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

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ClinicalTrials.gov Identifier: NCT00636220
Recruitment Status : Completed
First Posted : March 14, 2008
Results First Posted : February 15, 2010
Last Update Posted : August 17, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Cross-Sectional
Condition: HIV Infections

  Participant Flow

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   101 
NOT COMPLETED   0 



  Baseline Characteristics


  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

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