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Two Approaches to Routine HIV Testing in a Hospital Emergency Department
This study is currently recruiting participants.
Study NCT00502944   Information provided by National Institute of Mental Health (NIMH)
First Received: July 16, 2007   Last Updated: August 6, 2009   History of Changes

July 16, 2007
August 6, 2009
February 2007
June 2011   (final data collection date for primary outcome measure)
Acceptability of the HIV test, defined as the proportion of participants within each trial arm that had the HIV test performed. [ Time Frame: Measured throughout study ] [ Designated as safety issue: No ]
Linkage to care of newly diagnosed HIV infected participants [ Time Frame: throughout study and at Year 4.5 of the study ]
Complete list of historical versions of study NCT00502944 on ClinicalTrials.gov Archive Site
Test offer rate, maintenance of care, and medical personnel resource utilization [ Time Frame: Measured throughout study ] [ Designated as safety issue: Yes ]
Test offer rate, test acceptability, maintenance of care, and medical personnel resource utilization [ Time Frame: throughout study ]
 
Two Approaches to Routine HIV Testing in a Hospital Emergency Department
Optimizing Strategies for Universal HIV Testing (The USHER Trial)

This study was initially designed to compare the effectiveness of two different approaches to providing routine HIV counseling, testing, and referral services in an urban hospital emergency department setting. The initial phase was closed by the DSMB in July 2008. The second phase of this trial consists of establishing the differences in acceptability of HIV testingbased on the method of testing offered (rapid oral fluid vs. fingerstick).

About 25% of HIV infected people do not know that they are infected. These people lack medical care that could prolong their lives and access to counseling services that could prevent further spread of HIV. With so many people unaware of their HIV status, there is a clear need for more readily available HIV counseling, testing, and referral services throughout the United States. The Centers for Disease Control and Prevention (CDC) recommends routine HIV testing in U.S. hospitals in which HIV infected patients make up at least 1% of the total patient population for that hospital. However, routine HIV testing in such hospitals is rarely carried out, which might be because the CDC has not specified who should perform routine HIV testing. The purpose of this study is to compare the effectiveness of two different approaches to providing routine HIV counseling, testing, and referral services in an urban hospital emergency department setting. One approach will be led by an HIV counselor, and the other approach will be led by an emergency department staff member. For both approaches, the study will evaluate to what extent patients accept HIV testing, how well follow-up care is established, and the cost-effectiveness of the approach.

Participants in this study will include adults who visit Brigham and Women's Hospital emergency department in Boston, Massachusetts. Participants will be randomly assigned to oral vs. fingerstick HIV testing by a designated HIV counselor and to fill out a questionnaire while waiting in the emergency room. The questionnaire will be anonymous. Participants will then be offered a rapid HIV test. Test results will be available in about 20 minutes and will be provided to participants by either their assigned HIV counselor. Participants who test positive for HIV will be offered a more definitive blood test to confirm HIV infection. The blood test results will be available 2 weeks from testing, and participants must return to the hospital to get their test results. Participants who test positive for HIV will be offered counseling support and referral services by either their assigned HIV counselor or emergency department staff member. Follow-up care appointments will also be initiated at this time. For participants who test positive for HIV, the study will last about 6 months. There will be no follow-up visits for participants who do not test positive for HIV during their emergency room visit.

 
Interventional
Screening, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
HIV Infections
  • Procedure: Counselor-based HIV screening
  • Procedure: Emergency staff member-based HIV screening
  • Experimental: Oral HIV testing
  • Active Comparator: Fingerstick HIV testing
Walensky RP, Arbelaez C, Reichmann WM, Walls RM, Katz JN, Block BL, Dooley M, Hetland A, Kimmel S, Solomon JD, Losina E. Revising expectations from rapid HIV tests in the emergency department. Ann Intern Med. 2008 Aug 5;149(3):153-60.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
34200
June 2011
June 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Waiting to receive care in the Brigham and Women's Hospital emergency room
  • An estimated severity index score of 3, 4, or 5 as determined by emergency room staff
  • English- or Spanish-speaking
  • Enters the emergency room when an HIV counselor is available

Exclusion Criteria:

  • An estimated severity index score of 1 or 2 as determined by emergency room staff
  • HIV infected
Both
18 Years and older
No
Contact: Rochelle P. Walensky, MD, MPH 617-724-3467 rwalensky@partners.org
Contact: Elena Losina, PhD 617-724-4636 elosina@partners.org
United States
 
NCT00502944
Rochelle P. Walensky, MD, MPH, Massachusetts General Hospital
R01 MH073445, DAHBR 9A-ASPQ
National Institute of Mental Health (NIMH)
 
Principal Investigator: Rochelle P. Walensky, MD, MPH Massachusetts General Hospital
National Institute of Mental Health (NIMH)
August 2009

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