N/A
N=327
Pilot Study Evaluating the Use of Simultaneous HBV, HCV, and HIV Rapid Tests
HIV · Hepatitis B · Hepatitis C · Carcinoma, Hepatocellular · AIDS
Bottom Line
View on ClinicalTrials.gov: NCT01790633 ↗Enrolled (actual)
327
Serious AEs
0.0%
Results posted
Dec 2016
Primary outcome: Primary: Accessibility of Testing Results — 0.642; 0.981 proportion of participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ELISA (Other); Rapid Test (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
- Primary completion
- Jun 2013
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 |
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.
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.
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.