N/A Completed N=327 Randomized Screening

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

HIV · Hepatitis B · Hepatitis C · Carcinoma, Hepatocellular

Source: ClinicalTrials.gov NCT01790633 ↗

Enrolled (actual)

327

Serious AEs

0.0%

Results posted

Dec 2016

Primary outcomePrimary: Accessibility of Testing Results — 0.642; 0.981 proportion of participants — p=<0.001

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Accessibility of Testing Results	0.642; 0.981	<0.001 sig
SECONDARY Access to Care	0.938; 0.900	0.7

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01790633). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.