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

Not Applicable

Completed

• Conditions: HIV; Carcinoma, Hepatocellular; Hepatitis B; Hepatitis C; AIDS
• Interventions: Other: Rapid Test; Other: ELISA

• Registration Number: NCT01790633
• Lead Sponsor: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-07
• Study First Submitted QC: 2013-02-11
• Study First Posted: 2013-02-13
• Primary Completion: 2013-06
• Study Completion: 2013-10
• Results First Submitted: 2016-08-25
• Status Verified: 2016-10
• Results First Submitted QC: 2016-10-19
• Last Update Submitted: 2016-10-19
• Results First Posted: 2016-12-13
• Last Update Posted: 2016-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 327

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rapid testing	Rapid Test	HBV, HCV, and HIV infection status determined by a rapid test
Standard testing with ELISA	ELISA	HBV, HCV, and HIV infection status determined by enzyme-linked immuno-assay (ELISA).

Primary Outcome Measures

Name	Time	Method
Accessibility of Testing Results	Evaluated once, up to 4 months after testing	The number of individuals who obtained test results for HBV, HCV, and/or HIV divided by the total number of tested individuals.

Secondary Outcome Measures

Name	Time	Method
Access to Care	Evaluated once, up to 4 months after testing	The number of individuals seeking specialized care with a complete evaluation of disease severity divided by the total number of seropositive individuals.

Trial Locations

Locations (1)

Consultation d'Accueil, de Soins et d'Orientation (CASO) de Médecins du Monde (MDM); 🇫🇷 Paris, France