HIV Testing Strategies in the Perinatal Setting

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00503308
First received: July 16, 2007
Last updated: June 7, 2011
Last verified: June 2011
Results First Received: September 24, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   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  
Number of Participants  
[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
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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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