Behavioral Science Aspects of Rapid Test Acceptance - Full Text View

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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS Hepatitis Hepatitis A Hepatitis C Syphilis

Genetic and Rare Diseases Information Center resources: Treponema Infection

U.S. FDA Resources

Further study details as provided by California State University, Long Beach:

Primary Outcome Measures:

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?

Secondary Outcome Measures:

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?


Enrollment:	1200
Study Start Date:	May 2011
Study Completion Date:	August 2014
Primary Completion Date:	June 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.)

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 (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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


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:	July 27, 2015
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 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

ClinicalTrials.gov processed this record on September 23, 2016

Behavioral Science Aspects of Rapid Test Acceptance (BSARTA)