CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,087 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00987194
NCT00987194N/ACompleted

HIV Testing in the Emergency Department at Baystate Medical Center: A Pilot Program Version 1.5, May 2009

Baystate Medical Center·observational·Posted Sep 30, 2009·Updated Jul 14, 2010

In Brief

An observational study for HIV Infections. Completed, enrolled 1,087 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesUnited States

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 30, 2009
Enrollment StartMar 1, 2009
Primary CompletionMar 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 16.8 years ago