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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:
ClinicalTrials.gov Identifier:
NCT00636220
First Posted: March 14, 2008
Last Update Posted: August 17, 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:
University of Maryland
Information provided by (Responsible Party):
Chembio Diagnostic Systems, Inc.
Results First Submitted: January 8, 2009  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Cross-Sectional
Condition: HIV Infections

  Participant Flow


  Baseline Characteristics
  Hide 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
  Description
Confirmed HIV Infection participants with known (clinically or serologically) confirmed HIV infection.

Baseline Measures
   Confirmed HIV Infection 
Overall Participants Analyzed 
[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 
[1] Fresh Oral Fluid samples were collected from participants with known HIV+ status. HIV reactivity was clinically or serologically confirmed.
Participants with known HIV reactivity [1] 
[Units: Participants]
 101 
[1] 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.  


  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