Behavioral Science Aspects of Rapid Test Acceptance

Not Applicable

Completed

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

• Registration Number: NCT01317784
• Lead Sponsor: California State University, Long Beach

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.

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 Timeline

• Study First Submitted: 2011-03-16
• Study First Submitted QC: 2011-03-16
• Study First Posted: 2011-03-17
• Study Start: 2011-05
• Primary Completion: 2014-06
• Study Completion: 2014-08
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-27
• Last Update Posted: 2015-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1200

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
All tests.	Rapid tests for HIV, HCV, HBV, and syphilis	Choose from all 16 possible tests.
HIV only	HIV only	Choice of 4 rapid tests for HIV only.
HIV/HCV	HIV/HCV	Choice of 10 different HIV and hepatitis C tests in the bundle.
HIV/Syphilis	HIV/syphilis	Choice of 7 different tests for HIV and syphilis.

Primary Outcome Measures

Name	Time	Method
Test choice profile	one day (day one of study)	Which tests do participants choose to receive when bundled in different combinations?

Secondary Outcome Measures

Name	Time	Method
Return for standard test results	one week	Is there a different return for test results rate for the different arms of the study?

Trial Locations

Locations (1)

Center for Behavioral Research and Services; 🇺🇸 Long Beach, California, United States