Rapid HIV Testing Program in the Emergency Department

This study has been completed.
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Temple University
ClinicalTrials.gov Identifier:
NCT00548041
First received: October 19, 2007
Last updated: October 5, 2015
Last verified: October 2015
Results First Received: April 20, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: 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  
Number of Participants  
[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


No publications provided


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