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

Hepatitis c Clinical Trial

— RUNtoBBV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04363411
• Other study ID #: RUNtoBBV-001
• Status: Completed
• Phase: N/A
• Start date: October 25, 2018
• Est. completion date: October 22, 2019

Study information

• Verified date: April 2020
• Source: Hasselt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 425
• Est. completion date: October 22, 2019
• Est. primary completion date: October 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis c
• HIV Infections
• Human Immunodeficiency Virus
• Virus Diseases

Intervention

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.

Locations

Country	Name	City	State
Belgium	Free Clinic Antwerp	Antwerp
Belgium	Free Clinic Antwerpen	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

Sponsors (2)

Lead Sponsor	Collaborator
Hasselt University	Ziekenhuis Oost-Limburg

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HCV Ab+ (Hepatitis C Virus antibody)	test using whole capillary blood (finger prick testing)	day 1
Primary	HBsAg+ (Hepatitis B surface Antigen)	test using whole capillary blood (finger prick testing)	day 1
Primary	HIV Ab+ (human immunodeficiency virus) antibody	test using whole capillary blood (finger prick testing)	day 1
Secondary	4. Questionnaire to Identify risk factors associated with the aforementioned blood borne viral infections (hepatitis C, hepatitis B and HIV)	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
Secondary	Analysis of uptake of anti(retro)viral treatment	percentage of HCV positive clients who started treatment in relation of total of HCV positive clients needing treatment	Day 1
Secondary	Analysis of treatment adherence	percentage of patients reaching end-of treatment response, who present at the consultation, in relation to total patients in treatment	up to one year
Secondary	Analysis of treatment outcome	total number of cured or virally suppressed patients/total number of treated patients	month 18