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Completed

NCT Number: NCT04366492

HBV/HCV/HIV in Belgian Prisons

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.

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Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Flaviviridae Infections Genital Diseases HIV Infections Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Viral, Human Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Liver Diseases RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZ Gent, Ghent, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

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

Primary outcomes

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

    Time frame: day 1

    test using whole capillary blood (finger prick testing)

  2. Number of participants with HBsAg+ (Hepatitis B surface Antigen)

    Time frame: day 1

    test using whole capillary blood (finger prick testing)

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

    Time frame: day1

    test using whole capillary blood (finger prick testing)

Secondary outcomes

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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: day 1

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

Sponsors and collaborators

Lead sponsor

Hasselt University

Other

Collaborators

  • University Ghent

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 29, 2020
Registry last updated
Apr 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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