Behavioral Science Aspects of Rapid Test Acceptance (BSARTA)

This study is currently recruiting participants. (see Contacts and Locations)
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

March 16, 2011
February 29, 2012
May 2011
May 2014   (final data collection date for primary outcome measure)
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?
Same as current
Complete list of historical versions of study NCT01317784 on ClinicalTrials.gov Archive Site
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?
Same as current
Not Provided
Not Provided
 
Behavioral Science Aspects of Rapid Test Acceptance
Behavioral Science Aspects of Rapid Test Acceptance

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Screening
  • HIV
  • Hepatitis C
  • Hepatitis B
  • Syphilis
  • 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.)
  • 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.)
  • 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.)
  • 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.)
  • Experimental: All tests.
    Choose from all 16 possible tests.
    Intervention: Device: Rapid tests for HIV, HCV, HBV, and syphilis
  • Active Comparator: HIV/HCV
    Choice of 10 different HIV and hepatitis C tests in the bundle.
    Intervention: Device: HIV/HCV
  • Active Comparator: HIV/Syphilis
    Choice of 7 different tests for HIV and syphilis.
    Intervention: Device: HIV/syphilis
  • Active Comparator: HIV only
    Choice of 4 rapid tests for HIV only.
    Intervention: Device: HIV only
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1200
September 2015
May 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
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
United States
 
NCT01317784
07373710, R01DA030234
Yes
Dennis G. Fisher, California State University, Long Beach
California State University, Long Beach
National Institute on Drug Abuse (NIDA)
Principal Investigator: Dennis G Fisher, Ph.D. California State University, Long Beach
California State University, Long Beach
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP