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HIV Screening in the Emergency Department Setting

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ClinicalTrials.gov Identifier: NCT00667186
Recruitment Status : Completed
First Posted : April 25, 2008
Results First Posted : January 24, 2013
Last Update Posted : February 4, 2013
Sponsor:
Collaborator:
Ohio Department of Health, City of Cincinnati Board of Health
Information provided by (Responsible Party):
Michael S. Lyons, University of Cincinnati

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.

Condition or disease Intervention/treatment Phase
HIV Infections Other: Targeted Screening Other: Routine Screening Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 9572 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: HIV Screening in the Emergency Department Setting
Study Start Date : January 2008
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Active Comparator: Targeted Screening

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

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




Primary Outcome Measures :
  1. Percentage of Tested Participants Newly Diagnosed as HIV Infected [ Time Frame: 3 years ]
    Percentage of tested participants newly diagnosed as HIV infected


Secondary Outcome Measures :
  1. Percentage Consenting to Testing [ Time Frame: 3 years ]
    Percentage of those successfully offered testing who consent to testing



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00667186


Locations
United States, Ohio
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45267-0405
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Ohio Department of Health, City of Cincinnati Board of Health
Investigators
Principal Investigator: Michael S. Lyons, MD University of Cincinnati College of Medicine Department of Emergency Medicine

Publications:
Responsible Party: Michael S. Lyons, Assistant Professor Emergency Medicine, University of Cincinnati
ClinicalTrials.gov Identifier: NCT00667186     History of Changes
Other Study ID Numbers: K23AI068453 ( U.S. NIH Grant/Contract )
First Posted: April 25, 2008    Key Record Dates
Results First Posted: January 24, 2013
Last Update Posted: February 4, 2013
Last Verified: January 2013

Keywords provided by Michael S. Lyons, University of Cincinnati:
HIV
Prevention
Public Health
Screening

Additional relevant MeSH terms:
HIV Infections
Emergencies
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Disease Attributes
Pathologic Processes