NCT04959643

Brief Summary

A high number of people are infected by viral hepatitises B and C without knowing it, especially vulnerable population such as the ones who come in consultation in continuous health care access center (Permanence d'accès aux soins, PASS). Now that these infections can be rapidly treated, it is essential to diagnose them the quickest possible. The Identification and Diagnostic Orientation Test (Test de repérage et d'orientation diagnostique, TROD) technique is a rapid tool allowing to screen for hepatitis B and C by a simple capillary sample. The study aims to evaluate the accptability of a systematic screening using TROD for hepatitis B and C in adults in a PASS consultation in Montpellier. We also want to estimate the prevalence of theses infections in the population, to describe the HBV and HCV care cascades, to evaluate the acceptability of vaccinal catch-up for HBV, and to describe people with hepatits.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

June 18, 2021

Completed
25 days until next milestone

First Posted

Study publicly available on registry

July 13, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

October 5, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

January 10, 2022

Status Verified

October 1, 2021

Enrollment Period

1.7 years

First QC Date

June 18, 2021

Last Update Submit

December 16, 2021

Conditions

Keywords

HepatitisViral hepatitisHepatitis BHepatitis CAddictionRapid orientation toolTRODContinuous health care centerPASS

Outcome Measures

Primary Outcomes (1)

  • Rate of performed TROD

    Proportion of performed TROD out on the number of people it has been offered.

    Inclusion visit

Secondary Outcomes (21)

  • Prevalence of hepatits B in the population

    Inclusion visit

  • Prevalence of hepatits C in the population

    Inclusion visit

  • Care Cascade for HBV

    3 months

  • Care Cascade for HCV

    6 months

  • Age

    Inclusion visit

  • +16 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults in Montpellier's PASS consultation

You may qualify if:

  • People of 18 years old and more
  • Non objection to be a participant of the study

You may not qualify if:

  • Judicial protection (sauvegarde de justice, tutelle or curatelle)
  • Impossibility of offering clear information to the subject

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Montpellier, St Eloi Hospital,

Montpellier, Hérault, 34295, France

RECRUITING

MeSH Terms

Conditions

Hepatitis CHepatitis BBehavior, AddictiveHepatitis

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsLiver DiseasesDigestive System DiseasesHepadnaviridae InfectionsDNA Virus InfectionsCompulsive BehaviorImpulsive BehaviorBehavior

Study Officials

  • Helene DONNADIEU RIGOLE, MH PD

    Biochemistry department

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Helene DONNADIEU RIGOLE

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2021

First Posted

July 13, 2021

Study Start

October 5, 2021

Primary Completion

July 1, 2023

Study Completion

October 1, 2023

Last Updated

January 10, 2022

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations