- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05127187
Estimation of the Prevalence of HIV, Hepatitis C and Hepatitis B Infection Among Detainees in the Nîmes Administrative Detention Center (TRODUMCRA)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Nîmes, France
- CHU Nimes
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Detainees in an Administrative Detention Center
|
combined Insti VIH® + Toyo VHC®, then First response Ag Hbs tested on capillary blood sample
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prevalence of HIV infection in detainees at the Nîmes Administrative Detention Center
Time Frame: Inclusion
|
Rapid diagnosis test: Positive/negative
|
Inclusion
|
|
Prevalence of Hepatitis C infection in detainees at the Nîmes Administrative Detention Center
Time Frame: Inclusion
|
Rapid diagnosis test: Positive/negative
|
Inclusion
|
|
Prevalence of Hepatitis B infection in detainees at the Nîmes Administrative Detention Center
Time Frame: Inclusion
|
Rapid diagnosis test: Positive/negative
|
Inclusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prevalence of co-infections between HIV, Hepatitis C and Hepatitis B
Time Frame: Inclusion
|
Yes or no for co-infection (HIV-Hep C / HIV-Hep B / HepC-HepB / Hiv-HepC-HepB)
|
Inclusion
|
|
Participant country of origin
Time Frame: Inclusion
|
Country name
|
Inclusion
|
|
Knowledge of HIV, Hep C and Hep B status
Time Frame: Inclusion
|
Yes/no
|
Inclusion
|
|
Participant previous transfusion
Time Frame: Inclusion
|
Yes/no
|
Inclusion
|
|
Intravenous drug use
Time Frame: Inclusion
|
Yes/no
|
Inclusion
|
|
Intranasal drug use
Time Frame: Inclusion
|
Yes/no
|
Inclusion
|
|
Shared drug paraphernalia
Time Frame: Inclusion
|
Yes/no
|
Inclusion
|
|
Non-protected sexual activity
Time Frame: Inclusion
|
Yes/no
|
Inclusion
|
|
Participant with piercings
Time Frame: Inclusion
|
If yes, professional done or not
|
Inclusion
|
|
Participant with tattoos
Time Frame: Inclusion
|
If yes, professional done or not
|
Inclusion
|
|
Feasibility of screening
Time Frame: 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)
|
End of study (1 year)
|
|
Acceptability of the screening
Time Frame: End of study (1 year)
|
% of subjects giving samples
|
End of study (1 year)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Mélanie Kinne, Centre Hospitalier Universitaire de Nîmes
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Blood-Borne Infections
- Urogenital Diseases
- Genital Diseases
- Immune System Diseases
- Infections
- RNA Virus Infections
- Virus Diseases
- Digestive System Diseases
- Liver Diseases
- Hepatitis, Viral, Human
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- DNA Virus Infections
- Flaviviridae Infections
- Hepadnaviridae Infections
- Hepatitis
- HIV Infections
- Hepatitis B
- Hepatitis C
Other Study ID Numbers
- NIMAO/2020-2/MK-1
- 2021-A00544-37 (Other Identifier: ANSM)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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