Application of HBV Rapid Tests as a Tool for Wide-Use Screening

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.

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Key information

Conditions

Hepatitis B Adenocarcinoma Blood-Borne Infections Carcinoma Carcinoma, Hepatocellular Communicable Diseases DNA Virus Infections Digestive System Diseases Digestive System Neoplasms Fibrosis Hepadnaviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Cirrhosis Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CDAG de Belleville, Paris, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ELISA testing

Other

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

Other

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

Primary outcomes

Percentage of Patients Appropriately Seeking Care

Time frame: 6 months
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

Sponsors and collaborators

Lead sponsor

Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

Other

Collaborators

ANRS, Emerging Infectious Diseases
BioMérieux
Gilead Sciences
Mairie de Paris
Roche Pharma AG

Registry information

Official study title

Is the Combination of Screening Algorithms and Use of Hepatitis B Rapid Tests Useful in Optimizing the Screening and Prevention of Hepatitis B?

Acronym: OPTISCREEN-B

Important dates

Study start: 2012
Primary completion: 2012
Study completion: 2013
First posted: Jan 14, 2013
Registry last updated: Dec 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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