NCT05390424

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Dec 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

11 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
Dec 2022Jan 2027

First Submitted

Initial submission to the registry

May 20, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 25, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

December 2, 2022

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

4.1 years

First QC Date

May 20, 2022

Last Update Submit

February 12, 2026

Conditions

Keywords

Dried Blood Spot

Outcome Measures

Primary Outcomes (3)

  • Number of person with an active hepatitis C infection

    Day 1

  • Number of person with an active hepatitis B infection

    Day 1

  • Number of person with an active AIDS infection

    Day 1

Study Arms (1)

Drug user

EXPERIMENTAL

Drug users will be screened for Hepatitis C, Hepatitis B and AIDS using Dried Blood Spot for blood collection

Diagnostic Test: Blood collection using Dried Blood Spot

Interventions

Drug users will be screened for Hepatitis C, Hepatitis B and AIDS using Dried Blood Spot for blood collection

Drug user

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Former or active intravenous and/or nasal drug user
  • Person on opiate substitution therapy

You may not qualify if:

  • Person with known active viral infection(s)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Caarud Sud Manche

Avranches, 50300, France

RECRUITING

Csapa Barentin

Barentin, 76360, France

RECRUITING

Oeuvre Normande Des Meres

Dieppe, 76200, France

RECRUITING

Csapa Act

Elbeuf, 76500, France

RECRUITING

Csapa Gisors

Gisors, 27140, France

RECRUITING

Csapa Nautilia

Le Havre, 76600, France

RECRUITING

Csapa Pont-Audemer

Pont-Audemer, 27504, France

RECRUITING

Aides Region Normandie

Rouen, 76000, France

RECRUITING

Csapa-Caarud La Boussole

Rouen, 76000, France

RECRUITING

Chu Rouen

Rouen, 76031, France

RECRUITING

Csapa Caux Et Bray

Yvetot, 76190, France

RECRUITING

MeSH Terms

Conditions

Hepatitis BHepatitis CAcquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System DiseasesFlaviviridae InfectionsRNA Virus InfectionsHIV InfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Ghassan RIACHI, MD

    University Hospital, Rouen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2022

First Posted

May 25, 2022

Study Start

December 2, 2022

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

February 17, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations