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

Hoffmann-La Roche344 enrolled

Overview

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).

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

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

344

Conditions

Chlamydia Trachomatis Infection Neisseria Gonorrhoeae Infection Mycoplasma Genitalium Infection

Interventions

cobas® liat CT/NG/MG nucleic acid testDIAGNOSTIC_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.

Standard of Care (SOC): Clinician's Standard PracticeOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (4)

San Francisco City Clinic

San Francisco, California, United States

Planned Parenthood of Northern, Central, and Southern New Jersey, Inc.

Hamilton Square, New Jersey, United States

Planned Parenthood of Northern, Central and Southern New Jersey

Perth Amboy, New Jersey, United States

Baylor Scott & White Health - Kileen

Killeen, Texas, United States

Outcomes

Primary Outcomes

Percentage of Participants Given Inappropriate Treatments for All Pathogens Combined (CT, NG, and MG)

An inappropriate treatment is defined as under and/or overtreatment on the day of the medical encounter based on CDC recommendations for the pathogen-specific results obtained by EL-PCR.