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

NCT01790633 | Completed Results DMC

• 2 other identifiers: IMEA 38B2012-A01681-42
• Study Type: interventional
• Target: 327
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

rapid test; screening; ELISA; hepatitis B virus; hepatitis C virus; human immunodeficiency virus; access to care

Outcome Measures

Primary Outcomes (1)

• 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.

  Evaluated once, up to 4 months after testing

Secondary Outcomes (1)

• Access to Care

  Evaluated once, up to 4 months after testing

Other Outcomes (2)

• Proportion Participating

  At testing

• Proportion of Rapid Test Failures

  At testing

Study Arms (2)

Standard testing with ELISA

ACTIVE COMPARATOR

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

Other: ELISA

Rapid testing

EXPERIMENTAL

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

Other: Rapid Test

Interventions

ELISA OTHER

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).

Standard testing with ELISA

Rapid Test OTHER

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.

Also known as: VIKIA®, Biomerieux, Marcy-l'Étoile, France, OraQuick® HCV Rapid Antibody Test, OraSure Technologies, Inc., Bethlehem, PA, USA

Rapid testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba: lead
• ANRS, Emerging Infectious Diseases: collaborator
• Gilead Sciences: collaborator
• Roche Pharma AG: collaborator
• Mairie de Paris: collaborator
• BioMérieux: collaborator

Study Sites (1)

Consultation d'Accueil, de Soins et d'Orientation (CASO) de Médecins du Monde (MDM)

Paris, 75011, France

Location

Related Publications (2)

• Bottero J, Boyd A, Gozlan J, Lemoine M, Carrat F, Collignon A, Boo N, Dhotte P, Varsat B, Muller G, Cha O, Picard O, Nau J, Campa P, Silbermann B, Bary M, Girard PM, Lacombe K. Performance of rapid tests for detection of HBsAg and anti-HBsAb in a large cohort, France. J Hepatol. 2013 Mar;58(3):473-8. doi: 10.1016/j.jhep.2012.11.016. Epub 2012 Nov 23.

  PMID: 23183527 BACKGROUND

• Bottero J, Boyd A, Gozlan J, Carrat F, Nau J, Pauti MD, Rougier H, Girard PM, Lacombe K. Simultaneous Human Immunodeficiency Virus-Hepatitis B-Hepatitis C Point-of-Care Tests Improve Outcomes in Linkage-to-Care: Results of a Randomized Control Trial in Persons Without Healthcare Coverage. Open Forum Infect Dis. 2015 Oct 26;2(4):ofv162. doi: 10.1093/ofid/ofv162. eCollection 2015 Dec.

  PMID: 26668814 RESULT

MeSH Terms

Conditions

Hepatitis B; Hepatitis C; Carcinoma, Hepatocellular; Acquired Immunodeficiency Syndrome

Interventions

Enzyme-Linked Immunosorbent Assay; Rapid Diagnostic Tests

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Flaviviridae Infections; RNA Virus Infections; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; HIV Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunoenzyme Techniques; Immunoassay; Immunologic Techniques; Investigative Techniques; Immunosorbent Techniques; Immunohistochemistry; Molecular Probe Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Point-of-Care Testing; Point-of-Care Systems; Patient Care Management; Health Services Administration

Limitations and Caveats

Single-center pilot study, possibly reducing generalizability; small number of participants and infected individuals may have decreased power to detect differences in linkage-to-care; not all rapid tests were approved for routine use in France.

Results Point of Contact

• Title: Dr. Julie Bottero
• Organization: Service des maladies infectieuses et tropicales - Hôpital Saint-Antoine

julie.bottero@aphp.fr

+33 1 49 28 04 24

Study Officials

• Julie Bottero, MD

  Hôpital Saint-Antoine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2013
• First Posted: February 13, 2013
• Study Start: February 1, 2013
• Primary Completion: June 1, 2013
• Study Completion: October 1, 2013
• Last Updated: December 13, 2016
• Results First Posted: December 13, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

FR (1)