HBV/HCV/HIV in Belgian Prisons

Sponsor
Hasselt University (Other)
Overall Status
Completed
CT.gov ID
NCT04366492
Collaborator
University Ghent (Other)
3,045
2
1
12
1522.5
127

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Prevalence of blood borne viral infections (HBV/HCV/HIV)
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
3045 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Prevalence of Blood Borne Viral Infections (HBV/HCV/HIV) in the Belgian Prison System
Actual Study Start Date :
Apr 1, 2019
Actual Primary Completion Date :
Mar 31, 2020
Actual Study Completion Date :
Mar 31, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Number of participants with HCV Ab+ (Hepatitis C Virus Antibody) [day 1]

    test using whole capillary blood (finger prick testing)

  2. Number of participants with HBsAg+ (Hepatitis B surface Antigen) [day 1]

    test using whole capillary blood (finger prick testing)

  3. Number of participants with HIV Ab+ (human immunodeficiency virus antibody) [day1]

    test using whole capillary blood (finger prick testing)

Secondary Outcome Measures

  1. .Prevalence of blood-borne viral infections in Belgian prisons [day 1]

    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

  2. 5. Questionnaire to Identify risk factors associated with the aforementioned blood borne viral infections (hepatitis C, hepatitis B and HIV) in prison [day 1]

    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)

  3. Analysis of uptake counselling by physician in prison [day 1]

    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

  4. Analysis of uptake of anti(retro)viral treatment [day 1]

    percentage of positive clients who started treatment in relation of total of positive clients needing treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 UZ Gent Gent Belgium 9000
2 Hasselt University Hasselt Belgium 3500

Sponsors and Collaborators

  • Hasselt University
  • University Ghent

Investigators

  • Principal Investigator: Geert Robaeys, MD, PhD, Hasselt University
  • Study Chair: Dana Busschots, drs., Hasselt University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Geert Robaeys, Principal Investigator, Hasselt University
ClinicalTrials.gov Identifier:
NCT04366492
Other Study ID Numbers:
  • HBV-HCV-HIV-001
First Posted:
Apr 29, 2020
Last Update Posted:
Apr 29, 2020
Last Verified:
Apr 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 29, 2020