Reaching Out to the UNdiagnosed People Infected With Blood Borne Viral Infections (RUNtoBBV)
Primary Purpose
Hepatitis B, Hepatitis c, Human Immunodeficiency Virus
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
finger prick screening for BBV infections and questionnaires by outreaching methodology
Sponsored by
About this trial
This is an interventional prevention trial for Hepatitis B
Eligibility Criteria
Inclusion Criteria:
- 18 years of age
- History of drug use
- Active drug use
- Written informed consent obtained
Exclusion Criteria:
- Currently enrolled in OST program of Free Clinic or CAD Limburg (centralized OST provision)
Sites / Locations
- Free Clinic Antwerpen
- Free Clinic Antwerp
- ZNA Antwerp
- Ziekenhuis Oost-Limburg
- CAD Limburg
- Jessa Ziekenhuis
- Ziekenhuis Maas en Kempen
- Mariaziekenhuis Noord-limburg
- AZ Sint-Trudo
- AZ Vesalius
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
drug use
Arm Description
Outcomes
Primary Outcome Measures
HCV Ab+ (Hepatitis C Virus antibody)
test using whole capillary blood (finger prick testing)
HBsAg+ (Hepatitis B surface Antigen)
test using whole capillary blood (finger prick testing)
HIV Ab+ (human immunodeficiency virus) antibody
test using whole capillary blood (finger prick testing)
Secondary Outcome Measures
4. Questionnaire to Identify risk factors associated with the aforementioned blood borne viral infections (hepatitis C, hepatitis B and HIV)
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). The questionaire does not include a score on scale.
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
Analysis of treatment adherence
percentage of patients reaching end-of treatment response, who present at the consultation, in relation to total patients in treatment
Analysis of treatment outcome
total number of cured or virally suppressed patients/total number of treated patients
Full Information
NCT ID
NCT04363411
First Posted
January 7, 2020
Last Updated
April 27, 2020
Sponsor
Hasselt University
Collaborators
Ziekenhuis Oost-Limburg
1. Study Identification
Unique Protocol Identification Number
NCT04363411
Brief Title
Reaching Out to the UNdiagnosed People Infected With Blood Borne Viral Infections
Acronym
RUNtoBBV
Official Title
Reaching Out to the UNdiagnosed People Infected With Blood Borne Viral Infections
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
October 25, 2018 (Actual)
Primary Completion Date
October 22, 2019 (Actual)
Study Completion Date
October 22, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasselt University
Collaborators
Ziekenhuis Oost-Limburg
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, Hepatitis c, Human Immunodeficiency Virus
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
425 (Actual)
8. Arms, Groups, and Interventions
Arm Title
drug use
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
finger prick screening for BBV infections and questionnaires by outreaching methodology
Intervention Description
Screening by fingerprick for HCV Ab, HBsAg and HIV Ab and a questionnaire will be performed at sites outside of the regular treatment facilities.
Primary Outcome Measure Information:
Title
HCV Ab+ (Hepatitis C Virus antibody)
Description
test using whole capillary blood (finger prick testing)
Time Frame
day 1
Title
HBsAg+ (Hepatitis B surface Antigen)
Description
test using whole capillary blood (finger prick testing)
Time Frame
day 1
Title
HIV Ab+ (human immunodeficiency virus) antibody
Description
test using whole capillary blood (finger prick testing)
Time Frame
day 1
Secondary Outcome Measure Information:
Title
4. Questionnaire to Identify risk factors associated with the aforementioned blood borne viral infections (hepatitis C, hepatitis B and HIV)
Description
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). The questionaire does not include a score on scale.
Time Frame
day 1
Title
Analysis of uptake of anti(retro)viral treatment
Description
percentage of HCV positive clients who started treatment in relation of total of HCV positive clients needing treatment
Time Frame
Day 1
Title
Analysis of treatment adherence
Description
percentage of patients reaching end-of treatment response, who present at the consultation, in relation to total patients in treatment
Time Frame
up to one year
Title
Analysis of treatment outcome
Description
total number of cured or virally suppressed patients/total number of treated patients
Time Frame
month 18
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years of age
History of drug use
Active drug use
Written informed consent obtained
Exclusion Criteria:
Currently enrolled in OST program of Free Clinic or CAD Limburg (centralized OST provision)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geert Robaeys, prof. dr.
Organizational Affiliation
Hasselt University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rob Bielen, dr.
Organizational Affiliation
Hasselt University
Official's Role
Study Chair
Facility Information:
Facility Name
Free Clinic Antwerpen
City
Antwerp
ZIP/Postal Code
2000
Country
Belgium
Facility Name
Free Clinic Antwerp
City
Antwerp
ZIP/Postal Code
2000
Country
Belgium
Facility Name
ZNA Antwerp
City
Antwerp
ZIP/Postal Code
2000
Country
Belgium
Facility Name
Ziekenhuis Oost-Limburg
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Facility Name
CAD Limburg
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Facility Name
Jessa Ziekenhuis
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Facility Name
Ziekenhuis Maas en Kempen
City
Maaseik
Country
Belgium
Facility Name
Mariaziekenhuis Noord-limburg
City
Overpelt
ZIP/Postal Code
3900
Country
Belgium
Facility Name
AZ Sint-Trudo
City
Sint-Truiden
ZIP/Postal Code
3800
Country
Belgium
Facility Name
AZ Vesalius
City
Tongeren
ZIP/Postal Code
3700
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34001145
Citation
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.
Results Reference
derived
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Reaching Out to the UNdiagnosed People Infected With Blood Borne Viral Infections
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