NCT00667186

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9,572

participants targeted

Target at P75+ for not_applicable hiv-infections

Timeline
Completed

Started Jan 2008

Typical duration for not_applicable hiv-infections

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

January 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2008

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 25, 2008

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

January 24, 2013

Completed
Last Updated

February 4, 2013

Status Verified

January 1, 2013

Enrollment Period

2.9 years

First QC Date

April 3, 2008

Results QC Date

October 29, 2012

Last Update Submit

January 30, 2013

Conditions

HIV Infections

Keywords

HIVPreventionPublic HealthScreening

Outcome Measures

Primary Outcomes (1)

  • Percentage of Tested Participants Newly Diagnosed as HIV Infected

    Percentage of tested participants newly diagnosed as HIV infected

    3 years

Secondary Outcomes (1)

  • Percentage Consenting to Testing

    3 years

Study Arms (2)

Targeted Screening

ACTIVE COMPARATOR

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

Other: Targeted Screening

Routine Screening

ACTIVE COMPARATOR

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

Other: Routine Screening

Interventions

Targeted ScreeningOTHER

Selection method for screening is based on risk

Targeted Screening
Routine ScreeningOTHER

Selection method for screening is not based on risk

Routine Screening

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adult participants presenting for care in the ED

You may not qualify if:

  • Participants cognitively unable or unwilling to consent for voluntary HIV counseling and testing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cincinnati Medical Center

Cincinnati, Ohio, 45267-0405, United States

Location

Related Publications (4)

  • 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.

    PMID: 17136020BACKGROUND

  • 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.

    PMID: 17585288BACKGROUND

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

    PMID: 18073449BACKGROUND

  • 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.

    PMID: 17564488BACKGROUND

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Results Point of Contact

Title
Michael S. Lyons
Organization
University of Cincinnati College of Medicine
lyonsme@ucmail.uc.edu
513-558-0890

Study Officials

  • Michael S. Lyons, MD

    University of Cincinnati College of Medicine Department of Emergency Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor Emergency Medicine

Study Record Dates

First Submitted

April 3, 2008

First Posted

April 25, 2008

Study Start

January 1, 2008

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

February 4, 2013

Results First Posted

January 24, 2013

Record last verified: 2013-01

Locations

US(1)