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Many cases of mucopurulent cervicitis (MPC) are idiopathic and cannot be attributed to the known cervical pathogens Neisseria gonorrhoeae, Chlamydia trachomatis, or herpes simplex virus. Because Mycoplasma genitalium is associated with nongonoccocal urethritis in men, its role in MPC, the corresponding syndrome in women, was investigated. Archived cervical specimens from women recruited in the Harborview Sexually Transmitted Disease Clinic in Seattle from 1984 to 1986 were tested, using polymerase chain reaction, in a study that identified other causes of and risk factors for MPC. M. genitalium was detected in 50 (7.0%) of 719 women. Young age, multiple recent partners, prior miscarriage, smoking, menstrual cycle, and douching were positively associated with M. genitalium, whereas bacterial vaginosis and cunnilingus were negatively associated. After adjustment for age, phase of menstrual cycle, and presence of known cervical pathogens, women with M. genitalium had a 3.3-fold greater risk (95% confidence interval, 1.7-6.4) of MPC, which suggests that this organism may be a cause of MPC. [ABSTRACT FROM AUTHOR]

Background: Although condoms most likely prevent HIV infection, evidence of their effectiveness against other sexually transmitted diseases is mixed.Goal: The goal of the study was to determine whether condom use prevents genital human papillomavirus (HPV) infection and HPV-related conditions.Study Design: We conducted a literature review and meta-analysis of the effect of condom use on the prevention of genital warts, subclinical HPV infection, cervical intraepithelial neoplasia (CIN), and invasive cervical cancer (ICC).Results: Among 27 estimates from 20 studies, there was no consistent evidence that condom use reduces the risk of becoming HPV DNA-positive. However, risk for genital warts, CIN of grade II or III (CIN II or III), and ICC was somewhat reduced.Conclusions: Available data are too inconsistent to provide precise estimates. However, they suggest that while condoms may not prevent HPV infection, they may protect against genital warts, CIN II or III, and ICC. [ABSTRACT FROM AUTHOR]

A woman's partner and the characteristics of their partnership can play an important role in the health of her pregnancy. Yet, with the notable exception of intimate partner violence, there has been little previous research addressing the associations between partner- or partnership-related factors and birth outcomes. This analysis tested the hypothesis that risk factors related specifically to partner or partnership characteristics increased the risk for preterm birth. Between 2003 and 2005, a total of 580 preterm cases (20-36 weeks gestational age at delivery) and 633 term controls (> or =37 weeks) were selected from women delivering at an obstetric hospital in Lima, Peru. Each woman completed a confidential, structured interview and provided biological specimens within 48 h after delivery. Multivariable logistic regression was used to assess associations between partner and partnership characteristics and preterm birth. After adjustment for behavioral, demographic, and obstetric risk factors, ever having had a partner with a history of drug use (aOR = 1.91, 95% CI 1.22-2.99), ever having had anal sex (aOR = 1.40, 95% CI 1.07-1.84), having a current partner with a history of visiting prostitutes (aOR = 1.69, 95% CI 1.22-2.33), and perceiving one's current partner as a 'womanizer' (aOR = 1.34, 95% CI 1.02-1.77) were significantly associated with an elevated risk of preterm birth when tested in separate models. These four factors were then used to create a composite partnership risk score, which showed an increasing dose-response relationship with preterm birth risk (per additional partner risk factor: aOR = 1.31, 95% CI 1.16-1.49). These results highlight the importance of considering a broader set of risk factors for preterm birth, specifically those related to a woman's partner and partnership characteristics. Further research could clarify the specific mechanisms through which these partner and partnership characteristics may increase the risk of preterm birth. [ABSTRACT FROM AUTHOR]

Background: The etiology of nongonococcal urethritis (NGU) is incompletely understood. We sought to determine if genitourinary bacterial diversity or specific taxa were associated with incident NGU., Methods: From August 2014-July 2018, men who have sex with women attending a sexual health clinic were clinically evaluated, including Mycoplasma genitalium (MG) and Chlamydia trachomatis (CT) testing, at enrollment and six monthly visits. New cases of NGU (≥5 PMNs/HPF in urethral exudates plus either symptoms or visible discharge) and their visit preceding NGU diagnosis were matched 1:1 to two sequential visits without NGU (controls). We determined associations with incident NGU and applied broad-range 16S rRNA gene polymerase chain reaction and sequencing to urine samples from each visit. We used conditional logistic regression to evaluate the association of Shannon Diversity Index (SDI), species richness, Haemophilus influenzae, Fannyhessea vaginae, Lactobacillus iners, and Streptococcus mitis group with incident non-CT-non-MG-NGU (NCNM-NGU)., Results: Of 62 matched case-control pairs, median age was 32. Higher SDI the previous month was associated with higher odds of incident NCNM-NGU (adjusted odds ratio [aOR] = 2.8 per unit increase; 95% CI = 1.03-7.47), as was F. vaginae at NGU diagnosis (aOR = 5.1; 95% CI = 1.28-20.15), F. vaginae acquisition (aOR = 13.8; 95% CI = 1.96-97.33) and consistent carriage of F. vaginae (aOR = 16.1; 95% CI = 1.66-156.29). Odds of NCNM-NGU were higher when L. iners cleared between visits (aOR = 18.0; 95% CI = 1.08-299.24). Neither H. influenzae nor S. mitis group were associated with incident NCNM-NGU., Conclusions: F. vaginae acquisition/detection and L. iners clearance were associated with urethritis. This merits investigation in larger longitudinal studies using species-specific detection methods., Competing Interests: Conflicts of Interest: LEM has received consulting fees from Health Advances, speaker’s fees from MedConnect, research funding and materials from Hologic, Inc. and Nabriva Therapeutics, and travel support from Hologic, Inc. DNF and TLF receive a royalty from BD for intellectual property around molecular diagnosis of bacterial vaginosis. CMK has received research supplies from Hologic, Inc. and research support from Gilead Sciences., (Copyright © 2024 American Sexually Transmitted Diseases Association. All rights reserved.)

Objectives: Women who report sex with women are thought to have lower risk for Chlamydia trachomatis (CT) infection than women who report sex with men only (WSM-only), but comparisons of lifetime burden are limited., Methods: Among 1,418 sexually-experienced women aged 18-39 years participating in the National Health and Nutrition Examination Survey (2013-2016), we estimated weighted CT seroprevalence and Wald-based 95% confidence intervals (CI) in women who reported ever having sex with a woman (all reported having sex with men also) (WSWM) compared to WSM-only. We defined seropositivity as detection of Pgp3 antibodies and used stratified Poisson regression with robust standard errors to estimate prevalence ratios., Results: Over half (58.3%) were White non-Hispanic; 16.2% were WSWM. WSWM were somewhat younger (mean = 27.8 vs. 29.0 years, p = 0.07), younger at sexual debut (mean = 15.6 vs. 17.5 years, p < 0.001), and had more lifetime male sexual partners (mean = 15.9 vs. 6.4, p < 0.001) than WSM-only. Weighted CT seroprevalence was 38.9% (95%CI = 30.4-47.4) in WSWM and 28.6% (95%CI = 24.4-32.9) in WSM-only. Correlates of higher CT seroprevalence in both groups were Black non-Hispanic race/ethnicity, Hispanic ethnicity, and CT infection in the prior year. Having ≥5 lifetime male partners compared to 1-2 partners was associated with higher seroprevalence among WSWM (PR = 4.5; 95%CI = 1.77-11.44) and WSM-only (PR = 2.7; 95%CI = 1.87-3.69). Among WSWM, bisexual identity was associated with lower seroprevalence. Among WSM-only, low income and younger age at sexual debut were associated with higher seroprevalence., Conclusion: Lifetime CT burden was higher in WSWM than WSM-only. Number of lifetime male partners was the strongest predictor of seropositivity for WSWM., Competing Interests: Sources of Funding and Conflicts of Interest: This work was supported by the National Institutes of Health (grant number R01AI161019). LEM has received research support from Nabriva Therapeutics and research and travel support from Hologic, Inc for studies unrelated to this work. CMK has received research support from Hologic, Inc and Gilead Sciences, for studies unrelated to the submitted work. JEB has received consulting fees from proPharma and Ferring unrelated to this work., (Copyright © 2024 American Sexually Transmitted Diseases Association. All rights reserved.)

Background The best method for measuring a history of Chlamydia trachomatis (CT) infections is unknown. We examined the reliability of three methods as markers of past CT infections: IgG serum antibodies, the electronic health record (EHR) and self-report. Methods This cross-sectional study used data from a cohort study of 122 MSM in King County, Washington, United States. Sera were tested for IgG using the mixed CT peptide enzyme-linked immunosorbent assay (ELISA). Participant data for past CT diagnoses were extracted from the EHR. Self-report of past CT was collected via survey. We calculated positive and negative percent agreements of CT history using total IgG serum antibodies to CT, past EHR diagnosis and self-report of past CT as reference measures when they were compared with one another. Results Of those who were IgG seropositive, only 41.5% had a past diagnosis of CT in their EHRs, but 74.4% self-reported a history of CT. The majority (92.7%) of participants who had a diagnosis of CT in their EHRs reported a past CT infection. Conclusions Self-report in combination with IgG serum antibodies to CT may be a more reliable indicator of past CT than EHRs in settings without comprehensive EHRs.

Objectives: Mycoplasma genitalium (MG) causes urethritis and is associated with cervicitis, pelvic inflammatory disease and preterm delivery. Antimicrobial resistance is widespread and cure rates are declining. Lefamulin, a novel pleuromutilin, may be effective in cases of treatment failure., Methods: Under compassionate access in Australia and a pilot open-label parallel arm randomised clinical trial in the USA, patients with urogenital MG infection and microbiological treatment failure or contraindications to moxifloxacin were treated with lefamulin monotherapy (600 mg orally two times per for 7 days) or sequential doxycycline-lefamulin (doxycycline 100 mg orally two times per day for 7 days followed by lefamulin for 7 days) (1:1 randomisation in the USA). Two additional regimens were also evaluated in Australia: combination therapy with doxycycline plus lefamulin for 7 days and extended lefamulin therapy with doxycycline for 7 days followed by lefamulin for 14 days. Microbiological cure (negative MG NAAT) was assessed 21-35 days after completing lefamulin. Sustained cure was assessed 42-49 days after treatment., Results: Seventeen heavily pretreated Australian (seen between October 2020 and December 2023) and 11 US cases (recruited between April 2022 and February 2023; 5 randomised to lefamulin monotherapy, 6 randomised to sequential doxycycline-lefamulin) received lefamulin-containing regimens. Sequential doxycycline-lefamulin demonstrated microbiological cure 21-35 days post-treatment in 6 of 12 (50%) Australian and US patients. Three of five (60%) US patients but none of five (0%) Australian patients were cured with lefamulin monotherapy. Combination therapy with doxycycline and lefamulin was ineffective (n=0/2), but extended lefamulin therapy cured two of three (67%). Gastrointestinal side effects occurred in 77% (Australia) and 91% (USA)., Conclusion: While cure rates were low, lefamulin was effective in some individuals with MG treatment failure. Additional antibacterial agents for multidrug-resistant infections are needed., Competing Interests: Competing interests: LM has received research funding from Hologic, Inc. and Nabriva Therapeutics, Ltd., consulting fees from Health Advances, and speaker’s fees from MedConnect. CSB has received diagnostic kits for Mycoplasma genitalium testing from Speedx Pty Ltd and Cepheid Pty Ltd but not for this study. JSJ has received grants, speaker’s fee and non-financial support from Hologic, speaker’s fees from LeoPharma and grants from Nabriva, all outside the submitted work, and serves on the scientific advisory board of Roche Molecular Systems, Abbott Molecular, BioMerieux and Cepheid. LAB received funding from Nabriva Therapeutics, Ltd for this study. LAB and OOS received research support, unrelated to this study, from Hologic, Inc, and SpeeDx Pty Ltd. For the rest of the authors, no conflicts of interest were declared., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

Chlamydia trachomatis (CT) is a sexually transmitted infection that can lead to adverse reproductive health outcomes. CT prevalence estimates are primarily derived from screening using nucleic acid amplification tests (NAATs). However, screening guidelines in the United States only include particular subpopulations, and NAATs only detect current infections. In contrast, seroassays identify past CT infections, which is important for understanding the public health impacts of CT, including pelvic inflammatory disease and tubal factor infertility. Older seroassays have been plagued by low sensitivity and specificity and have not been validated using a consistent reference measure, making it challenging to compare studies, define the epidemiology of CT, and determine the effectiveness of control programs. Newer seroassays have better performance characteristics. This narrative review summarizes the "state of the science" for CT seroassays that have been applied in epidemiologic studies and provides practical considerations for interpreting the literature and employing seroassays in future research., Competing Interests: Potential conflicts of interest. L. E. M. has received research materials and research funding from Hologic, Inc, and Nabriva Therapeutics, as well as an honorarium from Health Advances. C. M. K. has received donations of study collection kits and reagents from Hologic, Inc, for research studies outside the submitted work. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed., (© The Author(s) 2024. Published by Oxford University Press on behalf of Infectious Diseases Society of America. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

Background: Ukraine has implemented ambitious HIV-prevention programs since 1999 and began offering preexposure prophylaxis (PrEP) in 2017. Little is known about PrEP uptake and persistence in this setting., Setting: We analyzed data from 40 facilities providing PrEP in 11 oblasts (regions) of Ukraine between October 2020 and February 2022., Methods: We estimated the time between PrEP visits and conducted Kaplan-Meier analyses to estimate retention on PrEP stratified by sex, age, and key populations (KPs): men who have sex with men (MSM), people who inject drugs (PWID), sex workers (SW), discordant couples, and others vulnerable to HIV acquisition (DC/other). We used Cox regression to estimate the risk of PrEP discontinuation by KP group and sex, adjusting for age., Results: Overall, 2033 clients initiated PrEP across regions; the majority (51%) were DC/other, 22% were MSM, 22% were PWID, and 5% were SW. The overall 3-month persistence was 52.3% (95% confidence interval [CI]: 49.9% to 54.8%) and was lowest among MSM (46.7%; 95% CI: 41.9% to 52.2%) and SW (25.9%; 95% CI: 18.2% to 36.9%) (P < 0.05 for differences by KP group). After adjusting for age, PrEP discontinuation was not statistically significantly different across groups, although female PWID tended to have the lowest discontinuation risk (adjusted hazard ratio [aHR] 0.59; 95% CI: 0.31 to 1.11) while male SW tended to have the highest risk (aHR 1.87, 95% CI: 0.57 to 6.11) compared with females in the DC/other group., Conclusion: Three-month PrEP persistence was low across KP groups, especially in SW. Further research examining the barriers and enablers of persistence by KPs is needed., Competing Interests: The authors have no funding or conflicts of interest to disclose., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc.)

Background: Differences in opinion concerning the contribution of M. genitalium to pelvic inflammatory disease (PID) has resulted in inconsistencies across global testing and treatment guidelines. We conducted a systematic review and meta-analysis to determine the association between M. genitalium and PID and M. genitalium positivity within PID cases to provide a contemporary evidence base to inform clinical practice (PROSPERO registration: CRD42022382156)., Methods: PubMed, Embase, Medline and Web of Science were searched to Dec 1, 2023 for studies that assessed women for PID using established clinical criteria and used nucleic acid amplification tests to detect M. genitalium. We calculated summary estimates of the 1) association of M. genitalium with PID (pooled odds ratio [OR]) and 2) proportion of PID cases with M. genitalium detected (pooled M. genitalium positivity in PID), using random-effects meta-analyses, with 95% confidence intervals (CI)., Results: Nineteen studies were included: 10 estimated M. genitalium association with PID, and 19 estimated M. genitalium positivity in PID. M. genitalium infection was significantly associated with PID (pooled OR=1.67 [95%CI: 1.24-2.24]). The pooled positivity of M. genitalium in PID was 10.3% [95%CI: 5.63-15.99]. Subgroup and meta-regression analyses showed that M. genitalium positivity in PID was highest in the Americas, in studies conducted in both inpatient and outpatient clinic settings, and in populations at high risk of sexually transmitted infections., Conclusions: M. genitalium was associated with a 67% increase in odds of PID and was detected in about one in ten clinical diagnoses of PID. These data support testing women for M. genitalium at initial PID diagnosis., (© The Author(s) 2024. Published by Oxford University Press on behalf of Infectious Diseases Society of America.)

Background: Sexual behavior may influence the composition of the male urethral microbiota, but this hypothesis has not been tested in longitudinal studies of men who have sex with men (MSM)., Methods: From December 2014 to July 2018, we enrolled MSM with nongonococcal urethritis (NGU) attending a sexual health clinic. Men attended 5 in-clinic visits at 3-week intervals, collected weekly urine specimens at home, and reported daily antibiotics and sexual activity on weekly diaries. We applied broad-range 16S rRNA gene sequencing to urine. We used generalized estimating equations to estimate the association between urethral sexual exposures in the prior 7 days (insertive oral sex [IOS] only, condomless insertive anal intercourse [CIAI] only, IOS with CIAI [IOS + CIAI], or none) and Shannon index, number of species (observed, oral indicator, and rectal indicator), and specific taxa, adjusting for recent antibiotics, age, race/ethnicity, HIV, and preexposure prophylaxis., Results: Ninety-six of 108 MSM with NGU attended ≥1 follow-up visit. They contributed 1140 person-weeks of behavioral data and 1006 urine specimens. Compared with those with no urethral sexual exposures, those with IOS only had higher Shannon index ( P = 0.03 ) but similar number of species and presence of specific taxa considered, adjusting for confounders; the exception was an association with Haemophilus parainfluenzae . CIAI only was not associated with measured aspects of the urethral microbiota. IOS + CIAI was only associated with presence of H. parainfluenzae and Haemophilus ., Conclusions: Among MSM after NGU, IOS and CIAI did not seem to have a substantial influence on measured aspects of the composition of the urethral microbiota., Competing Interests: Conflict of Interest of Sources of Funding: This work was supported by the National Institutes of Health (grant number U19 AI113173). L.C.C. was supported by the National Institutes of Health (grant number TL1 TR002318 trainee support). K.A.T. was supported by the University of Washington/Fred Hutch Center for AIDS Research, a program funded by the National Institutes of Health (grant number P30 AI027757). Study data were collected and managed using Research Electronic Data Capture (REDCap) tools hosted at the University of Washington Institute of Translational Health Sciences and supported by the National Institutes of Health (grant number UL1 TR002319). C.M.K. has received donations of test kits and reagents from Hologic, Inc. M.R.G. has conducted studies unrelated to this work supported by grants from Hologic, Inc. L.E.M. has received research support and honoraria from Hologic, Inc., and Nabriva Therapeutics. All other authors declare that they have no conflict of interest., (Copyright © 2024 American Sexually Transmitted Diseases Association. All rights reserved.)

Background: In 2021, national Chlamydia trachomatis (CT) treatment guidelines changed from recommending either azithromycin (1 g; single dose) or doxycycline (100 mg twice daily for 7 days) to recommending only doxycycline as first-line treatment. The distribution and trends in CT prescribing practices before the guidelines change is largely unknown., Methods: We conducted a trends analysis using Washington STD surveillance data. We included all female cases of urogenital CT 15 years or older who resided in King County and were diagnosed between 2010 and 2018. Surveillance data included information on demographics, sexual history, clinical features, diagnosing facility (eg, emergency department, family planning), and treatment regimen. We conducted descriptive analyses to examine trends in prescribing practices over time and by facility type. We used Poisson regression to examine the association between CT case characteristics and receipt of receipt of azithromycin., Results: There were 36,830 cases of female urogenital CT during the study period. The percent of cases receiving azithromycin increased significantly from 86% in 2010 to 94% in 2018; the percent receiving doxycycline decreased from 13% to 5%. Five of the 8 facility types prescribed azithromycin to >95% of CT cases by 2018. Cases who were younger or cases of color were more likely to receive azithromycin (versus doxycycline) compared with older and White cases, respectively., Conclusions: A substantial shift in CT prescribing practices will be needed to adhere to new CT treatment guidelines. Our findings highlight the need for targeted provider education and training to encourage the transition to doxycycline use., Competing Interests: Conflicts of Interest: C.M.K. and M.R.G. report research support from Hologic, Inc. for studies unrelated to the submitted work. L.E.M. reports research support and donations of study materials from Hologic, Inc. and Nabriva Therapeutics for studies unrelated to the submitted work, and an honorarium from Health Advances. All other authors declare no conflicts of interest., (Copyright © 2024 American Sexually Transmitted Diseases Association. All rights reserved.)

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., Competing Interests: Potential conflicts of interest. All authors’ institutions received research funding support from Hologic, Inc, for this work. In addition, L. E. M. reports consulting fees from Nabriva Therapeutics and Health Advances (paid to the author); has received honoraria from Hologic, Inc, and Health Advances and research funding and donated antibiotics for a research study from Nabriva Therapeutics. O. O. S. has received research funding from Hologic, Inc, and SpeeDx, Inc, and reports a role on the American Sexually Transmitted Diseases (ASTDA) Board. C. M. has received contracts from the National Institutes of Health (NIH), BD, Binx, Cepheid, and GSK/Biomedical Advanced Research and Development Authority (BARDA); grants from Gilead and CDC; payment or honoraria for speaking engagements or events from Area Health Education Center (AHEC), Contraceptive Technologies, and Core Concepts in Health; travel support from the Infectious Diseases Society of America (IDSA); a role on a Data Safety Monitoring or Advisory Board with NIH; and other research support from Lupin paid to her employer, Wake Forest University School of Medicine. M. R. G. has received research funding from Hologic, Inc, and from SpeeDx Pty. A. P. has received travel and conference attendance support from Hologic, Inc. S. J. J. has received consulting fees from Preventx. K. W. reports HIV and STI training grants from CDC, Epidemiology and Laboratory Capacity for Prevention and Control of Emerging Infectious Diseases (ELC) funding for gonorrhea surveillance and resistance testing from CDC, and STI and HIV clinical service grants or contracts from the Colorado Department of Public Health and Environment (all paid to their institution); travel support for a CDC grantee meeting from the National Association of County and City Health Officials; and participation on a collective impact group with Denver Metro STI Coalition (paid to their institution). H. R. serves as a board member for ASTDA. W. M. G. reports consulting fees from Visby (paid to the author) and payments or honoraria from Hologic and Abbott (paid to the author). D. G. reports a pending patent for detection of drug-resistant Mycoplasma genitalium and is an employee of Hologic. All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed., (© The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America.)

Study Question: Is Mycoplasma genitalium-infection associated with reduced fecundability?, Summary Answer: Preconception M. genitalium-infection was associated with 27% lower fecundability though confidence intervals were wide, and the association between M. genitalium and fecundability may be dependent on concurrent bacterial vaginosis (BV)., What Is Known Already: M. genitalium has been associated with cervicitis, pelvic inflammatory disease, infertility, and preterm birth, but the extent to which M. genitalium is causally related to adverse reproductive sequelae in women is debated., Study Design, Size, Duration: Kenyan women enrolled in a prospective preconception cohort provided vaginal fluid specimens and underwent monthly pregnancy testing. Stored samples from 407 women who had been trying to conceive for ≤6 months were tested for M. genitalium using a nucleic acid amplification test., Participants/materials, Setting, Methods: Data on first day of last menstrual period, sexual behavior, pregnancy status, and vaginal specimens were collected at monthly preconception visits. The association between M. genitalium detected at the visit prior to each pregnancy test and fecundability was estimated using discrete time proportional probabilities models. Secondary analyses explored the influence of concurrent BV on the association between M. genitalium and fecundability., Main Results and the Role of Chance: The 407 participants experienced 1220 menstrual cycles and 213 pregnancies. The prevalence of M. genitalium at enrollment was 7.7%. After adjustment for age, frequency of condomless sex in the last 4 weeks, and study site, M. genitalium was associated with a 27% lower fecundability, but confidence intervals were wide (adjusted fecundability ratio (aFR) 0.73, 95% CI 0.44, 1.23). In secondary analyses, when compared to cycles without M. genitalium or BV at the visit prior, women with both M. genitalium and BV at the visit prior had a 51% lower fecundability (aFR = 0.49, 95% CI 0.22, 1.09) whereas there was no association of M. genitalium alone (aFR = 0.98 (95% CI 0.54, 1.76)), and a smaller reduction in fecundability for women with BV only (aFR = 0.80 (95% CI 0.60, 1.07))., Limitations, Reasons for Caution: Results should be interpreted cautiously given the relatively low prevalence of M. genitalium and wide confidence intervals., Wider Implications of the Findings: In this cohort of Kenyan women trying to conceive, the association between M. genitalium and fecundability was influenced by concurrent BV status, suggesting there may be a synergistic effect of M. genitalium and BV on fecundability., Study Funding/competing Interest(s): This work was supported by a National Institutes of Health grant (NICHD R01 HD087346-RSM). R.S.M. received additional support for mentoring (NICHD K24 HD88229). E.M.L. was supported by pre- and post-doctoral fellowships (NIAID T32 AI07140, NICHD F32 HD100202). Data collection and management were completed using REDCap electronic data capture tools hosted at the University of Washington's Institute of Translational Health Science supported by grants from NCATS/NIH (UL1 TR002319). The content of this paper is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. R.S.M. receives research funding, paid to the University of Washington, from Hologic Corporation and consulting fees from Lupin Pharmaceuticals. L.E.M. receives research funding and material for research studies, paid to the University of Washington, from Hologic Corporation and Nabriva Therapeutics, travel support from Hologic, and consulting fees from Health Advances. E.M.L.'s contributions to this study primarily occurred while affiliated with the University of Washington; at the time of submission, E.M.L. was an employee of and holds stock or stock grants for AbbVie, Inc. The other authors have no conflicts of interest., Trial Registration Number: N/A., (© The Author(s) 2023. Published by Oxford University Press on behalf of European Society of Human Reproduction and Embryology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Abstract: The antibody response to Mycoplasma genitalium in serum and urethral secretions of men with nongonococcal urethritis was examined longitudinally. Serum and urethral antibodies reacted primarily with the MgpB and MgpC adhesins. Serum antibodies persisted throughout follow-up, whereas urethral antibodies waned despite organism persistence. Declining antibodies may facilitate chronic infection., Competing Interests: Conflict of Interest and Sources of Funding: The authors have no conflicts to declare. This study was supported by the National Institutes of Health (grants U19AI031448 and R21AI148816)., (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Sexually Transmitted Diseases Association.)

Objectives: Epidemiological treatment of persons who are sexual contacts to partners with Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT) often results in treatment of uninfected persons, which may increase the risk of antibiotic-resistant infections. We sought to identify the predictors of NG and/or CT infections to develop a risk score that could be used to limit epidemiological treatment to persons most likely to have these infections., Methods: We included visits to the Public Health - Seattle & King County Sexual Health Clinic by asymptomatic cisgender men who have sex with men (MSM) aged ≥18 who presented as a sexual contact to partner(s) with CT or NG infection between 2011 and 2019. We used logistic regression to estimate the odds of CT and/or NG infections associated with demographic and clinical predictors, selecting the final set of predictors using the Akaike information criteria and obtaining score weights from model coefficients. We used a cross-validation approach to obtain average model discrimination from each of 10 models, leaving out 10% of the data, and evaluated sensitivity and specificity at various score cut-offs., Results: The final model for predicting NG or CT infection included seven predictors (age <35 years, HIV status, receptive oral sex in the prior 2 months, CT diagnosis, condomless receptive anal intercourse, condomless insertive anal intercourse and methamphetamine use in the prior 12 months). Model discrimination, as measured by the receiver operating curve, was 0.60 (95% CI 0.54 to 0.66). Sensitivity for detection of infection was ≥90% for scores ≥3, ≥5 and ≥7; specificity for these cut-offs was <16%. At scores ≥9, ≥12 and ≥14, specificity increased but sensitivity decreased to ≤76%., Conclusions: Our risk score did not sufficiently discriminate between asymptomatic MSM with and without NG/CT infection. Additional studies evaluating epidemiological treatment as a standard of care in diverse populations are needed to guide best practices in the management of contacts to NG/CT infection., Competing Interests: Competing interests: CMK: donations of specimen collection kits and reagents from Hologic for research outside the submitted work. LM: Hologic and Nabriva for research support unrelated to this work. MRG: Hologic for research support unrelated to this work. LAB: Hologic, Nabriva and SpeeDx for research support unrelated to this work., (© Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: Bacterial vaginosis-associated bacterium 2 (BVAB2), Mageeibacillus indolicus and Sneathia spp are highly predictive of bacterial vaginosis (BV) in cisgender women. They have been associated with non-gonococcal urethritis (NGU) in cisgender men in some but not all populations. We evaluated this association in a cross-sectional study of cisgender men who have sex with women only (MSW)., Methods: MSW without gonorrhoea attending a sexual health clinic (SHC) from 2014 to 2018 completed a computer-assisted self-interview, clinical interview and examination. NGU was defined as ≥5 polymorphonuclear leucocytes/high-power field in urethral exudates plus either urethral symptoms or visible discharge. Urine was tested for Chlamydia trachomatis and Mycoplasma genitalium using Aptima (Hologic) and for BVAB2, M. indolicus , Sneathia spp, Trichomonas vaginalis , Ureaplasma urealyticum , Haemophilus influenzae , herpes simplex virus and adenovirus using quantitative PCR., Results: Of 317 MSW age 17-71, 67 (21.1%) had Sneathia spp, 36 (11.4%) had BVAB2, and 17 (5.4%) had M. indolicus at enrolment. Having ≥3 partners in the past 2 months was the only characteristic that was more common among MSW with than those without these bacteria (BVAB2: 47% vs 23%, M. indolicus : 53% vs 24%, Sneathia spp: 42% vs 22%; p≤0.03 for all). One-hundred seventeen men (37%) were diagnosed with NGU at enrolment. There was no significant association of BVAB2, M. indolicus or Sneathia spp with NGU (adjusted OR=0.59, 95% CI 0.14 to 2.43; aOR=3.40, 95% CI 0.68 to 17.06; aOR=0.46, 95% CI 0.16 to 1.27). Of 109 MSW with monthly samples, 34 (31.2%) had one of the bacteria at one or more follow-up visits, 22 of which were co-colonised with >1. Median persistence over 6 months did not differ significantly (BVAB2=30.5 days, IQR=28-87; M. indolicus =87 days, IQR=60-126; Sneathia spp=70 days, IQR=30-135; p≥0.20 for each comparison)., Conclusions: Neither BVAB2, M. indolicus nor Sneathia spp were associated with increased risk of prevalent NGU in MSW attending an SHC., Competing Interests: Competing interests: LEM has received research support and honoraria from Hologic and Nabriva Therapeutics., (© Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ.)

Mycoplasma genitalium is a frequent cause of urogenital syndromes in men and women and is associated with adverse sequelae in women. M genitalium also infects the rectum, and may cause proctitis, but rarely infects the pharynx. Diagnosis requires nucleic acid amplification testing. Antibiotic resistance is widespread: more than half of infections are resistant to macrolides and fluoroquinolone resistance is increasing. Resistance-guided therapy is recommended for symptomatic patients, involving initial treatment with doxycycline to reduce organism load followed by azithromycin for macrolide-sensitive infections or moxifloxacin for macrolide-resistant infections. Neither screening nor tests of cure are recommended in asymptomatic persons., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background: There is conflicting evidence on whether prior azithromycin (AZM) exposure is associated with reduced susceptibility to AZM (AZMRS) among persons infected with Neisseria gonorrhoeae (NG)., Methods: The study population included Public Health-Seattle and King County Sexual Health Clinic (SHC) patients with culture-positive NG infection at ≥1 anatomic site whose isolates were tested for AZM susceptibility in 2012-2019. We used multivariate logistic regression to examine the association of time since last AZM prescription from the SHC in ≤12 months with subsequent diagnosis with AZMRS NG (minimum inhibitory concentration [MIC], ≥2.0 µg/mL) and used linear regression to assess the association between the number of AZM prescriptions in ≤12 months and AZM MIC level, controlling for demographic, behavioral, and clinical characteristics., Results: A total of 2155 unique patients had 2828 incident NG infections, 156 (6%) of which were caused by AZMRS NG. AZMRS NG was strongly associated with receipt of AZM from the SHC in the prior 29 days (adjusted odds ratio, 6.76; 95% confidence interval [CI], 1.76 to 25.90) but not with receipt of AZM in the prior 30-365 days. Log AZM MIC level was not associated with the number of AZM prescriptions within ≤12 months (adjusted correlation, 0.0004; 95% CI, -.04 to .037) but was associated with number of prescriptions within <30 days (adjusted coefficient, 0.56; 95% CI, .13 to .98)., Conclusions: Recent individual-level AZM treatment is associated with subsequent AZMRS gonococcal infections. The long half-life and persistence of subtherapeutic levels of AZM may result in selection of resistant NG strains in persons with recent AZM use., Competing Interests: Potential conflicts of interest. E. R. reports grants from the NIH (1R03AI156261-01, TL1 TR002318). O. O. S. received research support unrelated to this study from the CDC, Hologic, Inc, and SpeeDx and is on the board of directors for the American Sexually Transmitted Diseases Association. J. P. H. reports grants or contracts from the NIH and participation on a data and safety monitoring board (DSMB) or advisory board for the NIH. C. T. reports support for attending meetings and/or travel from the CDC ELC cooperative agreement CK19-1904 (grant funding to institution, Public Health—Seattle and King County). C. M. K. received donations of specimen collection kits and reagents from Hologic, Inc, for research unrelated to this study and reports grants from the NIH for studies outside of the submitted work. L. E. M. reports research support unrelated to this study from the NIH, Hologic, Inc, and Nabriva (research grant paid to the University of Washington); consulting fees for service on a scientific advisory board, including payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Hologic, Inc, and Nabriva Therapeutics (scientific advisory board, payment to author); and receipt of equipment, materials, drugs, medical writing, gifts, or other services from Hologic, Inc (test kits and reagents provided to the University of Washington for research studies) and Nabriva Therapeutics (antibiotics provided to the University of Washington for research study). M. R. G. received research support unrelated to this study from Hologic, Inc, and grants or contracts from Speedex and reports receipt of equipment, materials, drugs, medical writing, gifts, or other services from Hologic. L. A. B. received research support unrelated to this study from Hologic, Inc, SpeeDx, the NIH, CDC, the Global Antibiotic Research and Development Partnership, and Nabriva and consulting fees from Nabriva; served on a DSMB for the Bexsero trial for mucosal immunity; participated on a DSMB or advisory board for the End Point Adjudication Committee for the DoxyPEP (post-exposure prophylaxis) study (NIH R01 to Celum and Lukemeijer); and received equipment, materials, drugs, medical writing, gifts, or other services from Hologic, Inc (test kits for study). All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed., (© The Author(s) 2022. Published by Oxford University Press on behalf of Infectious Diseases Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Although nuanced parameterization of sexual behavior may improve estimates from mathematical models of human immunodeficiency virus and sexually transmitted infection transmission, prospective estimates of the incidence of specific sexual behaviors among men who have sex with men (MSM) are limited. From December 2014 to July 2018, MSM with and without nongonococcal urethritis (NGU) completed weekly diaries over 3-12 weeks. Incidence rates of any sex, receptive anal sex, insertive anal sex, insertive oral sex, receptive rimming, and receptive hand-penile contact were 1.19, 0.28, 0.66, 0.90, 0.24, and 0.85 episodes per person-week, respectively, among 104 MSM with NGU at baseline, and 1.33, 0.54, 0.32, 0.95, 0.44, and 0.88 episodes per person-week, respectively, among 25 MSM without NGU at baseline. Most receptive anal sex (NGU + 83%, NGU - 86%) and insertive anal sex (NGU + 85%, NGU - 76%) episodes were condomless. MSM engaged in sex just over once per week, and condom use was infrequent. Insertive oral sex and receptive hand-penile contact were the most common behaviors., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Objective: To examine the association between cultivable vaginal Lactobacillus and fecundability in Kenyan women attempting nonmedically assisted conception., Design: Prospective preconception cohort., Setting: Nairobi and Mombasa, Kenya., Patient(s): Women trying to conceive who reported ≤3 months of pre-enrollment conception attempt time., Intervention(s): Cultivable Lactobacillus (primary), Lactobacillus morphotypes on Gram stain (secondary)., Main Outcome Measure(s): Participants reported the first day of their last menstrual period and recent sexual behavior, underwent pregnancy testing, and provided vaginal specimen samples for Lactobacillus culture and Gram stain at ≤6 monthly preconception visits. The outcome was fecundability-the per-menstrual cycle probability of pregnancy. Associations between cultivable Lactobacillus and Lactobacillus morphotypes on Gram stain at the visit before each pregnancy test and fecundability were estimated using proportional probabilities models to generate fecundability ratios (FRs)., Result(s): A total of 458 women contributed 1,376 menstrual cycles. At enrollment, 65.3% (n = 299) of participants had cultivable Lactobacillus, 47.4% (n = 217) had cultivable hydrogen peroxide producing Lactobacillus, and 64.6% (n = 296) had Lactobacillus detected on Gram stain. In unadjusted analysis, there was no association between cultivable Lactobacillus at the prior visit and fecundability (FR, 0.92; 95% CI, 0.73-1.16); results were similar after adjustment for age, frequency of condomless sex, and study site (adjusted FR, 0.92; 95% CI, 0.72-1.18). Lactobacillus on Gram stain at the visit prior was associated with modestly higher fecundability (adjusted FR, 1.18; 95% CI, 0.92-1.51)., Conclusion(s): Cultivable Lactobacillus was not associated with fecundability, although Lactobacillus morphotypes detected on Gram stain were somewhat associated with increased fecundability. The relationship between vaginal Lactobacillus and fecundity may be species-specific., (Copyright © 2021 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.)

Mycoplasma genitalium is a sexually transmitted bacterium associated with nongonococcal urethritis (NGU) in men and cervicitis, endometritis, and pelvic inflammatory disease in women. Effective treatment is challenging due to the inherent, and increasingly acquired, antibiotic resistance in this pathogen. In our treatment trial conducted from 2007 to 2011 in Seattle, WA, we demonstrated poor efficacy of azithromycin (AZM) and doxycycline (DOX) against M. genitalium among men with NGU. In the present study, we cultured M. genitalium from 74 of 80 (92.5%) PCR-positive men at enrollment (V-1) and defined the MICs of AZM ( N  = 56 isolates) of DOX ( N  = 62 isolates). Susceptibility to AZM was bimodal; MICs were >8 μg/ml (44.6%) and <0.004 μg/ml (55.4%) for these isolates. The association of MIC with treatment efficacy was determined for men initially treated with either AZM ( N  = 30) or DOX ( N  = 24). Men treated with AZM were more likely to experience microbiologic treatment failure ( P < 0.001) if infected with isolates that had AZM MICs of >8 μg/ml (18/18 men) than those with isolates that had AZM MICs of <0.004 μg/ml (1/12 men). Clinical treatment failure also was more likely to occur ( P = 0.002) with AZM MICs of >8 μg/ml (12/18 men) than with AZM MICs of <0.004 μg/ml (1/12 men). In contrast, DOX MICs ranged from <0.125 to 2 μg/ml and were not correlated with microbiologic ( P = 0.71) or clinical treatment ( P = 0.41) failure, demonstrating no relationship between DOX MICs and treatment efficacy. Given the rapid spread of AZM resistance and the emergence of quinolone resistance, the current second-line therapy, monitoring MICs and evaluating other potential treatments for M. genitalium will be critical.

Background: Nongonococcal urethritis (NGU) is a common syndrome with no known etiology in ≤50% of cases. We estimated associations between urethral bacteria and NGU in men who have sex with men (MSM) and men who have sex with women (MSW)., Methods: Urine was collected from NGU cases (129 MSM, 121 MSW) and controls (70 MSM, 114 MSW) attending a Seattle STD clinic. Cases had ≥5 polymorphonuclear leukocytes on Gram stain plus symptoms or discharge; controls had <5 PMNs, no symptoms, no discharge. NGU was considered idiopathic when Neisseria gonorrhoeae, Chlamydia trachomatis, Mycoplasma genitalium, Trichomonas vaginalis, adenovirus, and herpes simplex virus were absent. The urethral microbiota was characterized using 16S rRNA gene sequencing. Compositional lasso analysis was conducted to identify associations between bacterial taxa and NGU and to select bacteria for targeted qPCR., Results: Among NGU cases, 45.2% were idiopathic. Based on compositional lasso analysis, we selected Haemophilus influenzae (HI) and Mycoplasma penetrans (MP) for targeted qPCR. Compared with 182 men without NGU, the 249 men with NGU were more likely to have HI (14% vs 2%) and MP (21% vs 1%) (both P ≤ .001). In stratified analyses, detection of HI was associated with NGU among MSM (12% vs 3%, P = .036) and MSW (17% vs 1%, P < .001), but MP was associated with NGU only among MSM (13% vs 1%, P = .004). Associations were stronger in men with idiopathic NGU., Conclusions: HI and MP are potential causes of male urethritis. MP was more often detected among MSM than MSW with urethritis., (© The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.)

Pelvic inflammatory disease (PID) is a clinical syndrome that has been associated with a wide range of potential causal pathogens. Three broad groups of organisms have been isolated from the genital tract of people with PID: sexually transmitted organisms such as Neisseria gonorrhoeae, Chlamydia trachomatis, Mycoplasma genitalium, and Trichomonas vaginalis; bacterial vaginosis (BV)-associated species and genera such as Atopobium vaginae, Sneathia, and Megasphaera; and genera and species usually associated with the gastrointestinal or respiratory tracts such as Bacteroides, Escherichia coli, Streptococcus, or Haemophilus influenza. Although PID is often considered to be synonymous with gonorrhea or chlamydia, these pathogens are found in only one quarter to one third of people with PID, suggesting that broader screening and diagnostic and treatment strategies need to be considered to reduce the burden of PID and its associated sequelae., (© The Author(s) 2021. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.)

Background: Incidence and risk factors for nongonococcal urethritis (NGU) remain poorly defined. We conducted a cohort study to estimate the incidence of NGU and identify risk factors in men who have sex with women., Methods: We enrolled cisgender male sexually transmitted disease clinic attendees 16 years or older who reported exclusively female partners. At enrollment and 6 monthly follow-up visits, men underwent a clinical examination, provided urethral swab and urine specimens, completed a sexual behavior survey and biweekly diaries, and were tested for Chlamydia trachomatis (CT) and Mycoplasma genitalium (MG) using Aptima assays (Hologic, Inc). Nongonococcal urethritis was defined as ≥5 polymorphonuclear leukocytes per high-power field plus either urethral symptoms or visible discharge. We estimated the incidence of NGU overall, asymptomatic and symptomatic NGU, non-CT/non-MG NGU, and CT/MG-associated NGU using Poisson regression for clustered outcomes. We performed relative risk binomial regression for clustered data to identify characteristics associated with incident NGU., Results: From August 2014 to July 2018, 307 participants at risk for NGU contributed 109.4 person-years. Median age was 32 years, and 52% were White. At enrollment, 107 men had NGU; of these, 88% were symptomatic, 27% had CT, and 22% had MG. Fifty men had 60 cases of incident NGU (incidence rate, 56 per 100 person-years; 95% confidence interval, 43-74). Unlike prevalent NGU at enrollment, CT/MG-associated incident NGU was rare (incidence rate, 7; 95% confidence interval [CI], 4-15), and most (78%) incident NGU was asymptomatic. Risk factors for incident NGU were ≤ high school education (adjusted rate ratio [ARR], 2.45; 95% CI, 1.19-5.00), history of CT (ARR, 2.15; 95% CI, 1.08-4.27), history of NGU (ARR, 2.67; 95% CI, 1.27-5.62), and NGU at enrollment (ARR, 2.03; 95% CI, 1.04-3.98). Neither condom use nor having a new partner was associated with incident NGU; Black race was only associated with incident symptomatic and non-CT/non-MG NGU., Conclusions: Incidence of NGU was high, predominantly non-CT/non-MG and asymptomatic. Future studies should investigate the etiology and clinical significance of asymptomatic NGU., Competing Interests: Conflict of Interest and Sources of Funding: L.E.M. has received honoraria, reagents, and test kits for diagnostic assays from Hologic, Inc. L.C.C. and E.R. have received trainee support from the Institute of Translational Health Sciences (grant number TL1 TR002318). M.R.G. has received grants from the National Institutes of Health, Hologic, and GSK. All other authors report no potential conflicts. Conflicts that the editors consider relevant to the content of the article have been disclosed., (Copyright © 2020 American Sexually Transmitted Diseases Association. All rights reserved.)

Study Question: Is bacterial vaginosis (BV) associated with fecundability?, Summary Answer: Women with BV may be at increased risk for sub-fecundity., What Is Known Already: While BV has been associated with poor IVF outcomes, the association between vaginal microbiota disruption and non-medically assisted conception has not been thoroughly explored., Study Design, Size, Duration: Kenyan women with fertility intent were enrolled in prospective cohort that included monthly preconception visits with vaginal fluid specimen collection and pregnancy testing. Four hundred fifty-eight women attempting pregnancy for ≤3 menstrual cycles at enrollment were eligible for this fecundability analysis., Participants/materials, Setting, Methods: At monthly preconception visits, participants reported the first day of last menstrual period and sexual behavior, underwent pregnancy testing and provided vaginal specimens. Discrete time proportional probabilities models were used to estimate fecundability ratios (FRs) and 95% CI in menstrual cycles with and without BV (Nugent score ≥ 7) at the visit prior to each pregnancy test. We also assessed the association between persistent BV (BV at two consecutive visits) and fecundability., Main Results and the Role of Chance: Participants contributed 1376 menstrual cycles; 18.5% (n = 255) resulted in pregnancy. After adjusting for age, frequency of condomless sex and study site, BV at the visit prior to pregnancy testing was associated with a 17% lower fecundability (adjusted FR (aFR) 0.83, 95% CI 0.6-1.1). Persistent BV was associated with a 43% reduction in fecundability compared to cycles characterized by optimal vaginal health (aFR 0.57, 95% CI 0.4-0.8)., Limitations, Reasons for Caution: Detection of vaginal microbiota disruption using Gram stain and a point-of-care test for elevated sialidase identified a non-optimal vaginal environment, but these non-specific methods may miss important relationships that could be identified by characterizing individual vaginal bacteria and bacterial communities using molecular methods. In addition, results may be subject to residual confounding by condomless sex as this was reported for the prior month rather than for the fertile window during each cycle., Wider Implications of the Findings: Given the high global prevalence of BV and infertility, an association between BV and reduced fecundability could have important implications for a large number of women who wish to conceive. Multi-omics approaches to studying the vaginal microbiota may provide key insights into this association and identify potential targets for intervention., Study Funding/competing Interest(s): This work was supported by a National Institutes of Health grant (NICHD R01 HD087346-R.S.M.). R.S.M. received additional support for mentoring (NICHD K24 HD88229). E.M.L. was supported by pre- and post-doctoral fellowships (NIAID T32 AI07140, NICHD F32 HD100202). Data collection and management were made possible using REDCap electronic data capture tools hosted at the University of Washington's Institute of Translational Health Science supported by grants from NCATS/NIH (UL1 TR002319). The content of this paper is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. R.S.M. receives research funding, paid to the University of Washington, from Hologic Corporation, and has received honoraria for consulting from Lupin Pharmaceuticals. L.E.M. receives research funding, paid to the University of Washington, from Hologic Corporation, and has received honoraria for service on scientific advisory boards from Hologic and Nabriva Therapeutics., Trial Registration Number: N/A., (© The Author(s) 2021. Published by Oxford University Press on behalf of European Society of Human Reproduction and Embryology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Background: Antimicrobial resistance in Mycoplasma genitalium (MG), a cause of urethritis, is a growing concern. Yet little is known about the geographic distribution of MG resistance in the United States or about its associated clinical outcomes. We evaluated the frequency of MG among men with urethritis, resistance mutations, and posttreatment symptom persistence., Methods: We enrolled men presenting with urethritis symptoms to 6 US sexually transmitted disease (STD) clinics during June 2017-July 2018; men with urethritis were eligible for follow-up contact and, if they had persistent symptoms or MG, a chart review. Urethral specimens were tested for MG and other bacterial STDs. Mutations in 23S ribosomal ribonucleic acid (rRNA) loci (macrolide resistance-associated mutations [MRMs]) and in parC and gyrA (quinolone-associated mutations) were detected by targeted amplification/Sanger sequencing., Results: Among 914 evaluable participants, 28.7% (95% confidence interval [CI], 23.8-33.6) had MG. Men with MG were more often Black (79.8% vs 66%, respectively), <30 years (72.9% vs 56.1%, respectively), and reported only female partners (83.7% vs 74.2%, respectively) than men without MG. Among MG-positive participants, 64.4% (95% CI, 58.2-70.3%) had MRM, 11.5% (95% CI, 7.9-16.0%) had parC mutations, and 0% had gyrA mutations. Among participants treated with azithromycin-based therapy at enrollment and who completed the follow-up survey, persistent symptoms were reported by 25.8% of MG-positive/MRM-positive men, 13% of MG-positive/MRM-negative men, and 17.2% of MG-negative men., Conclusions: MG infection was common among men with urethritis; the MRM prevalence was high among men with MG. Persistent symptoms following treatment were frequent among men both with and without MG., (Published by Oxford University Press for the Infectious Diseases Society of America 2020.)

Mycoplasma genitalium is a sexually transmitted bacterial pathogen that infects men and women. Antigenic variation of MgpB and MgpC, the immunodominant adherence proteins of M. genitalium, is thought to contribute to immune evasion and chronic infection. We investigated the evolution of mgpB and mgpC sequences in men with non-gonococcal urethritis persistently infected with M. genitalium, including two men with anti-M. genitalium antibodies at enrollment and two that developed antibodies during follow-up. Each of the four patients was persistently infected with a different strain type and each patient produced antibodies targeting MgpB and MgpC. Amino acid sequence evolution in the variable regions of MgpB and MgpC occurred in all four patients with changes observed in single and multiple variable regions over time. Using the available crystal structure of MgpC of the G37 type strain we found that predicted conformational B cell epitopes localize predominantly to the variable region of MgpC, amino acids that changed during patient infection lie in these epitopes, and variant amino acids are in close proximity to the conserved sialic acid binding pocket. These findings support the hypothesis that sequence variation functions to avoid specific antibodies thereby contributing to persistence in the genital tract., Competing Interests: The authors have declared that no competing interests exist.

Data from a large prospective multicenter clinical validation study of a nucleic acid amplification in vitro diagnostic test for Mycoplasma genitalium were analyzed to describe the prevalence of M. genitalium infection, risk factors, and disease associations in female and male patients seeking care in diverse geographic regions of the United States. Among 1,737 female and 1,563 male participants, the overall prevalence of M. genitalium infection was 10.3% and was significantly higher in persons ages 15 to 24 years than in persons ages 35 to 39 years (for females, 19.8% versus 4.7% [odds ratio {OR} = 5.05; 95% confidence interval {CI} = 3.01 to 8.46]; for males, 16.5% versus 9.4% [OR = 1.91; 95% CI = 1.20 to 3.02]). The risk for M. genitalium infection was higher in black than in white participants (for females, 12.0% versus 6.8% [OR = 1.88; 95% CI = 1.30 to 2.72]; for males, 12.9% versus 6.9% [OR = 2.02; 95% CI = 1.38 to 2.96]) and higher in non-Hispanic than in Hispanic participants (for females, 11.2% versus 6.0% [OR = 1.97; 95% CI = 1.25 to 3.10]; for males, 11.6% versus 6.8% [OR = 1.80; 95% CI = 1.14 to 2.85]). Participants reporting urogenital symptoms had a significantly elevated risk of M. genitalium infection compared to that for asymptomatic individuals (for females, OR = 1.53 [95% CI = 1.09 to 2.14]; for males, OR = 1.42 [95% CI = 1.02 to 1.99]). Women diagnosed with vaginitis and cervicitis had a higher prevalence of M. genitalium infection than women without those diagnoses, although this was statistically significant only for vaginitis (for vaginitis, OR = 1.88 [95% CI = 1.37 to 2.58]; for cervicitis, OR = 1.42 [95% CI = 0.61 to 2.96]). A diagnosis of urethritis in men was also significantly associated with M. genitalium infection (OR = 2.97; 95% CI = 2.14 to 4.13). Few characteristics distinguished asymptomatic from symptomatic M. genitalium infections. These results from persons seeking care in the United States suggest that M. genitalium infection should be considered in young persons presenting with urogenital symptoms., (Copyright © 2020 Manhart et al.)

Background: Rectal Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) are increasingly recognized as common infections among women. Little is known about the prevalence of rectal Mycoplasma genitalium (MG), rectal MG/CT/GC coinfection, or MG antimicrobial resistance patterns among women., Methods: In 2017 to 2018, we recruited women at high risk for CT from Seattle's municipal sexually transmitted disease clinic. Participants self-collected vaginal and rectal specimens for CT/GC nucleic acid amplification testing. We retrospectively tested samples for vaginal and rectal MG using nucleic acid amplification testing and tested MG-positive specimens for macrolide resistance-mediating mutations (MRM) and ParC quinolone resistance-associated mutations (QRAMs)., Results: Of 50 enrolled women, 13 (26%) tested positive for MG, including 10 (20%) with vaginal MG and 11 (22%) with rectal MG; 8 (62%) had concurrent vaginal/rectal MG. Five (38%) were coinfected with CT, none with GC. Only 2 of 11 women with rectal MG reported anal sex in the prior year. Of MG-positive specimens, 100% of rectal and 89% of vaginal specimens had an MRM. There were no vaginal or rectal MG-positive specimens with ParC QRAMs previously associated with quinolone failure. Five MG-infected women received azithromycin for vaginal CT, 4 of whom had a MG MRM detected in their vaginal and/or rectal specimens., Conclusions: We observed a high prevalence of macrolide-resistant vaginal and rectal MG among a population of women at high risk for CT. This study highlights how the use of antimicrobials designed to treat an identified infection-in this case, CT-could influence treatment outcomes and antimicrobial susceptibility in other unidentified infections.

From February 2015 to October 2017, among 20 men who have sex with men with Mycoplasma genitalium-associated nongonococcal urethritis, 15% had macrolide resistance and S83I ParC mutations. Azithromycin followed by moxifloxacin cleared Mycoplasma genitalium in 2 of 2 with and 11 of 13 without S83I mutations. Dual failures were cleared after doxycycline. S83I mutations were not associated with moxifloxacin failure.

A prospective multicenter clinical study involving subjects from 21 sites across the United States was conducted to validate the performance of a new in vitro diagnostic nucleic acid amplification test (NAAT) for the detection of Mycoplasma genitalium Seven urogenital specimen types ( n  = 11,556) obtained from 1,778 females, aged 15 to 74 years, and 1,583 males, aged 16 to 82 years, were tested with the Aptima Mycoplasma genitalium assay, an investigational transcription-mediated amplification (TMA) NAAT for the detection of M. genitalium 16S rRNA. Infected status for enrolled subjects was established using results obtained from testing either self-collected vaginal swab or clinician-collected male urethral swab specimens with a composite reference method consisting of three transcription-mediated amplification NAATs targeting unique regions of M. genitalium 16S or 23S rRNA. M. genitalium prevalence was 10.2% in females and 10.6% in males; prevalence was high in both symptomatic and asymptomatic subjects for both sexes. Compared to the subject infected status standard, the investigational test had sensitivity and specificity estimates, respectively, of 98.9% and 98.5% for subject-collected vaginal swabs, 92.0% and 98.0% for clinician-collected vaginal swabs, 81.5% and 98.3% for endocervical swabs, 77.8% and 99.0% for female urine, and 98.2% and 99.6% for male urethral swabs, 88.4% and 97.8% for self-collected penile meatal swabs, and 90.9% and 99.4% for male urine specimens. For all seven specimen types, within-specimen positive and negative agreements between the investigational test and the composite reference standard ranged from 94.2% to 98.3% and from 98.5 to 99.9%, respectively. These results provide clinical efficacy evidence for the first FDA-cleared NAAT for M. genitalium detection in the United States., (Copyright © 2019 Gaydos et al.)

Background: Standard counseling at nongonococcal urethritis (NGU) diagnosis includes advice to abstain from sex for at least 7 days and until symptoms resolve., Methods: From December 2014 to July 2018, we enrolled men who have sex with men and received azithromycin (1 g) for NGU at the Public Health-Seattle and King County STD Clinic. Over 12 weeks of follow-up, participants reported daily urethral symptoms and sexual activity on web-based diaries. Nongonococcal urethritis was defined as urethral symptoms or visible urethral discharge plus 5 or greater polymorphonuclear leukocytes per high-power field. Time of symptom resolution was defined as the first of 5 consecutive asymptomatic days., Results: Of 100 participants with NGU and no Chlamydia trachomatis (CT)/Mycoplasma genitalium (MG) coinfection, 36 (36%), 22 (22%), and 42 (42%) had CT-NGU, MG-NGU, and non-CT/non-MG NGU, respectively. Among men with MG-NGU, 94% had a macrolide resistance mutation. For all etiologies, median time to symptom resolution after azithromycin was 7 days (95% confidence interval [CI], 5-9); 37% had symptoms lasting longer than 7 days. For men with CT-NGU, MG-NGU, and non-CT/non-MG NGU, median time to symptom resolution was 4 days (95% CI, 2-6; 16% >7 days), undefined days (95% CI, 7 to undefined; 60% >7 days), and 7 days (95% CI, 5-11; 46% >7 days), respectively. Median time to first sexual activity (any type) was 12 days (95% CI, 11-17); it was 16 days (95% CI, 12-18) to first urethral sexual exposure. Twenty-seven percent did not avoid urethral exposure for the recommended period., Conclusions: Counseling at NGU diagnosis should educate patients that symptoms may persist more than 7 days, particularly for non-CT NGU, and emphasize the rationale for the 7-day abstinence period.

Urine is an acceptable, non-invasive sample for investigating the human urogenital microbiota and for the diagnosis of sexually transmitted infections. However, low quantities of bacterial DNA and PCR inhibitors in urine may prevent efficient PCR amplification for molecular detection of bacteria. Furthermore, cold temperatures used to preserve DNA and bacteria in urine can promote precipitation of crystals that interfere with DNA extraction. Saline, Dulbecco's Phosphate Buffered Saline, or Tris-EDTA buffer were added to urine from adult men to determine if crystal precipitation could be reversed without heating samples beyond ambient temperature. Total bacterial DNA concentrations and PCR inhibition were measured using quantitative PCR assays to compare DNA yields with and without buffer addition. Dissolution of crystals with Tris-EDTA prior to urine centrifugation was most effective in increasing bacterial DNA recovery and reducing PCR inhibition. DNA recovery using Tris-EDTA was further tested by spiking urine with DNA from bacterial isolates and median concentrations of Lactobacillus jensenii and Escherichia coli 16S rRNA gene copies were found to be higher in urine processed with Tris-EDTA. Maximizing bacterial DNA yield from urine may facilitate more accurate assessment of bacterial populations and increase detection of specific bacteria in the genital tract., Competing Interests: LEM has received donations of test kits, equipment, reagents, and speaking honoraria from Hologic Incorporated. The company had no role in the research presented in this paper and this does not alter our adherence to PLOS ONE policies on sharing data and materials. All other authors report no conflicts of interest.

Background: In Peru, there is an ongoing high-incidence HIV epidemic among men who have sex with men (MSM) and transgender women (TW). Sexual concurrency, or having sex with a partner in between two acts of sex with another partner, may be a key factor in onward HIV transmission. In this study, we quantify concurrency, evaluate factors associated with concurrency, and assess condom use with concurrent partners among MSM and TW in Peru., Methods: We conducted a secondary analysis of data from the 2011 Peruvian Biobehavioral Survey. Pearson's Chi-squared test was used to identify individual-level characteristics associated with concurrency. We estimated the association between participant characteristics, concurrent partnerships, partnership type (stable vs. non-stable), and CLAI within the context of concurrent partnerships using multivariate and repeated-measure Poisson regression., Results: 3-month cumulative prevalence of concurrency was higher among TW compared to MSM (30.7% vs 25.2%, p = 0.014). Among those with concurrent stable and non-stable partners, 45% used condoms with both partners (95% CI: 40%-50%) and 30% preferentially had CLAI with the stable partner only (95%CI: 26%-35%). Factors associated with CLAI within the context of concurrent partnerships varied between MSM and TW., Conclusions: Although concurrency is common among TW and MSM in Peru, patterns of concurrency and differential condom use may vary between TW and MSM. Future research may explore differential condom use with stable and non-stable partners to better understand behavioral factors that may alter vulnerability to HIV in TW compared to MSM., Competing Interests: The authors have declared that no competing interests exist.

Objective: The aim of this study was to determine whether MSM using preexposure prophylaxis (PrEP) are at a higher risk of bacterial sexually transmitted infections (STIs) than MSM not using PrEP., Design: Secondary analysis of longitudinal STI data obtained from MSM attending an STD Clinic in Seattle, Washington, USA, October 2011-September 2017., Methods: We identified patients obtaining PrEP through the STD Clinic, and used propensity score matching to select a historical group of similar patients not using PrEP for comparison. We linked patient data with STI surveillance data to compare the incidence of chlamydia, gonorrhoea and early syphilis, and time to first symptomatic STI among PrEP users and nonusers., Results: Three hundred and sixty-five PrEP users who picked up prescriptions and returned for follow-up and 730 propensity score matched nonusers were included in the analysis. Adjusted incidence rate ratios (aIRRs) for chlamydia, gonorrhoea and early syphilis were 3.2 [95% confidence interval (95% CI): 1.9-5.3], 2.8 (95% CI: 1.7-4.6) and 2.9 (95% CI: 1.5 - 5.6), respectively, comparing PrEP users to nonusers. Time to first symptomatic STI was shorter among PrEP users (120 days, 95% CI: 77 - 171) than among nonusers (185 days, 95% CI: 163-256)., Conclusion: Among MSM on PrEP, we observed a higher incidence of STIs and faster time to first symptomatic STI than MSM not using PrEP. PrEP may be a contributing factor in increasing STI rates among MSM.

Background: Rectal Chlamydia trachomatis (CT) is common among clinic-attending women, but little is known about clearance and health implications of rectal CT., Methods: At the municipal sexually transmitted disease clinic in Seattle, Washington, in 2017-2018, we enrolled women at high risk for urogenital CT into an 8-week prospective study. Women received standard CT treatment at enrollment. Women self-collected daily rectal and vaginal specimens for nucleic acid amplification tests (NAATs) and completed weekly sexual exposure diaries. We performed CT culture on the enrollment rectal specimen., Results: We enrolled 50 women; 13 (26%) tested positive for vaginal (n = 11) and/or rectal (n = 11) CT. Sixty percent of women with rectal CT per NAAT were also culture positive. Median time to CT clearance after azithromycin treatment was 8.0 days for vaginal CT and 7.0 days for rectal CT. Eight women with rectal CT at enrollment had at least 1 rectal CT-positive NAAT after clearance of the initial infection; none reported anal sex., Conclusions: Most NAAT-positive rectal infections were culture positive, suggesting active infection. Time to NAAT clearance of rectal and genital tract CT was similar, and intermittent rectal CT positivity was common in the absence of anal sexual exposure. The cause of recurrent/intermittent rectal CT and the clinical implications of these infections require further study., (© The Author(s) 2019. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.)

Background: Although Mycoplasma genitalium (MG) is an acknowledged cause of nongonococcal urethritis (NGU), access to diagnostic testing is limited. Syndromic management is common, yet little is known about natural history., Methods: Between August 2014 and April 2016, 13 heterosexual men aged ≥16 years with MG were identified within a cohort study of men with and without NGU attending an urban sexually transmitted diseases clinic. Men had 6-7 monthly visits. NGU was defined as ≥5 polymorphonuclear leukocytes per high-power field on urethral Gram stain plus either visible urethral discharge or urethral symptoms. Men with NGU received 1 g of azithromycin. Men with persistent NGU received moxifloxacin 400 mg for 14 days. First-void urine was retrospectively tested for MG using transcription-mediated amplification. Resistance-associated mutations were detected by polymerase chain reaction (PCR) and sequencing. Organism load was determined by quantitative PCR., Results: Sixty-two percent of MG-positive men had macrolide resistance-mediating mutations (MRMM) at enrollment; 31% had parC mutations (all outside the quinolone resistance-determining region). MG persisted after azithromycin in 7 men, 6 of whom had MRMM. The median duration of persistence in the absence of curative therapy was 143 days (range, 21-228). Five men experienced symptom resolution after azithromycin, but MG persisted for another 89-186 days before moxifloxacin. Organism load was somewhat lower in MRMM than wild-type infections (P = .16)., Conclusions: The high prevalence of macrolide resistance and long duration of infection after symptom resolution highlights the need for diagnostic MG testing of men with NGU to direct therapy., (© The Author(s) 2018. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.)

Objective: Although Chlamydia trachomatis (CT) and Mycoplasma genitalium (MG) are major causes of non-gonococcal urethritis (NGU), up to 50% of cases are of unknown aetiology. We sought to identify urethral exposures at last sexual episode associated with NGU and non-CT/non-MG NGU to identify anatomical sites from which aetiologically relevant micro-organisms may be acquired., Methods: We enrolled STD clinic patients with and without NGU assigned male sex at birth and age ≥16 into a cross-sectional study. NGU was urethral symptoms or visible discharge plus ≥5 polymorphonuclear leucocytes without Neisseria gonorrhoeae . Urine was tested for CT and MG (Aptima). We used logistic regression to estimate the association between urethral exposures at last sex and NGU separately among cisgender men and transgender women who have sex with men (MSM/TGWSM) and cisgender men who have sex with women (MSW)., Results: Between 8 August 2014 and 1 November 2017, we enrolled 432 patients, including 183 MSM/TGWSM (118 NGU+, 65 NGU-) and 249 MSW (126 NGU+, 123 NGU-). The mean age was 34; 59% were white. CT and MG were detected in 72 (30%) and 49 (20%) NGU+ participants, respectively. Compared with MSM/TGWSM reporting only non-urethral exposures at last sex, those reporting insertive anal intercourse (IAI) only (adjusted OR (AOR)=4.46, 95% CI 1.09 to 18.19) and IAI with insertive oral sex (IOS) (AOR=7.88, 95% CI 2.67 to 23.26) had higher odds of NGU. MSM/TGWSM reporting IOS only had no significant increased odds (AOR=1.67, 95% CI 0.58 to 4.85). Compared with MSW whose only urethral exposure at last sex was vaginal sex (VS), MSW reporting IOS and VS had similar odds of NGU (OR=0.84, 95% CI 0.50 to 1.41). The results were similar for non-CT/non-MG NGU., Conclusions: Among MSM/TGWSM, IAI may lead to transmission of yet-unidentified rectal micro-organisms that cause non-CT/non-MG NGU, in addition to transmission of known pathogens. Sites of urethral exposure appear less important for understanding NGU risk among MSW due to minimal variation in behaviour., Competing Interests: Competing interests: CMK and LEM have received donations of test kits and reagents from Hologic. All other authors declare that they have no conflict of interest., (© Author(s) (or their employer(s)) 2019. No commercial re-use. See rights and permissions. Published by BMJ.)

We documented urethral Treponema pallidum infection in a man with nongonococcal urethritis and a negative syphilis serology using broad-range bacterial polymerase chain reaction (PCR) and sequencing, targeted PCR, and immunofluorescence microscopy. He subsequently seroconverted for syphilis. Early syphilis may present as urethritis. Urethral T. pallidum shedding can occur before seroconversion., (© The Author(s) 2018. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.)

Tuberculosis (TB) is a leading infectious cause of human death worldwide. In cattle, TB infection results in productivity losses, trade barriers and zoonotic transmission via milk, meat or direct contact. We conducted a cross-sectional study in rural communities in Uganda between 2014 and 2016 to evaluate the association between tuberculosis skin test (TST) positivity in humans and cattle-associated risk factors: household herd positivity and raw milk consumption. Human and cattle TSTs were performed in communities followed by a survey of household practices. TST data were available on 493 humans, 184 (37.3%) with positive results, and 1,441 cattle, 50 (3.5%) with positive results. We fit separate log binomial generalized estimating equation models for the herd positivity-human TST positivity association, stratified on sex; and for the raw milk consumption-human TST positivity association, stratified on frequency of milk consumption. Having at least one TST-positive bovid in the household's herd was significantly associated with lower risk of TB among men (prevalence ratio [PR] 0.66, 95% CI 0.49, 0.87) but was not significantly associated with TB among women (PR 1.21, 95% CI 0.76, 1.95). This apparent protective effect was contrary to our a priori hypothesis of higher exposure effect among men, the primary caretakers of cattle. This finding may be the result of residual confounding by socioeconomic status; wealthier individuals may be less likely to be TB positive, but more likely to have TST-positive herds by virtue of larger herd sizes, ability to purchase new and possibly infected stock, and propensity to keep more TB-susceptible European breeds. For raw milk consumption, effect estimates were close to one and not statistically significant. Thus, in settings where bovine TB prevalence is low, such as Uganda, cattle-associated zoonotic transmission may be rare, and cattle-associated risk factors may not be important drivers of human TB burden., (© 2018 Blackwell Verlag GmbH.)

We examined changes in sexual behavior and sexually transmitted infection (STI) prevalence among 183 men who have sex with men (MSM) initiating pre-exposure prophylaxis (PrEP) at an STD Clinic in Seattle, WA. We used generalized estimating equations to measure changes in sexual behavior during PrEP use, and linked PrEP patient data with STI surveillance data to compare the prevalence of chlamydia, gonorrhea, and early syphilis in the periods prior to and during PrEP use. Reporting never using condoms in the prior 30 days increased (adjusted relative risk = 1.46; 95% confidence interval 1.13, 1.88) at 12 months after PrEP initiation compared to the initial PrEP visit. Reporting unknown status partners in the prior 30 days decreased at 12 months compared to the initial PrEP visit, but there was no change in number of sexual partners or reporting HIV-positive or HIV-negative partners. The percentage of patients diagnosed with any STI while using PrEP (49.2%) was higher than the percentage diagnosed in the 12 months prior to PrEP use (35.0%), likely driven in part by increased STI screening during PrEP use. Among MSM on PrEP, we observed decreases in condom use, and a higher prevalence of STIs during PrEP use compared to prior to PrEP initiation.

Background: The ideal approach to triaging sexually transmitted disease (STD) clinic patients between testing-only express visits and standard visits with clinician evaluation is uncertain., Methods: In this cross-sectional study, we used classification and regression tree analysis to develop and validate the optimal algorithm for predicting which patients need a standard visit with clinician assessment (i.e., to maximize correct triage). Using electronic medical record data, we defined patients as needing a standard visit if they reported STD symptoms, received any empiric treatment, or were diagnosed as having an infection or syndrome at the same visit. We considered 11 potential predictors for requiring medical evaluation collected via computer-assisted self-interview when constructing the optimized algorithm. We compared test characteristics of the optimized algorithm, the Public Health-Seattle and King County STD Clinic's current 13-component algorithm, and a simple 2-component algorithm including only presence of symptoms and contact to STD., Results: From October 2010 to June 2015, 18,653 unique patients completed a computer-assisted self-interview. In the validation samples, the optimized, current, and simple algorithms appropriately triaged 90%, 85%, and 89% of patients, respectively. The optimized algorithm had lower sensitivity for identifying patients needing standard visits (men, 94%; women, 93%) compared with the current algorithm (men, 95%; women, 98%), as did the simple algorithm (men, 91%; women, 93%). The optimized, current, and simple algorithms triaged 31%, 23%, and 33% of patients to express visits, respectively., Conclusions: The overall performance of the statistically optimized algorithm did not differ meaningfully from a simple 2-component algorithm. In contrast, the current algorithm had the highest sensitivity but lowest overall performance.

Background: Little is known about the natural history of Mycoplasma genitalium (MG) infection in women. We retrospectively tested archived vaginal fluid samples to assess MG prevalence, incidence, persistence, recurrence and antimicrobial resistance markers among women participating in the Preventing Vaginal Infections trial, a randomized trial of monthly presumptive treatment to reduce vaginal infections., Methods: High-risk, nonpregnant, HIV-negative women aged 18 to 45 years from Kenya and the United States were randomized to receive metronidazole 750 mg + miconazole 200 mg intravaginal suppositories or placebo for 5 consecutive nights each month for 12 months. Clinician-collected swabs containing cervicovaginal fluid were tested for MG using Hologic nucleic acid amplification testing at enrollment and every other month thereafter. Specimens that were MG+ underwent additional testing for macrolide resistance-mediating mutations by DNA sequencing., Results: Of 234 women enrolled, 221 had available specimens and 25 (11.3%) had MG at enrollment. Among 196 women without MG at enrollment, there were 52 incident MG infections (incidence, 33.4 per 100 person-years). Smoking was independently associated with incident MG infection (adjusted hazard ratio, 3.02; 95% confidence interval, 1.32-6.93), and age less than 25 years trended toward an association (adjusted hazard ratio, 1.70; 95% confidence interval, 0.95-3.06). Median time to clearance of incident MG infections was 1.5 months (interquartile range, 1.4-3.0 months). Of the 120 MG+ specimens, 16 specimens from 15 different women were macrolide resistance-mediating mutation positive (13.3%), with no difference by country., Conclusions: M. genitalium infection is common among sexually active women in Kenya and the Southern United States. Given associations between MG and adverse reproductive health outcomes, this high burden of MG in reproductive-aged women could contribute to substantial morbidity.