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

NCT04363411 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 425

Last updated 2020-04-29

No results posted yet for this study

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)

Conditions

Interventions

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.

Sponsors & Collaborators

  • Ziekenhuis Oost-Limburg

    collaborator OTHER

  • Hasselt University

    lead OTHER

Principal Investigators

  • Geert Robaeys, prof. dr. · Hasselt University

  • Rob Bielen, dr. · Hasselt University

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-25
Primary Completion
2019-10-22
Completion
2019-10-22

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04363411 on ClinicalTrials.gov