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

Background: Designathons can be used to enhance public health training and spur innovation. A designathon is a 3-stage participatory activity that includes preparation, intensive collaboration, and follow-up activities. We organized a designathon focused on developing actionable sexually transmitted disease (STD) control strategies and examined the content of ideas resulting from an STD designathon., Methods: For this designathon, we created four groups: early career researchers, silver group (people with >10 years of experience), travelers (people from low- and middle-income countries and those who received a conference scholarship) and a community group. Each group developed its own plan to consult members, iteratively develop ideas, and aggregate insights. Each group developed STD control strategies that were presented. Cross-cutting themes across these ideas were identified., Results: Designathon participants included a subset of conference participants. Cross-cutting themes from final ideas included cocreating STD interventions with end-users, using sex-positive framing, enhancing open access digital STD resources, and reducing STD stigma. Early career researchers presented a call for community ideas focusing on ending STD epidemics by increasing accessibility to STD care services among all populations. The silver group proposed digital innovations, including an AI-powered tool for testing and treatment and a social game to promote sex positivity. The traveler group conceptualized an information hub to support implementation of STD programs. Community members underscored the importance of a more human-centered approach to STD control, which reduces stigma and normalizes sex and sexual pleasure., Conclusion: Sex positive campaigns and open access digital resources should be considered within STD programs. Implementation research studies are needed to evaluate these ideas., Competing Interests: Conflicts of Interest and Source of Funding: J.D.T. received support from NIAID K24AI143471 and R.G. received money from NIMH K23MH126794. For the remaining authors none were declared., (Copyright © 2024 American Sexually Transmitted Diseases Association. All rights reserved.)

Background: Neisseria gonorrhoeae (NG) has acquired significant resistance, primarily due to extensive and unwarranted antibiotic utilization over several decades. This resistance has largely been associated with the syndromic management of sexually transmitted infections, particularly in low- and middle-income countries where affordable point of care tests are unavailable. To address this diagnostic gap, FIND has developed a low-cost lateral flow assay for the detection of NG at the point of care., Methods: The early performance of the lateral flow assay was evaluated using frozen clinical samples. Limit of detection, inclusivity, and exclusivity studies were performed using well-characterized NG strains, common commensal genital microorganisms, and other Neisseria bacteria. Subsequently, clinical performance was evaluated at 2 sexual health clinics in Birmingham, Alabama., Results: The observed limit of detection with reference NG strains was 5 × 103 CFU/mL. Inclusivity was demonstrated for 31 NG strains. Exclusivity testing showed no cross-reactivity with 28 non-Neisseria and nongonococcal Neisseria species; cross-reactivity was observed with Neisseria meningitidis, Neisseria lactamica, and Neisseria polysaccharea. The lateral flow assay demonstrated clinical sensitivity and specificity of 78.6% and 100% in female vaginal swabs and 100% and 89.7% in male urine, respectively., Conclusions: FIND has developed a lateral flow assay that aligns with the majority of the World Health Organization Target Product Profile criteria for confirming or excluding NG infection at the point of care. The NG lateral flow assay has now achieved design freeze (final device optimization) and is ready for technology transfer to a manufacturing partner. This test has the potential to support the shift in patient management from a syndromic to an etiological approach., Competing Interests: Conflict of Interest and Sources of Funding: B.V.D.P. reports receiving grants to her institution or consulting fees/honoraria from Abbott Molecular, Abbott Rapid Diagnostics, Becton Dickinson, BioFire, Cepheid, Cue, Detect, FIND, Hologic, Rheonix, and Roche., (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Sexually Transmitted Diseases Association.)

Abstract: The contribution of chlamydia to secondary infertility in women is poorly understood. Among 404 female participants enrolled in a previous study in Cameroon, 142 had secondary infertility (cases) and 262 were pregnant with no history of infertility (controls) , Chlamydia trachomatis seropositivity was 92%. Seropositivity did not significantly differ by case/control status., Competing Interests: Conflict of Interest and Sources of Funding: None declared., (Copyright © 2023 American Sexually Transmitted Diseases Association. All rights reserved.)

Background: Black cisgender women (CGW) are disproportionately impacted by the human immunodeficiency virus (HIV) epidemic in the United States. Black women account for 57% of the total new diagnoses among CGW. In addition, Black CGW women are 9 times more likely to be diagnosed with HIV than their White counterparts., Methods: We conducted surveys (September 2019-March 2020) and collected information on sociodemographics, HIV/preexposure prophylaxis (PrEP) knowledge, HIV/PrEP stigma, sexual practices, and other factors identified as PrEP barriers among Black CGW (n = 795). This cross-sectional study used logistic regression models to assess intrapersonal, interpersonal, and structural factors among individuals willing to use PrEP versus individuals unwilling or unsure to use PrEP., Results: Our study population had a mean age of 37 years, predominantly lived in urban areas (65%), had stable housing (96.7%), and had private insurance/Medicare (78.2%). Overall, 29.6% reported willingness to use PrEP, 35.6% reported unwillingness to use PrEP, and 34.8% were unsure of PrEP use. The multivariable analysis showed that, compared with individuals reporting unwillingness/unsure to PrEP use, those reporting willingness to PrEP use were younger (adjusted odds ratio [AOR; 95% confidence interval {CI}], 0.97 [0.96-0.99]), had lower odds of intimate partner violence (AOR [95% CI], 0.87 [0.78-0.98), and had higher odds of organizational religiosity (AOR [95% CI], 1.10 [1.01-1.20]), HIV knowledge (AOR [95% CI], 1.08 [1.03-1.13]), and perceived need for PrEP (AOR [95% CI], 6.38 [3.36-12.11])., Conclusions: Preexposure prophylaxis willingness among Black CGW was impacted by individual-level, interpersonal, and structural factors. Improving PrEP willingness and uptake among Black CGW will require multilevel interventions., Competing Interests: Conflict of Interest and Sources of Funding: L.E. serves as an investigator on a Merck pharmaceuticals research grant. The remaining authors have no conflict of interest to disclose., (Copyright © 2023 American Sexually Transmitted Diseases Association. All rights reserved.)

Abstract: In a prospective study conducted in 2020 to 2021, macrolide resistance-associated mutations were found in 41% of pregnant persons in Birmingham, AL, with Mycoplasma genitalium detected. We retrospectively evaluated M. genitalium in 203 pregnant persons participating in a study conducted in 1997 to 2001 in Birmingham and adjacent areas and found a prevalence of 11% (95% confidence interval, 6.9%-15.7%), but no macrolide resistance-associated mutations., Competing Interests: Conflict of Interest and Sources of Funding: W.M.G. reports having previously received honoraria as a speaker for Roche. B.V.D.P. reports receiving funding for research and honoraria for participation on advisory boards from Roche., (Copyright © 2023 American Sexually Transmitted Diseases Association. All rights reserved.)

Abstract: Most sexually transmitted infections (STIs) are acquired in resource-limited settings (RLSs) where laboratory diagnostic access is limited. Advancements in point-of-care testing (POC) technology have the potential to bring STI testing to many RLSs. We define POC as performed near the patient and with results readily available to inform clinical practice. The World Health Organization Special Programme for Research and Training in Tropical Diseases further outlines desirable POC characteristics with the REASSURED criteria.Despite advantages related to immediate test-and-treat care, integrating POC into RLS health care systems can present challenges that preclude reliance on these tests. In 2018, we incorporated molecular near-POC for chlamydia, gonorrhea, and trichomoniasis and SDBioline treponemal immunochromatographic testing confirmed by rapid plasma reagin for syphilis diagnosis at the Mbarara University of Science and Technology Research Laboratory in rural southwestern Uganda. We describe our experiences with STI POC as a case example to guide a narrative review of the field using the Consolidated Framework for Implementation Research as a conceptual framework.Although POC and near-POC are described as easy to use, the challenges of limited person-power, health care processes, limited infrastructure/resources, high costs, and quality control obstacles can impede the impact of these tests. Increased investment in operators, training, and infrastructure, restructuring health care systems to accommodate increased POC access, and optimizing costs are all crucial to the successful implementation of STI POC in RLS. Expanded STI POC in RLS will increase access to accurate diagnoses, appropriate treatment, and engagement in partner notification, treatment, and prevention efforts., Competing Interests: Conflict of Interest and Sources of Funding: The authors have no conflicts of interest to disclose. L.T.M. receives operational support from Gilead Sciences. P.C. and J.E.H. have received a GeneXpert cartridge donation from Cepheid. J.E.H. has been a consultant for Merck., (Copyright © 2023 American Sexually Transmitted Diseases Association. All rights reserved.)

Abstract: Disease intervention specialists are often at the forefront of adoption of new technologies in support of sexually transmitted infection (STI) contact tracing efforts. Newer technology for detection of treatable STI includes point-of-care molecular tests for detection of chlamydia, gonorrhea, and trichomonas and syphilis serology point-of-care tests. Other additions to our case finding toolbox are the use of telemedicine and the proliferation of direct-to-consumer offerings, both of which rely on remote sample collection involving self-collection of specimens in nonclinical settings. Finally, on the near horizon are over-the-counter tests that will support self-testing without the involvement of a medical professional. Each of these new developments is discussed and contextualized in experiences resulting from the COVID-19 pandemic response. Many options are now available, or will be soon, for detection of STIs in nontraditional settings, and we need to consider the processes involved as we move toward adoption of these new tools., Competing Interests: Conflict of Interest and Sources of Funding: None declared., (Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Sexually Transmitted Diseases Association.)

Background: Data are lacking on adherence to Centers for Disease Control and Prevention testing guidelines among insured US women presenting with vaginal health complaints; thus, we quantified vaginitis testing frequency and assessed the co-testing rate for causes of vaginitis and Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG)., Methods: This was a retrospective analysis of deidentified data from a medical database. Information from women aged 18 to 50 years was obtained from the Truven MarketScan Commercial Database (2012-2017) using Current Procedural Terminology ( CPT ) codes; χ2 testing was applied to determine co-testing differences for CT/NG based on vaginitis test type. Odds ratios were calculated to determine the association with CT/NG screening across vaginitis testing categories., Results: Approximately 48% of 1,359,289 women received a vaginitis diagnosis that involved a laboratory-based test. Of these women, only 34% were co-tested for CT/NG. CT/NG co-testing was highest for those with nucleic acid amplification testing for vaginitis and lowest for those with no vaginitis testing CPT code (71% vs. 23%, respectively; P < 0.0001)., Conclusions: The vaginitis nucleic acid amplification test, indicated by CPT code, was associated with statistically significantly higher CT/NG testing rates. Molecular diagnostics may support vaginitis testing in settings that have limited opportunities for microscopy and clinical examinations and offer greater opportunity to offer comprehensive women's health care that includes testing for chlamydia and/or gonorrhea infections., Competing Interests: Acknowledgments: Devin S. Gary, PhD, and Dorsey Mills (both employees of Becton, Dickinson and Company, BD Life Sciences–Integrated Diagnostic Solutions) provided input on the content of this article and editorial assistance. D.S.G. and D.M. have no other potential conflicts of interest. Conflict of Interest and Sources of Funding: M.J., M.W., C.G., N.S. (during the time of study conduct and manuscript preparation), and M.B. are employees of the study sponsor, Becton, Dickinson and Company, BD Life Sciences–Integrated Diagnostic Solutions. C.N.P. reports consulting for Becton, Dickinson and Company, and honorarium received from Roche. B.V.D.P. reports receiving grants to her institution, and honorarium and/or consulting fees from Abbott Molecular; Becton, Dickinson and Company; binx health; BioFire; Cepheid; Hologic; Rheonix; Roche, and SpeeDx., (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Sexually Transmitted Diseases Association.)

Background: The primary objectives of this study were to assess utilization of sexual health services at a university's student health and wellness center and to determine whether the presence of a dedicated sexual health clinic (SHC) was associated with different utilization patterns for sexual health services when compared with primary care clinics., Methods: This was a retrospective chart review of patients presenting to the University of Alabama at Birmingham's Student Health and Wellness Center for sexual health services between January 2015 and June 2019. Utilization of sexual health services, specifically sexually transmitted infection (STI) testing, was compared between the dedicated SHC and primary care clinics., Results: A total of 3081 cases were included. There were statistically significant differences in the proportion of male individuals and populations more burdened by STI tested for STI in the SHC (i.e., persons who identify as Black and younger female individual). We also observed a higher percentage of positive gonorrhea and chlamydia test results and a greater likelihood of extragenital screening in men who have sex with men in the SHC., Conclusions: The dedicated SHC within the University of Alabama at Birmingham's Student Health and Wellness Center was associated with an increase in STI screenings. There was a significant difference between the demographics of those presenting to the SHC versus primary care clinics, proportionally more diagnoses of gonorrhea and chlamydia, and, for men who have sex with men, more extragenital screenings performed in the SHC. These findings suggest that there may be a benefit of an embedded SHC in college and university health and wellness centers., Competing Interests: Conflict of Interest and Sources of Funding: All authors have no relevant conflicts of interest to disclose. Research reported in this publication was supported by the National Center for Advancing Translational Sciences of the National Institutes of Health under award number TL1TR003106 (to A.F.C.)., (Copyright © 2023 American Sexually Transmitted Diseases Association. All rights reserved.)

Background: The prevalence of sexually transmitted infections (STIs) is at an all-time high. Direct-to-consumer STI testing services may help alleviate this undue health burden. These products are sold online and rarely require interaction with a health care professional (HCP). Vendors offer STI self-collection kits or prescriptions for HCP specimen collection. The objective was to understand the scope of direct-to-consumer STI testing services offered and provide recommendations for consumers and industry., Methods: Seven volunteers searched for "STD tests" on Google from February 1 through March 31, 2021 and shared their top 3 results. The study team extracted data from consumer-facing information on each website. Descriptive statistics and thematic qualitative analyses were performed., Results: Twenty vendors were identified. Most vendors (95%) used Clinical Laboratory Improvement Amendments (CLIA)-certified or College of American Pathologists (CAP) accredited laboratories. Analyses distinguished between STI self-collection kits (n = 9) using independent laboratories and HCP specimen collection (n = 10), which used commercial laboratories (n = 1 offered both). The STI self-collection kits were cheaper per test and bundle on average (eg, $79.00 vs. $106.50 for chlamydia/gonorrhea), and more closely aligned with clinical recommendations compared with the HCP specimen collection options. Websites often contained inaccurate or misleading information (n = 13), often promoting testing outside of the recommendations., Conclusions: Direct-to-consumer STI testing services are part of an emerging market lacking regulation. Consumers should select vendors offering prescriptions for HCP specimen collection at CAP accredited and CLIA-certified laboratories. Vendors should provide a screening tool to assess individual patient risk prior to test purchase., Competing Interests: Conflicts of Interest: C.E. and E.M. have no conflicts of interest to disclose. C.N.P. reports receiving consulting or speaking honorarium from the following: BD and Roche. B.V.d.P. reports receiving grants to her institution, consulting or speaking honorarium from the following: Abbott, Applied BioCode, BD, BioFIre, Cepheid, Hologic, PrevenTx, and Roche., (Copyright © 2023 American Sexually Transmitted Diseases Association. All rights reserved.)

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

Background: Chlamydia vaccination is a potentially important strategy to prevent infections and reduce the global burden of disease. Ideally, chlamydia immunization programs would require vaccinating adolescents before they engage in sexual activity. Communication by health care providers (HCPs) has been shown to have an impact on vaccine acceptance. Therefore, it is imperative to understand their opinions on chlamydia vaccines and factors that would promote strong vaccine recommendations to patients to promote uptake., Methods: Semi-structured interviews with adolescent HCPs were conducted and focused on perceived need for chlamydia vaccine. Additional topics included vaccine characteristics, such as efficacy, cost, and booster vaccines, and potential vaccine recommendation strategies., Results: From January to July 2021, 22 interviews were completed. Health care providers discussed how chlamydia vaccines are needed, especially in settings with high prevalence rates. Health care providers thought a chlamydia vaccine would need to be very efficacious in preventing infections and related sequalae and cost-effective. However, there were concerns about low completion rates if this vaccine required multiple doses or boosters. In addition, vaccine misinformation was prevalent among HCPs regarding potential benefits of vaccination., Conclusions: Health care providers' perceptions that an adolescent chlamydia vaccine would be beneficial offers great promise for future promotion. However, there is need for targeted education programs about chlamydia and the benefits of vaccination for HCPs. These programs will be especially important in order for HCPs to effectively communicate about the benefits of vaccination to parents and adolescents provide strong vaccine recommendations., Competing Interests: Conflict of Interest: L.M.N. has served as a scientific advisor for Merck, Moderna, and Janssen. G.D.Z. has served as a consultant and advisory committee member for Merck regarding HPV vaccination and as an advisory committee member for Moderna regarding COVID-19 vaccination. He has also received investigator-initiated research funding from Merck, administered through Indiana University. E.T.O. served as a consultant for ViiV. All other authors have no conflicts to disclose., (Copyright © 2022 American Sexually Transmitted Diseases Association. All rights reserved.)

Background: Chlamydia vaccines are currently under development and have the potential to lower the incidence of infection and disease, which are highest among adolescents and young adults. Ideally, a chlamydia vaccine would be administered to adolescents before sexual debut, a time when parents are the primary vaccine decision makers. This study explores parent opinions about an adolescent chlamydia vaccine to understand barriers and facilitators to uptake., Methods: Semistructured interviews were conducted with parents of adolescents. Topics included conversations parents have with their children about chlamydia, opinions on chlamydia vaccine development, and vaccine characteristics, such as efficacy and cost. Interviews were analyzed using a thematic analysis approach., Results: From March to April 2021, 21 interviews were completed. Few parents discuss chlamydia with their children and sex education was seen as limited. Overall, 16 parents indicated that a chlamydia vaccine is needed. However, there were mixed opinions about vaccinating their own children, related to the need to vaccinate at a young age, vaccine efficacy, and confusion about benefits of vaccination. Finally, healthcare provider recommendations were seen as important before deciding to vaccinate a child., Conclusions: Although parents think that chlamydia vaccines are needed, lack of awareness about infections and potential benefits of vaccination could serve as barriers to uptake. Healthcare provider recommendations can help to improve knowledge and vaccine uptake. However, there is a need for multilevel approaches to improve chlamydia awareness and ensure that vaccination initiation and completion rates remain high., Competing Interests: Conflict of Interest and Sources of Funding: Dr Niccolai has served as a scientific advisor for Merck, Moderna, and Janssen. Dr Zimet has served as a consultant and advisory committee member for Merck regarding human papillomavirus vaccination and as an advisory committee member for Moderna regarding COVID-19 vaccination. He has also received investigator-initiated research funding from Merck, administered through Indiana University. Dr Overton served as a consultant for ViiV. All other authors have no conflicts to disclose., (Copyright © 2022 American Sexually Transmitted Diseases Association. All rights reserved.)

Abstract: Among 73 women presenting to a sexually transmitted infection (STI) clinic in Birmingham, Alabama for reported sexual contact to a chlamydia-infected partner, Chlamydia trachomatis was detected in genital specimens in 24 (32.8%), less often in women reporting prior chlamydial infection ( P = 0.001). Most women (93.2%) were C. trachomatis seropositive., Competing Interests: Conflict of Interest and Sources of Funding: B.V.D.P. reports receiving honorarium, consulting fees, or research support paid to her institution from Abbott Molecular, binx health, BD Diagnostics, BioFire, Cepheid, Hologic, Rheonix, Roche Molecular Systems, Inc and SpeeDx. W.M.G. reports receiving honoraria from Hologic, Inc. and Sanofi, and research support paid to his institution by Hologic, Inc. All other authors declare no conflict of interests., (Copyright © 2022 American Sexually Transmitted Diseases Association. All rights reserved.)

Abstract: The American Sexually Transmitted Diseases Association has, for several years, been conducting a cross-sector workshop to bring together a variety of stakeholders to develop ideas for collaboratively improving the sexually transmitted infection control efforts in the United States. In this summary, we share the content of discussions and ideas of the fourth annual workshop for future research and potential changes to practice with a focus on diagnostic capacity., Competing Interests: Conflict of Interest and Sources of Funding: Funding support for the workshop was received by ASTDA from Abbott Molecular, BD Diagnostics, BioFire Diagnostics, Hologic, Quest Diagnostics Nichols Institute, Roche Molecular, and SpeeDx. Authors from several of those entities contributed to the preparation of this manuscript. All other authors declare no conflict of interests., (Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Sexually Transmitted Diseases Association.)

Abstract: The impact of preexposure prophylaxis uptake on sexual and injection-related behaviors among women who inject drugs is poorly understood. Over 24 weeks, preexposure prophylaxis uptake among women who inject drugs was associated with increased sharing of injection equipment but not syringes and no changes in condomless sex, providing limited evidence of risk compensation in this vulnerable population., Competing Interests: Conflict of Interest and Sources of Funding: None declared., (Copyright © 2021 American Sexually Transmitted Diseases Association. All rights reserved.)

Abstract: Direct-to-consumer test services have gained popularity for sexually transmitted infections in recent years, with substantially increased use as a result of the SARS-CoV-2 (CoVID-19) global pandemic. This method of access has been variously known as "self-testing," "home testing," and "direct access testing." Although these online services may be offered through different mechanisms, here we focus on those that are consumer-driven and require self-collected samples, and sample shipment to a centralized laboratory without involvement of health care providers and/or local health departments. We provide the American Sexually Transmitted Diseases Association's position on utilization of these services and recommendations for both consumers and health care providers., Competing Interests: Conflict of Interest: C.E., B.M., and S.B.G. have nothing to disclose. C.N.P. reports receiving honorarium/consulting fees paid directly to her by Becton Dickinson. A.M.G. reports receiving funding to her institution from Abbott, BD, Cepheid, DiaSorin, IDEXX, Illumina, Hologic, Luminex, National Jewish Health, Roche, SpeeDx, ThermoFisher Scientific, and Qiagen. B.V.D.P. reports receiving funding to her institution from Abbott, Becton Dickinson, binx health, Cepheid, Hologic, Rheonix, Roche, and SpeeDx, and honorarium/consulting fees paid directly to her from Abbott, BD, and Roche., (Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Sexually Transmitted Diseases Association.)

Background: The reverse algorithm for syphilis diagnosis consists of a treponemal antibody screening immunoassay followed by confirmatory nontreponemal antibody testing. It is increasingly used in the United States despite studies suggesting limited cost-effectiveness in high-prevalence groups., Methods: In this retrospective cross-sectional study, we included men who have sex with men tested with the reverse algorithm in an Alabama HIV clinic between March 2015 and February 2017. Trep-Sure enzyme immunoassay (EIA) was used for the initial screen, followed by reflex nontreponemal reactive rapid plasma reagin (RPR) testing of specimens with positive results. Sociodemographic and clinical data were extracted from the electronic medical record and stratified according to EIA screen positivity. Quantitative EIA antibody index values were collected to assess test performance at various thresholds., Results: Among 1693 men tested for syphilis with the reverse algorithm in HIV clinic, 808 (48%) had a positive initial EIA screen. A majority (53%) of men with subsequent RPR testing had a nonreactive RPR (EIA+/RPR-), and 19% (19/98) of these EIA+/RPR- samples tested had a negative confirmatory Treponema pallidum particle agglutination testing result. Analysis of quantitative EIA index values using a receiver operating characteristics curve suggested that a threshold >8 (rather the current threshold of antibody index 1.2) improved the performance of the test., Conclusions: Among men who have sex with men tested in HIV clinic, the syphilis reverse algorithm was inefficient because of high rates of prior syphilis and false-positive EIA screening. Frequent syphilis screening in high-prevalence populations is an important part of the US epidemic response, and the traditional algorithm is preferred., Competing Interests: Conflict of Interest and Sources of Funding: None declared., (Copyright © 2021 American Sexually Transmitted Diseases Association. All rights reserved.)

Background: Chlamydia trachomatis (CT) infection remains highly prevalent, and young women are disproportionately affected. Most CT-infected women are asymptomatic, and their infection often goes unrecognized and untreated. We hypothesized that testing for active CT infection with molecular diagnostics and obtaining a reported history of CT infection underestimate the prevalence of current and past CT infection, and incorporating serum CT antibody testing in addition to these other prevalence measures would generate more accurate estimates of the prevalence of CT infection in asymptomatic young women., Methods: We enrolled 362 asymptomatic women aged 16 to 29 years at 4 different clinical settings in Birmingham, AL, between August 2016 and January 2020 and determined the prevalence of CT infection based on having 1 or more of the following prevalence measures: an active urogenital CT infection based on molecular testing, reported prior CT infection, and/or being CT seropositive. Multivariable regression analysis was used to determine predictors of the prevalence of CT infection after adjustment for participant characteristics., Results: The prevalence of CT infection was 67.7% (95% confidence interval, 62.6%-72.5%). Addition of CT antibody testing to the other individual prevalence measures more than doubled the CT infection prevalence. Non-Hispanic Black race, reported prior gonorrhea, and reported prior trichomoniasis predicted a higher prevalence of CT infection., Conclusions: More than half of women were unaware of ever having CT infection, suggesting many were at risk for CT-associated reproductive complications. These data reinforce the need to adhere to chlamydia screening guidelines and to increase screening coverage in those at risk., Competing Interests: Conflict of Interest and Sources of Funding: W.M.G. and B.V.D.P. report receiving research funding from Hologic, Inc, outside the range of the current work. The other authors report no potential conflicts of interest., (Copyright © 2021 American Sexually Transmitted Diseases Association. All rights reserved.)

Abstract: Chlamydia and gonorrhea are 2 of the most common bacterial sexually transmitted infections (STIs) worldwide. Rising chlamydia and gonorrhea rates along with increased closing of STI clinics has led many to seek STI testing in clinical settings such as urgent cares and walk-in clinics. However, with competing priorities, providing effective and efficient STI care can be difficult in these settings. This has left a growing need for the implementation of novel STI screening programs in other clinical settings. This review summarizes previous studies that have evaluated the clinical implementation of chlamydia and gonorrhea screening programs in these settings. Literature from January 2015 to February 2020 regarding the implementation or evaluation of STI screening programs in clinical settings was reviewed. Constructs from the Capability, Opportunity, Motivation, and Behavior model were used to organize results, as this model can aid in identifying specific strategies for behavior/process change interventions. We found that multiple STI screening programs have been implemented and evaluated in 5 different countries and multiple health care facilities including sexual health clinics, urgent cares, walk-in clinics, and university health clinics. When implementing new STI screening programs, sample-first, test-and-go services and molecular point-of-care (POC) testing approaches were found to be effective in increasing screening and reducing costs and time to treatment. At the health care systems level, these programs can help reduce STI screening costs and generate additional revenue for clinics. At the provider level, clear communication and guidance can help clinical and administrative staff in adopting new screening programs. Finally, at the patient level, new programs can reduce time to treatment and travel costs in visiting clinics multiple times for testing and treatment services., Competing Interests: Conflict of Interest and Sources of Funding: Dr Van Der Pol receives research support to her institution from the following: Abbott Molecular, BD Diagnostics, BioFire Diagnostics, Hologic, Rheonix, Roche Diagnostics, and SpeeDx. For remaining authors, no potential conflicts were declared. The authors received no financial support for the research, authorship, or publication of this article., (Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Sexually Transmitted Diseases Association.)

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.)

Abstract: We used the Food and Drug Administration-cleared Aptima Mycoplasma genitalium assay to evaluate for M. genitalium infection among young women without urogenital symptoms presenting to a community-based emergency department in Birmingham, Alabama, between August 2016 to August 2019 for evaluation of nongynecological concerns. M. genitalium was detected in 23 (14.8%) of 155 women., Competing Interests: Conflict of Interest and Sources of Funding: K.B.W. reports receiving research support paid to his institution from Roche Molecular Systems, Inc. B.V.D.P. reports receiving honorarium, consulting fees, or research support paid to her institution from Abbott Molecular, Atlas Genetics, BD Diagnostics, Click Diagnostics, Cepheid, Luminex, Rheonix, and Roche Molecular Systems, Inc. W.M.G. reports receiving honoraria or consulting fees from Hologic, Inc.; Roche Molecular Systems, Inc.; and Quest Diagnostics, and research support paid to his institution by Hologic, Inc., (Copyright © 2020 American Sexually Transmitted Diseases Association. All rights reserved.)

Background: Nucleic acid amplification testing (NAAT) is the preferred method to detect Chlamydia trachomatis and Neisseria gonorrhoeae, but information regarding performance of currently available assays is needed. This study evaluated the performance of the Aptima Combo 2, GeneXpert, cobas4800, and ProbeTec Q (CTQ/GCQ) to detect chlamydia and gonorrhea in pharyngeal, rectal, and urine specimen., Methods: Adult male patients seen at an urban human immunodeficiency virus clinic in Birmingham, Alabama who reported sex with men (men who have sex with men) and no antibiotic use in the past 30 days were enrolled between November 2014 and December 2016. Following a baseline survey, rectal and initial void urine specimens were self-collected. A composite infection standard was used, where 1 assay was compared with 3 others to determine sensitivity and specificity estimates for rectal and urine samples. Two pharyngeal samples were clinician-collected for chlamydia and gonorrhea testing and both had to be positive to be considered a true positive., Results: Among the 181 men enrolled into the study, 15.5% and 7.2% had at least 1 positive chlamydia and gonorrhea result at any site, respectively. Among all 4 assays, chlamydia sensitivity rates ranged from 82% to 96% among rectal samples. Rectal gonorrhea sensitivity estimates ranged from 67% to 99%. The GCQ assay was less sensitive in detecting rectal gonorrhea compared with the other assays (P = 0.02)., Conclusions: More than 80% of chlamydia and gonorrhea infections would have been missed with urine-only screening, highlighting the importance in using NAATs to detect chlamydia and gonorrhea infections among men who have sex with men.

We examined the acceptability and feasibility of using a 30-minute chlamydia/gonorrhea test in a student health clinical setting. One hundred eight students were enrolled and 89.4% were willing to wait up to 20 minutes beyond the conclusion of their routine visit. The average amount of time added per clinic visit was less than 11 minutes. Patient and staff satisfaction were high.

We evaluated the prevalence of Mycoplasma genitalium coinfection in 302 chlamydia-infected women seen at a sexually transmitted disease clinic in Birmingham, AL. M genitalium coinfection was detected in 22 (7.3%). No participant characteristics predicted coinfection. Among coinfected women, M genitalium was detected again in 6 (28.6%) of 21 women returning for a 3-month follow-up visit after azithromycin treatment.

Background: The optimal timing for nucleic acid amplification testing (NAAT) posttreatment for Trichomonas vaginalis has not been fully established. Testing too soon posttreatment may detect remnant nucleic acid that is not from viable organisms, falsely misclassifying person as infected. The purpose of this study was to examine how long T. vaginalis nucleic acid is detectable postmetronidazole (MTZ) treatment., Methods: Women diagnosed with T. vaginalis treated with MTZ (2 g single-dose or 500 mg twice daily for 7 days multidose) self-collected a vaginal swab for NAAT at baseline and each week postcompletion of treatment through test of cure (TOC) at week 4, when a culture was also performed. Women who reported interim sexual exposure or who were culture positive at 4 weeks were excluded. Time to first negative NAAT was examined using Kaplan Meier analysis., Results: All women receiving multidose metronidazole were NAAT-negative by 21 days and those receiving single dose by 28 days postcompletion of treatment. Though over half (60.7%) of the cohort reinitiated sex during follow-up¸ all reported using condoms during sex or that they and their partner were treated before sex. Six (6.7%) of 89 had a positive NAAT following their first negative NAAT., Conclusions: The optimal timing for T. vaginalis retesting after completion of treatment is 3 weeks for those receiving multidose MTZ and 4 weeks for those receiving single-dose, though sexual reexposure and false negatives should be considered.

Background: Symptom awareness, behavioral factors, and other barriers associated with timely sexually transmitted infection (STI) health care provision in men is not well studied., Methods: Men attending an STI clinic answered a questionnaire regarding their symptoms, sexual behavior, and sociodemographic and behavioral characteristics. Characteristics of symptomatic men were compared between those who did and did not delay seeking health care services. Delayed care seeking was defined as clinic attendance longer than 7 days after symptoms, whereas early care seeking was defined as clinic attendance of 7 days or less., Results: Over a quarter (n = 43 [27.7%]) of men with urethritis symptoms (urethral discharge or dysuria) delayed seeking care for more than 7 days. Compared with men who sought treatment within 7 days, those that delayed care worried for longer periods that their symptoms were STI-related, were more likely to attempt self-treatment of STI symptoms, were more likely to continue engaging in sexual activity, and were less likely to use a condom during their last sexual encounter. Conversely, men that delayed care seeking were less likely to have urethral discharge on physical examination, to have 5 or more polymorphonuclear leukocytes, and to test positive for Neisseria gonorrhoeae. When compared with men that sought care earlier, men that delayed care seeking had fewer overall and new partners in the past 30 days., Conclusions: Our data suggest that over a quarter of men aware of STI symptoms delay seeking health services. Interventions that promote better patient understanding of the importance of symptom recognition and that facilitate timely access to care may provide new opportunities to reduce STI transmission.

Background: Mycoplasma genitalium (MG) is a sexually transmitted pathogen associated with inflammatory syndromes in men and women. Macrolides and fluoroquinolones are recommended MG treatments. The frequency of MG strains with macrolide resistance-associated mutations (MRMs) and quinolone resistance-associated mutations (qRMs) is increasing worldwide, however these data are sparse in populations in the United States., Methods: We investigated the prevalence of MG infections with MRMs and qRMs and MG infection concordance within African American couples in Birmingham, AL. We used a real-time polymerase chain reaction to detect MG and identify MRMs. quinolone resistance-associated mutations were detected using traditional polymerase chain reactions amplifying regions in gyrA, gyrB, parC, and parE. The MG concordance in couples was evaluated by MG positivity and MG genotypes., Results: Oral, anal, urine, and/or vaginal specimens were tested from 116 couples. Twenty-eight (12.1%) participants comprising 22 couples tested MG-positive (11.2% in men and 12.9% in women). Macrolide resistance-associated mutations were detected in 17 (60.7%) MG-positive participants, with gender-specific resistance rates of 69.2% for men and 53.3% for women. quinolone resistance-associated mutations were detected in 3 (11.1%) MG-positive participants, all of whom also had MRMs. By MG positivity status, 27.3% of couples were concordant. If MG strain genotypes are also considered, then concordance was 20.0%., Conclusions: Among heterosexual African Americans with MG infection, about 60% had strains with MRMs and 11% had strains with both MRMs and qRMs, highlighting the potential for MG treatment failure to not only macrolides, but also quinolones. These findings may help to guide clinicians in MG testing and treatment decisions in the United States.

Background: Rates of sexually transmitted infections (STIs) and HIV are highest in the southern United States but vary widely by sex, age, and risk behavior. Current guidelines recommend annual screening for chlamydia, gonorrhea, syphilis, and trichomoniasis in all sexually active women with HIV., Methods: Screening rates and test positivity for chlamydia, gonorrhea, syphilis, and trichomoniasis were determined per calendar year in this retrospective cohort study of women in care at an urban HIV clinic in Birmingham, Alabama, from 2013 to 2015. Chlamydia, gonorrhea, and trichomonas infections were detected by molecular diagnostics and syphilis by serology. A combined end point for chlamydia/gonorrhea/syphilis (STI-3) was created based on similar test positivity and predictors. Predictors of STI-3 were identified using logistic regression and generalized estimating equations., Results: Among 745 women with HIV, median age was 46.8 years, 78.8% were black, and 61% were sexually active. In 2015, 83.7% of women were tested for STI. Test positivity was 1.0% for chlamydia, 0.5% for gonorrhea, 1.6% for syphilis, and 13.3% for trichomoniasis. Independent predictors of STI-3 were recent chlamydia or gonorrhea (odds ratio [OR], 3.7; 95% confidence interval [CI], 1-13.4; P = 0.047), public insurance compared with private (OR, 3.5; CI, 1-11.8; P = 0.048), and sex after drugs/alcohol (OR, 3.0; CI, 1.2-8.0; P = 0.025). Women 50 years or older were less likely to have STI (OR, 0.3; CI, 0.1-1; P = 0.040)., Conclusions: In a cohort of women engaged in HIV care in the southern United States, detection of chlamydia, gonorrhea, and syphilis was infrequent but trichomoniasis was common. Many women screened for STI were low risk and universal testing strategies warrant evaluation.

To evaluate self-reported symptoms to guide urethritis diagnosis, symptomatic men being evaluated for urethritis were asked about 7 symptoms captured during history taking. Discharge and dysuria were significantly associated with urethritis and, when combined with genital irritation and itching, identified 95% of urethritis cases; odor and urinary frequency performed poorly.

Background: In 2015, approximately 50,000 new HIV infections occurred in the United States, 2,400 of which were attributable to injection drug use. Preexposure prophylaxis (PrEP) has the potential to curb HIV acquisition; however, uptake remains low among persons who inject drugs (PWID). The purpose of the study is to describe PrEP eligibility, willingness to use PrEP, and ability to access PrEP among PWID recruited from a pilot program that paired screening and treatment of sexually transmitted infections with mobile syringe exchange program (SEP) services., Methods: Between 2015 and 2016, 138 PWID 18 years or older were recruited from a mobile SEP in Camden, New Jersey. Participants completed a survey assessing sociodemographics and HIV risk and underwent chlamydia and gonorrhea screening. Centers for Disease Control clinical guidelines were used to calculate PrEP eligibility. Differences by sex were examined using inferential statistics., Results: Most women (95.4%) and men (84.5%) were considered PrEP eligible (P < 0.04). More women than men were willing to take PrEP (88.9% vs. 71.0%; P < 0.02). Participants reported substantial barriers to PrEP including feeling embarrassed (45.0%) or anxious (51.6%) about taking PrEP, nondisclosure to partners (51.4%), limited engagement with health care providers where PrEP might be provided (43.8%), and lacking health insurance (32.9%)., Conclusions: Despite reporting behavior that warrants the use of PrEP to prevent HIV and finding the concept acceptable, PWID face multiple barriers to PrEP access. Without tailored interventions to promote PrEP, uptake will likely remain suboptimal. Packaging PrEP with SEP services could provide a viable option for reaching eligible and interested PWID.

The goal of the point-of-care (POC) sexually transmitted infection (STI) Diagnostics meeting was to review the state-of-the-art research and develop recommendations for the use of POC STI diagnostics. Experts from academia, government, nonprofit, and industry discussed POC diagnostics for STIs such as Chlamydia trachomatis, human papillomavirus, Neisseria gonorrhoeae, Trichomonas vaginalis, and Treponema pallidum. Key objectives included a review of current and emerging technologies, clinical and public health benefits, POC STI diagnostics in developing countries, regulatory considerations, and future areas of development. Key points of the meeting are as follows: (i) although some rapid point-of-care tests are affordable, sensitive, specific, easy to perform, and deliverable to those who need them for select sexually transmitted infections, implementation barriers exist at the device, patient, provider, and health system levels; (ii) further investment in research and development of point-of-care tests for sexually transmitted infections is needed, and new technologies can be used to improve diagnostic testing, test uptake, and treatment; (iii) efficient deployment of self-testing in supervised (ie, pharmacies, clinics, and so on) and/or unsupervised (ie, home, offices, and so on) settings could facilitate more screening and diagnosis that will reduce the burden of sexually transmitted infections; (iv) development of novel diagnostic technologies has outpaced the generation of guidance tools and documents issued by regulatory agencies; and (v) questions regarding quality management are emerging including the mechanism by which poor-performing diagnostics are removed from the market and quality assurance of self-testing is ensured.

Chlamydia trachomatis/Neisseria gonorrhoeae assay performance in males is typically determined using post-swab urine, though pre-swab urine is used in practice. We collected swabs and urine from men and used the Cepheid Xpert® CT/NG sample adequacy control to determine the effect of swab collection on urine cellular content. No difference was observed.

Background: Sexual transmission rates of Chlamydia trachomatis (Ct) cannot be measured directly; however, the study of concordance of Ct infection in sexual partnerships (dyads) can help to illuminate factors influencing Ct transmission., Methods: Heterosexual men and women with Ct infection and their sex partners were enrolled and partner-specific coital and behavioral data collected for the prior 30 days. Microbiological data included Ct culture, and nucleic acid amplification testing (NAAT), quantitative Ct polymerase chain reaction, and ompA genotyping. We measured Ct concordance in dyads and factors (correlates) associated with concordance., Results: One hundred twenty-one women and 125 men formed 128 dyads. Overall, 72.9% of male partners of NAAT-positive women and 68.6% of female partners of NAAT-positive men were Ct-infected. Concordance was more common in dyads with culture-positive members (78.6% of male partners, 77% of female partners). Partners of women and men who were NAAT-positive only had lower concordance (33.3%, 46.4%, respectively). Women in concordant dyads had significantly higher median endocervical quantitative Ct polymerase chain reaction values (3,032) compared with CT-infected women in discordant dyads (1013 inclusion forming units DNA equivalents per mL; P < 0.01). Among 54 Ct-concordant dyads with ompA genotype data for both members, 96.2% had identical genotypes., Conclusions: Higher organism load appears associated with concordance among women. Same-genotype chlamydial concordance was high in sexual partnerships. No behavioral factors were sufficiently discriminating to guide partner services activities. Findings may help model coitus-specific transmission probabilities.

About 17.5% of sexually active injection drug users recruited from a syringe exchange in Camden, NJ (n = 120) screened positive for chlamydia/gonorrhea. Among these cases, 40% were detected via extragenital screening. This pilot demonstrates that colocating sexually transmitted infection control with syringe exchange leads to sexually transmitted infection case finding.

Disclosure of sexually transmitted infections (STIs) to sexual partners is critical to the prevention, treatment, and control of STIs. We examine personal intra and interpersonal influences on willingness to disclose STI status among college-aged men. Participants (n = 1064) were aged 17 to 24 years and recruited from a variety of university and community venues. Using independent-samples t test, Pearson χ test, and binary logistic regression, we examined the relationship between willingness to disclose an STI and intrapersonal and interpersonal factors, including age, masculinity values, interpersonal violence, partner cell phone monitoring, alcohol and/or drug use, condom use, number and characteristics of sex partners, and previous STI. Results reveal that among college-aged men, type of sex partner and masculinity values are significant variables in predicting whether or not an individual is willing to disclose. These data can inform STI control programs to more effectively address the complex issues associated with STI disclosure to sex partners.

We evaluated the BD Viper LT System for detection of Chlamydia trachomatis and Neisseria gonorrhoeae using samples collected from symptomatic patients that included urine, vaginal swabs, and cervical samples in liquid-based cytology media. Results were compared with those obtained using the BD Viper XTR platform. The positive and negative percent agreements for all sample types were at least 95.8% and at least 96.4% for chlamydia and gonorrhea and at least 95.0% when both organisms were present, respectively. This medium throughput system performs well compared with a high-throughput platform and may offer smaller health care facilities the opportunity to test for these infections locally.

Background: Intimate partner violence (IPV) research has primarily focused on heterosexual couples but has largely ignored IPV among men who have sex with men (MSM). We examined IPV prevalence among MSM and men who have sex with men and women (MSMW) in China., Methods: Men who have sex with men older than 16 years were recruited through 3 MSM-focused Web sites in China. An online survey containing items on sociodemographics, risk behaviors, IPV, and self-reported HIV or sexually transmitted infection diagnosis was completed. Multivariate regression was used to examine associations between IPV and risk behaviors and an HIV or sexually transmitted infection diagnosis., Results: Among 610 participants, 182 (29.8%) reported experiencing at least 1 type of IPV. Men who have sex with both men and women were at significantly greater risk for IPV (adjusted odds ratio [AOR], 1.65; 95% confidence interval [CI], 1.08-2.53) compared with MSM. Men who had experienced IPV were more likely to have participated in group sex (AOR, 1.86; 95% CI, 1.08-3.21), to have had sex in exchange for gifts or money (AOR, 5.06; 95% CI, 2.47-10.35), and to report a positive HIV diagnosis (AOR, 2.59; 95% CI, 1.22-5.51)., Conclusions: There is a hidden epidemic of IPV among MSM in China, especially among MSMW. The hidden nature of MSM and MSMW suggests the need for a clinical environment more conducive to disclosure. Research is needed to understand the pathways linking IPV and HIV risk among MSM to optimize the design of effective interventions.

Background: To avoid positive results attributable to residual DNA, the Centers for Disease Control and Prevention recommends avoiding repeat testing with nucleic-acid based tests within 3 weeks after treatment of chlamydial (Chlamydia trachomatis [CT]) or gonococcal (Neisseria gonorrhoeae [GC]) infection. We retrospectively analyzed the duration of detectable DNA from a longitudinal cohort of adolescent women after diagnosis and treatment of infection with CT, GC, or Trichomonas vaginalis (TV)., Methods: Vaginal swabs were obtained weekly from young women for up to 12 weeks (observation period) after treatment of CT, GC and TV infections. Swabs were tested using a commercially available first generation nucleic acid amplification test (NAAT) for CT and GC, and a laboratory developed NAAT for TV. Kaplan-Meier statistics were used to estimate median time to the first negative DNA-based polymerase chain reaction (PCR) result., Results: Observation periods were available for analysis for 195, 82 and 102 treatments for CT, GC, and TV infection, respectively. Median time to a first negative PCR result for CT, GC, and TV was 9 (range 0-84), 6 (0-76), and 7 (0-84) days, and by day 21, 89%, 95%, and 85% were negative, respectively., Conclusions: Data from this retrospective analysis indicate that greater than 85% of these young women did not have detectable CT, GC, or TV DNA by day 21 post-treatment. This data may be useful to clinicians for patient management and post-treatment testing purposes.

Semistructured interviews were completed with a sample of 25 men residing in an urban area of the Midwestern United States to elicit preferred methods of sexually transmitted infection service delivery. Results highlight the influence of stigma, social support, and perceived risk on sexually transmitted infection screening uptake and preferred methods of screening.

A specific real-time polymerase chain reaction followed by melt curve analysis was developed for the detection of the Swedish variant (nvCT) strain of Chlamydia trachomatis (CT). Surveillance was performed on 476 CT-positive clinical specimens obtained from 15 laboratories around the United States using nucleic acid amplification test assays, which would not miss the nvCT. All were negative for nvCT; thus, there is no evidence of the nvCT in the United States.

Performance characteristics of the Cobas 4800 CT/NG assay were estimated for vaginal swab samples from more than 4000 women. Vaginal samples identified 92.9% and 98.5% of Chlamydia and Gonorrhea infections, respectively, which was more than any other single specimen type (endocervical swabs or urine) regardless of collection method (clinician collected or self-obtained).

Background: The Roche cobas® CT/NG test (c4800), performed on the cobas 4800 system, is a new diagnostic assay using an automated workstation to isolate nucleic acids from clinical specimens and a real-time instrument for the detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG). This study compared the performance characteristics of the c4800 with the Becton Dickinson ProbeTec™ CT/GC Q(x) assay (Q(x)) and Gen-Probe® Aptima Combo 2 (AC2) assay for the detection of CT and NG in male urine using patient-infected-status (PIS)., Methods: Urine and urethral swabs were obtained from men attending STD, family planning, or OB/GYN clinics from 11 geographically distinct locations. Aliquot order was randomized for urine specimens between AC2, c4800, and Q(x). Urethral swabs were randomized between AC2 and Q(x). Urethral swabs were only used to define PIS and were not tested on the c4800. A participant was considered infected if the 2 comparator assays with different molecular targets had positive results from either sample type., Results: A total of 790 men were screened, with 768 evaluable for CT and NG. Symptoms were reported in 296 (38.5%) participants. For urine, the overall sensitivity and specificity of the c4800 assay for CT were 97.6% and 99.5%, respectively, when compared with PIS. Sensitivity and specificity for NG were 100% and 99.7%, respectively., Conclusions: The c4800 has excellent sensitivity and specificity for male urine specimens when compared with PIS. Assay performance was similar in symptomatic and asymptomatic men and was equivalent to nucleic acid amplification tests that are currently on the market.

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: The natural history of Neisseria gonorrhoeae (GC) infections is largely unknown. The objective of the current study was to use sequential weekly vaginal samples and molecular techniques to describe the natural history of incident gonorrhea infections in adolescent women., Methods: A cohort of 387 adolescent women aged 14 to 17 were enrolled from urban, primary care clinics and followed longitudinally for a period of up to 8 years. Weekly vaginal swabs and daily diaries were provided during 12-week periods biannually, beginning and ending with a clinic visit, where all identified infections were treated. For this study, specimens and data from 16 women who became infected with GC during a weekly sampling period were analyzed., Results: GC organism load was highly variable between subjects. The number of organisms did not significantly differ across the first 6 weeks of infection (P = 0.59). Organism load did not differ among women with a previously documented GC infection at week 1 (P = 0.43) or across the first 6 weeks of infection (P = 0.67). The association of concurrent chlamydial infection on gonorrhea organism load was borderline significant over the first 6 weeks of infection (P = 0.06)., Conclusions: Individual shedding patterns varied widely, and GC organism load did not decline in women for at least several weeks and were not associated with genitourinary symptoms. Chlamydia coinfection is associated with higher GC organism loads, potentially increasing chances of transmission. This study utilized a standardized quantification technique to assess GC organism load.