Screening With Portable X-rays for Rapid Recognition of TB

Официальное название

Mobilizing Innovative Strategies to Improve Tuberculosis (TB) Diagnosis and Retention in the TB Care Cascade for Migrant Communities in New York City

Обзор

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.

Подробное описание

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.

Вмешательства

• Диагностический тест Mobile chest radiography for tuberculosis screening
  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.

Первичные конечные точки

• Completion of Appropriate Clinical Referrals [Срок оценки: Up to 12 weeks post-visit]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Скрининг

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07737275 · AAAV3135 · R21AI191193

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗