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

Hasselt University

Status: Completed

Conditions: Human Immunodeficiency Virus; Hepatitis c; Hepatitis B

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04363411

RUNtoBBV-001

Details and patient eligibility

About

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)

Enrollment: 425 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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425 participants in 1 patient group

drug use

Experimental group

Treatment:

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