A Study of the Cobas® Liat CT/NG/MG Test Versus Current Standard Practice for Managing Participants at Increased Risk of Sexually Transmitted Infections

A Study of the Clinical Utility of Point of Care Cobas® Liat CT/NG/MG Nucleic Acid Test Versus Current Standard Practice

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).

Study Overview

• Status: Completed
• Conditions: Chlamydia Trachomatis Infection; Mycoplasma Genitalium Infection; Neisseria Gonorrhoeae Infection
• Intervention / Treatment: Other: Standard of Care (SOC): Clinician's Standard Practice; Diagnostic test: cobas® liat CT/NG/MG nucleic acid test

Detailed Description

The study is designed as a block randomized, controlled 2-arm prospective study. The study targets to enroll approximatively 348 participants at increased risk of sexually transmitted infections (STIs)-participants who have known contact with CT/NG/MG (including participants who report knowledge or suspicion of STI exposure, despite the uncertainty of the specific STI pathogen or contact testing results), or participants with symptoms suggestive of STI-to participate in this study. Participants who give consent will provide demographic information and urogenital specimen(s) for CT/NG/MG testing on the cobas® liat system and for external laboratory-polymerase chain reaction (EL-PCR) testing. Participants will be randomized in a 1:1 ratio in blocks (of multiples of 2) stratified by the site to either of the following arms:

• Standard of Care (SOC)
• Point of Care (POC)

In both arms, the clinician will see and evaluate the participant and will complete a standardized form, known as a patient management plan (PMP), at the conclusion of the participant's encounter. The critical difference between the arms is that the clinician in the POC arm will be provided POC test results upon which they may choose to base their clinical decisions, whereas the SOC arm will not receive POC test results.

• Study Type: Interventional
• Enrollment (Actual): 331
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94103
      • San Francisco City Clinic
  • New Jersey
    • Hamilton Square, New Jersey, United States, 08690
      • Planned Parenthood of Northern, Central, and Southern New Jersey, Inc.
    • Perth Amboy, New Jersey, United States, 08861
      • Planned Parenthood of Northern, Central and Southern New Jersey
  • Texas
    • Killeen, Texas, United States, 76543
      • Baylor Scott & White Health - Kileen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Sexually active people
• People seeking medical services for symptoms consistent with a sexually transmitted infection (STI) and/or known exposure to an STI

Exclusion Criteria:

• Previously enrolled in the study
• Unable to provide informed consent
• Currently pregnant
• Declines POC testing
• Presents for routine STI screening (asymptomatic)
• Use of antimicrobial agents active against CT, NG, or MG during the 21 days before sample collection. Example of such antimicrobial agents include the following: Macrolides (e.g., azithromycin and erythromycin); Penicillins (e.g., amoxicillin); Tetracyclines (e.g., doxycycline); Fluoroquinolones (e.g., ciprofloxacin, ofloxacin, levofloxacin, and moxifloxacin); Cephalosporins (e.g., ceftriaxone and cefixime)
• Use of phenazopyridine-containing urinary pain relief medicines (ie, Azo or Pyridium) within 2 days prior to sample collection
• Use of any over-the-counter feminine hygiene products (internally or externally), such as vaginal moisturizers, lubricants (e.g., Replens, RepHresh, etc.), and feminine washes/vaginal douches, etc. within the 3 days prior to sample collection. The use of tampons or pads during menses is not an exclusionary criterion.
• Contraindication to vaginal swab sampling where vaginal swab sampling is the only option available
• Urination within 1 hour prior to sample collection (for subjects providing urine sample)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Standard of Care (SOC) Arm: Standard Practice; In the SOC arm, the clinician will evaluate the participant based on standard practice.	Other: Standard of Care (SOC): Clinician's Standard Practice; Standard of care (SOC) is defined as the traditional/typical diagnosis and treatment steps in practice recommended by the CDC guidelines that rely upon clinical syndromic presentations and/or external laboratory testing.
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.	Diagnostic test: cobas® liat CT/NG/MG nucleic acid test; The cobas® CT/NG/MG nucleic acid test for use on the cobas® Liat® System is an investigational, automated, qualitative in vitro nucleic acid diagnostic test that utilizes real-time polymerase chain reaction (PCR) for the direct detection of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Mycoplasma genitalium (MG) nucleic acid in male/female urine and vaginal swabs (clinician-collected and self-collected) in cobas® PCR Media.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Given Inappropriate Treatments for All Pathogens Combined (CT, NG, and MG)	An inappropriate treatment was defined as under and/or overtreatment on the day of the medical encounter based on the CDC recommendations for the pathogen-specific results obtained by the EL-PCR testing. Overtreatment was defined by the provision of 2 or more antibiotics when only 1 is necessary, or provision of any unnecessary antibiotics. Undertreatment was defined by failure to provide pathogen-appropriate antimicrobials either alone or in combination.	On the day of the medical encounter (Day 1)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Given Inappropriate Treatment for CT Infection	An inappropriate treatment was defined as under and/or overtreatment on the day of the medical encounter based on CDC recommendations for the pathogen-specific results obtained by the EL-PCR testing. Overtreatment was defined by the provision of 2 or more antibiotics when only 1 is necessary, or provision of any unnecessary antibiotics. Undertreatment was defined by failure to provide pathogen-appropriate antimicrobials either alone or in combination.	On the day of the medical encounter (Day 1)
Percentage of Participants Given Inappropriate Treatment for NG Infection	An inappropriate treatment was defined as under and/or overtreatment on the day of the medical encounter based on CDC recommendations for the pathogen-specific results obtained by the EL-PCR testing. Overtreatment was defined by the provision of 2 or more antibiotics when only 1 is necessary, or provision of any unnecessary antibiotics. Undertreatment was defined by failure to provide pathogen-appropriate antimicrobials either alone or in combination.	On the day of the medical encounter (Day 1)
Percentage of Participants Given Inappropriate Treatment for MG Infection	An inappropriate treatment was defined as under and/or overtreatment on the day of the medical encounter based on CDC recommendations for the pathogen-specific results obtained by the EL-PCR testing. Overtreatment was defined by the provision of 2 or more antibiotics when only 1 is necessary, or provision of any unnecessary antibiotics. Undertreatment was defined by failure to provide pathogen-appropriate antimicrobials either alone or in combination.	On the day of the medical encounter (Day 1)
Percentage of Clinicians With Satisfaction Scores for SOC and POC According to the Clinician Satisfaction With Diagnostic Test Questionnaire (CSDT-Q)	The CSDT- Questionnaire assessed satisfaction with the test and SOC based on responses to the following: ease of use, time taken to perform, speed of results, ease of result interpretation, impact on the care plan, impact on consultations, impact on workload/workflow, and guidance and training, using a 5-point scale ranging from very satisfied to very dissatisfied. Only response categories with non-zero values are reported. Percentages have been rounded off.	Baseline until end of study (approximately 9.9 months)
Percentage of Clinicians With Confidence Scores for SOC and POC According to the CSDT-Q	The CSDT- Questionnaire assessed confidence in accuracy of the tests (POC and SOC), using a 5-point scale ranging from very confident to very unconfident. Only response categories with non-zero values are reported. Percentages have been rounded off.	Baseline until end of study (approximately 9.9 months)
Percentage of Participants With Satisfaction Scores for SOC and POC According to the Patient Satisfaction With Diagnostic Test Questionnaire (PSDT-Q)	The PSDT- Questionnaire assessed satisfaction with the diagnostic test process based on responses to the following: overall visit satisfaction, information provision, ease of completion, time taken to perform, speed of results, method of results delivery, ease of understanding, accuracy, impact on clinical pathway, overall satisfaction, and satisfaction with sample or measurement collection bases on as: comfort, convenience, type of sample or measurement, person collecting sample or measurement, hygiene using a 5-point scale ranging from very satisfied to very dissatisfied. Percentages have been rounded off.	On the day of the medical encounter (Day 1)
Percentage of Participants With Confidence Scores for SOC and POC According to the PSDT-Q	The PSDT-Q assessed confidence in accuracy of the tests (POC and SOC), using a 5-point scale ranging from very confident to very unconfident. Only response categories with non-zero values are reported. Percentages have been rounded off.	Baseline until end of study (approximately 9.9 months)

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Collaborators: Roche Molecular Systems, Inc
• Investigators: Study Director: Zune Huynh, MD, Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2024
• Primary Completion (Actual): May 28, 2025
• Study Completion (Actual): May 28, 2025

Study Registration Dates

• First Submitted: April 12, 2024
• First Submitted That Met QC Criteria: April 12, 2024
• First Posted (Actual): April 16, 2024

Study Record Updates

• Last Update Posted (Actual): June 23, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Point of care testing; Sexually transmitted infections; Urogenital infections
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Negative Bacterial Infections; Sexually Transmitted Diseases, Bacterial; Neisseriaceae Infections; Pathological Conditions, Signs and Symptoms; Sexually Transmitted Diseases; Gonorrhea; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: LIA-STI-542; RD006616 (Other Identifier: Roche Molecular Systems, Inc.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes