Behavioral Science Aspects of Rapid Test Acceptance

HIV Clinical Trial

— BSARTA  

Official title:

Behavioral Science Aspects of Rapid Test Acceptance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01317784
• Other study ID #: 07373710
• Secondary ID: R01DA030234
• Status: Completed
• Phase: N/A
• First received: March 16, 2011
• Last updated: July 27, 2015
• Start date: May 2011
• Est. completion date: August 2014

Study information

• Verified date: July 2015
• Source: California State University, Long Beach
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: August 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis C
• HIV
• Syphilis

Intervention

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.
• HIV/HCV
Choice of 10 different tests for HIV and hepatitis C.
• HIV/syphilis
Choice of 7 different tests for HIV and syphilis
• HIV only
Choice of 4 different tests for HIV only.

Locations

Country	Name	City	State
United States	Center for Behavioral Research and Services	Long Beach	California

Sponsors (2)

Lead Sponsor	Collaborator
California State University, Long Beach	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Test choice profile	Which tests do participants choose to receive when bundled in different combinations?	one day (day one of study)
Secondary	Return for standard test results	Is there a different return for test results rate for the different arms of the study?	one week