HBV/HCV/HIV in Belgian Prisons

NCT ID: NCT04366492

Last Updated: 2020-04-29

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3045 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2020-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To assess the prevalence of blood-borne viral infections in prisons in Belgium, screening will be executed in several prisons in Flanders, Brussels and Wallonia to obtain a geographical representative distribution.

Upon informed consent screening will be performed using whole capillary blood (finger prick testing) with three different tests for HCV Ab, HBsAg and HIV. Screening will be performed first. While awaiting the test result (15-20min), the participant can fill out a questionnaire (together with the study nurse), concerning risk factors for HCV, HBV and HIV infection. This questionnaire is filled out directly online, and will be immediately implemented in the encoded database. The database is set-up according to the rules of good clinical practice. (Castor EDC software). The results will be filled out immediately by the prison staff in this database after it is filled out by the participant, minimizing the risk of displacement of test results.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hepatitis C Hepatitis B HIV Infections

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

persons in prison

Group Type OTHER

Prevalence of blood borne viral infections (HBV/HCV/HIV)

Intervention Type OTHER

rapid finger prick test for HCV Ab, HBsAg and HIV and a questionnaire

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Prevalence of blood borne viral infections (HBV/HCV/HIV)

rapid finger prick test for HCV Ab, HBsAg and HIV and a questionnaire

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age ≥ 18 years
* Imprisoned in one of the predefined prisons in Flanders Brussels or Wallonia participating in this trial
* Written informed consent obtained

Exclusion Criteria

* Written informed consent not possible: (language barrier, illiteracy)
* Already participated in the study: re-entry within inclusion period in one of the prisons
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Ghent

OTHER

Sponsor Role collaborator

Hasselt University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Geert Robaeys

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Geert Robaeys, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hasselt University

Dana Busschots, drs.

Role: STUDY_CHAIR

Hasselt University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

UZ Gent

Ghent, , Belgium

Site Status

Hasselt University

Hasselt, , Belgium

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium

References

Explore related publications, articles, or registry entries linked to this study.

Busschots D, Kremer C, Bielen R, Koc OM, Heyens L, Brixko C, Laukens P, Orlent H, Bilaey P, De Smet F, Hellemans G, Muyldermans G, Van Baelen L, Hens N, Van Vlierberghe H, Robaeys G. A multicentre interventional study to assess blood-borne viral infections in Belgian prisons. BMC Infect Dis. 2021 Jul 27;21(1):708. doi: 10.1186/s12879-021-06405-z.

Reference Type DERIVED
PMID: 34315415 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HBV-HCV-HIV-001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.