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Completed

NCT Number: NCT05564299

Rapid Diagnostic Assay for Gonorrhea and Chlamydia

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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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: Day 1

    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.

Secondary outcomes

  1. Participant Visit Duration

    Time frame: Day 1

    The investigators will compare visit duration between participants randomized to the point-of-care test and those to the 30-minute desktop test. Participant visit duration will be calculated as the difference between when the participant enters the exam room and when they check out of the clinic, in minutes.

  2. Sample Processing Time

    Time frame: Day 1

    The investigators will compare the time taken to process clinical specimen using either the point-of-care gram stain or rapid 30-minute desktop test. The provider processing the samples will record the start and end times on a time sheet, and the sample processing time will be calculated as the difference between those entries, in minutes.

  3. Time to Result

    Time frame: Day 1

    The investigators will compare time from specimen collection to availability of test result between the point-of-care gram stain or rapid 30-minute desktop test. Providers will record time of specimen collection and time of result (for point of care gram stain), time of result for the rapid desktop platform will be extracted from the platform; time to result will be calculated as the difference between those times, in minutes.

  4. Test-concordant Antibiotic Use for Gonorrhea

    Time frame: Day 1

    Proportion of participants in each arm who recevied gonorrhea-active antibiotics if PCR-based testing (rapid test or MDPH) was positive for gonorrhea, or who did not receive gonorrhea-active antibiotics if PCR-based testing (rapid test or MDPH) was negative for gonorrhea

  5. Diagnosis-concordant Antibiotic Use for Gonorrhea

    Time frame: Day 1

    Proportion of participants in each arm who were prescribed an antibiotic with activity against gonorrhea on the day of clinic visit, either for a positive test result or for a clinical syndrome for which the antibiotics are indicated (e.g., a clinical diagnosis of pelvic inflammatory disease, a diagnosis of non-gonococcal urethritis) as determined by study PI; or who were not prescribed an antibiotic with activity against gonorrhea on the day of clinic visit in the absence of a positive test result for gonorrhea or clinical syndrome for which the antibiotics are indicated.

  6. Proportion of Participants With Invalid or Unavailable Point of Care Gram Stain or Rapid STI Test Results

    Time frame: Day 1

    The proportion of point of care gram stain results (control arm) or rapid test results (intervention arm) that were unavailable or invalid (unable to be read or provided an error message) at the time of the clinic visit.

Other outcomes

  1. Clinic Provider Perspectives on Rapid STI Testing

    Time frame: at study completion: 12 months

    Clinic provider perspectives will be elicited during a focus group discussion at the conclusion of the clinical study.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • American Sexually Transmitted Diseases Association

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 3, 2022
Registry last updated
Sep 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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