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

March 10, 2008
January 20, 2010
March 2008
July 2008   (final data collection date for primary outcome measure)
Number of Fresh Oral Fluid Samples With Known HIV (+) Status and HIV Reactivity [ Time Frame: 1 to 3 days ] [ Designated as safety issue: No ]
The DPP HIV test and HIV Stat Pak tests will provide a 100% agreement with known HIV(+) status using fresh oral fluid samples [ Time Frame: 1 to 3 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00636220 on ClinicalTrials.gov Archive Site
The Effectiveness of MPC and Chembio Oral Fluid Collection Devices [ Time Frame: 1-3 ] [ Designated as safety issue: No ]
Compare the effectiveness of MPC and Chembio Oral Fluid collection devices [ Time Frame: 1-3 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Evaluation of the DPP HIV 1/2 Test and the HIV 1/2 Stat Pak Test Using Oral Fluid
Evaluation of the DPP HIV Test With Reader and the HIV 1/2 Stat-Pak Test Using Oral Fluids

This protocol is intended to test the feasibility of using the HIV 1/2 STAT-PAK and the DPP HIV 1/2 test (with and without the DPP Handheld Reader) to detect HIV antibodies in oral fluids.

The objective of this study is to evaluate the feasibility of using fresh oral fluid specimens, from known HIV-positive individuals, to test for HIV-1 antibodies using both the DPP HIV 1/2 and HIV 1/2 STAT-PAK tests. Two oral fluid collection devices will be used and compared (MPC and Chembio collection devices) and the results obtained from oral fluids will be compared with those obtained from whole blood and plasma using paired samples from the same participants. The comparison between oral fluid, whole blood and plasma will be made in both Chembio devices (HIV 1/2 STAT-PAK and DPP HIV 1/2).

Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples Without DNA
Description:

oral fluid samples and venous blood

Non-Probability Sample

The study population consists of 100 participants with known (clinically or serologically) confirmed HIV infection. The participants, recruited by the staff of the Laboratory of Vial Diagnostics from the Evelyn Jordan Center, may be males or females (including pregnant women) at least 12 years of age from any ethnic and racial background.

HIV Infections
Not Provided
A, Observational
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
101
July 2008
July 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Participants with known HIV infection who are willing to participate in the study and who sign an informed consent (or assent), will be included in the study.
  • Patients on HAART treatment for HIV will be included, but this information as well as the dates (duration) of treatment will be obtained through the interview of study participants; a medical record review is not necessary or required. The study participant's responses will be recorded by study staff on a Data Collection Form.
  • Patients with immunosuppressive conditions other than HIV will be included if available, but will be limited to < 25% of the total test population. Immunosuppression will also be assessed through interview of study participants and/or through verbal confirmation by the treating physician; a medical record/chart review is not required.
  • Patients must be willing to undergo venipuncture to donate one tube of EDTA whole blood (not more than 10cc), and to provide three oral fluid samples.

Exclusion Criteria:

  • Patients who do not consent, withdraw consent, or for whom the investigator determines that venipuncture or gum swabbing may create a health risk will be excluded from the study.
  • Participants who have been enrolled in HIV vaccine studies will be excluded from the study. This will be ascertained through interview of study participants.
  • Participants who have been enrolled once in this study will be excluded from repeat enrollment.
  • Participants must not have introduced any substance into their oral cavity (gum, food, beverage, candy, lozenges, mouthwash, etc.) for 30 minutes prior to providing an oral fluid sample. This will be ascertained through interview of study participants.
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00636220
P-HIV-01, UMB Protocol # H-29110
Yes
Thomas D. Ippolito, Chembio Diagnostic Systems, Inc
Chembio Diagnostic Systems, Inc.
University of Maryland
Principal Investigator: Niel Constantine, PhD University of Maryland
Chembio Diagnostic Systems, Inc.
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP