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NCT01849653 · ClinicalTrials.gov registry record
Self-Obtained Vaginal Swabs for Chlamydia and Gonorrhea Testing
A clinical trial, sponsored by University of California, San Francisco.
- Completed
- Registry status
- 3,500
- Enrollment target
NCT01849653: Completed study, sponsored by University of California, San Francisco.
NCT01849653 is a clinical trial that has completed, run by University of California, San Francisco. The registered enrollment target is 3,500 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01849653 has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- 3,500 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,500 participants |
| Start Date | 2014-08 |
| Est. Completion | 2015-12 |
What the finished NCT01849653 record still lists
NCT01849653 is an observational study that tracks outcomes without assigning an intervention. Its 3,500 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 0 interventions.
NCT01849653 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01849653 about?
NCT01849653 is a clinical study titled "Self-Obtained Vaginal Swabs for Chlamydia and Gonorrhea Testing". 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 S...
What is the current status of trial NCT01849653?
This trial is currently completed. The enrollment target is 3,500 participants. The study started on 2014-08. Estimated completion is 2015-12.
Who is sponsoring clinical trial NCT01849653?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
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