TRODUMCRA: Estimation of the Prevalence of HIV, Hepatitis C and Hepatitis B Infection Among Detainees in the Nîmes Administrative Detention Center

Sponsor
Centre Hospitalier Universitaire de Nīmes (Other)
Overall Status
Recruiting
CT.gov ID
NCT05127187
Collaborator
(none)
350
1
12.7
27.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Rapid diagnosis test against HIV and hepatitis C and B

Study Design

Study Type:
Observational
Anticipated Enrollment :
350 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Estimation of the Prevalence of HIV, Hepatitis C and Hepatitis B Infection Among Detainees in the Nîmes Administrative Detention Center
Actual Study Start Date :
Feb 8, 2022
Anticipated Primary Completion Date :
Feb 1, 2023
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Detainees in an Administrative Detention Center

Diagnostic Test: Rapid diagnosis test against HIV and hepatitis C and B
combined Insti VIH® + Toyo VHC®, then First response Ag Hbs tested on capillary blood sample

Outcome Measures

Primary Outcome Measures

  1. Prevalence of HIV infection in detainees at the Nîmes Administrative Detention Center [Inclusion]

    Rapid diagnosis test: Positive/negative

  2. Prevalence of Hepatitis C infection in detainees at the Nîmes Administrative Detention Center [Inclusion]

    Rapid diagnosis test: Positive/negative

  3. Prevalence of Hepatitis B infection in detainees at the Nîmes Administrative Detention Center [Inclusion]

    Rapid diagnosis test: Positive/negative

Secondary Outcome Measures

  1. Prevalence of co-infections between HIV, Hepatitis C and Hepatitis B [Inclusion]

    Yes or no for co-infection (HIV-Hep C / HIV-Hep B / HepC-HepB / Hiv-HepC-HepB)

  2. Participant country of origin [Inclusion]

    Country name

  3. Knowledge of HIV, Hep C and Hep B status [Inclusion]

    Yes/no

  4. Participant previous transfusion [Inclusion]

    Yes/no

  5. Intravenous drug use [Inclusion]

    Yes/no

  6. Intranasal drug use [Inclusion]

    Yes/no

  7. Shared drug paraphernalia [Inclusion]

    Yes/no

  8. Non-protected sexual activity [Inclusion]

    Yes/no

  9. Participant with piercings [Inclusion]

    If yes, professional done or not

  10. Participant with tattoos [Inclusion]

    If yes, professional done or not

  11. Feasibility of screening [End of study (1 year)]

    % of subjects with available samples (ie no subject refusal, subjects arriving at weekend or holiday, study not offered on a weekday, technical problem with test interpretation)

  12. Acceptability of the screening [End of study (1 year)]

    % of subjects giving samples

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • The patient must have given their free and informed oral consent

  • Patient detained in the Nîmes Administrative Detention Center

Exclusion Criterion

• It is impossible to give the subject informed information

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Nîmes Nîmes France

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Nīmes

Investigators

  • Principal Investigator: Mélanie Kinne, Centre Hospitalier Universitaire de Nīmes

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT05127187
Other Study ID Numbers:
  • NIMAO/2020-2/MK-1
First Posted:
Nov 19, 2021
Last Update Posted:
Mar 18, 2022
Last Verified:
Mar 1, 2022

Study Results

No Results Posted as of Mar 18, 2022