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

Completed

• Conditions: HIV Infections

• Registration Number: NCT00636220
• Lead Sponsor: Chembio Diagnostic Systems, Inc.

Brief Summary

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.

Detailed Description

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).

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-03-10
• Study First Submitted QC: 2008-03-11
• Study First Posted: 2008-03-14
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Results First Submitted: 2009-01-08
• Results First Submitted QC: 2010-01-20
• Results First Posted: 2010-02-15
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-27
• Last Update Posted: 2015-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Fresh Oral Fluid Samples With Known HIV (+) Status and HIV Reactivity	1 to 3 days	Known HIV status determined clinically or serologically. HIV reactivity for all 100 samples determined first by licensed EIA and then confirmed with Western Blot and/or NAT testing.

Secondary Outcome Measures

Name	Time	Method
The Effectiveness of MPC and Chembio Oral Fluid Collection Devices	1-3

Trial Locations

Locations (1)

Evelyn Jordan Center, University of Maryland; 🇺🇸 Baltimore, Maryland, United States