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

Not Applicable

Completed

Conditions: Hepatitis B
Carcinoma, Hepatocellular
Liver Cirrhosis

Interventions: Other: ELISA testing
Other: Rapid testing

Registration Number: NCT01767597

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

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1000

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ELISA testing	ELISA testing	HBV infection status determined by enzyme-linked immuno-assay (ELISA)
Rapid testing	ELISA testing	HBV infection status determined initially by a rapid test, then confirmed by enzyme-linked immuno-assay (ELISA).
Rapid testing	Rapid testing	HBV infection status determined initially by a rapid test, then confirmed by enzyme-linked immuno-assay (ELISA).

Primary Outcome Measures

Name	Time	Method
Percentage of Patients Appropriately Seeking Care	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

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (5): Centre de Santé au Maire-Volta
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Paris, France
Centre d'examen de santé de la CPAM, antenne rue du Maroc
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Paris, France
Consultation Policlinique de l'hôpital Saint-Antoine
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Paris, France
Consultation Voyage de l'hôpital Saint-Antoine
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Paris, France
CDAG de Belleville
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Paris, France