Hepatitis BRUNtoBBVNCT04363411
Reaching Out to the UNdiagnosed People Infected With Blood Borne Viral Infections
A study testing finger prick screening for BBV infections and questionnaires by outreaching methodology in people with Hepatitis B and Hepatitis c, run by Hasselt University at 10 sites in Belgium.
Trial summary
Title Reaching out to the UNdiagnosed people infected with blood-borne viral infections (RUNtoBBV) Objectives 1. To study the efficacy of an outreach methodology to increase the uptake for screening, linkage to care and treatment in (active or former) people who use drugs (PWUD) Trial design Prospective multicenter… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis B, Hepatitis c, Human Immunodeficiency Virus
- What is being tested?
- finger prick screening for BBV infections and questionnaires by outreaching methodology
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 425 participants
- Where
- 10 sitesBelgium
- Study dates
- 25 Oct 2018to 22 Oct 2019
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age
- History of drug use
- Active drug use
- Written informed consent obtained
Who cannot join
- Currently enrolled in OST program of Free Clinic or CAD Limburg (centralized OST provision)
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Belgium10 sites
Free Clinic Antwerpen
Antwerp, 2000
Free Clinic Antwerp
Antwerp, 2000
ZNA Antwerp
Antwerp, 2000
Ziekenhuis Oost-Limburg
Genk, 3600
CAD Limburg
Hasselt, 3500
Jessa Ziekenhuis
Hasselt, 3500
Ziekenhuis Maas en Kempen
Maaseik
Mariaziekenhuis Noord-limburg
Overpelt, 3900
AZ Sint-Trudo
Sint-Truiden, 3800
AZ Vesalius
Tongeren, 3700
About this study
Title Reaching out to the UNdiagnosed people infected with blood-borne viral infections (RUNtoBBV) Objectives 1. To study the efficacy of an outreach methodology to increase the uptake for screening, linkage to care and treatment in (active or former) people who use drugs (PWUD) Trial design Prospective multicenter interventional cohort design Number of subjects 336 inclusions (with prevalence of HCV Ab: 30%)
- 168 Antwerp
- 168 Limburg
Read more
Selection criteria Inclusion criteria:
- 18 years of age
- History of/ or active drug use
- Written informed consent obtained Exclusion criteria
- Currently enrolled in centralized OST program of Free Clinic or CAD Limburg Endpoints The following endpoints will be compared between the centers in Limburg and Antwerp: (Main outcome in bold)
Main objectives:
- Prevalence of blood-borne viral infections in Belgian (former or active) PWUD:
- HCV infection (number of HCV Ab+ / number of screened PWUD)
- HBV infection (number of HBsAg+/number of screened PWUD)
- HIV infection (number of HIV Ab+/number of screened PWUD)
- Analysis of linkage to care to hepatologist/ infectiologist (number of patients who adhered to their consultation/number of referred patients)
Secondary objectives:
- Analysis of risk behavior/sociodemographics linked to presence of BBV infections
- Analysis of uptake of anti(retro)viral treatment (number of patients started on treatment/number of patients needing treatment)
- Analysis of treatment adherence (adherence to treatment consultations/total planned consultations)
- Analysis of treatment outcome (total number of cured or virally suppressed patients/total number of treated patients)
- Conditions
- Hepatitis B, Hepatitis c, Human Immunodeficiency Virus
- Being tested
- finger prick screening for BBV infections and questionnaires by outreaching methodology
- Medical subject headings
- Hepatitis B, Hepatitis C, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
finger prick screening for BBV infections and questionnaires by outreaching methodologyOther
Screening by fingerprick for HCV Ab, HBsAg and HIV Ab and a questionnaire will be performed at sites outside of the regular treatment facilities.
| Study group | Role | What they receive |
|---|---|---|
| drug use | Experimental | Not described Receives: Other: finger prick screening for BBV infections and questionnaires by outreaching methodology |
What is being measured
The primary outcome is the main question the study is designed to answer.
HCV Ab+ (Hepatitis C Virus antibody)
test using whole capillary blood (finger prick testing)
Measured: day 1
HBsAg+ (Hepatitis B surface Antigen)
test using whole capillary blood (finger prick testing)
Measured: day 1
HIV Ab+ (human immunodeficiency virus) antibody
test using whole capillary blood (finger prick testing)
Measured: day 1
Secondary outcomes (4)
4. Questionnaire to Identify risk factors associated with the aforementioned blood borne viral infections (hepatitis C, hepatitis B and HIV)
- Combine results from positive finger prick test with questionnaire regarding sociodemographic factors, migration, risk factors for blood born viruses (sexual contacts, incarceration, drug use). The questionaire does not include a score on scale.
Measured: day 1
Analysis of uptake of anti(retro)viral treatment
percentage of HCV positive clients who started treatment in relation of total of HCV positive clients needing treatment
Measured: Day 1
Analysis of treatment adherence
percentage of patients reaching end-of treatment response, who present at the consultation, in relation to total patients in treatment
Measured: up to one year
Analysis of treatment outcome
total number of cured or virally suppressed patients/total number of treated patients
Measured: month 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study start25 Oct 2018
- Primary completion22 Oct 2019
- Study completion22 Oct 2019
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 BStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 425 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- Ziekenhuis Oost-Limburg
- Responsible party
- Principal investigator, Geert Robaeys, Hasselt University
- Investigators
- Geert Robaeys, prof. dr., Principal investigator, Hasselt UniversityRob Bielen, dr., Study chair, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04363411
- Sponsor's protocol ID
- RUNtoBBV-001
- Acronym
- RUNtoBBV
- Status last verified
- Apr 2020
- First submitted
- 7 Jan 2020
- Last updated
- 29 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Busschots D, Kremer C, Bielen R, Koc OM, Heyens L, Dercon E, Verrando R, Windelinckx T, Maertens G, Bourgeois S, Hens N, Mathei C, Robaeys G. Identification and treatment of viral hepatitis C in persons who use drugs: a prospective, multicenter outreach study in Flanders, Belgium. Harm Reduct J. 2021 May 17;18(1):54. doi: 10.1186/s12954-021-00502-7.
PubMed 34001145
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
- Reaching Out to the UNdiagnosed People Infected With Blood Borne Viral Infections
- ClinicalTrials.gov ID
- NCT04363411
- Acronym / sponsor ID
- RUNtoBBV / RUNtoBBV-001
- Conditions
- Hepatitis B, Hepatitis c, Human Immunodeficiency Virus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 425 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- Ziekenhuis Oost-Limburg
- Study start
- 25 Oct 2018 (actual)
- Primary completion
- 22 Oct 2019 (actual)
- Study completion
- 22 Oct 2019 (actual)
- First posted
- 27 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.
Title Reaching out to the UNdiagnosed people infected with blood-borne viral infections (RUNtoBBV) Objectives 1. To study the efficacy of an outreach methodology to increase the uptake for screening, linkage to care and treatment in (active or former) people who use drugs (PWUD) Trial design Prospective multicenter interventional cohort design Number of subjects 336 inclusions (with prevalence of HCV Ab: 30%)
- 168 Antwerp
- 168 Limburg
Selection criteria Inclusion criteria:
- 18 years of age
- History of/ or active drug use
- Written informed consent obtained Exclusion criteria
- Currently enrolled in centralized OST program of Free Clinic or CAD Limburg Endpoints The following endpoints will be compared between the centers in Limburg and Antwerp: (Main outcome in bold)
Main objectives:
- Prevalence of blood-borne viral infections in Belgian (former or active) PWUD:
- HCV infection (number of HCV Ab+ / number of screened PWUD)
- HBV infection (number of HBsAg+/number of screened PWUD)
- HIV infection (number of HIV Ab+/number of screened PWUD)
- Analysis of linkage to care to hepatologist/ infectiologist (number of patients who adhered to their consultation/number of referred patients)
Secondary objectives:
- Analysis of risk behavior/sociodemographics linked to presence of BBV infections
- Analysis of uptake of anti(retro)viral treatment (number of patients started on treatment/number of patients needing treatment)
- Analysis of treatment adherence (adherence to treatment consultations/total planned consultations)
- Analysis of treatment outcome (total number of cured or virally suppressed patients/total number of treated patients)
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| drug use | Experimental | Other: finger prick screening for BBV infections and questionnaires by outreaching methodology |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age
- History of drug use
- Active drug use
- Written informed consent obtained
Key exclusion criteria (1 listed)
- Currently enrolled in OST program of Free Clinic or CAD Limburg (centralized OST provision)
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 |
|---|---|---|
| finger prick screening for BBV infections and questionnaires by outreaching methodologyScreening by fingerprick for HCV Ab, HBsAg and HIV Ab and a questionnaire will be performed at sites outside of the regular treatment facilities. | Other | drug use |
Primary outcome
HCV Ab+ (Hepatitis C Virus antibody)
Time frame: day 1
test using whole capillary blood (finger prick testing)
HBsAg+ (Hepatitis B surface Antigen)
Time frame: day 1
test using whole capillary blood (finger prick testing)
HIV Ab+ (human immunodeficiency virus) antibody
Time frame: day 1
test using whole capillary blood (finger prick testing)
4 secondary outcomes
4. Questionnaire to Identify risk factors associated with the aforementioned blood borne viral infections (hepatitis C, hepatitis B and HIV)
Time frame: day 1
Analysis of uptake of anti(retro)viral treatment
Time frame: Day 1
Analysis of treatment adherence
Time frame: up to one year
Analysis of treatment outcome
Time frame: month 18
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 34001145Busschots D, Kremer C, Bielen R, Koc OM, Heyens L, Dercon E, Verrando R, Windelinckx T, Maertens G, Bourgeois S, Hens N, Mathei C, Robaeys G. Identification and treatment of viral hepatitis C in persons who use drugs: a prospective, multicenter outreach study in Flanders, Belgium. Harm Reduct J. 2021 May 17;18(1):54. doi: 10.1186/s12954-021-00502-7.
- Individual participant dataSharing planned: Undecided
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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, prof. dr. principal investigator
Hasselt University
Rob Bielen, dr. study chair
Hasselt University
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing finger prick screening for BBV infections and questionnaires by outreaching methodology in people with Hepatitis B and Hepatitis c, run by Hasselt University at 10 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 4 inclusion and 1 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 10 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?
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 NCT04363411, 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.