Trial record 17 of 53 for:    " September 15, 2009":" October 15, 2009"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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

This study has been completed.
Sponsor:
Collaborator:
Massachusetts Department of Health
Information provided by:
Baystate Medical Center
ClinicalTrials.gov Identifier:
NCT00987194
First received: September 25, 2009
Last updated: July 13, 2010
Last verified: July 2010
  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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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:

  • None.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:

Responsible Party: Daniel Skiest, MD, Baystate Medical Center
ClinicalTrials.gov Identifier: NCT00987194     History of Changes
Other Study ID Numbers: IRB09-012
Study First Received: September 25, 2009
Last Updated: July 13, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Baystate Medical Center:
HIV
rapid testing
HIV seronegativity

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Emergencies
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
Disease Attributes
Pathologic Processes
HIV Antibodies
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014