A Study of the Clinical Utility of Point of Care Cobas® Liat CT/NG/MG Nucleic Acid Test Versus Current Standard Practice
Status: Completed
Location: See all (4) locations...
Intervention Type: Other, Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This study is designed to assess the comparative clinical utility of the point of care cobas® liat CT/NG/MG to current standard practices in the diagnosis and treatment of urogenital infections with Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Mycoplasma genitalium (MG).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Sexually active people
• People seeking medical services for symptoms consistent with a sexually transmitted infection (STI) and/or known exposure to an STI
Locations
United States
California
San Francisco City Clinic
San Francisco
New Jersey
Planned Parenthood of Northern, Central, and Southern New Jersey, Inc.
Hamilton Square
Planned Parenthood of Northern, Central and Southern New Jersey
Perth Amboy
Texas
Baylor Scott & White Health - Kileen
Killeen
Time Frame
Start Date: 2024-07-29
Completion Date: 2025-05-28
Participants
Target number of participants: 344
Treatments
Other: Standard of Care (SOC) Arm: Standard Practice
In the SOC arm, the clinician will evaluate the participant based on standard practice.
Experimental: Point of Care (POC) Arm: cobas® liat CT/NG/MG
In the POC arm, the clinician will evaluate the participant and will be provided POC test results upon which they may choose to base their clinical decisions.
Sponsors
Collaborators: Roche Molecular Systems, Inc
Leads: Hoffmann-La Roche