Trial record 38 of 1204 for:    "Observational" [STUDY-TYPES] AND HIV [CONDITION]

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

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. Identifier: NCT00636220
Recruitment Status : Completed
First Posted : March 14, 2008
Results First Posted : February 15, 2010
Last Update Posted : August 17, 2015
University of Maryland
Information provided by (Responsible Party):
Chembio Diagnostic Systems, Inc.

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
No text entered.

Reporting Groups
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 

  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.
No text entered.

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

Baseline Measures
   Confirmed HIV Infection 
Overall Participants Analyzed 
[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]
[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]
[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

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
No text entered.

  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Javan Esfandiari
Organization: Chembio Diagnostic Systems, Inc.
phone: (631) 924-1135 ext 112

Responsible Party: Chembio Diagnostic Systems, Inc. Identifier: NCT00636220     History of Changes
Other Study ID Numbers: P-HIV-01
UMB Protocol # H-29110
First Submitted: March 10, 2008
First Posted: March 14, 2008
Results First Submitted: January 8, 2009
Results First Posted: February 15, 2010
Last Update Posted: August 17, 2015