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Rapid HIV Testing for Emergency Department Patients

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HIV risk education
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for HIV Infections focused on measuring Patient Education, Emergency Medicine, HIV Prevention, HIV Seronegativity

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • English-speaking
  • Subcritical illness or injury

Exclusion Criteria:

  • Critical illness or injury
  • Mental or physical disability
  • Known HIV infection
  • Participation in an HIV vaccine study
  • Prison inmate
  • Acute psychiatric illness that, in the opinion of the investigator, would prevent the participant from completing the study

Sites / Locations

  • Rhode Island Hospital Emergency Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

1

2

Arm Description

Phase III participants who are educated about risk of HIV infection before receiving a rapid HIV test

Phase III participants who are not educated about risk of HIV infection before receiving a rapid HIV test

Outcomes

Primary Outcome Measures

Willingness of participant to have HIV testing

Secondary Outcome Measures

Participant comprehension of rapid HIV pre-test information

Full Information

First Posted
May 9, 2008
Last Updated
March 5, 2015
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Centers for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT00676481
Brief Title
Rapid HIV Testing for Emergency Department Patients
Official Title
Rapid HIV Testing for Emergency Department Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Centers for Disease Control and Prevention

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to test data collection options in emergency departments (EDs) and to enhance ED patient awareness of the risk of HIV infection.
Detailed Description
Rapid HIV testing is a new technology that speeds receipt of HIV test results. Its use in EDs has been demonstrated, but patient acceptance of rapid testing in the ED has not been optimal. It is likely that the low acceptance is partially due to ED patients not realizing the risk of acquiring an HIV infection or the importance of knowing their HIV status. The purpose of this study is to test data collection options in EDs and to enhance ED patient awareness of the risk for HIV infection. This three phase study will take place at the Rhode Island Hospital Emergency Department. Each participant will be followed for the duration of their ED visit. In Phase I, the proportion of participants who are willing to undergo rapid HIV testing in the ED will be measured. Additionally, the HIV testing history of these participants, their reasons for undergoing testing or for never having been tested for HIV, and factors associated with acceptance or decline of testing and history of HIV testing will be determined. An educational video will be developed and used to investigate its effectiveness in convincing participants to have the rapid HIV test. All participants agreeing to undergo a rapid HIV test will receive a survey to complete. In Phase II, a questionnaire and feedback tool to make participants aware of their risk for an HIV infection through injection drug use and sex will be developed and investigated. In Phase III, the questionnaire and feedback tool developed in Phase II will be used to determine whether or not making participants aware of their risk for an HIV infection increases their acceptance of being tested for HIV in the ED. Participants in Arm 1 will receive the questionnaire and feedback tool while participants in Arm 2 will not.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Patient Education, Emergency Medicine, HIV Prevention, HIV Seronegativity

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
570 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Phase III participants who are educated about risk of HIV infection before receiving a rapid HIV test
Arm Title
2
Arm Type
No Intervention
Arm Description
Phase III participants who are not educated about risk of HIV infection before receiving a rapid HIV test
Intervention Type
Behavioral
Intervention Name(s)
HIV risk education
Intervention Description
Education for Phase III participants about potential risk of HIV infection before being asked to take a rapid HIV test in the ED
Primary Outcome Measure Information:
Title
Willingness of participant to have HIV testing
Time Frame
Throughout study
Secondary Outcome Measure Information:
Title
Participant comprehension of rapid HIV pre-test information
Time Frame
Throughout study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: English-speaking Subcritical illness or injury Exclusion Criteria: Critical illness or injury Mental or physical disability Known HIV infection Participation in an HIV vaccine study Prison inmate Acute psychiatric illness that, in the opinion of the investigator, would prevent the participant from completing the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roland C Merchant, MD, MPH, ScD
Organizational Affiliation
Rhode Island Hospital/Warren Alpert Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rhode Island Hospital Emergency Department
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States

12. IPD Sharing Statement

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Rapid HIV Testing for Emergency Department Patients

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