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

Trichomonas Vaginalis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01427023
• Other study ID #: ATVPS-US11-001
• Status: Completed
• Phase: N/A
• First received: August 26, 2011
• Last updated: February 5, 2014
• Start date: August 2012
• Est. completion date: December 2013

Study information

• Verified date: February 2014
• Source: Gen-Probe, Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 532
• Est. completion date: December 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Trichomonas Infections
• Trichomonas Vaginalis

Intervention

Device:
• APTIMA Trichomonas vaginalis (ATV) Assay
APTIMA Trichomonas vaginalis (ATV) Assay

Locations

Country	Name	City	State
United States	University of Alabama, Birmingham	Birmingham	Alabama
United States	University of North Carolina, Chapel Hill	Chapel Hill	North Carolina
United States	New England Center for Clinical Research	Fall River	Massachusetts
United States	Planned Parenthood Gulf Coast	Houston	Texas
United States	Wishard Hospital - Indiana University School of Medicine	Indianapolis	Indiana
United States	Geneuity Clinical Research Services	Maryville	Tennessee
United States	Louisiana State University	New Orleans	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Gen-Probe, Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive Percent Agreement Using the TIGRIS Instrument as a Reference.	Positive Percent Agreement Using the TIGRIS Instrument as a Reference.	approximately one year	No
Primary	Negative Percent Agreement Using the TIGRIS Instrument as a Reference.	Negative Percent Agreement Using the TIGRIS Instrument as a Reference.	approximately one year	No
Secondary	Positivity Rate	Positivity Rate	approximately one year	No