Clinical Trial: Self-Obtained Vaginal Swabs for Chlamydia and Gonorrhea Testing

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Self-Obtained Vaginal Swabs for Chlamydia and Gonorrhea Testing: Concurrence in Non-Clinical Settings vs. Clinical Settings

Brief Summary: To evaluate the agreement between NAAT results for Chlamydia trachomatis and Neisseria gonorrhoeae infection obtained with self-obtained vaginal swabs (SOVS), collected in a non-clinical setting vs. NAAT results using SOVS collected in a clinical setting. This is a new use of this specimen type as SOVS are FDA cleared only for use in clinics. The NAAT (Gen-Probe APTIMA Combo 2® Assay (AC2)) result with the home-collected SOVS specimen will be compared to the result obtained with an SOVS collected in the clinic on multiple platforms (Direct Tube Sampling (DTS) / Panther / Tigris). The term "home-collected" is used to refer to any specimen that is not collected in a clinic, since there is no certainty that a specimen is collected "at home" or in a restroom in an office setting, etc. To compare the SOVS results to an FDA cleared predicate test with the collection of two clinician collected vaginal swabs.

Detailed Summary:

All potential participants enrolled in this study will undergo the following procedures:

  • Informed consent (written) to participate in this study along with review of the Participant Information Sheet and Experimental Subject's Bill of Rights (per site requirements)
  • Assessment of eligibility by nurse/clinician
  • Collection of two SOVS in clinic
  • Collection of two clinician collected vaginal swabs in the clinic
  • Assessment of clinical signs or symptoms
  • Group 1 - participants will collect two SOVS before clinic visit and deliver specimens to study staff at the clinic visit.
  • Group 2 - participants will repeat collection of two SOVS at home after clinic visit and mail the specimens directly to the laboratory.

Clinical examinations will be conducted as appropriate to the reason for the visit/exam but the clinic procedures are not included as part of the protocol.

The enrollment strategy is designed to recruit a total of 3500 women with an average of 42-60 women per month over a 12-month recruitment period (500-700 women per site over the recruitment period). Participants will be seen and recruited in clinics at the participating STI-CTG, and other site clinics. At each participating clinical center, recruitment personnel will follow a site specific process that is designed to help identify potential participants. Only one visit is required to complete the study procedures. The total time required for a participant to complete this study may vary but is expected to be 45 minutes total time over 1 or 2 days. Intervals of several days between
Sponsor: University of California, San Francisco

Current Primary Outcome: Chlamydia trachomatis detected by nucleic acid amplification test in vaginal swabs [ Time Frame: 24 hrs (at clinic visit) ]

AC2 testing on the DTS, Panther, and Tigris platforms for the presence or absence of Ct on "Home-collected" vs. "Clinic-collected" swab specimens, and clinician collected swabs.


Original Primary Outcome: Chlamydia trachomatis detected by nucleic acid amplification test in vaginal swabs [ Time Frame: 24 hrs (at clinic visit) ]

AC2 testing on the DTS, Panther, and Tigris platforms for the presence or absence of Ct on "Home-collected" vs. "Clinic-collected" swab specimens.


Current Secondary Outcome: Neisseria gonorrhoeae detected by nucleic acid amplification test in vaginal swabs [ Time Frame: 24 hrs (at clinic visit) ]

AC2 testing on the DTS, Panther, and Tigris platforms for the presence or absence of GC on "Home-collected" vs. "Clinic-collected" swab specimens, and clinician collected swabs.


Original Secondary Outcome: Neisseria gonorrhoeae detected by nucleic acid amplification test in vaginal swabs [ Time Frame: 24 hrs (at clinic visit) ]

AC2 testing on the DTS, Panther, and Tigris platforms for the presence or absence of GC on "Home-collected" vs. "Clinic-collected" swab specimens.


Information By: University of California, San Francisco

Dates:
Date Received: April 24, 2013
Date Started: August 2014
Date Completion:
Last Updated: June 1, 2016
Last Verified: June 2016