HIV Screening in the Emergency Department Setting

NCT ID: NCT00667186

Last Updated: 2013-02-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9572 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2010-12-31

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.

Conditions

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HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Targeted Screening

Targeted Screening

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

Group Type ACTIVE_COMPARATOR

Targeted Screening

Intervention Type OTHER

Selection method for screening is based on risk

Routine Screening

Routine Screening

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

Group Type ACTIVE_COMPARATOR

Routine Screening

Intervention Type OTHER

Selection method for screening is not based on risk

Interventions

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Targeted Screening

Selection method for screening is based on risk

Intervention Type OTHER

Routine Screening

Selection method for screening is not based on risk

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ohio Department of Health, City of Cincinnati Board of Health

UNKNOWN

Sponsor Role collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role lead

Responsible Party

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Michael S. Lyons

Assistant Professor Emergency Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael S. Lyons, MD

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati College of Medicine Department of Emergency Medicine

Locations

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University of Cincinnati Medical Center

Cincinnati, Ohio, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 17136020 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17585288 (View on PubMed)

Fenton KA. Sustaining HIV prevention: HIV testing in health care settings. Top HIV Med. 2007 Nov-Dec;15(5):146-9.

Reference Type BACKGROUND
PMID: 18073449 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17564488 (View on PubMed)

Other Identifiers

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K23AI068453

Identifier Type: NIH

Identifier Source: org_study_id

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