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
No text entered.

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.
No text entered.

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 ]

Measure Type Primary
Measure Title Linkage to Care of Newly Diagnosed HIV Infected Participants
Measure Description 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.
Time Frame Assessed within 8 weeks after receipt of reactive rapid HIV test results  
Safety Issue No  

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.
DSMB recommended the trial be ended early for likely inability to obtain this primary outcome. Thus the outcomes reported in paper are the secondary and other pre-specified outcomes listed.

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.

Measured Values
    Counselor     Provider  
Number of Participants Analyzed  
[units: participants]
  2446     2409  
Linkage to Care of Newly Diagnosed HIV Infected Participants  
[units: participants]
   
Positive HIV Test     0     7  
Linked to Care     0     4  

No statistical analysis provided for Linkage to Care of Newly Diagnosed HIV Infected Participants



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

Measure Type Secondary
Measure Title Overall Rapid HIV Testing Rate
Measure Description 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.
Time Frame Assess on day subject enrolled into the study  
Safety Issue No  

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.
Intention to treat analysis

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.

Measured Values
    Counselor     Provider  
Number of Participants Analyzed  
[units: participants]
  2446     2409  
Overall Rapid HIV Testing Rate  
[units: participants]
  1382     643  


Statistical Analysis 1 for Overall Rapid HIV Testing Rate
Groups [1] All groups
Method [2] Chi-squared
P Value [3] <0.001
Rate Difference (%) [4] 30
95% Confidence Interval ( 27 to 32 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  HIV test completed among patients randomized
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



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

Measure Type Other Pre-specified
Measure Title Test Offer Rate
Measure Description The offer rate of the HIV test was defined as the proportion of enrolled study participants who were actually offered a test.
Time Frame Assess on day subject enrolled into the study  
Safety Issue No  

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.
No text entered.

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.

Measured Values
    Counselor     Provider  
Number of Participants Analyzed  
[units: participants]
  2446     2409  
Test Offer Rate  
[units: participants]
  1959     861  


Statistical Analysis 1 for Test Offer Rate
Groups [1] All groups
Method [2] Chi-squared
P Value [3] <0.001
Rate Difference (%) [4] 44
95% Confidence Interval ( 42 to 47 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  HIV test offered
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



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

Measure Type Other Pre-specified
Measure Title Test Acceptance Rate
Measure Description Acceptance of the HIV test was defined as the proportion of study participants who received the HIV test among those offered the test.
Time Frame Assess on day subject enrolled into the study  
Safety Issue No  

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.
Number of participants analyzed equals the number of participants offered a rapid HIV test. Many participants left the ED before the opportunity was available to offer the test.

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.

Measured Values
    Counselor     Provider  
Number of Participants Analyzed  
[units: participants]
  1959     861  
Test Acceptance Rate  
[units: participants]
  1382     643  


Statistical Analysis 1 for Test Acceptance Rate
Groups [1] All groups
Method [2] Chi-squared
P Value [3] 0.02
Rate Difference (%) [4] -4
95% Confidence Interval ( -8 to -1 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  HIV test accepted among patients offered
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.




  Serious Adverse Events


  Other Adverse Events


  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
No text entered.  


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


Publications of Results:
Other Publications:

Publications automatically indexed to this study:

Responsible Party: Rochelle Walensky, 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