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Two Approaches to Routine HIV Testing in a Hospital Emergency Department

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Rochelle Walensky, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00502944
First received: July 16, 2007
Last updated: July 16, 2012
Last verified: July 2012
History of Changes

July 16, 2007
July 16, 2012
February 2007
July 2008   (final data collection date for primary outcome measure)
Linkage to Care of Newly Diagnosed HIV Infected Participants [ Time Frame: Assessed within 8 weeks after receipt of reactive rapid HIV test results ] [ Designated as safety issue: No ]
We define linkage to care as attendance at a first HIV clinic appointment where the following 3 events occur: 1) introduction to an HIV care primary provider; 2) receipt of confirmatory Western Blot HIV test results; and 3) phlebotomy for CD4 cell count and HIV RNA level.
Linkage to care of newly diagnosed HIV infected participants [ Time Frame: throughout study and at Year 4.5 of the study ]
Complete list of historical versions of study NCT00502944 on ClinicalTrials.gov Archive Site
Overall Rapid HIV Testing Rate [ Time Frame: Assess on day subject enrolled into the study ] [ Designated as safety issue: No ]
We defined the overall rapid HIV testing rate as the number of participants tested for HIV using the rapid test among those randomized to potentially be tested in each arm.
Test offer rate, test acceptability, maintenance of care, and medical personnel resource utilization [ Time Frame: throughout study ]
Not Provided
Not Provided
 
Two Approaches to Routine HIV Testing in a Hospital Emergency Department
Optimizing Strategies for Universal HIV Testing (The USHER Trial)

This study will compare the effectiveness of two different approaches to providing routine HIV counseling, testing, and referral services in an urban hospital emergency department setting.

About 25% of HIV infected people do not know that they are infected. These people lack medical care that could prolong their lives and access to counseling services that could prevent further spread of HIV. With so many people unaware of their HIV status, there is a clear need for more readily available HIV counseling, testing, and referral services throughout the United States. The Centers for Disease Control and Prevention (CDC) recommends routine HIV testing in U.S. hospitals in which HIV infected patients make up at least 1% of the total patient population for that hospital. However, routine HIV testing in such hospitals is rarely carried out, which might be because the CDC has not specified who should perform routine HIV testing. The purpose of this study is to compare the effectiveness of two different approaches to providing routine HIV counseling, testing, and referral services in an urban hospital emergency department setting. One approach will be led by an HIV counselor, and the other approach will be led by an emergency department staff member. For both approaches, the study will evaluate to what extent patients accept HIV testing, how well follow-up care is established, and the cost-effectiveness of the approach.

Participants in this study will include adults who visit Brigham and Women's Hospital emergency department in Boston, Massachusetts. Participants will be randomly assigned to a counselor versus provider and will be asked to fill out a questionnaire while waiting in the emergency room. The questionnaire will be anonymous. Participants will then be offered an oral rapid HIV test. Test results will be available in about 20 minutes and will be provided to participants by either their assigned HIV counselor. Participants who test positive for HIV will be offered a more definitive blood test to confirm HIV infection. The blood test results will be available 2 weeks from testing, and participants must return to the hospital to get their test results. Participants who test positive for HIV will be offered counseling support and referral services by either their assigned HIV counselor or emergency department staff member. Follow-up care appointments will also be initiated at this time. For participants who test positive for HIV, the study will last about 6 months. There will be no follow-up visits for participants who do not test positive for HIV during their emergency room visit.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
HIV Infections
  • Behavioral: Counselor-based HIV screening
    Participants will undergo oral HIV screening by HIV counselor and, if positive, further study visits for up to 6 months
  • Behavioral: Emergency staff member-based HIV screening
    Participants will undergo oral HIV screening by emergency staff member and, if positive, further study visits for up to 6 months
  • Experimental: Counselor-based HIV screening
    Intervention: Behavioral: Counselor-based HIV screening
  • Active Comparator: Emergency staff member-based HIV screening
    Intervention: Behavioral: Emergency staff member-based HIV screening

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4855
July 2008
July 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Waiting to receive care in the Brigham and Women's Hospital emergency room
  • English- or Spanish-speaking
  • Enters the emergency room when an HIV counselor is available

Exclusion Criteria:

  • An estimated severity index score of 1 or 2 who have mechanical ventilation or are not deemed alert, awake, and oriented to person, place and time by the triage nurse
  • HIV infected
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00502944
R01 MH073445, R01MH073445, DAHBR 9A-ASPQ
Yes
Rochelle Walensky, Massachusetts General Hospital
Massachusetts General Hospital
National Institute of Mental Health (NIMH)
Principal Investigator: Rochelle P. Walensky, MD, MPH Massachusetts General Hospital
Massachusetts General Hospital
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP