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Completed

NCT Number: NCT01790633

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Paris, 75011, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

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.

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

Primary outcomes

  1. Accessibility of Testing Results

    Time frame: 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 outcomes

  1. Access to Care

    Time frame: 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.

Other outcomes

  1. Proportion Participating

    Time frame: At testing

    The number of individuals accepting to participate in the study divided by the total number of individuals proposed.

  2. Proportion of Rapid Test Failures

    Time frame: At testing

    The number of rapid tests giving inconclusive results divided by the total number of rapid tests (only available in the rapid test arm).

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • ANRS, Emerging Infectious Diseases
  • BioMérieux
  • Gilead Sciences
  • Mairie de Paris
  • Roche Pharma AG

Registry information

Official study title

Pilot Study Evaluating the Use of Simultaneous HBV, HCV, and HIV Rapid Tests As a Tool for Screening and Access to Care Among At-Risk Populations

Acronym: OPTISCREEN-III

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Feb 13, 2013
Registry last updated
Dec 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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