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NCT03676816 · ClinicalTrials.gov registry record · NA
Self Sampling for Rapid Turnaround Testing in the Emergency Department
A NA study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- NA
- Development phase
- 533
- Enrollment target
NCT03676816: Completed NA study, sponsored by University of California, San Francisco.
NCT03676816 is a NA study that has completed, run by University of California, San Francisco. The registered enrollment target is 533 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03676816, a NA study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- NA
- Development phase
- 533 participants
- Enrollment target
Study Summary
Consenting adult female patient felt by the provider to require gonorrhea/chlamydia endocervical testing will be asked to provide an additional self sample specimen. The specimen will be sent to the laboratory using conventional diagnostic test for gonorrhea/chlamydia.
Primary Outcome
In order for vaginal self-sampling to be considered clinically noninferior to the standard provider-performed endocervical sampling method of collection, we established a minimum sensitivity of 90%. This was based on previous research showing Sexually Transmitted Infection (STI) clinicians' top priority for a point of care STI test is a minimum sensitivity of 90%. In addition, a previous ED study examining urine gonorrhea/chlamydia diagnosis using the same point of care test as this study also u
Interventions
- PROCEDURE vaginal self sampling
- PROCEDURE provider-performed endocervical sampling
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 533 participants |
| Start Date | 2018-09-17 |
| Est. Completion | 2020-06-09 |
| Phase | NA |
What the finished NCT03676816 record still lists
NCT03676816 is an interventional study that assigns participants to a tested intervention. The registered 533 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 2 interventions - of which vaginal self sampling is the first listed.
NCT03676816 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03676816 about?
NCT03676816 is a clinical study titled "Self Sampling for Rapid Turnaround Testing in the Emergency Department". Consenting adult female patient felt by the provider to require gonorrhea/chlamydia endocervical testing will be asked to provide an additional self sample specimen. The specimen will be sent to the laboratory using conventional diagnostic test for gonorrhea/chlamydia.
What is the current status of trial NCT03676816?
This trial is currently completed. It is a NA study. The enrollment target is 533 participants. The study started on 2018-09-17. Estimated completion is 2020-06-09.
What interventions are being tested in trial NCT03676816?
The interventions under investigation include: vaginal self sampling (PROCEDURE), provider-performed endocervical sampling (PROCEDURE).
Who is sponsoring clinical trial NCT03676816?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03676816's enrollment target sits among peer trials
533 188th of 2000 higher than 1,813 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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