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

Study Overview
=================
Brief Summary
-----------------
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.

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

Conditions
-----------------
Latent Tuberculosis Infection

Intervention / Treatment
-----------------
* Drug: BST
* Drug: TST
* Other: QFT
* Other: T-spot


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TB, tuberculosis diagnosis, TB screening