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

March 1, 2023 updated by: Henry M. Jackson Foundation for the Advancement of Military Medicine
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2017

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Columbia, South Carolina, United States, 29207
        • Fort Jackson, SC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: All study participants
Subjects administered the TB skin test, Battey skin test, QFT-GIT, and T-Spot
Drug: BST
0.1 mcg/mL (1 dose) Battey skin test (BST) antigen administered using the Mantoux method.
Drug: TST
Administer TB Skin test (TST)
Other: QFT
Perform QFT TB test
Other Names:
  • Quantiferon Gold-in-tube (QFT)
Other: T-spot
Perform T-Spot TB test
Other Names:
  • T-spot.TB test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TST Induration Will be Interpreted Relative to Risk, in Accordance With Published CDC Guidelines.
Time Frame: 48-72 hrs post administration

Risk stratification and test result. Risk was stratified by the use of risk factors identified by questionnaire according to the 5, 10 and 15 mm criteria (CDC Morbidity and Mortality Weekly Report Recommendations and Reports 2000. Targeted Testing for Latent Tuberculosis Infection.)

The number of 1803 is used here because that is the number for which valid results were available for all 4 tests.

The number presented in each category is the number of participants that had positive results.

We are only presented a risk stratified interpretation for the TST (not the QFT, T-spot, and BST) because that is the only test for which this methodology is accepted in scientific and medical use. It is also the only test for which we had pre-specified the use of this methodology in the protocol.
48-72 hrs post administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive QFT-GIT Result
Time Frame: 48-72 hours after enrollment
The number of subjects is 1781 (less than the original 1978) because we analyzed only those who had valid results by all 4 tests to have a fair comparison. Additionally, we excluded those subject who had a borderline T-Spot result, as we were not able to make valid comparisons with these results.
48-72 hours after enrollment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
T-Spot Result
Time Frame: 48-72 hours
Positive T-Spot results. The number of subjects is 1781 (less than the original 1978) because we analyzed only those who had valid results by all 4 tests to have a fair comparison. Additionally, we excluded those subject who had a borderline T-Spot result, as we were not able to make valid comparisons with these results.
48-72 hours
Battey Skin Test Result
Time Frame: 48-72 hours after administration
Battey skin test positive results defined as >= 100 mm reaction. The number of subjects is 1781 (less than the original 1978) because we analyzed only those who had valid results by all 4 tests to have a fair comparison. Additionally, we excluded those subject who had a borderline T-Spot result, as we were not able to make valid comparisons with these results.
48-72 hours after administration
TST Results for the Population for Which All 4 Tests Have Valid Results and no Borderline Results
Time Frame: 48-72 hours after adminstration
48-72 hours after adminstration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henry M. Jackson Foundation for the Advancement of Military Medicine

Collaborators

Infectious Diseases Clinical Research Program

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

August 1, 2022

Study Registration Dates

First Submitted

December 8, 2008

First Submitted That Met QC Criteria

December 8, 2008

First Posted (Estimate)

December 9, 2008

Study Record Updates

Last Update Posted (Actual)

March 29, 2023

Last Update Submitted That Met QC Criteria

March 1, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IDCRP-021

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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