Reaching Out to the UNdiagnosed People Infected With Blood Borne Viral Infections

NCT ID: NCT04363411

Last Updated: 2020-04-29

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

425 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-25

Study Completion Date

2019-10-22

Brief Summary

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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)

Detailed Description

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Conditions

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Hepatitis B Hepatitis c Human Immunodeficiency Virus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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drug use

Group Type EXPERIMENTAL

finger prick screening for BBV infections and questionnaires by outreaching methodology

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ziekenhuis Oost-Limburg

OTHER

Sponsor Role collaborator

Hasselt University

OTHER

Sponsor Role lead

Responsible Party

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Geert Robaeys

Principal Investigator

Responsibility Role 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

Site Status

Free Clinic Antwerp

Antwerp, , Belgium

Site Status

ZNA Antwerp

Antwerp, , Belgium

Site Status

Ziekenhuis Oost-Limburg

Genk, , Belgium

Site Status

CAD Limburg

Hasselt, , Belgium

Site Status

Jessa Ziekenhuis

Hasselt, , Belgium

Site Status

Ziekenhuis Maas en Kempen

Maaseik, , Belgium

Site Status

Mariaziekenhuis Noord-limburg

Overpelt, , Belgium

Site Status

AZ Sint-Trudo

Sint-Truiden, , Belgium

Site Status

AZ Vesalius

Tongeren, , Belgium

Site Status

Countries

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Belgium

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.

Reference Type DERIVED
PMID: 34001145 (View on PubMed)

Other Identifiers

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RUNtoBBV-001

Identifier Type: -

Identifier Source: org_study_id

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