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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chlamydia Trachomatis Infection; Neisseria Gonorrhoeae Infection
• Intervention / Treatment: Diagnostic test: Laboratory-based chlamydia and gonorrhea NAAT; Diagnostic test: Point-of-care assay for chlamydia and gonorrhea; Diagnostic test: CRISPR-based assay

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.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kevin L Ard, MD; Phone Number: 617-724-9441; Email: kard@mgh.harvard.edu
• Study Contact Backup: Name: Lao-Tzu Allan-Blitz, MD; Email: lallanblitz@mednet.ucla.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Indication for antimicrobial therapy for C. trachomatis or N. gonorrhoeae at the time of the visit, regardless of test results

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of Care; Participants randomized to the standard-of-care arm will receive STI testing via a routine, laboratory-based assay for C. trachomatis and N. gonorrhoeae.	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.
Experimental: Point-of-care Testing; Participants randomized to this arm will receive a point-of-care testing in addition to standard, laboratory-based testing for C. trachomatis and N. gonorrhoeae.	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: Point-of-care assay for chlamydia and gonorrhea; This intervention consists of use of Cobas® Liat CT/NG Assay (Roche, United States).
Other: CRISPR-based Assay Assessment; Participants in this arm will have collection of additional samples for testing via a research-only, novel CRISPR-based assay for STIs and antimicrobial resistance.	Diagnostic test: CRISPR-based assay; This is a novel assay using CRISPR technology to assess for STIs and antimicrobial resistance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Days to antibiotic initiation	Time, in days, to initiation of antimicrobial therapy for C. trachomatis and N. gonorrhoeae	Time in days (0-365)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antimicrobial therapy initiation within 7 days	Number and proportion of patients completing or starting antimicrobial therapy by day 7 after a positive test for C. trachomatis or N. gonorrhoeae	7 days from baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
CRISPR-based assay performance	Comparison of performance of the CRISPR-based assay to reference testing as measured by the sensitivity and specificity of the CRISPR-based assay for detection Chlamydia trachomatis and Neisseria gonorrhoeae, in relationship to reference testing.	At baseline

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Roche Diagnostic Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: January 4, 2026
• First Submitted That Met QC Criteria: February 5, 2026
• First Posted (Actual): February 10, 2026

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: STI; gonorrhea; chlamydia; sexually transmitted infection; point-of-care testing
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Negative Bacterial Infections; Chlamydiaceae Infections; Sexually Transmitted Diseases, Bacterial; Neisseriaceae Infections; Pathological Conditions, Signs and Symptoms; Sexually Transmitted Diseases; Chlamydia Infections; Gonorrhea
• Other Study ID Numbers: 2025P002645

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will share the de-identified data, study protocol, and analysis plan no later than the time of publication for a period of 2 years.
• IPD Sharing Time Frame: We plan to share this information beginning no later than the time of publication for a period of 2 years.
• IPD Sharing Access Criteria: Researchers will be able to access the information upon request from the investigators, with a description of what the researchers propose to do with the data. A data sharing agreement must be established and approved by both parties' institutions for data sharing to take place. Requests for data sharing will be reviewed by the principal investigator and co-investigator.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No