Hepatitis CNCT04366492
HBV/HCV/HIV in Belgian Prisons
A study testing Prevalence of blood borne viral infections (HBV/HCV/HIV) in people with Hepatitis C and Hepatitis B, run by Hasselt University at 2 sites in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C, Hepatitis B, HIV Infections
- What is being tested?
- Prevalence of blood borne viral infections (HBV/HCV/HIV)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,045 participants
- Where
- 2 sitesBelgium
- Study dates
- 1 Apr 2019to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Imprisoned in one of the predefined prisons in Flanders Brussels or Wallonia participating in this trial
- Written informed consent obtained
Who cannot join
- Written informed consent not possible: (language barrier, illiteracy)
- Already participated in the study: re-entry within inclusion period in one of the prisons
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Prevalence of Blood Borne Viral Infections (HBV/HCV/HIV) in the Belgian Prison System
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.
- Conditions
- Hepatitis C, Hepatitis B, HIV Infections
- Being tested
- Prevalence of blood borne viral infections (HBV/HCV/HIV)
- Medical subject headings
- Hepatitis C, Hepatitis B, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevalence of blood borne viral infections (HBV/HCV/HIV)Other
rapid finger prick test for HCV Ab, HBsAg and HIV and a questionnaire
| Study group | Role | What they receive |
|---|---|---|
| persons in prison | Other | Not described Receives: Other: Prevalence of blood borne viral infections (HBV/HCV/HIV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with HCV Ab+ (Hepatitis C Virus Antibody)
test using whole capillary blood (finger prick testing)
Measured: day 1
Number of participants with HBsAg+ (Hepatitis B surface Antigen)
test using whole capillary blood (finger prick testing)
Measured: day 1
Number of participants with HIV Ab+ (human immunodeficiency virus antibody)
test using whole capillary blood (finger prick testing)
Measured: day1
Secondary outcomes (4)
.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
Measured: day 1
5. Questionnaire to Identify risk factors associated with the aforementioned blood borne viral infections (hepatitis C, hepatitis B and HIV) in prison
- Combine results from positive finger prick test with questionnaire regarding sociodemographic factors, migration, risk factors for blood born viruses (sexual contacts, incarceration, drug use)
Measured: day 1
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
Measured: day 1
Analysis of uptake of anti(retro)viral treatment
percentage of positive clients who started treatment in relation of total of positive clients needing treatment
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start1 Apr 2019
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3,045 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent
- Responsible party
- Principal investigator, Geert Robaeys, Hasselt University
- Investigators
- Geert Robaeys, MD, PhD, Principal investigator, Hasselt UniversityDana Busschots, drs., Study chair, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04366492
- Sponsor's protocol ID
- HBV-HCV-HIV-001
- Status last verified
- Apr 2020
- First submitted
- 5 Feb 2020
- Last updated
- 29 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34315415
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Blood Borne Viral Infections (HBV/HCV/HIV) in the Belgian Prison System
- ClinicalTrials.gov ID
- NCT04366492
- Acronym / sponsor ID
- HBV-HCV-HIV-001
- Conditions
- Hepatitis C, Hepatitis B, HIV Infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,045 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- University Ghent
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 29 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| persons in prison | Other | Other: Prevalence of blood borne viral infections (HBV/HCV/HIV) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Imprisoned in one of the predefined prisons in Flanders Brussels or Wallonia participating in this trial
- Written informed consent obtained
Key exclusion criteria (2 listed)
- Written informed consent not possible: (language barrier, illiteracy)
- Already participated in the study: re-entry within inclusion period in one of the prisons
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prevalence of blood borne viral infections (HBV/HCV/HIV)rapid finger prick test for HCV Ab, HBsAg and HIV and a questionnaire | Other | persons in prison |
Primary outcome
Number of participants with HCV Ab+ (Hepatitis C Virus Antibody)
Time frame: day 1
test using whole capillary blood (finger prick testing)
Number of participants with HBsAg+ (Hepatitis B surface Antigen)
Time frame: day 1
test using whole capillary blood (finger prick testing)
Number of participants with HIV Ab+ (human immunodeficiency virus antibody)
Time frame: day1
test using whole capillary blood (finger prick testing)
4 secondary outcomes
.Prevalence of blood-borne viral infections in Belgian prisons
Time frame: day 1
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
Analysis of uptake counselling by physician in prison
Time frame: day 1
Analysis of uptake of anti(retro)viral treatment
Time frame: day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2020.
- Derived from this study: PubMed 34315415Busschots 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geert Robaeys, MD, PhD principal investigator
Hasselt University
Dana Busschots, drs. study chair
Hasselt University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prevalence of blood borne viral infections (HBV/HCV/HIV) in people with Hepatitis C and Hepatitis B, run by Hasselt University at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with HCV Ab+ (Hepatitis C Virus Antibody) (time frame: day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04366492, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2020.