Rapid Diagnostic Assay for Gonorrhea and Chlamydia

NCT05564299 | Completed Results FDA Device

• 1 other identifier: 2022P002099
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Urethritis; Cervicitis; Sexually Transmitted Infections

Outcome Measures

Primary Outcomes (1)

• Mean Antibiotic Days of Therapy (DOT) Administered Per Patient With Symptomatic Urethritis or Cervicitis

  The investigators will compare the mean antibiotic days of therapy (DOT) administered per patient at the time of initial ciinical visit when evaluated with either point-of-care gram stain or rapid 30-minute desktop test.

  Day 1

Secondary Outcomes (6)

• Participant Visit Duration

  Day 1

• Sample Processing Time

  Day 1

• Time to Result

  Day 1

• Test-concordant Antibiotic Use for Gonorrhea

  Day 1

• Diagnosis-concordant Antibiotic Use for Gonorrhea

  Day 1

Other Outcomes (1)

• Clinic Provider Perspectives on Rapid STI Testing

  at study completion: 12 months

Study Arms (2)

Standard of Care

NO INTERVENTION

Point-of-care gram stain

Rapid STI Test

EXPERIMENTAL

Diagnostic Test: Rapid 30-minute Desktop Assay

Interventions

Rapid 30-minute Desktop Assay DIAGNOSTIC_TEST

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.

Rapid STI Test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age and older
• Presenting with symptoms of acute urethritis or cervicitis
• Willing to provide urine or additional vaginal swab specimen

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• American Sexually Transmitted Diseases Association: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Urethritis; Uterine Cervicitis; Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Urethral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Genital Diseases; Communicable Diseases; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Ingrid V Bassett
• Organization: Massachusetts General Hospital

ibassett@mgh.harvard.edu

617-724-3341

Study Officials

• Ingrid V. Bassett, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: September 15, 2022
• First Posted: October 3, 2022
• Study Start: March 22, 2023
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: September 23, 2025
• Results First Posted: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)