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Rapid Diagnostic Assay for Gonorrhea and Chlamydia

Sexually Transmitted Infections Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05564299
Study type Interventional
Source Massachusetts General Hospital
Contact Jana Jarolimova, MD, MPH
Phone (617) 726-3813
Email JJAROLIMOVA@PARTNERS.ORG
Status Recruiting
Phase N/A
Start date March 22, 2023
Completion date June 30, 2024
View Details
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