HIV Screening in the Emergency Department Setting

Not Applicable

Completed

• Conditions: HIV Infections
• Interventions: Other: Targeted Screening; Other: Routine Screening

• Registration Number: NCT00667186
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

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.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-04-03
• Study First Submitted QC: 2008-04-23
• Study First Posted: 2008-04-25
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Results First Submitted: 2012-10-29
• Results First Submitted QC: 2012-12-14
• Status Verified: 2013-01
• Results First Posted: 2013-01-24
• Last Update Submitted: 2013-01-30
• Last Update Posted: 2013-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9572

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Targeted Screening	Targeted Screening	Targeted Screening Participants approached at ED for voluntary HIV counseling and testing based on risk for HIV
Routine Screening	Routine Screening	Routine Screening Participants approached at ED for voluntary HIV counseling and testing regardless of established risk according to age criteria

Primary Outcome Measures

Name	Time	Method
Percentage of Tested Participants Newly Diagnosed as HIV Infected	3 years	Percentage of tested participants newly diagnosed as HIV infected

Secondary Outcome Measures

Name	Time	Method
Percentage Consenting to Testing	3 years	Percentage of those successfully offered testing who consent to testing

Trial Locations

Locations (1)

University of Cincinnati Medical Center; 🇺🇸 Cincinnati, Ohio, United States