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

NCT04363411 | Completed

• 1 other identifier: RUNtoBBV-001
• Study Type: interventional
• Target: 425
• Locations: 1 country
• Sites: 10

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)

Conditions

Hepatitis B; Hepatitis c; Human Immunodeficiency Virus

Outcome Measures

Primary Outcomes (3)

• HCV Ab+ (Hepatitis C Virus antibody)

  test using whole capillary blood (finger prick testing)

  day 1

• HBsAg+ (Hepatitis B surface Antigen)

  test using whole capillary blood (finger prick testing)

  day 1

• HIV Ab+ (human immunodeficiency virus) antibody

  test using whole capillary blood (finger prick testing)

  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)

  day 1

• Analysis of uptake of anti(retro)viral treatment

  Day 1

• Analysis of treatment adherence

  up to one year

• Analysis of treatment outcome

  month 18

Study Arms (1)

drug use

EXPERIMENTAL

Other: finger prick screening for BBV infections and questionnaires by outreaching methodology

Interventions

finger prick screening for BBV infections and questionnaires by outreaching methodology 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.

drug use

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• History of drug use
• Active drug use
• Written informed consent obtained

You may not qualify if:

• Currently enrolled in OST program of Free Clinic or CAD Limburg (centralized OST provision)

Sponsors & Collaborators

• Hasselt University: lead
• Ziekenhuis Oost-Limburg: collaborator

Study Sites (10)

Free Clinic Antwerpen

Antwerp, 2000, Belgium

Location

Free Clinic Antwerp

Antwerp, 2000, Belgium

Location

ZNA Antwerp

Antwerp, 2000, Belgium

Location

Ziekenhuis Oost-Limburg

Genk, 3600, Belgium

Location

CAD Limburg

Hasselt, 3500, Belgium

Location

Jessa Ziekenhuis

Hasselt, 3500, Belgium

Location

Ziekenhuis Maas en Kempen

Maaseik, Belgium

Location

Mariaziekenhuis Noord-limburg

Overpelt, 3900, Belgium

Location

AZ Sint-Trudo

Sint-Truiden, 3800, Belgium

Location

AZ Vesalius

Tongeren, 3700, Belgium

Location

Related Publications (1)

• 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.

  PMID: 34001145 DERIVED

MeSH Terms

Conditions

Hepatitis B; Hepatitis C; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Flaviviridae Infections; RNA Virus Infections; HIV Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Geert Robaeys, prof. dr.

  Hasselt University

  PRINCIPAL INVESTIGATOR

• Rob Bielen, dr.

  Hasselt University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 7, 2020
• First Posted: April 27, 2020
• Study Start: October 25, 2018
• Primary Completion: October 22, 2019
• Study Completion: October 22, 2019
• Last Updated: April 29, 2020

Record last verified: 2020-04

Locations

BE (10)