Screening With Portable X-rays for Rapid Recognition of TB

NCT07737275 | Not Yet Recruiting

• 2 other identifiers: AAAV3135R21AI191193
• Study Type: interventional
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

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

Keywords

Tuberculosis; Mobile Screening; Chest x-ray; HIV

Outcome Measures

Primary Outcomes (1)

• Completion of Appropriate Clinical Referrals

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

  Up to 12 weeks post-visit

Study Arms (1)

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.

Diagnostic Test: Mobile chest radiography for tuberculosis screening

Interventions

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.

SPOT-TB Screening Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult persons 18 years or older
• Self-identifying as migrants to the US
• Self-reporting migration within the 24 months

You may not qualify if:

• Lack capacity for informed consent
• Unable to perform translation/study materials not available in appropriate language
• Unwilling to participate
• Prisoner
• Pregnancy

Sponsors & Collaborators

• Columbia University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

MeSH Terms

Conditions

Tuberculosis; Latent Tuberculosis; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Latent Infection; HIV Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Central Study Contacts

Allison Wolf, MPH

CONTACT

212-342-44'1; aw2565@cumc.columbia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine and Associate Professor of Epidemiology

Study Record Dates

• First Submitted: July 27, 2026
• First Posted: July 30, 2026
• Study Start (Estimated): August 15, 2026
• Primary Completion (Estimated): May 14, 2027
• Study Completion (Estimated): March 10, 2028
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share