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HIV Testing in the Emergency Department at Baystate Medical Center: A Pilot Program

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00987194
First Posted: September 30, 2009
Last Update Posted: July 14, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Massachusetts Department of Health
Information provided by:
Baystate Medical Center
  Purpose

Background Recently, the CDC issued recommendations calling for HIV screening for patients aged 13-64, when the individual accesses the health care system. For many patients, the emergency department (ED) is the primary or only contact point for health care. The rapid HIV test can be done as a point of care test in the ED.

Study Objectives

A. Primary:

1. To initiate HIV testing in the Baystate ED.

B. Secondary:

  1. To estimate the resources involved in initiating a rapid HIV testing program in the ED.
  2. To describe the process of initiating a rapid HIV testing program.
  3. To compare the yield of testing for HIV in patients with known HIV risk factors compared to those without known risk factors.
  4. To describe the characteristics of the population tested for HIV in the ED.
  5. To determine the number of patients who declined testing and the reasons for declining testing.
  6. To analyze ED staff attitudes re: HIV rapid testing in the ED.

Methods A trained HIV Educator/counselor will approach patients in the ED to offer free rapid HIV testing, at a time they are not currently engaged with the health care provider. Study informed consent and HIV consent will be obtained prior to testing. The HIV educator will obtain demographic and clinical information on the enrolled subjects including prior HIV testing and HIV risk factors. Patients testing negative will be counseled regarding HIV risk reduction strategies. Patients with an initial positive rapid HIV test will have blood drawn for confirmation (Western Blot) and will be referred to an HIV clinic for follow-up and treatment. Additionally, to assess acceptability of rapid testing in the ED, a brief anonymous electronic survey will be conducted of health care providers in the ED prior to starting this pilot program and following the program.

Data Analysis The yield of testing will be calculated as will the seroprevalence of those tested. Among patients who decline HIV testing but agree to study participation (sign consent form), the number refusing testing will be recorded and reasons for refusing will be analyzed. The yield of testing will be compared in patients with to those without known HIV risk factors.


Condition
HIV Infections

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: HIV Testing in the Emergency Department at Baystate Medical Center: A Pilot Program Version 1.5, May 2009

Resource links provided by NLM:


Further study details as provided by Baystate Medical Center:

Primary Outcome Measures:
  • The feasibility of initiating a rapid HIV testing program in the emergency department of a community teaching hospital in an a medium size city. [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • To determine the number of newly diagnosed individuals who were successfully linked to an HIV provider and the number who received antiretroviral therapy within one year of initial diagnosis. [ Time Frame: 2 years ]

Enrollment: 1087
Study Start Date: March 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Emergency department patients aged 18 years or older
Criteria

Inclusion Criteria:

  • Emergency department patients aged 18 years or older, appropriate for HIV testing will be identified by the HIV health educator.
  • Patients who are not otherwise occupied and who are not known to be HIV+ will be approached for consent to the study and for rapid HIV testing.

Exclusion Criteria:

  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): NCT00987194


Locations
United States, Massachusetts
Baystate Medical Center
Springfield, Massachusetts, United States, 01199
Sponsors and Collaborators
Baystate Medical Center
Massachusetts Department of Health
Investigators
Principal Investigator: Daniel J Skiest, MD Baystate Medical Center
  More Information

Publications:
Branson BM, Handsfield HH, Lampe MA, Janssen RS, Taylor AW, Lyss SB, Clark JE; Centers for Disease Control and Prevention (CDC). Revised recommendations for HIV testing of adults, adolescents, and pregnant women in health-care settings. MMWR Recomm Rep. 2006 Sep 22;55(RR-14):1-17; quiz CE1-4.
Palella FJ Jr, Deloria-Knoll M, Chmiel JS, Moorman AC, Wood KC, Greenberg AE, Holmberg SD; HIV Outpatient Study Investigators. Survival benefit of initiating antiretroviral therapy in HIV-infected persons in different CD4+ cell strata. Ann Intern Med. 2003 Apr 15;138(8):620-6.
Keiser P, Nassar N, Kvanli MB, Turner D, Smith JW, Skiest D. Long-term impact of highly active antiretroviral therapy on HIV-related health care costs. J Acquir Immune Defic Syndr. 2001 May 1;27(1):14-9.
Centers for Disease Control and Prevention (CDC). False-positive oral fluid rapid HIV tests--New York City, 2005-2008. MMWR Morb Mortal Wkly Rep. 2008 Jun 20;57(24):660-5.
Hutchinson AB, Branson BM, Kim A, Farnham PG. A meta-analysis of the effectiveness of alternative HIV counseling and testing methods to increase knowledge of HIV status. AIDS. 2006 Aug 1;20(12):1597-604. Review.
Lubelchek R, Kroc K, Hota B, Sharief R, Muppudi U, Pulvirenti J, Weinstein RA. The role of rapid vs conventional human immunodeficiency virus testing for inpatients: effects on quality of care. Arch Intern Med. 2005 Sep 26;165(17):1956-60.
Marks G, Crepaz N, Senterfitt JW, Janssen RS. Meta-analysis of high-risk sexual behavior in persons aware and unaware they are infected with HIV in the United States: implications for HIV prevention programs. J Acquir Immune Defic Syndr. 2005 Aug 1;39(4):446-53.
Holtgrave DR. Costs and consequences of the US Centers for Disease Control and Prevention's recommendations for opt-out HIV testing. PLoS Med. 2007 Jun;4(6):e194.
Bogart LM, Howerton D, Lange J, Setodji CM, Becker K, Klein DJ, Asch SM. Provider-related barriers to rapid HIV testing in U.S. urban non-profit community clinics, community-based organizations (CBOs) and hospitals. AIDS Behav. 2010 Jun;14(3):697-707. doi: 10.1007/s10461-008-9456-3. Epub 2008 Sep 3.
Ehrenkranz PD, Ahn CJ, Metlay JP, Camargo CA Jr, Holmes WC, Rothman R. Availability of rapid human immunodeficiency virus testing in academic emergency departments. Acad Emerg Med. 2008 Feb;15(2):144-50. doi: 10.1111/j.1553-2712.2008.00028.x.
Centers for Disease Control and Prevention (CDC). Missed opportunities for earlier diagnosis of HIV infection--South Carolina, 1997-2005. MMWR Morb Mortal Wkly Rep. 2006 Dec 1;55(47):1269-72.
Rothman RE, Ketlogetswe KS, Dolan T, Wyer PC, Kelen GD. Preventive care in the emergency department: should emergency departments conduct routine HIV screening? a systematic review. Acad Emerg Med. 2003 Mar;10(3):278-85. Review.

Responsible Party: Daniel Skiest, MD, Baystate Medical Center
ClinicalTrials.gov Identifier: NCT00987194     History of Changes
Other Study ID Numbers: IRB09-012
First Submitted: September 25, 2009
First Posted: September 30, 2009
Last Update Posted: July 14, 2010
Last Verified: July 2010

Keywords provided by Baystate Medical Center:
HIV
rapid testing
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


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