Back to resultsScreening for Hepatitis B, Hepatitis C and AIDS Viruses Using Dried Blood Spot (BUVARD)
Primary Purpose
Hepatitis B, Hepatitis C, AIDS
Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood collection using Dried Blood Spot
Sponsored by
About this trial
This is an interventional diagnostic trial for Hepatitis B focused on measuring Dried Blood Spot
Eligibility Criteria
Inclusion Criteria:
- Former or active intravenous and/or nasal drug user
- Person on opiate substitution therapy
Exclusion Criteria:
- Person with known active viral infection(s)
Sites / Locations
- CSAPA la Boussole
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Drug user
Arm Description
Drug users will be screened for Hepatitis C, Hepatitis B and AIDS using Dried Blood Spot for blood collection
Outcomes
Primary Outcome Measures
Number of person with an active hepatitis C infection
Number of person with an active hepatitis B infection
Number of person with an active AIDS infection
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05390424
Brief Title
Screening for Hepatitis B, Hepatitis C and AIDS Viruses Using Dried Blood Spot
Acronym
BUVARD
Official Title
Screening for Hepatitis B, Hepatitis C and AIDS Viruses Using Dried Blood Spot
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2022 (Anticipated)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the study is to screen for hepatitis B, hepatitis C and AIDS viruses using a Dried Blood Spot in drug users
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, Hepatitis C, AIDS
Keywords
Dried Blood Spot
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Drug user
Arm Type
Experimental
Arm Description
Drug users will be screened for Hepatitis C, Hepatitis B and AIDS using Dried Blood Spot for blood collection
Intervention Type
Diagnostic Test
Intervention Name(s)
Blood collection using Dried Blood Spot
Intervention Description
Drug users will be screened for Hepatitis C, Hepatitis B and AIDS using Dried Blood Spot for blood collection
Primary Outcome Measure Information:
Title
Number of person with an active hepatitis C infection
Time Frame
Day 1
Title
Number of person with an active hepatitis B infection
Time Frame
Day 1
Title
Number of person with an active AIDS infection
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Former or active intravenous and/or nasal drug user
Person on opiate substitution therapy
Exclusion Criteria:
Person with known active viral infection(s)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ghassan RIACHI, MD
Phone
+3323288
Ext
8265
Email
ghassan.riachi@chu-rouen.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Julien BLOT
Phone
+3323288
Ext
8265
Email
julien.blot@chu-rouen.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ghassan RIACHI, MD
Organizational Affiliation
Rouen University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CSAPA la Boussole
City
Rouen
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Screening for Hepatitis B, Hepatitis C and AIDS Viruses Using Dried Blood Spot
We'll reach out to this number within 24 hrs