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Completed

NCT Number: NCT01427023

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

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.

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Key information

Age range

14 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of Alabama, Birmingham, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

APTIMA Trichomonas vaginalis (ATV) Assay

Device

APTIMA Trichomonas vaginalis (ATV) Assay

Primary outcomes

  1. Positive Percent Agreement Using the TIGRIS Instrument as a Reference.

    Time frame: approximately one year

    Positive Percent Agreement Using the TIGRIS Instrument as a Reference.

  2. Negative Percent Agreement Using the TIGRIS Instrument as a Reference.

    Time frame: approximately one year

    Negative Percent Agreement Using the TIGRIS Instrument as a Reference.

Secondary outcomes

  1. Positivity Rate

    Time frame: approximately one year

    Positivity Rate

Sponsors and collaborators

Lead sponsor

Gen-Probe, Incorporated

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Sep 1, 2011
Registry last updated
Feb 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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