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Evaluation of Opt-Out Rapid HIV Testing in the Emergency Department

This study has been completed.
Sponsor:
Information provided by:
Denver Health and Hospital Authority
ClinicalTrials.gov Identifier:
NCT00742898
First received: January 10, 2008
Last updated: September 14, 2009
Last verified: September 2009
  Purpose

The purpose of this study is to evaluate the clinical effectiveness of performing opt-out rapid HIV screening in an urban, inner-city emergency department, as well as to evaluate its clinical efficiency, cost effectiveness, and patient and staff satisfaction.


Condition Intervention
HIV Infections
Other: Non-targeted opt-out rapid HIV screening

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Non-targeted Opt-out Rapid HIV Screening in the Emergency Department: a Controlled Clinical Trial

Resource links provided by NLM:


Further study details as provided by Denver Health and Hospital Authority:

Primary Outcome Measures:
  • HIV seropositivity [ Time Frame: Immediate ] [ Designated as safety issue: No ]

Estimated Enrollment: 120000
Study Start Date: April 2007
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Non-targeted opt-out rapid HIV screening fully integrated into an urban, inner-city ED.
Other: Non-targeted opt-out rapid HIV screening
Experimental Arm: Integrated non-targeted opt-out rapid HIV screening Active Comparator Arm: Integrated diagnostic rapid HIV testing
Active Comparator: 2
Diagnostic rapid HIV testing fully integrated into an urban, inner-city ED.
Other: Non-targeted opt-out rapid HIV screening
Experimental Arm: Integrated non-targeted opt-out rapid HIV screening Active Comparator Arm: Integrated diagnostic rapid HIV testing

Detailed Description:

An estimated 40,000 new HIV infections occur annually in the United States. Although significant effort has been devoted to improving identification of patients with undiagnosed HIV infection, this rate has changed very little in the last decade and new infections appear to be increasing most in non-traditional risk groups, including racial and ethnic minorities. Most persons infected with HIV still do not get tested until late in their disease courses, primarily due to its long asymptomatic period and their relatively poor access to routine medical care. Over 100 million people visit emergency departments (EDs) annually, and the ED commonly serves as a patient's only source for medical care, and thus the only potential opportunity to receive HIV counseling, testing, and referral (CTR). Also, patients who are most likely to use the ED as their only source of care are often those for whom the HIV epidemic is spreading most. The primary objective of the proposed research is to demonstrate clinical effectiveness, clinical efficiency, cost effectiveness, and patient-staff satisfaction with performing routine voluntary opt-out rapid HIV CTR in a high-volume urban ED, when compared to a targeted rapid HIV CTR program in the same setting. The primary hypothesis of the proposed investigations is that opt-out rapid HIV CTR is associated with a higher rate of overall testing, identification of patients infected with HIV, identification of patients infected with HIV earlier in their disease courses, and successful linkage into medical and preventative care for those patients who test positive for HIV infection. The secondary hypotheses are that opt-out rapid HIV CTR: (1) is not associated with increased ED processes of care, defined by patient waiting times, length of stays, the proportion of patients who leave before completing their evaluations, and an overcrowding index; and (2) is cost-effective. The tertiary hypotheses are that opt-out rapid HIV CTR is associated with a higher level of patient and ED staff satisfaction. To address these hypotheses, we will perform a prospective quasi-experimental equivalent time-samples clinical trial in which consecutive patients who present to the ED during interventional periods will be offered opt-out rapid HIV CTR as part of their visits, and during the control periods, patients will be targeted by physicians for rapid HIV CTR using a previously developed and validated CTR model. The results obtained from this study will improve our understanding of how best to identify patients with HIV infection in ED, and whether opt-out rapid HIV CTR is an effective means to achieve the CDC's goals of identifying more asymptomatic HIV-infected patients earlier in their disease courses.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 16 years or older
  • Emergency department patients

Exclusion Criteria:

  • <16 years
  • Unable to provide consent (e.g., intoxicated, altered mental status)
  • Critical illness
  • Prisoners or detainees
  • Already known to be infected with HIV
  • Victims of sexual assault
  • Occupational exposures
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00742898

Locations
United States, Colorado
Denver Health Medical Center
Denver, Colorado, United States, 80204
Sponsors and Collaborators
Denver Health and Hospital Authority
Investigators
Principal Investigator: Jason S. Haukoos, MD, MSc Denver Health Medical Center
Study Director: Emily Hopkins, MSPH Denver Health Medical Center
  More Information

No publications provided by Denver Health and Hospital Authority

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jason S. Haukoos, MD, MSc / Director of Emergency Medicine Research, Denver Health Medical Center
ClinicalTrials.gov Identifier: NCT00742898     History of Changes
Other Study ID Numbers: 06-0820, U18 PS000314
Study First Received: January 10, 2008
Last Updated: September 14, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Denver Health and Hospital Authority:
Quasi-experimental design
Non-targeted opt-out rapid HIV screening
Diagnostic rapid HIV testing
Emergency department
Effectiveness
Efficiency
Health services research
Program evaluation
Effectiveness and efficiency of non-targeted rapid HIV screening in the ED

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Emergencies
Disease Attributes
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Pathologic Processes
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
HIV Antibodies
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014