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NCT Number: NCT07399873

Outcomes From Point-of-Care Sexually Transmitted Infection (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.

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Key information

Conditions

Neisseria Gonorrhoeae Infection Bacterial Infections Bacterial Infections and Mycoses Chlamydia Infections Chlamydia Trachomatis Infection Chlamydiaceae Infections Communicable Diseases Disease Attributes Genital Diseases Gonorrhea Gram-Negative Bacterial Infections Infections Neisseriaceae Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Bacterial Urogenital Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Point-of-care assay for chlamydia and gonorrhea

Diagnostic Test

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

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.

CRISPR-based assay

Diagnostic Test

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

Primary outcomes

  1. Days to antibiotic initiation

    Time frame: Time in days (0-365)

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

Secondary outcomes

  1. Antimicrobial therapy initiation within 7 days

    Time frame: 7 days from baseline

    Number and proportion of patients completing or starting antimicrobial therapy by day 7 after a positive test for C. trachomatis or N. gonorrhoeae

Other outcomes

  1. CRISPR-based assay performance

    Time frame: At baseline

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kevin L Ard, MD

CONTACT

[email protected]

617-724-9441

Lao-Tzu Allan-Blitz, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Roche Diagnostic Ltd.

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 10, 2026
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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