Pulmonary TuberculosisTB TRIAGE+NCT04666311
Diagnostic Accuracy of CAD4TB and C-reactive Protein Assay as Triage Tests for Pulmonary Tuberculosis
An observational study of Pulmonary Tuberculosis and Tuberculosis Diagnosis, run by Klaus Reither at 2 sites in 2 countries.
Trial summary
In the TB TRIAGE+ ACCURACY study, the accuracy of the following products will be determined: CAD4TB (Delft Imaging System, NL), a digital chest x-ray analysis software Afinion CRP assay (Alere Afinion, USA), which detects a cytokine induced acute phase protein CAD4TB and the C-reactive protein assay are two tests with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Tuberculosis, Tuberculosis Diagnosis, Covid-19
- What is being tested?
- Accuracy of CAD4TB and Afinion CRP assay for pulmonary TB and CAD4COVID+WBC and COVID-19 RDT for SARS-CoV-2 infection
- How many people
- 1,400 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 15 Feb 2021to 11 Aug 2022
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult presumptive TB cases (age ≥18years) with one or more TB symptoms (WHO recommended four-symptom screening; cough, weight loss, night sweats, fever) of any duration. Presumptive TB patients will be recruited (i) at the outpatient departments of the Butha-Buthe District Hospital (Butha-Buthe, Lesotho) and the Caluza Clinic (Pietermaritzburg, KwaZulu-Natal, South Africa) and (ii) during community-based health campaigns by SolidarMed in Lesotho and HSRC in South Africa.
Who may be able to join
- Willing and able to provide signed written consent or witnessed oral consent in the case of illiteracy, prior to undertaking any study-related procedure
- Adults (≥18 years)
- Any of the cardinal symptoms of TB (cough, weight loss, night sweats, fever) of any duration
Who cannot join
- Pregnancy (based on oral information from participant)
- Any condition for which participation in the study, as judged by the investigator, could compromise the well-being of the subject or prevent, limit or confound protocol specified assessments
- Critically sick patients who need immediate medical care
- Current anti-TB treatment
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Prospective, Multicentre Evaluation of the Accuracy of CAD4TB and C-reactive Protein Assay as Triage Tests for the Diagnosis of Pulmonary Tuberculosis in Presumptive Adult TB Patients (TB TRIAGE+ Accuracy)
In the TB TRIAGE+ ACCURACY study, the accuracy of the following products will be determined:
- CAD4TB (Delft Imaging System, NL), a digital chest x-ray analysis software
- Afinion CRP assay (Alere Afinion, USA), which detects a cytokine induced acute phase protein
Read more
CAD4TB and the C-reactive protein assay are two tests with great potential of becoming a triage test for the diagnosis of tuberculosis (TB). These potential triage tests for TB are intended to serve as rule-out tests with a high sensitivity and negative predictive value.
Before impact and cost-effectiveness of new TB triage tests for intensified active case finding can be determined, the diagnostic test accuracy needs to be assessed in comparison to confirmatory reference tests. This accuracy study will define cut-off values for CAD4TB as well as for the Afinion CRP assay to be used in a future cluster-randomised trial on impact and cost-effectiveness of TB triage strategies for intensified active case finding in Lesotho and KwaZulu-Natal, South Africa.
A sub-study (detailed in a separate study protocol), hereafter called AHD-FEASIBILITY, explores the feasibility of implementing a series of point-of-care tests, including the new VISITECT CD4 Advanced Disease Test (Omega Diagnostics, UK) as part of the WHO-recommended advanced HIV Disease care package in the context of community-based HIV/TB campaigns.
Due to the coinciding pandemics and the overlapping symptoms of TB and COVID-19, it is critical to test for SARS-Cov-2 infections in the study population. In addition, this study will contribute to the evaluation of a novel SARS-Cov-2 antigen rapid diagnostic test (from the diagnostic pipeline of FIND) and CAD4COVID, a digital chest x-ray analysis software (Delft Imaging System, NL) in combination with differential white blood cell count.
Read the detailed description
This is a prospective, partially blinded, two-centre cross-sectional study in which the diagnostic test accuracy of CAD4TB and an Afinion CRP assay test for TB will be assessed at facility level by evaluating a sample of 1400 adults (age ≥18years) with one or more TB symptoms (WHO recommended four-symptom screening; cough, weight loss, night sweats, fever) of any duration.
Presumptive TB patients will be recruited (i) at the outpatient departments of the Butha-Buthe District Hospital (Butha-Buthe, Lesotho) and the Caluza Clinic (Pietermaritzburg, KwaZulu-Natal, South Africa) and (ii) during community-based health campaigns by SolidarMed in Lesotho and HSRC in South Africa. Participants will be enrolled after giving written informed consent.
Study procedures comprise the following (detailed in the schedule of events): collection of contact, anthropometric, demographic and clinical data, HIV testing and counselling per national guidelines, collection of capillary blood for HIV testing, Afinion CRP assay, differential white blood cell count, VISITECT CD4 Advanced Disease Test (if HIV-positive), CrAg Lateral Flow Assay (if HIV positive and CD4 count <200 cells/μl as per VISITECT CD4 Advanced Disease Test, and no history of cryptococcal meningitis treatment); collection of urine (if HIV positive) for Alere Determine TB LAM Ag test; chest radiography for CAD4TB and CAD4COVID analysis and remote expert reading; nasopharyngeal swabs for SARS-Cov-2 real-time PCR and SARS-Cov-2 antigen test, collection of two spot sputa samples (S1,S2) for Xpert MTB/RIF, Xpert MTB/RIF Ultra (S1) and for mycobacterial culture [MGIT] (S2). At week 12 (±2weeks), we will contact each participant by phone and collect data on their vital status, and any TB treatment since enrolment. For individuals on TB treatment, further information, e.g. on reasons for empirical treatment, will be collected at the health facility the participant started TB treatment.
- Conditions
- Pulmonary Tuberculosis, Tuberculosis Diagnosis, Covid-19, HIV
- Being tested
- Accuracy of CAD4TB and Afinion CRP assay for pulmonary TB, CAD4COVID+WBC and COVID-19 RDT for SARS-CoV-2 infection
- Keywords
- Presumptive adult TB, C Reactive Protein assay, CAD4TB, Point of Care Test, TB Triage Test, Diagnostic Accuracy, CAD4COVID, COVID-19 RDT, Advanced HIV Disease (AHD) care package, HIV testing, Community-based triage testing for TB
- Medical subject headings
- Tuberculosis, Pulmonary, COVID-19, Alagille Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accuracy of CAD4TB and Afinion CRP assay for pulmonary TBDiagnostic test
CAD4TB version 6 and 7: Software tool for detecting lung abnormalities in computer tomogram images (pulmonary abnormalities) and frontal chest radiograph images (tuberculosis abnormalities) ; availability is guaranteed by Delft Imaging System; EC 0344 Certificate (vs.6); CE mark pending (vs.7). Will be performed by a registered and qualified radiographer in accordance with national regulations.
Afinion AS100 Analyzer and Afinion CRP: In vitro diagnostic to determine the amount of CRP in human whole blood, serum or plasma; CE-mark ; Will be performed by qualified, GCP-trained study personnel.
CAD4COVID+WBC and COVID-19 RDT for SARS-CoV-2 infectionDiagnostic test
CAD4COVID: Non-commercial product. Software tool for detecting pneumonia-related features to be expected in COVID-19 patients; availability is guaranteed by Delft Imaging System; CE certified. Will be performed by a registered and qualified radiographer/health professional in accordance with national regulations. Analysis in combination with differential white blood cell count.
SD Biosensor, STANDARDTM Q COVID-19 Ag Test (rapid chromatographic immunoassay for the qualitative detection of specific antigens to SARS-CoV-2)
| Study group | Role | What they receive |
|---|---|---|
| Adult presumptive TB cases | Adult presumptive TB cases (age ≥18years) with one or more TB symptoms (WHO recommended four-symptom screening; cough, weight loss, night sweats, fever) of any duration. Receives: Diagnostic Test: Accuracy of CAD4TB and Afinion CRP assay for pulmonary TB; Diagnostic Test: CAD4COVID+WBC and COVID-19 RDT for SARS-CoV-2 infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine CAD4TB cut-off value
Receiver operating characteristic analysis (ROC) of CAD4TB against a composite microbiological reference standard (mycobacterial culture [MGIT] or Xpert MTB/RIF) to define an acceptable diagnostic cut-off value.
Measured: 15 months after first patient visit
Determine Afinion CRP assay cut-off value
Receiver operating characteristic analysis (ROC) of Afinion CRP assay against a composite microbiological reference standard (mycobacterial culture [MGIT] or Xpert MTB/RIF) to define an acceptable diagnostic cut-off value.
Measured: 15 months after first patient visit
Secondary outcomes (3)
Evaluate CAD4TB ROC against reference standard
Receiver operating characteristic analysis (ROC) of CAD4TB against a single microbiological reference standard (mycobacterial culture [MGIT] alone, Xpert MTB/RIF alone, Xpert MTB/RIF Ultra alone), against a composite reference standard and against a radiological reference standard
Measured: 15 months after first patient visit
Evaluate Afinion CRP assay ROC against reference standard
Receiver operating characteristic analysis (ROC) of Afinion CRP assay against a single microbiological reference standard (mycobacterial culture [MGIT] alone, Xpert MTB/RIF alone, Xpert MTB/RIF Ultra alone) and against a composite reference standard
Measured: 15 months after first patient visit
Evaluate CAD4COVID and COVID-19 RDT ROC against reference standard
Receiver operating characteristic analysis (ROC) of CAD4COVID combined with differential white blood cell count and point estimates of sensitivity and specificity the novel SARS-Cov-2 antigen rapid diagnostic test, both against a single microbiological reference standard (SARS-Cov-2 real-time PCR)
Measured: 15 months after first patient visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start15 Feb 2021
- Primary completion5 Apr 2022
- Study completion11 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pulmonary 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klaus Reither
- Sponsor type
- University, hospital or other
- Collaborators
- SolidarMed, Human Sciences Research Council, Institute of Tropical Medicine, Belgium, Radboud University Medical Center, Charite University, Berlin, Germany, University Hospital, Basel, Switzerland, Foundation for Innovative New Diagnostics, Switzerland, European and Developing Countries Clinical Trials Partnership (EDCTP), Ministry of Health, Lesotho
- Responsible party
- Sponsor-investigator, Klaus Reither, Swiss Tropical & Public Health Institute
- Investigators
- Klaus Reither, MD, PhD, Principal investigator, Swiss Tropical & Public Health Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04666311
- Sponsor's protocol ID
- P1685-20A
- Acronym
- TB TRIAGE+
- Status last verified
- Sep 2025
- First submitted
- 7 Dec 2020
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be stored securely in a way that allows future access for the research team. We will adhere to the FAIR Guiding Principles for data management and stewardship 20. After completion of the studies and after anonymization (e.g. replace subject identifier with a new random subject identifier), analysis datasets will be made publicly available in a timely manner on a non-commercial data platform according to the FAIR principles. The principles of data sharing will be explained in the informed consent form. All data will be owned by the Sponsor-Investigator and investigators of TB TRIAGE+, while a Data Access Committee will review all requests for data sharing.
Publications
Glaser N, Bosman S, Madonsela T, van Heerden A, Mashaete K, Katende B, Ayakaka I, Murphy K, Signorell A, Lynen L, Bremerich J, Reither K. Incidental radiological findings during clinical tuberculosis screening in Lesotho and South Africa: a case series. J Med Case Rep. 2023 Aug 25;17(1):365. doi: 10.1186/s13256-023-04097-4.
PubMed 37620921Bosman S, Ayakaka I, Muhairwe J, Kamele M, van Heerden A, Madonsela T, Labhardt ND, Sommer G, Bremerich J, Zoller T, Murphy K, van Ginneken B, Keter AK, Jacobs BKM, Bresser M, Signorell A, Glass TR, Lynen L, Reither K. Evaluation of C-Reactive Protein and Computer-Aided Analysis of Chest X-rays as Tuberculosis Triage Tests at Health Facilities in Lesotho and South Africa. Clin Infect Dis. 2024 Nov 22;79(5):1293-1302. doi: 10.1093/cid/ciae378.
PubMed 39190813Gils T, Lynen L, Muhairwe J, Mashaete K, Lejone TI, Joseph P, Ngubane T, Keter AK, Reither K, van Heerden A. Feasibility of implementing the advanced HIV disease care package as part of community-based HIV/TB activities: a mixed-methods study protocol. BMJ Open. 2022 Feb 7;12(2):e057291. doi: 10.1136/bmjopen-2021-057291.
PubMed 35131835
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicentre Evaluation of the Accuracy of CAD4TB and C-reactive Protein Assay as Triage Tests for the Diagnosis of Pulmonary Tuberculosis in Presumptive Adult TB Patients (TB TRIAGE+ Accuracy)
- ClinicalTrials.gov ID
- NCT04666311
- Acronym / sponsor ID
- TB TRIAGE+ / P1685-20A
- Conditions
- Pulmonary Tuberculosis, Tuberculosis Diagnosis, Covid-19, HIV
- Keywords
- Presumptive adult TB, C Reactive Protein assay, CAD4TB, Point of Care Test, TB Triage Test, Diagnostic Accuracy, CAD4COVID, COVID-19 RDT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,400 participants (actual)
- Lead sponsor
- Klaus ReitherUniversity, hospital or other
- Collaborators
- SolidarMed, Human Sciences Research Council, Institute of Tropical Medicine, Belgium, Radboud University Medical Center, Charite University, Berlin, Germany, University Hospital, Basel, Switzerland, Foundation for Innovative New Diagnostics, Switzerland, European and Developing Countries Clinical Trials Partnership (EDCTP), Ministry of Health, Lesotho
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 5 Apr 2022 (actual)
- Study completion
- 11 Aug 2022 (actual)
- First posted
- 14 Dec 2020 (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.
In the TB TRIAGE+ ACCURACY study, the accuracy of the following products will be determined:
- CAD4TB (Delft Imaging System, NL), a digital chest x-ray analysis software
- Afinion CRP assay (Alere Afinion, USA), which detects a cytokine induced acute phase protein
CAD4TB and the C-reactive protein assay are two tests with great potential of becoming a triage test for the diagnosis of tuberculosis (TB). These potential triage tests for TB are intended to serve as rule-out tests with a high sensitivity and negative predictive value.
Before impact and cost-effectiveness of new TB triage tests for intensified active case finding can be determined, the diagnostic test accuracy needs to be assessed in comparison to confirmatory reference tests. This accuracy study will define cut-off values for CAD4TB as well as for the Afinion CRP assay to be used in a future cluster-randomised trial on impact and cost-effectiveness of TB triage strategies for intensified active case finding in Lesotho and KwaZulu-Natal, South Africa.
A sub-study (detailed in a separate study protocol), hereafter called AHD-FEASIBILITY, explores the feasibility of implementing a series of point-of-care tests, including the new VISITECT CD4 Advanced Disease Test (Omega Diagnostics, UK) as part of the WHO-recommended advanced HIV Disease care package in the context of community-based HIV/TB campaigns.
Due to the coinciding pandemics and the overlapping symptoms of TB and COVID-19, it is critical to test for SARS-Cov-2 infections in the study population. In addition, this study will contribute to the evaluation of a novel SARS-Cov-2 antigen rapid diagnostic test (from the diagnostic pipeline of FIND) and CAD4COVID, a digital chest x-ray analysis software (Delft Imaging System, NL) in combination with differential white blood cell count.
Detailed description
This is a prospective, partially blinded, two-centre cross-sectional study in which the diagnostic test accuracy of CAD4TB and an Afinion CRP assay test for TB will be assessed at facility level by evaluating a sample of 1400 adults (age ≥18years) with one or more TB symptoms (WHO recommended four-symptom screening; cough, weight loss, night sweats, fever) of any duration.
Presumptive TB patients will be recruited (i) at the outpatient departments of the Butha-Buthe District Hospital (Butha-Buthe, Lesotho) and the Caluza Clinic (Pietermaritzburg, KwaZulu-Natal, South Africa) and (ii) during community-based health campaigns by SolidarMed in Lesotho and HSRC in South Africa. Participants will be enrolled after giving written informed consent.
Study procedures comprise the following (detailed in the schedule of events): collection of contact, anthropometric, demographic and clinical data, HIV testing and counselling per national guidelines, collection of capillary blood for HIV testing, Afinion CRP assay, differential white blood cell count, VISITECT CD4 Advanced Disease Test (if HIV-positive), CrAg Lateral Flow Assay (if HIV positive and CD4 count <200 cells/μl as per VISITECT CD4 Advanced Disease Test, and no history of cryptococcal meningitis treatment); collection of urine (if HIV positive) for Alere Determine TB LAM Ag test; chest radiography for CAD4TB and CAD4COVID analysis and remote expert reading; nasopharyngeal swabs for SARS-Cov-2 real-time PCR and SARS-Cov-2 antigen test, collection of two spot sputa samples (S1,S2) for Xpert MTB/RIF, Xpert MTB/RIF Ultra (S1) and for mycobacterial culture [MGIT] (S2). At week 12 (±2weeks), we will contact each participant by phone and collect data on their vital status, and any TB treatment since enrolment. For individuals on TB treatment, further information, e.g. on reasons for empirical treatment, will be collected at the health facility the participant started TB treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult presumptive TB cases | – | Diagnostic Test: Accuracy of CAD4TB and Afinion CRP assay for pulmonary TB, Diagnostic Test: CAD4COVID+WBC and COVID-19 RDT for SARS-CoV-2 infectionAdult presumptive TB cases (age ≥18years) with one or more TB symptoms (WHO recommended four-symptom screening; cough, weight loss, night sweats, fever) of any duration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult presumptive TB cases (age ≥18years) with one or more TB symptoms (WHO recommended four-symptom screening; cough, weight loss, night sweats, fever) of any duration. Presumptive TB patients will be recruited (i) at the outpatient departments of the Butha-Buthe District Hospital (Butha-Buthe, Lesotho) and the Caluza Clinic (Pietermaritzburg, KwaZulu-Natal, South Africa) and (ii) during community-based health campaigns by SolidarMed in Lesotho and HSRC in South Africa.
Key inclusion criteria (3 listed)
- Willing and able to provide signed written consent or witnessed oral consent in the case of illiteracy, prior to undertaking any study-related procedure
- Adults (≥18 years)
- Any of the cardinal symptoms of TB (cough, weight loss, night sweats, fever) of any duration
Key exclusion criteria (4 listed)
- Pregnancy (based on oral information from participant)
- Any condition for which participation in the study, as judged by the investigator, could compromise the well-being of the subject or prevent, limit or confound protocol specified assessments
- Critically sick patients who need immediate medical care
- Current anti-TB treatment
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 |
|---|---|---|
| Accuracy of CAD4TB and Afinion CRP assay for pulmonary TBCAD4TB version 6 and 7: Software tool for detecting lung abnormalities in computer tomogram images (pulmonary abnormalities) and frontal chest radiograph images (tuberculosis abnormalities) ; availability is guaranteed by Delft Imaging System; EC 0344 Certificate (vs.6); CE mark pending (vs.7). Will be performed by a registered and qualified radiographer in accordance with national regulations. Afinion AS100 Analyzer and Afinion CRP: In vitro diagnostic to determine the amount of CRP in human whole blood, serum or plasma; CE-mark ; Will be performed by qualified, GCP-trained study personnel. | Diagnostic test | Adult presumptive TB cases |
| CAD4COVID+WBC and COVID-19 RDT for SARS-CoV-2 infectionCAD4COVID: Non-commercial product. Software tool for detecting pneumonia-related features to be expected in COVID-19 patients; availability is guaranteed by Delft Imaging System; CE certified. Will be performed by a registered and qualified radiographer/health professional in accordance with national regulations. Analysis in combination with differential white blood cell count. SD Biosensor, STANDARDTM Q COVID-19 Ag Test (rapid chromatographic immunoassay for the qualitative detection of specific antigens to SARS-CoV-2) | Diagnostic test | Adult presumptive TB cases |
Primary outcome
Determine CAD4TB cut-off value
Time frame: 15 months after first patient visit
Receiver operating characteristic analysis (ROC) of CAD4TB against a composite microbiological reference standard (mycobacterial culture [MGIT] or Xpert MTB/RIF) to define an acceptable diagnostic cut-off value.
Determine Afinion CRP assay cut-off value
Time frame: 15 months after first patient visit
Receiver operating characteristic analysis (ROC) of Afinion CRP assay against a composite microbiological reference standard (mycobacterial culture [MGIT] or Xpert MTB/RIF) to define an acceptable diagnostic cut-off value.
3 secondary outcomes
Evaluate CAD4TB ROC against reference standard
Time frame: 15 months after first patient visit
Evaluate Afinion CRP assay ROC against reference standard
Time frame: 15 months after first patient visit
Evaluate CAD4COVID and COVID-19 RDT ROC against reference standard
Time frame: 15 months after first patient visit
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 22 Sep 2025.
- Results publication: PubMed 37620921Glaser N, Bosman S, Madonsela T, van Heerden A, Mashaete K, Katende B, Ayakaka I, Murphy K, Signorell A, Lynen L, Bremerich J, Reither K. Incidental radiological findings during clinical tuberculosis screening in Lesotho and South Africa: a case series. J Med Case Rep. 2023 Aug 25;17(1):365. doi: 10.1186/s13256-023-04097-4.
- Results publication: PubMed 39190813Bosman S, Ayakaka I, Muhairwe J, Kamele M, van Heerden A, Madonsela T, Labhardt ND, Sommer G, Bremerich J, Zoller T, Murphy K, van Ginneken B, Keter AK, Jacobs BKM, Bresser M, Signorell A, Glass TR, Lynen L, Reither K. Evaluation of C-Reactive Protein and Computer-Aided Analysis of Chest X-rays as Tuberculosis Triage Tests at Health Facilities in Lesotho and South Africa. Clin Infect Dis. 2024 Nov 22;79(5):1293-1302. doi: 10.1093/cid/ciae378.
- Derived from this study: PubMed 35131835Gils T, Lynen L, Muhairwe J, Mashaete K, Lejone TI, Joseph P, Ngubane T, Keter AK, Reither K, van Heerden A. Feasibility of implementing the advanced HIV disease care package as part of community-based HIV/TB activities: a mixed-methods study protocol. BMJ Open. 2022 Feb 7;12(2):e057291. doi: 10.1136/bmjopen-2021-057291.
- Individual participant dataSharing planned: Yes. All data will be stored securely in a way that allows future access for the research team. We will adhere to the FAIR Guiding Principles for data management and stewardship 20. After completion of the studies and after anonymization (e.g. replace subject identifier with a new random subject identifier), analysis datasets will be made publicly available in a timely manner on a non-commercial data platform according to the FAIR principles. The principles of data sharing will be explained in the informed consent form. All data will be owned by the Sponsor-Investigator and investigators of TB TRIAGE+, while a Data Access Committee will review all requests for data sharing.
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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.
Klaus Reither, MD, PhD principal investigator
Swiss Tropical & Public Health Institute
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Tuberculosis and Tuberculosis Diagnosis, run by Klaus Reither at 2 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 3 inclusion and 4 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 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Lesotho, South Africa. 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?
Determine CAD4TB cut-off value (time frame: 15 months after first patient visit). The study lists 2 primary outcomes in all. 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 NCT04666311, which also lists 3 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 22 Sep 2025; AzTrials last refreshed its copy on 8 Nov 2026.