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Two Approaches to Routine HIV Testing in a Hospital Emergency Department
This study has been completed.

First Received on July 16, 2007.   Last Updated on December 10, 2010   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 will compare the effectiveness of two different approaches to providing routine HIV counseling, testing, and referral services in an urban hospital emergency department setting.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
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: No ]

Estimated Enrollment: 34200
Study Start Date: February 2007
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Counselor-based HIV screening Behavioral: Counselor-based HIV screening
Participants will undergo oral HIV screening by HIV counselor and, if positive, further study visits for up to 6 months
Active Comparator: Emergency staff member-based HIV screening Behavioral: Emergency staff member-based HIV screening
Participants will undergo oral HIV screening by emergency staff member 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
  • 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 who have mechanical ventilation or are not deemed alert, awake, and oriented to person, place and time by the triage nurse
  • HIV infected
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00502944

Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Investigators
Principal Investigator: Rochelle P. Walensky, MD, MPH Massachusetts General Hospital
  More Information

Publications:
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.
Arbelaez C, Block B, Losina E, Wright EA, Reichmann WM, Mikulinsky R, Solomon JD, Dooley MM, Walensky RP. Rapid HIV testing program implementation: lessons from the emergency department. Int J Emerg Med. 2009 Sep 1;2(3):187-94.
Arbelaez C, Wright EA, Losina E, Millen JC, Kimmel S, Dooley M, Reichmann WM, Mikulinsky R, Walensky RP. Emergency Provider Attitudes and Barriers to Universal HIV Testing in the Emergency Department. J Emerg Med. 2009 Oct 13; [Epub ahead of print]
Reichmann WM, Losina E, Seage GR, Arbelaez C, Safren SA, Katz JN, Hetland A, Walensky RP. Does modality of survey administration impact data quality: audio computer assisted self interview (ACASI) versus self-administered pen and paper? PLoS One. 2010 Jan 15;5(1):e8728.
Millen JC, Arbelaez C, Walensky RP. Implications and Impact of the New US Centers for Disease Control and Prevention HIV Testing Guidelines. Curr Infect Dis Rep. 2008 Mar;10(2):157-163.
Walensky RP, Freedberg KA, Weinstein MC, Paltiel AD. Cost-effectiveness of HIV testing and treatment in the United States. Clin Infect Dis. 2007 Dec 15;45 Suppl 4:S248-54. Review.
Ganguli I, Bassett IV, Dong KL, Walensky RP. Home testing for HIV infection in resource-limited settings. Curr HIV/AIDS Rep. 2009 Nov;6(4):217-23. Review.

Responsible Party: Rochelle P. Walensky, MD, MPH, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00502944     History of Changes
Other Study ID Numbers: R01 MH073445, DAHBR 9A-ASPQ
Study First Received: July 16, 2007
Last Updated: December 10, 2010
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
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
HIV Antibodies
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012