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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
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 
Overall Participants Analyzed 
[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 
[1] Numbers within the gender category do not add up to total number randomized due to missing data/numbers.
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 


  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
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Time Frame 1 week after rapid HIV testing.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   0  

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.

Other Adverse Events
    Counselor   Provider
Total, other (not including serious) adverse events     
# participants affected / at risk   33/1382 (2.39%)   14/643 (2.18%) 
Investigations     
False-positive rapid test result     
# participants affected / at risk   27/1382 (1.95%)   9/643 (1.40%) 
# events   27   9 
Subject did not follow-up after reactive test     
# participants affected / at risk   6/1382 (0.43%)   5/643 (0.78%) 
# events   6   5 
* Events were collected by non-systematic assessment



  Limitations and Caveats
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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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