NCT05564299

Rapid Diagnostic Assay for Gonorrhea and Chlamydia

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urethritis
• Cervicitis
• Sexually Transmitted Infections

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Rapid 30-minute Desktop Assay	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.

Timeline

• Start date: 2023-03-22
• Primary completion: 2024-06-30
• Completion: 2024-06-30
• First posted: 2022-10-03
• Last updated: 2025-09-23
• Results posted: 2025-09-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study