Reaching Out to the UNdiagnosed People Infected With Blood Borne Viral Infections
NCT ID: NCT04363411
Last Updated: 2020-04-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
425 participants
INTERVENTIONAL
2018-10-25
2019-10-22
Brief Summary
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* 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)
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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drug use
finger prick screening for BBV infections and questionnaires by outreaching methodology
Screening by fingerprick for HCV Ab, HBsAg and HIV Ab and a questionnaire will be performed at sites outside of the regular treatment facilities.
Interventions
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finger prick screening for BBV infections and questionnaires by outreaching methodology
Screening by fingerprick for HCV Ab, HBsAg and HIV Ab and a questionnaire will be performed at sites outside of the regular treatment facilities.
Eligibility Criteria
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Inclusion Criteria
* History of drug use
* Active drug use
* Written informed consent obtained
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Ziekenhuis Oost-Limburg
OTHER
Hasselt University
OTHER
Responsible Party
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Geert Robaeys
Principal Investigator
Principal Investigators
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Geert Robaeys, prof. dr.
Role: PRINCIPAL_INVESTIGATOR
Hasselt University
Rob Bielen, dr.
Role: STUDY_CHAIR
Hasselt University
Locations
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Free Clinic Antwerpen
Antwerp, , Belgium
Free Clinic Antwerp
Antwerp, , Belgium
ZNA Antwerp
Antwerp, , Belgium
Ziekenhuis Oost-Limburg
Genk, , Belgium
CAD Limburg
Hasselt, , Belgium
Jessa Ziekenhuis
Hasselt, , Belgium
Ziekenhuis Maas en Kempen
Maaseik, , Belgium
Mariaziekenhuis Noord-limburg
Overpelt, , Belgium
AZ Sint-Trudo
Sint-Truiden, , Belgium
AZ Vesalius
Tongeren, , Belgium
Countries
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References
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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.
Other Identifiers
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RUNtoBBV-001
Identifier Type: -
Identifier Source: org_study_id
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