Prevalence of M Genitalium, T Vaginalis, C Trachomatis and N Gonorrhoeae in Women Enrolled in a Prospective Multi-Center US Clinical Study

Background:  This study evaluated the prevalence of M genitalium (MG), C trachomatis (CT), N gonorrhoeae (NG) and T vaginalis (TV) in urogenital samples from female subjects enrolled in a prospective multi-center US clinical trial.

Methods:  Residual specimens [physician-collected vaginal swab (VS), endocervical swab (ES), ThinPrep liquid Pap (TP), and self-collected urine (FU)] obtained from among 800 asymptomatic or symptomatic (urethritis, vaginitis, or cervicitis) women, consented and enrolled from 7 diverse US clinical sites, were tested using a research-use only molecular assay for MG, and FDA-cleared molecular assays for TV, CT, and NG.

Results:  Prevalence of TV and MG infections was high (23.3%, 21.6%) in endocervical swabs and in vaginal swabs (21.7%, 21.7%). CT and NG prevalence rates ranged from 3% to 9.4% in these sample types. TV and MG also showed higher prevalence in TP samples (13%, 11.2%) than CT and NG (8.4%, 1.4%). FU sample prevalence rates for TV, CT, MG and NG were 11.5%, 8.1%, 7.2%, and 1.5%, respectively. Among women with any STI, TV had the highest proportion of single infections (range 32-39% for all sample types), followed by MG (range 20%-31%), and CT (range 9%-20%). MG/TV co-infections ranged from 5%-13%, followed by MG/CT co-infections (4% for all sample types). Among symptomatic women with single infections, NG and MG had slightly higher prevalence for all sample types, compared to women diagnosed with TV or CT. Women with CT/MG, TV/MG, and CT/NG co-infections reported symptoms at higher rates than women with CT/TV co-infection.

Conclusions:  TV and MG had higher prevalence than CT and NG, both as single infections and as co-infections with other sexually-transmitted organisms. Women with single MG infections reported similar rates of urogenital symptoms compared to women with single NG infections.