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Two Approaches to Routine HIV Testing in a Hospital Emergency Department (USHER)

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:
NCT01258582
First received: December 10, 2010
Last updated: June 10, 2012
Last verified: May 2012
History of Changes
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: Procedure: Oral HIV screening
Procedure: Fingerstick 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
The USHER-Phase II study was conducted in the emergency department at Brigham and Women’s Hospital, Boston, MA. Between May 5, 2009 and January 4, 2010, USHER-Phase II consented eligible patients for the opportunity to be offered routine opt-in, rapid HIV screening. Enrolled subjects were randomized to fingerstick or oral specimen collection.

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
Fingerstick Fingerstick rapid HIV testing
Oral Fluid Oral fluid rapid HIV testing

Participant Flow:   Overall Study
    Fingerstick     Oral Fluid  
STARTED     830     821  
COMPLETED     548     563  
NOT COMPLETED     282     258  



  Baseline Characteristics
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Reporting Groups
  Description
Fingerstick Fingerstick rapid HIV testing
Oral Fluid Oral fluid rapid HIV testing
Total Total of all reporting groups

Baseline Measures
    Fingerstick     Oral Fluid     Total  
Number of Participants  
[units: participants]
 		  830     821     1651  
Age  
[units: years]
Mean ± Standard Deviation 		  34  ± 13     33  ± 13     33  ± 13  
Gender [1]
[units: participants]
 		     
Female     536     529     1065  
Male     283     288     571  
Race/Ethnicity, Customized  
[units: participants]
 		     
Non-Hispanic White     198     201     399  
Non-Hispanic Black     188     200     388  
Hispanic     329     297     626  
Asian/Asain-American     22     22     44  
Native American/Alaskan Native     1     4     5  
Multi-racial/Other     85     92     177  
Missing     7     5     12  
Primary Language  
[units: participants]
 		     
English     643     644     1287  
Spanish     148     141     289  
Other     34     29     63  
Missing     5     7     12  
Education  
[units: participants]
 		     
Less than High School     116     96     212  
High School/General Education Diploma     255     261     516  
Some College     198     222     420  
College Degree     173     144     317  
Some Post-College/Graduate Degree     67     82     149  
Missing     21     16     37  
[1] Numbers in gender category do not add up to total number randomized due to missing data/numbers.



  Outcome Measures

1.  Primary:   Acceptability of the HIV Test   [ Time Frame: Assess on day subject enrolled into the study ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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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Results Point of Contact:  
Name/Title: Rochelle P. Walensky, MD, MPH
Organization: Massachusetts General Hospital
phone: (617) 724-8445
e-mail: rwalensky@partners.org


No publications provided by Massachusetts General Hospital

Publications automatically indexed to this study:


Responsible Party: Rochelle Walensky, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01258582     History of Changes
Other Study ID Numbers: R01 MH073445 (Phase II), R01MH073445
Study First Received: December 10, 2010
Results First Received: May 3, 2012
Last Updated: June 10, 2012
Health Authority: United States: Federal Government