Screening for Latent Tuberculosis Infection (LTBI) in US Army Recruits

IDCRP-021

The overall objective of this study is to assess the feasibility and potential impact of using a targeted testing approach and 2 interferon-gamma release assays (IGRA) to screen for latent tuberculosis (TB) infection (LTBI) among military recruits. The current policy of universal application of the Mantoux tuberculin skin test (TST) to screen for LTBI may result in many TST reactions among recruits who are at low risk for LTBI. The central hypothesis is that targeted testing by use of the questionnaire will reduce unnecessary testing of low-risk recruits without affecting the identification of higher-risk recruits. The secondary hypothesis is that many discordant results between the TST and IGRA may be explained by cross-reactivity to non-tuberculous mycobacteria (NTM) with the TST.

2009-03-01

2009-06-01

2022-08-01

Completed

2017

Inclusion Criteria: * Any recruit, age 18 years or older, undergoing routine entry-level medical processing at Fort Jackson Exclusion Criteria: * If they have history of severe reactions to TST (e.g., blistering, scar, or symptoms of immediate hypersensitivity) * If they are unwilling to provide written consent for the study * If they are unwilling to provide Health Insurance Portability and Accountability Act (HIPAA) authorization

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'SCREENING', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'All study participants received 4 tests, including the use of two skin tests, one on each arm. However, the participant and outcomes assessors were blinded to which skin test was placed on which arm to avoid bias in assessment of the outcomes.', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 2017, 'type': 'ACTUAL'}}

2023-03-29