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Competing Interests: Conflict of Interest and Sources of Funding: None declared.

Background: High prevalence of asymptomatic rectal chlamydia and gonorrhea among women is increasingly recognized. Screening is controversial because of lack of natural history data. Barriers to screening may include reluctance to discuss anal sex and collect rectal samples. This study describes the prevalence of sexual contact exposing adolescent and young adult women to extragenital sexually transmitted infections and acceptability of self-collection and clinician collection of rectal samples, preference for self- versus clinician-collected rectal samples, and preference for home or doctor's office for sample collection., Methods: Participants were recruited from a primary care office and completed structured interviews assessing types of sexual contact and attitudes about rectal sampling. Differences were tested using χ2 and 2-sided Fisher exact test., Results: Of 110 cisgender women (aged 14-22 years) enrolled, the average age was 18.4 years (SD, 1.7 years), 83% reported a history of extragenital contact, 22% reported history of receptive anal intercourse. A majority of participants reported self- and clinician-collected rectal samples to be acceptable (86% and 73%, respectively), with preferences for self-collection (71%) over clinician collection (29%, P < 0.001) and collection at the doctor's office (85%) over home (15%, P < 0.001)., Conclusions: Adolescent and young adult (AYA) women engage in behaviors that increase the risk of rectal sexually transmitted infection (STI). Self- and clinician-collected rectal samples were acceptable. A majority of AYA women preferred to collect rectal samples in the doctor's office rather than at home. This may reduce adolescents' access to direct-to-consumer STI services. Offering in-clinic, self-collected rectal samples may improve uptake of rectal STI screening in adolescent girls., Competing Interests: Conflict of Interest and Sources of Funding: The authors have no conflict of interest to declare. Study funding was provided through U54 EB007958 from the National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health. REDCap funding was provided through UL1TR001425., (Copyright © 2023 American Sexually Transmitted Diseases Association. All rights reserved.)

Background: Shifts in public health infrastructure to respond to one emerging health threat may have unanticipated consequences for preexisting diseases. Previous research evaluating the impact of COVID-19 on sexually transmitted infections (STIs) has been conducted nationally, with little exploration of the impact on a granular geospatial level. This ecological study seeks to quantify the association between COVID-19 cases or deaths and chlamydia, gonorrhea, and syphilis cases for all US counties in 2020., Methods: Separate, adjusted multivariable quasi-Poisson models with robust standard errors modeled the county-level association between 2020 COVID-19 cases and deaths per 100,000 and 2020 chlamydia, gonorrhea, or syphilis cases per 100,000. Models were adjusted for sociodemographic characteristics., Results: Every 1000 additional COVID-19 cases per 100,000 was associated with a 1.80% increase in the average number of chlamydia cases ( P < 0.001) and a 5.00% increase in the average number of gonorrhea cases ( P < 0.001). Every 1000 additional COVID-19 deaths per 100,000 was associated with a 57.9% increase in the average number gonorrhea cases ( P < 0.001) and a 74.2% decrease in the average number of syphilis cases ( P = 0.004)., Conclusions: Higher rates of COVID-19 cases and deaths were associated with increased rates of some STIs at the US county level. The underlying reasons for these associations could not be established by this study. The emergency response to an emerging threat may have unanticipated influence on preexisting diseases that varies by level of governance., Competing Interests: Conflict of Interest and Sources of Funding: The authors declare no conflict of interest. Research reported in this publication was supported by the National Institute of Biomedical Imaging and Bioengineering of the National Institutes of Health under Award Number U54EB007958. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health., (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Sexually Transmitted Diseases Association.)

Background: The 2021 Centers for Disease Control and Prevention sexually transmitted infection treatment guidelines recommend extragenital testing for gonorrhea and chlamydia in men who have sex with men and for women based on reported behaviors and exposures. The "IWantTheKit (IWTK)" program is a free online platform for specimen self-collection and mail-in for combined chlamydia/gonorrhea testing. We sought to assess the additional diagnostic value of extragenital testing compared with genital testing only for chlamydia/gonorrhea and determine factors associated with a positive extragenital test result among IWTK users., Methods: From August 2013 to January 2022, 7612 unique IWTK users returned swabs for testing; 3407 (45%) users requested both genital and extragenital tests and were included in this analysis. Descriptive statistics were summarized for demographic characteristics, reported behaviors, and genital and extragenital test results, and data were stratified by gender and age group. A logistic regression model was used to estimate associations between factors and extragenital sexually transmitted infection positivity., Results: Chlamydia positivity rates were 4.7%, 2.4%, and 1.5% at genital, extragenital, and both sites, respectively; for gonorrhea, 0.4%, 1.1%, and 0.4% were positive at those sites, respectively. Among women, age 25 years and younger was significantly associated with extragenital chlamydia (odds ratio [OR], 4.0; P = 0.010). Being in high-risk quiz score group was associated with extragenital chlamydia (OR, 2.6; P = 0.005) and extragenital gonorrhea in men and women (OR, 8.5; P = 0.005)., Conclusions: Extragenital testing detected additional chlamydia and gonorrhea cases in the IWTK user population that would have been missed by genital-only testing, especially for women younger than 25 years and people reported to be at high risk., Competing Interests: Conflict of Interest and Sources of Funding: None declared., (Copyright © 2022 American Sexually Transmitted Diseases Association. All rights reserved.)

Background: Combination HIV prevention and treatment interventions (CHIs) have led to substantial declines in HIV incidence in sub-Saharan Africa; however, population-level data on non-HIV sexually transmitted infections (STIs) in the context of CHIs are rare. We aimed to assess STI burden following scale-up of CHIs in Uganda., Methods: The Sexually Transmitted Infection Prevalence Study (STIPS) was a cross-sectional study nested within a population-based cohort among inland agrarian and Lake Victoria fishing populations in southern Uganda. STIPS enrolled consenting residents aged 18-49 years in two communities (one inland and one fishing) between May and October, 2019, and measured the prevalence of chlamydia, gonorrhoea, trichomonas, syphilis, and herpes simplex virus 2 (HSV-2)., Findings: Between May 27, 2019 and Oct 25, 2019, STIPS enrolled 1825 participants. HIV prevalence was 14·0% among the inland population and 39·8% among the fishing population, with about 90% HIV viral load suppression in both communities. Among inland and fishing populations, chlamydia prevalence was 9·6% (95% CI 7·9-11·7) and 9·9% (8·1-12·0), gonorrhoea prevalence 5·0% (3·8-6·7) and 8·4% (6·8-10·5), trichomonas prevalence 9·4% (7·7-11·5) and 12·2% (10·2-14·5), and HSV-2 prevalence 43·0% (39·9-46·3) and 64·4% (61·3-67·6), respectively. In the fishing population, syphilis seropositivity was 24·2% (21·5-27·2) with 9·4% (7·7-11·5) having high-titre (rapid plasma reagin ≥1:8) infection, including 16·9% (11·9-24·0%) of men living with HIV. Prevalence of at least one curable STI (chlamydia, gonorrhoea, trichomonas, or high-titre syphilis) was 51% higher among people living with HIV (vs HIV negative; adjusted prevalence risk ratio [PRR] 1·51; 95% CI 1·27-1·78), including among pregnant women (adjusted PRR 1·87, 1·11-3·17), with no differences by HIV suppression status., Interpretation: Despite near universal HIV treatment, STI burden remains extremely high in southern Uganda, particularly among people living with HIV. There is an urgent need to integrate STI care with HIV services in African settings., Funding: National Institutes of Health., Competing Interests: Declaration of interests MJW and RHG are paid consultants to the Rakai Health Sciences Program and serve on its Board of Directors. These arrangements have been reviewed and approved by the Johns Hopkins University in accordance with its conflict of interest policies. YCM has received grant support to John Hopkins University from Hologic, Cepheid, Roche, ChemBio, Becton Dickinson, and miDiagnostics, and has provided consultative support to Abbot. All other authors declare no competing interests., (Copyright © 2022 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

The Baltimore City Health Department (Baltimore, MD) promoted IWantTheKit for chlamydia, gonorrhea, and HIV testing to city residents and clinic patients when COVID-19 restricted in-person clinic services. From April to October 2020, monthly online IWantTheKit orders increased by 645%. A high prevalence of chlamydia and gonorrhea was detected, and 96% of users who tested positive for chlamydia and gonorrhea were successfully contacted for treatment. Uptake by Baltimore City Health Department priority populations and excellent treatment linkage demonstrated how a public health-academic partnership successfully addressed a service gap during the pandemic. ( Am J Public Health . 2022;112(7):985-989. https://doi.org/10.2105/AJPH.2022.306835).

Background: Black sexual minority men (BSMM) and Black transgender women face a disproportionate risk of incarceration and sexually transmitted infection (STI)/HIV, yet research on the longitudinal association between incarceration and STI/HIV risk in these groups is limited., Methods: We used data from the HIV Prevention Trials Network (HPTN) 061 study conducted among BSMM and Black transgender women in Atlanta, Boston, Los Angeles, New York City, San Francisco, and Washington, DC, restricting analyses to those who returned for the 6-month follow-up visit when recent incarceration was measured (n = 1169). Using inverse probability of treatment weighting, we measured associations between incarceration and next 6-month multiple partnerships; selling or buying sex; condomless anal intercourse; and incident chlamydia, gonorrhea, syphilis, and HIV. We explored differences by study city, and among BSMM who had sex with men only, BSMM who had sex with men and women, and Black transgender women., Results: Approximately 14% reported past 6-month incarceration. Incarceration was associated with next 6-month selling sex (adjusted risk ratio [ARR], 1.80; 95% confidence interval [CI], 1.12-2.87) in the overall sample and multiple partnerships among BSMM who had sex with men and women (ARR, 1.34; 95% CI, 1.10-1.63) and transgender women (ARR, 1.77; 95% CI, 1.22-2.57). There is evidence suggesting that incarceration may predict gonorrhea (ARR, 2.35; 95% CI, 0.95-5.77), with particularly strong associations observed in Los Angeles (ARR, 6.48; 95% CI, 1.48-28.38)., Conclusions: Incarceration may increase STI/HIV risk among BSMM and Black transgender women. Additional mixed-methods research is needed to validate associations and understand pathways., Competing Interests: Conflict of Interest and Sources of Funding: This research uses data from the HIV Prevention Trials Network 061 (HPTN 061) study. HPTN 061 grant support was provided by the National Institute of Allergy and Infectious Disease, National Institute on Drug Abuse, and National Institute of Mental Health: Cooperative Agreements UM1 AI068619, UM1 AI068617, and UM1 AI068613. Additional site funding included Fenway Institute Clinical Research Site (CRS): Harvard University CFAR (P30 AI060354) and CTU for HIV Prevention and Microbicide Research (UM1 AI069480); George Washington University CRS: District of Columbia Developmental CFAR (P30 AI087714); Harlem Prevention Center CRS and NY Blood Center/Union Square CRS: Columbia University CTU (5U01 AI069466) and ARRA funding (3U01 AI069466-03S1); Hope Clinic of the Emory Vaccine Center CRS and The Ponce de Leon Center CRS: Emory University HIV/AIDS CTU (5U01 AI069418), CFAR (P30 AI050409), and CTSA (UL1 RR025008); San Francisco Vaccine and Prevention CRS: ARRA funding (3U01 AI069496-03S1, 3U01 AI069496-03S2); and UCLA Vine Street CRS: UCLA Department of Medicine, Division of Infectious Diseases CTU (U01 AI069424)., (Copyright © 2021 American Sexually Transmitted Diseases Association. All rights reserved.)

Background: Accurate same-day sexually transmitted infection (STI) diagnostic testing is generally unavailable, leading to syndromic management with high rates of overtreatment and undertreatment. We analyzed the ease of integration of the Visby STI Panel into clinical practice, studied acceptance by patients and clinic personnel, and assessed the potential to inform accurate treatment decisions., Methods: In a cross-sectional single-visit study of 55 women aged 18 to 56 years, women self-collected vaginal swab samples that were analyzed using the Visby STI Panel for Chlamydia trachomatis, Neisseria gonorrhoeae (NG), and Trichomonas vaginalis (TV). Results were compared with standard-of-care clinic results from send-out laboratory polymerase chain reaction tests. Surveys assessed patient and device operator experiences with the Visby STI Panel and clinicians' perceived need for and acceptance of the device. Time parameters were measured to evaluate the impact on clinical workflow, and syndromic treatment decisions were compared with anticipated treatment based on the Visby STI Panel results., Results: Patients strongly agreed that sample self-collection was easy, and operators reported the device easy to use. Clinicians valued the rapid return of results, and patients were comfortable waiting up to 30 minutes to receive them. In 13 of 15 cases, the Visby STI Panel correctly identified undertreated patients as infected and correctly identified all 33 incidences of overtreatment., Conclusions: Clinical adoption of the Visby STI Panel into primary care clinics and doctors' offices could reduce overtreatment and undertreatment of STIs. If integrated efficiently into the clinical workflow, the test would have minimal impact on staff time and visit duration for patients., Competing Interests: Conflict of Interest and Sources of Funding: MD, LB, KD, GH, and CAG received research funding from Visby Medical, Inc. All other authors declared no potential conflicts of interest., (Copyright © 2021 American Sexually Transmitted Diseases Association. All rights reserved.)

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., Competing Interests: Conflict of Interest and Sources of Funding: This work was generously supported by an unrestricted grant from Hologic, Inc., to Johns Hopkins University and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (T32HD052459; principal investigator: M. Trent; funded: J. Ronda). Investigators M. Trent, J. Perin, and C.A. Gaydos were also supported by the National Institute of Nursing Research (5R01NR013507). Aside from this grant, Dr. Trent also receives research support through a material transfer agreement with SpeeDx, LLC, through Johns Hopkins University and serves on the Trojan Sexual Health Advisory Council (Church & Dwight, Inc.). Dr. Gaydos reports receiving research funding grants from Hologic and receiving speaker funding for educational lectures. The other coauthors declare that they have no competing interests., (Copyright © 2021 American Sexually Transmitted Diseases Association. All rights reserved.)

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., Competing Interests: Conflict of Interest and Sources of Funding: K.H.M. has received unrestricted research grants to study antiretrovirals for prevention from Gilead Sciences and Merck, Inc. The work is partially supported by the Bio-behavioral and Community Science Core of the Harvard Center for AIDS Research (NIAID P30AI060354)., (Copyright © 2021 American Sexually Transmitted Diseases Association. All rights reserved.)

Introduction : Point-of-care (POC) tests for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) are urgently needed to control the STI epidemic in order to offer patients an immediate diagnoses and accurate treatment before they leave a clinical encounter and thus reduce transmission and sequelae. Nucleic acid amplification tests (NAATs) have increased sensitivity and specificity, but very few POC assays can provide results of such tests within the usual time of the patient visit. Areas covered : This review describes the technology and performance characteristics of the binx health io ® [Boston, MA] (binx io) CT/NG assay, a new rapid molecular POC assay. The assay is compared to other available molecular POC tests. We also describe the importance of time to results and assay performance for this POC assay. Expert opinion : The binx io CT/NG assay offers the ability to incorporate the use of POC tests to identify and immediately treat chlamydia and gonococcal infections into the clinical visit, which will provide improved outcomes for patients. Additional implementation studies are needed to optimize the adoption of this new test.

Background: Point-of-care (POC) tests enable immediate diagnosis and targeted treatment of sexually transmitted infections (STIs), which could accelerate control of ongoing epidemics. Although older nucleic acid amplification tests have improved the accuracy of laboratory-based tests for STIs, newer POC tests can facilitate control efforts. We sought to review the performance and time to result of POC assays for STIs in the last 10 years., Methods: The authors performed a PubMed, US National Library of Medicine, National Center for Biotechnology Information search for POC tests for STIs or sexually transmitted diseases., Results: Diagnostic technology for POC assays for STIs has achieved high sensitivity and specificity (>90%) using recent molecular advances in the last 10 years. Three POC tests for chlamydia and gonorrhea and 2 for trichomonas have been cleared by the Food and Drug Administration and can provide rapid results during the clinical encounter. Two POC assays for syphilis are now cleared by the Food and Drug Administration. Other similar POC assays are in development. These "fast followers" have faster time to result and will extend the diagnostic armamentarium at POC., Conclusions: New technology has improved the performance accuracy of STI POC diagnostics. Innovation in device format has resulted in accurate POC assays, which can decrease the time to result and accelerate the detection and treatment of STIs during the clinical encounter. The full implementation potential of these newer tests will depend on the ability of these tests to achieve Clinical Laboratory Improvement Amendments-waived status so they can be performed by nonlaboratorians with no previous training., Competing Interests: Conflict of Interest and Sources of Funding: This work was supported by the National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health (U54EB007958), and the National Institute of Allergy and Infectious Diseases, National Institutes of Health (U-01 068613, K01AI153546). The authors declare no conflict of interest., (Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Sexually Transmitted Diseases Association.)

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 <15 min. The duplex test was integrated into a low-cost thermoplastic cartridge with automated processing of penile swab samples from patients using magnetic beads. A compact instrument conducted DNA extraction, PCR, and analysis of results while relaying data to the user via a smartphone app. This platform was tested on penile swab samples from sexual health clinics in Baltimore, MD, USA ( n = 66) and Kampala, Uganda ( n = 151) with an overall sensitivity and specificity of 97.7% (95% CI, 94.7 to 100%) and 97.6% (95% CI, 94.1 to 100%), respectively, for N. gonorrhoeae detection and 100% concordance with culture results for ciprofloxacin resistance. This study paves the way for delivering accessible PCR diagnostics for rapidly detecting STIs at the point of care, helping to guide treatment decisions and combat the rise of antimicrobial resistant pathogens., (Copyright © 2021 The Authors, some rights reserved; exclusive licensee American Association for the Advancement of Science. No claim to original U.S. Government Works.)

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: 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., Competing Interests: Conflict of Interest and Sources of Funding: B.V.D.P. received institutional research support, honorarium, or consulting fees from Becton, Dickinson and Company; Atlas Genetics; Beckman Coulter; Click Diagnostics; Hologic; Luminex; Roche; and SpeeDx. C.A.G. received institutional research support, honorarium, or consulting fees from Becton, Dickinson and Company; Atlas Genetics; Beckman Coulter; Click Diagnostics; Hologic; Quidel; and SpeeDx. E.T.-C., S.K., and C.K.C. are employees of the study sponsor. T.E.D., K.H.F., S.N.T., and M.H.A. have no conflicts of interest., (Copyright © 2020 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Sexually Transmitted Diseases Association.)

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.

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) has 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, and 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 tests with AMR testing capacity is needed to help guide antimicrobial stewardship.

Importance: Rates of chlamydial and gonococcal infection continue to increase in the United States, as do the associated costs of untreated infections. Improved diagnostic technologies that support testing and treating in 1 clinical visit are critical to advancing efforts to control the rates of chlamydial and gonococcal infection., Objective: To evaluate the clinical performance of a point-of-care (POC) molecular diagnostic assay for the detection of chlamydia and gonorrhea., Design, Setting, and Participants: A noninterventional, cross-sectional clinical study was conducted from September 18, 2018, through March 13, 2019, at sexually transmitted infection (STI), HIV, family planning, and obstetrics and gynecology clinics where STI screening is routine, using a convenience sample and comparing commercially available assays with a new 30-minute POC assay. Patients included were those eligible for STI screening or diagnostic testing who had not taken antibiotics effective against chlamydia or gonorrhea within the previous 28 days. Four vaginal swab samples were collected from women and a first-catch urine sample was obtained from men., Main Outcomes and Measures: A composite infection status was used to classify participants as infected if 2 or more comparator results were positive, as not infected if 2 or more comparator samples were negative, and as unevaluable if 1 result was invalid and the other 2 results did not agree with each other., Results: Swab samples from 1523 women (median age, 27 years [interquartile range, 17-37 years]), 817 (53.6%) of whom presented with symptoms, and 922 men (median age, 29 years [interquartile range, 17-41 years]), 308 (33.4%) of whom were symptomatic, were tested. For chlamydia, sensitivity of the new POC assay was 96.1% (95% CI, 91.2%-98.3%) for women and 92.5% (95% CI, 86.4%-96.0%) for men. For gonorrhea, sensitivity estimates were 100.0% (95% CI, 92.1%-100.0%) for women and 97.3% (95% CI, 90.7%-99.3%) for men. For chlamydia, specificity of the new POC assay was 99.1% (95% CI, 98.4%-99.5%) for women and 99.3% (95% CI, 98.4%-99.7%) for men. For gonorrhea, specificity estimates were 99.9% (95% CI, 99.5%-100%) for women and 100% (95% CI, 95.5%-100%) for men. Non-laboratory-trained personnel performed 94.8% of all tests (2318 of 2445) during the study., Conclusions and Relevance: This study suggests that self-obtained vaginal swab samples were associated with performance equivalent to laboratory-based molecular diagnostics, which can support use of this POC assay in many settings. The availability of an easy-to-use, rapid (30-minute) molecular test for accurate detection of chlamydia and gonorrhea has the power to facilitate testing and treatment in a single patient visit for these STIs.

Urogenital and rectal specimens collected from the "IWantTheKit" Internet-based sexually transmitted infection screening program were evaluated for Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis. Of 881 paired specimens submitted from August 2013 to December 2016, 15.0% (n = 132) tested positive for 1 or more sexually transmitted infections, of which 50.8% (n = 67) were identified exclusively through rectal testing.

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., (Copyright © 2018 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.)

The anogenital prevalence of sexually transmitted infections (STIs) and the use of cervico-vaginal self-collected vs. clinician-collected samples were evaluated for the diagnosis of human immunodeficiency virus (HIV)-infected and HIV-uninfected women in the Tapajós region, Amazon, Brazil. We recruited 153 women for a cross-sectional study (112 HIV-uninfected and 41 HIV-infected) who sought health services. Anal and cervical scrapings and cervico-vaginal self-collection samples were collected. Real-time polymerase chain reaction methods were used for Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis and Mycoplasma genitalium. A syphilis test was also performed. Risk factors for STIs were identified by multivariate analysis. The overall prevalence of STIs was 30.4% (34/112) in HIV-uninfected women and 24.4% (10/41) in HIV-infected women. Anogenital Chlamydia trachomatis infection was the most prevalent in both groups of women (20.5% vs 19.5%). There was significant agreement for each STI between self-collected and clinician-collected samples: 91.7%, kappa 0.67, 95% confidence interval (CI) 0.49-0.85 for Chlamydia trachomatis; 99.2%, kappa 0.85, 95% CI 0.57-1.00 for Neisseria gonorrhoeae; 97.7%, kappa 0.39, 95% CI -0.16-0.94 for Trichomonas vaginalis; and 94.7%, kappa 0.51, 95% CI 0.20-0.82 for Mycoplasma genitalium. Women with human papillomavirus had coinfection or multiple infections with other STIs. Risk factors for STIs were being ≤ 25 years old, being employed or a student, reporting a history of STI and having a positive HPV test. A high prevalence of STIs in women in the Tapajós region was found. Cervico-vaginal self-collection is a useful tool for STI screening and can be used in prevention control programs in low-resource settings, such as in northern Brazil., Competing Interests: The authors have declared that no competing interests exist.

Antimicrobial-resistant Neisseria gonorrhoeae (NG) is a global public health issue that threatens effectiveness of current treatments of NG. Increased use of nucleic acid amplification tests (NAATs) in lieu of cultures makes obtaining clinical isolates for susceptibility testing difficult and samples collected in commercial transport buffer for NAATs do not preserve viable organism, while molecular methods of assessing antibiotic susceptibility do not require viable organism. We evaluated 243 NG-positive samples in Aptima transport media including urine, oral, and rectal swabs from Nigerian men who have sex with men for markers to penicillinase-producing NG, ciprofloxacin ( GyrA and ParC mutations), and extended spectrum cephalosporins (ESCs, PenA mosaic [allele X], PonA, mtrR, PorB mutations) by real-time PCR. NG DNA was recovered in 75% (183/243) of samples. Of these, 93% (171/183) were positive for at least one resistance marker. We observed a prevalence of dual resistance markers to penicillin and ciprofloxacin at 46.2% (79/171). Six percent of samples (10/171) tested positive for the PenA mosaic (allele X) ESC marker. These data indicate that antibiotic-resistant NG is common in Nigeria. Laboratory and clinical capacity building in Nigeria should include development of methods to culture NG and determine antimicrobial susceptibility.

Multidrug-resistant gonorrhea has become an urgent issue for global public health. As the causative agent of gonorrhea, Neisseria gonorrhoeae, has been progressively developing resistance to nearly all prescribed antimicrobial drugs, monitoring its antimicrobial resistance on a broader scale has become a crucial agenda for effective antibiotic stewardship. Unfortunately, gold standard antimicrobial susceptibility testing (AST) relies on time and labor-intensive phenotypic assays, which lag behind the current diagnostic workflow for N. gonorrhoeae identification based on nucleic acid amplification tests (NAAT). Newer assay technologies based on NAAT can rapidly identify N. gonorrhoeae from clinical specimen but fundamentally lack the capacity to provide phenotypic AST information. Herein, we propose a direct-quantitative PCR (direct-qPCR) assay that enables pathogen-specific identification and phenotypic AST via quantitative measurement of N. gonorrhoeae growth directly from a liquid medium without any sample preprocessing. The assay has an analytical sensitivity of 10 2  CFU/mL and is highly specific to N. gonorrhoeae in the presence of urogenital flora and clinical swab eluent. We tested seven N. gonorrhoeae strains against three antibiotic agents, penicillin, tetracycline, and ciprofloxacin, and achieved 95.2% category agreement and 85.7% essential agreement with the FDA-approved E-test. The assay presented in this work has the unique ability to identify N. gonorrhoeae and provide phenotypic AST directly from the liquid medium with cell densities as low as 10 2 CFU/mL, demonstrating an accelerated, sensitive, and scalable workflow for performing both identification and AST of  N. gonorrhoeae.

Background: To extend our previous observation of a short-term rise in prostate-specific antigen (PSA) concentration, a marker of prostate inflammation and cell damage, during and immediately following sexually transmitted and systemic infections, we examined the longer-term influence of these infections, both individually and cumulatively, on PSA over a mean of 10 years of follow-up in young active duty U.S. servicemen., Methods: We measured PSA in serum specimens collected in 1995-7 (baseline) and 2004-6 (follow-up) from 265 men diagnosed with chlamydia (CT), 72 with gonorrhea (GC), 37 with non-chlamydial, non-gonococcal urethritis (NCNGU), 58 with infectious mononucleosis (IM), 91 with other systemic or non-genitourinary infections such as varicella; and 125-258 men with no infectious disease diagnoses in their medical record during follow-up (controls). We examined the influence of these infections on PSA change between baseline and follow-up., Results: The proportion of men with any increase in PSA (>0 ng/mL) over the 10-year average follow-up was significantly higher in men with histories of sexually transmitted infections (CT, GC, and NCNGU; 67.7% vs 60.8%, P = 0.043), systemic infections (66.7% vs 54.4%, P = 0.047), or any infections (all cases combined; 68.5% vs 54.4%, P = 0.003) in their military medical record compared to controls., Conclusions: While PSA has been previously shown to rise during acute infection, these findings demonstrate that PSA remains elevated over a longer period. Additionally, the overall infection burden, rather than solely genitourinary-specific infection burden, contributed to these long-term changes, possibly implying a role for the cumulative burden of infections in prostate cancer risk., (© 2018 Wiley Periodicals, Inc.)

Objective: Research exploring the clinical and sexual risk correlates is essential to define universal standards for screening and management for Mycoplasma genitalium (MG). The objective of this study is to determine the baseline prevalence of MG and associated clinical risks using cross-sectional data., Methods: Adolescent and young adult women 13-29 years were recruited during clinical visits during which biological specimens were collected for Neisseriagonorrhoeae (NG) and Chlamydia trachomatis (CT) testing to provide vaginal specimens for MG and Trichomonasvaginalis (TV) testing. Demographic, clinical and sexual risk data were collected after obtaining written consent. MG was tested using the Hologic Gen-Probe transcription-mediated amplification-MG analyte-specific reagent assay and TV by the Aptima TV assay. Bivariate analyses were used to evaluate differences in MG prevalence based on pregnancy status, demographic factors, clinical symptoms, concurrent STI and sexual risk behaviour quiz score (maximum score=10)., Results: 483 patients with a mean age of 22.4 years (SD 3.6) were enrolled. Most participants were not pregnant (66%) and asymptomatic (59%). MG was the most common STI (MG 16%, TV 9%, CT 8%, NG 1%). Neither pregnancy nor symptoms were predictive of STI positivity. Thirty-five percent of non-pregnant and 45% of pregnant adolescents ≤19 years were positive for any STI. Participants with MG were 3.4 times more likely to be co-infected with other STIs compared with those with other STIs (OR 3.4, 95% CI 1.17 to 10.3, P=0.021). Mean risk quiz scores for STI positive women were six points higher than those who were STI negative (β=0.63, 95% CI 0.36 to 0.90, P<0.001). There were no differences in risk scores for MG-positive participants compared with other STI positivity., Conclusion: MG infection was common, associated with STI co-infection and often asymptomatic, and pregnancy status did not confer protection., Competing Interests: Competing interests: MT reports grants from Hologic, Inc, grants from National Institutes of Health, during the conduct of the study; personal fees and other from Church & Dwight, Inc, outside the submitted work. CAG reports grants from Hologic, Inc, grants from National Institutes of Health, during the conduct of the study., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Background: The emergence and spread of antimicrobial-resistant (AMR) Neisseria gonorrhoeae (NG) is a major public health concern. In the era of nucleic acid amplifications tests, rapid and accurate molecular approaches are needed to help increase surveillance, guide antimicrobial stewardship, and prevent outbreaks., Methods: Residual urethral swabs, collected prospectively in the Baltimore City Health Department during a 6-month period, were analyzed by real-time polymerase chain reaction assays for NG DNA and AMR determinants to fluoroquinolones, penicillin, and extended-spectrum cephalosporins., Results: N. gonorrhoeae DNA was detected in 34.8% (73/210) of samples, including 67.3% (68/101) of the swabs that had been previously identified as NG positive by culture. Markers associated with decreased susceptibility to fluoroquinolones were detected in 22.4% of the polymerase chain reaction NG-positive samples. The rate of penicillinase-producing NG was very low (1.6%), and no markers associated with decreased susceptibility to extended-spectrum cephalosporins were detected in this cohort of men using the AMR assays herein described., Conclusions: Detection of molecular markers associated with AMR in NG can be performed directly from residual clinical samples, although the recovery rate of adequate DNA for molecular testing from these samples can be suboptimal. A high number of samples with mutations associated with decreased susceptibility to fluoroquinolones were identified.

Our previous pilot study during 2010-2013, based on the IWantTheKit (IWTK) home self-collection program for sexually transmitted infections (STIs), showed that voluntary risk score tool predicted STIs well in female volunteers compared to their male counterparts. Risk score became a required part of the IWTK program in August 2013. We investigated association of IWTK risk score and presence of STI in 592 male participants living in Maryland and Washington DC from August 2013 to April 2015. The risk score quiz includes questions on demographic and sexual risk behavior. Data were analyzed using the Cochran-Armitage test for trend to determine if prevalence of STIs (Chlamydia, gonorrhea, or trichomoniasis) increased with the higher risk score category. Overall, 57% of participants were aged < 30 years (mean: 30.1 ± 9.3 years); 42% white, 42% black, and 16% other races. The majority (67%) of participants had medium risk scores of 3-6, followed by high scores of 7-10 (22%), and 0-2 (11%). The overall prevalence of STIs was 10.5% (62/592). The prevalence of STIs was 3.1% for users with risk scores of 0-2, 10.4% for those with scores 3-6, and 14.3% for those with scores 7-10 (trend test: p = 0.019). Medium and high IWTK risk scores successfully predicted the probability of STIs in male participants after elimination of potential selection biases.

Background: To investigate mechanisms underlying our previous observation of a large rise in serum prostate-specific antigen, a marker of prostate pathology, during both sexually transmitted and systemic infections, we measured serum high-sensitivity C-reactive protein (hsCRP), a marker of systemic inflammation, in our previous case-control study of young, male US military members and compared our findings to those for PSA., Methods: We measured hsCRP before and during infection for 299 chlamydia, 112 gonorrhea, and 59 non-chlamydial, non-gonococcal urethritis (NCNGU) cases; before and after infection for 55 infectious mononucleosis (IM) and 90 other systemic/non-genitourinary cases; and for 220-256 controls., Results: Only gonorrhea cases were significantly more likely to have a large hsCRP rise (≥1.40 mg/L or ≥239%) during infection than controls (P < 0.01). However, gonorrhea, IM, and other systemic/non-genitourinary cases were more likely to have a rise of any magnitude up to one year post-diagnosis than controls (p = 0.038-0.077)., Conclusions: These findings, which differ from those for PSA, suggest distinct mechanisms of elevation for hsCRP and PSA, and support both direct (eg, prostate infection) and indirect (eg, systemic inflammation-mediated prostate cell damage) mechanisms for PSA elevation. Future studies should explore our PSA findings further for their relevance to both prostate cancer screening and risk., (© 2017 Wiley Periodicals, Inc.)

The Aptima Combo 2 (AC2) and Aptima CT (ACT) (Hologic Inc., San Diego, CA) are nucleic acid amplification tests (NAATs) that detect Chlamydia trachomatis AC2 also detects Neisseria gonorrhoeae Storage and temperature conditions may impact the utility of NAATs in some settings and screening programs. We evaluated specimen stability for use beyond the Aptima package insert specifications for temperature and duration of storage (between 2°C and 30°C and 60 days, respectively) in two studies: (i) dry C. trachomatis -seeded swabs were used with ACT after storage at 4°C, 23°C, or 36°C for up to 84 days and (ii) swabs seeded with C. trachomatis and N. gonorrhoeae and then placed in transport medium were tested with AC2, after being mailed via the U.S. Postal Service to three different sites. Prolonged storage of samples had no effect, and samples stored at 4°C, 23°C, and 36°C for up to 84 days yielded comparable ACT positivities, although there was a drop in signal intensity for virtually all specimens under all storage/shipping conditions after day 21. In the mailing study, 80%, 52% and 29% of seeded swabs were exposed to temperatures of >30°C during three rounds in transit, and 2% reached temperatures of >40°C. No evidence of signal degradation in the AC2 assay for detection of C. trachomatis or N. gonorrhoeae was observed, although some mailed swabs took more than 5 weeks to reach the laboratory site. These two studies support the potential use of swabs at temperatures above 36°C and storage beyond 60 days and provide confidence regarding this commercially available NAAT for testing of specimens after mailing., (Copyright © 2017 American Society for Microbiology.)

Introduction: Sexually transmitted infection (STI) and HIV prevalence have been reported to be higher amongst men who have sex with men (MSM) in Nigeria than in the general population. The objective of this study was to characterize the prevalence of HIV, chlamydia and gonorrhoea in this population using laboratory-based universal testing., Methods: TRUST/RV368 represents a cohort of MSM and transgender women (TGW) recruited at trusted community centres in Abuja and Lagos, Nigeria, using respondent-driven sampling (RDS). Participants undergo a structured comprehensive assessment of HIV-related risks and screening for anorectal and urogenital Chlamydia trachomatis and Neisseria gonorrhoeae , and HIV. Crude and RDS-weighted prevalence estimates with 95% confidence intervals (CIs) were calculated. Log-binomial regression was used to explore factors associated with prevalent HIV infection and STIs., Results: From March 2013 to January 2016, 862 MSM and TGW (316 in Lagos and 546 in Abuja) underwent screening for HIV, chlamydia and gonorrhoea at study enrolment. Participants' median age was 24 years [interquartile range (IQR) 21-27]. One-third (34.2%) were identified as gay/homosexual and 65.2% as bisexual. The overall prevalence of HIV was 54.9%. After adjusting for the RDS recruitment method, HIV prevalence in Abuja was 43.5% (95% CI 37.3-49.6%) and in Lagos was 65.6% (95% CI 54.7-76.5%). The RDS-weighted prevalence of chlamydia was 17.0% (95% CI 11.8-22.3%) in Abuja and 18.3% (95% CI 11.1-25.4%) in Lagos. Chlamydia infection was detected only at the anorectal site in 70.2% of cases. The RDS-weighted prevalence of gonorrhoea was 19.1% (95% CI 14.6-23.5%) in Abuja and 25.8% (95% CI 17.1-34.6%) in Lagos. Overall, 84.2% of gonorrhoea cases presented with anorectal infection only. Over 95% of STI cases were asymptomatic. In a multivariable model, increased risk for chlamydia/gonorrhoea was associated with younger age, gay/homosexual sexual orientation and higher number of partners for receptive anal sex. HIV infection was associated with older age, female gender identity and number of partners for receptive anal sex., Conclusions: There is a high burden of infection with HIV and asymptomatic chlamydia and gonorrhoea among MSM and TGW in Nigeria. Most cases would have been missed without anorectal screening. Interventions are needed to target this population for appropriate STI screening and management beginning at a young age., Competing Interests: TC has received a speaker fee from Gilead Science. The other authors have no competing interests to disclose.

The www.iwantthekit.org provides Internet-based, at-home sexually transmitted infection screening. The Web site implemented an automated test result access system. To evaluate potential deleterious effects of the new system, we analyzed demographics, Web site usage, and treatment. The post-Web site design captured more participant information and no decrease in requests, kit return, or treatment adherence.

Background: Internet-based screening for vaginal sexually transmitted infections (STI) has been shown to reach high-risk populations. Published studies of internet-based screening for rectal STIs in women are needed. Our objectives were to describe the female users of a rectal internet-based screening intervention and assess what factors correlated with rectal positivity for STIs., Methods: The website http://www.iwantthekit.org offers free STI testing via home self-sampling kits. Women could order vaginal and rectal kits, both containing questionnaires. Rectal and vaginal swabs were tested for Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis using nucleic acid amplification tests. Data were analysed from 205 rectal kits from January 2009 through February 2011. Self-reported characteristics of participants were examined, and correlates of rectal STI positivity were analysed., Results: Of the 205 rectal samples returned and eligible for testing, 38 (18.5%) were positive for at least one STI. The women were young (mean age 25.8 years), mostly African-American (50.0%), and only 14.0% always used condoms. After adjusting for age and race, Black race (AOR=3.06) and vaginal STI positivity (AOR=40.6) were significantly correlated with rectal STI positivity. Of women testing positive for rectal STIs who also submitted vaginal swabs, 29.4% were negative in the vaginal sample., Conclusions: Internet-based rectal screening can reach populations that appear to be at high risk for rectal STIs (18.5% prevalence) and led to the diagnosis of STIs in women who would not have been diagnosed vaginally. Black race and vaginal STI positivity were highly correlated with rectal STI positivity., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)

Rapid diagnostics for Chlamydia trachomatis and Neisseria gonorrhoeae are desirable so that patients can be treated while they are still in the clinic or doctor's office. The Cepheid GeneXpert(®) (Xpert) CT/NG assay was US FDA-cleared in December 2012. The assay is a rapid real-time PCR nucleic acid amplified test. The cartridge-based assay detects DNA of Chlamydia trachomatis and Neisseria gonorrhoeae. It is FDA-cleared for use in female endocervical swabs, patient-collected vaginal swabs and for female and male urine specimens from symptomatic and asymptomatic patients. It has demonstrated near-perfect sensitivity and specificity in urogenital specimens. The Xpert is a modular platform for testing samples directly from patients, which requires no hands-on manipulation from specimen loading until results are available. Results are provided in approximately 90 minutes. It has been graded by the FDA as moderately complex for Clinical Laboratory Improvement Amendments. Several publications have reported its promising use in clinical settings.

Tests for Chlamydia trachomatis and Neisseria gonorrhoeae, which can provide results rapidly to guide therapeutic decision-making, offer patient care advantages over laboratory-based tests that require several days to provide results. We compared results from the Cepheid GeneXpert CT/NG (Xpert) assay to results from two currently approved nucleic acid amplification assays in 1,722 female and 1,387 male volunteers. Results for chlamydia in females demonstrated sensitivities for endocervical, vaginal, and urine samples of 97.4%, 98.7%, and 97.6%, respectively, and for urine samples from males, a sensitivity of 97.5%, with all specificity estimates being ≥ 99.4%. Results for gonorrhea in females demonstrated sensitivities for endocervical, vaginal, and urine samples of 100.0%, 100.0%, and 95.6%, respectively, and for urine samples from males, a sensitivity of 98.0%, with all estimates of specificity being ≥ 99.8%. These results indicate that this short-turnaround-time test can be used to accurately test patients and to possibly do so at the site of care, thus potentially improving chlamydia and gonorrhea control efforts.

Background: The excellent sensitivity and specificity of commercially available nucleic acid amplification tests (NAATs) for the identification of Neisseria gonorrhoeae have been demonstrated. This study evaluated the performance of the BD ProbeTec™ N. gonorrhoeae Q (GCQ) Amplified DNA Assay on the BD Viper™ System with XTR™ Technology in a multicenter study., Methods: Specimens were collected at 7 geographically diverse clinical sites from 1846 women and men attending sexually transmitted disease, family planning, and obstetrics and gynecology clinics. There were 1768 evaluable participants, 994 women and 774 men. GCQ results from female endocervical, self-collected vaginal, male urethral swab specimens, and male and female neat (unpreserved) urine specimens, as well as those obtained using the urine preservative transport (UPT) tube for the GCQ assay were compared with patient infected status (PIS). For each participant, PIS was determined based on the combined results from the reference assays Aptima Combo 2® (AC2) and BD ProbeTec™ ET GC Amplified DNA Assay (PT)., Results: The sensitivity versus PIS for endocervical, vaginal, and female UPT urine, and female neat urine samples was 98.5%, 100.0%, 98.5%, and 96.9%, respectively; the specificity was 99.7%, 99.1%, 99.7%, and 99.5%, respectively. The sensitivity versus PIS for male urethral swabs and both male UPT and neat urine was 100.0%, with specificities of 99.1% for the urethral swab and UPT urine and 98.9% for the neat urine. The overall GCQ assay performance was not statistically different from that of AC2 or PT., Conclusions: The GCQ assay demonstrated performance characteristics comparable with other commercially available nucleic acid-based tests such as AC2 and PT. Vaginal swabs, endocervical swabs, urethral swabs, and urine specimens may all be used for gonorrhea screening.

Background: Internet-based screening for sexually transmitted infections (STIs) has been acceptable to women, and can reach high-risk populations. No prior published data describe internet-based screening for Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis in men. We studied whether internet-based screening was acceptable and reached a high-risk population, and what risk factors were associated with STI positivity., Methods: The website, www.iwantthekit.org, encouraged men ≥14 years of age to request a home self-sampling kit and a questionnaire on risk factors and acceptability of internet-based screening. Penile swabs and urine samples were tested for C. trachomatis, N. gonorrhoeae, and T. vaginalis using a nucleic acid amplification test. Risk factors and acceptability were examined using chi squared tests and logistic regression., Results: Of 501 samples received for testing, 106 (21%) were positive for at least one STI, 64 (13%) for chlamydia, 4 (1%) for gonorrhea, and 49 (10%) for trichomonas. In multivariable analyses, age, race, household income, and frequency of condom use were independently associated with infection with at least one STI. Of the total respondents, 34% had a prior STI; 29% reported having a partner with an STI, but only 13% reported always using a condom. Among the men who participated in this study, 77% preferred a self-administered specimen versus attending a clinic, 89% reported that swab use was easy, and 89% reported that they would use internet-based screening again., Conclusions: Men who accessed internet-based screening had known risk factors for STIs and had a high prevalence of infection. Internet-based screening was acceptable and could reach these high-risk men who might not otherwise be reached through traditional means.

We evaluated the Leukocyte Esterase Test (LET) as a screening tool by testing urine from 1,438 non-health care-seeking male Army basic trainees with LET and a Nucleic Acid Amplification Test. Compared to Nucleic Acid Amplification Test results, LET sensitivity and specificity for detection of chlamydia and gonorrhea were 45.8% and 97.4%, and 60.0% and 96.2%, respectively. The prevalence of chlamydia and gonorrhea was 3.3% and 0.3%, respectively. In this population, the prevalence of gonorrhea was too low to produce reliable estimates of performance characteristics of the LET for gonorrhea. The LET is not warranted for use in screening non-health care-seeking male Army trainees.

Objectives: Injection drug users (IDUs) consistently demonstrate high-risk behaviors for sexually transmitted infections (STIs). This study examines STI prevalence and correlates among young IDUs., Study: This cross-sectional study recruited IDUs aged 18 to 30 years. Participants completed a behavioral risk assessment and were tested for chlamydia, gonorrhea, and trichomoniasis by nucleic acid amplification methods. Women were also tested for bacterial vaginosis (BV). Gender-specific analyses were done comparing infected with noninfected participants using chi-square, Mann-Whitney tests, and logistic regression., Results: Of the 115 (35.3%) women and 211 (64.7%) men in the study, STI prevalence, respectively, was: chlamydia, 5.3% and 3.3%; gonorrhea, 3.5% and 0%; and trichomoniasis, 8.6% and 1.9%. Most (68.0%) participants had 2 or more sex partners in the past 3 months, of whom fewer than half consistently used condoms. Independent correlates for prevalent STIs included douching (adjusted odds ratio [AOR], 4.9; 95% confidence interval [CI], 1.5-23.6) for women and anal sex with female partners (AOR, 6.3; 95% CI, 1.5-25.8) for men. BV prevalence was 56.3% and was associated with douching (OR, 2.5; 95% CI, 1.1-5.7)., Conclusions: Despite high sexual risk, STI prevalence among young IDUs was similar to that of the general population. BV prevalence was high, suggesting that future STI assessments among female IDUs should include BV.

Nucleic acid amplification tests (NAATs), which are highly sensitive and specific, have provided the ability to use alternative sam-ple types for the diagnosis of sexually transmitted infections (STIs). Self-collected genital specimens, such as urine or even vaginal swabs, can now be accurately used to diagnose gonorrhea or chlamydia infections. In many cases, use of these sample types can decrease the necessity for a clinician to perform a pelvic examination on women or to collect a urethral swab from men, thus extending the diagnostic capability for detecting these infections to nonclinic screening venues. As most chlamydia infections and many gonorrhea infections are asymptomatic, the use of NAATs for self-collected samples greatly increases the types and numbers of patients that can be screened outside of clinic settings. Self-sampling also allows clinicians to easily screen patients in the clinic for STIs who are not presenting for pelvic or urogenital examinations. The application of NAATs to self-collected specimens has the potential to augment public health programs designed to control the epidemic of STIs in the community.

Objective: The objective of this study was to assess the feasibility of an intervention for sexually transmitted diseases (STDs) and a screening program for Chlamydia trachomatis and Neisseria gonorrhoeae infections in male Army recruits., Goals: The goals of this study were to identify and treat chlamydia and gonorrhea infections in recruits, assess their perceptions of risk, and increase their STD knowledge and behavioral intentions., Study Design: Volunteers (n = 3911) entering basic training (July 1999-June 2000) at Fort Jackson, South Carolina, attended an educational intervention, completed pre- and post-questionnaires, and provided a urine specimen for chlamydia and gonorrhea screening by nucleic acid amplification testing., Results: Chlamydia and gonorrhea prevalences were 4.7% and 0.4%, respectively. The mean STD knowledge score, intent to use condoms, and confidence in using condoms correctly increased (P <0.001). Participants reported increased risk perception and considered the educational program valuable (96.9%) and a learning experience (94.6%)., Conclusions: A linked educational and screening program is feasible and acceptable in male Army recruits.

Background: There is an increasing reliance on noninvasive techniques to collect specimens for the detection of sexually transmitted infections. The acceptability of these methods among the general population has been explored, but little is known about their acceptability among women confined in prison., Goal: The goal was to compare female prisoners' preferences for collection of specimens (self-collected vaginal swab specimens, urine collection, or pelvic examination) for detection of Chlamydia trachomatis and Neisseria gonorrhoeae., Study Design: A cross-section of inmates in a large federal prison provided urine samples and self-collected vaginal swab specimens. Women then completed a questionnaire regarding the ease of each method and their preferences for future specimen collection., Results: A total of 535 women between the ages of 18 and 52 years (median = 33) participated in the study. More than half of the participants (57%) reported no difference between urine and swab in terms of ease of collection. Approximately 30% of participants said they would prefer to give a swab specimen in the future rather than collect urine (21%), but nearly half of the women expressed no preference for one method over the other. Most participants (60%) expressed a preference for providing a self-collected swab specimen rather than having a pelvic examination (23%), but nearly 17% expressed a preference for one over the other., Conclusion: The study population of female federal prisoners expressed no aversion to the self-collection of either vaginal swab or urine specimens for STD testing. A majority of participants expressed a preference for noninvasive techniques rather than a pelvic examination.

Background: In conjunction with a program to expand syphilis and HIV infection services, women were also offered screening for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) during intake at the Baltimore Women's Detention Center., Goal: The goal was to assess the effectiveness of a routine screening program for CT and GC in women in a detention setting. The association among infection, race, and area of residence was also explored., Study Design: CT and GC prevalences were determined and analyzed by demographic data, including zipcode, for 1,858 women enrolled over a 48-week period. Informed consent was obtained, and infections were detected with use of urine samples tested by ligase chain reaction., Results: Overall, the population had prevalence rates of 5.9% (109/1,858) and 3.4% (63/1,858) for CT and GC respectively. Among whites, CT and GC prevalences were 9.0% (29/323) and 8.7% (28/323), respectively. Among African Americans the prevalence rates were 5.1% (77/1,510) and 2.3% (34/1,510) for CT and GC, respectively. White women <25 years of age were associated with the highest CT and GC prevalences, at 20.0% (13/65) and 13.9% (9/65), respectively. African American women <25 years of age also were associated with the highest CT and GC prevalences, at 13.9% (24/173) and 5.8% (10/173), respectively. Multivariate analysis of risk factors and demographic data indicated that ages <25 years and 25 to 34 years, white race, and certain zipcodes of residence were risk factors for infection., Conclusion: This study illustrated that urine-based screening for CT and GC is feasible in detention settings and can be productive in high-prevalence areas. Geographic analysis demonstrated no definitive relationship among race, infection, and area of residence, although it did demonstrate clustering of infected individuals and could be useful in future interventions. These findings demonstrated the need for implementing screening programs for sexually transmitted infections in detention centers.

Background: Women entering jails are at high risk for sexually transmitted diseases; however, screening for chlamydial and gonococcal infection is not routinely performed in most jails. New urine tests have made it easier to screen for these infections in nonclinical settings., Goal: The feasibility and acceptability of urine-based screening for women entering jails and the prevalence of and treatment rates for chlamydial and gonococcal infections were determined., Study Design: Women entering jails in Chicago, Illinois; Birmingham, Alabama; and Baltimore, Maryland, who signed consent forms were tested for chlamydial and gonococcal infection by means of the urine ligase chain reaction assay. Those testing positive were treated in jail; health department staff members attempted to contact those already released., Results: Most women who were approached agreed to be tested (range, 87-98%, depending on city), and most of these women provided a specimen (range, 92-100%). Among 5364 women aged 16 to 75 years who were tested, the prevalence of chlamydial and gonococcal infections was high, especially among those <25 years of age (range, 15.3-21.5% for chlamydial infection and 8.2-9.2% for gonorrhea, depending on city). The majority of women testing positive were treated in jail or outside of jail (61-85%)., Conclusions: Screening women in jails for chlamydial and gonococcal infection with urine tests is feasible, is acceptable to most women, and leads to detection and treatment of many infections. Routine screening should reduce medical complications in this population and should prevent transmission in the community, given that many women are soon released.

BackgroundTimely 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.MethodsWomen 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.FindingsBetween 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).InterpretationThis 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.FundingDivision of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases.

BackgroundBlack men who have sex with men (MSM) have a high prevalence of bacterial sexually transmitted infections (STIs), and individual risk behavior does not fully explain the higher prevalence when compared with other MSM. Using the social-ecological framework, we evaluated individual, social and sexual network, and structural factors and their association with prevalent STIs among Black MSM.MethodsThe HIV Prevention Trials Network 061 was a multi-site cohort study designed to determine the feasibility and acceptability of a multi-component intervention for Black MSM in six US cities. Baseline assessments included demographics, risk behavior, and social and sexual network questions collected information about the size, nature and connectedness of their sexual network. Logistic regression was used to estimate the odds of having any prevalent sexually transmitted infection (gonorrhea, chlamydia, or syphilis).ResultsA total of 1,553 Black MSM were enrolled in this study. In multivariate analysis, older age (aOR = 0.57; 95% CI 0.49-0.66, p