Status:
COMPLETED
Self-Obtained Vaginal Swabs for Chlamydia and Gonorrhea Testing
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
University of Alabama at Birmingham
Conditions:
Chlamydial Infection
Gonococcal Infection
Eligibility:
FEMALE
16-75 years
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. N...
Detailed Description
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 She...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
3500 Patients enrolled
Trial Details
Trial ID
NCT01849653
Start Date
August 1 2014
End Date
December 1 2015
Last Update
June 3 2016
Active Locations (1)
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1
University of California, San Francisco
San Francisco, California, United States, 94110