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OpenTrials
Completed

NCT Number: NCT00667186

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.

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Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Cincinnati Medical Center

Cincinnati, Ohio, 45267-0405, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Targeted Screening

Other

Selection method for screening is based on risk

Routine Screening

Other

Selection method for screening is not based on risk

Primary outcomes

  1. Percentage of Tested Participants Newly Diagnosed as HIV Infected

    Time frame: 3 years

    Percentage of tested participants newly diagnosed as HIV infected

Secondary outcomes

  1. Percentage Consenting to Testing

    Time frame: 3 years

    Percentage of those successfully offered testing who consent to testing

Sponsors and collaborators

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Nih

Collaborators

  • Ohio Department of Health, City of Cincinnati Board of Health

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Apr 25, 2008
Registry last updated
Feb 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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