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

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.