HIVBSARTANCT01317784
Behavioral Science Aspects of Rapid Test Acceptance
A study testing Rapid tests for HIV, HCV, HBV, and syphilis, HIV/HCV and HIV/syphilis in people with HIV and Hepatitis C, run by California State University, Long Beach at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV, Hepatitis C, Hepatitis B
- What is being tested?
- Rapid tests for HIV, HCV, HBV, and syphilis, HIV/HCV and HIV/syphilis
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Behavioral Research and Services
Long Beach, California, 90813
About this study
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.
Read the 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.
- Conditions
- HIV, Hepatitis C, Hepatitis B, Syphilis
- Being tested
- Rapid tests for HIV, HCV, HBV, and syphilis, HIV/HCV, HIV/syphilis, HIV only
- Keywords
- diagnosis screening, HIV serodiagnosis, HCV antibodies, serologic tests, Bedside testing, diagnostic test kits, syphilis serodiagnosis
- Medical subject headings
- Hepatitis C, Hepatitis B, Syphilis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid tests for HIV, HCV, HBV, and syphilisDevice
Also called 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)
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/HCVDevice
Also called 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)
Choice of 10 different tests for HIV and hepatitis C.
HIV/syphilisDevice
Also called 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.)
Choice of 7 different tests for HIV and syphilis
HIV onlyDevice
Also called 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.)
Choice of 4 different tests for HIV only.
| Study group | Role | What they receive |
|---|---|---|
| All tests. | Experimental | Choose from all 16 possible tests. Receives: Device: Rapid tests for HIV, HCV, HBV, and syphilis |
| HIV/HCV | Active comparator | Choice of 10 different HIV and hepatitis C tests in the bundle. Receives: Device: HIV/HCV |
| HIV/Syphilis | Active comparator | Choice of 7 different tests for HIV and syphilis. Receives: Device: HIV/syphilis |
| HIV only | Active comparator | Choice of 4 rapid tests for HIV only. Receives: Device: HIV only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test choice profile
Which tests do participants choose to receive when bundled in different combinations?
Measured: one day (day one of study)
Secondary outcomes (1)
Return for standard test results
Is there a different return for test results rate for the different arms of the study?
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2011 (estimated)
- Study startMay 2011
- Primary completionJun 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- California State University, Long Beach
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Dennis G. Fisher, California State University, Long Beach
- Investigators
- Dennis G Fisher, Ph.D., Principal investigator, California State University, Long Beach
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01317784
- Sponsor's protocol ID
- 07373710
- Other IDs
- R01DA030234
- Acronym
- BSARTA
- Status last verified
- Jul 2015
- First submitted
- 16 Mar 2011
- Last updated
- 29 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Science Aspects of Rapid Test Acceptance
- ClinicalTrials.gov ID
- NCT01317784
- Acronym / sponsor ID
- BSARTA / 07373710
- Conditions
- HIV, Hepatitis C, Hepatitis B, Syphilis
- Keywords
- diagnosis screening, HIV serodiagnosis, HCV antibodies, serologic tests, Bedside testing, diagnostic test kits, syphilis serodiagnosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- California State University, Long BeachUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- May 2011
- Primary completion
- Jun 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 17 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| All tests. | Experimental | Device: Rapid tests for HIV, HCV, HBV, and syphilisChoose from all 16 possible tests. |
| HIV/HCV | Active comparator | Device: HIV/HCVChoice of 10 different HIV and hepatitis C tests in the bundle. |
| HIV/Syphilis | Active comparator | Device: HIV/syphilisChoice of 7 different tests for HIV and syphilis. |
| HIV only | Active comparator | Device: HIV onlyChoice of 4 rapid tests for HIV only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Over 17 years old
- Mentally stable
- Sober
- Able to understand English or Spanish
- At least one good vein for phlebotomy
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rapid tests for HIV, HCV, HBV, and syphilisAlso: 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)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. | Device | All tests. |
| HIV/HCVAlso: 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)Choice of 10 different tests for HIV and hepatitis C. | Device | HIV/HCV |
| HIV/syphilisAlso: 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.)Choice of 7 different tests for HIV and syphilis | Device | HIV/Syphilis |
| HIV onlyAlso: 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.)Choice of 4 different tests for HIV only. | Device | HIV only |
Primary outcome
Test choice profile
Time frame: one day (day one of study)
Which tests do participants choose to receive when bundled in different combinations?
1 secondary outcome
Return for standard test results
Time frame: one week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2015.
Related trials for HIV
RecruitingObservational study
Studies of the Pathogenesis of HIV Infection in Human Peripheral Blood Cells and/or Body Fluids in People Living With and Without HIV
HIV, Immunodeficiencies
Active, not recruitingPhase 2
Virotherapy and Natural History Study of KHSV-Associated Multricentric Castleman s Disease With Correlates of Disease Activity
Lymphoproliferative Disorder, HHV-8
Enrolling by invitationObservational study
Analysis of HIV-1 Replication During Antiretroviral Therapy
HIV
RecruitingObservational study
Clinical and Immunologic Monitoring of Patients With Known or Suspected HIV Infection
HIV
Active, not recruitingPhase 2
Immunogenicity of the 9-Valent Human Papillomavirus Recombinant Vaccine in People With Idiopathic CD4 T Cell Lymphocytopenia
Idiopathic CD4 T Cell Lymphocytopenia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dennis G Fisher, Ph.D. principal investigator
California State University, Long Beach
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rapid tests for HIV, HCV, HBV, and syphilis, HIV/HCV and HIV/syphilis in people with HIV and Hepatitis C, run by California State University, Long Beach at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test choice profile (time frame: one day (day one of study)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2015; AzTrials last refreshed its copy on 30 Oct 2026.