Prospective Collection of Female Specimens for Testing With Gen-Probe APTIMA (Registered Trademark) Assays

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

The objective of this study is to obtain female first-catch urine, vaginal, cervical and endocervical swabs for testing with multiple APTIMA Assays on the Gen-Probe PANTHER® and TIGRIS® Systems.

Study Overview

• Status: Terminated
• Conditions: Gonorrhea; Chlamydia Infections; Trichomonas Infections
• Intervention / Treatment: Device: APTIMA® Trichomonas vaginalis & APTIMA® COMBO 2® Assays

• Study Type: Observational
• Enrollment (Actual): 1336

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Infectious Diseases STD Program University of Alabama at Birmingham
  • California
    • San Diego, California, United States, 92108
      • Medical Center for Clinical Research
  • Florida
    • North Miami, Florida, United States, 33161
      • Healthcare Clinical Data
  • Georgia
    • Sandy Springs, Georgia, United States, 30328
      • Mount Vernon Clinical Research
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Louisiana State University Health Sciences Center Dept. of Medicine, Infectious Disease
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • John Hopkins University
  • Massachusetts
    • Fall River, Massachusetts, United States, 02720
      • New England Center for Clinical Research
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599-7030
      • University of North Carolina Chapel Hill
  • Ohio
    • Cincinnati, Ohio, United States, 45229-3039
      • Cincinnati Children's Hospital Medical Center Division of Pediatric & Adolescent Gynecology
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Planned Parenthood Southeastern Pennsylvania
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Tennessee
    • Jackson, Tennessee, United States, 38305
      • The Jackson Clinic
  • Texas
    • Houston, Texas, United States, 77023
      • Planned Parenthood Gulf Coast
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Tidewater Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Female subjects at least 16 years of age, with or without symptoms of sexually transmitted disease.

Description

Inclusion Criteria:

• The subject is at least 16 years of age at the time of enrollment and is currently sexually active (has had penile/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 his/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:

• The subject reports symptoms consistent with a suspected sexually transmissible infection (STI) such as abnormal discharge, genital itching, pain/discomfort during sexual intercourse or urination, and/or lower abdominal discomfort
• Subject is asymptomatic and known to be partners with, or a contact of, a person with a confirmed or suspected STI(s)
• Subject is asymptomatic and undergoing screening evaluation for possible STIs
• Subject is asymptomatic and undergoing a routine examination with a pelvic examination

Exclusion Criteria:

• The subject took antibiotic medications within the last 21 days
• Subject already participated in this 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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
No Treatment	Device: APTIMA® Trichomonas vaginalis & APTIMA® COMBO 2® Assays; In Vitro Diagnostic Assays

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Qualitative detection of ribosomal RNA from Chlamydia trachomatis and/or Neisseria gonorrhoeae (NG) and Trichomonas vaginalis (TV) to aid in the diagnosis of chlamydial and/or gonococcal and/or trichomonal urogenital disease	approximately one year

Collaborators and Investigators

• Sponsor: Gen-Probe, Incorporated
• Investigators: Study Director: Renee Wait, Gen-Probe, Incorporated

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: November 12, 2012
• First Submitted That Met QC Criteria: November 13, 2012
• First Posted (Estimate): November 16, 2012

Study Record Updates

• Last Update Posted (Actual): August 16, 2017
• Last Update Submitted That Met QC Criteria: August 14, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Sexually Transmitted Diseases; Disease Attributes; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Parasitic Diseases; Protozoan Infections; Neisseriaceae Infections; Chlamydiaceae Infections; Sexually Transmitted Diseases, Bacterial; Infections; Communicable Diseases; Chlamydia Infections; Gonorrhea; Trichomonas Infections
• Other Study ID Numbers: ATVTS-US12-001; AC2PS-US12-002 (Other Identifier: Gen-Probe); ATVPS-US12-001 (Other Identifier: Gen-Probe); ATVTS-US12-003 (Other Identifier: Gen-Probe)