Rapid Diagnostic Assay for Gonorrhea and Chlamydia

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-22

Study Completion Date

2024-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Urethritis Cervicitis Sexually Transmitted Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Standard of Care

Point-of-care gram stain

Group Type NO_INTERVENTION

No interventions assigned to this group

Rapid STI Test

Group Type EXPERIMENTAL

Rapid 30-minute Desktop Assay

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No