Self-Obtained Vaginal Swabs for Chlamydia and Gonorrhea Testing
Completed
Conditions studied: Chlamydial Infection, Gonococcal Infection
In brief
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.
Key facts
- Study ID
- NCT01849653
- Run by
- University of California, San Francisco
- People needed
- 3500
- Starts
- 2014-08-01
- Expected to finish
- 2015-12-01
- Last updated by the study team
- 2016-06-03
Who can join
Age: 16 and older, up to 75. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Asymptomatic and symptomatic females ages 16-75
- Subjects scheduled for visits or presenting at Family Planning, OB/Gyn, STD or other clinics requesting (or candidates for) routine screening for Ct/GC
- Willing to provide informed consent (written per site institutional review board approval)
You may not qualify if…
- Inability to provide informed consent
- Inability or unwillingness to collect a specimen at home (and mail it)
- On antibiotic therapy within the last 30 days
- Clinical conditions, such as cervicitis or pelvic inflammatory disease that would indicate presumptive treatment
- Contact to person with Ct or GC in need of epidemiologic treatment
Where it is running
- University of California, San Francisco — San Francisco, California, United States
Full record on ClinicalTrials.gov
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