Impact of a Rapid Test for Gonorrhea and Chlamydia on the Clinical Management of Urethritis and Cervicitis in a Sexual Health Clinic
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 98
- Locations
- 2
- Primary Endpoint
- Mean Antibiotic Days of Therapy (DOT) Administered Per Patient With Symptomatic Urethritis or Cervicitis
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
Outcomes
Primary Outcomes
Mean Antibiotic Days of Therapy (DOT) Administered Per Patient With Symptomatic Urethritis or Cervicitis
Time Frame: Day 1
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.
Secondary Outcomes
- Sample Processing Time(Day 1)
- Participant Visit Duration(Day 1)
- Sample Processing Time(Day 1)
- Time to Result(Day 1)
- Test-concordant Antibiotic Use for Gonorrhea(Day 1)
- Diagnosis-concordant Antibiotic Use for Gonorrhea(Day 1)
- Proportion of Participants With Invalid or Unavailable Point of Care Gram Stain or Rapid STI Test Results(Day 1)
Investigators
Ingrid V. Bassett, MD, MPH
Associate Professor of Medicine
Massachusetts General Hospital