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OpenTrials
Completed

NCT Number: NCT01317784

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Rapid tests for HIV, HCV, HBV, and syphilis

Device

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.)

HIV/HCV

Device

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.)

HIV/syphilis

Device

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.)

HIV only

Device

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.)

Primary outcomes

  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 outcomes

  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?

Sponsors and collaborators

Lead sponsor

California State University, Long Beach

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Acronym: BSARTA

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Mar 17, 2011
Registry last updated
Jul 29, 2015

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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