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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
98
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.
Massachusetts General Hospital
Boston, Massachusetts, United States
Mean Antibiotic Days of Therapy (DOT) Administered Per Patient With Symptomatic Urethritis or Cervicitis
The investigators will compare the mean antibiotic days of therapy (DOT) administered per patient at the time of initial ciinical visit when evaluated with either point-of-care gram stain or rapid 30-minute desktop test.
Time frame: Day 1
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.
Time frame: Day 1
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.
Time frame: Day 1
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.
Time frame: Day 1
Test-concordant Antibiotic Use for Gonorrhea
Proportion of participants in each arm who recevied gonorrhea-active antibiotics if PCR-based testing (rapid test or MDPH) was positive for gonorrhea, or who did not receive gonorrhea-active antibiotics if PCR-based testing (rapid test or MDPH) was negative for gonorrhea
Time frame: Day 1
Diagnosis-concordant Antibiotic Use for Gonorrhea
Proportion of participants in each arm who were prescribed an antibiotic with activity against gonorrhea on the day of clinic visit, either for a positive test result or for a clinical syndrome for which the antibiotics are indicated (e.g., a clinical diagnosis of pelvic inflammatory disease, a diagnosis of non-gonococcal urethritis) as determined by study PI; or who were not prescribed an antibiotic with activity against gonorrhea on the day of clinic visit in the absence of a positive test result for gonorrhea or clinical syndrome for which the antibiotics are indicated.
Time frame: Day 1
Proportion of Participants With Invalid or Unavailable Point of Care Gram Stain or Rapid STI Test Results
The proportion of point of care gram stain results (control arm) or rapid test results (intervention arm) that were unavailable or invalid (unable to be read or provided an error message) at the time of the clinic visit.
Time frame: Day 1
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