UrethritisNCT05564299
Rapid Diagnostic Assay for Gonorrhea and Chlamydia
A study testing Rapid 30-minute Desktop Assay in people with Urethritis and Cervicitis, run by Massachusetts General Hospital at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urethritis, Cervicitis, Sexually Transmitted Infections
- What is being tested?
- Rapid 30-minute Desktop Assay
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2023to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age and older
- Presenting with symptoms of acute urethritis or cervicitis
- Willing to provide urine or additional vaginal swab specimen
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Impact of a Rapid Test for Gonorrhea and Chlamydia on the Clinical Management of Urethritis and Cervicitis in a Sexual Health Clinic
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
- Being tested
- Rapid 30-minute Desktop Assay
- Medical subject headings
- Urethritis, Uterine Cervicitis, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid 30-minute Desktop AssayDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | Point-of-care gram stain |
| Rapid STI Test | Experimental | Not described Receives: Diagnostic Test: Rapid 30-minute Desktop Assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (6)
Participant Visit Duration
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.
Measured: Day 1
Sample Processing Time
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.
Measured: Day 1
Time to Result
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.
Measured: Day 1
Test-concordant Antibiotic Use for Gonorrhea
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
Measured: Day 1
Diagnosis-concordant Antibiotic Use for Gonorrhea
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.
Measured: Day 1
Proportion of Participants With Invalid or Unavailable Point of Care Gram Stain or Rapid STI Test Results
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start22 Mar 2023
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for UrethritisStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- American Sexually Transmitted Diseases Association
- Responsible party
- Principal investigator, Ingrid V. Bassett, MD, MPH, Massachusetts General Hospital
- Investigators
- Ingrid V. Bassett, MD, MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05564299
- Sponsor's protocol ID
- 2022P002099
- Status last verified
- Sep 2025
- First submitted
- 15 Sep 2022
- Last updated
- 23 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Jarolimova J, Kong D, Sanders G, Shah P, Psaros C, Parker RA, Ard KL, Bassett IV; STI Rapid Testing Research Group (Nancy H Nicholson, CNP 1, Robert P Ober, FNP 1, Vitor G Cardoso, CNP 1, Diane G Kanjilal, CNP 1, Emily L Perriello, CNP 1, Daniel P Worrall, CNP 8). A rapid molecular test for gonorrhea and chlamydia compared to Gram stain for symptomatic patients in a specialized STI clinic: a randomized controlled trial. Sex Transm Dis. 2026 Apr 22:10.1097/OLQ.0000000000002324. doi: 10.1097/OLQ.0000000000002324. Online ahead of print.
PubMed 42017665
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Rapid Test for Gonorrhea and Chlamydia on the Clinical Management of Urethritis and Cervicitis in a Sexual Health Clinic
- ClinicalTrials.gov ID
- NCT05564299
- Acronym / sponsor ID
- 2022P002099
- Conditions
- Urethritis, Cervicitis, Sexually Transmitted Infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- American Sexually Transmitted Diseases Association
- Study start
- 22 Mar 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 3 Oct 2022 (actual)
- Results
- Posted 23 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –Point-of-care gram stain |
| Rapid STI Test | Experimental | Diagnostic Test: Rapid 30-minute Desktop Assay |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age and older
- Presenting with symptoms of acute urethritis or cervicitis
- Willing to provide urine or additional vaginal swab specimen
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rapid 30-minute Desktop AssayParticipants 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. | Diagnostic test | Rapid STI Test |
Primary outcome
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.
6 secondary outcomes
Participant Visit Duration
Time frame: Day 1
Sample Processing Time
Time frame: Day 1
Time to Result
Time frame: Day 1
Test-concordant Antibiotic Use for Gonorrhea
Time frame: Day 1
Diagnosis-concordant Antibiotic Use for Gonorrhea
Time frame: Day 1
Proportion of Participants With Invalid or Unavailable Point of Care Gram Stain or Rapid STI Test Results
Time frame: Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42017665Jarolimova J, Kong D, Sanders G, Shah P, Psaros C, Parker RA, Ard KL, Bassett IV; STI Rapid Testing Research Group (Nancy H Nicholson, CNP 1, Robert P Ober, FNP 1, Vitor G Cardoso, CNP 1, Diane G Kanjilal, CNP 1, Emily L Perriello, CNP 1, Daniel P Worrall, CNP 8). A rapid molecular test for gonorrhea and chlamydia compared to Gram stain for symptomatic patients in a specialized STI clinic: a randomized controlled trial. Sex Transm Dis. 2026 Apr 22:10.1097/OLQ.0000000000002324. doi: 10.1097/OLQ.0000000000002324. Online ahead of print.
- Individual participant dataSharing planned: No
Related trials for Urethritis
Not yet recruitingPhase 2
Omadacycline for Treatment Refractory Mycoplasma Genitalium Urethritis
Mycoplasma Genitalium Infection, Urethritis
RecruitingPhase 2
"Sexual Health Assessment of TinidaZole Against M. Genitalium (SHAZAM)"
Mycoplasma Genitalium, Non-gonococcal Urethritis (NGU)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ingrid V. Bassett, MD, MPH principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rapid 30-minute Desktop Assay in people with Urethritis and Cervicitis, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Antibiotic Days of Therapy (DOT) Administered Per Patient With Symptomatic Urethritis or Cervicitis (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05564299, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.