COMPLETED

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

Conditions

Chlamydia Trachomatis Infection Neisseria Gonorrhoeae Infection Mycoplasma Genitalium Infection Sexually transmitted infections Urogenital infections Point of care testing

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2024-07-29

Study Completion:2025-05-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06369220

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

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

Inclusion Criteria

Exclusion Criteria

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

* 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)

Contacts and Locations

Principal Investigator

Zune Huynh, MD

STUDY_DIRECTOR

Hoffmann-La Roche

Study Locations (Sites)

San Francisco City Clinic

San Francisco, California, 94103

United States

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

Hamilton Square, New Jersey, 08690

United States

Planned Parenthood of Northern, Central and Southern New Jersey

Perth Amboy, New Jersey, 08861

United States

Baylor Scott & White Health - Kileen

Killeen, Texas, 76543

United States

Collaborators and Investigators

Sponsor: Hoffmann-La Roche

Zune Huynh, MD, STUDY_DIRECTOR, Hoffmann-La Roche

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-29

Study Completion Date2025-05-28

Study Record Updates

Study Start Date2024-07-29

Study Completion Date2025-05-28

Terms related to this study

Keywords Provided by Researchers

Sexually transmitted infections
Urogenital infections
Point of care testing

Additional Relevant MeSH Terms

Chlamydia Trachomatis Infection
Neisseria Gonorrhoeae Infection
Mycoplasma Genitalium Infection