Behavioral Science Aspects of Rapid Test Acceptance (BSARTA)

This study is currently recruiting participants.
Verified February 2012 by California State University, Long Beach
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Dennis G. Fisher, California State University, Long Beach
ClinicalTrials.gov Identifier:
NCT01317784
First received: March 16, 2011
Last updated: February 29, 2012
Last verified: February 2012
  Purpose

The relevance of this research to public health is to make it possible to test for hepatitis C and syphilis at point of care so that people will receive their results immediately instead of requiring people to wait for at least a week to get their test results. This research will make rapid tests for HIV available that can detect HIV infection earlier and are more accurate than current tests available in the United States.


Condition Intervention
HIV
Hepatitis C
Hepatitis B
Syphilis
Device: Rapid tests for HIV, HCV, HBV, and syphilis
Device: HIV/HCV
Device: HIV/syphilis
Device: HIV only

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Screening
Official Title: Behavioral Science Aspects of Rapid Test Acceptance

Resource links provided by NLM:


Further study details as provided by California State University, Long Beach:

Primary Outcome Measures:
  • Test choice profile [ Time Frame: one day (day one of study) ] [ Designated as safety issue: No ]
    Which tests do participants choose to receive when bundled in different combinations?


Secondary Outcome Measures:
  • Return for standard test results [ Time Frame: one week ] [ Designated as safety issue: Yes ]
    Is there a different return for test results rate for the different arms of the study?


Estimated Enrollment: 1200
Study Start Date: May 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: All tests.
Choose from all 16 possible tests.
Device: Rapid tests for HIV, HCV, HBV, and syphilis
Choice of 16 different rapid tests. Only 12 manufacturer and names are shown because some are used with both blood and oral fluid. When they are used on both specimens, they are counted as two tests.
Other Names:
  • INSTITM HIV-1 Antibody Test (bioLytical Laboratories, Inc.)
  • Determine HIV-1/2 Ag/Ab Combo (Alere, Inc.)
  • DPP® HIV 1/2 Screen Assay (Chembio, Inc.)
  • OraQuick HCV antibody test (Orasure)
  • DPP® HCV Screen Assay (Chembio, Inc.)
  • DPP® HIV-HCV Screen Assay (Chembio, Inc.)
  • Multiplo Rapid HIV/HCV Antibody Test (MedMira, Inc.)
  • DPP® Syphilis Screen & Confirm Assay (Chembio, Inc.)
  • DPP® HIV-Syphilis Screen Assay (Chembio, Inc.)
  • DPP® HIV-HCV-Syphilis Screen Assay (Chembio, Inc.)
  • Multiplo Rapid HIV/HCV/HBV Antibody Test (MedMira, Inc.)
Active Comparator: HIV/HCV
Choice of 10 different HIV and hepatitis C tests in the bundle.
Device: HIV/HCV
Choice of 10 different tests for HIV and hepatitis C.
Other Names:
  • INSTITM HIV-1 Antibody Test (bioLytical Laboratories, Inc.)
  • Determine HIV-1/2 Ag/Ab Combo (Alere, Inc.)
  • DPP® HIV 1/2 Screen Assay (Chembio, Inc.)
  • OraQuick HCV antibody test (Orasure)
  • DPP® HCV Screen Assay (Chembio, Inc.)
  • DPP® HIV-HCV Screen Assay (Chembio, Inc.)
  • Multiplo Rapid HIV/HCV Antibody Test (MedMira, Inc.)
Active Comparator: HIV/Syphilis
Choice of 7 different tests for HIV and syphilis.
Device: HIV/syphilis
Choice of 7 different tests for HIV and syphilis
Other Names:
  • INSTITM HIV-1 Antibody Test (bioLytical Laboratories, Inc.)
  • Determine HIV-1/2 Ag/Ab Combo (Alere, Inc.)
  • DPP® HIV 1/2 Screen Assay (Chembio, Inc.)
  • DPP® Syphilis Screen & Confirm Assay (Chembio, Inc.)
  • DPP® HIV-Syphilis Screen Assay (Chembio, Inc.)
Active Comparator: HIV only
Choice of 4 rapid tests for HIV only.
Device: HIV only
Choice of 4 different tests for HIV only.
Other Names:
  • INSTITM HIV-1 Antibody Test (bioLytical Laboratories, Inc.)
  • Determine HIV-1/2 Ag/Ab Combo (Alere, Inc.)
  • DPP® HIV 1/2 Screen Assay (Chembio, Inc.)

Detailed Description:

This application addresses "Studies to improve access and utilization of HIV counseling and testing" for "HIV/AIDS and AIDS-related co-infections" such as "hepatitis C virus (HCV), other sexually transmitted infections (STIs)" that are part of PA-07-307 Drug Abuse Aspects of HIV/AIDS. The only rapid tests that are approved for use in the US currently are for HIV infection. Tests for other conditions such as hepatitis C (HCV) and syphilis are in use in other countries. In response to an Opportunity that the CDC published in the Federal Register, there are now candidate rapid test kits for HCV and syphilis available for experimental use in the US. Different combinations of rapid and standard tests will be offered to participants in a four-arm trial to assess which tests are accepted by the participants. Only a minority of clients at CBRS who have been offered the rapid test for HIV have accepted it. Those who chose rapid HIV tests were more likely to be male, educated, gay, young and White. They were less likely to be Black, or injection drug users. The proposed study has the potential to have a significant impact upon screening for HIV, syphilis, and HCV. Rapid tests have the potential to increase the receipt of test results, particularly among groups that are less likely to return for their results using traditional testing. The candidate tests are designed for Point of Care (either oral fluid and/or whole blood), and thus will require real-time testing, so the trial will be able to evaluate both the accuracy of the tests in settings of intended use and their acceptability to potential clients in real-world situations.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Over 17 years old
  • Mentally stable
  • Sober
  • Able to understand English or Spanish
  • At least one good vein for phlebotomy
  • Member of Behavioral Risk Group
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01317784

Contacts
Contact: Grace L Reynolds, D.P.A. 562-495-2330 ext 125 Grace.Reynolds@csulb.edu
Contact: Kristen Hess, Ph.D. 562-495-2330 ext 111 Kristen.Hess@csulb.edu

Locations
United States, California
Center for Behavioral Research and Services Recruiting
Long Beach, California, United States, 90813
Principal Investigator: Dennis G Fisher, Ph.D.         
Sponsors and Collaborators
California State University, Long Beach
Investigators
Principal Investigator: Dennis G Fisher, Ph.D. California State University, Long Beach
  More Information

Additional Information:
No publications provided

Responsible Party: Dennis G. Fisher, Professor and Director, California State University, Long Beach
ClinicalTrials.gov Identifier: NCT01317784     History of Changes
Other Study ID Numbers: 07373710, R01DA030234
Study First Received: March 16, 2011
Last Updated: February 29, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by California State University, Long Beach:
diagnosis screening
HIV serodiagnosis
HCV antibodies
serologic tests
Bedside testing
diagnostic test kits
syphilis serodiagnosis

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis C
Syphilis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Flaviviridae Infections
Treponemal Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Spirochaetales Infections
Sexually Transmitted Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female
Antibodies
Immunoglobulins
Hepatitis C Antibodies
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 22, 2014