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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

Primary Purpose

HIV Counseling and Testing, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HIV educational video
Sponsored by
North Bronx Healthcare Network
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional educational/counseling/training trial for HIV Counseling and Testing focused on measuring HIV prevention, HIV screening, Emergency Medicine, HIV counseling and Testing, HIV Seronegativity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Jacobi Medical Center

Outcomes

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.

Full Information

First Posted
September 19, 2005
Last Updated
October 21, 2005
Sponsor
North Bronx Healthcare Network
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1. Study Identification

Unique Protocol Identification Number
NCT00218881
Brief Title
An Effective Alternative to the Standard Referral System for HIV Testing in the Emergency Department During Off Hour Tours: A Randomized Trial
Official Title
An Effective Alternative to the Standard Referral System for HIV Testing in the ED
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
North Bronx Healthcare Network

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Counseling and Testing, HIV Infections
Keywords
HIV prevention, HIV screening, Emergency Medicine, HIV counseling and Testing, HIV Seronegativity

7. Study Design

Primary Purpose
Educational/Counseling/Training
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
408 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
HIV educational video
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Comparing return rates for HIV results in both groups.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yvette Calderon, MD<MS
Organizational Affiliation
North Bronx Healthcare Network, Jacobi Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jacobi Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States

12. IPD Sharing Statement

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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

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