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

NCT01767597 | Completed Results DMC

• 2 other identifiers: IMEA 382011-A01603-38
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 5

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.

Conditions

Hepatitis B; Liver Cirrhosis; Carcinoma, Hepatocellular

Keywords

rapid test; screening; ELISA; hepatitis B virus; access to care

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

ELISA testing

ACTIVE COMPARATOR

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

Other: ELISA testing

Rapid testing

EXPERIMENTAL

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

Other: ELISA testing; Other: Rapid testing

Interventions

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).

ELISA testing; Rapid testing

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.

Also known as: VIKIA®, Biomerieux, Marcy-l'Étoile, France, Quick ProfileTM, Lumiquick, Santa Clara, CA, USA

Rapid testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba: lead
• ANRS, Emerging Infectious Diseases: collaborator
• Gilead Sciences: collaborator
• Roche Pharma AG: collaborator
• Mairie de Paris: collaborator
• BioMérieux: collaborator

Study Sites (5)

Centre de Santé au Maire-Volta

Paris, 75003, France

Location

Centre d'examen de santé de la CPAM, antenne rue du Maroc

Paris, 75012, France

Location

Consultation Policlinique de l'hôpital Saint-Antoine

Paris, 75012, France

Location

Consultation Voyage de l'hôpital Saint-Antoine

Paris, 75012, France

Location

CDAG de Belleville

Paris, 75020, France

Location

Related Publications (1)

• 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.

  PMID: 26954517 RESULT

MeSH Terms

Conditions

Hepatitis B; Liver Cirrhosis; Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Low prevalence of HBV infection; individuals with barriers to healthcare were underrepresented; Quick Profile anti-HBsAb rapid test unable to confirm nonimmunized status; intervention had same-day blood draws, which is not done in routine practice.

Results Point of Contact

• Title: Dr. Julie Bottero
• Organization: Service des maladies infectieuses et tropicales - Hôpital Saint-Antoine

julie.bottero@aphp.fr

+33 1 49 28 04 24

Study Officials

• Julie Bottero, MD

  Hôpital Saint-Antoine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2013
• First Posted: January 14, 2013
• Study Start: February 1, 2012
• Primary Completion: July 1, 2012
• Study Completion: January 1, 2013
• Last Updated: December 13, 2016
• Results First Posted: December 13, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

FR (5)