Rapid Diagnostic Assay for Gonorrhea and Chlamydia

Not Applicable

Completed

• Conditions: Sexually Transmitted Infections; Urethritis; Cervicitis

• Registration Number: NCT05564299
• Lead Sponsor: Massachusetts General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-15
• Study First Submitted QC: 2022-09-28
• Study First Posted: 2022-10-03
• Study Start: 2023-03-22
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30
• Results First Submitted: 2025-06-20
• Status Verified: 2025-09
• Results First Submitted QC: 2025-09-03
• Last Update Submitted: 2025-09-03
• Results First Posted: 2025-09-23
• Last Update Posted: 2025-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mean Antibiotic Days of Therapy (DOT) Administered Per Patient With Symptomatic Urethritis or Cervicitis	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 Outcome Measures

Name	Time	Method
Participant Visit Duration	Day 1	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.
Sample Processing Time	Day 1	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 to Result	Day 1	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.
Test-concordant Antibiotic Use for Gonorrhea	Day 1	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
Diagnosis-concordant Antibiotic Use for Gonorrhea	Day 1	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.
Proportion of Participants With Invalid or Unavailable Point of Care Gram Stain or Rapid STI Test Results	Day 1	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.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States