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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hepatitis B, Liver Cirrhosis, Carcinoma, Hepatocellular

Intervention / Treatment
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* Other: ELISA testing
* Other: Rapid testing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ELISA testing<br>HBV infection status determined by enzyme-linked immuno-assay (ELISA) | Other: ELISA testing<br>* 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).<br>|
| Experimental: Rapid testing<br>HBV infection status determined initially by a rapid test, then confirmed by enzyme-linked immuno-assay (ELISA). | Other: ELISA testing<br>* 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).<br>Other: Rapid testing<br>* 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.<br>* Other names: Quick ProfileTM, Lumiquick, Santa Clara, CA, USA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients Appropriately Seeking Care | 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 | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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access to care, rapid test, screening, ELISA, hepatitis B virus