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

Status: Not yet recruiting
Intervention Type: Diagnostic Test
Study Type: Interventional
Study Phase: Not Applicable

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.

Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No

• 18 years of age and older

• Presenting with symptoms of acute urethritis or cervicitis

• Willing to provide urine or additional vaginal swab specimen

Contact Information
Jana Jarolimova, MD, MPH
(617) 726-3813
Time Frame
Start Date: January 2023
Estimated Completion Date: December 2023
Target number of participants: 100
No Intervention: Standard of Care
Point-of-care gram stain
Experimental: Rapid STI Test
Ingrid V. Bassett
Related Therapeutic Areas
Collaborators: American Sexually Transmitted Diseases Association
Leads: Massachusetts General Hospital

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