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Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
No Intervention
Standard of Care 		Point-of-care gram stain
Experimental
Rapid STI Test
  • 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.

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Ingrid Bassett, MD

More Details

Status
Recruiting
Sponsor
Massachusetts General Hospital

Study Contact

Jana Jarolimova, MD, MPH
(617) 726-3813
JJAROLIMOVA@PARTNERS.ORG

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.