Rebecca Lillis

Background: Evidence suggests low diagnostic test utilization and high empiric prescribing rates for vaginitis symptoms. This study retrospectively assessed real-world bacterial vaginosis (BV), vulvovaginal candidiasis (VVC), and trichomoniasis (TV) treatment patterns in the United States relative to test results and their timing. Methods: Patients with vaginitis or related symptom diagnosis were identified between 2018 and 2023 in an ambulatory electronic medical record database linked to prescription and outpatient medical claims databases. Pregnant and nonpregnant subgroups were stratified by test type (nucleic acid amplification test [NAAT] panel [BV, VVC, and TV], direct probe, or traditional methods) up to first diagnosis date +2 days. Treatment claims before (empiric) and up to 7 days after (informed) the test result date were assessed. Results: There were 1465 pregnant and 13,447 nonpregnant patients meeting selection criteria; 31.7%, 26.3%, and 2.0% of pregnant and 26.6%, 16.1%, and 2.0% of nonpregnant cohorts had positive results for BV, VVC, and TV, respectively. Empiric treatment was common across treated pregnant subgroups tested with laboratory NAAT panel (55.0%), direct probe (35.5%), and traditional methods (66.7%), and nonpregnant subgroups (55.7%, 52.2%, 74.2%, respectively). Many empiric treatments were not aligned to positive test results, including coinfections (e.g., 6.5%–8.2% of pregnant and 11.7%–13.0% of nonpregnant patients who tested BV positive by NAAT panel or direct probe were empirically treated with antifungal agents for VVC). Conclusions: High empiric treatment rates and evidence of inappropriate treatment highlight the potential utility for rapid, accurate tests to diagnose common vaginal infections, to inform clinical decision making and results-guided prescribing at the point of care.

Background: Given the continued increases in rates of both Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) infection, additional diagnostic assays may be useful in increasing access to testing for these sexually transmitted infections. We evaluated the performance of the NeuMoDx CT/NG Assay 2.0 on the NeuMoDx-96 and NeuMoDx-288 Molecular Systems. Methods: The clinical sensitivity and specificity of the assay were assessed when used with (1) endocervical swabs, (2) self- and clinician-collected vaginal swabs, and (3) first-catch urine specimens (female and male). Results were compared with a patient infection status based on US Food and Drug Administration–cleared assays. Results: The NeuMoDx CT/NG Assay 2.0 demonstrated high sensitivity and specificity in both symptomatic and asymptomatic participants. All specimen types other than endocervical swabs had ≥95% sensitivity and >99% specificity for both pathogens. For endocervical samples, sensitivities were 93.2% and 93.3% for CT and NG, respectively. There was no difference in performance based on platform. The frequency of invalid results was low (<1%). Conclusions: The NeuMoDx CT/NG Assay 2.0 demonstrated performance similar to currently US Food and Drug Administration–cleared assays, with the added choice of a moderate- (96-sample) or a high-throughput (288-sample) platform. The system therefore offers solutions to laboratories running lower volumes of testing that may obviate the need for outsourcing to larger reference laboratories.

Background: Approximately 15% of patients in sexually transmitted infection (STI) clinics report penicillin allergies, complicating treatment for syphilis and gonorrhea. Nonetheless, >90% do not have a penicillin allergy when evaluated. We developed and validated an algorithm to define which patients reporting penicillin allergy can be safely treated at STI clinics with these drugs. Methods: Randomized controlled trial to assess feasibility and safety of penicillin allergy evaluations in STI clinics. Participants with reported penicillin allergy answered an expert-developed questionnaire to stratify risk. Low-risk participants underwent penicillin skin testing (PST) followed by amoxicillin 250 mg challenge or a graded oral challenge (GOC)—amoxicillin 25 mg followed by 250 mg. Reactions were recorded, and participant/provider surveys were conducted. Results: Of 284 participants, 72 (25.3%) were deemed high risk and were excluded. Of 206 low-risk participants, 102 (49.5%) underwent PST without reactions and 3 (3%) had mild reactions during the oral challenge. Of 104 (50.5%) participants in the GOC, 95 (91.3%) completed challenges without reaction, 4 (4.2%) had mild symptoms after 25 mg, and 4 (4.2%) after 250-mg doses. Overall, 195 participants (94.7%) successfully completed the study and 11 (5.3%) experienced mild symptoms. Of 14 providers, 12 (85.7%) completed surveys and 11 (93%) agreed on the safety/effectiveness of penicillin allergy assessment in STI clinics. Conclusions: An easy-to-administer risk-assessment questionnaire can safely identify patients for penicillin allergy evaluation in STI clinics by PST or GOC, with GOC showing operational feasibility. Using this approach, 67% of participants with reported penicillin allergy could safely receive first-line treatments for gonorrhea or syphilis. Clinical Trials Registration. Clinicaltrials.gov (NCT04620746).

The 2022 outbreak of Mpox in Louisiana was limited to just over 300 cases, perhaps an unexpected outcome given the state’s high rates of HIV and other STIs. We aimed to describe the local outbreak within two health centers in the New Orleans region, partnering with the Louisiana Department of Health to offer additional statewide data. We reviewed charts of persons testing positive for Mpox in New Orleans from July to November 2022 at two local health centers that together accounted for half of local cases. We abstracted data on HIV status, immune function (CD4 count, viral load), anti-retroviral therapy regimen, symptoms and severity of infection, vaccinations status, and whether tecovirimat was administered. We present local data relative to statewide data (July 2022-January 2023). Of 103 individuals in our network for whom charts were reviewed, 96 (93%) identified as male, 52 (50%) were Black, and 69 (67%) had HIV, including 12 (17%) with uncontrolled HIV (CD4 200 copies/ml). The most common presenting symptoms were rash (n=71, 69%), fever (n=36, 35%), and rectal pain (n=33, 32%). Of 6 (6%) patients hospitalized, 4 (67%) were persons with HIV (PWH). Two were hospitalized for severe Mpox infection with more than 100 lesions at presentation; both were PWH, and one had uncontrolled infection. Across the state, 307 cases have been identified and 24 have been hospitalized. Of those hospitalized, 18 (75%) were PWH, including 9 (50%) with uncontrolled HIV. The demographic data from Louisiana, a state with high prevalence of STIs and HIV/AIDS, are consistent with prior reports describing the 2022 Mpox outbreak. Our results contribute to accumulating data on the severity of infection in individuals with HIV-related immunocompromise.

Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) are the most common notifiable sexually transmitted infections (STIs) in the United States. Because symptoms of these infections often overlap with other urogenital infections, misdiagnosis and incorrect treatment can occur unless appropriate STI diagnostic testing is performed in clinical settings. The objective of this study was to describe STI diagnostic testing and antimicrobial treatment patterns and trends among adolescent and adult men and women with lower genitourinary tract symptoms (LGUTS). We analyzed insurance claims data from the IBM® MarketScan® Research Databases. Patients included were between 14 and 64 years old with LGUTS as determined by selected International Classification of Diseases codes between January 2010 and December 2019. Testing of STIs and relevant drug claims were captured, and distribution of testing patterns and drug claims were described. In total, 23,537,812 episodes with LGUTS (87.4% from women; 12.6% from men) were analyzed from 12,341,154 patients. CT/NG testing occurred in only 17.6% of all episodes. For episodes where patients received treatment within 2 weeks of the visit date, 89.3% received treatment within the first 3 days (likely indicating presumptive treatment), and 77.7% received it on the first day. For women with pelvic inflammatory disease and men with orchitis/epididymitis and acute prostatitis, ≤ 15% received CT/NG testing, and around one-half received antibiotic treatment within 3 days. Our study revealed low CT/NG testing rates, even in patients diagnosed with complications commonly associated with these STIs, along with high levels of potentially inappropriate presumptive treatment. This highlights the need for timely and accurate STI diagnosis in patients with LGUTS to inform appropriate treatment recommendations.

The epidemiology of bacterial vaginosis (BV) suggests it is sexually transmissible, yet no transmissible agent has been identified. It is probable that BV-associated bacterial communities are transferred from male to female partners during intercourse; however, the microbiota of sexual partners has not been well-studied. Pyrosequencing analysis of PCR-amplified 16S rDNA was used to examine BV-associated bacteria in monogamous couples with and without BV using vaginal, male urethral, and penile skin specimens. The penile skin and urethral microbiota of male partners of women with BV was significantly more similar to the vaginal microbiota of their female partner compared to the vaginal microbiota of non-partner women with BV. This was not the case for male partners of women with normal vaginal microbiota. Specific BV-associated species were concordant in women with BV and their male partners. In monogamous heterosexual couples in which the woman has BV, the significantly higher similarity between the vaginal microbiota and the penile skin and urethral microbiota of the male partner, supports the hypothesis that sexual exchange of BV-associated bacterial taxa is common.

This study assessed the utility of urine, vaginal, cervical, and rectal specimens for the detection of Mycoplasma genitalium in women by using our laboratory-developed PCR assay. The relative sensitivity was 85.7% for the vaginal swab specimen, 74.3% for the endocervical swab specimen, 61.4% for the urine specimen, and 24.3% for the rectal swab specimen.

Several methods have been reported for strain typing of Mycoplasma genitalium. The value of these methods has never been comparatively assessed. The aims of this study were: 1) to identify new potential genetic markers based on an analysis of short tandem repeat (STR) sequences in the published M. genitalium genome sequence; 2) to apply previously and newly identified markers to a panel of clinical strains in order to determine the optimal combination for an efficient multi-locus genotyping system; 3) to further confirm sexual transmission of M. genitalium using the newly developed system.