Rapid HIV Testing Program in the Emergency Department

This study has been completed.
Gilead Sciences
Information provided by (Responsible Party):
Temple University
ClinicalTrials.gov Identifier:
First received: October 19, 2007
Last updated: October 5, 2015
Last verified: October 2015
The purpose of the study is to evaluate the feasibility of a rapid HIV testing program in the Temple University Hospital(TUH)Emergency Department. We hypothesize that a rapid HIV testing program in the TUH Emergency Department is feasible. Patients presenting to the Adult TUH Emergency Department with certain conditions will be offered rapid HIV testing. Testing will be performed by oral swab using the OraQuick Advance test. Patients will receive post-test counseling.

Condition Intervention
HIV Infections
Other: HIV test by oral swab

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Pilot Study to Evaluate a Rapid HIV Testing Program in the Emergency Department

Resource links provided by NLM:

Further study details as provided by Temple University:

Primary Outcome Measures:
  • Feasibility of Rapid HIV Testing in Emergency Department [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Feasibility was assessed as number of participants who were approached and agreed to participate in rapid HIV testing and then had testing completed.

Enrollment: 100
Study Start Date: April 2007
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Rapid HIV Tested
Subjects have HIV testing by oral swab performed.
Other: HIV test by oral swab
Eligible subjects underwent rapid HIV testing by oral swab.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

One of the following conditions:

  • Sexually transmitted disease evaluation or prior history of sexually transmitted disease
  • Pregnancy
  • Clinical condition that suggests possible immunodeficiency
  • History of illicit drug use
  • History of chronic viral hepatitis
  • Patients with unexplained pneumonia or recurrent pneumonia
  • Male patients who have a history of sex with men
  • Abdominal pain in a sexually active woman or urethritis in a man
  • Trauma.
  • Age 18 years old or older.

Exclusion Criteria:

  • Age less than 18 years.
  • None of the above conditions.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00548041

United States, Pennsylvania
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
Sponsors and Collaborators
Temple University
Gilead Sciences
Principal Investigator: Ellen Tedaldi, M.D. Temple University
  More Information

Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT00548041     History of Changes
Other Study ID Numbers: 11007 
Study First Received: October 19, 2007
Results First Received: April 20, 2015
Last Updated: October 5, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Temple University:
Emergency Department
HIV Seronegativity

Additional relevant MeSH terms:
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on May 26, 2016