TuberculosisADAPTNCT05941052
Assessing Diagnostics At Point-of-care for Tuberculosis
A study testing Tongue swab-based molecular assays in people with Tuberculosis, run by University of California, San Francisco at 3 sites in 3 countries.
Trial summary
Every year, more than 3 million people with TB remain undiagnosed and 1 million die. Better diagnostics are essential to reducing the enormous burden of TB worldwide. The Assessing Diagnostics At Point-of-care for Tuberculosis (ADAPT) study seeks to reduce the burden of TB worldwide by evaluating faster, simpler, and… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Tuberculosis
- What is being tested?
- Tongue swab-based molecular assays
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,350 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 28 Aug 2023to 30 Sep 2028
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The investigators will include non-hospitalized adults (age ≥ 12 years) with either:
- cough ≥2 weeks' duration, a commonly accepted criterion for identifying people with presumed pulmonary TB (to facilitate standardization across sites and comparison of test performance across sub-groups; OR
- risk factors for which TB screening is recommended (HIV infection, self-reported close contact, history of mining work). People with risk factors will be included if they screen positive for TB based on WHO-recommended screening tools as specified below:
- Positive TB screening definitions by risk factor:
- People Living with Human Immunodeficiency Virus (PLHIV) (Risk Factor): C Reactive Protein (CRP) >5 mg/dL OR abnormal chest x-ray (CXR)
- Self-reported Close Contact (Risk Factor): abnormal CXR History of mining work (Risk Factor): abnormal CXR
Show all 9Show fewer
- The investigators will include health workers at each clinical site who are:
- aged ≥18 years; AND
- involved in routine TB testing (collecting specimens for or performing TB tests).
Who cannot join
- Completed latent or active TB treatment within the past 12 months (to increase TB prevalence and reduce false-positive results, respectively);
- Have taken any medication with anti-mycobacterial activity (including fluoroquinolones) for any reason, within 2 weeks of study entry (to reduce false-negatives);
- Reside >20km from the study site or are unwilling to return for follow-up visits; OR
- Are unwilling to provide informed consent
- Assessment of the usability of novel TB tests:
- The investigators will exclude staff who are:
- 1) unwilling to provide informed consent
Trial locations and contacts
3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 3 countries
Nigeria1 site, 1 recruiting
- Recruiting
Zankli Research Center, Bingham University
Abuja
John Bimba, john.bimba@binghamuni.edu.ng
Philippines1 site, 1 recruiting
- Recruiting
De La Salle Medical and Health Sciences Institute
Dasmariñas
Charles Yu, chrlsyu@yahoo.com
Zambia1 site, 1 recruiting
- Recruiting
Centre for Infectious Disease Research in Zambia
Lusaka
Monde Muyoyeta, monde.muyoyeta@cidrz.org
About this study
Official title: Supporting, Mobilizing and Accelerating Research for Tuberculosis Elimination (SMART4TB)- Technical Area (TA) 1: Diagnostics- Assessing Diagnostics At Point-of-care for Tuberculosis (ADAPT)
Every year, more than 3 million people with TB remain undiagnosed and 1 million die. Better diagnostics are essential to reducing the enormous burden of TB worldwide. The Assessing Diagnostics At Point-of-care for Tuberculosis (ADAPT) study seeks to reduce the burden of TB worldwide by evaluating faster, simpler, and less expensive TB triage and diagnostic tests.
Read the detailed description
The Assessing Diagnostics At Point-of-care for Tuberculosis (ADAPT) seeks to identify and rigorously assess promising, design-locked point-of-care (POC) tuberculosis (TB) diagnostic tests (hereafter referred to as "novel tests") in clinical studies conducted in settings of intended use. Rapid diagnosis and effective treatment are critical for improving patient outcomes and reducing TB transmission. However, nearly one-third of people with TB are not diagnosed or reported to public health authorities.The different types of tests required to reduce this "diagnostic gap" have been described in the form of target product profiles (TPPs) defined by the World Health Organization (WHO). The highest priority TPP is that for a point-of-care, non-sputum biomarker-based test to facilitate rapid TB diagnosis using easily accessible samples (i.e., a biomarker-based diagnostic test). The ADAPT study will evaluate the sensitivity, specificity and yield of novel diagnostic tests against a reference standard including sputum Xpert® Mycobacterium tuberculosis/Rifampicin (MTB/RIF) Ultra and sputum mycobacterial culture among adolescents and adults with presumptive TB (based on having TB symptoms, or TB risk factor + positive TB screening test) presenting to outpatient health facilities in high burden countries. In addition, the usability and acceptability of novel TB diagnostic tests will be assessed through direct observations and surveys of routine health workers.
- Conditions
- Tuberculosis
- Being tested
- Tongue swab-based molecular assays
- Keywords
- Tuberculosis, Diagnostics, Global Health
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tongue swab-based molecular assaysDiagnostic test
The investigators will evaluate semi-automated or automated molecular assays intended for use at near point of care or point of care.
| Study group | Role | What they receive |
|---|---|---|
| Evaluation of various novel TB triage and diagnostic tests | Experimental | For the novel TB triage and diagnostic tests, the investigators will conduct large-scale evaluation of design-locked tests in a cohort of adults with presumed TB. The investigators aim to enroll 450 participants per year at each of three enrollment sites for evaluation of various novel TB triage and diagnostic tests and 50 health workers to assess test usability. Receives: Diagnostic Test: Tongue swab-based molecular assays |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion with positive index test result among participants with tuberculosis (TB)
Sensitivity - Number with positive index test result/(Number with positive or negative index t test result) among participants with TB. TB will be defined based on a microbiological reference standard (sputum mycobacterial culture results)
Measured: 2 years
Proportion with negative index test result among participants without tuberculosis (TB)
Specificity - Number with negative index test results/(Number with positive or negative index t test result) among participants without TB. TB will be defined based on a microbiological reference standard (sputum mycobacterial culture results)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start28 Aug 2023
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Heidelberg, KNCV Tuberculosis Foundation, Bingham University, University of California, Irvine, De La Salle University Medical Center, Centre for Infectious Disease Research in Zambia, Johns Hopkins University
- Responsible party
- Sponsor
- Investigators
- Adithya Cattamanchi, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05941052
- Sponsor's protocol ID
- 7200AA22RFA00004
- Acronym
- ADAPT
- Status last verified
- Sep 2026
- First submitted
- 3 Jul 2023
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Cho SN, Brennan PJ. Tuberculosis: diagnostics. Tuberculosis (Edinb). 2007 Aug;87 Suppl 1:S14-7. doi: 10.1016/j.tube.2007.05.001. Epub 2007 Jun 20.
PubMed 17584529World Health Organization. Global tuberculosis report Geneva, Switzerland: World Health Organization, 2015.
Organization WH. High-priority target product profiles for new tuberculosis diagnostics: report of a consensus meeting. Geneva, Switzerland: WHO Press, 2014.
Boehme CC, Nabeta P, Hillemann D, Nicol MP, Shenai S, Krapp F, Allen J, Tahirli R, Blakemore R, Rustomjee R, Milovic A, Jones M, O'Brien SM, Persing DH, Ruesch-Gerdes S, Gotuzzo E, Rodrigues C, Alland D, Perkins MD. Rapid molecular detection of tuberculosis and rifampin resistance. N Engl J Med. 2010 Sep 9;363(11):1005-15. doi: 10.1056/NEJMoa0907847. Epub 2010 Sep 1.
PubMed 20825313Walusimbi S, Bwanga F, De Costa A, Haile M, Joloba M, Hoffner S. Meta-analysis to compare the accuracy of GeneXpert, MODS and the WHO 2007 algorithm for diagnosis of smear-negative pulmonary tuberculosis. BMC Infect Dis. 2013 Oct 30;13:507. doi: 10.1186/1471-2334-13-507.
PubMed 24172543Xpert MTB/RIF Implementation Manual: Technical and Operational 'How-To'; Practical Considerations. Geneva: World Health Organization; 2014. Available from http://www.ncbi.nlm.nih.gov/books/NBK254323/
PubMed 25473699Subbaraman R, Nathavitharana RR, Satyanarayana S, Pai M, Thomas BE, Chadha VK, Rade K, Swaminathan S, Mayer KH. The Tuberculosis Cascade of Care in India's Public Sector: A Systematic Review and Meta-analysis. PLoS Med. 2016 Oct 25;13(10):e1002149. doi: 10.1371/journal.pmed.1002149. eCollection 2016 Oct.
PubMed 27780217Yerlikaya S, Chirwa M, Ajide B, Castro MDM, Ha H, Kato-Maeda M, Kisakye E, Marcelo D, Mochizuki T, Rockman L, Steadman A, Thangakunam B, Bimba JS, Christopher DJ, Muyoyeta M, Phan H, Theron G, Yu C, Kremer K, Phillips PPJ, Nahid P, Denkinger CM, Cattamanchi A, Andama A; R2D2 TB Network and SMART4TB Consortia. Pulmonary Tuberculosis Detection with MiniDock MTB Using Swab Samples. N Engl J Med. 2026 Apr 30;394(17):1710-1722. doi: 10.1056/NEJMoa2509761.
PubMed 42054680
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting, Mobilizing and Accelerating Research for Tuberculosis Elimination (SMART4TB)- Technical Area (TA) 1: Diagnostics- Assessing Diagnostics At Point-of-care for Tuberculosis (ADAPT)
- ClinicalTrials.gov ID
- NCT05941052
- Acronym / sponsor ID
- ADAPT / 7200AA22RFA00004
- Conditions
- Tuberculosis
- Keywords
- Tuberculosis, Diagnostics, Global Health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,350 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- University Hospital Heidelberg, KNCV Tuberculosis Foundation, Bingham University, University of California, Irvine, De La Salle University Medical Center, Centre for Infectious Disease Research in Zambia, Johns Hopkins University
- Study start
- 28 Aug 2023 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 12 Jul 2023 (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.
Every year, more than 3 million people with TB remain undiagnosed and 1 million die. Better diagnostics are essential to reducing the enormous burden of TB worldwide. The Assessing Diagnostics At Point-of-care for Tuberculosis (ADAPT) study seeks to reduce the burden of TB worldwide by evaluating faster, simpler, and less expensive TB triage and diagnostic tests.
Detailed description
The Assessing Diagnostics At Point-of-care for Tuberculosis (ADAPT) seeks to identify and rigorously assess promising, design-locked point-of-care (POC) tuberculosis (TB) diagnostic tests (hereafter referred to as "novel tests") in clinical studies conducted in settings of intended use. Rapid diagnosis and effective treatment are critical for improving patient outcomes and reducing TB transmission. However, nearly one-third of people with TB are not diagnosed or reported to public health authorities.The different types of tests required to reduce this "diagnostic gap" have been described in the form of target product profiles (TPPs) defined by the World Health Organization (WHO). The highest priority TPP is that for a point-of-care, non-sputum biomarker-based test to facilitate rapid TB diagnosis using easily accessible samples (i.e., a biomarker-based diagnostic test). The ADAPT study will evaluate the sensitivity, specificity and yield of novel diagnostic tests against a reference standard including sputum Xpert® Mycobacterium tuberculosis/Rifampicin (MTB/RIF) Ultra and sputum mycobacterial culture among adolescents and adults with presumptive TB (based on having TB symptoms, or TB risk factor + positive TB screening test) presenting to outpatient health facilities in high burden countries. In addition, the usability and acceptability of novel TB diagnostic tests will be assessed through direct observations and surveys of routine health workers.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evaluation of various novel TB triage and diagnostic tests | Experimental | Diagnostic Test: Tongue swab-based molecular assaysFor the novel TB triage and diagnostic tests, the investigators will conduct large-scale evaluation of design-locked tests in a cohort of adults with presumed TB. The investigators aim to enroll 450 participants per year at each of three enrollment sites for evaluation of various novel TB triage and diagnostic tests and 50 health workers to assess test usability. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- cough ≥2 weeks' duration, a commonly accepted criterion for identifying people with presumed pulmonary TB (to facilitate standardization across sites and comparison of test performance across sub-groups; OR
- risk factors for which TB screening is recommended (HIV infection, self-reported close contact, history of mining work). People with risk factors will be included if they screen positive for TB based on WHO-recommended screening tools as specified below:
- People Living with Human Immunodeficiency Virus (PLHIV) (Risk Factor): C Reactive Protein (CRP) >5 mg/dL OR abnormal chest x-ray (CXR)
- Self-reported Close Contact (Risk Factor): abnormal CXR History of mining work (Risk Factor): abnormal CXR
- aged ≥18 years; AND
Key exclusion criteria (7 listed)
- Completed latent or active TB treatment within the past 12 months (to increase TB prevalence and reduce false-positive results, respectively);
- Have taken any medication with anti-mycobacterial activity (including fluoroquinolones) for any reason, within 2 weeks of study entry (to reduce false-negatives);
- Reside >20km from the study site or are unwilling to return for follow-up visits; OR
- Are unwilling to provide informed consent
- 1) unwilling to provide informed consent
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 |
|---|---|---|
| Tongue swab-based molecular assaysThe investigators will evaluate semi-automated or automated molecular assays intended for use at near point of care or point of care. | Diagnostic test | Evaluation of various novel TB triage and diagnostic tests |
Primary outcome
Proportion with positive index test result among participants with tuberculosis (TB)
Time frame: 2 years
Sensitivity - Number with positive index test result/(Number with positive or negative index t test result) among participants with TB. TB will be defined based on a microbiological reference standard (sputum mycobacterial culture results)
Proportion with negative index test result among participants without tuberculosis (TB)
Time frame: 2 years
Specificity - Number with negative index test results/(Number with positive or negative index t test result) among participants without TB. TB will be defined based on a microbiological reference standard (sputum mycobacterial culture results)
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 2 Sep 2026.
- Background: PubMed 17584529Cho SN, Brennan PJ. Tuberculosis: diagnostics. Tuberculosis (Edinb). 2007 Aug;87 Suppl 1:S14-7. doi: 10.1016/j.tube.2007.05.001. Epub 2007 Jun 20.
- BackgroundWorld Health Organization. Global tuberculosis report Geneva, Switzerland: World Health Organization, 2015.
- BackgroundOrganization WH. High-priority target product profiles for new tuberculosis diagnostics: report of a consensus meeting. Geneva, Switzerland: WHO Press, 2014.
- Background: PubMed 20825313Boehme CC, Nabeta P, Hillemann D, Nicol MP, Shenai S, Krapp F, Allen J, Tahirli R, Blakemore R, Rustomjee R, Milovic A, Jones M, O'Brien SM, Persing DH, Ruesch-Gerdes S, Gotuzzo E, Rodrigues C, Alland D, Perkins MD. Rapid molecular detection of tuberculosis and rifampin resistance. N Engl J Med. 2010 Sep 9;363(11):1005-15. doi: 10.1056/NEJMoa0907847. Epub 2010 Sep 1.
- Background: PubMed 24172543Walusimbi S, Bwanga F, De Costa A, Haile M, Joloba M, Hoffner S. Meta-analysis to compare the accuracy of GeneXpert, MODS and the WHO 2007 algorithm for diagnosis of smear-negative pulmonary tuberculosis. BMC Infect Dis. 2013 Oct 30;13:507. doi: 10.1186/1471-2334-13-507.
- Background: PubMed 25473699Xpert MTB/RIF Implementation Manual: Technical and Operational 'How-To'; Practical Considerations. Geneva: World Health Organization; 2014. Available from http://www.ncbi.nlm.nih.gov/books/NBK254323/
- Background: PubMed 27780217Subbaraman R, Nathavitharana RR, Satyanarayana S, Pai M, Thomas BE, Chadha VK, Rade K, Swaminathan S, Mayer KH. The Tuberculosis Cascade of Care in India's Public Sector: A Systematic Review and Meta-analysis. PLoS Med. 2016 Oct 25;13(10):e1002149. doi: 10.1371/journal.pmed.1002149. eCollection 2016 Oct.
- Derived from this study: PubMed 42054680Yerlikaya S, Chirwa M, Ajide B, Castro MDM, Ha H, Kato-Maeda M, Kisakye E, Marcelo D, Mochizuki T, Rockman L, Steadman A, Thangakunam B, Bimba JS, Christopher DJ, Muyoyeta M, Phan H, Theron G, Yu C, Kremer K, Phillips PPJ, Nahid P, Denkinger CM, Cattamanchi A, Andama A; R2D2 TB Network and SMART4TB Consortia. Pulmonary Tuberculosis Detection with MiniDock MTB Using Swab Samples. N Engl J Med. 2026 Apr 30;394(17):1710-1722. doi: 10.1056/NEJMoa2509761.
- Individual participant dataSharing planned: No
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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.
Adithya Cattamanchi principal investigator
University of California, Irvine
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tongue swab-based molecular assays in people with Tuberculosis, run by University of California, San Francisco at 3 sites in 3 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 9 inclusion and 7 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 2 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 3 sites in Nigeria, Philippines, Zambia. 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 Adithya Cattamanchi (+1-415-206-5489, adithya.cattamanchi@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion with positive index test result among participants with tuberculosis (TB) (time frame: 2 years). 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 NCT05941052, which also lists 8 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 2 Sep 2026.