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.
University of Maryland
Information provided by (Responsible Party):
Chembio Diagnostic Systems, Inc.
ClinicalTrials.gov Identifier:
First received: March 10, 2008
Last updated: July 27, 2015
Last verified: July 2015
Results First Received: January 8, 2009  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Cross-Sectional
Condition: HIV Infections

  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.
No text entered.

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

Baseline Measures
    Confirmed HIV Infection  
Number of Participants  
[units: participants]
[units: participants]
<=18 years     0  
Between 18 and 65 years     101  
>=65 years     0  
[units: years]
Mean (Standard Deviation)
  46  (7.1)  
[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]
Participants with known HIV reactivity [2]
[units: Participants]
[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 reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

  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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  More Information