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Two Approaches to Routine HIV Testing in a Hospital Emergency Department

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00502944
First Posted: July 18, 2007
Last Update Posted: July 19, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Rochelle Walensky, Massachusetts General Hospital
Results First Submitted: May 3, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Screening
Condition: HIV Infections
Interventions: Behavioral: Counselor-based HIV screening
Behavioral: Emergency staff member-based HIV screening

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment took place from February 7, 2007 to July 9, 2008 at Brigham and Women's Hospital emergency department. Oral HIV testing was offered to eligible patients by either HIV counselors or emergency service assistants (existing members of emergency department personnel).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Counselor Counselor-based HIV screening intervention where a dedicated HIV counselor does all the screening.
Provider Emergency staff member-based HIV screening intervention where an emergency staff member does all the screening.

Participant Flow:   Overall Study
    Counselor   Provider
STARTED   2446   2409 
COMPLETED   1382   643 
NOT COMPLETED   1064   1766 



  Baseline Characteristics


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Linkage to Care of Newly Diagnosed HIV Infected Participants   [ Time Frame: Assessed within 8 weeks after receipt of reactive rapid HIV test results ]

2.  Secondary:   Overall Rapid HIV Testing Rate   [ Time Frame: Assess on day subject enrolled into the study ]

3.  Other Pre-specified:   Test Offer Rate   [ Time Frame: Assess on day subject enrolled into the study ]

4.  Other Pre-specified:   Test Acceptance Rate   [ Time Frame: Assess on day subject enrolled into the study ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information