HIV Testing in the Emergency Department at Baystate Medical Center: A Pilot Program Version 1.5, May 2009
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,087
- 试验地点
- 1
- 主要终点
- The feasibility of initiating a rapid HIV testing program in the emergency department of a community teaching hospital in an a medium size city.
研究概览
简要总结
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:
- 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.
详细描述
I. Background Recently, CDC issued recommendations calling for HIV screening for patients aged 13-64, when the individual accesses the health care system 1. For many patients, especially those without a primary care provider, the emergency department (ED) is the primary or only contact point for the health care system. Testing individuals while they are in the ED has the potential to identify persons who do not perceive themselves to be at risk for HIV. Several academic EDs have begun to offer HIV testing 10, and have initially indicated promising results.
II. Rationale for testing in ED Testing in the ED has several potential advantages. It leads to shorter hospital stays, increases the number of newly diagnosed patients with HIV who are discharged from the hospital aware of their HIV status, and improved entry into outpatient care for patients admitted at the time of their initial HIV diagnosis. Another advantage of HIV testing in the ED is the ability to link newly diagnosed patients to an HIV clinician.
The optimal approach to testing for HIV in the ED is not known. Testing without risk assessment can identify persons with undiagnosed HIV infection and reduce reluctance assessing risk behavior.
While widespread routine HIV screening (e.g. testing as many patients as possible presenting to the ED) is likely to result in the highest number of positive tests, this strategy is expensive, burdensome and will not be practical in a busy city ED. In the setting of limited resources, a strategy of targeted testing (testing patients with established risk factors for HIV) may be a more cost-effective strategy. It may also be more practical and may be more acceptable to ED staff.
Another issue which needs further study is identifying the optimal personnel to conduct rapid HIV testing in the ED. There are advantages and disadvantages to requiring ED staff to counsel and consent patients for HIV testing. The ED staff may believe the testing is not in their purview and may not believe they have time to devote to testing.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- 未提供
结局指标
主要结局
The feasibility of initiating a rapid HIV testing program in the emergency department of a community teaching hospital in an a medium size city.
时间窗: 2 years
次要结局
- 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.(2 years)