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HIV Screening in the Emergency Department Setting

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Targeted Screening
Routine Screening
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for HIV Infections focused on measuring HIV, Prevention, Public Health, Screening

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Cincinnati Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Targeted Screening

Routine Screening

Arm Description

Targeted Screening Participants approached at ED for voluntary HIV counseling and testing based on risk for HIV

Routine Screening Participants approached at ED for voluntary HIV counseling and testing regardless of established risk according to age criteria

Outcomes

Primary Outcome Measures

Percentage of Tested Participants Newly Diagnosed as HIV Infected
Percentage of tested participants newly diagnosed as HIV infected

Secondary Outcome Measures

Percentage Consenting to Testing
Percentage of those successfully offered testing who consent to testing

Full Information

First Posted
April 3, 2008
Last Updated
January 30, 2013
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Ohio Department of Health, City of Cincinnati Board of Health
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1. Study Identification

Unique Protocol Identification Number
NCT00667186
Brief Title
HIV Screening in the Emergency Department Setting
Official Title
HIV Screening in the Emergency Department Setting
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Ohio Department of Health, City of Cincinnati Board of Health

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV, Prevention, Public Health, Screening

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
9572 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Targeted Screening
Arm Type
Active Comparator
Arm Description
Targeted Screening Participants approached at ED for voluntary HIV counseling and testing based on risk for HIV
Arm Title
Routine Screening
Arm Type
Active Comparator
Arm Description
Routine Screening Participants approached at ED for voluntary HIV counseling and testing regardless of established risk according to age criteria
Intervention Type
Other
Intervention Name(s)
Targeted Screening
Intervention Description
Selection method for screening is based on risk
Intervention Type
Other
Intervention Name(s)
Routine Screening
Intervention Description
Selection method for screening is not based on risk
Primary Outcome Measure Information:
Title
Percentage of Tested Participants Newly Diagnosed as HIV Infected
Description
Percentage of tested participants newly diagnosed as HIV infected
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Percentage Consenting to Testing
Description
Percentage of those successfully offered testing who consent to testing
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael S. Lyons, MD
Organizational Affiliation
University of Cincinnati College of Medicine Department of Emergency Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cincinnati Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0405
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17136020
Citation
Centers for Disease Control and Prevention (CDC). Missed opportunities for earlier diagnosis of HIV infection--South Carolina, 1997-2005. MMWR Morb Mortal Wkly Rep. 2006 Dec 1;55(47):1269-72.
Results Reference
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PubMed Identifier
17585288
Citation
Centers for Disease Control and Prevention (CDC). Rapid HIV testing in emergency departments--three U.S. sites, January 2005-March 2006. MMWR Morb Mortal Wkly Rep. 2007 Jun 22;56(24):597-601.
Results Reference
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PubMed Identifier
18073449
Citation
Fenton KA. Sustaining HIV prevention: HIV testing in health care settings. Top HIV Med. 2007 Nov-Dec;15(5):146-9.
Results Reference
background
PubMed Identifier
17564488
Citation
Holtgrave DR. Costs and consequences of the US Centers for Disease Control and Prevention's recommendations for opt-out HIV testing. PLoS Med. 2007 Jun;4(6):e194. doi: 10.1371/journal.pmed.0040194.
Results Reference
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Learn more about this trial

HIV Screening in the Emergency Department Setting

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