title: Design and implementation of a controlled clinical trial to evaluate the effectiveness and efficiency of routine opt-out rapid human immunodeficiency virus screening in the emergency department.
abstract: In 2006, the Centers for Disease Control and Prevention (CDC) released revised recommendations for performing human immunodeficiency virus (HIV) testing in health care settings, including implementing routine rapid HIV screening, the use of an integrated opt-out consent, and limited prevention counseling. Emergency departments (EDs) have been a primary focus of these efforts. These revised CDC recommendations were primarily based on feasibility studies and have not been evaluated through the application of rigorous research methods. This article describes the design and implementation of a large prospective controlled clinical trial to evaluate the CDC's recommendations in an ED setting. From April 15, 2007, through April 15, 2009, a prospective quasi-experimental equivalent time-samples clinical trial was performed to compare the clinical effectiveness and efficiency of routine (nontargeted) opt-out rapid HIV screening (intervention) to physician-directed diagnostic rapid HIV testing (control) in a high-volume urban ED. In addition, three nested observational studies were performed to evaluate the cost-effectiveness and patient and staff acceptance of the two rapid HIV testing methods. This article describes the rationale, methodologies, and study design features of this program evaluation clinical trial. It also provides details regarding the integration of the principal clinical trial and its nested observational studies. Such ED-based trials are rare, but serve to provide valid comparisons between testing approaches. Investigators should consider similar methodology when performing future ED-based health services research.
authors: Department of Emergency Medicine, Denver Health Medical Center, Denver, CO, USA. Jason.Haukoos@dhha.org
authors: Jason S
authors: JS
authors: Haukoos
authors: Emily
authors: E
authors: Hopkins
authors: Richard L
authors: RL
authors: Byyny
authors: Amy A
authors: AA
authors: Conroy
authors: Morgan
authors: M
authors: Silverman
authors: Sheri
authors: S
authors: Eisert
authors: Mark
authors: M
authors: Thrun
authors: Michael
authors: M
authors: Wilson
authors: Brian
authors: B
authors: Boyett
authors: James D
authors: JD
authors: Heffelfinger
mesh_terms: D015492:AIDS Serodiagnosis / Q000191:economics / Q000379:methods*; D000293:Adolescent; D000328:Adult; D001291:Attitude of Health Personnel; D003120:Colorado / Q000453:epidemiology; D003362:Cost-Benefit Analysis; D004636:Emergency Service, Hospital; D005260:Female; D006786:Hospitals, Urban; D006801:Humans; D015994:Incidence; D008297:Male; D008403:Mass Screening / Q000379:methods*; D010342:Patient Acceptance of Health Care; D012107:Research Design; D016036:Seroepidemiologic Studies; D013997:Time Factors; D014481:United States / Q000453:epidemiology