New Test for Sexually Transmitted Infections

N/A

Recruiting

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up once every 2 weeks until end of study (approximately 4 months)

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to compare a new test called cobas liat CT/NG/MG with the current standard tests for diagnosing and treating Chlamydia, Gonorrhea, and Mycop

Who is the study for?

This trial is for sexually active individuals seeking medical attention for symptoms that suggest a sexually transmitted infection (STI) or those who know they've been exposed to an STI.

What is being tested?

The study compares the cobas® liat CT/NG/MG test, which quickly detects Chlamydia, Gonorrhea, and Mycoplasma Genitalium at the point of care, against the usual diagnostic practices by clinicians.

What are the potential side effects?

Since this trial involves diagnostic testing rather than medication or treatment procedures, there are no direct side effects from the interventions being studied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am seeking treatment for symptoms or exposure to an STI.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ once every 2 weeks until end of study (approximately 4 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~once every 2 weeks until end of study (approximately 4 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and once every 2 weeks until end of study (approximately 4 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Mean Satisfaction Rating Scores of SOC and POC, According to Participants' Responses to the PSDT Questionnaire

Mean Satisfaction and Confidence Rating Scores of SOC and POC, According to Healthcare Professionals' Responses to the CSDT Questionnaire

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Standard of Care (SOC) Arm: Standard PracticeExperimental Treatment1 Intervention

In the SOC arm, the clinician will evaluate the participant based on standard practice.

Group II: Point of Care (POC) Arm: cobas® liat CT/NG/MGExperimental Treatment1 Intervention

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.

0 / 1Eligibility criteria met