Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2025-12-25 @ 4:53 PM
Study NCT ID:
NCT05361603
Status:
RECRUITING
Last Update Posted:
2022-05-04
First Post:
2022-04-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Acceptability of Simultaneous Screening for Viral Hepatitis B, C and HIV Among Drug Users in Non-conventional Structures
Sponsor:
University Hospital, Limoges
Organization:
Study Overview
Official Title:
Acceptability of Simultaneous Screening for Viral Hepatitis B, C and HIV Among Drug Users in Non-conventional Facilities "Outside the Walls" Using the Dual Screening Method TROD (Rapid Diagnostic Tests) and FibroScan
Status:
RECRUITING
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SCANVIR
Brief Summary:
The principle is to propose dedicated monthly screening days bringing together the health personnel involved (hepatologist, addictologist, nurse in charge of the program, addictology nurse and social worker) and to propose appropriate management for each situation assessed.
Detailed Description:
1. Information on screening, the days are announced by :
* Mailing to health professionals in the Haute-Vienne Department,
* Announcement to the different professional orders concerned (doctors, pharmacists, midwives, nurses, etc.),
* Flyers and posters in health care facilities,
* Distribution in the AddictLim network newsletter (pharmacists, nurses, social workers members),
* Various: Liaison team, health delegate of the network, intranet site of the hospital, CCAS, AMPA, day care centers.
2. Conduct of a SCANVIR day in the non-conventional structure " Hors les murs " :
Each patient presenting during the screening day will have an individualized welcome.
Addictological and hepatological data will be collected throughout the process by the various workers on the individual Scanvir form (attached).
1. The patient accepts one or more of the examinations proposed as part of the routine care. After information, he/she does not object to the collection of his/her personal data.
2. One or more TRODs and a FibroScan® are performed by the nurse in charge of the care pathway and/or the facility.
3. Performing, by the biologist or the authorized person, the delocalized PCR in case of positive HCV TROD
4. Consultation with the hepatologist, who gives the results of the TROD and FibroScan® in a closed and dedicated place where the confidentiality of exchanges is guaranteed.
5. A written document with the results of the TROD and FibroScan® and GeneXpert is given to the patient.
Method for routine management of patients according to results :
1. HCV HBV HIV TROD are negative and FibroScan® \> 7.1 KPa:
The patient meets directly with the hepatologist to screen for risk factors for chronic liver disease (alcohol, medications ...).
2. The HCV HBV HIV TROD are negative and the FibroScan ® \< 7.1 KPa :
The nurse at the facility reviews with the patient the modes of transmission of the viruses and discusses with him/her risk reduction and harm reduction and what to do in case of recent exposure.
3. Positive HCV TROD:
The hepatologist offers to do an immediate and on-site HCV RNA by delocalized PCR (GeneXpert). If the HCV RNA is positive, HCV treatment is started immediately (excluding comorbidity). An appointment is proposed 3 months after treatment to control the cure by delocalized PCR on site (RVS12)
4. HIV or HBV TROD positivity:
The hepatologist proposes to do immediately and on site a complete blood test (HIV serology, HBV serologies (HBsAg, HBcAb, HBsAb) by the nurse present, assesses other risk factors and schedules an appointment for the results and management.
For all situations, a prevention action to reduce the risks of transmission of HCV and HBV will be carried out at the same time.
An anti-viral B vaccination may be offered.
* Mailing to health professionals in the Haute-Vienne Department,
* Announcement to the different professional orders concerned (doctors, pharmacists, midwives, nurses, etc.),
* Flyers and posters in health care facilities,
* Distribution in the AddictLim network newsletter (pharmacists, nurses, social workers members),
* Various: Liaison team, health delegate of the network, intranet site of the hospital, CCAS, AMPA, day care centers.
2. Conduct of a SCANVIR day in the non-conventional structure " Hors les murs " :
Each patient presenting during the screening day will have an individualized welcome.
Addictological and hepatological data will be collected throughout the process by the various workers on the individual Scanvir form (attached).
1. The patient accepts one or more of the examinations proposed as part of the routine care. After information, he/she does not object to the collection of his/her personal data.
2. One or more TRODs and a FibroScan® are performed by the nurse in charge of the care pathway and/or the facility.
3. Performing, by the biologist or the authorized person, the delocalized PCR in case of positive HCV TROD
4. Consultation with the hepatologist, who gives the results of the TROD and FibroScan® in a closed and dedicated place where the confidentiality of exchanges is guaranteed.
5. A written document with the results of the TROD and FibroScan® and GeneXpert is given to the patient.
Method for routine management of patients according to results :
1. HCV HBV HIV TROD are negative and FibroScan® \> 7.1 KPa:
The patient meets directly with the hepatologist to screen for risk factors for chronic liver disease (alcohol, medications ...).
2. The HCV HBV HIV TROD are negative and the FibroScan ® \< 7.1 KPa :
The nurse at the facility reviews with the patient the modes of transmission of the viruses and discusses with him/her risk reduction and harm reduction and what to do in case of recent exposure.
3. Positive HCV TROD:
The hepatologist offers to do an immediate and on-site HCV RNA by delocalized PCR (GeneXpert). If the HCV RNA is positive, HCV treatment is started immediately (excluding comorbidity). An appointment is proposed 3 months after treatment to control the cure by delocalized PCR on site (RVS12)
4. HIV or HBV TROD positivity:
The hepatologist proposes to do immediately and on site a complete blood test (HIV serology, HBV serologies (HBsAg, HBcAb, HBsAb) by the nurse present, assesses other risk factors and schedules an appointment for the results and management.
For all situations, a prevention action to reduce the risks of transmission of HCV and HBV will be carried out at the same time.
An anti-viral B vaccination may be offered.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: