Screening With Portable X-rays for Rapid Recognition of TB

ConditionsTuberculosis (TB)Tuberculosis Infection, Latent HIV (Human Immunodeficiency Virus)

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorColumbia University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adult persons 18 years or older

Self-identifying as migrants to the US

Self-reporting migration within the 24 months

Disqualifiers

Lack capacity for informed consent

Unable to perform translation/study materials not available in appropriate language

Unwilling to participate

Prisoner

Trial design

Design model

Single group

Treatments tested in this trial

Mobile chest radiography for tuberculosis screening
Diagnostic 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.

Treatment groups

1,000 Participants

are divided into 1 treatment group

Group A: SPOT-TB Screening InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Completion of Appropriate Clinical Referrals

Proportion of participants who complete recommended diagnostic evaluations and clinical referrals, stratified by tuberculosis risk screening group.

Time frame

Up to 12 weeks post-visit

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Columbia University

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Source ClinicalTrials.gov

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