Rapid Diagnostic Assay for Gonorrhea and Chlamydia

Study Overview
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Brief Summary
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This study is a pilot randomized controlled trial evaluating the use of either a) rapid 30-minute desktop assay or b) point-of-care gram stain (current standard of care) to guide the clinical management of patients with symptomatic urethritis or cervicitis evaluated in the Massachusetts General Hospital Sexual Health Clinic. Patients presenting with symptoms of urethritis or cervicitis and meeting inclusion criteria will be randomized to have diagnostic specimens tested during the clinical encounter using either the 30-minute desktop assay or point-of-care gram stain. Patients randomized to the intervention arm of the study will also have a gram stain created, which will be held for interpretation by the clinician following the clinical encounter. Patients will not be followed longitudinally. Recruitment will conclude when 100 participants enroll in the study.

Official Title
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Impact of a Rapid Test for Gonorrhea and Chlamydia on the Clinical Management of Urethritis and Cervicitis in a Sexual Health Clinic

Conditions
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Urethritis, Cervicitis, Sexually Transmitted Infections

Intervention / Treatment
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* Diagnostic Test: Rapid 30-minute Desktop Assay


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age and older Presenting with symptoms of acute urethritis or cervicitis Willing to provide urine or additional vaginal swab specimen Exclusion Criteria: Younger than 18 years old Presenting with symptoms not consistent with urethritis or cervicitis Unwilling or unable to provide urine or vaginal swab specimen Pregnant Contact of index patients with Gonorrhea or Chlamydia Known exposure to Gonorrhea or Chlamydia Reporting concurrent symptoms at a non-genital site Suspected or confirmed to have Monkeypox

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of Care<br>Point-of-care gram stain | |
| Experimental: Rapid STI Test<br> | Diagnostic Test: Rapid 30-minute Desktop Assay<br>* Participants will undergo routine evaluation and specimen collection per current clinic protocols. Specimens will be processed by the rapid 30-minute desktop assay. Concurrently, specimens will be used to create a point-of-care gram stain, to be read by the clinician following the clinical encounter. Treatment for urethritis and cervicitis will be provided based on results from the 30-minute assay. Specimens will also be plated for Gonorrhea culture and sent to the Massachusetts Department of Public Health for additional Gonorrhea and Chlamydia polymerase chain reaction testing, as per clinic protocols.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean number of antibiotic doses administered per patient with symptomatic urethritis or cervicitis | The investigators will compare the mean number of antibiotic doses administered per patient when evaluated with either point-of-care gram stain or rapid 30-minute desktop test. Doses will be defined as treatment courses required for standard, guideline-directed regimens for sexually transmitted infections (e.g., 500mg intramuscular ceftriaxone for uncomplicated gonorrhea). | Months 1-6 | 
| Participant Visit Duration | The investigators will compare visit duration between participants randomized to the point-of-care test and those to the 30-minute desktop test. Participant visit duration will be calculated as the difference between when the participant enters the exam room and when they check out of the clinic, in minutes. | Months 1-6 | 
| Sample Processing Time | The investigators will compare the time taken to process clinical specimen using either the point-of-care gram stain or rapid 30-minute desktop test. The provider processing the samples will record the start and end times on a time sheet, and the sample processing time will be calculated as the difference between those entries, in minutes. | Months 1-6 | 
| Time to result | The investigators will compare time from specimen collection to availability of test result between the point-of-care gram stain or rapid 30-minute desktop test. Providers will record time of specimen collection and time of result (for point of care gram stain), time of result for the rapid desktop platform will be extracted from the platform; time to result will be calculated as the difference between those times, in minutes. | Months 1-6 |