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

Completed

• Conditions: Trichomonas Vaginalis

• Registration Number: NCT01427023
• Lead Sponsor: Gen-Probe, Incorporated

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-08-26
• Study First Submitted QC: 2011-08-30
• Study First Posted: 2011-09-01
• Study Start: 2012-08
• Primary Completion: 2013-03
• Study Completion: 2013-12
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-05
• Last Update Posted: 2014-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 532

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Negative Percent Agreement Using the TIGRIS Instrument as a Reference.	approximately one year	Negative Percent Agreement Using the TIGRIS Instrument as a Reference.
Positive Percent Agreement Using the TIGRIS Instrument as a Reference.	approximately one year	Positive Percent Agreement Using the TIGRIS Instrument as a Reference.

Secondary Outcome Measures

Name	Time	Method
Positivity Rate	approximately one year	Positivity Rate

Trial Locations

Locations (7)

University of North Carolina, Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States

Planned Parenthood Gulf Coast; 🇺🇸 Houston, Texas, United States

University of Alabama, Birmingham; 🇺🇸 Birmingham, Alabama, United States

Louisiana State University; 🇺🇸 New Orleans, Louisiana, United States

Geneuity Clinical Research Services; 🇺🇸 Maryville, Tennessee, United States

Wishard Hospital - Indiana University School of Medicine; 🇺🇸 Indianapolis, Indiana, United States

New England Center for Clinical Research; 🇺🇸 Fall River, Massachusetts, United States