Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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:
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

May 9, 2008
May 9, 2008
July 2004
March 2009   (final data collection date for primary outcome measure)
Willingness of participant to have HIV testing [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Participant comprehension of rapid HIV pre-test information [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Rapid HIV Testing for Emergency Department Patients
Rapid HIV Testing for Emergency Department Patients

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Screening
HIV Infections
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
  • Active Comparator: 1
    Phase III participants who are educated about risk of HIV infection before receiving a rapid HIV test
    Intervention: Behavioral: HIV risk education
  • No Intervention: 2
    Phase III participants who are not educated about risk of HIV infection before receiving a rapid HIV test
Teja VD, Sudha T, Lakshmi V. Emergency department based HIV screening: An opportunity for early diagnosis in high prevalent areas. Indian J Med Microbiol. 2008 April-June;26(2):167-171.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
5000
June 2009
March 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 64 Years
Yes
Contact: Roland C Merchant, MD, MPH, ScD 401-444-5109 rmerchant@lifespan.org
United States
 
NCT00676481
K23 A1060363, K23 A1060363, U65/CCU124504
No
Rona Siskind, DAIDS
National Institute of Allergy and Infectious Diseases (NIAID)
Centers for Disease Control and Prevention
Principal Investigator: Roland C Merchant, MD, MPH, ScD Rhode Island Hospital/Warren Alpert Medical School
National Institute of Allergy and Infectious Diseases (NIAID)
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP