HIV InfectionsTRODUMCRANCT05127187
Estimation of the Prevalence of HIV, Hepatitis C and Hepatitis B Infection Among Detainees in the Nîmes Administrative Detention Center
A study testing Rapid diagnosis test against HIV and hepatitis C and B in people with HIV Infections and Hepatitis C, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, Hepatitis C, Hepatitis B
- What is being tested?
- Rapid diagnosis test against HIV and hepatitis C and B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteFrance
- Study dates
- 8 Feb 2022to 7 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient must have given their free and informed oral consent
- Patient detained in the Nîmes Administrative Detention Center
Who cannot join
- It is impossible to give the subject informed information
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- HIV Infections, Hepatitis C, Hepatitis B
- Being tested
- Rapid diagnosis test against HIV and hepatitis C and B
- Medical subject headings
- HIV Infections, Hepatitis C, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Detainees in an Administrative Detention Center | Experimental | Not described Receives: Diagnostic Test: Rapid diagnosis test against HIV and hepatitis C and B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of HIV infection in detainees at the Nîmes Administrative Detention Center
Rapid diagnosis test: Positive/negative
Measured: Inclusion
Prevalence of Hepatitis C infection in detainees at the Nîmes Administrative Detention Center
Rapid diagnosis test: Positive/negative
Measured: Inclusion
Prevalence of Hepatitis B infection in detainees at the Nîmes Administrative Detention Center
Rapid diagnosis test: Positive/negative
Measured: Inclusion
Secondary outcomes (12)
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)
Measured: Inclusion
Participant country of origin
Country name
Measured: Inclusion
Knowledge of HIV, Hep C and Hep B status
Yes/no
Measured: Inclusion
Participant previous transfusion
Yes/no
Measured: Inclusion
Intravenous drug use
Yes/no
Measured: Inclusion
Intranasal drug use
Yes/no
Measured: Inclusion
Shared drug paraphernalia
Yes/no
Measured: Inclusion
Non-protected sexual activity
Yes/no
Measured: Inclusion
Participant with piercings
If yes, professional done or not
Measured: Inclusion
Participant with tattoos
If yes, professional done or not
Measured: Inclusion
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)
Measured: End of study (1 year)
Acceptability of the screening
% of subjects giving samples
Measured: End of study (1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start8 Feb 2022
- Primary completion7 Dec 2022
- Study completion7 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mélanie Kinne, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05127187
- Sponsor's protocol ID
- NIMAO/2020-2/MK-1
- Other IDs
- 2021-A00544-37
- Acronym
- TRODUMCRA
- Status last verified
- Dec 2025
- First submitted
- 12 Nov 2021
- Last updated
- 18 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38739355
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimation of the Prevalence of HIV, Hepatitis C and Hepatitis B Infection Among Detainees in the Nîmes Administrative Detention Center
- ClinicalTrials.gov ID
- NCT05127187
- Acronym / sponsor ID
- TRODUMCRA / NIMAO/2020-2/MK-1
- Conditions
- HIV Infections, Hepatitis C, Hepatitis B
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 8 Feb 2022 (actual)
- Primary completion
- 7 Dec 2022 (actual)
- Study completion
- 7 Dec 2022 (actual)
- First posted
- 19 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Detainees in an Administrative Detention Center | Experimental | Diagnostic Test: Rapid diagnosis test against HIV and hepatitis C and B |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The patient must have given their free and informed oral consent
- Patient detained in the Nîmes Administrative Detention Center
Key exclusion criteria (1 listed)
- It is impossible to give the subject informed information
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rapid diagnosis test against HIV and hepatitis C and Bcombined Insti VIH® + Toyo VHC®, then First response Ag Hbs tested on capillary blood sample | Diagnostic test | Detainees in an Administrative Detention Center |
Primary outcome
Prevalence of HIV infection in detainees at the Nîmes Administrative Detention Center
Time frame: Inclusion
Rapid diagnosis test: Positive/negative
Prevalence of Hepatitis C infection in detainees at the Nîmes Administrative Detention Center
Time frame: Inclusion
Rapid diagnosis test: Positive/negative
Prevalence of Hepatitis B infection in detainees at the Nîmes Administrative Detention Center
Time frame: Inclusion
Rapid diagnosis test: Positive/negative
12 secondary outcomes
Prevalence of co-infections between HIV, Hepatitis C and Hepatitis B
Time frame: Inclusion
Participant country of origin
Time frame: Inclusion
Knowledge of HIV, Hep C and Hep B status
Time frame: Inclusion
Participant previous transfusion
Time frame: Inclusion
Intravenous drug use
Time frame: Inclusion
Intranasal drug use
Time frame: Inclusion
Shared drug paraphernalia
Time frame: Inclusion
Non-protected sexual activity
Time frame: Inclusion
Participant with piercings
Time frame: Inclusion
Participant with tattoos
Time frame: Inclusion
Feasibility of screening
Time frame: End of study (1 year)
Acceptability of the screening
Time frame: End of study (1 year)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Results publication: PubMed 38739355Mancy 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mélanie Kinne principal investigator
Centre Hospitalier Universitaire de Nīmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rapid diagnosis test against HIV and hepatitis C and B in people with HIV Infections and Hepatitis C, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of HIV infection in detainees at the Nîmes Administrative Detention Center (time frame: Inclusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05127187, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.