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.

Incidence of sexually transmitted infections and association with behavioural factors: Time-to-event analysis of a large pre-exposure prophylaxis (PrEP) cohort.

OBJECTIVES: Our objective was to obtain long-term data on the incidence of sexually transmitted infections (STIs) and their association with behavioural factors after widespread pre-exposure prophylaxis (PrEP) implementation. METHODS: This was a time-to-event analysis of a national PrEP cohort in Switzerland (SwissPrEPared study). Participants were people without HIV interested in taking PrEP with at least two STI screening visits. Primary outcomes were incidence rate of gonorrhoea, chlamydia, and syphilis. The association between behavioural factors and STI diagnosis was expressed using hazard ratios. We adjusted for testing frequency and calendar year. RESULTS: This analysis included 3907 participants enrolled between April 2019 and April 2022, yielding 3815.7 person-years of follow-up for gonorrhoea (15 134 screenings), 3802.5 for chlamydia (15 141 screenings), and 3858.6 for syphilis (15 001 screenings). The median age was 39 years (interquartile range [IQR] 32-47), 93.8% (n = 3664) identified as men who have sex with men (MSM). The incidence was 22.8 (95% confidence interval [CI] 21.3-24.4) per 100 person-years for gonorrhoea, 26.3 (95% CI 24.7-28.0) for chlamydia, and 4.4 (95% CI 3.8-5.1) for syphilis. Yearly incidence rates decreased between 2019 (all bacterial STIs: 81.6; 95% CI 59.1-109.9) and 2022 (all bacterial STIs: 49.8; 95% CI 44.6-55.3). Participants reporting chemsex substance use were at higher risk of incident STIs, as were those reporting multiple sexual partners. Younger age was associated with a higher risk of gonorrhoea and chlamydia. CONCLUSIONS: Incidence rates of bacterial STIs decreased over time. Young MSM, those with multiple partners, and those using chemsex substances were at increased risk of STIs.

Early adopters of doxycycline as post-exposure prophylaxis to prevent bacterial sexually transmitted infections in a real-world clinical setting.

OBJECTIVES: Doxycycline as post-exposure prophylaxis (DoxyPEP) is a novel prevention approach which has demonstrated efficacy in preventing bacterial sexually transmitted infections (STIs) in men who have sex with men (MSM) and transgender women (TGW) including people who are living with HIV and those on HIV pre-exposure prophylaxis (PrEP). We evaluated patient knowledge and interest in DoxyPEP, as well as early adopters of its use. METHODS: In 2023, patients presenting for HIV and STI services at a primary care and sexual health clinic were asked about DoxyPEP knowledge, interest and use. Bivariate and multivariate analyses were used to evaluate demographics and behaviours associated with these outcomes. RESULTS: A total of n=421 people presented for care. Of these, 314 were MSM/TGW. Fifteen percent were Black/African-American, and 21% were Hispanic/Latino. A total of 50% of MSM/TGW had heard of DoxyPEP, 49% were interested and 18% reported prior DoxyPEP use. Having a history of STI infection ever (adjusted OR (aOR) 5.95, 95% CI 2.69 to 13.13) and in the past 12 months (aOR 2.99, 95% CI 1.56 to 5.72) were both associated with DoxyPEP use. Individuals who had ever used HIV PrEP had nearly three times the odds of ever taking DoxyPEP (aOR 2.88, 95% CI 1.56 to 5.30). There was no association between the use of DoxyPEP and race, ethnicity or HIV status. CONCLUSIONS: Among MSM and TGW, there is already significant awareness, interest and use of DoxyPEP to prevent bacterial STIs. Public health efforts should focus on improving access and delivery of this STI prevention intervention to MSM and TGW.

Factors associated with bacterial sexually transmitted infections among people of South Asian ethnicity in England.

OBJECTIVES: Despite being the largest ethnic minority group in England, South Asians have historically had low levels of utilisation of sexual health services (SHS) and sexually transmitted infection (STI) diagnoses, although recent data suggests this may be changing. This study aimed to investigate factors associated with a bacterial STI diagnosis among South Asians attending SHS in England. METHODS: Using data from the GUMCAD STI Surveillance system, a descriptive analysis of South Asians attending SHS in England in 2019 was carried out. Factors associated with a bacterial STI diagnosis were examined using univariate and multivariable logistic regression models adjusted for age, Asian ethnic subgroup, HIV status, patient's region of residence and Index of Multiple Deprivation quintile. Analyses were stratified by gender and sexual orientation (heterosexual male versus gay, bisexual and other men who have sex with men (GBMSM) versus women of any sexual orientation). Crude and adjusted associations were derived using binary logistic regression. RESULTS: There were 121 842 attendances by South Asians to SHS in England in 2019. Compared with heterosexual South Asian men, GBMSM had a higher odds of being diagnosed with a bacterial STI (adjusted odds ratio (aOR) 2.32, 95% CI 2.19 to 2.44) and South Asian women had a lower odds (aOR 0.83, 95% CI 0.78 to 0.87). For women and heterosexual South Asian men, a diagnosis was associated with younger age, being of any other Asian background other than Bangladeshi, Indian or Pakistani and not being HIV positive. For heterosexual South Asian men, there was an association with increasing socioeconomic deprivation. For GBMSM, a bacterial STI diagnosis was associated with known HIV-positive status and living in London. CONCLUSION: People of South Asian ethnicity in England are heterogeneous with regard to their sexual health needs, which should be explored further through focused research and policy.

Human Immunodeficiency Virus Treatment Attitudes and Bacterial Sexually Transmitted Infections Among Gay and Bisexual Men.

BACKGROUNDS: Positive attitudes toward human immunodeficiency virus (HIV) treatment, such as reduced concern about HIV transmissibility, are associated with sexual behaviors that may increase the risk of bacterial sexually transmitted infections (STIs) among gay, bisexual, and other men who have sex with men (GBM). We examined associations between HIV treatment attitudes and bacterial STI diagnoses among GBM in Canada's three largest cities. METHODS: We fit a structural equation model between HIV treatment attitudes and bacterial STI diagnoses via sexual behaviors in the Engage study's baseline data. We estimated direct and indirect paths between scores on HIV treatment attitudes and STIs via number of male anal sex partners, condomless anal sex, and oral sex. We conducted sub-analyses with participants stratified by HIV serostatus. RESULTS: Among 2449 GBM recruited in 2017 to 2019, there was a direct association between HIV treatment attitudes and current STI diagnoses (ß = 0.13; 95% CI, 0.07-0.19; P < 0.001). The mediated model revealed a positive total indirect effect through 2 pathways: (1) engaging in condomless anal sex and (2) number of male anal sex partners and condomless anal sex. These 2 indirect pathways remained in the stratified mediation models for both HIV negative GBM and for GBM living with HIV. CONCLUSIONS: The association between HIV treatment attitudes and diagnosed STIs is mediated through a higher number of male anal sex partners and condomless anal sex. The results highlight the importance of providers educating patients when providing effective STI counseling, testing, and prevention for GBM about how accurate HIV treatment attitudes may inadvertently be associated with the bacterial STI epidemic.

Doxycycline Post-Exposure Prophylaxis for Bacterial Sexually Transmitted Infections: The Current Landscape and Future Directions.

PURPOSE OF REVIEW: The incidence of bacterial sexually transmitted infections (STI) continues to rise particularly among men who have sex with men (MSM). Doxycycline post-exposure prophylaxis (doxy-PEP) has emerged as a promising biomedical prevention strategy. This review aims to summarize the results of recent studies, highlight the current normative guidance on the use of doxy-PEP, and discuss remaining questions. RECENT FINDINGS: In the past decade, there have been four randomized controlled trials and three real-world analyses of doxy-PEP, which consistently demonstrated a reduction in Chlamydia trachomatis and Treponema pallidum infections among MSM. Questions remain regarding the efficacy of doxy-PEP for Neisseria gonorrhoeae infection and among cisgender women. Possible detrimental impacts include an increase in antimicrobial resistance as well as alterations to the gut microbiome Doxy-PEP is an effective strategy for preventing Chlamydia trachomatis and Treponema pallidum among MSM. Further work is needed to investigate the benefits among other populations, as well as to monitor for adverse effects.

Self-Reported PrEP Use and Risk of Bacterial STIs Among Ontarian Men Who Are Gay or Bisexual or Have Sex With Men.

PURPOSE: HIV pre-exposure prophylaxis (PrEP) may increase rates of bacterial sexually transmitted infections (STIs) among gay, bisexual, and other men who have sex with men (GBM) through risk compensation (eg, an increase in condomless sex or number of partners); however, longitudinal studies exploring the time-dependent nature of PrEP uptake and bacterial STIs are limited. We used marginal structural models to estimate the effect of PrEP uptake on STI incidence. METHODS: We analyzed data from the iCruise study, an online longitudinal study of 535 Ontarian GBM from July 2017 to April 2018, to estimate the effects of PrEP uptake on incidence of self-reported bacterial STIs (chlamydia, gonorrhea, and syphilis) collected with 12 weekly diaries. The incidence rate was calculated as the number of infections per 100 person-months, with evaluation of the STIs overall and individually. We used marginal structural models to account for time-varying confounding and quantitative bias analysis to evaluate the sensitivity of estimates to nondifferential outcome misclassification. RESULTS: Participating GBM were followed up for a total of 1,623.5 person-months. Overall, 70 participants (13.1%) took PrEP during the study period. Relative to no uptake, PrEP uptake was associated with an increased incidence rate of gonorrhea (incidence rate ratio = 4.00; 95% CI, 1.67-9.58), but not of chlamydia or syphilis, and not of any bacterial STI overall. Accounting for misclassification, the median incidence rate ratio for gonorrhea was 2.36 (95% simulation interval, 1.08-5.06). CONCLUSIONS: We observed an increased incidence rate of gonorrhea associated with PrEP uptake among Ontarian GBM that was robust to misclassification. Although our findings support current guidelines for integrating gonorrhea screening with PrEP services, additional research should consider the long-term impact of PrEP among this population.Annals Early Access article.

Pre-exposure prophylaxis and bacterial sexually transmitted infections (STIs) among gay and bisexual men.

OBJECTIVES: While pre-exposure prophylaxis (PrEP) prevents HIV acquisition among gay, bisexual and other men who have sex with men (GBM), PrEP-using GBM may be more likely to engage in sexual behaviours associated with bacterial STIs. We examined associations between PrEP use, condomless anal sex (CAS), number of anal sex partners, oral sex and bacterial STI diagnoses among GBM living in Canada's three largest cities. METHODS: Among HIV-negative/unknown-status GBM in the baseline of the Engage cohort study, we fit a structural equation model of the associations between any PrEP use, sexual behaviours and bacterial STI diagnosis. We estimated direct and indirect paths between PrEP use and STI via CAS, number of anal sex partners and oral sex. RESULTS: The sample included 2007 HIV-negative/unknown status GBM in Montreal, Toronto and Vancouver. There was a significant direct association between PrEP use and current STI diagnosis (ß=0.181; 95% CI: 0.112 to 0.247; p<0.001), CAS (ß=0.275; 95% CI: 0.189 to 0.361; p<0.001) and number of anal sex partners (ß=0.193; 95% CI: 0.161 to 0.225; p<0.001). In the mediated model, the direct association between PrEP use and STIs was non-significant. However, the indirect paths from PrEP to CAS to STIs (ß=0.064; 95% CI: 0.025 to 0.120; p=0.008), and from PrEP to greater number of anal sex partners to CAS to STIs were significant (ß=0.059; 95% CI: 0.024 to 0.108; p=0.007). CONCLUSIONS: Our study adds to the growing awareness that PrEP use among GBM may be associated with bacterial STIs because PrEP users have more anal sex partners and are more likely to engage in CAS. The results underscore the importance of providing effective STI counselling and regular testing to PrEP users, adapting PrEP care and related STI testing to individual needs, and the need for effective prevention strategies for bacterial STIs.

Factors Associated With Willingness to Use Daily Antibiotics as Sexually Transmitted Infection Prophylaxis Among HIV Preexposure Prophylaxis-Experienced Gay and Bisexual Men in Australia.

BACKGROUND: Gay and bisexual men (GBM) who use HIV preexposure prophylaxis (HIV-PrEP) have high rates of bacterial sexually transmitted infections (STIs). The use of daily antibiotics as STI preexposure prophylaxis (STI-PrEP) may be appealing to GBM who are using or have previously used HIV-PrEP (HIV-PrEP-experienced) for the prevention of bacterial STIs. METHODS: We examined willingness to use daily STI-PrEP among a cross-sectional sample of HIV-PrEP-experienced GBM in Australia who participated in an observational online cohort study from August 2018 to March 2020. Factors associated with willingness to use daily STI-PrEP were determined using bivariate and multivariate logistic regression. RESULTS: Of the 1347 participants, half (54.3%) were willing to use daily STI-PrEP. Factors independently associated with greater willingness to use daily STI-PrEP included having >10 sexual partners in the last 6 months, using methamphetamine in the last 6 months, being more conscious about avoiding STIs, having a greater number of STIs since commencing HIV-PrEP, being willing to take HIV-PrEP for as long as they were at risk of acquiring HIV, and only using condoms when a sexual partner requested them. Conversely, factors associated with less willingness to use daily STI-PrEP included being university educated, using nondaily dosing regimens of HIV-PrEP, preferring event-driven HIV-PrEP, and being concerned about long-term HIV-PrEP adverse effects. CONCLUSIONS: Sexually transmitted infection PrEP is likely to be appealing to many HIV-PrEP-experienced GBM, especially those who engage in activities associated with a higher risk of STI transmission. However, they are less likely to be willing to use STI-PrEP unless it aligns with their HIV-PrEP dosing regimen, suggesting that research into the safety and efficacy of alternative STI prophylaxis dosing options should be prioritized.

Geosexual Archetype, Preventive Behaviors, and Sexually Transmitted Infections Among High-Risk Men Who Have Sex With Men.

BACKGROUND: Social geography plays an important role in transmission of sexually transmitted infections (STIs) among men who have sex with men. Previous qualitative work had identified 7 "geosexual archetypes," each with distinct travel patterns for sex and potentially important differences in STI rates. The objective of this article was to explore what could be learned about STI transmission by looking at STI prevention strategies (condom use and preexposure prophylaxis use) and prevalence of STIs among these geosexual archetypes. METHODS: We analyzed data from the Sex Now 2019 online survey in Canada. Men who have sex with men who reported 3 or more partners in the past 6 months were included in the analysis (n = 3649). RESULTS: The most common archetype was "geoflexible" (sex at home, partner's home, and other places; 35.6%), followed by "privates" (sex only at own/partner's home; 23.0%); the least common archetypes was "rover" (sex not at home or partner's place; 4.0%). There were significant variations in both STI prevention strategies and prevalence of bacterial STIs in the past year by geosexual archetype. In particular, among those who were HIV negative, those who reported a geoflexible archetype and used preexposure prophylaxis but did not use condoms consistently had a 52.6% prevalence of bacterial STIs, which was much higher compared with all other groups. Within other archetypes, those living with HIV had the highest prevalence of bacterial STIs. CONCLUSIONS: Geosexual archetype together with participant's STI prevention strategies was a strong predictor of bacterial STI risk. Understanding how place is connected to bacterial STIs is key in prevention as individuals do not live in isolation.

Bacterial Sexually Transmitted Infection Incidence Among Southern Men Who Have Sex With Men With Human Immunodeficiency Virus in the Treatment as Prevention Era, 2014-2019.

In this retrospective analysis of men who have sex with men with human immunodeficiency virus (HIV) in the South from 2014 through 2019, incident bacterial sexually transmitted infections (STIs) increased regardless of virologic control. Clinicians should prioritize STI screening and management in primary HIV care.

Differing Correlates of Incident Bacterial Sexually Transmitted Infections Among a Cohort of Black Cisgender Men Who Have Sex With Men and Transgender Women Recruited in 6 US Cities (HIV Prevention Trials Network 061).

ABSTRACT: Compared with Black cisgender men who have sex with men (MSM), Black transgender women had a higher incidence of bacterial sexually transmitted infections (25.9 [11.1-46.3] vs. 9.6 [8.10-11.3] per 100 person-years), higher rates of income and housing insecurity, and condomless receptive anal intercourse. Further investigation of unique risk pathways among transgender women is critical.

Shigellosis Cases With Bacterial Sexually Transmitted Infections: Population-Based Data From 6 US Jurisdictions, 2007 to 2016.

BACKGROUND: Shigella species, which cause acute diarrheal disease, are transmitted via fecal-oral and sexual contact. To better understand the overlapping populations affected by Shigella infections and sexually transmitted infections (STIs) in the United States, we examined the occurrence of reported STIs within 24 months among shigellosis case-patients. METHODS: Culture-confirmed Shigella cases diagnosed from 2007 to 2016 among residents of 6 US jurisdictions were matched to reports of STIs (chlamydia, gonorrhea, and all stages of syphilis) diagnosed 12 months before or after the shigellosis case. We examined epidemiologic characteristics and reported temporal trends of Shigella cases by sex and species. RESULTS: From 2007 to 2016, 10,430 shigellosis cases were reported. The annual number of reported shigellosis cases across jurisdictions increased 70%, from 821 cases in 2007 to 1398 cases in 2016; males saw a larger increase compared with females. Twenty percent of male shigellosis case-patients had an STI reported in the reference period versus 4% of female case-patients. The percentage of male shigellosis case-patients with an STI increased from 11% (2007) to 28% (2016); the overall percentage among females remained low. CONCLUSIONS: We highlight the substantial proportion of males with shigellosis who were diagnosed with STIs within 24 months and the benefit of matching data across programs. Sexually transmitted infection screening may be warranted for male shigellosis case-patients.

Acceptability of a Gonococcal Vaccine Among Sexually Active Men Who Have Sex With Men.

BACKGROUND: Prospects for a gonococcal vaccine have advanced. Vaccine acceptability is crucial to maximizing population-level protection among key groups, such as men who have sex with men (MSM). We assessed the prevalence of gonococcal vaccine acceptability among sexually active MSM in the United States. METHODS: We used data from the American Men's Internet Study conducted from August 2019 to December 2019. We calculated frequencies of sociodemographic characteristics, vaccine acceptability, and preferred location for vaccine receipt. Using log-binomial regression analyses, we calculated unadjusted prevalence rates (PRs) and 95% confidence intervals (CIs) to evaluate factors associated with vaccine acceptability. RESULTS: Of 4951 MSM, 83.5% were willing to accept a vaccine and 16.5% were unwilling. Preferred vaccination locations were primary care provider's clinics (83.5%) and sexually transmitted disease (STD) clinics (64.6%). Vaccine acceptability was greater among young MSM (15-24 years [PR, 1.09; 95% CI, 1.05-1.12], 25-29 years [PR, 1.13; 95% CI, 1.09-1.17], and 30-39 years [PR, 1.10; 95% CI, 1.05-1.14] compared with MSM ≥40 years), MSM living with HIV (PR, 1.05; 95% CI, 1.02-1.09), and MSM who reported (in the past 12 months) condomless anal sex (PR, 1.09; 95% CI, 1.06-1.12), a bacterial STD test (PR, 1.18; 95% CI, 1.15-1.21), HIV preexposure prophylaxis use (PR, 1.17; 95% CI, 1.14-1.19), a bacterial STD diagnosis (PR, 1.04; 95% CI, 1.02-1.07), or a health care provider visit (PR, 1.11; 95% CI, 1.06-1.16). Men who have sex with men who reported ≤high school education (PR, 0.93; 95% CI, 0.91-0.97) were less willing to accept a vaccine compared with those with >high school education. CONCLUSIONS: Most respondents were willing to accept a gonococcal vaccine. These findings can inform the planning and implementation of a future gonococcal vaccination program that focuses on MSM.

Surveillance and epidemiology of syphilis, gonorrhoea and chlamydia in the non-European Union countries of the World Health Organization European Region, 2015 to 2020.

BackgroundEpidemics of sexually transmitted infections (STI) are a major public health challenge in the World Health Organization (WHO) European Region.AimWe aimed to provide an overview of case reporting and other surveillance data for syphilis, gonorrhoea and chlamydia for the non-European Union (EU)/European Economic Area (EEA) countries of the Centre and East part of the WHO European Region as per classification used by the WHO Regional Office for Europe (WHO/Europe) and the European Centre for Disease Prevention and Control.MethodsData were provided by the surveillance agencies of the Member States for the period 2015 to 2019 through the WHO/Europe Communicable Diseases Annual Reporting Form. We analysed reported cases, explored data reported to the WHO Gonococcal Antimicrobial Surveillance Programme (GASP) and performed a review of publications on antimicrobial resistance (AMR) in gonorrhoea in the period 2015 to 2020 using systematic methodology.ResultsFrom 2015 to 2019, in most of the countries with three or more data points, there was a pattern of decrease in reported syphilis, gonorrhoea and chlamydia cases, which is in contrast to the EU/EEA. The number of reported cases per 100,000 population was 0.4-26.5 for syphilis, 0-18.5 for gonorrhoea and 0-43.3 for chlamydia. Four countries reported recent data on AMR in gonorrhoea to GASP, and we identified further publications from Georgia, Russia and Ukraine.ConclusionWe found wide heterogeneity in reported rates of STI. There is a strong need to improve availability and quality of STI surveillance data in the non-EU/EEA countries.

Projected HIV and Bacterial Sexually Transmitted Infection Incidence Following COVID-19-Related Sexual Distancing and Clinical Service Interruption.

BACKGROUND: The global COVID-19 pandemic has the potential to indirectly impact transmission dynamics and prevention of HIV and other sexually transmitted infections (STI). It is unknown what combined impact reductions in sexual activity and interruptions in HIV/STI services will have on HIV/STI epidemic trajectories. METHODS: We adapted a model of HIV, gonorrhea, and chlamydia for a population of approximately 103 000 men who have sex with men (MSM) in the Atlanta area. Model scenarios varied the timing, overlap, and relative extent of COVID-19-related sexual distancing and service interruption within 4 service categories (HIV screening, preexposure prophylaxis, antiretroviral therapy, and STI treatment). RESULTS: A 50% relative decrease in sexual partnerships and interruption of all clinical services, both lasting 18 months, would generally offset each other for HIV (total 5-year population impact for Atlanta MSM, -227 cases), but have net protective effect for STIs (-23 800 cases). If distancing lasted only 3 months but service interruption lasted 18 months, the total 5-year population impact would be an additional 890 HIV cases and 57 500 STI cases. CONCLUSIONS: Immediate action to limit the impact of service interruptions is needed to address the indirect effects of the global COVID-19 pandemic on the HIV/STI epidemic.

Meningococcal disease and sexual transmission: urogenital and anorectal infections and invasive disease due to Neisseria meningitidis.

Neisseria meningitidis is an obligate human commensal bacterium that frequently colonises the upper respiratory tract. Person-to-person transmission occurs via direct contact or through dispersion of respiratory droplets from a carrier of the bacteria, and can lead to invasive meningococcal disease. Rare sporadic cases of meningococcal urogenital and anorectal infections, including urethritis, proctitis, and cervicitis, have been reported, typically following orogenital contact with an oropharyngeal meningococcal carrier. The resulting infections were clinically indistinguishable from infections caused by Neisseria gonorrhoeae. Over the past two decades, there have also been multiple outbreaks across North America and Europe of invasive meningococcal disease among men who have sex with men (MSM). The responsible meningococci belong to a highly virulent and predominantly serogroup C lineage, including strains that are able to express nitrite reductase and grow in anaerobic environments, such as the urogenital and anorectal tracts. More recently, a distinct clade within this lineage has expanded to cause urethritis predominantly among men who have sex with women. Evolutionary events giving rise to this clade included the loss of the ability to express a capsule, and acquisition of several gonococcal alleles, including one allele encoding a highly efficient gonococcal nitrite reductase. Members of the clade continue to acquire gonococcal alleles, including one allele associated with decreased antibiotic susceptibility. This evolution has implications for the clinical and public health management of those who are infected and their close contacts, in terms of both antibiotic treatment, and prevention through vaccination.

EVO100 prevents chlamydia and gonorrhea in women at high risk of infection.

BACKGROUND: According to the Centers for Disease Control and Prevention, rates of infection for Chlamydia trachomatis and Neisseria gonorrhoeae are increasing in the United States. EVO100 is an investigational antimicrobial, pH-modulating, vaginal gel with active ingredients L-lactic acid, citric acid, and potassium bitartrate that is being evaluated for the prevention of sexually transmitted infections. OBJECTIVE: The objective of this phase 2B/3 study was to assess the efficacy and safety of EVO100 for the prevention of chlamydia and gonorrhea. STUDY DESIGN: AMPREVENCE was a double-blinded, placebo-controlled, multicenter study based in the United States conducted over approximately 16 weeks in women at the age of 18 to 45 years who were at risk of urogenital chlamydia and gonorrhea infection. Enrolled women had been diagnosed as having and treated for chlamydia or gonorrhea ≤16 weeks before enrollment. Women received either EVO100 or placebo vaginal gel and were instructed to apply the study drug immediately before or up to 1 hour before each act of vaginal sexual intercourse. The primary and secondary endpoints were the prevention of urogenital chlamydia and gonorrhea, respectively. Exploratory outcomes include women's overall satisfaction with EVO100. RESULTS: In total, 860 women were randomized 1:1 to receive EVO100 (n=426) or placebo (n=434), and 764 women (EVO100, n=376; placebo, n=388) were documented as using the study drug at least once. Baseline characteristics were similar between treatment arms. Overall, women had a mean age of 27.7 years (standard deviation, 6.9) and body mass index of 28.9 kg/m2 (standard deviation, 8.0). Most women were of White (54.3% [467 of 860]) or African American (41.6% [358 of 860]) race and of non-Hispanic/Latina ethnicity (67.1% [577 of 860]). The chlamydia infection rate in EVO100 users was 4.8% (14 of 289) compared with 9.7% (28 of 290) among placebo users (P=.0256), representing a relative risk reduction of 50%. For gonorrhea, the infection rate was 0.7% (2 of 280) in the EVO100 arm compared with 3.2% (9 of 277) in the placebo arm (P=.0316), representing a relative risk reduction of 78%. Increased efficacy was observed with increased adherence, and chlamydia infection rates were significantly reduced with increased adherence in the EVO100 group compared with placebo. Across both arms, there were similar rates of all-cause adverse events (EVO100, 21.3% [80 of 376]; placebo, 20.4% [79 of 388]) and treatment-related adverse events (EVO100, 7.2% [27 of 376]; placebo, 7.5% [29 of 388]). The most common adverse events in the EVO100 arm were vulvovaginal candidiasis (5.1% [19 of 376]), vaginal discharge (3.2% [12 of 376]), and urinary tract infection (3.2% [12 of 376]) and, in the placebo arm, bacterial vaginosis (4.6% [18 of 388]), urinary tract infection (2.6% [10 of 388]), and vaginal discharge (2.6% [10 of 388]). Few women discontinued owing to adverse events in either arm (EVO100, 1.1% [4 of 376]; placebo, 1.5% [6 of 388]). No treatment-related serious adverse events were reported. Most EVO100 users (88%) were satisfied or very satisfied with EVO100 after 16 weeks of use. CONCLUSION: EVO100 significantly reduced the risk of chlamydia and gonorrhea infections in women at high risk of Chlamydia trachomatis and Neisseria gonorrhoeae infection and was well tolerated, with observed adverse events consistent with its known safety profile.

Clinical evaluation of commercial PCR assays for antimicrobal resistance in Mycoplasma genitalium and estimation of resistance-mediated mutation prevalence in Moscow and Moscow region.

Mycoplasma genitalium is a widespread sexually transmitted infection (STI) with growing rate of antimicrobials resistance. In our study, 137 vaginal and 131 urethral M. genitalium-positive swabs were sequentially collected through the work of Reference Center for STI during 2019. For prevalence evaluation of macrolide-resistance mutations three commercially available kits were used: AmpliSens® M. genitalium-ML/FQ-Resist-FL (Central Research Institute of Epidemiology, Russia), ResistancePlus® MG (SpeeDx, Australia), and S-DiaMGRes™ (Diagenode, Belgium). Macrolide resistance mutations were detected in 16% (43 of 268) of samples. Diagnostic characteristics were evaluated against Sanger sequencing. For AmpliSens® M. genitalium-ML/FQ-Resist-FL specificity was shown to be 100% (CI 95%, 98.4-100), and sensitivity was 90.7% (CI 95%, 77.9-97.4). ResistancePlus® MG specificity was 100% (CI 95%, 98.3-100), and sensitivity was 92.1% (CI 95%, 78.6-98.3). S-DiaMGRes™ specificity was shown to be 88.6% (CI 95%, 83.9-92.4), and sensitivity was 100% (CI 95%, 84.4-100). Mutations of parC gene region were detected in 14.5% (38 of 268) using AmpliSens® M. genitalium-ML/FQ-Resist-FL with further validation by Sanger sequencing. Of studied samples, 6.3% (17 of 268) contained both antimicrobials of class resistance mutations. Prevalence of macrolide-resistant M. genitalium in Moscow was 21.7% (23 of 106) and of fluoroquinolone-resistant M. genitaliuim was 20.8% (22 of 106). In Moscow region, macrolide-resistant M. genitalium were 12.3% (20 of 162) and 9.9% (16 of 162) of fluoroquinolone-resistant M. genitalium. All three kits can be used both for epidemiological monitoring of M. genitalium presence and mutation prevalence estimation. In Moscow, macrolide- and fluoroquinolone-resistant mutant prevalence increased in 3.9 and 2.7 times in 3 years.

Multi-year prevalence and macrolide resistance of Mycoplasma genitalium in clinical samples from a southern Italian hospital.

The use of azithromycin for the treatment of Mycoplasma genitalium infections has led to resistance to macrolides. From July 2014 to July 2020, 7150 samples were analysed for the detection of sexually transmitted infections at the Policlinico of Bari. A total of 67/7150 samples (0.93%) were positive for MG DNA and 47 samples were analysed for the evaluation of six azithromycin resistance-associated mutations. In 5/47 samples, the A2058G mutation was detected (10.63%). Although the cases of positive MG samples and mutations are low in our reality, diagnostic tests to detect azithromycin resistant-associated genes may provide a convenient way to monitor resistance rate.