Study Results
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View full resultsBasic Information
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COMPLETED
NA
9572 participants
INTERVENTIONAL
2008-01-31
2010-12-31
Brief Summary
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Detailed Description
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Participants will be recruited from the University of Cincinnati Emergency Medicine Clinical Trials Center. The existing ED-based clinical HIV counseling and testing program in a lower HIV prevalence area will randomly alternate between two strategies for offering testing to ED participants: 1) targeted screening based on self-reported HIV risk and 2) routine screening. Participants will be randomly assigned to the targeted or routine screening group based on their presence in the ED during randomized days and times.
At study entry an interview, blood collection, and counseling will occur. Participants will be telephoned following their ED visit to be given their negative results. Participants with positive results will be asked to return to the ED for notification, counseling, and connections to subsequent care. Participants who are HIV infected will be transferred to the University of Cincinnati Infectious Disease Center for care.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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Targeted Screening
Targeted Screening
Participants approached at ED for voluntary HIV counseling and testing based on risk for HIV
Targeted Screening
Selection method for screening is based on risk
Routine Screening
Routine Screening
Participants approached at ED for voluntary HIV counseling and testing regardless of established risk according to age criteria
Routine Screening
Selection method for screening is not based on risk
Interventions
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Targeted Screening
Selection method for screening is based on risk
Routine Screening
Selection method for screening is not based on risk
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
64 Years
ALL
No
Sponsors
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Ohio Department of Health, City of Cincinnati Board of Health
UNKNOWN
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Michael S. Lyons
Assistant Professor Emergency Medicine
Principal Investigators
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Michael S. Lyons, MD
Role: PRINCIPAL_INVESTIGATOR
University of Cincinnati College of Medicine Department of Emergency Medicine
Locations
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University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Countries
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References
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Centers for Disease Control and Prevention (CDC). Missed opportunities for earlier diagnosis of HIV infection--South Carolina, 1997-2005. MMWR Morb Mortal Wkly Rep. 2006 Dec 1;55(47):1269-72.
Centers for Disease Control and Prevention (CDC). Rapid HIV testing in emergency departments--three U.S. sites, January 2005-March 2006. MMWR Morb Mortal Wkly Rep. 2007 Jun 22;56(24):597-601.
Fenton KA. Sustaining HIV prevention: HIV testing in health care settings. Top HIV Med. 2007 Nov-Dec;15(5):146-9.
Holtgrave DR. Costs and consequences of the US Centers for Disease Control and Prevention's recommendations for opt-out HIV testing. PLoS Med. 2007 Jun;4(6):e194. doi: 10.1371/journal.pmed.0040194.
Other Identifiers
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