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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Denver Health and Hospital Authority

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 10, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 28, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 15, 2009

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2009

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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