HIV Screening in the Emergency Department Setting
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
|Official Title:||HIV Screening in the Emergency Department Setting|
- Percentage of Tested Participants Newly Diagnosed as HIV Infected [ Time Frame: 3 years ] [ Designated as safety issue: No ]Percentage of tested participants newly diagnosed as HIV infected
- Percentage Consenting to Testing [ Time Frame: 3 years ] [ Designated as safety issue: No ]Percentage of those successfully offered testing who consent to testing
|Study Start Date:||January 2008|
|Study Completion Date:||December 2010|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Active Comparator: Targeted Screening
Participants approached at ED for voluntary HIV counseling and testing based on risk for HIV
Other: Targeted Screening
Selection method for screening is based on risk
Active Comparator: Routine Screening
Participants approached at ED for voluntary HIV counseling and testing regardless of established risk according to age criteria
Other: Routine Screening
Selection method for screening is not based on risk
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00667186
|United States, Ohio|
|University of Cincinnati Medical Center|
|Cincinnati, Ohio, United States, 45267-0405|
|Principal Investigator:||Michael S. Lyons, MD||University of Cincinnati College of Medicine Department of Emergency Medicine|