The HIV Testing Using Enhanced Screening Techniques in Emergency Departments Trial
- Conditions
- Rapid HIV Screening
- Registration Number
- NCT01781949
- Lead Sponsor
- Denver Health and Hospital Authority
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 76235
- Greater than or equal to 16 years of age
- Clinically stable
- Capable of providing consent for medical care
- < 16 years old
- Unable to consent for medical care
- Prisoners or detainees
- Self-identified as infected with HIV
- Occupational exposure
- Sexual assault
- Fast-track patients
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Confirmed Newly-Diagnosed HIV Infection Day 1 Confirmed newly-diagnosed and previously-diagnosed HIV infection; classified as binary "yes" or "no"; assessed using structured medical record and laboratory data abstraction.
- Secondary Outcome Measures
Name Time Method CD4 Count Day 1 CD4 count (cells/mm3) at the time of diagnosis; assessed using structured laboratory data abstraction.
Hospitalization 1 year after diagnosis Hospitalization is defined as any unscheduled hospital admission, occurring at any time during the year following diagnosis; measured as binary "yes" or "no" and as number of unique hospitalizations; assessed using structured medical record abstraction.
Initiation of Antiretroviral Therapy 1 year after diagnosis Whether antiretroviral therapy (ART) was planned or initiated at any time during the year following diagnosis; classified as binary "yes" or "no"; assessed using structured medical record abstraction.
HIV Viral Load Day 1 HIV viral load (copies/mL) at the time of diagnosis; assessed using structured laboratory data abstraction.
Development of AIDS 1 year after diagnosis Using conventional definitions for the development of AIDS during any time during the year following diagnosis; classified as binary "yes" or "no"; assessed using structured medical record abstraction.
Treatment for Opportunistic Infections 1 year after diagnosis Whether treatment for specific opportunistic infections were initiated at any time during the year following diagnosis; assessed using structured medical record abstraction.
Unscheduled Medical Care Visits 1 year after diagnosis Unscheduled medical care visits is defined as all unscheduled visits (both outpatient and inpatient), occurring at any time during the year following diagnosis; classified as an interval value of unique visits; assessed using structured medical record abstraction.
Mortality 1 year after diagnosis Mortality is defined as death at any time during the year following diagnosis; classified as binary "yes" or "no"; assessed using structured medical record abstraction.
Linkage-to-Care Expected average of 1 week, but may be up to 1 month Determined by completion of a follow-up linkage-to-care visit within 30 days of initial ED diagnosis; classified as binary "yes" or "no"; assessed using structured medical record abstraction.
Scheduled Medical Care Visits 1 year after diagnosis Scheduled medical care visits is defined as all scheduled visits (both outpatient and inpatient), occurring at any time during the year following diagnosis; classified as an interval value of unique visits; assessed using structured medical record abstraction.
Trial Locations
- Locations (4)
Alameda County Medical Center
🇺🇸Oakland, California, United States
Denver Health and Hospital Authority
🇺🇸Denver, Colorado, United States
University of Cincinnati Medical Center
🇺🇸Cincinnati, Ohio, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States