Two Approaches to Routine HIV Testing in a Hospital Emergency Department

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. Identifier: NCT00502944
Recruitment Status : Completed
First Posted : July 18, 2007
Results First Posted : July 13, 2012
Last Update Posted : July 19, 2012
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Rochelle Walensky, Massachusetts General Hospital

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

  Baseline Characteristics

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
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 
[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 
[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

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

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