Clinical trial NCT04363411: Reaching Out to the UNdiagnosed People Infected With Blood Borne Viral Infections
Official title: Reaching Out to the UNdiagnosed People Infected With Blood Borne Viral Infections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis B
Hepatitis c
Human Immunodeficiency Virus
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: Ziekenhuis Oost-Limburg
First posted: 2020-04-27
Enrollment: 425
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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)


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)

Primary outcomes:
measure: HCV Ab+ (Hepatitis C Virus antibody)
timeFrame: day 1
measure: HBsAg+ (Hepatitis B surface Antigen)
timeFrame: day 1
measure: HIV Ab+ (human immunodeficiency virus) antibody
timeFrame: day 1
Secondary outcomes:
measure: 4. Questionnaire to Identify risk factors associated with the aforementioned blood borne viral infections (hepatitis C, hepatitis B and HIV)
timeFrame: day 1
measure: Analysis of uptake of anti(retro)viral treatment
timeFrame: Day 1
measure: Analysis of treatment adherence
timeFrame: up to one year
measure: Analysis of treatment outcome
timeFrame: month 18
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: Free Clinic Antwerpen
city: Antwerp
country: Belgium
facility: Free Clinic Antwerp
city: Antwerp
country: Belgium
facility: ZNA Antwerp
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
city: Hasselt
country: Belgium
facility: CAD Limburg
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
city: Maaseik
country: Belgium
facility: Ziekenhuis Maas en Kempen
city: Overpelt
country: Belgium
facility: Mariaziekenhuis Noord-limburg
city: Sint-Truiden
country: Belgium
facility: AZ Sint-Trudo
city: Tongeren
country: Belgium
facility: AZ Vesalius
Study officials:
affiliation: Hasselt University
name: Geert Robaeys, prof. dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hasselt University
name: Rob Bielen, dr.
role: STUDY_CHAIR
References:
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.