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

NCT07399873 | Not Yet Recruiting

• 1 other identifier: 2025P002645
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

gonorrhea; chlamydia; sexually transmitted infection; STI; point-of-care testing

Outcome Measures

Primary Outcomes (1)

• Days to antibiotic initiation

  Time, in days, to initiation of antimicrobial therapy for C. trachomatis and N. gonorrhoeae

  Time in days (0-365)

Secondary Outcomes (1)

• Antimicrobial therapy initiation within 7 days

  7 days from baseline

Other Outcomes (1)

• CRISPR-based assay performance

  At baseline

Study Arms (3)

Standard of Care

ACTIVE COMPARATOR

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

Point-of-care Testing

EXPERIMENTAL

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: Point-of-care assay for chlamydia and gonorrhea; Diagnostic Test: Laboratory-based chlamydia and gonorrhea NAAT

CRISPR-based Assay Assessment

OTHER

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

Interventions

Point-of-care assay for chlamydia and gonorrhea DIAGNOSTIC_TEST

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

Point-of-care Testing

Laboratory-based chlamydia and gonorrhea NAAT DIAGNOSTIC_TEST

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

Point-of-care Testing; Standard of Care

CRISPR-based assay DIAGNOSTIC_TEST

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

CRISPR-based Assay Assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Roche Diagnostic Ltd.: collaborator

MeSH Terms

Conditions

Gonorrhea; Chlamydia Infections; Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Communicable Diseases; Genital Diseases; Urogenital Diseases; Chlamydiaceae Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Kevin L Ard, MD

CONTACT

617-724-9441; kard@mgh.harvard.edu

Lao-Tzu Allan-Blitz, MD

CONTACT

lallanblitz@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Sexual Health Clinic

Study Record Dates

• First Submitted: January 4, 2026
• First Posted: February 10, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: We plan to share this information beginning no later than the time of publication for a period of 2 years.
• 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.