Back to resultsRapid HIV Testing Program in the Emergency Department
Primary Purpose
HIV Infections
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HIV test by oral swab
Sponsored by
About this trial
This is an interventional diagnostic trial for HIV Infections focused on measuring HIV, Emergency Department, HIV Seronegativity
Eligibility 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.
Sites / Locations
- Temple University Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Rapid HIV Tested
Arm Description
Subjects have HIV testing by oral swab performed.
Outcomes
Primary Outcome Measures
Feasibility of Rapid HIV Testing in Emergency Department
Feasibility was assessed as number of participants who were approached and agreed to participate in rapid HIV testing and then had testing completed.
Secondary Outcome Measures
Full Information
NCT ID
NCT00548041
First Posted
October 19, 2007
Last Updated
October 5, 2015
Sponsor
Temple University
Collaborators
Gilead Sciences
1. Study Identification
Unique Protocol Identification Number
NCT00548041
Brief Title
Rapid HIV Testing Program in the Emergency Department
Official Title
Pilot Study to Evaluate a Rapid HIV Testing Program in the Emergency Department
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Temple University
Collaborators
Gilead Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV, Emergency Department, HIV Seronegativity
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rapid HIV Tested
Arm Type
Other
Arm Description
Subjects have HIV testing by oral swab performed.
Intervention Type
Other
Intervention Name(s)
HIV test by oral swab
Intervention Description
Eligible subjects underwent rapid HIV testing by oral swab.
Primary Outcome Measure Information:
Title
Feasibility of Rapid HIV Testing in Emergency Department
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellen Tedaldi, M.D.
Organizational Affiliation
Temple University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
12. IPD Sharing Statement
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Rapid HIV Testing Program in the Emergency Department
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