Clinical trial NCT01767597: Application of HBV Rapid Tests as a Tool for Wide-Use Screening
Official title: Is the Combination of Screening Algorithms and Use of Hepatitis B Rapid Tests Useful in Optimizing the Screening and Prevention of Hepatitis B?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis B
Liver Cirrhosis
Carcinoma, Hepatocellular
Keywords: rapid test
screening
ELISA
hepatitis B virus
access to care
Lead sponsor: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
Sponsor class: OTHER
Collaborators: name: ANRS, Emerging Infectious Diseases
name: Gilead Sciences
name: Roche Pharma AG
name: Mairie de Paris
name: BioMérieux
First posted: 2013-01-14
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Patients Appropriately Seeking Care
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Centre de Santé au Maire-Volta
city: Paris
country: France
facility: Centre d'examen de santé de la CPAM, antenne rue du Maroc
city: Paris
country: France
facility: Consultation Policlinique de l'hôpital Saint-Antoine
city: Paris
country: France
facility: Consultation Voyage de l'hôpital Saint-Antoine
city: Paris
country: France
facility: CDAG de Belleville
Study officials:
affiliation: Hôpital Saint-Antoine
name: Julie Bottero, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.