Trial record 3 of 1436 for:    HIV | Open Studies

The HIV Testing Using Enhanced Screening Techniques in Emergency Departments Trial (HIV TESTED)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Denver Health and Hospital Authority
Sponsor:
Collaborators:
Alameda County Medical Center
Johns Hopkins University
University of Cincinnati
Information provided by (Responsible Party):
Denver Health and Hospital Authority
ClinicalTrials.gov Identifier:
NCT01781949
First received: January 11, 2013
Last updated: May 6, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Rapid HIV Screening
Other: A: Nontargeted rapid HIV screening
Other: B: Enhanced targeted rapid HIV screening
Other: C: Traditional targeted rapid HIV screening

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Effectiveness of Rapid HIV Screening Methods in Urban Emergency Departments

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Confirmed Newly-Diagnosed HIV Infection [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    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:
  • CD4 Count [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    CD4 count (cells/mm3) at the time of diagnosis; assessed using structured laboratory data abstraction.

  • HIV Viral Load [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    HIV viral load (copies/mL) at the time of diagnosis; assessed using structured laboratory data abstraction.

  • Linkage-to-Care [ Time Frame: Expected average of 1 week, but may be up to 1 month ] [ Designated as safety issue: No ]
    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.

  • Development of AIDS [ Time Frame: 1 year after diagnosis ] [ Designated as safety issue: No ]
    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.

  • Initiation of Antiretroviral Therapy [ Time Frame: 1 year after diagnosis ] [ Designated as safety issue: No ]
    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.

  • Treatment for Opportunistic Infections [ Time Frame: 1 year after diagnosis ] [ Designated as safety issue: No ]
    Whether treatment for specific opportunistic infections were initiated at any time during the year following diagnosis; assessed using structured medical record abstraction.

  • Hospitalization [ Time Frame: 1 year after diagnosis ] [ Designated as safety issue: No ]
    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.

  • Scheduled Medical Care Visits [ Time Frame: 1 year after diagnosis ] [ Designated as safety issue: No ]
    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.

  • Unscheduled Medical Care Visits [ Time Frame: 1 year after diagnosis ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 year after diagnosis ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 120000
Study Start Date: April 2014
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Nontargeted Opt-Out HIV screening
Eligible patients randomized to this arm will be offered rapid HIV screening without assessment of risk. HIV testing will occur on a 24-hour basis as part of routine ED care.
Other: A: Nontargeted rapid HIV screening
Patients who present to the ED for evaluation, who meet criteria for inclusion, and who are randomized to this arm will be offered voluntary, free, and confidential rapid HIV testing by nurses using opt-out consent during medical screening.
B: Enhanced targeted rapid HIV screening
Eligible patients randomized to this arm will be asked to answer questions regarding HIV risk using the Denver HIV Risk Score (DHRS), an empirically-developed clinical prediction instrument for assessing HIV risk, to identify patients at increased risk for HIV infection. Patients identified as being at increased risk for HIV infection will be offered rapid HIV testing. HIV testing will occur on a 24-hour basis as part of routine ED care.
Other: B: Enhanced targeted rapid HIV screening
Patients who present to the ED for evaluation, who meet criteria for inclusion, and who are randomized to this arm will be asked questions from the Denver HIV Risk Score (DHRS). Patients will be considered at increased risk for HIV infection if they have a DHRS score of 30 or more. These increased-risk patients will be offered rapid HIV testing using opt-out consent by nurses during medical screening. Patients identified as low risk (DHRS <30) will not be offered rapid HIV testing but will eligible for diagnostic HIV testing.
C: Traditional targeted rapid HIV screening
Eligible patients randomized to this arm will be asked to answer questions related to HIV risk using a traditional behavioral risk screening tool to identify patients at increased risk for HIV infection. Patients identified as being at increased risk for HIV infection will be offered rapid HIV testing. HIV testing will occur on a 24-hour basis as part of routine ED care.
Other: C: Traditional targeted rapid HIV screening
Patients who present to the ED for evaluation, who meet criteria for inclusion, and who are randomized to this arm will be asked questions from a Behavioral Risk Screening Tool (BRST). The BRST was adopted from the 2001 Centers for Disease Control and Prevention's recommendations for targeted HIV screening, and includes 6 questions. An affirmative response to 1 or more questions identifies the person as being at increased risk for HIV infection. These patients will be offered rapid HIV testing using opt-out consent by nurses during medical screening. Patients who do not respond affirmatively to any of the questions will not be offered rapid HIV testing but will eligible for diagnostic HIV testing.

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.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Greater than or equal to 13 years of age
  • Clinically stable
  • Capable of providing consent for medical care

Exclusion Criteria:

  • < 13 years old
  • Unable to consent for medical care
  • Prisoners or detainees
  • Self-identified as infected with HIV
  • Occupational exposure
  • Sexual assault
  • Fast-track patients
  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: NCT01781949

Contacts
Contact: Jason S Haukoos, MD, MSc (303) 602-5174 jason.haukoos.@dhha.org
Contact: Emily H Caruso, MSPH (303) 602-5178 emily.caruso@dhha.og

Locations
United States, California
Alameda County Medical Center Not yet recruiting
Oakland, California, United States, 94602
Contact: Douglas AE White, MD         
Principal Investigator: Douglas AE White, MD         
United States, Colorado
Denver Health and Hospital Authority Recruiting
Denver, Colorado, United States, 80204
Contact: Jason S Haukoos, MD, MSc    303-602-5174    jason.haukoos@dhha.org   
Contact: Emily H Caruso, MSPH    (303) 602-5178    emily.caruso@dhha.org   
Principal Investigator: Jason S Haukoos, MD, MSc         
United States, Maryland
Johns Hopkins University Not yet recruiting
Baltimore, Maryland, United States, 21287
Contact: Richard Rothman, MD, PhD         
Principal Investigator: Richard Rothman, MD, PhD         
United States, Ohio
University of Cincinnati Medical Center Not yet recruiting
Cincinnati, Ohio, United States, 45229
Contact: Michael Lyons, MD, MPH         
Principal Investigator: Michael Lyons, MD, MPH         
Sponsors and Collaborators
Denver Health and Hospital Authority
Alameda County Medical Center
Johns Hopkins University
University of Cincinnati
Investigators
Principal Investigator: Jason S Haukoos, MD, MSc Denver Health and Hospital Authority
  More Information

Additional Information:
No publications provided

Responsible Party: Denver Health and Hospital Authority
ClinicalTrials.gov Identifier: NCT01781949     History of Changes
Other Study ID Numbers: NIAID R01 AI106057
Study First Received: January 11, 2013
Last Updated: May 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Denver Health and Hospital Authority:
HIV infection
Targeted screening
Nontargeted screening
Emergency department
Urgent care
Effectiveness

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes
HIV Antibodies
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014