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

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).


Condition Intervention
HIV Infections
Procedure: Counselor-based HIV screening
Procedure: Emergency staff member-based HIV screening

Study Type: Interventional
Study Design: Screening, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Official Title: Optimizing Strategies for Universal HIV Testing (The USHER Trial)

Resource links provided by NLM:


Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Test offer rate, maintenance of care, and medical personnel resource utilization [ Time Frame: Measured throughout study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 34200
Study Start Date: February 2007
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Oral HIV testing
Procedure: Counselor-based HIV screening
Participants will undergo oral HIV screening and, if positive, further study visits for up to 6 months
2: Active Comparator
Fingerstick HIV testing
Procedure: Emergency staff member-based HIV screening
Participants will undergo fingerstick HIV screening and, if positive, further study visits for up to 6 months

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00502944

Contacts
Contact: Rochelle P. Walensky, MD, MPH 617-724-3467 rwalensky@partners.org
Contact: Elena Losina, PhD 617-724-4636 elosina@partners.org

Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Christian Arbelaez     617-732-8947     carbelaez@partners.org    
Contact: Laurel Donnell-Fink, MPH     617-732-7897     ldonnell-fink@partners.org    
Sponsors and Collaborators
Investigators
Principal Investigator: Rochelle P. Walensky, MD, MPH Massachusetts General Hospital
  More Information

Publications:
Responsible Party: Massachusetts General Hospital ( Rochelle P. Walensky, MD, MPH )
Study ID Numbers: R01 MH073445, DAHBR 9A-ASPQ
Study First Received: July 16, 2007
Last Updated: August 6, 2009
ClinicalTrials.gov Identifier: NCT00502944     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
HIV
Testing
HIV Seronegativity

Additional relevant MeSH terms:
Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on February 08, 2010