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Outcomes From Point-of-Care Sexually Transmitted Infection (STI) Testing in an Urban Sexual Health Clinic: A Randomized Trial

ConditionsNeisseria Gonorrhoeae InfectionChlamydia Trachomatis Infection
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Indication for antimicrobial therapy for C. trachomatis or N. gonorrhoeae at the time of the visit, regardless of test results

Trial design

Design model

Parallel

Treatments tested in this trial

  • Point-of-care assay for chlamydia and gonorrhea

    Diagnostic test

    This intervention consists of use of Cobas® Liat CT/NG Assay (Roche, United States).

  • Laboratory-based chlamydia and gonorrhea NAAT

    Diagnostic test

    This intervention consists of routine, laboratory-based diagnostic testing for chlamydia and gonorrhea via nucleic acid amplification.

  • CRISPR-based assay

    Diagnostic test

    This is a novel assay using CRISPR technology to assess for STIs and antimicrobial resistance.

Treatment groups

400 Participants
are divided into 3 treatment groups
Group A: Standard of CareActive comparator 1 intervention
Group B: Point-of-care TestingExperimental treatment 2 interventions
Group C: CRISPR-based Assay AssessmentOther 1 intervention

Trial outcomes

Primary outcomes

1

Days to antibiotic initiation

Time, in days, to initiation of antimicrobial therapy for C. trachomatis and N. gonorrhoeae

Time frame
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

Time frame
7 days from baseline

Other outcomes

1

CRISPR-based assay performance

Comparison of performance of the CRISPR-based assay to reference testing as measured by the sensitivity and specificity of the CRISPR-based assay for detection Chlamydia trachomatis and Neisseria gonorrhoeae, in relationship to reference testing.

Time frame
At baseline

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts General Hospital

Lead sponsor

Roche Diagnostic Ltd.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: