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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 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
Enrollment 100
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Subjects Undergoing Rapid HIV Testing in the ED
Hide Arm/Group Description Subjects were seen in the ED and had rapid HIV testing performed.
Period Title: Overall Study
Started 100
Completed 100
Not Completed 0
Arm/Group Title Subjects Undergoing Rapid HIV Testing in the ED
Hide Arm/Group Description Subjects were seen in the ED and had rapid HIV testing performed.
Overall Number of Baseline Participants 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants
<=18 years
0
   0.0%
Between 18 and 65 years
97
  97.0%
>=65 years
3
   3.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants
Female
64
  64.0%
Male
36
  36.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 100 participants
100
1.Primary Outcome
Title Feasibility of Rapid HIV Testing in Emergency Department
Hide Description Feasibility was assessed as number of participants who were approached and agreed to participate in rapid HIV testing and then had testing completed.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Subjects Undergoing Rapid HIV Testing in the ED
Hide Arm/Group Description:
Subjects were seen in the ED and had rapid HIV testing performed.
Overall Number of Participants Analyzed 100
Measure Type: Number
Unit of Measure: participants
100
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Subjects Undergoing HIV Testing in the ED
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Subjects Undergoing HIV Testing in the ED
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Subjects Undergoing HIV Testing in the ED
Affected / at Risk (%) # Events
Total   0/0    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Subjects Undergoing HIV Testing in the ED
Affected / at Risk (%) # Events
Total   0/0    
Blood and lymphatic system disorders   
Adverse Events were not collected/addressed [1]  0/0  0
[1]
Adverse Events were not collected/assessed
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
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