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Rapid HIV Testing Program in the Emergency Department

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ClinicalTrials.gov Identifier: NCT00548041
Recruitment Status : Completed
First Posted : October 23, 2007
Results First Posted : November 2, 2015
Last Update Posted : November 2, 2015
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Temple University

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
HIV Infections Other: HIV test by oral swab Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pilot Study to Evaluate a Rapid HIV Testing Program in the Emergency Department
Study Start Date : April 2007
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Feasibility of Rapid HIV Testing in Emergency Department [ Time Frame: 2 years ]
    Feasibility was assessed as number of participants who were approached and agreed to participate in rapid HIV testing and then had testing completed.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00548041


Locations
United States, Pennsylvania
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
Sponsors and Collaborators
Temple University
Gilead Sciences
Investigators
Principal Investigator: Ellen Tedaldi, M.D. Temple University
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT00548041     History of Changes
Other Study ID Numbers: 11007
First Posted: October 23, 2007    Key Record Dates
Results First Posted: November 2, 2015
Last Update Posted: November 2, 2015
Last Verified: October 2015

Keywords provided by Temple University:
HIV
Emergency Department
HIV Seronegativity

Additional relevant MeSH terms:
HIV Infections
Emergencies
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Disease Attributes
Pathologic Processes