Clinical trial NCT01427023: Female Urine, Vaginal & Endocervical Swab & Cervical Specimen Collections for APTIMA Trichomonas Vaginalis Assay Testing
Official title: Prospective Collection of Female First-catch Urine, Vaginal Swab, Endocervical Swab, and Cervical Specimens for Testing With the APTIMA Trichomonas Vaginalis Assay
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trichomonas Vaginalis
Keywords: APTIMA Trichomonas vaginalis Assay
APTIMA
trichomonas
trichomonas vaginalis
Lead sponsor: Gen-Probe, Incorporated
Sponsor class: INDUSTRY
First posted: 2011-09-01
Enrollment: 532
Sex: FEMALE
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Women attending participating US OB/GYN, family planning, or STD clinics will be eligible to participate.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Positive Percent Agreement Using the TIGRIS Instrument as a Reference.
timeFrame: approximately one year
measure: Negative Percent Agreement Using the TIGRIS Instrument as a Reference.
timeFrame: approximately one year
Secondary outcomes:
measure: Positivity Rate
timeFrame: approximately one year
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama, Birmingham
state: Alabama
city: Indianapolis
country: United States
facility: Wishard Hospital - Indiana University School of Medicine
state: Indiana
city: New Orleans
country: United States
facility: Louisiana State University
state: Louisiana
city: Fall River
country: United States
facility: New England Center for Clinical Research
state: Massachusetts
city: Chapel Hill
country: United States
facility: University of North Carolina, Chapel Hill
state: North Carolina
city: Maryville
country: United States
facility: Geneuity Clinical Research Services
state: Tennessee
city: Houston
country: United States
facility: Planned Parenthood Gulf Coast
state: Texas
Study officials:
affiliation: Gen-Probe, Incorporated
name: Jennifer Reid, PhD
role: STUDY_DIRECTOR
References: