Comparing a new test for sexually transmitted infections to standard care
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 testing a new quick test for sexually transmitted infections to see if getting results right away helps people get better care compared to the usual method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 348 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hoffmann-La Roche Industry-sponsored |
| Locations | 4 sites (San Francisco, California and 3 other locations) |
| Trial ID | NCT06369220 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of the cobas® Liat CT/NG/MG test in diagnosing urogenital infections compared to current standard practices. It involves approximately 348 participants at increased risk of sexually transmitted infections (STIs), including those with known exposure or symptoms. Participants will be randomized into two groups: one receiving point-of-care test results and the other following standard care without immediate test results. The study aims to determine if immediate access to test results improves clinical decision-making and patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are sexually active individuals seeking medical services for STI symptoms or known exposure.
Not a fit: Patients who are asymptomatic or those who decline point-of-care testing may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to faster and more accurate diagnosis and treatment of sexually transmitted infections.
How similar studies have performed: Previous studies have shown promise in using point-of-care testing for STIs, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
San Francisco, California and 3 other locations
- San Francisco City Clinic — San Francisco, California, United States (Recruiting)
- Planned Parenthood of Northern, Central, and Southern New Jersey, Inc. — Hamilton Square, New Jersey, United States (Recruiting)
- Planned Parenthood of Northern, Central and Southern New Jersey — Perth Amboy, New Jersey, United States (Recruiting)
- Baylor Scott & White Health - Kileen — Killeen, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Babar Javed, MBA
- Email: babar.javed@roche.com
- Phone: 925-596-8295
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.