An Effective Alternative to the Standard Referral System for HIV Testing in the Emergency Department During Off Hour Tours: A Randomized Trial - Full Text View

Sponsored by:	North Bronx Healthcare Network
Information provided by:	North Bronx Healthcare Network
ClinicalTrials.gov Identifier:	NCT00218881

Purpose

To compare HIV testing rates in ED patients offered video-assisted informed consent off-hours versus those referred to an HIV counselor the next business day.

Condition	Intervention
HIV Counseling and Testing HIV Infections	Procedure: HIV educational video

Study Type:	Interventional
Study Design:	Educational/Counseling/Training, Randomized, Open Label, Active Control, Factorial Assignment, Safety/Efficacy Study
Official Title:	An Effective Alternative to the Standard Referral System for HIV Testing in the ED

Resource links provided by NLM:

MedlinePlus related topics: AIDS

U.S. FDA Resources

Further study details as provided by North Bronx Healthcare Network:

Primary Outcome Measures:

HIV testing rates in ED patients offered video-assisted informed consent off-hours versus those referred to an HIV counselor the next business day.

Secondary Outcome Measures:

Comparing return rates for HIV results in both groups.

Estimated Enrollment:	408
Study Start Date:	October 2003
Estimated Study Completion Date:	July 2004

Detailed Description:

ED-based HIV counseling and testing (C&T) is in its early stages of development. Most urban ED patients requesting or requiring HIV testing are referred to C&T sites that are usually available only during regular business hours. Patient compliance with these referrals has been disappointing.

To improve ED access to HIV testing, we developed a video alternative to in-person pre-test counseling to provide the fundamental elements of the counseling. The video was based on the educational elements required by the New York State Department of Health (DOH) for HIV pre-test counseling. In a previous study, we demonstrated that the educational video performed as well as live counselors in conveying the information needed for inner city ED patients to consent to HIV testing. The present study was designed to compare HIV testing rates in ED patients offered video-assisted informed consent for HIV testing versus the standard referral for live C&T the next business day.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

All patients 18 years and older were approached while waiting for ED provider.

Exclusion Criteria:

Patients who were clinically unstable
Unable to understand the consent process
Had been HIV tested within 6 months and were informed of the result, or had a confirmed diagnosis of HIV were excluded from the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00218881

Locations

United States, New York
Jacobi Medical Center
Bronx, New York, United States, 10461

Sponsors and Collaborators

North Bronx Healthcare Network

Investigators

Principal Investigator:

Yvette Calderon, MD<MS

North Bronx Healthcare Network, Jacobi Medical Center

More Information

No publications provided

Study ID Numbers:	03-090
Study First Received:	September 19, 2005
Last Updated:	October 21, 2005
ClinicalTrials.gov Identifier:	NCT00218881 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by North Bronx Healthcare Network:

HIV prevention
HIV screening
Emergency Medicine
HIV counseling and Testing
HIV Seronegativity

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Antibodies
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Emergencies
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on September 01, 2009