CDC Clinical Guidelines on the Use of Doxycycline Postexposure Prophylaxis for Bacterial Sexually Transmitted Infection Prevention, United States, 2024.

No vaccines and few chemoprophylaxis options exist for the prevention of bacterial sexually transmitted infections (STIs) (specifically syphilis, chlamydia, and gonorrhea). These infections have increased in the United States and disproportionately affect gay, bisexual, and other men who have sex with men (MSM) and transgender women (TGW). In three large randomized controlled trials, 200 mg of doxycycline taken within 72 hours after sex has been shown to reduce syphilis and chlamydia infections by >70% and gonococcal infections by approximately 50%. This report outlines CDC's recommendation for the use of doxycycline postexposure prophylaxis (doxy PEP), a novel, ongoing, patient-managed biomedical STI prevention strategy for a selected population. CDC recommends that MSM and TGW who have had a bacterial STI (specifically syphilis, chlamydia, or gonorrhea) diagnosed in the past 12 months should receive counseling that doxy PEP can be used as postexposure prophylaxis to prevent these infections. Following shared decision-making with their provider, CDC recommends that providers offer persons in this group a prescription for doxy PEP to be self-administered within 72 hours after having oral, vaginal, or anal sex. The recommended dose of doxy PEP is 200 mg and should not exceed a maximum dose of 200 mg every 24 hours.Doxy PEP, when offered, should be implemented in the context of a comprehensive sexual health approach, including risk reduction counseling, STI screening and treatment, recommended vaccination and linkage to HIV PrEP, HIV care, or other services as appropriate. Persons who are prescribed doxy PEP should undergo bacterial STI testing at anatomic sites of exposure at baseline and every 3-6 months thereafter. Ongoing need for doxy PEP should be assessed every 3-6 months as well. HIV screening should be performed for HIV-negative MSM and TGW according to current recommendations.

Social Factors Associated with Congenital Syphilis in Missouri.

BACKGROUND: Congenital syphilis disproportionately affects individuals impacted by adverse social determinants of health. Understanding these determinants may help facilitate holistic care. METHODS: We performed a retrospective review of mother-infant dyads with potential congenital syphilis in a Missouri hospital system. Cases were classified per Centers for Disease Control and Prevention clinical scenarios. Information was collected regarding demographics, prenatal care, substance use, and other social factors. Dyads with confirmed/highly probable or possible congenital syphilis ("congenital syphilis outcomes") were compared to those with less likely/unlikely congenital syphilis ("non-congenital syphilis outcomes") using descriptive statistics. RESULTS: We identified 131 dyads with infant dates of birth from 12/2015-6/2022: 74 (56%) with congenital syphilis outcomes and 56 (43%) with non-congenital syphilis outcomes. Most mothers were Black/African American (n = 84, 65%) and lived in areas with high Social Vulnerability Indices. Many had inadequate prenatal care (n = 61, 47%) and/or substance use histories (n = 55, 42%). Significant associations with congenital syphilis outcomes included limited prenatal care (OR 3.01, 95% CI 1.38-6.56), no prenatal care (OR 16.08, 95% CI 1.96-132.11), substance use (OR 3.42, 95% CI 1.61-7.25), housing instability (OR 3.42, 95% CI 1.39-8.38), and justice system interactions (OR 2.29, 95% CI 1.00-5.24). Substance use correlated with prenatal care adequacy (p < 0.001). 30% of infants with congenital syphilis outcomes were taken into protective custody. CONCLUSIONS: Adverse social determinants of health are common in dyads impacted by congenital syphilis. Health systems should consider interdisciplinary programming to improve testing and linkage to care. Future studies should evaluate social support for congenital syphilis prevention and management.

Lasting Impact of the COVID-19 Pandemic on Care and Prevention of Sexually Transmitted Infections in the Midwest.

BACKGROUND: The COVID-19 pandemic reduced the general accessibility of health services. Many sexually transmitted infection (STI) testing and treatment sites modified services (e.g., reduced hours, limited walk-in availability, decreased testing capacity), changes that may result in permanent change in STI service availability. At the same time, systems were driven to innovate in ways that could benefit patients. This study aimed to describe how the COVID-19 pandemic changed STI clinical services, with a focus on long-term impacts. METHODS: In July 2022, a phone survey was designed to assess services for STIs at the 105 STI testing and treatment providers in the St. Louis metropolitan statistical area. Sexually transmitted infection testing providers included STI clinics, primary care clinics that cater to a broad population, and community-based organizations, and excluded emergency departments and urgent care centers. In most cases, the survey was completed by a clinic manager, medical director, or nursing staff member. RESULTS: Of the 75 locations that were interviewed, 12 (16%) had not returned to prepandemic capacity and operations as of July 2022. Five sites had closed completely since the pandemic began, 3 of which are in the northwestern region of the metropolitan statistical area. Most (58.6%) of the open clinics had added telehealth appointments. CONCLUSIONS: Sexually transmitted infection testing sites decreased during the pandemic with lasting impact in one area of the Midwest. Resources to support STI infrastructure should be expanded. Maintaining updated information on STI care providers in the region can aid future assessments.

Taking a Sexual History: Best Practices.

Recognizing the holistic definitions of sexual health, health-care providers must approach sexual health history taking with sensitivity, inclusivity, and a trauma-informed perspective. Many versions of what a sexual history should look like exist but certain principles are commonly found. Education of health-care providers on sexual history taking can involve reviewing the components of the sexual history but should also include the importance of using nonstigmatizing language, having a patient-centered approach, and practicing trauma-informed and culturally sensitive care.

Safety of Longer-Term Doxycycline Use: A Systematic Review and Meta-Analysis With Implications for Bacterial Sexually Transmitted Infection Chemoprophylaxis.

BACKGROUND: Sexually transmitted infections (STIs) such as syphilis, gonorrhea, and chlamydia have significantly increased over the past decade in the United States. Doxycycline as chemoprophylaxis (i.e., postexposure prophylaxis) offers promise for addressing bacterial STIs. The goal of the current study was to evaluate the safety of longer-term doxycycline use (defined as 8 or more weeks) in the context of potential use as STI chemoprophylaxis through a systematic literature review and meta-analysis. METHODS: This review used the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines to search MEDLINE/PubMed for clinical studies published from August 2003 to January 2023 that reported on adverse events with doxycycline use with a focus on side effects and metabolic effects of long-term use. RESULTS: A total of 67 studies were included in the systematic review. Overall, studies on longer-term doxycycline use reported 0% to greater than 50% adverse events ranging from mild to severe. Most common adverse events included gastrointestinal symptoms (i.e., nausea, vomiting, and abdominal pain), dermatologic (i.e., rash), and neurological (i.e., headache and dizziness) symptoms. Discontinuation of doxycycline due to adverse events was relatively uncommon in most studies. A meta-analysis of placebo controlled clinical trials (N = 18) revealed that gastrointestinal and dermatological adverse events were more likely to occur in the doxycycline group. CONCLUSIONS: Longer-term (8+ weeks) doxycycline use is generally safe and may be associated with minor side effects. Further research is needed on the potential metabolic impact of longer-term doxycycline use.

Mycoplasma genitalium in the US (MyGeniUS): Surveillance Data From Sexual Health Clinics in 4 US Regions.

BACKGROUND: Mycoplasma genitalium (MG) is on the CDC Watch List of Antimicrobial Resistance Threats, yet there is no systematic surveillance to monitor change. METHODS: We initiated surveillance in sexual health clinics in 6 cities, selecting a quota sample of urogenital specimens tested for gonorrhea and/or chlamydia. We abstracted patient data from medical records and detected MG and macrolide-resistance mutations (MRMs) by nucleic acid amplification testing. We used Poisson regression to estimate adjusted prevalence ratios (aPRs) and 95% CIs, adjusting for sampling criteria (site, birth sex, symptom status). RESULTS: From October-December 2020 we tested 1743 urogenital specimens: 57.0% from males, 46.1% from non-Hispanic Black persons, and 43.8% from symptomatic patients. MG prevalence was 16.6% (95% CI: 14.9-18.5%; site-specific range: 9.9-23.5%) and higher in St Louis (aPR: 1.9; 1.27-2.85), Greensboro (aPR: 1.8; 1.18-2.79), and Denver (aPR: 1.7; 1.12-2.44) than Seattle. Prevalence was highest in persons <18 years (30.4%) and declined 3% per each additional year of age (aPR: .97; .955-.982). MG was detected in 26.8%, 21.1%, 11.8%, and 15.4% of urethritis, vaginitis, cervicitis, and pelvic inflammatory disease (PID), respectively. It was present in 9% of asymptomatic males and 15.4% of asymptomatic females, and associated with male urethritis (aPR: 1.7; 1.22-2.50) and chlamydia (aPR: 1.7; 1.13-2.53). MRM prevalence was 59.1% (95% CI: 53.1-64.8%; site-specific range: 51.3-70.6%). MRMs were associated with vaginitis (aPR: 1.8; 1.14-2.85), cervicitis (aPR: 3.5; 1.69-7.30), and PID cervicitis (aPR: 1.8; 1.09-3.08). CONCLUSIONS: MG infection is common in persons at high risk of sexually transmitted infections; testing symptomatic patients would facilitate appropriate therapy. Macrolide resistance is high and azithromycin should not be used without resistance testing.

Sustained effect of LACTIN-V (Lactobacillus crispatus CTV-05) on genital immunology following standard bacterial vaginosis treatment: results from a randomised, placebo-controlled trial.

BACKGROUND: Bacterial vaginosis might increase HIV risk by eliciting genital inflammation and epithelial barrier disruption, whereas vaginal Lactobacillus crispatus is associated with immune quiescence and HIV protection. We investigated the effect of a live biotherapeutic containing L crispatus CTV-05 (LACTIN-V) on genital immunology and key vaginal bacteria. METHODS: This substudy included women aged 18-45 years who participated in the randomised, placebo-controlled, phase 2b trial of LACTIN-V to reduce bacterial vaginosis recurrence, conducted at four universities and hospitals in the USA. Women with negative results for sexually transmitted infection, pregnancy, and urinary tract infection were provided a 5-day course of vaginal metronidazole 0·75% gel. Those who met at least three of four clinical Amsel criteria for bacterial vaginosis and had a Nugent score of 4-10 from Gram staining were eligible. Participants in the LACTIN-V trial were randomly assigned (2:1) to receive either LACTIN-V or placebo, applied vaginally once per day for 5 days during the first week and then twice per week for 10 more weeks. Follow-up visits occurred 4, 8, 12, and 24 weeks after enrolment. Soluble immune factors and the absolute abundance of bacterial taxa were assayed by mutliplex ELISA and quantitative PCR. The primary outcomes were vaginal levels of IL-1α and soluble E-cadherin at 24 weeks (ie, 13 weeks after treatment cessation). FINDINGS: Between Feb 21, 2020 and March 18, 2021, we characterised genital immune parameters and the vaginal microbiota in a subset of 66 highly adherent participants who were randomly selected, with no exclusion criteria, from those who had attended all study follow-up visits (n=166) in the larger LACTIN-V clinical trial (n=288). 32 (48%) participants received LACTIN-V and 34 (52%) received placebo. LACTIN-V treatment was significantly associated with lower concentrations of the proinflammatory cytokine IL-1α (ß coefficient 0·310, SE 0·149; p=0·042) and soluble E-cadherin (0·429, 0·199; p=0·035), a biomarker of epithelial barrier disruption. INTERPRETATION: Vaginal administration of LACTIN-V following standard bacterial vaginosis therapy resulted in a sustained reduction in genital inflammation and a biomarker of epithelial integrity. The potential of LACTIN-V to reduce HIV susceptibility merits further investigation. FUNDING: Canadian Institutes of Health Research and the National Institutes of Health National Institute of Allergy and Infectious Diseases.

Selective Whole-Genome Amplification as a Tool to Enrich Specimens with Low Treponema pallidum Genomic DNA Copies for Whole-Genome Sequencing.

Downstream next-generation sequencing (NGS) of the syphilis spirochete Treponema pallidum subspecies pallidum (T. pallidum) is hindered by low bacterial loads and the overwhelming presence of background metagenomic DNA in clinical specimens. In this study, we investigated selective whole-genome amplification (SWGA) utilizing multiple displacement amplification (MDA) in conjunction with custom oligonucleotides with an increased specificity for the T. pallidum genome and the capture and removal of 5'-C-phosphate-G-3' (CpG) methylated host DNA using the NEBNext Microbiome DNA enrichment kit followed by MDA with the REPLI-g single cell kit as enrichment methods to improve the yields of T. pallidum DNA in isolates and lesion specimens from syphilis patients. Sequencing was performed using the Illumina MiSeq v2 500 cycle or NovaSeq 6000 SP platform. These two enrichment methods led to 93 to 98% genome coverage at 5 reads/site in 5 clinical specimens from the United States and rabbit-propagated isolates, containing >14 T. pallidum genomic copies/µL of sample for SWGA and >129 genomic copies/µL for CpG methylation capture with MDA. Variant analysis using sequencing data derived from SWGA-enriched specimens showed that all 5 clinical strains had the A2058G mutation associated with azithromycin resistance. SWGA is a robust method that allows direct whole-genome sequencing (WGS) of specimens containing very low numbers of T. pallidum, which has been challenging until now. IMPORTANCE Syphilis is a sexually transmitted, disseminated acute and chronic infection caused by the bacterial pathogen Treponema pallidum subspecies pallidum. Primary syphilis typically presents as single or multiple mucocutaneous lesions and, if left untreated, can progress through multiple stages with various clinical manifestations. Molecular studies often rely on direct amplification of DNA sequences from clinical specimens; however, this can be impacted by inadequate samples due to disease progression or timing of patients seeking clinical care. While genotyping has provided important data on circulating strains over the past 2 decades, WGS data are needed to better understand strain diversity, perform evolutionary tracing, and monitor antimicrobial resistance markers. The significance of our research is the development of an SWGA DNA enrichment method that expands the range of clinical specimens that can be directly sequenced to include samples with low numbers of T. pallidum.

Characteristics of the Audience Reached by the National Network of Sexually Transmitted Disease Clinical Prevention Training Centers and Correlation With Sexually Transmitted Infection Rates, 2015 to 2020.

BACKGROUND: The National Network of Sexually Transmitted Disease Clinical Prevention Training Centers (NNPTC) trains clinical providers to diagnose and treat sexually transmitted infections (STIs) in the United States. The purpose of this study was to examine the demographics of clinical providers and to correlate the number of training episodes with STI rates at the county level. METHODS: Registration data were collected between April 1, 2015, and March 31, 2020, in a custom Learning Management System from clinical providers taking NNPTC training. Using the 2018 STI surveillance data, counties were divided into quartiles based on reportable STI case rates and the number of county-level training events was compared per quartile. Univariate and multivariate analyses were conducted in IBM SPSS Statistics 23 (Armonk, NY) and SAS Enterprise Guide 7.1 (Cary, NC). RESULTS: From 2015 to 2020, the NNPTC trained 21,327 individuals, predominantly in the nursing professions and working in a public health environment. In multivariate analysis, the number of training events was significantly associated with higher STI rates at the county level (P < 0.0001) and the state where a prevention training center is located (P < 0001). CONCLUSIONS: The analysis suggests that NNPTC trainings are reaching the clinical providers working in geographic areas with higher STI rates.

Metronidazole treatment rapidly reduces genital inflammation through effects on bacterial vaginosis-associated bacteria rather than lactobacilli.

BackgroundBacterial vaginosis (BV) causes genital inflammation and increases HIV risk, whereas a vaginal microbiota dominated by Lactobacillus species is associated with immune quiescence and relative HIV protection. BV treatment reduces genital inflammation, but it is unclear whether this reduction is driven by a decrease in BV-associated bacteria or an increase in Lactobacillus species.METHODSTo evaluate the short-term effect of standard BV treatment on genital immunology and the vaginal microbiota, vaginal swabs were collected immediately before and after metronidazole treatment for BV and analyzed with multiplex ELISA, metagenomic sequencing, and quantitative PCR.RESULTSTopical metronidazole treatment rapidly reduced vaginal levels of proinflammatory cytokines, chemokines, and soluble immune markers of epithelial barrier disruption. Although the vaginal microbiota shifted to dominance by L. iners or L. jensenii, this proportional shift was primarily driven by a 2 to 4 log10-fold reduction in BV-associated bacteria absolute abundance. BV treatment induced no change in the absolute abundance of L. crispatus or L. iners and only minor (<1 log10-fold) increases in L. gasseri and L. jensenii that were not independently associated with reduced inflammation in multivariable models.CONCLUSIONThe genital immune benefits that are associated with Lactobacillus dominance after BV treatment were not directly attributable to an absolute increase in lactobacilli, but rather to the loss of BV-associated bacteria.Trial REGISTRATIONParticipants were recruited as part of a randomized controlled trial (ClinicalTrials.gov NCT02766023) from 2016 to 2019.FUNDINGCanadian Institutes of Health Research (PJT-156123) and the National Institute of Allergy and Infectious Diseases (HHSN2722013000141 and HHSN27200007).

Value of Packaged Testing for Sexually Transmitted Infections for Persons who Inject Drugs Hospitalized With Serious Injection-Related Infections.

BACKGROUND: Persons who inject drugs (PWID) are frequently admitted for serious injection-related infections (SIRIs). PWID are also at risk for sexually transmitted infections (STIs). METHODS: We conducted a multicenter quality improvement project at 3 hospitals in Missouri. PWID with SIRI who received an infectious diseases consultation were prospectively identified and placed into an electronic database as part of a Centers for Disease Control and Prevention-funded quality improvement project. Baseline data were collected from 8/1/2019 to 1/30/2020. During the intervention period (2/1/2020-2/28/2021), infectious diseases physicians caring for patients received 2 interventions: (1) email reminders of best practice screening for HIV, viral hepatitis, and STIs; (2) access to a customized EPIC SmartPhrase that included checkboxes of orders to include in assessment and plan of consultation notes. STI screening rates were compared before and after the intervention. We then calculated odds ratios to evaluate for risk factors for STIs in the cohort. RESULTS: Three hundred ninety-four unique patients were included in the cohort. Initial screening rates were highest for hepatitis C (88%), followed by HIV (86%). The bundled intervention improved screening rates for all conditions and substantially improved screening rates for gonorrhea, chlamydia, and syphilis (30% vs 51%, 30% vs 51%, and 39 vs 60%, respectively; P < .001). Of patients who underwent screening, 16.9% were positive for at least 1 STI. In general, demographics were not strongly associated with STIs. CONCLUSIONS: PWID admitted for SIRI frequently have unrecognized STIs. Our bundled intervention improved STI screening rates, but additional interventions are needed to optimize screening.

Sexually Transmitted Infections Treatment Guidelines, 2021.

These guidelines for the treatment of persons who have or are at risk for sexually transmitted infections (STIs) were updated by CDC after consultation with professionals knowledgeable in the field of STIs who met in Atlanta, Georgia, June 11-14, 2019. The information in this report updates the 2015 guidelines. These guidelines discuss 1) updated recommendations for treatment of Neisseria gonorrhoeae, Chlamydia trachomatis, and Trichomonas vaginalis; 2) addition of metronidazole to the recommended treatment regimen for pelvic inflammatory disease; 3) alternative treatment options for bacterial vaginosis; 4) management of Mycoplasma genitalium; 5) human papillomavirus vaccine recommendations and counseling messages; 6) expanded risk factors for syphilis testing among pregnant women; 7) one-time testing for hepatitis C infection; 8) evaluation of men who have sex with men after sexual assault; and 9) two-step testing for serologic diagnosis of genital herpes simplex virus. Physicians and other health care providers can use these guidelines to assist in prevention and treatment of STIs.

Post-exposure prophylaxis for human immunodeficiency virus after sexual assault in a Midwestern U.S. emergency department.

BACKGROUND: Emergency departments (EDs) play an essential role in the timely initiation of HIV post-exposure prophylaxis (PEP) for sexual assault victims. METHODS: Retrospective analysis of sexual assault victims evaluated and offered HIV PEP in an urban academic ED between January 1, 2005 and January 1, 2018. Data on demographics, comorbidities, nature of sexual assault, initial ED care, subsequent healthcare utilization within 28 days of initial ED visit, and evidence of seroconversion within 6 months of the initial ED visit were obtained. Predictors of subsequent ED visit and follow-up in the infectious diseases clinic were evaluated using logistic regression analysis. RESULTS: Four hundred twenty-three ED visits met criteria for inclusion in this study. Median age at ED presentation was 25 years (IQR 21-34 years), with the majority of victims being female (95.5%), Black (63.4%), unemployed (66.3%) and uninsured (53.9%); psychiatric comorbidities (38.8%) and substance abuse (23.6%) were common. About 87% of the patients accepted HIV PEP (368 of 423 ED visits). Age (OR 0.97, 95% CI 0.94-0.99, p = 0.025) and sexual assault involving >1 assailant (OR 0.48, 95% CI 0.26-0.88, p = 0.018) were associated with lower likelihood of HIV PEP acceptance. Ten patients (2.7%) followed up with the infectious disease clinic within 28 days of starting HIV PEP; 70 patients (19%) returned to the ED for care during the same time period. Psychiatric comorbidity (OR 2.48, 95% CI 1.43-4.30, p = 0.001) and anal penetration (OR 2.02, 95% CI 1.10-3.70, p = 0.024) were associated with greater likelihood of repeat ED visit; female gender (OR 0.30, 95% CI 0.11-0.85, p = 0.023) was associated with lower likelihood of repeat visit. Completion of HIV PEP was documented for 14 (3.3%) individuals. CONCLUSIONS: While ED patient acceptance of HIV PEP after sexual assault was high, infectious disease clinic follow-up and documented completion of PEP remained low. Innovative care models bridging EDs to outpatient clinics and community support services are needed to optimize transitions of care for sexual assault victims, including those receiving HIV PEP.

Sexual History Taking in Clinical Settings: A Narrative Review.

BACKGROUND: This study aimed to explore gaps between Centers for Disease Control and Prevention's clinical guidelines for obtaining a sexual history and regular clinical practice. We examine how patient, provider, and setting characteristics may influence the likelihood of obtaining comprehensive sexual histories and examine patient outcomes linked to sexual history taking. METHODS: We performed a narrative review to identify studies that examined clinical practice and sexual history taking via 8 databases. A 2-level inclusion protocol was followed, wherein the abstract and full text of the article were reviewed, respectively. Data were abstracted using a standardized tool developed for this study. RESULTS: The search yielded 2700 unique studies, of which 2193 were excluded in level 1, and 497 were excluded in level 2, leaving 10 studies for data abstraction. None of the studies reported comprehensive sexual history taking, and 8 studies reported differences in how providers obtain a sexual history when patient and provider demographics are considered. Three studies found a positive link between providers who discuss sexual history and provider sexually transmitted disease testing. CONCLUSIONS: When sexual histories are obtained, they are not comprehensive, and providers may discuss sexual history differentially based on patients' demographic characteristics. Providers who discuss patients' sexual history may be more likely to also provide sexual health preventive care.

The Emerging Intersection Between Injection Drug Use and Early Syphilis in Nonurban Areas of Missouri, 2012-2018.

BACKGROUND: The national rate of syphilis has increased among persons who inject drugs (PWID). Missouri is no exception, with increases in early syphilis (ES), congenital syphilis, and PWID, especially in nonurban counties. METHODS: Disease intervention specialist records for ES cases in Missouri (2012-2018) were examined. Drug use was classified as injection drug use (IDU) (opioid or methamphetamine) or non-IDU (opioid, methamphetamine, or cocaine). Rates were compared based on residence, sex of sex partner, and drug use. RESULTS: Rates of ES in Missouri increased 365%, particularly in small metropolitan and rural areas (1170%). Nonurban areas reported a higher percentage of persons with ES who used injection drugs (12%-15%) compared with urban regions (2%-5%). From 2012 to 2018, women comprised an increasing number of ES cases (8.3%-21%); 93% of women were of childbearing age. Increasingly more women in rural areas with ES also reported IDU during this time (8.4%-21.1%). CONCLUSIONS: As syphilis increases in small metropolitan and rural regions, access to high-quality and outreach-based sexual health services is imperative. Healthcare policy to equip health departments with harm reduction services and drug treatment resources offers an opportunity to impact both syphilis increases as well as health outcomes associated with IDU.

Glycan cross-feeding supports mutualism between Fusobacterium and the vaginal microbiota.

Women with bacterial vaginosis (BV), an imbalance of the vaginal microbiome, are more likely to be colonized by potential pathogens such as Fusobacterium nucleatum, a bacterium linked with intrauterine infection and preterm birth. However, the conditions and mechanisms supporting pathogen colonization during vaginal dysbiosis remain obscure. We demonstrate that sialidase activity, a diagnostic feature of BV, promoted F. nucleatum foraging and growth on mammalian sialoglycans, a nutrient resource that was otherwise inaccessible because of the lack of endogenous F. nucleatum sialidase. In mice with sialidase-producing vaginal microbiotas, mutant F. nucleatum unable to consume sialic acids was impaired in vaginal colonization. These experiments in mice also led to the discovery that F. nucleatum may also "give back" to the community by reinforcing sialidase activity, a biochemical feature of human dysbiosis. Using human vaginal bacterial communities, we show that F. nucleatum supported robust outgrowth of Gardnerella vaginalis, a major sialidase producer and one of the most abundant organisms in BV. These results illustrate that mutually beneficial relationships between vaginal bacteria support pathogen colonization and may help maintain features of dysbiosis. These findings challenge the simplistic dogma that the mere absence of "healthy" lactobacilli is the sole mechanism that creates a permissive environment for pathogens during vaginal dysbiosis. Given the ubiquity of F. nucleatum in the human mouth, these studies also suggest a possible mechanism underlying links between vaginal dysbiosis and oral sex.

Randomized Trial of Lactin-V to Prevent Recurrence of Bacterial Vaginosis.

BACKGROUND: Bacterial vaginosis affects 15 to 50% of women of reproductive age, and recurrence is common after treatment with an antibiotic agent. The high incidence of recurrence suggests the need for new treatments to prevent recurrent bacterial vaginosis. METHODS: We conducted a randomized, double-blind, placebo-controlled, phase 2b trial to evaluate the ability of Lactobacillus crispatus CTV-05 (Lactin-V) to prevent the recurrence of bacterial vaginosis. Women 18 to 45 years of age who had received a diagnosis of bacterial vaginosis and who had completed a course of vaginal metronidazole gel as part of the eligibility requirements were randomly assigned, in a 2:1 ratio, to receive vaginally administered Lactin-V or placebo for 11 weeks; follow-up occurred through week 24. The primary outcome was the percentage of women who had a recurrence of bacterial vaginosis by week 12. RESULTS: A total of 228 women underwent randomization: 152 to the Lactin-V group and 76 to the placebo group; of these participants, 88% in the Lactin-V group and 84% in the placebo group could be evaluated for the primary outcome. In the intention-to-treat population, recurrence of bacterial vaginosis by week 12 occurred in 46 participants (30%) in the Lactin-V group and in 34 participants (45%) in the placebo group (risk ratio after multiple imputation for missing responses, 0.66; 95% confidence interval [CI], 0.44 to 0.87; P = 0.01). The risk ratio for recurrence by week 24 (also calculated with multiple imputation for missing responses) was 0.73 (95% CI, 0.54 to 0.92). At the 12-week visit, L. crispatus CTV-05 was detected in 79% of participants in the Lactin-V group. The percentage of participants who had at least one adverse event related to Lactin-V or placebo by week 24 did not differ significantly between the groups. The percentage of participants with local or systemic adverse events was similar in the two groups. CONCLUSIONS: The use of Lactin-V after treatment with vaginal metronidazole resulted in a significantly lower incidence of recurrence of bacterial vaginosis than placebo at 12 weeks. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT02766023.).

The influence of race and sex on gonorrhea and chlamydia treatment in the emergency department.

BACKGROUND: Emergency Departments (EDs) are a care source for patients with sexually transmitted diseases (STDs). St. Louis, MO reports among the highest rates of gonorrhea and chlamydia infection. We examined STD treatment in a high-volume urban ED, in St. Louis MO, to identify factors that may influence treatment. METHODS: A retrospective chart review and analysis was conducted on visits to a high volume, academic ED in St. Louis, MO where patients received a gonorrhea/chlamydia nucleic acid amplification test (NAAT) with a valid matching test result over two years. Using multiple logistic regression, we examined available predictors for under and overtreatment. RESULTS: NAATs were performed on 3.3% of all ED patients during the study period. Overall prevalence was 6.9% for gonorrhea (95% CI: 6.2, 7.7) and 11.6% for chlamydia (95% CI: 10.6, 12.5). Race was not a statistically significant predictor for undertreatment but Black patients were significantly more likely to be overtreated compared to White patients. (OR 1.83, 95% CI: 1.5, 2.2). Females were more likely to be undertreated when positive for infection compared to males (OR 7.34, 95% CI: 4.8, 11.2) and less likely to be overtreated when negative for infection (OR 0.27, 95% CI: 0.2, 0.3). CONCLUSION: The burden of STDs in a high-volume academic ED was significant and treatment varied across groups. Attention should be paid to particular groups, specifically women and patients reporting Black as their race, to ensure appropriate treatment is administered. Patients would benefit from targeted STD management protocols and training in the ED.