Female Urine, Vaginal & Endocervical Swab & Cervical Specimen Collections for APTIMA Trichomonas Vaginalis Assay Testing

Prospective Collection of Female First-catch Urine, Vaginal Swab, Endocervical Swab, and Cervical Specimens for Testing With the APTIMA Trichomonas Vaginalis Assay

The objective of this study is to obtain female first-catch urine, vaginal swab, endocervical swab, and cervical specimens collected in PreservCyt Solution ("PreservCyt Specimens") for testing with the APTIMA Trichomonas vaginalis (ATV) Assay.

These specimens will be used to demonstrate assay performance on the PANTHER System is comparable to performance on the TIGRIS System.

Study Overview

• Status: Completed
• Conditions: Trichomonas Vaginalis
• Intervention / Treatment: Device: APTIMA Trichomonas vaginalis (ATV) Assay

• Study Type: Observational
• Enrollment (Actual): 532

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama, Birmingham
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Wishard Hospital - Indiana University School of Medicine
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Louisiana State University
  • Massachusetts
    • Fall River, Massachusetts, United States, 02720
      • New England Center for Clinical Research
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina, Chapel Hill
  • Tennessee
    • Maryville, Tennessee, United States, 37804
      • Geneuity Clinical Research Services
  • Texas
    • Houston, Texas, United States, 77023
      • Planned Parenthood Gulf Coast

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Women attending participating US OB/GYN, family planning, or STD clinics will be eligible to participate.

Description

Inclusion Criteria:

• Subject must be female and attend a participating clinic
• Subject must be at least 14 years of age at the time of enrollment and is currently sexually active (has had vaginal intercourse within the past 12 months)
• The subject and/or legally authorized representative is willing to undergo the informed consent process prior to study participation (a minor will need the documented consent of her parent or legal guardian, unless the site has an institutional review board (IRB)- approved waiver for parental consent for minors)

• In addition, the subject must meet at least one of the following criteria:

  • Subject must demonstrate symptoms consistent with a suspected STD such as vaginal odor, vaginal discharge, vaginal/vulvar itching or irritation, pain/discomfort during sexual intercourse or urination, and/or lower abdominal discomfort
  • Subject must be asymptomatic and known to be partners with, or a contact of, a person with a confirmed or suspected STD(s)
  • Subject must be asymptomatic and undergoing screening evaluation for possible STDs
  • Subject must be undergoing Pap screening

Exclusion Criteria:

• Subject took antibiotic medications within the last 14 days
• Subject already participated in the study
• Subject has a history of illness that the principal investigator (PI) or designee considers could interfere with or affect the conduct, results, and/or completion of the clinical trial
• Subject has a history of illness that the PI or designee considers could create an unacceptable risk to the subject if enrolled

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive Percent Agreement Using the TIGRIS Instrument as a Reference.	Positive Percent Agreement Using the TIGRIS Instrument as a Reference.	approximately one year
Negative Percent Agreement Using the TIGRIS Instrument as a Reference.	Negative Percent Agreement Using the TIGRIS Instrument as a Reference.	approximately one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positivity Rate	Positivity Rate	approximately one year

Collaborators and Investigators

• Sponsor: Gen-Probe, Incorporated

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (ACTUAL): March 1, 2013
• Study Completion (ACTUAL): December 1, 2013

Study Registration Dates

• First Submitted: August 26, 2011
• First Submitted That Met QC Criteria: August 30, 2011
• First Posted (ESTIMATE): September 1, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): February 6, 2014
• Last Update Submitted That Met QC Criteria: February 5, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: trichomonas; APTIMA; APTIMA Trichomonas vaginalis Assay; trichomonas vaginalis
• Additional Relevant MeSH Terms: Infections; Parasitic Diseases; Protozoan Infections; Trichomonas Infections
• Other Study ID Numbers: ATVPS-US11-001