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
1 other identifier
observational
532
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2012
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 26, 2011
CompletedFirst Posted
Study publicly available on registry
September 1, 2011
CompletedStudy Start
First participant enrolled
August 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedFebruary 6, 2014
February 1, 2014
7 months
August 26, 2011
February 5, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Positivity Rate
approximately one year
Interventions
APTIMA Trichomonas vaginalis (ATV) Assay
Eligibility Criteria
Women attending participating US OB/GYN, family planning, or STD clinics will be eligible to participate.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
University of Alabama, Birmingham
Birmingham, Alabama, 35294, United States
Wishard Hospital - Indiana University School of Medicine
Indianapolis, Indiana, 46202, United States
Louisiana State University
New Orleans, Louisiana, 70112, United States
New England Center for Clinical Research
Fall River, Massachusetts, 02720, United States
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Geneuity Clinical Research Services
Maryville, Tennessee, 37804, United States
Planned Parenthood Gulf Coast
Houston, Texas, 77023, United States
Biospecimen
urine specimen, vaginal swab specimen, endocervical swab specimen and PreservCyt specimen
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jennifer Reid, PhD
Gen-Probe, Incorporated
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2011
First Posted
September 1, 2011
Study Start
August 1, 2012
Primary Completion
March 1, 2013
Study Completion
December 1, 2013
Last Updated
February 6, 2014
Record last verified: 2014-02