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

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. Identifier: NCT00987194
Recruitment Status : Completed
First Posted : September 30, 2009
Last Update Posted : July 14, 2010
Massachusetts Department of Health
Information provided by:
Baystate Medical Center

Brief Summary:

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 or disease
HIV Infections

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Study Type : Observational
Actual Enrollment : 1087 participants
Time Perspective: Prospective
Official Title: HIV Testing in the Emergency Department at Baystate Medical Center: A Pilot Program Version 1.5, May 2009
Study Start Date : March 2009
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Primary Outcome Measures :
  1. 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 :
  1. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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:

  • None.

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 identifier (NCT number): NCT00987194

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

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Responsible Party: Daniel Skiest, MD, Baystate Medical Center Identifier: NCT00987194    
Other Study ID Numbers: IRB09-012
First Posted: September 30, 2009    Key Record Dates
Last Update Posted: July 14, 2010
Last Verified: July 2010
Keywords provided by Baystate Medical Center:
rapid testing
HIV seronegativity
Additional relevant MeSH terms:
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Disease Attributes
Pathologic Processes