NCT07399873

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

Investigators will prospectively enroll asymptomatic individuals presenting for STI screening. Individuals will be randomized in a 1:1 manner to receive either standard-of-care screening or standard-of-care plus point-of-care testing for Chlamydia trachomatis and Neisseria gonorrhoeae. Among individuals enrolled and randomized to the intervention arm, investigators will collect an additional vaginal swab among women or urine sample among men for point-of-care testing using the Cobas® Liat CT/NG Assay (Roche, United States). Individuals who test positive for either pathogen (in either arm) will receive treatment according to Centers for Disease Control and Prevention (CDC) guidelines. The time to treatment and the proportion of patients who are on or have completed treatment at day 7 day after the initial visit will be evaluated. Primary Objective: To compare the time to antimicrobial therapy initiation for C. trachomatis and/or N. gonorrhoeae among patients treated according to a point-of-care test plus standard of care versus patients treated according to standard of care alone. Secondary Objective: To evaluate the proportion of patients who have completed or have started therapy by day 7 after a positive C. trachomatis and/or N. gonorrhoeae test result among patients treated according to a point-of-care test plus standard of care versus patients treated according to standard of care alone. As a second aim, investigators will seek to compare performance of a novel clustered regularly interspaced short palindromic repeats (CRISPR)-based point-of-care STI and antimicrobial resistance assay to reference testing on additional samples collected from symptomatic participants in this study.

Conditions

• Neisseria Gonorrhoeae Infection
• Chlamydia Trachomatis Infection

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-06-01
• Primary completion: 2027-01-01
• Completion: 2027-02-01
• First posted: 2026-02-10
• Last updated: 2026-04-17