Tuberculosis (TB)SPOT-TBNCT07737275
Screening With Portable X-rays for Rapid Recognition of TB
A study testing Mobile chest radiography for tuberculosis screening in people with Tuberculosis (TB) and Tuberculosis Infection, Latent, run by Columbia University at 1 site in United States.
Trial summary
SPOT-TB (Screening with Portable X-rays for rapid recOgniTion of TB) is a prospective study evaluating a community-based tuberculosis (TB) screening strategy for migrant populations in New York City. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis (TB), Tuberculosis Infection, Latent, HIV (Human Immunodeficiency Virus)
- What is being tested?
- Mobile chest radiography for tuberculosis screening
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2026to 25 May 2028
- Phase
- Interventional
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult persons 18 years or older
- Self-identifying as migrants to the US
- Self-reporting migration within the 24 months
Who cannot join
- Lack capacity for informed consent
- Unable to perform translation/study materials not available in appropriate language
- Unwilling to participate
- Prisoner
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
African Services Committee
New York, New York, 10027
Allison Wolf, MPH, 425-408-2122, aw2565@cumc.columbia.edu
Max O'Donnell, MD, 6465736650, mo2130@cumc.columbia.edu
About this study
Official title: Mobilizing Innovative Strategies to Improve Tuberculosis (TB) Diagnosis and Retention in the TB Care Cascade for Migrant Communities in New York City
SPOT-TB (Screening with Portable X-rays for rapid recOgniTion of TB) is a prospective study evaluating a community-based tuberculosis (TB) screening strategy for migrant populations in New York City. The screening intervention integrates mobile ultra-portable digital chest radiography with artificial intelligence-assisted image interpretation, tuberculosis symptom assessment, latent tuberculosis infection testing, and HIV testing. Participants with concerning screening findings are referred for appropriate clinical evaluation. The study will evaluate the feasibility, acceptability, and effectiveness of this integrated screening strategy for improving early identification of active pulmonary tuberculosis and linkage to care in community settings.
Read the detailed description
Tuberculosis (TB) remains a major public health challenge in the United States, with increasing numbers of reported cases in recent years. Delayed diagnosis contributes to ongoing transmission and poorer clinical outcomes, particularly among populations facing barriers to healthcare access. Migrant populations in New York City experience a disproportionately high burden of TB infection and disease, highlighting the need for innovative community-based screening strategies.
SPOT-TB (Screening with Portable X-rays for rapid recOgniTion of TB) is a prospective study evaluating a novel community-based TB screening strategy. The intervention combines mobile ultra-portable digital chest radiography, artificial intelligence-assisted image interpretation, tuberculosis symptom assessment, latent tuberculosis infection testing, and HIV testing to provide rapid, front-loaded screening while minimizing loss to follow-up. Participants with concerning screening findings are referred for appropriate clinical evaluation according to standard clinical practice.
The study will evaluate the feasibility, acceptability, and effectiveness of this integrated screening strategy for improving early identification of active pulmonary tuberculosis, facilitating linkage to care, and informing future community-based TB screening programs. The study will also provide information on TB and latent TB infection prevalence among migrant populations and the implementation of mobile AI-assisted screening in an urban U.S. setting.
- Being tested
- Mobile chest radiography for tuberculosis screening
- Keywords
- Tuberculosis, Mobile Screening, Chest x-ray, HIV
- Medical subject headings
- Tuberculosis, Latent Tuberculosis, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile chest radiography for tuberculosis screeningDiagnostic test
The diagnostic screening includes a digital chest x-ray (includes AI software to interpret x-rays), optional lung ultrasound, oral swab for HIV testing, and a blood draw for TB testing.
| Study group | Role | What they receive |
|---|---|---|
| SPOT-TB Screening Intervention | Experimental | Participants undergo the SPOT-TB screening strategy, which includes symptom screening, chest radiography interpreted using AI software, HIV testing, and collection of sputum for confirmatory microbiologic testing when indicated. Receives: Diagnostic Test: Mobile chest radiography for tuberculosis screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of Appropriate Clinical Referrals
Proportion of participants who complete recommended diagnostic evaluations and clinical referrals, stratified by tuberculosis risk screening group.
Measured: Up to 12 weeks post-visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start25 Aug 2026
- Primary completion25 May 2027 (estimated)
- Study completion25 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tuberculosis (TB)Studies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Max O'Donnell, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07737275
- Sponsor's protocol ID
- AAAV3135
- Other IDs
- R21AI191193
- Acronym
- SPOT-TB
- Status last verified
- Sep 2026
- First submitted
- 27 Jul 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in publications will be shared in accordance with the study's Data Management and Sharing Plan and applicable institutional and regulatory requirements.