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

Sponsor

Hasselt University (Other)

Overall Status

Completed

CT.gov ID

NCT04363411

Collaborator

Ziekenhuis Oost-Limburg (Other)

425

Enrollment

Locations

Arm

11.9

Actual Duration (Months)

42.5

Patients Per Site

3.6

Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Hepatitis B Hepatitis c Human Immunodeficiency Virus	Other: finger prick screening for BBV infections and questionnaires by outreaching methodology	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

425 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Oct 25, 2018

Actual Primary Completion Date :

Oct 22, 2019

Actual Study Completion Date :

Oct 22, 2019

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

HCV Ab+ (Hepatitis C Virus antibody) [day 1]
test using whole capillary blood (finger prick testing)
HBsAg+ (Hepatitis B surface Antigen) [day 1]
test using whole capillary blood (finger prick testing)
HIV Ab+ (human immunodeficiency virus) antibody [day 1]
test using whole capillary blood (finger prick testing)

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Free Clinic Antwerpen	Antwerp	Belgium	2000
2	Free Clinic Antwerp	Antwerp	Belgium	2000
3	ZNA Antwerp	Antwerp	Belgium	2000
4	Ziekenhuis Oost-Limburg	Genk	Belgium	3600
5	CAD Limburg	Hasselt	Belgium	3500
6	Jessa Ziekenhuis	Hasselt	Belgium	3500
7	Ziekenhuis Maas en Kempen	Maaseik	Belgium
8	Mariaziekenhuis Noord-limburg	Overpelt	Belgium	3900
9	AZ Sint-Trudo	Sint-Truiden	Belgium	3800
10	AZ Vesalius	Tongeren	Belgium	3700