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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gen-Probe, Incorporated
ClinicalTrials.gov Identifier:
NCT01427023
First received: August 26, 2011
Last updated: February 5, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Trichomonas Vaginalis
Device: APTIMA Trichomonas vaginalis (ATV) Assay

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Prospective Collection of Female First-catch Urine, Vaginal Swab, Endocervical Swab, and Cervical Specimens for Testing With the APTIMA Trichomonas Vaginalis Assay

Resource links provided by NLM:


Further study details as provided by Gen-Probe, Incorporated:

Primary Outcome Measures:
  • Positive Percent Agreement Using the TIGRIS Instrument as a Reference. [ Time Frame: approximately one year ] [ Designated as safety issue: No ]
    Positive Percent Agreement Using the TIGRIS Instrument as a Reference.

  • Negative Percent Agreement Using the TIGRIS Instrument as a Reference. [ Time Frame: approximately one year ] [ Designated as safety issue: No ]
    Negative Percent Agreement Using the TIGRIS Instrument as a Reference.


Secondary Outcome Measures:
  • Positivity Rate [ Time Frame: approximately one year ] [ Designated as safety issue: No ]
    Positivity Rate


Biospecimen Retention:   Samples With DNA

urine specimen, vaginal swab specimen, endocervical swab specimen and PreservCyt specimen


Enrollment: 532
Study Start Date: August 2012
Study Completion Date: December 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: APTIMA Trichomonas vaginalis (ATV) Assay
    APTIMA Trichomonas vaginalis (ATV) Assay
  Eligibility

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Women attending participating US OB/GYN, family planning, or STD clinics will be eligible to participate.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01427023

Locations
United States, Alabama
University of Alabama, Birmingham
Birmingham, Alabama, United States, 35294
United States, Indiana
Wishard Hospital - Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
United States, Louisiana
Louisiana State University
New Orleans, Louisiana, United States, 70112
United States, Massachusetts
New England Center for Clinical Research
Fall River, Massachusetts, United States, 02720
United States, North Carolina
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, United States, 27599
United States, Tennessee
Geneuity Clinical Research Services
Maryville, Tennessee, United States, 37804
United States, Texas
Planned Parenthood Gulf Coast
Houston, Texas, United States, 77023
Sponsors and Collaborators
Gen-Probe, Incorporated
Investigators
Study Director: Jennifer Reid, PhD Gen-Probe, Incorporated
  More Information

No publications provided

Responsible Party: Gen-Probe, Incorporated
ClinicalTrials.gov Identifier: NCT01427023     History of Changes
Other Study ID Numbers: ATVPS-US11-001
Study First Received: August 26, 2011
Last Updated: February 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Gen-Probe, Incorporated:
APTIMA Trichomonas vaginalis Assay
APTIMA
trichomonas
trichomonas vaginalis

Additional relevant MeSH terms:
Trichomonas Infections
Protozoan Infections
Parasitic Diseases

ClinicalTrials.gov processed this record on April 17, 2014