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NOT YET RECRUITING
NCT07399873
NA

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

Sponsor: Massachusetts General Hospital

View on ClinicalTrials.gov

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.

Official title: Outcomes From Point-of-Care STI Testing in an Urban Sexual Health Clinic: A Randomized Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

400

Start Date

2026-03

Completion Date

2027-02

Last Updated

2026-02-10

Healthy Volunteers

Yes

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.