Rapid Diagnostic Assay for Gonorrhea and Chlamydia

Not Applicable

Completed

• Conditions: Sexually Transmitted Infections; Urethritis; Cervicitis
• Interventions: Diagnostic Test: Rapid 30-minute Desktop Assay

• 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
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-08

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

Arm && Interventions

Group	Intervention	Description
Rapid STI Test	Rapid 30-minute Desktop Assay	-

Primary Outcome Measures

Name	Time	Method
Mean number of antibiotic doses administered per patient with symptomatic urethritis or cervicitis	Months 1-6	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).
Time to result	Months 1-6	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.
Sample Processing Time	Months 1-6	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.
Participant Visit Duration	Months 1-6	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.

Trial Locations

Locations (1)

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