HBV/HCV/HIV in Belgian Prisons

Prevalence of Blood Borne Viral Infections (HBV/HCV/HIV) in the Belgian Prison System

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections; Hepatitis B; Hepatitis C
• Intervention / Treatment: Other: Prevalence of blood borne viral infections (HBV/HCV/HIV)

• Study Type: Interventional
• Enrollment (Actual): 3045
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Gent, Belgium, 9000
    • UZ Gent
  • Hasselt, Belgium, 3500
    • Hasselt University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: persons in prison	Other: Prevalence of blood borne viral infections (HBV/HCV/HIV); rapid finger prick test for HCV Ab, HBsAg and HIV and a questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with HCV Ab+ (Hepatitis C Virus Antibody)	test using whole capillary blood (finger prick testing)	day 1
Number of participants with HBsAg+ (Hepatitis B surface Antigen)	test using whole capillary blood (finger prick testing)	day 1
Number of participants with HIV Ab+ (human immunodeficiency virus antibody)	test using whole capillary blood (finger prick testing)	day1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
.Prevalence of blood-borne viral infections in Belgian prisons	number of HCV Ab+/number of screened prisoners by finger prick; number of HBsAg+/number of screened prisoners by finger prick; number of HIV Ab+/number of screened prisoners by finger prick	day 1
5. Questionnaire to Identify risk factors associated with the aforementioned blood borne viral infections (hepatitis C, hepatitis B and HIV) in prison	i. Combine results from positive finger prick test with questionnaire regarding sociodemographic factors, migration, risk factors for blood born viruses (sexual contacts, incarceration, drug use)	day 1
Analysis of uptake counselling by physician in prison	Percentage of patients with a positive finger prick test who attend a consultation by the prison physician in relation of total tested positive on finger prick	day 1
Analysis of uptake of anti(retro)viral treatment	percentage of positive clients who started treatment in relation of total of positive clients needing treatment	day 1

Collaborators and Investigators

• Sponsor: Hasselt University
• Collaborators: University Ghent
• Investigators: Principal Investigator: Geert Robaeys, MD, PhD, Hasselt University; Study Chair: Dana Busschots, drs., Hasselt University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): March 31, 2020
• Study Completion (Actual): March 31, 2020

Study Registration Dates

• First Submitted: February 5, 2020
• First Submitted That Met QC Criteria: April 24, 2020
• First Posted (Actual): April 29, 2020

Study Record Updates

• Last Update Posted (Actual): April 29, 2020
• Last Update Submitted That Met QC Criteria: April 24, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Enterovirus Infections; Picornaviridae Infections; Infections; Hepatitis B; Hepatitis; Hepatitis A; Hepatitis C
• Other Study ID Numbers: HBV-HCV-HIV-001

Drug and device information, study documents

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