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BACKGROUND Black men who have sex with men are at a disproportionate risk for sexually transmitted infections (STI). Understanding the drivers of those disparities can lead to culturally tailored interventions. We aimed to characterize the incidence and correlates of STI among Black individuals from HIV Prevention Trials Network 061, a multicity cohort study conducted from 2009 to 2011 in the United States. METHODS We used Cox proportional hazards regression to estimate adjusted hazard ratios (aHRs) accounting for within-participant correlation over multiple follow-up visits (enrollment, 6 and 12 months). We examined correlates of incident rectal and urethral STI as well as incident syphilis. RESULTS Among 1522 individuals, the incidences of urethral and rectal Neisseria gonorrhoeae infection were 1.0 (95% confidence interval, 0.6-1.8) and 4.6 (95% CI, 3.5-6.3) cases per 100 person-years, respectively. The incidences of urethral and rectal Chlamydia trachomatis infection were 2.5 (95% CI, 1.7-3.6) and 2.5 (95% CI, 1.7-3.7) cases per 100 person-years, respectively. The incidence of syphilis was 3.6 (95% CI, 2.7-4.9) cases per 100 person-years. Younger age was associated with increased odds of incident urethral (aHR, 5.1; 95% CI, 2.3-11.1) and rectal (aHR, 2.6; 95% CI, 1.6-4.3) STI. Diagnosis of a rectal STI at baseline (aHR, 2.3; 95% CI, 1.1-4.0) and use of saliva as lubricant (aHR, 1.7; 95% CI, 1.1-2.8) were associated with incident rectal STI. Diagnosis of syphilis at baseline was associated with incident syphilis during follow-up (aHR, 5.6; 95% CI, 2.5-12.2). CONCLUSIONS Younger participants had the highest STI incidence. Use of saliva as lubricant may be a driver of rectal infection, which deserves further study.

Sexual harassment is pervasive in science. A 2018 report found that the prevalence of sexual harassment in academia in the United States is 58%. An activity held at an international scientific congress was designed to advance sexual harassment prevention and elimination and empower binary and nonbinary persons at risk for harassment, discrimination, and violence. The objective is to describe the activity and outcomes to provide a promising model for other scientific communities.A description of the plenary and key components as well as the data collection and analysis of selected outcomes are provided.Among 1338 congress participants from 61 countries, 526 (39%) attended the #MeToo plenary, and the majority engaged in some way during the plenary session. Engagement included standing for the pledge (~85%), participating in the question and answer session (n = 5), seeking counseling (n = 3), and/or providing written post-it comments (n = 96). Respondents to a postcongress survey (n = 388 [24% of all attendees]) ranked the plenary as number 1 among 14 congressional plenaries. In postanalysis, the written post-it comments were sorted into 14 themes within 6 domains, including: (1) emotional responses, (2) barriers to speaking out, (3) public health priorities, (4) reframing narratives about the issue, (5) allyship, and (6) moving the issue forward.Scientific organizations, agencies, and institutions have an important role to play in setting norms and changing enabling policies toward a zero-tolerance culture of sexual harassment. The activity presented offers a promising model for scientific communities with similar goals. The outcomes suggest that the plenary successfully engaged participants and had a measurable impact on the participants.

The aim of this study was to establish the prevalence of asymptomatic Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) in key populations at increased risk of transmission of HIV. Additionally, we aimed to identify the associated risk factors for asymptomatic sexually transmitted infections (STIs) and evaluate the acceptability of self-collected samples. Asymptomatic people living with HIV (PLHIV) in the following categories were offered testing: discordant couples, young adults, pregnant patients and those attending the ‘most-at-risk-population’ clinic. Patients provided first-pass urine, self-collected vaginal swabs or both to test for NG and CT by polymerase chain reaction using BD ProbeTec™. Patients also completed an acceptability questionnaire, including the negative partner of an HIV-positive participant. Three hundred and sixty-three PLHIV had an STI screen. Asymptomatic STIs were only diagnosed in women (prevalence 5.7%), overall prevalence 3.9% ( n = 14). Factors independently associated with an STI in women were being under 25 years (OR 9.63 95% CI 1.56–59.5) and having more than one sexual partner (OR 8.06 95% CI 1.07–60.6). Four hundred and seven completed the acceptability questionnaire. More than 95% of patients found self-sampling easy and comfortable and 83.8% would believe the results. Women significantly preferred the option of self-sampling, 56.9% versus 29.3% of men ( p < 0.001). Acceptability of self-sampling was high. Young women with or at risk of HIV are an important target for STI testing regardless of symptoms. There is need for diagnostic tests that are inexpensive, rapid and accurate especially in resource-limited settings.

Background Chlamydia trachomatis is the most common nationally notifiable sexually transmitted infection in the United States; however, the seroprevalence of C. trachomatis infection is unknown. Methods This cross-sectional study was conducted among 1725 females aged 18 to 39 years who provided serum and urine samples in the 2013 through 2016 National Health and Nutrition Examination Surveys. Presence of anti-C. trachomatis Pgp3 immunoglobulin G (IgG) was determined using both an enzyme-linked immunosorbent assay (ELISA) and multiplex bead array (MBA). Weighted seroprevalence estimates were calculated. Correlates of seroprevalence were examined by multivariable Poisson regression. Results In 2013 through 2016, overall seroprevalence of C. trachomatis Pgp3 IgG was 30.0% (95% confidence interval [CI], 25.5-35.0) as measured by ELISA and 29.4% (95% CI, 25.8-33.0) as measured by the MBA assay. Overall agreement between tests was 87.1% (1503/1725). There was a high positive agreement by the MBA assay with current detection of chlamydia in urine (86% [36/42]), a past-year diagnosis of chlamydia (81.8% [27/33]), and a history of treatment for pelvic inflammatory disease (60.7% [37/61]). Seroprevalence of C. trachomatis Pgp3 IgG, as measured by MBA, was significantly higher among non-Hispanic Blacks (68.0%; adjusted prevalence ratio (aPR) = 2.7 [95% CI, 2.3-3.3]), Mexican Americans (30.9%; aPR = 1.5 [95% CI, 1.2-1.9]), and other Hispanics (35.0%; aPR = 1.9 [95% CI, 1.4-2.5]) compared with non-Hispanic Whites (21.4%). A higher lifetime number of sexual partners and a younger age at sexual debut was also associated with higher seroprevalence. Conclusion Both the ELISA and MBA serologic assays revealed a high prevalence of antibodies to C. trachomatis Pgp3 in young adult females in the US household population. There were major racial/ethnic disparities in exposure to C. trachomatis, with increased vulnerability among non-Hispanic Black females.

We evaluated the accuracy and perception of a patient self-administered, tablet-facilitated rapid Trichomonas vaginalis (TV) point-of-care (POC) test in adult female emergency department (ED) patients. ED patients undergoing gynecologic examination were eligible. Each consented participant self-collected a vaginal swab, performed a tablet-facilitated TV rapid test using the OSOM® Trichomonas Rapid Test, and completed pre- and post-test self-surveys. After the self-test, the clinician collected one standard-of-care (SOC) vaginal swab for wet-mount testing and two for research. The research coordinator performed the TV rapid test using the clinician-collected swab, and reported the results to the clinician and patient. If the self- and coordinator-performed results were discordant, a TV nucleic acid amplification test (NAAT) was performed in a clinical laboratory. A survey was later administered to providers to assess their perceptions of the utility of the POC TV test. Of the 136 participants, 134 (98.5%) completed self-testing; two had invalid results. Comparing coordinator-performed TV rapid test adjudicated with NAAT, the sensitivity and specificity of self-administered test was 96.0% and 100%, respectively. The wet mount had a sensitivity of 52.0% and specificity of 100%. TV detection increased from 9.6% with wet mount to 18.4% with the TV rapid test. Most women (82.0%) stated self-testing was “not at all hard” (versus 66.2% before testing, p ED patients were able to reliably collect, perform, and interpret their own POC TV test using tablet instructions. Both participants and providers reported high levels of acceptability of POC TV testing, which nearly doubled rates of TV detection.

A study including female and male participants across 12 US clinics found that a triplex assay, BD CTGCTV2, performed on the benchtop BD MAX instrument, shows good performance for detection of Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis. Supplemental digital content is available in the text., Background Diagnostic options to combat the increasing rates of sexually transmitted infections recorded throughout the world increasingly include multiplex assays. Here we describe the estimated sensitivity and specificity of a triplex molecular assay that simultaneously detects Chlamydia trachomatis (CT), Neisseria gonorrhoeae (or gonococci [GC]), and Trichomonas vaginalis (TV). Methods Participants (2547 women and 1159 men) were recruited from 12 clinics in the United States. BD CTGCTV2 for BD MAX System assay (CTGCTV2) results were obtained from vaginal and endocervical swabs, endocervical samples in cytology medium, and female and male urine. Results were compared with infection standards that were sample type and pathogen dependent. Results Female specimen sensitivity estimates ranged from 92.7% to 98.4%, 92.9% to 100%, and 86.6% to 100% for CT, GC and TV, respectively. Male urine sensitivity estimates were 96.7%, 99.2%, and 97.9% for CT, GC, and TV, respectively. Specificity estimates were >98.7% for all sample types. Conclusions BD CTGCTV2 performed well using a variety of sample types. As a true triplex assay, performed using a benchtop instrument, BD CTGCTV2 may be useful in settings where no testing is currently performed and in settings, such as reference laboratories, where testing turnaround time may be several days. Use of this assay at local laboratories may result in greater access to testing and a shorter time to result, which are important steps for improving our ability to combat sexually transmitted infections.

Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) presents a large risk to healthcare personnel (HCP). Quantifying the risk of coronavirus infection associated with workplace activities is an urgent need. Methods We assessed the association of worker characteristics, occupational roles and behaviors, and participation in procedures with the risk of endemic coronavirus infection among HCP who participated in the Respiratory Protection Effectiveness Clinical Trial (ResPECT), a cluster randomized trial to assess personal protective equipment to prevent respiratory infections and illness conducted from 2011 to 2016. Results Among 4689 HCP seasons, we detected coronavirus infection in 387 (8%). HCP who participated in an aerosol-generating procedure (AGP) at least once during the viral respiratory season were 105% (95% confidence interval, 21%–240%) more likely to be diagnosed with a laboratory-confirmed coronavirus infection. Younger individuals, those who saw pediatric patients, and those with household members Conclusions Our analysis suggests that the risk of HCP becoming infected with an endemic coronavirus increases approximately 2-fold with exposures to AGPs. Our findings may be relevant to the coronavirus disease 2019 (COVID-19) pandemic; however, SARS-CoV-2, the virus that causes COVID-19, may differ from endemic coronaviruses in important ways. Clinical Trials Registration NCT01249625.

INTRODUCTION: Point-of-care (POC) tests for Neisseria gonorrhoeae (Ng) are urgently needed to control the gonorrhea epidemic, so patients can receive immediate diagnoses and treatment. While the advent of nucleic acid amplification tests (NAATs) have improved the accuracy of Ng identification, very few POC assays are able to provide results of such tests at the clinical visit. Additionally, antimicrobial resistance (AMR) presents a unique treatment challenge for NG. AREAS COVERED: This review notes that older POC tests have lower sensitivity for Ng, compared to the currently-available NAATs, are not adequate for the current demand for high sensitivity. Promising newer assays, which can be used at the POC are covered. This review also includes data about clinicians’ and patients’ acceptability and expectations of POC tests for Ng, testing of extragenital specimens, pooling studies, as well as their impact clinically and use in low-resource settings. EXPERT OPINION: The ability to use POC tests to identify and immediately treat Ng infections at the patient encounter offers many benefits and opportunities. POC tests for Ng are currently available, but not widely used especially in low-resource settings. Further development of POC test with AMR testing capacity is needed to help guide antimicrobial stewardship.

Background: This study was launched in response to an American Indian (AI) community's concern regarding the comorbid occurrence of substance use, poor mental health, and other risk factors on sexual health. The purpose of this manuscript was to assess the relationship between alcohol use, violence, depression and STI/HIV risk behaviors on the frequency of unprotected sex acts and number of sexual partners among AI adults.Methods: Specifically, this analysis examines sociodemographic characteristics, experience of sexual and physical violence, binge drinking, depression, and sexual risk taking among n = 281 AI adults ages 18-55. Regression models examine associations between the aforementioned risk factors, number of sex partners and number of unprotected sex acts, by depression status and sex, among participants.Results: Frequent binge drinking predicted frequency of unprotected sex for both males and females; ever experiencing physical violence was a powerful predictor of unprotected sex for females, but not males. Ever experiencing physical violence strongly predicted having multiple sexual partners for females but was related to decreased number of sexual partners for males. Females ever experiencing sexual violence had more sexual partners; this was not observed for males. Binge drinking predicted frequency of unprotected sex acts, regardless of depression status.Discussion: Interventions for AI adults seeking to reduce sexual health risk should reflect past violence victimization in sexual decision making, primarily among women. The significant role of binge alcohol use for modifying sexual decisions should be of prime focus and interventions should be personalized to address individuals' own alcohol use patterns. Additional research should explore how binge alcohol use moderates the relationship between depression and sexual risk.

With the emergence of the COVID-19 pandemic, restrictions were implemented globally to control the virus. Data on respiratory pathogens in sub-Saharan Africa during the COVID-19 pandemic are scarce. This analysis was conducted to evaluate patterns of respiratory pathogens in rural Zambia before and during the first year of the pandemic.Surveillance was established in December 2018 at Macha Hospital in southern Zambia. Patients with respiratory symptoms in the outpatient and inpatient clinics were recruited. Nasopharyngeal samples were collected and tested for respiratory pathogens. The prevalence of respiratory symptoms and pathogens was evaluated and compared in the first (December 10, 2018-December 9, 2019) and second (December 10, 2019-November 30, 2020) years of surveillance.Outpatient visits and admissions for respiratory illness significantly decreased from the first to second year, especially among children. SARS-CoV-2 was not detected from any participants in Year 2. Among outpatients and inpatients with respiratory symptoms, the prevalence of respiratory syncytial virus and influenza viruses decreased from the first to second year. In contrast, the prevalence of rhinovirus/enterovirus, metapneumovirus and parainfluenza virus increased.The epidemiology of respiratory viruses in rural Zambia changed during the first year of the COVID-19 pandemic, suggesting that public health interventions may have had an impact on the introduction and circulation of respiratory pathogens in this area.

BackgroundCombination HIV interventions (CHIs) have led to significant declines in HIV incidence in sub-Saharan Africa; however, population-level data on non-HIV sexually transmitted infection (STI) burden in the context of CHIs are rare. We aimed to assess STI burden in Uganda following mass scale-up of CHIs, including universal HIV treatment.MethodsThe Sexually Transmitted Infection Prevalence Study (STIPS) was a cross-sectional study nested within the Rakai Community Cohort Study (RCCS), a population-based cohort among inland agrarian and Lake Victoria fishing populations in southern Uganda. STIPS enrolled consenting participants, 18-49 years, between May and October 2019 and measured prevalence of Chlamydia trachomatis (chlamydia), Neisseria gonorrhoeae (gonorrhea), Trichomonas vaginalis (trichomonas), syphilis, and herpes simplex virus type 2 (HSV-2).FindingsSTIPS enrolled 1,825 participants, including 965 women (53%), of whom 9% (n=107) were pregnant. Overall, there was 9.8% prevalence of chlamydia (95%CI:8.5-11%), 6.7% gonorrhea (95%CI:5.7-8.0%), and 11% trichomonas (95%CI:9.5-12%). In the fishing population, syphilis reactivity was 24% (95%CI:22-27%), with 9.4% (95%CI:7.7-11%) having high titer (RPR ≥ 1:8) infection, including 17% (95%CI:12-24%) of HIV-positive men. Prevalence of ≥ 1 curable STI (chlamydia, gonorrhea, trichomonas, or high titer syphilis) was 44% higher among HIV-positive persons (adjusted prevalence risk ratio [adjPRR]=1.44,95%CI:1.22-1.71), with no differences by HIV treatment status. HIV-positive pregnant women were more likely than HIV-negative pregnant women to have a curable STI (adjPRR=1.87, 95%CI: 1.08-3.23).InterpretationSTI burden remains extremely high in Uganda, particularly among HIV-positive persons. There is an urgent need to integrate STI diagnostic testing and treatment with HIV services in African settings.FundingNational Institutes of Health

Research using nucleic acid amplification tests (NAATs) have repeatedly found rectal and oropharyngeal infections with Chlamydia trachomatis and Neisseria gonorrhoeae to be common and potentially more difficult to treat than genital infections. Unfortunately, public health and patient care efforts have been hampered by the lack of FDA-cleared NAATs with claims for anorectal or oropharyngeal samples. At the time of the initiation of this study, no commercially available assays had these claims. We formed a novel partnership among academic institutions and diagnostic manufacturers to address this public health need. From May 2018 through August 2019, we recruited 1108 women, 1256 men, and 26 transgender persons each of whom provided 3 anal and 3 oropharyngeal swab specimens. The 3 anal swabs were pooled into a single transport tube as were the 3 oropharyngeal swabs. The performance of each of three study assays was estimated by comparison to the composite result and relative to one another. Percent positivity for chlamydia was 5.9 and 1.2% from anal and oropharyngeal specimens, respectively, compared to 4.2 and 4.1% for gonorrhea. Sensitivity for chlamydia detection ranged from 81.0 to 95.1% and 82.8 to 100% for anal and oropharyngeal specimens, respectively. Gonorrhea sensitivity ranged from 85.9 to 99.0% and 74.0 to 100% for anal and oropharyngeal samples, respectively. Specificity estimates were ≥ 98.9% for all assays, organisms, and sample types. Although there was heterogeneity between sensitivity estimates, these assays offer better ability to detect extragenital infections than culture and potential solutions for providing appropriate sexual health care for populations in which these infections are of concern.

BACKGROUND Despite evidence that Mycoplasma genitalium (MG) is a risk factor for adverse outcomes in pregnancy, screening in pregnant women is not currently recommended. METHODS Pregnant women between the ages of 13 and 29 years were recruited during their routine prenatal visits, screened for sexually transmitted infections (STIs) and followed for 1 year. We compared women with MG to those with no STIs, excluding women with STIs other than MG (Chlamydia trachomatis [CT], Neisseria gonorrhoeae [NG], or Trichomonas vaginalis [TV]) unless they were also codiagnosed with MG. Adverse outcomes were extracted from participants' medical records and compared between women with MG and those without STIs using exact or nonparametric approaches. Estimated differences were also adjusted for demographics using propensity scores with linear and logistic regression, where appropriate. We exclude women with MG and CT, NG, or TV diagnosis for primary analysis. RESULTS Of 281 participants enrolled from September 2015 until July 2019, 51 (18.1%) were diagnosed with MG. Of 51 women with MG, 12 (24%) were also diagnosed with CT, NG, or TV. All women with MG were offered treatment with azithromycin; however, only 28 (55%) were documented to receive treatment. Women with MG had similar outcomes to those with no STIs with a few exceptions. Average birth weight was lower among women with MG alone compared with women with no STIs when excluding coinfections (169-g difference, 15-323). CONCLUSIONS Our results indicate that MG is common in pregnant women and often presents as a coinfection. More research using population-based designs is needed to determine whether screening or treatment for women at risk for low birth weight or coinfections is warranted.

Chlamydia trachomatis (CT) and Mycoplasma genitalium (MG) are two highly prevalent bacterial sexually transmitted infections (STIs) with a significant rate of co-infection in some populations. Vaginal metabolites are influenced by resident vaginal microbiota, affect susceptibility to sexually transmitted infections (STIs), and may impact local inflammation and patient symptoms. Examining the vaginal metabolome in the context of CT mono (CT+) and CT/MG co-infection (CT+/MG+) may identify biomarkers for infection or provide new insights into disease etiology and pathogenesis. Yet, the vaginal metabolome in the setting of CT infection is understudied and the composition of the vaginal metabolome in CT/MG co-infected women is unknown. Therefore, in this analysis, we used an untargeted metabolomic approach combined with 16S rRNA gene amplicon sequencing to characterize the vaginal microbiota and metabolomes of CT+, CT+/MG+, and uninfected women. We found that CT+ and CT+/MG+ women had distinct vaginal metabolomic profiles as compared to uninfected women both before and after adjustment for the vaginal microbiota. This study provides important foundational data documenting differences in the vaginal metabolome between CT+, CT+/MG+ and uninfected women. These data may guide future mechanistic studies that seek to provide insight into the pathogenesis of CT and CT/MG infections.

Background Sexually transmitted infections (STIs) are a public health crisis with Native Americans suffering a high burden of disease. Studies across gender and racial/ethnic groups have found varying risk factors associated with STI positivity. Understanding how risk factors are associated with STI positivity can help design interventions for those most at risk. Methods Participants were Native American binge substance using adults enrolled in a randomized controlled trial evaluating a brief intervention to increase STI screening and reduce sexual risk-taking behaviors. Participants completed a self-report assessment at baseline that included questions about sexual risk factors and STI testing behaviors and diagnosis. This analysis includes those who had ever completed an STI test at baseline. Bivariate and multivariate analyses using logistical regression were utilized to identify associations between risk factors and past STI diagnosis. Results A total of 193 people were included in the analysis. Over half (50.6%) of the participants had ever been diagnosed with an STI. Risk behaviors varied by gender. More women with a self-reported history of STI reported having sex with someone they thought had an STI, past experience of physical/sexual violence, and having passed out from drinking. Men with a self-reported history of STI were more likely to report past marijuana and other drug use. Among women with a self-reported history of STI, having sex with someone they thought had an STI was associated with STI positivity, whereas other drug use was associated with STI positivity among men with a self-reported history of STI. Conclusions Findings provide information for those working to reduce STIs in Native Communities to better identify and design programs for those at highest risk for STIs. Additional studies examining gender dynamics and sexual risk taking among native adults are warranted.

Among 413 Nigerian men who have sex with men and transgender women, retrospective testing for Mycoplasma genitalium revealed mostly asymptomatic infections of the anorectum (prevalence, 36.8%; incidence, 18.4 cases/100 person-years) and urogenital tract (12.4%, 4.0 cases/100 person-years). Risk factors included HIV and increasing number of sex partners.

Background Cisgender female sex workers (CFSWs) have elevated rates of sexually transmitted infections (STI) yet are underrepresented in targeted programming and research in the United States. We examined the prevalence, incidence and predictors of chlamydia, gonorrhea, and trichomonas infection among CFSW. Methods Two hundred fifty street-based CFSWs were recruited into a prospective observational cohort in Baltimore, Maryland using targeted sampling in 2016 to 2017 and completed surveys and STI testing at baseline, 3, 6, 9, and 12 months. Cox proportional hazards regression was used to model the predictors of STI. Results Mean age was 36 years, and 66.5% of respondents were white. Baseline prevalence of chlamydia, gonorrhea, trichomonas was 10.5%, 12.6%, and 48.5%, respectively. The incidence of chlamydia, gonorrhea, and trichomonas was 14.3, 19.3, 69.1 per 100 person-years. Over one year of observation, past year sex work initiation predicted both chlamydia incidence (adjusted hazard ratio [aHR], 2.7; 95% confidence interval [CI], 1.3-6.0) and gonorrhea incidence (aHR, 1.7; 95% CI, 1.0-2.8). Client sexual violence predicted gonorrhea incidence (aHR, 2.9; 95% CI, 1.2-7.1) and having female sexual partners predicted trichomonas incidence (aHR, 3.4; 95% CI, 1.3-8.5). Having a usual health care provider (aHR, 0.6; 95% CI, 0.5-0.7) was inversely associated with trichomonas. Conclusions In this study of urban US street-based CFSW, interpersonal and structural factors differentially predicted STIs, and infection rates remained elevated through follow-up despite regular testing, notification, and treatment referral. Focused and multifaceted interventions for sex workers and their sexual partners are urgently needed.

Background Point-of-care testing (POCT) assays for chlamydia are being developed. Their potential impact on the burden of chlamydial infection in the United States, in light of suboptimal screening coverage, remains unclear. Methods Using a transmission model calibrated to data in the United States, we estimated the impact of POCT on chlamydia prevalence, incidence, and chlamydia-attributable pelvic inflammatory disease (PID) incidence, assuming status quo (Analysis 1) and improved (Analysis 2) screening frequencies. We tested the robustness of results to changes in POCT sensitivity, the proportion of patients getting treated immediately, the baseline proportion lost to follow-up (LTFU), and the average treatment delay. Results In Analysis 1, high POCT sensitivity was needed to reduce the chlamydia-associated burden. With a POCT sensitivity of 90%, reductions from the baseline burden only occurred in scenarios in which over 60% of the screened individuals would get immediate treatment and the baseline LTFU proportion was 20%. With a POCT sensitivity of 99% (baseline LTFU 10%, 2-week treatment delay), if everyone were treated immediately, the prevalence reduction was estimated at 5.7% (95% credible interval [CrI] 3.9–8.2%). If only 30% of tested persons would wait for results, the prevalence reduction was only 1.6% (95% CrI 1.1–2.3). POCT with 99% sensitivity could avert up to 12 700 (95% CrI 5000–22 200) PID cases per year, if 100% were treated immediately (baseline LTFU 20% and 3-week treatment delay). In Analysis 2, when POCT was coupled with increasing screening coverage, reductions in the chlamydia burden could be realized with a POCT sensitivity of 90%. Conclusions POCT could improve chlamydia prevention efforts if test performance characteristics are significantly improved over currently available options., Point-of-care testing (POCT) could improve chlamydia prevention efforts if there is considerable improvement in currently available POCT performance.

The aim of this study was to evaluate the prevalence of herpes simplex virus 2 (HSV-2) and HSV-2/human papillomavirus (HPV) co-infection by self-collected samples compared to clinician-collected samples in human immunodeficiency virus 1 (HIV-1)-infected and -uninfected women from the Tapajós region, Amazon, Brazil. A cross-sectional study was conducted with 439 anal and cervical scrapings and cervico-vaginal self-collected samples obtained from 153 eligible HIV-infected and -uninfected women. Real-time PCR for HSV-2 and nested PCR for HPV detection were performed. A multivariate analysis identified risk factors for HSV-2/HPV co-infection. The anogenital prevalence of HSV-2 was 9.2% (14/153), HPV was 67.3% (103/153) and HSV-2/HPV co-infection was 6.5% (10/153). There was a significant overall agreement (95.5%, 11/133, kappa 0.64, 95% CI 0.38–0.90, p

BACKGROUND The protist Trichomonas vaginalis causes a common, sexually transmitted infection and has been proposed to contribute to the development of chronic prostate conditions, including benign prostatic hyperplasia and prostate cancer. However, few studies have investigated the extent to which it involves the prostate in the current antimicrobial era. We addressed this question by investigating the relation between T. vaginalis antibody serostatus and serum prostate-specific antigen (PSA) concentration, a marker of prostate infection, inflammation, and/or cell damage, in young, male, US military members. METHODS We measured T. vaginalis serum IgG antibodies and serum total PSA concentration in a random sample of 732 young, male US active duty military members. Associations between T. vaginalis serostatus and PSA were investigated by linear regression. RESULTS Of the 732 participants, 341 (46.6%) had a low T. vaginalis seropositive score and 198 (27.0%) had a high score, with the remainder seronegative. No significant differences were observed in the distribution of PSA by T. vaginalis serostatus. However, slightly greater, nonsignificant differences were observed when men with high T. vaginalis seropositive scores were compared with seronegative men, and when higher PSA concentrations were examined (≥0.70 ng/mL). Specifically, 42.5% of men with high seropositive scores had a PSA concentration greater than or equal to 0.70 ng/mL compared with 33.2% of seronegative men (adjusted P = .125). CONCLUSIONS Overall, our findings do not provide strong support for prostate involvement during T. vaginalis infection, although our suggestive positive findings for higher PSA concentrations do not rule out this possibility entirely. These suggestive findings may be relevant for prostate condition development because higher early- to mid-life PSA concentrations have been found to predict greater prostate cancer risk later in life.

Study objective In emergency departments (EDs), diagnosis and treatment of Chlamydia trachomatis and Neisseria gonorrhoeae are challenging. We conducted a randomized clinical trial to assess rapid C trachomatis and N gonorrhoeae testing on overtreatment and undertreatment of women evaluated for C trachomatis and N gonorrhoeae. Methods Women undergoing pelvic examinations and C trachomatis and N gonorrhoeae testing (n=254) were randomized to control or rapid test groups. The control group received standard-of-care C trachomatis and N gonorrhoeae nucleic acid amplification tests of endocervical specimens, with 2- to 3-day turnaround times. For the rapid test group, clinicians collected an extra endocervical swab for GeneXpert C trachomatis and N gonorrhoeae rapid testing, in addition to the standard-of-care nucleic acid amplification test swab. Rapid results were immediately provided, and all patients were treated according to providers’ clinical judgment. Results In the rapid test group, 7.9% of patients had positive test results for C trachomatis; 3.9% had positive test results for N gonorrhoeae. In the control standard-of-care group, 10.2% of patients had positive nucleic acid amplification test results for C trachomatis; 5.5% had positive results for N gonorrhoeae. Undertreatment for both C trachomatis and N gonorrhoeae in the ED was 0% for the rapid test group and 43.8% for the control standard-of-care group. Clinicians overtreated 46.5% of uninfected standard-of-care control patients for C trachomatis compared with 23.1% of uninfected rapid test patients. For patients uninfected with N gonorrhoeae, clinicians overtreated 46.7% of standard-of-care control patients compared with 25.4% of rapid test patients. The length of stay did not differ significantly between groups. Conclusion Rapid C trachomatis and N gonorrhoeae testing in the ED led to a significant reduction in overtreatment for women without infections compared with the standard-of-care control group. Additionally, in the rapid test group there was significant improvement in appropriate treatment for patients with infections.

BACKGROUND Influenza B accounts for approximately one fourth of the seasonal influenza burden. However, research on the importance of influenza B has received less attention compared to influenza A. We sought to describe the association of both coinfections and comorbidities with disease severity among adults presenting to emergency departments (ED) with influenza B. METHODS Nasopharyngeal samples from patients found to be influenza B positive in four US and three Taiwanese ED over four consecutive influenza seasons (2014-2018) were tested for coinfections with the ePlex RP RUO panel. Multivariable logistic regressions were fitted to model adjusted odds ratios (aOR) for two severity outcomes separately: hospitalization and pneumonia diagnosis. Adjusting for demographic factors, underlying health conditions, and the National Early Warning Score (NEWS), we estimated the association of upper respiratory coinfections and comorbidity with disease severity (including hospitalization or pneumonia). RESULTS Amongst all influenza B positive individuals (n = 446), presence of another upper respiratory pathogen was associated with an increased likelihood of hospitalization (aOR = 2.99 [95% confidence interval (95% CI): 1.14-7.85, p = 0.026]) and pneumonia (aOR = 2.27 [95% CI: 1.25-4.09, p = 0.007]). Chronic lung diseases (CLD) were the strongest predictor for hospitalization (aOR = 3.43 [95% CI: 2.98-3.95, p

This national survey demonstrates age-disparate (≥5 years; AD-5) sexual partnerships remain common among males and females aged 20 to 29 years in the United States (2005-2016). Females reported more older AD-5 partners, and males reported more younger AD-5 partners. Having AD-5 partners was associated with greater lifetime and recent number of sexual partners.

New approaches to pelvic inflammatory disease (PID) care among adolescents and young adults (AYAs) that optimize self-care and personalize treatment are warranted to address age and racial-ethnic PID-related health disparities. Here we describe the 13-month preliminary feasibility and acceptability outcomes of recruitment, retention, and intervention delivery for Technology Enhanced Community Health Precision Nursing (TECH-PN) randomized controlled trial. Urban AYAs 13–25 years assigned female sex at birth with acute mild-moderate PID provided baseline and follow-up interview data and vaginal specimens for sexually transmitted infection (STI), cytokine, and microbiota assessment. All participants received medications and text-messaging support. Participants were block randomized to either control or intervention. Control participants received 1 community nursing visit with self-management for interim care per national guidelines. Intervention participants received unlimited precision care services driven by interim STI and macrolide resistance testing results by an advanced practice provider. In the first 13 months, 75.2% patients were eligible, and 76.1% of eligible patients enrolled. Of the participants, 94% completed the intervention and 96%, 91%, and 89%, respectively, completed their 14-, 30-, and 90-day visits. Baseline laboratory results revealed infection rates that were highest for Mycoplasma genitalium (45%) followed by Chlamydia trachomatis (31%). Preliminary enrollment, STI, intervention delivery, and retention data demonstrate the feasibility and acceptability of the TECH-PN intervention and support rationale for precision care for PID among urban AYAs. ClinicalTrials.gov Identifier. NCT03828994.

Background SARS Co-V-2 (COVID-19) mitigation strategies have resulted in limited clinical operations for sexual health services and adolescents and young adults (AYA) have received mixed messages about the risk for serious COVID-19 infection. This work describes the sexual behavior and relationship between COVID-19 risk perceptions and sexual behaviors among urban AYA during the pandemic. Methods Cross-sectional data were used from AYA enrolled across four sexual health studies in Baltimore, Maryland (USA). Participants had an active STI, HIV, or were at risk for STI/HIV. The March 16, 2020 ‘stay-at-home’ orders were used to define the pandemic period in the human subjects’ approved telephone survey. Demographics, COVID-19 risk perception, testing behavior, positivity in their social circle, and relationship/sexual behaviors data were evaluated using regression analyses. Results 194 participants with a mean (sd) age of 22.7 (2.8) years were surveyed. Most were female (81%) with public health insurance (68%), 61% were in a relationship, 36% were cohabiting, 79% had sex during the stay-at-home order, 68% used some form of contraception, 39% used a condom at last sex, and 23% had STI screening during the pandemic. 51% had COVID-19 testing, and 31% and 8% experienced a COVID-19-related diagnosis or death, respectively, in their social circle. Using a 10-point Likert scale (10=most concerned), the mean concern score for contracting COVID-19 was 5.0 (3.7) and during intercourse was 3.0 (4.1). Those with COVID-19 positivity within their social circle were marginally more likely to have COVID-19 testing (adjusted OR 1.69, 95% CI 0.89 – 3.19, p = 0.107). Concern for COVID infection or COVID-19 in social circle was not associated with sexual intercourse or condom use. Conclusion Urban AYAs remain at risk for STIs and COVID-19 given community rates, low condom use, and low COVID risk perceptions. Youth-focused mitigation strategies to reduce STI/HIV and COVID-19 are warranted.

Background After effective treatment, persons diagnosed with a sexually transmitted infections (STI) are encouraged to modify behavior and notify partners. In resource-limited settings (RLS), follow-up assessment is limited by a variety of factors, including access to knowledge, material resources, and reliable communication. Methods A study conducted in 2019 within the existing WHO-based Enhanced Gonococcal Antimicrobial Surveillance Program (EGASP) collected urogenital samples and blood from men with urethral discharge syndrome (UDS). Samples were tested for Neisseria gonorrhoeae (NG), Chlamydia trachomatis (CT), Trichomonas vaginalis (TV) and Mycoplasma genitalium (MG), and HIV. Participants received treatment and were then followed up using phone calls on days 7, 14 and 21 post-enrolment. Results Of the 250 participants recruited for this study, 66.7%, 20.5%, 11.6%, and 2.0% were positive for NG, CT, MG, TV, respectively, and 20% (50/250) were HIV-positive. Follow-up visits on days 7, 14, and 21 were completed by 98.8%, 96.0%, and 96.4% of participants, respectively. The majority (94.5%) of participants completed their prescribed treatment regimen. Resolution of symptoms (penile discharge and dysuria) was reported by 76.7% of participants 3–5 days post-treatment while 7.5% reported no resolution of symptoms. The majority (77.2%) reported sexual activity while on treatment; 31.6% of those reported condom use, and 15.1% reported multiple partners. PN was reported by 66.9% of participants; 16.8% of participants reported that they had no intention of notifying their partners. Conclusions The prevalence of STIs was high in this group of men with UDS who also reported low condom use and multiple sex partners. While completion rate of follow-up visits was very high, innovative ways to follow-up patients to ensure response to treatment and to incentivize PN are necessary in future STI control interventions.

BackgroundAdolescents and young adults (AYA) who experience dating violence (DV) are at increased STI risk. Social restrictions during the COVID-19 pandemic have stressed AYA relationships and may cut them off from sources of support. AYA have been shown to respond to relationship stressors with behaviors that increase STI risk. This work examines whether relationship stressors (jealousy and worry about the relationship) exacerbate violence and STI risk among urban AYA during the COVID-19 pandemic.MethodsParticipants from four sexual and reproductive health studies in Baltimore, Maryland (USA) were invited to complete a cross-sectional telephone survey on relationship experiences/sexual behavior during the pandemic. March 16, 2020 ‘stay-at-home’ order was used to define the pandemic period. Partner support, jealousy, worry about the relationship making it through the pandemic, current DV, change in DV during pandemic, and condom use at last sex were evaluated using regression analyses. Data collection is still underway in 2021.ResultsOf 194 participants surveyed, mean (sd) age 22.7 (2.8) years, 61% were in a romantic/sexual relationship. Of these, 14% reported current TDV, 6% experienced an increase in DV, 66% did not use a condom at last sex. AYA who worried their relationship would not make it through the pandemic were more likely to experience DV (OR: 5.64, 95%CI: 1.69, 18.9). AYA who felt jealous of other people their partner was talking to/hanging out with during the pandemic were more likely to experience DV (OR: 4.51, 95%CI: 1.39, 14.6). Greater partner support was associated with experiencing less DV (OR: 0.71, 95%CI: 0.56, 0.90). Relationship stressors were not associated with condom use.ConclusionsRelationship insecurity exacerbated by the COVID-19 pandemic may increase risk for DV among AYA. As DV and STI are interconnected, romantic relationship context must be a key focus of STI prevention strategies during and after the pandemic.

Background The association of hemagglutination inhibition (HAI) antibodies with protection from influenza among healthcare personnel (HCP) with occupational exposure to influenza viruses has not been well-described. Methods The Respiratory Protection Effectiveness Clinical Trial was a cluster-randomized, multisite study that compared medical masks to N95 respirators in preventing viral respiratory infections among HCP in outpatient healthcare settings for 5180 participant-seasons. Serum HAI antibody titers before each influenza season and influenza virus infection confirmed by polymerase chain reaction were studied over 4 study years. Results In univariate models, the risk of influenza A(H3N2) and B virus infections was associated with HAI titers to each virus, study year, and site. HAI titers were strongly associated with vaccination. Within multivariate models, each log base 2 increase in titer was associated with 15%, 26% and 33%–35% reductions in the hazard of influenza A(H3N2), A(H1N1), and B infections, respectively. Best models included preseason antibody titers and study year, but not other variables. Conclusions HAI titers were associated with protection from influenza among HCP with routine exposure to patients with respiratory illness and influenza season contributed to risk. HCP can be reassured about receiving influenza vaccination to stimulate immunity.

Few studies have assessed HIV incidence in men who have sex with men (MSM) and transgender women (TGW) in sub-Saharan Africa (SSA). We assessed HIV incidence and its correlates among MSM and TGW in SSA enrolled in the prospective, multi-country HIV Prevention Trials Network (HPTN) 075 study, conducted from 2015 to 2017. Participants were enrolled at four sites in SSA (Kisumu, Kenya; Blantyre, Malawi; Cape Town and Soweto, South Africa). Eligible participants reported male sex assignment at birth, were 18 to 44 years of age, and had engaged in anal intercourse with a man in the preceding three months. Participation involved five study visits over 12 months. Visits included behavioral assessments and testing for HIV and sexually transmitted infections. Twenty-one of 329 persons acquired HIV during the study [incidence rate: 6.96/100 person-years (PY) (95% CI: 4.3, 10.6)]. Among TGW, HIV incidence was estimated to be 8.4/100 PY (95% CI: 2.3, 21.5). Four participants were found to have acute HIV infection at their first HIV-positive visit. HIV incidence varied among the four study sites, ranging from 1.3/100 PY to 14.4/100 PY. In multivariate longitudinal analysis, factors significantly associated with HIV acquisition were engagement in unprotected receptive anal intercourse [adjusted hazard ratio (AHR) 5.8, 95% confidence interval (CI): 2.4, 14.4] and incident rectal gonorrhea and/or chlamydia (AHR: 2.7, 95% CI: 1.1, 6.8). The higher HIV incidence in Cape Town compared to Blantyre could be explained by the higher prevalence of several risk factors for HIV infection among participants in Cape Town. Annual HIV incidence observed in this study is substantially higher than reported HIV incidence in the general populations in the respective countries and among MSM in the United States. Intensification of HIV prevention efforts for MSM and TGW in SSA is urgently needed.

Background Health care personnel (HCP) working in outpatient settings routinely interact with patients with acute respiratory illnesses. Absenteeism following symptom development and lack of staff trained to obtain samples limit efforts to identify pathogens among infected HCP. Methods The Respiratory Protection Effectiveness Clinical Trial assessed respiratory infection incidence among HCP between 2011 and 2015. Research assistants obtained anterior nasal and oropharyngeal swabs from HCP in the workplace following development of respiratory illness symptoms and randomly while asymptomatic. Participants received take-home kits to self-collect swabs when absent from work. Samples mailed to a central laboratory were tested for respiratory viruses by reverse transcription polymerase chain reaction. Results Among 2,862 participants, 3,467 swabs were obtained from symptomatic participants. Among symptomatic HCP, respiratory virus was detected in 904 of 3,467 (26.1%) samples. Self-collected samples by symptomatic HCP at home had higher rates of viral detection (40.3%) compared to 24% obtained by trained research assistants in the workplace (P Conclusions In this randomized clinical trial, take-home kits were an easily implemented, effective method to self-collect samples by HCP. Other studies have previously shown relative equivalence of self-collected samples to those obtained by trained healthcare workers. Take-home kit self-collection could diminish workforce exposures and decrease the demand for personnel protective equipment worn to protect workers who collect respiratory samples.

Major technical challenges often prevent developers from producing new point-of-care technologies that deliver the required clinical performance in the intended settings of use. But even when devices meet clinical requirements, they can fail to be adopted and successfully implemented. Adoption barriers occur when decision makers do not understand the "value proposition" of new technologies. Current discussions of value in the context of point-of-care testing focus predominantly on the intended use and performance of the device from the manufacturer's point-of-view. However, the perspective of potential adopters in determining whether new devices provide value is also important, as is the opinion of all stakeholders who will be impacted. Incorporating value concepts into decisions made across the full development-to-adoption continuum can increase the likelihood that point-of-care testing will have the desired impact on health care delivery and patient outcomes. This article discusses how various approaches to technology development impact adoption and compares the characteristics of these approaches to emerging value concepts. It also provides an overview of value initiatives and tools that are being developed to support the evaluation of value propositions. These are presented for a range of technology adoption decision contexts, with particular applicability to point-of-care testing. Expanding the focus of research to address gaps in both the creation and evaluation of value propositions is imperative in order for value concepts to positively influence the adoption of point-of-care testing.

The emergence of SARS-CoV-2 and subsequent COVID-19 pandemic highlights the morbidity and potential disease severity caused by respiratory viruses. To elucidate pathogen prevalence, etiology of coinfections and URIs from symptomatic adult Emergency department patients in a pre-SARS-CoV-2 environment, we evaluated specimens from four geographically diverse Emergency departments in the United States from 2013-2014 utilizing ePlex RP RUO cartridges (Genmark Diagnostics). The overall positivity was 30.1% (241/799), with 6.6% (16/241) coinfections. Noninfluenza pathogens from most to least common were rhinovirus/enterovirus, coronavirus, human metapneumovirus and RSV, respectively. Broad differences in disease prevalence and pathogen distributions were observed across geographic regions; the site with the highest detection rate (for both mono and coinfections) demonstrated the greatest pathogen diversity. A variety of respiratory pathogens and geographic variations in disease prevalence and copathogen type were observed. Further research is required to evaluate the clinical relevance of these findings, especially considering the SARS-CoV-2 pandemic and related questions regarding SARS-CoV-2 disease severity and the presence of co-infections.

Effective treatment of sexually transmitted infections (STIs) is limited by diagnostics that cannot deliver results rapidly while the patient is still in the clinic. The gold standard methods for identification of STIs are nucleic acid amplification tests (NAATs), which are too expensive for widespread use and have lengthy turnaround times. To address the need for fast and affordable diagnostics, we have developed a portable, rapid, on-cartridge magnetofluidic purification and testing (PROMPT) polymerase chain reaction (PCR) test. We show that it can detect Neisseria gonorrhoeae, the pathogen causing gonorrhea, with simultaneous genotyping of the pathogen for resistance to the antimicrobial drug ciprofloxacin in

As the healthcare system evolves from a centralized, hospital- and office-based model to an emphasis on patient-centric care delivered in decentralized settings from the community and/or home to low resource settings domestically and internationally, some Point-of-Care Technologies (POCT) have become important and others may soon become important in facilitating care. These portable diagnostic and monitoring devices enable moving care closer to the patient. We review recent developments in a national model to accelerate the development of POCT, specifically the Point-of-Care Technology Research Network (POCTRN), comprising a multi-center scientific network supported by a coordinating center. We summarize the history of the Network, and then describe the primary objectives and key activities of the Network and highlight the role of a new coordinating center providing administrative and infrastructure support. POCTRN is committed to building evidence-based best practices for high-quality translation and commercialization in biomedical engineering to maximize clinical impact of Point-of-Care Technologies.

BACKGROUND Several national guidelines consider illicit drug use as an indication for testing and/or counseling for some sexually transmitted infections (STIs). The legal and social landscape of marijuana use is changing, and its relevance with STI risk is unclear. METHODS Sex-specific prevalence of T. vaginalis and/or C. trachomatis infection was examined by past-year marijuana use (no vs yes) among 2958 sexually experienced, 20- to 39-year-old participants of the 2013-2016 National Health and Nutrition Examination Surveys. Prevalence ratios (PRs) with 95% confidence intervals [CIs] were estimated by Poisson regression. Adjusted PRs (aPR) were estimated following propensity score covariate-adjustment accounting for sociodemographics, alcohol use, injection drug use, depression, and age at sexual debut. RESULTS Past-year marijuana use was reported by 27.3% and 36.3% of females and males, respectively. Male and female past-year marijuana users were more likely to have new and multiple sexual partners in the past year (P < 0.05). Past-year marijuana use was associated with prevalent C. trachomatis and/or T. vaginalis infection among females (7.4% vs. 2.9%; PR, 2.57 [95% CI, 1.62-4.07]) and males (4.0% vs. 1.1%; PR, 3.59 [95% CI, 1.96-6.58]), but this association was attenuated after propensity score covariate adjustment among females (aPR, 1.15 [95% CI, 0.72-1.83]) and males (aPR, 2.10 [95% CI, 0.88-5.02]). Additional adjustment for new or multiple sexual partners further attenuated the associations (aPRs, 1.02 [95% CI, 0.65-1.51] and 1.91 [95% CI, 0.82-4.47] for females and males, respectively). CONCLUSIONS Sexually transmitted infection prevalence was higher among persons with a past-year history of marijuana use; however, this association was not significant after accounting for measured confounders. Additional work is needed to characterize STI prevalence by the mode, duration, and frequency of marijuana use.

Objectives: The role of respiratory co-infections in modulating disease severity remains understudied in southern Africa, particularly in rural areas. This study was performed to characterize the spectrum of respiratory pathogens in rural southern Zambia and the prognostic impact of co-infections. Methods: Respiratory specimens collected from inpatient and outpatient participants in a viral surveillance program in 2018–2019 were tested for selected viruses and a typical bacteria using the Xpert Xpress Flu/RSV assay and FilmArray Respiratory Panel EZ. Participants were followed for 3–5 weeks to assess their clinical course. Multivariable regression was used to examine the role of co-infections in influencing disease severity. Results: A respiratory pathogen was detected in 63.2% of samples from 671 participants who presented with influenza-like illness. Common pathogens identified included influenza virus (18.2% of samples), respiratory syncytial virus (RSV) (11.8%), rhinovirus (26.4%), and coronavirus (6.0%). Overall, 6.4% of participants were co-infected with multiple respiratory pathogens. Compared to mono-infections, co-infections were found not to be associated with severe clinical illness either overall (relative risk (RR) 0.72, 95% confidence interval (CI) 0.39–1.32) or specifically with influenza virus (RR 0.80, 95% CI 0.14–4.46) or RSV infections (RR 0.44, 95% CI 0.17–1.11). Conclusions: Respiratory infections in rural southern Zambia were associated with a wide range of viruses. Respiratory co-infections in this population were not associated with clinical severity.

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., 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.

Current pelvic inflammatory disease (PID) treatment effectively treats Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT). However, coverage may be inadequate for Mycoplasma genitalium (MG)/Trichomonas vaginalis (TV) infections. We compared the longitudinal MG and TV outcomes with NG/CT outcomes for women enrolled in a longitudinal randomized controlled trial to optimize outcomes after PID. The prevalences of CT and NG were lower at 30- and 90-day follow-up compared with the prevalence at the time of diagnosis. No significant difference was observed for MG (odds ratio, 0.95; 0.86-1.04; P = 0.265) and TV (odds ratio, 0.89; 0.75-1.04; P = 0.146) over time for both treatment groups, showing that persistence and/or reinfection with MG and TV occurs more frequently than with CT or NG after treatment of PID using current national treatment guidelines.

Syphilis screening can be successfully integrated into antenatal clinics, and potentially avert significant morbidity and mortality to unborn infants. A minority of male partners report for testing and treatment, increasing the likelihood of reinfection. We conducted a qualitative study to understand factors influencing male partners to seek treatment after syphilis notification by their pregnant partners. A purposeful sample of 54 adults who participated in the STOP (Syphilis Treatment of Partners) study was stratified by gender (24 women, 30 male partners) and enrolled for in-depth interviews which were audio recorded, transcribed, and analyzed using the thematic approach. The participants’ median age (IQR) was 32 years (25–44), 87% were married, and 57.4% (31/74) had attained secondary education. Fourteen of 22 (63%) female participants reported that they sometimes experienced domestic violence. Male participant’s knowledge of syphilis and their perception of their valued role as responsible fathers of an unborn baby facilitated return. Female’s fear of partner‘s violence and poor communication between partners, were barriers against delivery of the notification forms to partners and subsequent treatment of partners. For men, fear of injection pain, perceptions of syphilis as a genetic disease and as a woman’s problem, busy work schedules, poor access to good STD services, shared facilities with women in clinics, as well as HIV-related stigma were important barrier factors. The return to the clinic for treatment of male partners after partner notification by infected pregnant women, was low due to limited knowledge about syphilis, fear of painful injection, fears of domestic violence, lack of communication skills (individual characteristics) and syphilis disease characteristics such as signs and symptoms. This, combined with health services characteristics such as structural barriers that hinder male partner treatment, low access, low capacity, work/time challenges, inadequate laboratory services and low clinic personnel capacity; threatens efforts to eliminate mother-to-child infection of syphilis. Improved public messaging about syphilis, better services, legal and policy frameworks supporting STD notification and treatment in resource-constrained settings are needed for effective STD control. Clinicaltrials.gov NCT02262390 ., Date Registered October 8 2014.

Summary Background Timely detection and treatment are important for the control of Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis. The objective of this study was to measure the performance of the Visby Medical Sexual Health Test, a single-use, point-of-care PCR device. Methods Women aged 14 years and older who presented consecutively to ten clinical sites across seven US states were enrolled for a cross-sectional, single-visit study. Patients who consented to participate, and who had not used any exclusionary products in the genital area in the previous 48 h, provided self-collected vaginal swabs for testing with the investigational device. Untrained operators received the specimens and ran the device using the guide provided. Specimens had to be run within 2 h of collection to be considered valid. For comparison, patient-infected status was derived by testing clinician-collected vaginal specimens with the Hologic Aptima Combo 2 Assay and Aptima Trichomonas vaginalis Assay, as well as the BD ProbeTec CT/GC Qx Amplified DNA Assay and BD ProbeTec Trichomonas vaginalis Qx Assay. If the results of those assays did not match, the BD MAX CT/GC/TV was used as a tiebreaker. The primary outcomes were the sensitivity and specificity of the investigational device for the detection of C trachomatis, N gonorrhoeae, and T vaginalis compared with patient-infected status. Findings Between Feb 25, 2019, and Jan 6, 2020, 1585 participants aged between 14 years and 80 years (mean 34·8 [SD 14·2]) were enrolled. 1555 participants had tests run with the investigational device, of whom 1532 (98·5%) had a valid result on either the first or repeat test. Among the patients with evaluable results (including a determinate patient-infected status), the device had a sensitivity of 97·6% (95% CI 93·2–99·2) and specificity of 98·3% (97·5–98·9) for C trachomatis (n=1457), sensitivity of 97·4% (86·5–99·5) and specificity of 99·4% (98·9–99·7) for N gonorrhoeae (n=1468), and sensitivity of 99·2% (95·5–99·9) and specificity of 96·9% (95·8–97·7) for T vaginalis (n=1449). Interpretation This innovative, rapid, easy-to-use, single-use, point-of-care device to detect C trachomatis, N gonorrhoeae, and T vaginalis infections showed excellent sensitivity and specificity, and could represent an important advance in the development of rapid diagnostics for sexually transmitted infections and other infectious diseases. Funding Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases.