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

NCT00636220 | Completed Results DMC

• 2 other identifiers: P-HIV-01UMB Protocol # H-29110
• Study Type: observational
• Target: 101
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Keywords

HIV-1 Infections

Outcome Measures

Primary Outcomes (1)

• 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.

  1 to 3 days

Secondary Outcomes (1)

• The Effectiveness of MPC and Chembio Oral Fluid Collection Devices

  1-3

Study Arms (1)

A, Observational

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chembio Diagnostic Systems, Inc.: lead
• University of Maryland: collaborator

Study Sites (1)

Evelyn Jordan Center, University of Maryland

Baltimore, Maryland, 21201, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

oral fluid samples and venous blood

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Javan Esfandiari
• Organization: Chembio Diagnostic Systems, Inc.

jesfandiari@chembio.com

(631) 924-1135

Study Officials

• Niel Constantine, PhD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2008
• First Posted: March 14, 2008
• Study Start: March 1, 2008
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: August 17, 2015
• Results First Posted: February 15, 2010

Record last verified: 2015-07

Locations

US (1)