Behavioral Science Aspects of Rapid Test Acceptance

Study Overview
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Brief Summary
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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
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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.

Official Title
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Behavioral Science Aspects of Rapid Test Acceptance

Conditions
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HIV, Hepatitis C, Hepatitis B, Syphilis

Intervention / Treatment
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* Device: Rapid tests for HIV, HCV, HBV, and syphilis
* Device: HIV/HCV
* Device: HIV/syphilis
* Device: HIV only


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All tests.<br>Choose from all 16 possible tests. | Device: Rapid tests for HIV, HCV, HBV, and syphilis<br>* 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.<br>* Other names: Multiplo Rapid HIV/HCV/HBV Antibody Test (MedMira, Inc.);|
| Active Comparator: HIV/HCV<br>Choice of 10 different HIV and hepatitis C tests in the bundle. | Device: HIV/HCV<br>* Choice of 10 different tests for HIV and hepatitis C.<br>* Other names: Multiplo Rapid HIV/HCV Antibody Test (MedMira, Inc.);|
| Active Comparator: HIV/Syphilis<br>Choice of 7 different tests for HIV and syphilis. | Device: HIV/syphilis<br>* Choice of 7 different tests for HIV and syphilis<br>* Other names: DPP® HIV-Syphilis Screen Assay (Chembio, Inc.);|
| Active Comparator: HIV only<br>Choice of 4 rapid tests for HIV only. | Device: HIV only<br>* Choice of 4 different tests for HIV only.<br>* Other names: DPP® HIV 1/2 Screen Assay (Chembio, Inc.);|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diagnosis screening, HIV serodiagnosis, HCV antibodies, serologic tests, Bedside testing, diagnostic test kits, syphilis serodiagnosis