Behavioral Science Aspects of Rapid Test Acceptance (BSARTA)
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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 |
- 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?
- 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.
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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:
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Active Comparator: HIV/HCV
Choice of 10 different HIV and hepatitis C tests in the bundle.
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Device: HIV/HCV
Choice of 10 different tests for HIV and hepatitis C.
Other Names:
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Active Comparator: HIV/Syphilis
Choice of 7 different tests for HIV and syphilis.
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Device: HIV/syphilis
Choice of 7 different tests for HIV and syphilis
Other Names:
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Active Comparator: HIV only
Choice of 4 rapid tests for HIV only.
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Device: HIV only
Choice of 4 different tests for HIV only.
Other Names:
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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 |
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| 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, California | |
| Center for Behavioral Research and Services | Recruiting |
| Long Beach, California, United States, 90813 | |
| Principal Investigator: Dennis G Fisher, Ph.D. | |
| 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 February 28, 2013
