Rapid HIV Testing Program in the Emergency Department

• Sponsor: Temple University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00548041
• Collaborator: Gilead Sciences (Industry)
• Enrollment: 100
• Location: 1
• Arm: 1
• Duration (Months): 25
• Patients Per Site Per Month: 4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Other: HIV test by oral swab	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: N/A
• 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: Apr 1, 2007
• Actual Primary Completion Date: May 1, 2009
• Actual Study Completion Date: May 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Other: 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

Primary Outcome Measures

1. Feasibility of Rapid HIV Testing in Emergency Department [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

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Temple University Hospital	Philadelphia	Pennsylvania	United States	19140

Sponsors and Collaborators

• Temple University
• Gilead Sciences

Investigators

• Principal Investigator: Ellen Tedaldi, M.D., Temple University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Temple University
• ClinicalTrials.gov Identifier: NCT00548041
• Other Study ID Numbers: 11007
• First Posted: Oct 23, 2007
• Last Update Posted: Nov 1, 2015
• Last Verified: Oct 1, 2015

• Keywords provided by Temple University: HIV; Emergency Department; HIV Seronegativity
• Additional relevant MeSH terms: Emergencies

Study Results

Participant Flow

Arm/Group Title	Subjects Undergoing Rapid HIV Testing in the ED
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

Baseline Characteristics

Arm/Group Title	Subjects Undergoing Rapid HIV Testing in the ED
Arm/Group Description	Subjects were seen in the ED and had rapid HIV testing performed.
Overall Participants	100
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	97 97%
>=65 years	3 3%
Sex: Female, Male (Count of Participants)
Female	64 64%
Male	36 36%
Region of Enrollment (participants) [Number]
United States	100 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Subjects Undergoing Rapid HIV Testing in the ED
Arm/Group Description	Subjects were seen in the ED and had rapid HIV testing performed.
Measure Participants	100
Number [participants]	100 100%

Adverse Events

Arm/Group Title	Subjects Undergoing HIV Testing in the ED
Arm/Group Description
All Cause Mortality
	Subjects Undergoing HIV Testing in the ED
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Subjects Undergoing HIV Testing in the ED
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Subjects Undergoing HIV Testing in the ED
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Blood and lymphatic system disorders
Adverse Events were not collected/addressed	0/0 (NaN)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.