(PL20) A RAPID DIAGNOSTIC TEST FOR GONORRHEA AND CHLAMYDIA COMPARED TO GRAM STAIN FOR SYMPTOMATIC PATIENTS IN A SPECIALIZED STI CLINIC: A RANDOMIZED CONTROLLED TRIAL

Background:
Rapid diagnostic platforms that enable point-of-care testing for sexually transmitted infections (STIs) have the potential to decrease empiric antibiotic use, time to treatment, and loss to follow-up. However, the real-world impact of these platforms compared to gram stain in clinical settings has not been evaluated.

Methods:
We are conducting a randomized controlled trial to evaluate the impact of a 30-minute, PCR-based test for gonorrhea and chlamydia on clinical management in a specialized STI clinic. Patients ≥18-years-old of any gender identity presenting with symptoms suggesting urethritis or cervicitis and not known to be STI contacts are eligible. Participants are randomized 1:1 to standard of care (SOC; point-of-care gram stain) or in-clinic urogenital specimen testing for gonorrhea and chlamydia on the binx io platform. Outcomes include antibiotic use per patient (number of treatment courses), time to results, time to etiologic treatment, duration of clinic visit, and 30-day antibiotic use.

Results:
As of June 4, 2024, we have enrolled 96 of 100 participants, 47 to the intervention arm, median age 29 years (interquartile range [IQR] 25-38), 63% identifying as male, 33% female, 3% transgender. Among 94 participants with complete STI results, 15/94 (16.0%) tested positive for gonorrhea and 7/94 (7.5%) for chlamydia. In the rapid test arm, 37/47 (78.7%) remained in clinic to receive results. Overall, 35/96 participants (36.5%) were not prescribed antibiotics active against gonorrhea or chlamydia during the clinic visit; 40/96 (41.7%), 19/96 (19.8%), and 2/96 (2.1%) received one, two, or ≥3 courses of any antibiotics, respectively. Median visit time was 57 minutes [IQR 45-69] for SOC and 87 minutes [IQR 72-97] for the rapid test.

Conclusion:
The majority of symptomatic patients offered a 30-minute diagnostic test for gonorrhea and chlamydia are willing to wait for results. PCR-based rapid tests may enable etiologic diagnoses at the point of care but will extend visit duration.