A Systemic Screening for TB Disease in High-risk Groups in Barcelona (SYS-TB-S)

Implementing a Systemic Screening for TB Disease in High-risk Groups in Barcelona Area

The purpose of this screening study is to identify and screen vulnerable population in Barcelona for active pulmonary tuberculosis

Study Overview

• Status: Recruiting
• Conditions: Tuberculosis; Tuberculosis, Pulmonary
• Intervention / Treatment: Other: Screening for TB symptoms; Diagnostic test: Chest X-ray

Detailed Description

If eligible and verbal consent is obtained, individuals:

1. Will attend a small talk/lecture about Tuberculosis (TB) disease
2. Will be interviewed and screened for the presence of TB symptoms: cough, blood in sputum, fever, weight loss, night sweats and chills lasting for >2 weeks
3. Individuals screened positive for TB will be referred to the hospital for further testing (Chest X-ray, visit, lab tests)

• Study Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

• Study Contact: Name: Cristina Vilaplana, MD, PhD; Phone Number: +34930330527; Email: cvilaplana@igtp.cat
• Study Contact Backup: Name: Nino Gogichadze, MD, MsC; Phone Number: +34661079125; Email: ngogichadze@igtp.cat

Study Locations

• Spain
  • Badalona, Spain, 08916
    • Recruiting
    • IGTP
    • Contact: Cristina Vilaplana, MD, PhD; Email: cvilaplana@igtp.cat
    • Contact: Nino Gogichadze, MD, MsC; Email: ngogichadze@igtp.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Individuals from populations identified as high-risk for tuberculosis in the Barcelona metropolitan area

Description

Inclusion Criteria:

-Belonging to a population at high risk for tuberculosis (TB)

Exclusion Criteria:

-Not belonging to a population at high risk for tuberculosis (TB)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Vulnerable populations residing in the Barcelona metropolitan area with a high risk of developing TB; Individuals from vulnerable populations residing in the Barcelona metropolitan area who are at high risk of developing tuberculosis (i.e. war refugees, migrants, individuals living in socio-deprived neighborhoods)	Other: Screening for TB symptoms; Individuals will be screened for cough, blood in sputum, fever, weight loss, night sweats and chills lasting for >2 weeks; Diagnostic test: Chest X-ray; Chest X-ray will be performed to diagnose or exclude TB

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of individuals who screen positive for pulmonary TB symptoms	Number of individuals who screen positive for pulmonary TB symptoms (cough, blood in sputum, fever, weight loss, night sweats and chills lasting for >2 weeks)	1 day
Number of individuals who are diagnosed with pulmonary TB symptoms	Number of individuals who are diagnosed with pulmonary TB symptoms after referral to the hospital	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost-effectiveness analysis	Cost-effectiveness analysis of the TB screening	1 day
Time spent during screening	Duration of each step of the screening will be analysed: duration of talk about TB, duration of waiting time before individual gets screened, duration of screening	1 day

Collaborators and Investigators

• Sponsor: Fundació Institut Germans Trias i Pujol
• Collaborators: Germans Trias i Pujol Hospital; Catalan Public Health Agency; Consorci Sanitari de Barcelona (CSB); SMA-TB Consortium; INNOVA4TB Consortium; Fundació Lluita contra les Infeccions; Hospital Vall d'Hebron -Unitat de Drassanes; ADVANCE-TB Consortium
• Investigators: Study Chair: Cristina Vilaplana, MD, PhD, Fundació i Hospital Germans Trias i Pujol (IGTP-HUGTIP)

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: November 22, 2024
• First Submitted That Met QC Criteria: November 22, 2024
• First Posted (Actual): November 26, 2024

Study Record Updates

• Last Update Posted (Actual): November 29, 2024
• Last Update Submitted That Met QC Criteria: November 26, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Tuberculosis; Refugees; Vulnerable populations; Pulmonary tuberculosis; Migrants; Tuberculosis infection; Tuberculosis screening
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis; Tuberculosis, Pulmonary
• Other Study ID Numbers: SYS-TB-S

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No