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Rapid HIV Testing for Emergency Department Patients

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ClinicalTrials.gov Identifier: NCT00676481
Recruitment Status : Completed
First Posted : May 13, 2008
Last Update Posted : March 9, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
HIV Infections Behavioral: HIV risk education

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 570 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Screening
Official Title: Rapid HIV Testing for Emergency Department Patients
Study Start Date : July 2004
Primary Completion Date : March 2009
Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

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

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Willingness of participant to have HIV testing [ Time Frame: Throughout study ]

Secondary Outcome Measures :
  1. Participant comprehension of rapid HIV pre-test information [ Time Frame: Throughout study ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00676481


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

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00676481     History of Changes
Other Study ID Numbers: K23 A1060363
U65/CCU124504
First Posted: May 13, 2008    Key Record Dates
Last Update Posted: March 9, 2015
Last Verified: May 2008

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
Emergencies
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Disease Attributes
Pathologic Processes