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

• Confirmed HIV Infection [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  Confirmed newly-diagnosed and previously-diagnosed HIV infection.
  
  

• 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 ]
  

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.