BSARTA: Behavioral Science Aspects of Rapid Test Acceptance

Sponsor

California State University, Long Beach (Other)

Overall Status

Completed

CT.gov ID

NCT01317784

Collaborator

National Institute on Drug Abuse (NIDA) (NIH)

1,200

Enrollment

Location

Arms

Duration (Months)

30.7

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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

Study Type:

Interventional

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 1, 2011

Actual Primary Completion Date :

Jun 1, 2014

Actual Study Completion Date :

Aug 1, 2014

Arms and Interventions

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.)