Behavioral Science Aspects of Rapid Test Acceptance (BSARTA)

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.

Study Overview

• Status: Completed
• Conditions: Hepatitis B; Hepatitis C; HIV; Syphilis
• Intervention / Treatment: Device: Rapid tests for HIV, HCV, HBV, and syphilis; Device: HIV/HCV; Device: HIV/syphilis; Device: HIV only

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 Type: Interventional
• Enrollment (Actual): 1200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Long Beach, California, United States, 90813
      • Center for Behavioral Research and Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / 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.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Test choice profile	Which tests do participants choose to receive when bundled in different combinations?	one day (day one of study)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Return for standard test results	Is there a different return for test results rate for the different arms of the study?	one week

Collaborators and Investigators

• Sponsor: California State University, Long Beach
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Dennis G Fisher, Ph.D., California State University, Long Beach

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: March 16, 2011
• First Submitted That Met QC Criteria: March 16, 2011
• First Posted (Estimate): March 17, 2011

Study Record Updates

• Last Update Posted (Estimate): July 29, 2015
• Last Update Submitted That Met QC Criteria: July 27, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: HIV serodiagnosis; diagnosis screening; HCV antibodies; serologic tests; Bedside testing; diagnostic test kits; syphilis serodiagnosis
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Enterovirus Infections; Picornaviridae Infections; Sexually Transmitted Diseases, Bacterial; Spirochaetales Infections; Treponemal Infections; Hepatitis B; Hepatitis; Hepatitis A; Hepatitis C; Syphilis; Physiological Effects of Drugs; Immunologic Factors; Antibodies; Immunoglobulins; Hepatitis C Antibodies
• Other Study ID Numbers: 07373710; R01DA030234 (U.S. NIH Grant/Contract)