Self-Obtained Vaginal Swabs for Chlamydia and Gonorrhea Testing (SOVS-CTG)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Self-Obtained Vaginal Swabs for Chlamydia and Gonorrhea Testing: Concurrence in Non-Clinical Settings vs. Clinical Settings|
- Chlamydia trachomatis detected by nucleic acid amplification test in vaginal swabs [ Time Frame: 24 hrs (at clinic visit) ] [ Designated as safety issue: No ]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.
- Neisseria gonorrhoeae detected by nucleic acid amplification test in vaginal swabs [ Time Frame: 24 hrs (at clinic visit) ] [ Designated as safety issue: No ]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.
Biospecimen Retention: Samples With DNA
Residual vaginal swab specimens collected with the APTIMA® Vaginal Swab Specimen Collection Kit.
|Study Start Date:||August 2014|
|Estimated Study Completion Date:||August 2015|
|Estimated Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
Women - Upcoming routine clinic visit
This group of women will self-obtain vaginal swabs at home on the day of their medical appointment and bring the specimens to the clinic. Subjects will then self-obtain another set of vaginal swabs at the clinic. Clinician/nurse will obtain another set of vaginal swabs from the subject at the clinic.
Women - Recruited while at the clinic
This group of women will self-obtain vaginal swabs at the clinic. Clinician/nurse will obtain another set of vaginal swabs from the subject at the clinic. Within 24 hours of their clinic visit, subjects will self-obtain another set of vaginal swabs at their home and mail them to the laboratory.
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01849653
|Contact: Julius Schachter, PhD||415 824 firstname.lastname@example.org|
|Contact: Jeanne Moncada, MT||415 824 email@example.com|
|United States, California|
|University of California, San Francisco||Recruiting|
|San Francisco, California, United States, 94110|
|Contact: Kohar Der Simonian, MD 415-206-3372 DerSimonianK@fcm.ucsf.edu|
|Contact: Beth Brown, MA, MPA 415 514-1480 firstname.lastname@example.org|
|Principal Investigator: Julius Schachter, PhD|
|Study Chair:||Julius Schachter, PhD||University of California, San Francisco|