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Clinical Trials/NCT00667186
NCT00667186
Completed
Not Applicable

HIV Screening in the Emergency Department Setting

National Institute of Allergy and Infectious Diseases (NIAID)1 site in 1 country9,572 target enrollmentJanuary 2008
ConditionsHIV Infections

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV Infections
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Enrollment
9572
Locations
1
Primary Endpoint
Percentage of Tested Participants Newly Diagnosed as HIV Infected
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

Late diagnosis of HIV infection is believed to be responsible for high rates of HIV transmission. The purpose of this study is to determine whether targeted screening versus routine screening will identify a greater number of HIV infected participants. This study will also compare the costs of the resources used for targeted screening versus routine screening.

Detailed Description

Novel strategies are needed to reduce HIV transmission, particularly among individuals who are unaware of their HIV status. Emergency departments (EDs) routinely receive individuals in a medical setting where an opportunity exists to screen them for HIV. The purposes of this study are to determine whether the proportion of tested participants identified as HIV infected by targeted screening exceeds routine screening and to determine whether the program resources used per infected patient identified are lower for targeted screening than for routine screening. 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.

Registry
clinicaltrials.gov
Start Date
January 2008
End Date
December 2010
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Michael S. Lyons

Assistant Professor Emergency Medicine

University of Cincinnati

Eligibility Criteria

Inclusion Criteria

  • Adult participants presenting for care in the ED

Exclusion Criteria

  • Participants cognitively unable or unwilling to consent for voluntary HIV counseling and testing

Outcomes

Primary Outcomes

Percentage of Tested Participants Newly Diagnosed as HIV Infected

Time Frame: 3 years

Percentage of tested participants newly diagnosed as HIV infected

Secondary Outcomes

  • Percentage Consenting to Testing(3 years)

Study Sites (1)

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