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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00218881
First Posted: September 22, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
North Bronx Healthcare Network
  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: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Educational/Counseling/Training
Official Title: An Effective Alternative to the Standard Referral System for HIV Testing in the ED

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00218881     History of Changes
Other Study ID Numbers: 03-090
First Submitted: September 19, 2005
First Posted: September 22, 2005
Last Update Posted: December 9, 2005
Last Verified: September 2005

Keywords provided by North Bronx Healthcare Network:
HIV prevention
HIV screening
Emergency Medicine
HIV counseling and Testing
HIV Seronegativity

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases