Trial record 1 of 25 for:    " June 27, 2007":" July 27, 2007"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]
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Two Approaches to Routine HIV Testing in a Hospital Emergency Department

This study has been completed.
Sponsor:
Collaborator:
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
  Purpose

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.


Condition Intervention
HIV Infections
Behavioral: Counselor-based HIV screening
Behavioral: Emergency staff member-based HIV screening

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Optimizing Strategies for Universal HIV Testing (The USHER Trial)

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 4855
Study Start Date: February 2007
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Counselor-based HIV screening 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
Active Comparator: Emergency staff member-based HIV screening 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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00502944

Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Rochelle P. Walensky, MD, MPH Massachusetts General Hospital
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rochelle Walensky, Associate Professor, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00502944     History of Changes
Other Study ID Numbers: R01 MH073445, R01MH073445, DAHBR 9A-ASPQ
Study First Received: July 16, 2007
Results First Received: May 3, 2012
Last Updated: July 16, 2012
Health Authority: United States: Federal Government

Keywords provided by Massachusetts General Hospital:
HIV
Testing
HIV Seronegativity

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 August 21, 2014