Tuberculosis Screening in Paraguayan Prisons

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

5000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-18

Study Completion Date

2023-12-01

Brief Summary

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Two diagnostic tools for TB screening in high risk groups need additional assessment: the AeoNose™, an 'electronic nose device' for breath sampling, and digital chest X-ray (CXR) with computer aided detection with CAD4TB® software. This study will systematically screen prisoners and its' employees for TB, test the diagnostic performance of AeoNose™ and CAD4TB (both individually and together) as a TB screening tool and and establish Mycobacterium tuberculosis epidemiology in Paraguayan prisons.

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Detailed Description

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The aim of the World Health Organization (WHO) "End TB Strategy" is to end the global pandemic by 2035. To be able to succeed, better point-of-care (POC) tests are urgently needed to improve screening of high-risk populations. Prisons are recognized worldwide as high risk environments for the concentration, amplification and transmission of TB among prisoners and their communities outside. Paraguayan penal institutions are known to have very high incidence rates of active TB (3000-5000/100.000, according to Paraguayan Ministry of Justice). Two diagnostic tools for TB screening in high risk groups will be evaluated: the AeoNose™, an 'electronic nose device' for breath sampling, and digital chest X-ray (CXR) with computer aided detection with CAD4TB® software. This study will systematically screen prisoners and its' employees for TB, test the diagnostic performance of AeoNose™ and CAD4TB® and assess prison Mycobacterium tuberculosis epidemiology through several objectives: Objective: 1. Assessment of the sensitivity and specificity of the AeoNose™ and its utility for mass TB screening in high incidence settings. 2. Evaluation of the feasibility and utility of CAD4TB® digital CXR as a mass screening tool for TB. 3. Identification of factors that affect diagnostic accuracy of AeoNose™ and CAD4TB®. 4. Assessment of TB epidemiology in Paraguayan prisons and identification of mycobacterial strains.

Study design: Diagnostic cohort study. Study population: Detainees (PPL) of Paraguayan penal institutions as well as their employees. Nature and extent of the burden and risks associated with participation, benefit and group relatedness.

Individual burden: all participants will perform one visit with a medical doctor for medical history, physical exam, digital X-ray (with CAD4TB®) and AeoNose sampling. Participants will be offered voluntary HIV testing and counseling. In case of presumptive TB (estimated 20-30% of participants) two sputum samples will be taken, either spontaneous or saline-induced. One sample is tested with GeneXpert and the other with liquid mycobacterial culture. Cases of presumptive TB with both negative GeneXpert® and culture results will be followed-up after three and six months for repeat testing.

Conditions

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Volatile Organic Compounds Radiography

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

outcomes of individual smell prints and digital ChestXrays will be compared with sputum sampling for GenXpert and Mycobacterial culture

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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AeoNose

the AeoNose will be compared with digital ChestXray and the conventional methods of establishing TB diagnosis

Group Type EXPERIMENTAL

electronic nose device

Intervention Type DEVICE

electronic nose device will be tested as a triage instrument for tuberculosis in a high risk population

dig chest Xray with automated readings

Intervention Type DEVICE

software for tuberculosis detection on digital Chest Xray providing a probability score from 0-100

Interventions

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electronic nose device

electronic nose device will be tested as a triage instrument for tuberculosis in a high risk population

Intervention Type DEVICE

dig chest Xray with automated readings

software for tuberculosis detection on digital Chest Xray providing a probability score from 0-100

Intervention Type DEVICE

Other Intervention Names

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(AeoNose, The eNose Company, the Netherlands) CAD4TB computed automated detection software

Eligibility Criteria

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Inclusion Criteria

* All persons, either being a prisoner or employee, of the involved penal institutions after providing informed consent, including those with known active TB disease and/or currently on TB treatment

Exclusion Criteria

* A potential participant who meets any of the following criteria will be excluded from participation in this study:

1. Unable to exhale breath through the AeoNose™ during five minutes due to respiratory insufficiency
2. Unable to stand in an upright position for the CXR
3. Unable to communicate and comply with the instructions of the study team

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes