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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00502944 |
This study will compare the effectiveness of two different approaches to providing routine HIV counseling, testing, and referral services in an urban hospital emergency department setting.
Condition | Intervention |
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HIV Infections |
Procedure: Counselor-based HIV screening Procedure: Emergency staff member-based HIV screening |
Study Type: | Interventional |
Study Design: | Screening, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study |
Official Title: | Optimizing Strategies for Universal HIV Testing (The USHER Trial) |
Estimated Enrollment: | 34200 |
Study Start Date: | February 2007 |
Estimated Study Completion Date: | June 2011 |
Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Participants who meet with an HIV counselor
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Procedure: Counselor-based HIV screening
Participants will undergo counselor-based HIV screening and, if positive, further study visits for up to 6 months
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2: Active Comparator
Participants who meet with an emergency room staff member
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Procedure: Emergency staff member-based HIV screening
Participants will undergo emergency staff member-based HIV screening and, if positive, further study visits for up to 6 months
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About 25% of HIV infected people do not know that they are infected. These people lack medical care that could prolong their lives and access to counseling services that could prevent further spread of HIV. With so many people unaware of their HIV status, there is a clear need for more readily available HIV counseling, testing, and referral services throughout the United States. The Centers for Disease Control and Prevention (CDC) recommends routine HIV testing in U.S. hospitals in which HIV infected patients make up at least 1% of the total patient population for that hospital. However, routine HIV testing in such hospitals is rarely carried out, which might be because the CDC has not specified who should perform routine HIV testing. The purpose of this study is to compare the effectiveness of two different approaches to providing routine HIV counseling, testing, and referral services in an urban hospital emergency department setting. One approach will be led by an HIV counselor, and the other approach will be led by an emergency department staff member. For both approaches, the study will evaluate to what extent patients accept HIV testing, how well follow-up care is established, and the cost-effectiveness of the approach.
Participants in this study will include adults who visit Brigham and Women's Hospital emergency department in Boston, Massachusetts. Participants will be randomly assigned to meet with either an HIV counselor or an emergency department staff member and to fill out a questionnaire while waiting in the emergency room. The questionnaire will be anonymous. Participants will then be offered a rapid HIV test. The HIV test will involve collecting a swab of fluid from the inside of the mouth. Test results will be available in about 20 minutes and will be provided to participants by either their assigned HIV counselor or emergency department staff member. Participants who test positive for HIV will be offered a more definitive blood test to confirm HIV infection. The blood test results will be available 2 weeks from testing, and participants must return to the hospital to get their test results. Participants who test positive for HIV will be offered counseling support and referral services by either their assigned HIV counselor or emergency department staff member. Follow-up care appointments will also be initiated at this time. For participants who test positive for HIV, the study will last about 6 months. There will be no follow-up visits for participants who do not test positive for HIV during their emergency room visit.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Rochelle P. Walensky, MD, MPH | 617-724-3467 | rwalensky@partners.org |
Contact: Elena Losina, PhD | 617-724-4636 | elosina@partners.org |
United States, Massachusetts | |
Brigham and Women's Hospital | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Contact: Christian Arbelaez 617-732-8947 carbelaez@partners.org | |
Contact: Regina Mikulinsky 617-732-7886 rmikulinsky@partners.org |
Principal Investigator: | Rochelle P. Walensky, MD, MPH | Massachusetts General Hospital |
Responsible Party: | Massachusetts General Hospital ( Rochelle P. Walensky, MD, MPH ) |
Study ID Numbers: | R01 MH73445, DAHBR 9A-ASPQ |
Study First Received: | July 16, 2007 |
Last Updated: | October 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00502944 |
Health Authority: | United States: Federal Government |
HIV Testing HIV Seronegativity |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Antibodies HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Emergencies Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |