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Rapid HIV Testing for Emergency Department Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by National Institute of Allergy and Infectious Diseases (NIAID).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00676481
First received: May 9, 2008
Last updated: NA
Last verified: May 2008
History: No changes posted
  Purpose

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.


Condition Intervention
HIV Infections
 Behavioral: HIV risk education

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Screening
Official Title: Rapid HIV Testing for Emergency Department Patients

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Willingness of participant to have HIV testing [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Participant comprehension of rapid HIV pre-test information [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment: 5000
Study Start Date: July 2004
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00676481

Contacts
Contact: Roland C Merchant, MD, MPH, ScD 401-444-5109 rmerchant@lifespan.org

Locations
United States, Rhode Island
Rhode Island Hospital Emergency Department Recruiting
Providence, Rhode Island, United States, 02903
Principal Investigator: Roland C Merchant, MD, MPH, ScD            
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Centers for Disease Control and Prevention
Investigators
Principal Investigator: Roland C Merchant, MD, MPH, ScD Rhode Island Hospital/Warren Alpert Medical School
  More Information

Publications:

Responsible Party: Rona Siskind, DAIDS
ClinicalTrials.gov Identifier: NCT00676481     History of Changes
Other Study ID Numbers: K23 A1060363, K23 A1060363, U65/CCU124504
Study First Received: May 9, 2008
Last Updated: May 9, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Patient Education
Emergency Medicine
HIV Prevention
HIV Seronegativity

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Emergencies
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
 Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Disease Attributes
Pathologic Processes
HIV Antibodies
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013