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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2017 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2022-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Latent Tuberculosis Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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.

Study Groups

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All study participants

Subjects administered the TB skin test, Battey skin test, QFT-GIT, and T-Spot

Group Type EXPERIMENTAL

BST

Intervention Type DRUG

0.1 mcg/mL (1 dose) Battey skin test (BST) antigen administered using the Mantoux method.

TST

Intervention Type DRUG

Administer TB Skin test (TST)

QFT

Intervention Type OTHER

Perform QFT TB test

T-spot

Intervention Type OTHER

Perform T-Spot TB test

Interventions

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BST

0.1 mcg/mL (1 dose) Battey skin test (BST) antigen administered using the Mantoux method.

Intervention Type DRUG

TST

Administer TB Skin test (TST)

Intervention Type DRUG

QFT

Perform QFT TB test

Intervention Type OTHER

T-spot

Perform T-Spot TB test

Intervention Type OTHER

Other Intervention Names

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Quantiferon Gold-in-tube (QFT) T-spot.TB test

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes