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

History of Changes

Purpose

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	Intervention
HIV Infections	Other: HIV test by oral swab


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	Pilot Study to Evaluate a Rapid HIV Testing Program in the Emergency Department

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by Temple University:

Primary Outcome Measures:

Feasibility of Rapid HIV Testing in Emergency Department [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Feasibility was assessed as number of participants who were approached and agreed to participate in rapid HIV testing and then had testing completed.


Enrollment:	100
Study Start Date:	April 2007
Study Completion Date:	May 2009
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00548041

Locations


United States, Pennsylvania
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140

Sponsors and Collaborators

Temple University

Gilead Sciences

Investigators


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

More Information


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

Keywords provided by Temple University:


HIV Emergency Department HIV Seronegativity

Additional relevant MeSH terms:


Emergencies HIV Infections Disease Attributes Pathologic Processes Lentivirus Infections Retroviridae Infections	RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases

ClinicalTrials.gov processed this record on September 27, 2016

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