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

NCT07399873 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2026-04-17

No results posted yet for this study

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. 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.

Conditions

  • Neisseria Gonorrhoeae Infection
  • Chlamydia Trachomatis Infection

Interventions

DIAGNOSTIC_TEST

Point-of-care assay for chlamydia and gonorrhea

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

DIAGNOSTIC_TEST

Laboratory-based chlamydia and gonorrhea NAAT

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

DIAGNOSTIC_TEST

CRISPR-based assay

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2027-01-31
Completion
2027-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07399873 on ClinicalTrials.gov