomised controlled trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40,000 participants (estimated)
- Lead sponsor
- Universitas PadjadjaranUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, University of Otago, University of Melbourne, Radboud University Medical Center, Universitas Sebelas Maret
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 19 Dec 2025 (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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Near Point-of-Care (nPOC) Testing | Active comparator | Diagnostic Test: nPOC Testing Intervention PackageThe 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. |
| 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. |
Who may qualify
- Ages
- 29 days and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- Aged between >28 days and 14 years old with the following symptoms:
- Aged ≥15 years old who had a cough for ≥2 weeks or bloody cough, with or without the following symptoms:
Key exclusion criteria (1 listed)
- Have started TB treatment or TB prophylaxis therapy.
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 |
|---|---|---|
| nPOC Testing Intervention PackageThe 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. | Diagnostic test | Near Point-of-Care (nPOC) Testing |
Primary outcome
Change in TB case notifications per population attending healthcare facilities
Time frame: 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.
8 secondary outcomes
Change in TB case notifications in CHC areas, who live in the area, per CHC area population
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Up to 10 months during the follow-up period.
Propensity to test for TB (Standardised Patient Sub-study)
Time frame: Up to 6 months during the follow-up period
Patient costs for TB diagnosis (Patient Pathway and Patient Cost Sub-study)
Time frame: Up to 10 months during the follow-up period.
TB diagnostic costs in the healthcare facilities and community settings (Health System Costing Sub-study)
Time frame: Up to 6 months during the follow-up period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Background: PubMed 34327397Lestari 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.
- Background: PubMed 19426477Sakundarno 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.
- Background: PubMed 37127703Pai 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.
- Background: PubMed 38097297Church 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.
- Background: PubMed 38306491Steadman 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.
- EVIDENT Indonesia Official WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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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.
Nur Afifah, MD, MSc contact
Bachti Alisjahbana, Professor, MD, PhD principal investigator
Research Center for Care and Control of Infectious Diseases Universitas Padjadjaran (RC3ID Unpad)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nPOC Testing Intervention Package in people with Tuberculosis, run by Universitas Padjadjaran at 1 site in Indonesia.
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 14 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: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact EVIDENT Study Contact Centre (+6281324285417, evident.pokja3@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in TB case notifications per population attending healthcare facilities (time frame: 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.). 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 NCT07293455, 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 25 Sep 2026.