Application of HBV Rapid Tests as a Tool for Wide-Use Screening
NCT ID: NCT01767597
Last Updated: 2016-12-13
Study Results
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View full resultsBasic Information
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COMPLETED
NA
1000 participants
INTERVENTIONAL
2012-02-29
2013-01-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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ELISA testing
HBV infection status determined by enzyme-linked immuno-assay (ELISA)
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).
Rapid testing
HBV infection status determined initially by a rapid test, then confirmed by enzyme-linked immuno-assay (ELISA).
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).
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.
Interventions
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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).
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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ANRS, Emerging Infectious Diseases
OTHER_GOV
Gilead Sciences
INDUSTRY
Roche Pharma AG
INDUSTRY
Mairie de Paris
UNKNOWN
BioMérieux
INDUSTRY
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
OTHER
Responsible Party
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Principal Investigators
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Julie Bottero, MD
Role: PRINCIPAL_INVESTIGATOR
Hôpital Saint-Antoine
Locations
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Centre de Santé au Maire-Volta
Paris, , France
Centre d'examen de santé de la CPAM, antenne rue du Maroc
Paris, , France
Consultation Policlinique de l'hôpital Saint-Antoine
Paris, , France
Consultation Voyage de l'hôpital Saint-Antoine
Paris, , France
CDAG de Belleville
Paris, , France
Countries
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References
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Bottero J, Boyd A, Gozlan J, Carrat F, Lemoine M, Rougier H, Varsat B, Boo N, Charlois-Ou C, Collignon A, Cha O, Campa P, Dhotte P, Girard PM, Lacombe K. Effectiveness of hepatitis B rapid tests toward linkage-to-care: results of a randomized, multicenter study. Eur J Gastroenterol Hepatol. 2016 Jun;28(6):633-9. doi: 10.1097/MEG.0000000000000620.
Other Identifiers
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2011-A01603-38
Identifier Type: REGISTRY
Identifier Source: secondary_id
IMEA 38
Identifier Type: -
Identifier Source: org_study_id