Ignite Creation Date:
2024-05-06 @ 2:35 PM
Last Modification Date:
2024-10-26 @ 1:33 PM
Study NCT ID:
NCT04363411
Status:
COMPLETED
Last Update Posted:
2020-04-29
First Post:
2020-01-07
Brief Title:
Reaching Out to the UNdiagnosed People Infected With Blood Borne Viral Infections
Sponsor:
Hasselt University
Organization:
Hasselt University
Study Overview
Official Title:
Reaching Out to the UNdiagnosed People Infected With Blood Borne Viral Infections
Status:
COMPLETED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RUNtoBBV
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 HBsAgnumber of screened PWUD
HIV infection number of HIV Abnumber of screened PWUD
Analysis of linkage to care to hepatologist infectiologist number of patients who adhered to their consultationnumber of referred patients
Secondary objectives
Analysis of risk behaviorsociodemographics linked to presence of BBV infections
Analysis of uptake of antiretroviral treatment number of patients started on treatmentnumber of patients needing treatment
Analysis of treatment adherence adherence to treatment consultationstotal planned consultations
Analysis of treatment outcome total number of cured or virally suppressed patientstotal number of treated patients
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 HBsAgnumber of screened PWUD
HIV infection number of HIV Abnumber of screened PWUD
Analysis of linkage to care to hepatologist infectiologist number of patients who adhered to their consultationnumber of referred patients
Secondary objectives
Analysis of risk behaviorsociodemographics linked to presence of BBV infections
Analysis of uptake of antiretroviral treatment number of patients started on treatmentnumber of patients needing treatment
Analysis of treatment adherence adherence to treatment consultationstotal planned consultations
Analysis of treatment outcome total number of cured or virally suppressed patientstotal number of treated patients
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None