Know Cancer

or
forgot password

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


N/A
18 Years
N/A
Not Enrolling
Both
Hepatitis B, Liver Cirrhosis, Carcinoma, Hepatocellular

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Outcome Measure:

Percentage of patients appropriately seeking care

Outcome Description:

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

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Julie Bottero, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hôpital Saint-Antoine

Authority:

France: Committee for the Protection of Personnes

Study ID:

IMEA 38

NCT ID:

NCT01767597

Start Date:

February 2012

Completion Date:

Related Keywords:

  • Hepatitis B
  • Liver Cirrhosis
  • Carcinoma, Hepatocellular
  • rapid test
  • screening
  • ELISA
  • hepatitis B virus
  • access to care
  • Carcinoma
  • Hepatitis
  • Hepatitis A
  • Hepatitis B
  • Liver Cirrhosis
  • Fibrosis
  • Carcinoma, Hepatocellular

Name

Location