NCT00742898

Brief Summary

The purpose of this study is to evaluate the clinical effectiveness of performing opt-out rapid HIV screening in an urban, inner-city emergency department, as well as to evaluate its clinical efficiency, cost effectiveness, and patient and staff satisfaction.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120,000

participants targeted

Target at P75+ for not_applicable hiv-infections

Timeline
Completed

Started Apr 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2008

Completed
8 months until next milestone

First Posted

Study publicly available on registry

August 28, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

September 15, 2009

Status Verified

September 1, 2009

Enrollment Period

2 years

First QC Date

January 10, 2008

Last Update Submit

September 14, 2009

Conditions

HIV Infections

Keywords

Quasi-experimental designNon-targeted opt-out rapid HIV screeningDiagnostic rapid HIV testingEmergency departmentEffectivenessEfficiencyHealth services researchProgram evaluationEffectiveness and efficiency of non-targeted rapid HIV screening in the ED

Outcome Measures

Primary Outcomes (1)

  • HIV seropositivity

    Immediate

Study Arms (2)

1

EXPERIMENTAL

Non-targeted opt-out rapid HIV screening fully integrated into an urban, inner-city ED.

Other: Non-targeted opt-out rapid HIV screening

2

ACTIVE COMPARATOR

Diagnostic rapid HIV testing fully integrated into an urban, inner-city ED.

Other: Non-targeted opt-out rapid HIV screening

Interventions

Non-targeted opt-out rapid HIV screeningOTHER

Experimental Arm: Integrated non-targeted opt-out rapid HIV screening Active Comparator Arm: Integrated diagnostic rapid HIV testing

12

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • years or older
  • Emergency department patients

You may not qualify if:

  • \<16 years
  • Unable to provide consent (e.g., intoxicated, altered mental status)
  • Critical illness
  • Prisoners or detainees
  • Already known to be infected with HIV
  • Victims of sexual assault
  • Occupational exposures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Denver Health Medical Center

Denver, Colorado, 80204, United States

Location

Related Publications (1)

  • Haukoos JS, Hopkins E, Byyny RL, Conroy AA, Silverman M, Eisert S, Thrun M, Wilson M, Boyett B, Heffelfinger JD; Denver ED HIV Opt-Out Study Group. Design and implementation of a controlled clinical trial to evaluate the effectiveness and efficiency of routine opt-out rapid human immunodeficiency virus screening in the emergency department. Acad Emerg Med. 2009 Aug;16(8):800-8. doi: 10.1111/j.1553-2712.2009.00477.x.

    PMID: 19673717DERIVED

MeSH Terms

Conditions

HIV InfectionsEmergencies

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jason S. Haukoos, MD, MSc

    Denver Health Medical Center

    PRINCIPAL INVESTIGATOR

  • Emily Hopkins, MSPH

    Denver Health Medical Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 10, 2008

First Posted

August 28, 2008

Study Start

April 1, 2007

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

September 15, 2009

Record last verified: 2009-09

Locations

US(1)