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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
Results First Received: May 3, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: 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
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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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.
Total Total of all reporting groups

Baseline Measures
    Counselor     Provider     Total  
Number of Participants  
[units: participants]
  2446     2409     4855  
Age  
[units: years]
Mean ± Standard Deviation
  37.1  ± 14     37.1  ± 14     37.1  ± 14  
Gender [1]
[units: participants]
     
Female     1585     1554     3139  
Male     849     832     1681  
Race/Ethnicity, Customized  
[units: participants]
     
Non-Hispanic White     938     928     1866  
Non-Hispanic Black     526     546     1072  
Hispanic     707     670     1377  
Asian/Asian-American     66     59     125  
Native American/Alaskan Native     12     8     20  
Multi-racial/Other     176     164     340  
Missing     21     34     55  
Primary Language  
[units: participants]
     
English     1788     1807     3595  
Spanish     483     448     931  
Other     154     137     291  
Missing     21     17     38  
Education  
[units: participants]
     
Less than High School     310     310     620  
High School Degree     566     575     1141  
Some College     696     713     1409  
College Degree     517     438     955  
Some Post-College/Graduate Degree     342     347     689  
Missing     15     26     41  
[1] Numbers within the gender category do not add up to total number randomized due to missing data/numbers.



  Outcome Measures
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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


  More Information