Pilot Study Evaluating the Use of Simultaneous HBV, HCV, and HIV Rapid Tests

Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba327 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Enrollment

327

Conditions

HIV Hepatitis B Hepatitis C

Interventions

ELISAOTHER

Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg), anti-HBsAg antibody (anti-HBs Ab), anti-HCV antibody, and anti-HIV antibody status. Results will be given after test results are available (8-10 days).

Rapid TestOTHER

A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®), anti-HCV antibody (HCV, using OraQuick®), and anti-HIV antibody (HIV, using VIKIA®) status. Results will be given the same day.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Accessibility of Testing Results

The number of individuals who obtained test results for HBV, HCV, and/or HIV divided by the total number of tested individuals.

Time frame: Evaluated once, up to 4 months after testing

Secondary Outcomes

Access to Care

The number of individuals seeking specialized care with a complete evaluation of disease severity divided by the total number of seropositive individuals.