- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00742898
Evaluation of Opt-Out Rapid HIV Testing in the Emergency Department
September 14, 2009 updated by: Denver Health and Hospital Authority
Non-targeted Opt-out Rapid HIV Screening in the Emergency Department: a Controlled Clinical Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
120000
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Colorado
-
Denver, Colorado, United States, 80204
- Denver Health Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Non-targeted opt-out rapid HIV screening fully integrated into an urban, inner-city ED.
|
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.
|
Experimental Arm: Integrated non-targeted opt-out rapid HIV screening Active Comparator Arm: Integrated diagnostic rapid HIV testing
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
HIV seropositivity
Time Frame: Immediate
|
Immediate
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jason S. Haukoos, MD, MSc, Denver Health Medical Center
- Study Director: Emily Hopkins, MSPH, Denver Health Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2007
Primary Completion (Actual)
April 1, 2009
Study Completion (Actual)
April 1, 2009
Study Registration Dates
First Submitted
January 10, 2008
First Submitted That Met QC Criteria
August 26, 2008
First Posted (Estimate)
August 28, 2008
Study Record Updates
Last Update Posted (Estimate)
September 15, 2009
Last Update Submitted That Met QC Criteria
September 14, 2009
Last Verified
September 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 06-0820
- U18PS000314 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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