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

HIV Infections Clinical Trial

— TRODUMCRA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05127187
• Other study ID #: NIMAO/2020-2/MK-1
• Status: Completed
• Start date: February 8, 2022
• Est. completion date: December 7, 2022

Study information

• Verified date: September 2023
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: December 7, 2022
• Est. primary completion date: December 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis C
• HIV Infections
• Infections

Intervention

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

Locations

Country	Name	City	State
France	CHU Nîmes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of HIV infection in detainees at the Nîmes Administrative Detention Center	Rapid diagnosis test: Positive/negative	Inclusion
Primary	Prevalence of Hepatitis C infection in detainees at the Nîmes Administrative Detention Center	Rapid diagnosis test: Positive/negative	Inclusion
Primary	Prevalence of Hepatitis B infection in detainees at the Nîmes Administrative Detention Center	Rapid diagnosis test: Positive/negative	Inclusion
Secondary	Prevalence of co-infections between HIV, Hepatitis C and Hepatitis B	Yes or no for co-infection (HIV-Hep C / HIV-Hep B / HepC-HepB / Hiv-HepC-HepB)	Inclusion
Secondary	Participant country of origin	Country name	Inclusion
Secondary	Knowledge of HIV, Hep C and Hep B status	Yes/no	Inclusion
Secondary	Participant previous transfusion	Yes/no	Inclusion
Secondary	Intravenous drug use	Yes/no	Inclusion
Secondary	Intranasal drug use	Yes/no	Inclusion
Secondary	Shared drug paraphernalia	Yes/no	Inclusion
Secondary	Non-protected sexual activity	Yes/no	Inclusion
Secondary	Participant with piercings	If yes, professional done or not	Inclusion
Secondary	Participant with tattoos	If yes, professional done or not	Inclusion
Secondary	Feasibility of screening	% 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)
Secondary	Acceptability of the screening	% of subjects giving samples	End of study (1 year)