Clinical trial NCT04366492: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis C
Hepatitis B
HIV Infections
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: University Ghent
First posted: 2020-04-29
Enrollment: 3045
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.


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

Primary outcomes:
measure: Number of participants with HCV Ab+ (Hepatitis C Virus Antibody)
timeFrame: day 1
measure: Number of participants with HBsAg+ (Hepatitis B surface Antigen)
timeFrame: day 1
measure: Number of participants with HIV Ab+ (human immunodeficiency virus antibody)
timeFrame: day1
Secondary outcomes:
measure: .Prevalence of blood-borne viral infections in Belgian prisons
timeFrame: day 1
measure: 5. Questionnaire to Identify risk factors associated with the aforementioned blood borne viral infections (hepatitis C, hepatitis B and HIV) in prison
timeFrame: day 1
measure: Analysis of uptake counselling by physician in prison
timeFrame: day 1
measure: Analysis of uptake of anti(retro)viral treatment
timeFrame: day 1
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: UZ Gent
city: Hasselt
country: Belgium
facility: Hasselt University
Study officials:
affiliation: Hasselt University
name: Geert Robaeys, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hasselt University
name: Dana Busschots, drs.
role: STUDY_CHAIR
References:
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.