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

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

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

Treatments tested in this trial

  • Point-of-care assay for chlamydia and gonorrhea
  • Laboratory-based chlamydia and gonorrhea NAAT
  • CRISPR-based assay

Treatment groups

400 Participants
are divided into 3 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Massachusetts General Hospital

Lead sponsor

Roche Diagnostic Ltd.

Collaborator