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

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

Status: Completed

Conditions: Carcinoma, Hepatocellular; Liver Cirrhosis; Hepatitis B

Treatments: Other: Rapid testing; Other: ELISA testing

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01767597

IMEA 38

2011-A01603-38 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 1,000 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

1,000 participants in 2 patient groups

ELISA testing

Active Comparator group

Description:

HBV infection status determined by enzyme-linked immuno-assay (ELISA)

Treatment:

Other: ELISA testing

Rapid testing

Experimental group

Description:

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

Treatment:

Other: ELISA testing

Other: Rapid testing