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HBV/HCV/HIV in Belgian Prisons

Primary Purpose

Hepatitis C, Hepatitis B, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Prevalence of blood borne viral infections (HBV/HCV/HIV)
Sponsored by
Hasselt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Hepatitis C

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • UZ Gent
  • Hasselt University

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

persons in prison

Arm Description

Outcomes

Primary Outcome Measures

Number of participants with HCV Ab+ (Hepatitis C Virus Antibody)
test using whole capillary blood (finger prick testing)
Number of participants with HBsAg+ (Hepatitis B surface Antigen)
test using whole capillary blood (finger prick testing)
Number of participants with HIV Ab+ (human immunodeficiency virus antibody)
test using whole capillary blood (finger prick testing)

Secondary Outcome Measures

.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
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)
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
Analysis of uptake of anti(retro)viral treatment
percentage of positive clients who started treatment in relation of total of positive clients needing treatment

Full Information

First Posted
February 5, 2020
Last Updated
April 24, 2020
Sponsor
Hasselt University
Collaborators
University Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT04366492
Brief Title
HBV/HCV/HIV in Belgian Prisons
Official Title
Prevalence of Blood Borne Viral Infections (HBV/HCV/HIV) in the Belgian Prison System
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
March 31, 2020 (Actual)
Study Completion Date
March 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasselt University
Collaborators
University Ghent

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Hepatitis B, HIV Infections

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3045 (Actual)

8. Arms, Groups, and Interventions

Arm Title
persons in prison
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Prevalence of blood borne viral infections (HBV/HCV/HIV)
Intervention Description
rapid finger prick test for HCV Ab, HBsAg and HIV and a questionnaire
Primary Outcome Measure Information:
Title
Number of participants with HCV Ab+ (Hepatitis C Virus Antibody)
Description
test using whole capillary blood (finger prick testing)
Time Frame
day 1
Title
Number of participants with HBsAg+ (Hepatitis B surface Antigen)
Description
test using whole capillary blood (finger prick testing)
Time Frame
day 1
Title
Number of participants with HIV Ab+ (human immunodeficiency virus antibody)
Description
test using whole capillary blood (finger prick testing)
Time Frame
day1
Secondary Outcome Measure Information:
Title
.Prevalence of blood-borne viral infections in Belgian prisons
Description
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
Time Frame
day 1
Title
5. Questionnaire to Identify risk factors associated with the aforementioned blood borne viral infections (hepatitis C, hepatitis B and HIV) in prison
Description
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)
Time Frame
day 1
Title
Analysis of uptake counselling by physician in prison
Description
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
Time Frame
day 1
Title
Analysis of uptake of anti(retro)viral treatment
Description
percentage of positive clients who started treatment in relation of total of positive clients needing treatment
Time Frame
day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geert Robaeys, MD, PhD
Organizational Affiliation
Hasselt University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dana Busschots, drs.
Organizational Affiliation
Hasselt University
Official's Role
Study Chair
Facility Information:
Facility Name
UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Hasselt University
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
34315415
Citation
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.
Results Reference
derived

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HBV/HCV/HIV in Belgian Prisons

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