The HIV Testing Using Enhanced Screening Techniques in Emergency Departments Trial (HIV TESTED)

• CD4 Count [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  CD4 count at the time of diagnosis
• HIV Viral Load [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  HIV viral Load at the time of diagnosis
• Linkage-to-Care [ Time Frame: Expected average of 1 week ] [ Designated as safety issue: No ]
• Development of AIDS [ Time Frame: 1 year after diagnosis ] [ Designated as safety issue: No ]
• Initiation of Antiretroviral Therapy [ Time Frame: 1 year after diagnosis ] [ Designated as safety issue: No ]
• Treatment for Opportunistic Infections [ Time Frame: 1 year after diagnosis ] [ Designated as safety issue: No ]
• Hospitalization [ Time Frame: 1 year after diagnosis ] [ Designated as safety issue: No ]
• Scheduled Medical Care Visits [ Time Frame: 1 year after diagnosis ] [ Designated as safety issue: No ]
• Unscheduled Medical Care Visits [ Time Frame: 1 year after diagnosis ] [ Designated as safety issue: No ]
• Mortality [ Time Frame: 1 year after diagnosis ] [ Designated as safety issue: No ]

The purpose of this study is to evaluate the effectiveness of 3 modern rapid HIV screening methods, including a novel targeted strategy, in urban emergency department settings in the United States.

Early identification of undiagnosed HIV infection remains a critical public health priority. In the United States, approximately 250,000 HIV-infected individuals remain undiagnosed and 50,000 new infections occur annually, despite several substantial HIV-related public health initiatives. Although HIV testing is an important intervention, controversy still exists as to how it should be implemented.

In 2006, the Centers for Disease Control and Prevention (CDC) recommended nontargeted opt-out HIV screening in clinical settings where the undiagnosed prevalence was ≥0.1%. Emergency departments (EDs) have been a major focus of these recommendations, prompted by the fact that over 120 million ED visits occur annually in the United States, they serve large proportions of underserved patients, and are the most common site of missed diagnostic opportunities for HIV infection. In contrast, in 2007 the United States Preventive Services Task Force recommended targeted HIV screening (i.e., testing high-risk subpopulations) as the principal approach to HIV testing because insufficient evidence existed to support the CDC recommendations.

Led by Jason Haukoos, MD, MSc, the research team has pioneered investigations in this area since 2004, recently publishing the largest clinical trial to date, concluding that nontargeted opt-out rapid HIV screening in the ED was associated with a small increase in number of newly-identified HIV-infected patients when compared to diagnostic testing (i.e., testing based on clinical signs or symptoms) by physicians. The investigators also recently developed the Denver HIV Risk Score (DHRS), the first multivariable tool to estimate risk of HIV infection. The DHRS combines 3 demographic and 5 behavioral characteristics, and classifies patients into distinct strata with increasing HIV prevalence.

To build on this work, the investigators propose the following specific aims: (1) to evaluate and compare the effectiveness of 3 rapid HIV screening strategies when fully-integrated into ED care; (2) to measure and compare programmatic costs of each HIV screening strategy; and (3) to measure and compare ED operational processes of each HIV screening strategy. In doing so, the investigators will perform a multi-center prospective clinical trial using a quasi-experimental equivalent time-samples design to test the following hypotheses: (1) targeted rapid HIV screening using the DHRS to identify high-risk patients is significantly associated with new HIV diagnoses when compared to traditional targeted rapid HIV screening and nontargeted rapid HIV screening; (2) targeted rapid HIV screening is more cost effective per newly-identified patient than nontargeted rapid HIV screening; and (3) targeted rapid HIV screening does not significantly impact ED processes of care when compared to nontargeted rapid HIV screening.

• Other: A: Nontargeted rapid HIV screening
  This screening phase will consist of implementing nontargeted rapid opt-in HIV screening on a 24-hour basis as a part of routine ED care. Consecutive patients who present to the ED for evaluation and who meet criteria for inclusion will be offered voluntary, free, and confidential rapid HIV testing by nurses using opt-in consent during medical screening.
• Other: B: Enhanced targeted rapid HIV screening
  This screening phase will consist of implementing targeted rapid opt-in screening using the Denver HIV Risk Score (DHRS) to identify patients at increased risk for HIV infection on a 24-hour basis as part of routine ED care. Patients will be considered at increased risk for HIV infection if they score 30 or more on the DHRS. These high-risk patients will be offered rapid HIV testing by nurses using opt-in consent. Patients identified as low risk (<30) will not be offered rapid HIV testing, but will eligible for diagnostic HIV testing.
• Other: C: Traditional targeted rapid HIV screening
  This screening intervention will consist of implementing targeted rapid opt-in HIV screening using conventional risk behaviors to identify patients at increased risk for HIV infection on a 24-hour basis as part of routine ED care. A Behavioral Risk Screening Tool (BRST) will be incorporated into the electronic medical screening and patient tracking systems in each ED. Each of the 6 risk categories will be weighted equally so that the BRST score will range from 0 to 6. Nurses will apply the BRST to all patients who meet criteria fo inclusion, and those who score 1 or greater will be offered rapid HIV testing using opt-in consent. Patients who score 0 will not be offered rapid HIV testing, but will eligible for diagnostic testing.

• A: Nontargeted rapid HIV screening
  Nontargeted rapid opt-in HIV screening on a 24-hour basis as a part of routine ED care.
  Intervention: Other: A: Nontargeted rapid HIV screening
• B: Enhanced targeted rapid HIV screening
  Implementation of targeted rapid opt-in HIV screening using the Denver HIV Risk Score (DHRS) to identify patients at increased risk for HIV infection on a 24-hour basis as a part of routine ED care.
  Intervention: Other: B: Enhanced targeted rapid HIV screening
• C: Traditional targeted rapid HIV screening
  Implementation of targeted rapid opt-in HIV screening using conventional risk behaviors to identify patients at increased risk for HIV infection on a 24-hour basis as part of routine HIV care.
  Intervention: Other: C: Traditional targeted rapid HIV screening

Inclusion Criteria:

• Greater than or equal to 13 years of age
• Clinically stable
• Capable of providing consent for medical care

Exclusion Criteria:

• < 13 years old
• Unable to consent for medical care
• Prisoners or detainees
• Self-identified as infected with HIV

• Alameda County Medical Center
• University of Cincinnati
• Johns Hopkins University