Rapid HIV Testing for Emergency Department Patients

March 5, 2015 updated by: National Institute of Allergy and Infectious Diseases (NIAID)
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

570

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital Emergency Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Phase III participants who are educated about risk of HIV infection before receiving a rapid HIV test
Behavioral: HIV risk education
Education for Phase III participants about potential risk of HIV infection before being asked to take a rapid HIV test in the ED
No Intervention: 2
Phase III participants who are not educated about risk of HIV infection before receiving a rapid HIV test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Willingness of participant to have HIV testing
Time Frame: Throughout study
Throughout study

Secondary Outcome Measures

Outcome Measure
Time Frame
Participant comprehension of rapid HIV pre-test information
Time Frame: Throughout study
Throughout study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

Centers for Disease Control and Prevention

Investigators

  • Principal Investigator: Roland C Merchant, MD, MPH, ScD, Rhode Island Hospital/Warren Alpert Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

May 9, 2008

First Submitted That Met QC Criteria

May 9, 2008

First Posted (Estimate)

May 13, 2008

Study Record Updates

Last Update Posted (Estimate)

March 9, 2015

Last Update Submitted That Met QC Criteria

March 5, 2015

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K23 A1060363
  • U65/CCU124504

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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