Self Sampling for Rapid Turnaround Testing in the Emergency Department

NACompletedINTERVENTIONAL
Enrollment

533

Participants

Timeline

Start Date

September 17, 2018

Primary Completion Date

June 9, 2020

Study Completion Date

June 9, 2020

Conditions
Chlamydia TrachomatisNeisseria Gonorrhoeae
Interventions
PROCEDURE

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.

PROCEDURE

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.

Trial Locations (1)

93721

Community Regional Trauma and Burn Center, Fresno

All Listed Sponsors
collaborator

Central California Faculty Medical Group

OTHER

lead

University of California, San Francisco

OTHER

NCT03676816 - Self Sampling for Rapid Turnaround Testing in the Emergency Department | Biotech Hunter | Biotech Hunter