Neisseria Gonorrhoeae InfectionNCT07399873
Outcomes From Point-of-Care Sexually Transmitted Infection (STI) Testing in an Urban Sexual Health Clinic: A Randomized Trial
A study testing Point-of-care assay for chlamydia and gonorrhea, Laboratory-based chlamydia and gonorrhea NAAT and CRISPR-based assay in people with Neisseria Gonorrhoeae Infection and Chlamydia Trachomatis Infection, run by Massachusetts General Hospital.
Trial summary
The goal of this clinical trial is to learn about the impact of a point-of-care test for gonorrhea and chlamydia in people without symptoms who are seeking sexually transmitted infection testing. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neisseria Gonorrhoeae Infection, Chlamydia Trachomatis Infection
- What is being tested?
- Point-of-care assay for chlamydia and gonorrhea, Laboratory-based chlamydia and gonorrhea NAAT and CRISPR-based assay
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Willing and able to provide informed consent
- Asymptomatic at the urogenital site
- Being screened for urogenital C. trachomatis and/or N. gonorrhoeae as part of routine clinical care
Who cannot join
- Indication for antimicrobial therapy for C. trachomatis or N. gonorrhoeae at the time of the visit, regardless of test results
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Lao-Tzu Allan-Blitz, MD contact
About this study
Official title: Outcomes From Point-of-Care STI Testing in an Urban Sexual Health Clinic: A Randomized Trial
The goal of this clinical trial is to learn about the impact of a point-of-care test for gonorrhea and chlamydia in people without symptoms who are seeking sexually transmitted infection testing. The main questions it aims to answer are:
Does the point of care test reduce the time to antibiotic treatment? Does the point of care test increase the number of people who have completed treatment by day 7?
Researchers will compare the point-of-care test to a standard laboratory-based test for gonorrhea and chlamydia.
Participants will be asked to provide a urine sample or vaginal swab for testing. They will also complete surveys about their experiences with the testing.
Read the detailed description
Investigators will prospectively enroll asymptomatic individuals presenting for STI screening. Individuals will be randomized in a 1:1 manner to receive either standard-of-care screening or standard-of-care plus point-of-care testing for Chlamydia trachomatis and Neisseria gonorrhoeae. Among individuals enrolled and randomized to the intervention arm, investigators will collect an additional vaginal swab among women or urine sample among men for point-of-care testing using the Cobas® Liat CT/NG Assay (Roche, United States). Individuals who test positive for either pathogen (in either arm) will receive treatment according to Centers for Disease Control and Prevention (CDC) guidelines. The time to treatment and the proportion of patients who are on or have completed treatment at day 7 day after the initial visit will be evaluated.
Primary Objective: To compare the time to antimicrobial therapy initiation for C. trachomatis and/or N. gonorrhoeae among patients treated according to a point-of-care test plus standard of care versus patients treated according to standard of care alone.
Secondary Objective: To evaluate the proportion of patients who have completed or have started therapy by day 7 after a positive C. trachomatis and/or N. gonorrhoeae test result among patients treated according to a point-of-care test plus standard of care versus patients treated according to standard of care alone.
As a second aim, investigators will seek to compare performance of a novel clustered regularly interspaced short palindromic repeats (CRISPR)-based point-of-care STI and antimicrobial resistance assay to reference testing on additional samples collected from symptomatic participants in this study.
- Being tested
- Point-of-care assay for chlamydia and gonorrhea, Laboratory-based chlamydia and gonorrhea NAAT, CRISPR-based assay
- Keywords
- gonorrhea, chlamydia, sexually transmitted infection, STI, point-of-care testing
- Medical subject headings
- Gonorrhea, Chlamydia Infections, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point-of-care assay for chlamydia and gonorrheaDiagnostic test
This intervention consists of use of Cobas® Liat CT/NG Assay (Roche, United States).
Laboratory-based chlamydia and gonorrhea NAATDiagnostic test
This intervention consists of routine, laboratory-based diagnostic testing for chlamydia and gonorrhea via nucleic acid amplification.
CRISPR-based assayDiagnostic test
This is a novel assay using CRISPR technology to assess for STIs and antimicrobial resistance.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | Participants randomized to the standard-of-care arm will receive STI testing via a routine, laboratory-based assay for C. trachomatis and N. gonorrhoeae. Receives: Diagnostic Test: Laboratory-based chlamydia and gonorrhea NAAT |
| Point-of-care Testing | Experimental | Participants randomized to this arm will receive a point-of-care testing in addition to standard, laboratory-based testing for C. trachomatis and N. gonorrhoeae. Receives: Diagnostic Test: Point-of-care assay for chlamydia and gonorrhea; Diagnostic Test: Laboratory-based chlamydia and gonorrhea NAAT |
| CRISPR-based Assay Assessment | Other | Participants in this arm will have collection of additional samples for testing via a research-only, novel CRISPR-based assay for STIs and antimicrobial resistance. Receives: Diagnostic Test: CRISPR-based assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days to antibiotic initiation
Time, in days, to initiation of antimicrobial therapy for C. trachomatis and N. gonorrhoeae
Measured: Time in days (0-365)
Secondary outcomes (1)
Antimicrobial therapy initiation within 7 days
Number and proportion of patients completing or starting antimicrobial therapy by day 7 after a positive test for C. trachomatis or N. gonorrhoeae
Measured: 7 days from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study startNov 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neisseria Gonorrhoeae InfectionStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Diagnostic Ltd.
- Responsible party
- Principal investigator, Kevin L, Ard, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07399873
- Sponsor's protocol ID
- 2025P002645
- Status last verified
- Apr 2026
- First submitted
- 4 Jan 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share the de-identified data, study protocol, and analysis plan no later than the time of publication for a period of 2 years.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes From Point-of-Care STI Testing in an Urban Sexual Health Clinic: A Randomized Trial
- ClinicalTrials.gov ID
- NCT07399873
- Acronym / sponsor ID
- 2025P002645
- Keywords
- gonorrhea, chlamydia, sexually transmitted infection, STI, point-of-care testing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Roche Diagnostic Ltd.
- Study start
- Nov 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 10 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn about the impact of a point-of-care test for gonorrhea and chlamydia in people without symptoms who are seeking sexually transmitted infection testing. The main questions it aims to answer are:
Does the point of care test reduce the time to antibiotic treatment? Does the point of care test increase the number of people who have completed treatment by day 7?
Researchers will compare the point-of-care test to a standard laboratory-based test for gonorrhea and chlamydia.
Participants will be asked to provide a urine sample or vaginal swab for testing. They will also complete surveys about their experiences with the testing.
Detailed description
Investigators will prospectively enroll asymptomatic individuals presenting for STI screening. Individuals will be randomized in a 1:1 manner to receive either standard-of-care screening or standard-of-care plus point-of-care testing for Chlamydia trachomatis and Neisseria gonorrhoeae. Among individuals enrolled and randomized to the intervention arm, investigators will collect an additional vaginal swab among women or urine sample among men for point-of-care testing using the Cobas® Liat CT/NG Assay (Roche, United States). Individuals who test positive for either pathogen (in either arm) will receive treatment according to Centers for Disease Control and Prevention (CDC) guidelines. The time to treatment and the proportion of patients who are on or have completed treatment at day 7 day after the initial visit will be evaluated.
Primary Objective: To compare the time to antimicrobial therapy initiation for C. trachomatis and/or N. gonorrhoeae among patients treated according to a point-of-care test plus standard of care versus patients treated according to standard of care alone.
Secondary Objective: To evaluate the proportion of patients who have completed or have started therapy by day 7 after a positive C. trachomatis and/or N. gonorrhoeae test result among patients treated according to a point-of-care test plus standard of care versus patients treated according to standard of care alone.
As a second aim, investigators will seek to compare performance of a novel clustered regularly interspaced short palindromic repeats (CRISPR)-based point-of-care STI and antimicrobial resistance assay to reference testing on additional samples collected from symptomatic participants in this study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Diagnostic Test: Laboratory-based chlamydia and gonorrhea NAATParticipants randomized to the standard-of-care arm will receive STI testing via a routine, laboratory-based assay for C. trachomatis and N. gonorrhoeae. |
| Point-of-care Testing | Experimental | Diagnostic Test: Point-of-care assay for chlamydia and gonorrhea, Diagnostic Test: Laboratory-based chlamydia and gonorrhea NAATParticipants randomized to this arm will receive a point-of-care testing in addition to standard, laboratory-based testing for C. trachomatis and N. gonorrhoeae. |
| CRISPR-based Assay Assessment | Other | Diagnostic Test: CRISPR-based assayParticipants in this arm will have collection of additional samples for testing via a research-only, novel CRISPR-based assay for STIs and antimicrobial resistance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At least 18 years of age
- Willing and able to provide informed consent
- Asymptomatic at the urogenital site
- Being screened for urogenital C. trachomatis and/or N. gonorrhoeae as part of routine clinical care
Key exclusion criteria (1 listed)
- Indication for antimicrobial therapy for C. trachomatis or N. gonorrhoeae at the time of the visit, regardless of test results
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 |
|---|---|---|
| Point-of-care assay for chlamydia and gonorrheaThis intervention consists of use of Cobas® Liat CT/NG Assay (Roche, United States). | Diagnostic test | Point-of-care Testing |
| Laboratory-based chlamydia and gonorrhea NAATThis intervention consists of routine, laboratory-based diagnostic testing for chlamydia and gonorrhea via nucleic acid amplification. | Diagnostic test | Point-of-care Testing, Standard of Care |
| CRISPR-based assayThis is a novel assay using CRISPR technology to assess for STIs and antimicrobial resistance. | Diagnostic test | CRISPR-based Assay Assessment |
Primary outcome
Days to antibiotic initiation
Time frame: Time in days (0-365)
Time, in days, to initiation of antimicrobial therapy for C. trachomatis and N. gonorrhoeae
1 secondary outcome
Antimicrobial therapy initiation within 7 days
Time frame: 7 days from baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: Yes. We will share the de-identified data, study protocol, and analysis plan no later than the time of publication for a period of 2 years.
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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.
Lao-Tzu Allan-Blitz, MD contact
Questions about this trial
What is this clinical trial studying?
A study testing Point-of-care assay for chlamydia and gonorrhea, Laboratory-based chlamydia and gonorrhea NAAT and CRISPR-based assay in people with Neisseria Gonorrhoeae Infection and Chlamydia Trachomatis Infection, run by Massachusetts General Hospital.
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 4 inclusion and 1 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: opening soon, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kevin L Ard, MD (617-724-9441, kard@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Days to antibiotic initiation (time frame: Time in days (0-365)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Oct 2026.