NCT04366492

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,045

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
29 days until next milestone

First Posted

Study publicly available on registry

April 29, 2020

Completed
Last Updated

April 29, 2020

Status Verified

April 1, 2020

Enrollment Period

1 year

First QC Date

February 5, 2020

Last Update Submit

April 24, 2020

Conditions

Hepatitis CHepatitis BHIV Infections

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (4)

  • .Prevalence of blood-borne viral infections in Belgian prisons

    day 1

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

    day 1

  • Analysis of uptake counselling by physician in prison

    day 1

  • Analysis of uptake of anti(retro)viral treatment

    day 1

Study Arms (1)

persons in prison

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

Interventions

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

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

persons in prison

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Written informed consent not possible: (language barrier, illiteracy)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UZ Gent

Ghent, 9000, Belgium

Location

Hasselt University

Hasselt, 3500, Belgium

Location

Related Publications (1)

  • 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.

    PMID: 34315415DERIVED

MeSH Terms

Conditions

Hepatitis CHepatitis BHIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesHepadnaviridae InfectionsDNA Virus InfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Geert Robaeys, MD, PhD

    Hasselt University

    PRINCIPAL INVESTIGATOR

  • Dana Busschots, drs.

    Hasselt University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 5, 2020

First Posted

April 29, 2020

Study Start

April 1, 2019

Primary Completion

March 31, 2020

Study Completion

March 31, 2020

Last Updated

April 29, 2020

Record last verified: 2020-04

Locations

BE(2)