HIV Screening in the Emergency Department Setting

Study Overview
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Brief Summary
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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
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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.

Official Title
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HIV Screening in the Emergency Department Setting

Conditions
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HIV Infections

Intervention / Treatment
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* Other: Targeted Screening
* Other: Routine Screening


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Targeted Screening<br>Targeted Screening Participants approached at ED for voluntary HIV counseling and testing based on risk for HIV | Other: Targeted Screening<br>* Selection method for screening is based on risk<br>|
| Active Comparator: Routine Screening<br>Routine Screening Participants approached at ED for voluntary HIV counseling and testing regardless of established risk according to age criteria | Other: Routine Screening<br>* Selection method for screening is not based on risk<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Tested Participants Newly Diagnosed as HIV Infected | Percentage of tested participants newly diagnosed as HIV infected | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage Consenting to Testing | Percentage of those successfully offered testing who consent to testing | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Prevention, Public Health, Screening