HIV Screening in the Emergency Department Setting

This study has been completed.
Sponsor:
Collaborator:
Ohio Department of Health, City of Cincinnati Board of Health
Information provided by (Responsible Party):
Michael S. Lyons, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00667186
First received: April 3, 2008
Last updated: January 30, 2013
Last verified: January 2013
  Purpose

Late diagnosis of HIV infection is believed to be responsible for high rates of HIV transmission. The purpose of this study is to determine whether targeted screening versus routine screening will identify a greater number of HIV infected participants. This study will also compare the costs of the resources used for targeted screening versus routine screening.


Condition Intervention
HIV Infections
Other: Targeted Screening
Other: Routine Screening

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: HIV Screening in the Emergency Department Setting

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Percentage of Tested Participants Newly Diagnosed as HIV Infected [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Percentage of tested participants newly diagnosed as HIV infected


Secondary Outcome Measures:
  • Percentage Consenting to Testing [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Percentage of those successfully offered testing who consent to testing


Enrollment: 9572
Study Start Date: January 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Targeted Screening

Targeted Screening

Participants approached at ED for voluntary HIV counseling and testing based on risk for HIV

Other: Targeted Screening
Selection method for screening is based on risk
Active Comparator: Routine Screening

Routine Screening

Participants approached at ED for voluntary HIV counseling and testing regardless of established risk according to age criteria

Other: Routine Screening
Selection method for screening is not based on risk

Detailed Description:

Novel strategies are needed to reduce HIV transmission, particularly among individuals who are unaware of their HIV status. Emergency departments (EDs) routinely receive individuals in a medical setting where an opportunity exists to screen them for HIV. The purposes of this study are to determine whether the proportion of tested participants identified as HIV infected by targeted screening exceeds routine screening and to determine whether the program resources used per infected patient identified are lower for targeted screening than for routine screening.

Participants will be recruited from the University of Cincinnati Emergency Medicine Clinical Trials Center. The existing ED-based clinical HIV counseling and testing program in a lower HIV prevalence area will randomly alternate between two strategies for offering testing to ED participants: 1) targeted screening based on self-reported HIV risk and 2) routine screening. Participants will be randomly assigned to the targeted or routine screening group based on their presence in the ED during randomized days and times.

At study entry an interview, blood collection, and counseling will occur. Participants will be telephoned following their ED visit to be given their negative results. Participants with positive results will be asked to return to the ED for notification, counseling, and connections to subsequent care. Participants who are HIV infected will be transferred to the University of Cincinnati Infectious Disease Center for care.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult participants presenting for care in the ED

Exclusion Criteria:

  • Participants cognitively unable or unwilling to consent for voluntary HIV counseling and testing
  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: NCT00667186

Locations
United States, Ohio
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45267-0405
Sponsors and Collaborators
Ohio Department of Health, City of Cincinnati Board of Health
Investigators
Principal Investigator: Michael S. Lyons, MD University of Cincinnati College of Medicine Department of Emergency Medicine
  More Information

Publications:
Responsible Party: Michael S. Lyons, Assistant Professor Emergency Medicine, University of Cincinnati
ClinicalTrials.gov Identifier: NCT00667186     History of Changes
Other Study ID Numbers: K23AI068453
Study First Received: April 3, 2008
Results First Received: October 29, 2012
Last Updated: January 30, 2013
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
HIV
Prevention
Public Health
Screening

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on October 02, 2014