NCT05127187

Brief Summary

People in Administrative Detention Centers often come from areas of medium or high HIV, hepatitis C \& B endemic, and are often unaware of their serological status. Currently, HIV, hepatitis C \& B screening is not systematically performed at the CRA of Nîmes, and when performed, serological tests are used. The main disadvantage of this method is the length of time it takes to obtain the results, with subjects frequently discharged before receiving their results. To improve the care of these vulnerable persons, the aim of this study is to estimate the prevalence of HIV, hepatitis C and hepatitis B in the detainees of the administrative detention center of Nîmes, by systematically screening with a rapid diagnosis test. In case of a positive rapid diagnosis test test, a serology test will confirm the rapid diagnosis test result.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
350

participants targeted

Target at P50-P75 for not_applicable hiv-infections

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

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

November 12, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 19, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

February 8, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2022

Completed
Last Updated

December 18, 2025

Status Verified

December 1, 2025

Enrollment Period

10 months

First QC Date

November 12, 2021

Last Update Submit

December 10, 2025

Conditions

HIV InfectionsHepatitis CHepatitis B

Outcome Measures

Primary Outcomes (3)

  • Prevalence of HIV infection in detainees at the Nîmes Administrative Detention Center

    Rapid diagnosis test: Positive/negative

    Inclusion

  • Prevalence of Hepatitis C infection in detainees at the Nîmes Administrative Detention Center

    Rapid diagnosis test: Positive/negative

    Inclusion

  • Prevalence of Hepatitis B infection in detainees at the Nîmes Administrative Detention Center

    Rapid diagnosis test: Positive/negative

    Inclusion

Secondary Outcomes (12)

  • Prevalence of co-infections between HIV, Hepatitis C and Hepatitis B

    Inclusion

  • Participant country of origin

    Inclusion

  • Knowledge of HIV, Hep C and Hep B status

    Inclusion

  • Participant previous transfusion

    Inclusion

  • Intravenous drug use

    Inclusion

  • +7 more secondary outcomes

Study Arms (1)

Detainees in an Administrative Detention Center

EXPERIMENTAL
Diagnostic Test: Rapid diagnosis test against HIV and hepatitis C and B

Interventions

Rapid diagnosis test against HIV and hepatitis C and BDIAGNOSTIC_TEST

combined Insti VIH® + Toyo VHC®, then First response Ag Hbs tested on capillary blood sample

Detainees in an Administrative Detention Center

Eligibility Criteria

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

You may qualify if:

  • The patient must have given their free and informed oral consent
  • Patient detained in the Nîmes Administrative Detention Center
  • It is impossible to give the subject informed information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Nîmes

Nîmes, France

Location

Related Publications (1)

  • Mancy S, Fabbro-Peray P, Alonso S, Berkaoui H, Lambremon L, Vidal H, Hilaire C, Herrmann D, Dapoigny J, Kinne M. Prevalence of HIV, Hepatitis C and Hepatitis B Infection Among Detainees in a French Administrative Detention Centre. J Epidemiol Glob Health. 2024 Sep;14(3):923-932. doi: 10.1007/s44197-024-00238-0. Epub 2024 May 13.

    PMID: 38739355RESULT

MeSH Terms

Conditions

HIV InfectionsHepatitis CHepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesHepatitis, Viral, HumanFlaviviridae InfectionsHepatitisLiver DiseasesDigestive System DiseasesHepadnaviridae InfectionsDNA Virus Infections

Study Officials

  • Mélanie Kinne

    Centre Hospitalier Universitaire de Nīmes

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 12, 2021

First Posted

November 19, 2021

Study Start

February 8, 2022

Primary Completion

December 7, 2022

Study Completion

December 7, 2022

Last Updated

December 18, 2025

Record last verified: 2025-12

Locations

FR(1)