Reaching Out to the UNdiagnosed People Infected With Blood Borne Viral Infections
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 425
- Locations
- 10
- Primary Endpoint
- HIV Ab+ (human immunodeficiency virus) antibody
Study Overview
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)
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
drug use
Intervention: finger prick screening for BBV infections and questionnaires by outreaching methodology (Other)
Outcomes
Primary Outcomes
HIV Ab+ (human immunodeficiency virus) antibody
Time Frame: day 1
test using whole capillary blood (finger prick testing)
HCV Ab+ (Hepatitis C Virus antibody)
Time Frame: day 1
test using whole capillary blood (finger prick testing)
HBsAg+ (Hepatitis B surface Antigen)
Time Frame: day 1
test using whole capillary blood (finger prick testing)
Secondary Outcomes
- Analysis of uptake of anti(retro)viral treatment(Day 1)
- Analysis of treatment adherence(up to one year)
- Analysis of treatment outcome(month 18)
- 4. Questionnaire to Identify risk factors associated with the aforementioned blood borne viral infections (hepatitis C, hepatitis B and HIV)(day 1)
Investigators
Geert Robaeys
Principal Investigator
Hasselt University