533
Participants
Start Date
September 17, 2018
Primary Completion Date
June 9, 2020
Study Completion Date
June 9, 2020
vaginal self sampling
This is a prospective, non-inferiority trial comparing two methods of collection using a US Food and Drug Administration- cleared 90-minute rapid nucleic acid amplification assay, the Xpert CT/NG assay. Any adult female patient admitted to the Emergency Department at Community Regional Medical Center felt by the provider to require gonorrhea/chlamydia endocervical testing may be entered in the study.
provider-performed endocervical sampling
provider-performed endocervical sampling is the gold standard for both gonorrhea and chlamydia. The provider takes a endocervical sample which will get sent to the laboratory as the standard care in comparison to the device being studied.
Community Regional Trauma and Burn Center, Fresno
Central California Faculty Medical Group
OTHER
University of California, San Francisco
OTHER