Gonococcal Infection Clinical Trial
— SOVS-CTGOfficial title:
Self-Obtained Vaginal Swabs for Chlamydia and Gonorrhea Testing: Concurrence in Non-Clinical Settings vs. Clinical Settings
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.
Status | Completed |
Enrollment | 3500 |
Est. completion date | December 2015 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 16 Years to 75 Years |
Eligibility |
Inclusion Criteria: - 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) Exclusion Criteria: - 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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | University of California, San Francisco | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco | University of Alabama at Birmingham |
United States,
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* Note: There are 22 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Chlamydia trachomatis detected by nucleic acid amplification test in vaginal swabs | 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. | 24 hrs (at clinic visit) | No |
Secondary | Neisseria gonorrhoeae detected by nucleic acid amplification test in vaginal swabs | 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. | 24 hrs (at clinic visit) | No |
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