HIV Testing in the Emergency Department at Baystate Medical Center: A Pilot Program
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
- To estimate the resources involved in initiating a rapid HIV testing program in the ED.
- To describe the process of initiating a rapid HIV testing program.
- To compare the yield of testing for HIV in patients with known HIV risk factors compared to those without known risk factors.
- To describe the characteristics of the population tested for HIV in the ED.
- To determine the number of patients who declined testing and the reasons for declining testing.
- 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 |
- 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 ]
- 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 |
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.
Contacts and Locations| United States, Massachusetts | |
| Baystate Medical Center | |
| Springfield, Massachusetts, United States, 01199 | |
| 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 June 18, 2013