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Behavioral Science Aspects of Rapid Test Acceptance (BSARTA)

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ClinicalTrials.gov Identifier: NCT01317784
Recruitment Status : Completed
First Posted : March 17, 2011
Last Update Posted : July 29, 2015
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Dennis G. Fisher, California State University, Long Beach

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
HIV Hepatitis C Hepatitis B Syphilis Device: Rapid tests for HIV, HCV, HBV, and syphilis Device: HIV/HCV Device: HIV/syphilis Device: HIV only Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Screening
Official Title: Behavioral Science Aspects of Rapid Test Acceptance
Study Start Date : May 2011
Actual Primary Completion Date : June 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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.)


Outcome Measures
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Primary Outcome Measures :
  1. Test choice profile [ Time Frame: one day (day one of study) ]
    Which tests do participants choose to receive when bundled in different combinations?


Secondary Outcome Measures :
  1. Return for standard test results [ Time Frame: one week ]
    Is there a different return for test results rate for the different arms of the study?


Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01317784


Locations
United States, California
Center for Behavioral Research and Services
Long Beach, California, United States, 90813
Sponsors and Collaborators
California State University, Long Beach
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Dennis G Fisher, Ph.D. California State University, Long Beach
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ( U.S. NIH Grant/Contract )
First Posted: March 17, 2011    Key Record Dates
Last Update Posted: July 29, 2015
Last Verified: July 2015

Keywords provided by Dennis G. Fisher, 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 C
Hepatitis B
Syphilis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepadnaviridae Infections
DNA Virus 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