Clinical trial NCT01317784: Behavioral Science Aspects of Rapid Test Acceptance
Official title: Behavioral Science Aspects of Rapid Test Acceptance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Hepatitis C
Hepatitis B
Syphilis
Keywords: diagnosis screening
HIV serodiagnosis
HCV antibodies
serologic tests
Bedside testing
diagnostic test kits
syphilis serodiagnosis
Lead sponsor: California State University, Long Beach
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2011-03-17
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

Eligibility 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

Primary outcomes:
measure: Test choice profile
timeFrame: one day (day one of study)
Secondary outcomes:
measure: Return for standard test results
timeFrame: one week
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Center for Behavioral Research and Services
state: California
Study officials:
affiliation: California State University, Long Beach
name: Dennis G Fisher, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: