Pilot Study Evaluating the Use of Simultaneous HBV, HCV, and HIV Rapid Tests (OPTISCREEN-III)

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

Status: Completed

Conditions: AIDS; Carcinoma, Hepatocellular; Hepatitis C; HIV; Hepatitis B

Treatments: Other: ELISA; Other: Rapid Test

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01790633

IMEA 38B

2012-A01681-42 (Other Identifier)

Details and patient eligibility

About

This is a pilot, monocentric, prospective, randomized control trial looking at the use of rapid tests as a part of normal care. The investigators will be testing for hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV). Testing will be proposed to all persons seeking care at the Centre d'Accueil, de Soins et d'Orientation from the organization Médecin du Monde (CASO, MDM).

Infection status of participants will be determined by either the standard test (ELISA) or rapid test. The choice between tests will be determined randomly.

The overall goal is to determine the general acceptability and feasibility of rapid tests and to see if they can help individuals increase their awareness of infection status when compared to longer, routine methods of testing. In addition, results from these tests will allow the medical doctor to guide participants to appropriate care. All positive tests will be confirmed at a specialized hospital (Hôptial Saint-Antoine, Paris, France) and health-specific information will be obtained four months after testing.

Enrollment: 327 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• At least 18 years of age
• Seeking care at the CASO MDM health care center
• Accept to be followed at Saint-Antoine Hospital in the event of a positive test.

Exclusion criteria

• Currently under physician's care for viral hepatitis (HBV/HCV-specific) or HIV

• Already has been tested (must give any of the following as evidence):

  • results from HBV and HCV and HIV tests dating at least 3 months back
  • results from HCV and HIV tests dating at least 3 months back and HBV serology indicating that the participant is immunized against HBV.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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327 participants in 2 patient groups

Standard testing with ELISA

Active Comparator group

Description:

HBV, HCV, and HIV infection status determined by enzyme-linked immuno-assay (ELISA).

Treatment:

Other: ELISA

Rapid testing

Experimental group

Description:

HBV, HCV, and HIV infection status determined by a rapid test

Treatment:

Other: Rapid Test