HBV/HCV/HIV in Belgian Prisons

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04366492
• Other study ID #: HBV-HCV-HIV-001
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: March 31, 2020

Study information

• Verified date: April 2020
• Source: Hasselt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3045
• Est. completion date: March 31, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis C
• HIV Infections
• Infection

Intervention

Other:
• Prevalence of blood borne viral infections (HBV/HCV/HIV)
rapid finger prick test for HCV Ab, HBsAg and HIV and a questionnaire

Locations

Country	Name	City	State
Belgium	UZ Gent	Gent
Belgium	Hasselt University	Hasselt

Sponsors (2)

Lead Sponsor	Collaborator
Hasselt University	University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

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