Clinical trial NCT00636220: Evaluation of the DPP HIV 1/2 Test and the HIV 1/2 Stat Pak Test Using Oral Fluid
Official title: Evaluation of the DPP HIV Test With Reader and the HIV 1/2 Stat-Pak Test Using Oral Fluids
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: HIV-1 Infections
Lead sponsor: Chembio Diagnostic Systems, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of Maryland
First posted: 2008-03-14
Enrollment: 101
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Fresh Oral Fluid Samples With Known HIV (+) Status and HIV Reactivity
timeFrame: 1 to 3 days
Secondary outcomes:
measure: The Effectiveness of MPC and Chembio Oral Fluid Collection Devices
timeFrame: 1-3
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Evelyn Jordan Center, University of Maryland
state: Maryland
Study officials:
affiliation: University of Maryland, Baltimore
name: Niel Constantine, PhD
role: PRINCIPAL_INVESTIGATOR
References: