A rapid molecular test for gonorrhea and chlamydia compared to Gram stain for symptomatic patients in a specialized STI clinic: a randomized controlled trial

Background: Molecular point-of-care testing (POCT) for sexually transmitted infections (STIs) may decrease antibiotic use, time to treatment, and loss to follow-up. However, the real-world impact of molecular POCTs on clinical management and outcomes in STI clinics is unknown. Methods: We conducted a randomized controlled trial to evaluate the impact of a 30-minute, PCR-based test for gonorrhea and chlamydia among symptomatic patients in an STI clinic. Patients ≥18y with urethritis or cervicitis were randomized 1:1 to standard of care (SOC; point-of-care Gram stain) or PCR-based urogenital gonorrhea and chlamydia testing using the binx io (PCR). Primary outcome was antibiotic days of therapy (DOT); secondary outcomes included diagnosis-concordant antibiotic use and process measures. Focus group discussions with clinic providers explored implementation. Results: We enrolled 49 participants per arm; median age 29.5y (IQR 25-39), 63.3% male. Overall, 16 (16.3%) tested positive for gonorrhea, 7 (7.1%) for chlamydia. In the PCR arm, 39/49 (79.6%) waited to receive results. There was a trend towards fewer antibiotic DOT in the PCR arm (median 1 [IQR 0-7] vs 7 [0-8], p=0.053). At time of clinic visit, 10% more SOC participants unnecessarily received gonorrhea-active antibiotics. Median visit time was 57 minutes [45-69] for SOC and 87 [72-97] for PCR. Providers valued results-directed treatment, however, PCR testing disrupted clinic workflows. Conclusions: A PCR-based POCT for gonorrhea and chlamydia non-significantly decreased antibiotic DOT and overuse in this small study. PCR STI POCTs may improve diagnosis-concordant antibiotic use for symptomatic patients in STI clinics, however, clinic workflows will need to adapt. Trial registration: NCT05564299