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HIV Testing Strategies in the Perinatal Setting

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00503308
First Posted: July 18, 2007
Last Update Posted: May 22, 2015
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.
Collaborator:
Pfizer
Information provided by:
University of California, San Francisco
Results First Submitted: September 24, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Health Services Research
Conditions: HIV Infections
Pregnancy Related
Intervention: Procedure: Abbreviated HIV test counseling

  Participant Flow


  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
Standard Consenting Intervention The standardized HIV pre-test counseling and consent process took approximately 2–5 minutes and reviewed the definition of HIV, modes of transmission and prevention, interpretation of test results and the benefits of testing.
Abbreviated Consenting Intervention The intervention arm used a 2-sentence script which lasted approximately 30 seconds.
Total Total of all reporting groups

Baseline Measures
   Standard Consenting Intervention   Abbreviated Consenting Intervention   Total 
Overall Participants Analyzed 
[Units: Participants]
 146   135   281 
Age 
[Units: Participants]
     
<=18 years   8   5   13 
Between 18 and 65 years   138   130   268 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 26.99  (6.1)   26.39  (5.3)   26.7  (5.73) 
Gender 
[Units: Participants]
     
Female   146   135   281 
Male   0   0   0 
Region of Enrollment 
[Units: Participants]
     
United States   146   135   281 


  Outcome Measures

1.  Primary:   Satisfaction With HIV Testing Experience (O'Connor Decisional Conflict Scale)   [ Time Frame: same day as HIV test counseling (cross-sectional study) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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