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

An Effective Alternative to the Standard Referral System for HIV Testing in the ED

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections; HIV Counseling and Testing
• Intervention / Treatment: Procedure: HIV educational video

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.

• Study Type: Interventional
• Enrollment: 408
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: ECT
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
Comparing return rates for HIV results in both groups.

Collaborators and Investigators

• Sponsor: North Bronx Healthcare Network
• Investigators: Principal Investigator: Yvette Calderon, MD<MS, North Bronx Healthcare Network, Jacobi Medical Center

Study record dates

Study Major Dates

• Study Start: October 1, 2003
• Study Completion: July 1, 2004

Study Registration Dates

• First Submitted: September 19, 2005
• First Submitted That Met QC Criteria: September 19, 2005
• First Posted (ESTIMATE): September 22, 2005

Study Record Updates

• Last Update Posted (ESTIMATE): October 25, 2005
• Last Update Submitted That Met QC Criteria: October 21, 2005
• Last Verified: September 1, 2005

More Information

Terms related to this study

• Keywords: HIV Seronegativity; Emergency Medicine; HIV prevention; HIV screening; HIV counseling and Testing
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: 03-090