Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

21. oktober 2016 opdateret af: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

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

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

1000

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Frankrig
      • Paris, Frankrig, 75003
        • Centre de Santé au Maire-Volta
      • Paris, Frankrig, 75012
        • Centre d'examen de santé de la CPAM, antenne rue du Maroc
      • Paris, Frankrig, 75012
        • Consultation Policlinique de l'hôpital Saint-Antoine
      • Paris, Frankrig, 75012
        • Consultation Voyage de l'hôpital Saint-Antoine
      • Paris, Frankrig, 75020
        • CDAG de Belleville

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Screening
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: ELISA testing
HBV infection status determined by enzyme-linked immuno-assay (ELISA)
Andet: ELISA testing
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).
Eksperimentel: Rapid testing
HBV infection status determined initially by a rapid test, then confirmed by enzyme-linked immuno-assay (ELISA).
Andet: ELISA testing
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).
Andet: Rapid testing
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.
Andre navne:
  • VIKIA®, Biomerieux, Marcy-l'Étoile, Frankrig
  • Quick ProfileTM, Lumiquick, Santa Clara, CA, USA

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Patients Appropriately Seeking Care
Tidsramme: 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
6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

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

Samarbejdspartnere

Gilead Sciences
Roche Pharma AG
ANRS, Emerging Infectious Diseases
BioMérieux
Mairie de Paris

Efterforskere

  • Ledende efterforsker: Julie Bottero, MD, Hopital Saint-Antoine

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. februar 2012

Primær færdiggørelse (Faktiske)

1. juli 2012

Studieafslutning (Faktiske)

1. januar 2013

Datoer for studieregistrering

Først indsendt

10. januar 2013

Først indsendt, der opfyldte QC-kriterier

10. januar 2013

Først opslået (Skøn)

14. januar 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

13. december 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. oktober 2016

Sidst verificeret

1. oktober 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IMEA 38
  • 2011-A01603-38 (Registry Identifier: ANSM)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Data will be shared upon official request by interested parties. All requests are subject to approval by the Scientific Committee.

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Levercirrhose

Kliniske forsøg med ELISA testing

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Sweden

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner