Evaluation of the DPP HIV 1/2 Test and the HIV 1/2 Stat Pak Test Using Oral Fluid (HIVOF)

This study has been completed.
Sponsor:
Collaborator:
University of Maryland
Information provided by:
Chembio Diagnostic Systems, Inc.
ClinicalTrials.gov Identifier:
NCT00636220
First received: March 10, 2008
Last updated: January 20, 2010
Last verified: December 2009
Results First Received: January 8, 2009  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Cross-Sectional
Condition: HIV Infections

  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 time period was from March 13, 2008 to July 1, 2008. All enrollment was at the Evelyn Jordan Center, University of Maryland Baltimore (UMD).

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
Confirmed HIV Infection The study population will consist of 100 participants with known (clinically or serologically) confirmed HIV infection.

Participant Flow:   Overall Study
    Confirmed HIV Infection  
STARTED     101  
COMPLETED     100  
NOT COMPLETED     1  
Lost to Follow-up                 0  
Protocol Violation                 1  



  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
Confirmed HIV Infection participants with known (clinically or serologically) confirmed HIV infection.

Baseline Measures
    Confirmed HIV Infection  
Number of Participants  
[units: participants]
  101  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     101  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  46  ± 7.1  
Gender  
[units: participants]
 
Female     41  
Male     60  
Region of Enrollment  
[units: participants]
 
United States     101  
Fresh Oral Fluid Samples with known HIV reactivity [1]
[units: samples]
  101  
Participants with known HIV reactivity [2]
[units: Participants]
  101  
[1] Fresh Oral Fluid samples were collected from participants with known HIV+ status. HIV reactivity was clinically or serologically confirmed.
[2] participants with known HIV reactivity



  Outcome Measures

1.  Primary:   Number of Fresh Oral Fluid Samples With Known HIV (+) Status and HIV Reactivity   [ Time Frame: 1 to 3 days ]

2.  Secondary:   The Effectiveness of MPC and Chembio Oral Fluid Collection Devices   [ Time Frame: 1-3 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

Reporting Groups
  Description
Confirmed HIV Infection The study population will consist of 100 participants with known (clinically or serologically) confirmed HIV infection.

Serious Adverse Events
    Confirmed HIV Infection  
Total, serious adverse events    
# participants affected / at risk     0/100 (0.00%)  




  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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  More Information