Application of HBV Rapid Tests as a Tool for Wide-Use Screening (OPTISCREEN-B)

This study has been completed.
Sponsor:
Collaborators:
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Gilead Sciences
Roche Pharma AG
Mairie de Paris
Biomerieux
Information provided by (Responsible Party):
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
ClinicalTrials.gov Identifier:
NCT01767597
First received: January 10, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  Purpose

With over 280 000 chronic carriers, 2,500 new annual cases and 1,300 deaths each year, hepatitis B is currently a frequent and potentially severe disease in France, despite efforts towards prevention and effective care.

In terms of prevention, France has very low immunization coverage (27.7%) and a high percentage of people ignoring HBV status (55%), leading to a delay in care. This is partly explained by poor knowledge of hepatitis B infection in the general population and an underestimation of the health impact of hepatitis B by doctors and health officials. Until recently, there have been no national guidelines governing its implementation (which is variable depending on the structures where screening is performed) and an insufficient evaluation of screening practices. Thus, data on the severity of liver disease, indications for treatment of HBV-infected patients and data on the use of vaccination for nonimmunized people are scarce. Furthermore, while HIV rapid tests are beginning to be used more widely, particularly to address the issue of people who do not come back and collect their results and to better adapt "counselling", their usefulness to detect of hepatitis B virus has not been evaluated to date.

The main objective of the Optiscreen B Study is to determine the benefit, if any, of using rapid tests as a screening tool to improve diagnosis, care and prevention of hepatitis B. Individuals risk of HBV-infection will be randomized into 2 groups, one group for which screening will be performed by usual serological test and a second group for which screening will be based on rapid tests. Centers will be selected to represent a diverse range of health centers whose aims include screening, prevention and/or vaccination.


Condition Intervention
Hepatitis B
Liver Cirrhosis
Carcinoma, Hepatocellular
Other: ELISA testing
Other: Rapid testing

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Is the Combination of Screening Algorithms and Use of Hepatitis B Rapid Tests Useful in Optimizing the Screening and Prevention of Hepatitis B?

Resource links provided by NLM:


Further study details as provided by Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba:

Primary Outcome Measures:
  • Percentage of patients appropriately seeking care [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    Subjects who are considered required to seek further care are as follows:

    • those who need HBV vaccination (non-immunized)
    • those who are infected with hepatitis B virus (infected)

    Of these patients, subjects who have achieved appropriate care are considered as follows:

    • non immunized subjects who have initiated HBV vaccination sequence (vaccinated)
    • infected subjects who seek health care at a specialized center, allowing to quantify the severity of liver-related disease (infected with care)

    The percentage of patients appropriately seeking care will be then calculated by the following formula:

    ((nb Vaccinated + nb infected with care) / (nb non-immunized + nb infected))*100



Enrollment: 1000
Study Start Date: February 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ELISA testing
HBV infection status determined by enzyme-linked immuno-assay (ELISA)
Other: ELISA testing
Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg) and anti-HBsAg antibody (anti-HBs Ab) status. Results will be given after test results are available (8-10 days).
Experimental: Rapid testing
HBV infection status determined initially by a rapid test, then confirmed by enzyme-linked immuno-assay (ELISA).
Other: ELISA testing
Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg) and anti-HBsAg antibody (anti-HBs Ab) status. Results will be given after test results are available (8-10 days).
Other: Rapid testing
A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®) and anti-HBs antibody status (anti-HBs Ab, using Quick ProfileTM). Results will be given the same day.
Other Names:
  • VIKIA®, Biomerieux, Marcy-l'Étoile, France
  • Quick ProfileTM, Lumiquick, Santa Clara, CA, USA

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Born in a country of middle or high HBV endemicity
  • Parents born in a country of middle or high HBV endemicity
  • Travellers or residents from a country of middle or high HBV endemicity
  • Blood, organ, tissue, sperm, and/or ovary donners or candidate donners.
  • Health-care workers suspected of coming into direct contact with an HBV-infected individual and/or exposed to blood or any biological products from an HBV-infected individual
  • Close contact with HBsAg-positive individuals (living in the same household, sexual partner, sharing needles, etc.)
  • Individuals with accidental exposure to HBV
  • Individuals with multiple sexual partners
  • Men who have sex with men
  • Pregnant women
  • Hemodialysis
  • Individuals requiring immunosuppressive therapy
  • Individuals with persistently elevated transaminase levels
  • HIV-positive
  • Intravenous drug users

Exclusion Criteria:

  • Age <18 years old
  • Not capable of providing informed consent
  • Already participated in a multi-center validation of HBV rapid tests
  • Having, in their possession, irrefutable results of a prior test for hepatitis B virus
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01767597

Locations
France
CDAG de Belleville
Paris, France, 75020
Centre de Santé au Maire-Volta
Paris, France, 75003
Centre d'examen de santé de la CPAM, antenne rue du Maroc
Paris, France, 75012
Consultation Policlinique de l'hôpital Saint-Antoine
Paris, France, 75012
Consultation Voyage de l'hôpital Saint-Antoine
Paris, France, 75012
Sponsors and Collaborators
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Gilead Sciences
Roche Pharma AG
Mairie de Paris
Biomerieux
Investigators
Principal Investigator: Julie Bottero, MD Hôpital Saint-Antoine
  More Information

Additional Information:
No publications provided

Responsible Party: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
ClinicalTrials.gov Identifier: NCT01767597     History of Changes
Other Study ID Numbers: IMEA 38, 2011-A01603-38
Study First Received: January 10, 2013
Last Updated: January 10, 2013
Health Authority: France: Committee for the Protection of Personnes
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba:
rapid test
screening
ELISA
hepatitis B virus
access to care

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Liver Cirrhosis
Carcinoma, Hepatocellular
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on September 18, 2014