Active Close Contact Investigation of Tuberculosis Through Computer-aided Detection and Stool Xpert MTB/RIF Among People Living in Ethiopia

Summary

Tuberculosis is the 13th cause of death from all causes, infecting roughly the 25% of the world population, and Ethiopia is listed among the 30 high-burden countries both for TB and for HIV/TB. In recent years, the immediate consequence of the COVID-19 pandemic was a large fall in the number of newly reported TB cases indicators that represent a relevant drawback in the pursue of the 2025 End TB Milestones.

For active case investigation of TB close contacts, WHO recently recommended the use of Computer- aided detection (CAD), a technology that can help chest X-ray interpretation in situations of human resources constrains, and it may be cost-effective in low-resource settings. Also, for tuberculosis diagnosis, widely-available GeneXpert on stool samples showed high diagnostic performances in term of both sensitivity and specificity.

It is important to assess alternative modalities that could improve diagnosis during TB contact investigation in Ethiopia and the other countries where TB represents a crucial burden.

Conditions

• Diagnosis
• Tuberculosis
• geneXpert

Interventions

DIAGNOSTIC_TEST

Diagnosis of Tuberculosis with computer-aided detection (CAD) software

After enrolment, each subject will be assessed according to ARM 1 (assessment by clinician #1 without CAD) or ARM 2 (assessment by clinician #1 with CAD). Allocation to sequence ARM 1 or ARM 2 will be performed using a computer-generated random assignment list (with a 1:1 ratio), and assignments will be included in sealed opaque envelopes sequentially numbered. Clinicians cannot be masked to the assessment method (with or without CAD) and cannot be masked to the further assessment (referral for microbiological diagnosis with stool and sputum Xpert) due to care process. However, the statistician will be masked to the assessment during data analysis.

Sponsors & Collaborators

• University of Bari

  collaborator OTHER

• Armauer Hansen Research Institute, Ethiopia

  collaborator OTHER

• Doctors with Africa - CUAMM

  lead OTHER

Principal Investigators

• Worku Nigussa, MD · Doctors with Africa - CUAMM

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Model

SEQUENTIAL

Eligibility

Min Age

4 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-05-31

Primary Completion

2023-12-31

Completion

2024-12-31

Countries

• Ethiopia

Study Locations