The HIV Testing Using Enhanced Screening Techniques in Emergency Departments Trial

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 randomized control trial 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) enhanced
and traditional targeted rapid HIV screening is more cost effective per newly-identified
patient than nontargeted rapid HIV screening; and (3) enhanced targeted rapid HIV screening
is associated with non-inferior ED process metrics and crowding when compared to traditional
targeted screening or nontargeted screening.

To accomplish these aims, the investigative team will conduct: (1) a prospective randomized
controlled "pragmatic" clinical effectiveness trial in the EDs at Denver Health Medical
Center (Denver, CO), Alameda County Medical Center (Oakland, CA), Johns Hopkins Hospital
(Baltimore, MD), and the University of Cincinnati Medical Center (Cincinnati, OH); and (2)
nested observational studies to evaluate programmatic costs and operational metrics between
the 3 rapid HIV screening strategies and using newly-diagnosed HIV infection as the primary
outcome.

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

- Occupational exposure

- Sexual assault

- Fast-track patients