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Rapid HIV Testing Program in the Emergency Department

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00548041
First Posted: October 23, 2007
Last Update Posted: November 2, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Temple University
Results First Submitted: April 20, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition: HIV Infections
Intervention: Other: HIV test by oral swab

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Subjects Undergoing Rapid HIV Testing in the ED Subjects were seen in the ED and had rapid HIV testing performed.

Participant Flow:   Overall Study
    Subjects Undergoing Rapid HIV Testing in the ED
STARTED   100 
COMPLETED   100 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Subjects Undergoing Rapid HIV Testing in the ED Subjects were seen in the ED and had rapid HIV testing performed.

Baseline Measures
   Subjects Undergoing Rapid HIV Testing in the ED 
Overall Participants Analyzed 
[Units: Participants]
 100 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   97 
>=65 years   3 
Gender 
[Units: Participants]
 
Female   64 
Male   36 
Region of Enrollment 
[Units: Participants]
 
United States   100 


  Outcome Measures

1.  Primary:   Feasibility of Rapid HIV Testing in Emergency Department   [ Time Frame: 2 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Ellen Tedaldi
Organization: Temple University Hospital
phone: 215-707-2000
e-mail: ellen.tedaldi@tuhs.temple.edu



Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT00548041     History of Changes
Other Study ID Numbers: 11007
First Submitted: October 19, 2007
First Posted: October 23, 2007
Results First Submitted: April 20, 2015
Results First Posted: November 2, 2015
Last Update Posted: November 2, 2015