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

April 27, 2020 updated by: Geert Robaeys, Hasselt University

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

425

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerp, Belgium, 2000
        • Free Clinic Antwerpen
      • Antwerp, Belgium, 2000
        • Free Clinic Antwerp
      • Antwerp, Belgium, 2000
        • ZNA Antwerp
      • Genk, Belgium, 3600
        • Ziekenhuis Oost-Limburg
      • Hasselt, Belgium, 3500
        • Jessa Ziekenhuis
      • Hasselt, Belgium, 3500
        • CAD Limburg
      • Maaseik, Belgium
        • Ziekenhuis Maas en Kempen
      • Overpelt, Belgium, 3900
        • Mariaziekenhuis Noord-Limburg
      • Sint-Truiden, Belgium, 3800
        • AZ Sint-Trudo
      • Tongeren, Belgium, 3700
        • AZ Vesalius

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: drug use
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HCV Ab+ (Hepatitis C Virus antibody)
Time Frame: day 1
test using whole capillary blood (finger prick testing)
day 1
HBsAg+ (Hepatitis B surface Antigen)
Time Frame: day 1
test using whole capillary blood (finger prick testing)
day 1
HIV Ab+ (human immunodeficiency virus) antibody
Time Frame: day 1
test using whole capillary blood (finger prick testing)
day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
4. Questionnaire to Identify risk factors associated with the aforementioned blood borne viral infections (hepatitis C, hepatitis B and HIV)
Time Frame: day 1
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.
day 1
Analysis of uptake of anti(retro)viral treatment
Time Frame: Day 1
percentage of HCV positive clients who started treatment in relation of total of HCV positive clients needing treatment
Day 1
Analysis of treatment adherence
Time Frame: up to one year
percentage of patients reaching end-of treatment response, who present at the consultation, in relation to total patients in treatment
up to one year
Analysis of treatment outcome
Time Frame: month 18
total number of cured or virally suppressed patients/total number of treated patients
month 18

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hasselt University

Collaborators

Ziekenhuis Oost-Limburg

Investigators

  • Study Chair: Rob Bielen, dr., Hasselt University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 25, 2018

Primary Completion (ACTUAL)

October 22, 2019

Study Completion (ACTUAL)

October 22, 2019

Study Registration Dates

First Submitted

January 7, 2020

First Submitted That Met QC Criteria

April 24, 2020

First Posted (ACTUAL)

April 27, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 29, 2020

Last Update Submitted That Met QC Criteria

April 27, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RUNtoBBV-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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