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

StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 months later Jan 2027 → Apr 2027
See other at-risk trials from Massachusetts General Hospital

Record History

  1. Start date: Jun 2026 to Nov 2026 Primary completion pushed from Jan 2027 to Apr 2027 · Completion pushed from Feb 2027 to Jul 2027 · Eligibility criteria expanded, about 5 words Show 3 more changesShow less
    • Primary completion pushed from Jan 2027 to Apr 2027
    • Completion pushed from Feb 2027 to Jul 2027
    • Eligibility criteria expanded, about 5 words
  2. Start date: Mar 2026 to Jun 2026v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07399873
Lead Sponsor Massachusetts General Hospital
Collaborators: Roche Diagnostic Ltd.
Conditions Neisseria Gonorrhoeae Infection, Chlamydia Trachomatis Infection
Enrollment 400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov