HIV Infections
Conditions
Keywords
HIV-1 Infections
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).
Interventions
None listed
Sponsors
University of Maryland
Chembio Diagnostic Systems, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| The Effectiveness of MPC and Chembio Oral Fluid Collection Devices | 1-3 |
Countries
United States
Participant flow
Recruitment details
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).
Participants by arm
| Arm | Count |
|---|---|
| Confirmed HIV Infection participants with known (clinically or serologically) confirmed HIV infection. | 101 |
| Total | 101 |
Baseline characteristics
| Characteristic | Confirmed HIV Infection |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 101 Participants |
| Age, Continuous | 46 years STANDARD_DEVIATION 7.1 |
| Fresh Oral Fluid Samples with known HIV reactivity | 101 samples |
| Participants with known HIV reactivity | 101 Participants |
| Region of Enrollment United States | 101 participants |
| Sex: Female, Male Female | 41 Participants |
| Sex: Female, Male Male | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 100 |
Outcome results
Primary
Number of Fresh Oral Fluid Samples With Known HIV (+) Status and HIV Reactivity
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.
Time frame: 1 to 3 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Confirmed HIV Infection | Number of Fresh Oral Fluid Samples With Known HIV (+) Status and HIV Reactivity | 100 samples |
Secondary
The Effectiveness of MPC and Chembio Oral Fluid Collection Devices
Time frame: 1-3