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A serologic test for antibodies to chlamydia may be a useful tool for trachoma surveillance. However, little is known about the longitudinal stability of antibody status, especially following Mass Drug Administration (MDA), which is critical to understanding serostatus in trachoma-endemic areas. A longitudinal cohort of 1908 children ages 1–9 years in Tanzania from 50 communities were followed at baseline and for 6 months after MDA. They were evaluated for clinical trachoma, conjunctival swabs were tested for chlamydial infection using GeneXpert platform, and blood spots were collected on filter paper and dried to test for antibodies to Chlamydia trachomatis pgp3 using the Luminex platform. 6.3% of children in the study had infection, and coverage with MDA was 97%. 670 (35%) were sero-positive for pgp3 antibodies at baseline, and 4.0% of these seroreverted to negative following MDA. Of those seronegative at baseline, 3.6% seroconverted. The individual change in log median fluorescence intensity(MFI-BG) values was -0.15 overall (p

Willingness to self-collect vaginal swabs at a pharmacy clinic is of interest as a venue to increase sexually transmissible infections (STIs) screening for chlamydia, gonorrhoea and trichomonas. Women self-collected vaginal swabs at the pharmacy, completed questionnaires and received STI results within 2 h. Women with STIs were offered free treatment. A total of 313 of 777 (40.3%) women consented and prevalence for any STI was 3.9%. Questionnaires demonstrated acceptability for self-collection at the pharmacy, with 63% (95% CI 57.3–68) and 32.3% (95% CI 27.4–37.8) indicating they ‘strongly agreed’ or ‘agreed’ that they felt comfortable with pharmacy collection, respectively. Self-collected vaginal swabs for STI testing for women who were at a pharmacy were feasible and acceptable to women.

ObjectivesThough highly vulnerable to HIV and STIs, transgender female sex workers (TFSW) are understudied in the U.S. HIV and STI response. This study examined the correlates of laboratory-confirmed STIs among a cohort of 62 TFSW followed over the course of one year and explored associations between specimen site and self-reported engagement in insertive and receptive anal intercourse.MethodsParticipants completed an interviewer-administered computer assisted personal interview at baseline, 3-, 6-, 9-, and 12-month visits where self-administered anal swabs and urine samples for gonorrhea, chlamydia, and trichomonas were also collected. HIV testing was conducted at baseline, 6-, and 12-month visits.ResultsBaseline HIV prevalence was 40.3% with no HIV seroconversions over follow-up. Baseline prevalence of gonorrhea, chlamydia, and trichomonas was 9.7%, 17.7%, and 14.5%, respectively. In the multivariable regression modeling, recent arrest was significantly associated with testing positive for any STI (aRR 1.77; 95% CI: 1.10-2.84). Insertive anal sex with clients was associated with increased risk of testing positive for an STI via urine specimen (RR 3.48; 95% CI: 1.14-10.62), while receptive anal sex was not significantly associated with specimen site.ConclusionOur findings confirm a high prevalence of STIs among TFSW and highlight the importance of addressing structural drivers such as criminal justice involvement as well as the need to ensure screening for STIs at all anatomical sites regardless of self-reported sites of potential exposure. More research is needed to better understand HIV and STI vulnerabilities and appropriate interventions for TFSW in the U.S.KEY MESSAGESTransgender female sex workers in the U.S. face substantial vulnerability to HIV and STIs, and interventions to reduce their risk for HIV and STI acquisition are needed.Engagement with criminal justice significantly increases the risk for STIs among transgender women engaged in street-based sex work, suggesting the need to address factors that lead to disproportionate arrest and incarceration of transgender women.Screening for STIs among transgender women should include all potential sites of exposure, regardless of reported sexual positioning.

BACKGROUND Syphilis is a cause of morbidity and mortality and is of particular concern in pregnancy in low-income countries because of the risks associated with maternal-fetal transmission. Ugandan national guidelines recommend a nontreponemal rapid plasma reagin (RPR) followed by treponemal testing for diagnosis of syphilis. The RPR test confirms a reactive specific treponemal test, or confirms serological "cure" with a 4-fold dilutional decrease; RPR is beset with technical and biological limitations, making accurate diagnosis and appropriate treatment problematic. The aim of this analysis was to compare performance of RPR testing in different laboratories. METHODS Stored, freeze-thawed sera from 215 participants were additionally tested for RPR and dilutional titer in 2 different reference laboratories. Discrepant results were tested at a third reference laboratory which served as a tie-breaker. Equivalence in RPR titer was defined as within 2-fold or less. All patients with reactive rapid tests were treated as per Ugandan National Guidelines. RESULTS Of 215 sera, 97 (45.1%) were RPR reactive in clinic laboratory A, 81 (37.7%) and 65 (30.2%) were RPR reactive in laboratories B and C, respectively. All reported positive in laboratory C were positive in laboratory B. Discrepant results were tested in laboratory D. χ Test was highly significant (P =

PURPOSE: This study compared performance of Atlas io(®) diagnostic platform, a point-of-care (POC) PCR assay for Chlamydia trachomatis (CT), to Aptima Combo 2™, a standard of care laboratory-based nucleic acid amplification assay (NAAT), and evaluated patient attitudes toward POC testing. METHODS: Women ≥14 years undergoing CT screening/testing were recruited from an urban adolescent primary care practice (Teen Health Center, THC) and a sexually transmitted disease (STD) clinic. Participants provided self-obtained vaginal swabs for testing with the Atlas io(®) platform and Aptima Combo 2™ testing and completed a questionnaire assessing attitudes toward POC testing. RESULTS: Of 296 women recruited, 284 (192 from the STD clinic, 92 from THC) had Aptima Combo 2™ and Atlas io(®) results available; 273 completed the questionnaire. Average age was 27.4 years (SD 10.8). Sensitivity and specificity of the Atlas io(®) test were 83.9% (26/31 specimens; 95% CI, 70.9–96.8%) and 98.8% (250/253 specimens; 95% CI, 97.5–100%), respectively. When specimens with discrepant results were included in analyses, adjudicated sensitivity and specificity were 92.9% (26/28 specimens; 95% CI, 83.3 to 100%) and 98.8% (253/256 specimens; 95% CI, 97.5 to 100%), respectively. A majority (70%) of women preferred to collect vaginal self-swab if a POC test were available. Most (61%) were willing to wait up to 20 minutes and 26% were willing to wait up to 40 minutes for results, if they could be treated before leaving clinic. CONCLUSION: A POC PCR test detecting CT had high sensitivity and specificity when testing prospective, vaginal swab samples. Availability of CT results during patients’ visits may decrease time to treatment.

Background:Chronic asymptomatic chlamydial genital infection caused by the wild-type ofChlamydia trachomatis(wtCT) is the most common bacterial infection causing human infertility. The novel ‘Swedish’ variant ofС.trachomatis(nvCT) which contains a 377 bp deletion in a region that is specifically targeted in some nucleic acid amplification tests may impede diagnosis.Objective:The study aimed to investigate whether nvCT may be a possible cause of infertility in a couple undergoingin vitrofertilization (IVF).Method:Clinical specimens from both genital (urethra and cervix) and extra-genital sites (pharynx, conjunctive, blood) of a couple who experienced multiple unsuccessful attempts at pregnancy by natural fertilization and IVF procedures were analyzed before and after antibiotic therapy. Both partners had neither somatic nor endocrinal abnormality nor any clinically apparent genital manifestations ofChlamydiaor other STIs.Results:Before antibiotic therapy all the samples of the Female Partner (FP) contained DNA of only the nvCT. After antibiotic therapy, additionally, DNA of wtCT of genovars E and D was detected in specimens from her conjunctiva and oropharynx. All samples of the Male Partner (MP) revealed co-infection of nvCT and wtCT. Identical SNP within the variable region 4 (VD4) of theompAgene confirmed the identity of the wtCT strains found in both partners. The FP had a positive anti-chlamydial IgG titer. The sperm characteristics of the MP, motility (immotile spermatozoa was 51.1% versus 21.6%) and vitality (46% versus 68%) declined progressively, and the MP anti-chlamydial IgG titer was negative.Conclusion:Infertility in this couple may have been caused by chronic asymptomatic and persistent nvCT-associated infection that was complicated by re-infection later with wtCT. This study illustrates the importance of including detection methods for nvCT strains in the investigation of infertility cases.

Antibody-based epidemiologic surveillance to determine population-level exposure to sexually transmitted infections could help inform public health fertility preservation strategies. We compared the performance of three platforms to detect antibodies against the Chlamydia trachomatis (CT) antigen Pgp3 – multiplex bead array (MBA), enzyme-linked immunosorbent assay (ELISA), and lateral flow assay (LFA) – on sera from adolescents and young adults (AYAs) with pelvic inflammatory disease (PID). Ninety-five of 118 AYAs diagnosed with PID (80.5%) had positive antibody response to Pgp3 antigen by at least one test, and 78 (66.1%) tested positive by all three tests. Among 27 individuals with infection detected using nucleic acid amplification testing, 92.6% were positive by MBA (25/27), 77.8% (21/27) were positive by ELISA, and 74.1% (20/27) were positive by LFA. These data suggest that the MBA was the most sensitive of the three tests and could be useful in seroepidemiologic studies designed to assess population-level exposure to CT.

Human immunodeficiency virus (HIV) self-testing presents an empowering alternative to facility-based testing for reaching undiagnosed HIV infected individuals, but is not currently available in Canada. We surveyed stakeholders (clinical providers, public health professionals, researchers) engaged in HIV testing initiatives nationwide to identify the concerns, opportunities and challenges to implementing HIV self-testing in Canada. An online cross-sectional survey was disseminated by the Canadian Institutes of Health Research Centre for REACH 2.0 National HIV & sexually transmitted and blood borne infections working group to stakeholders nationwide, with a target sample size of 200. Quantitative and qualitative data were analyzed using a mixed-methods, respondent-informed approach, to inform subsequent HIV self-testing in a country where self-testing is not yet accessible. A total of 183 responses were received. A majority (70.7%) (128/181) felt that self-testing was a necessary investment to reach the undiagnosed. 64.6% (117/181) felt that self-tests should be made available to their clients and 71.5% (128/179) of respondents agreed that self-test instructions required improvements. However, 50% (90/180) felt that self-testing will pose an economic challenge to current HIV testing models. Regardless, 21% urged for timely action and availability of HIV self-tests. Thematic analyses reflected the following concerns: (a) need for affordable self-tests, (b) need for expedited, customized, and accessible linkages to counselling, (c) concern for patients to cope with positive self-test results, (d) accuracy of self-tests to detect acute HIV and (e) liability in the context of non-disclosure. Stakeholders agreed to the provision of an option of HIV self-testing to reach the undiagnosed individuals. Concerns regarding costs and accuracy of self-tests, expedited linkages to counselling, and integration of self-test within prevailing HIV testing models, will need to be addressed before their widespread implementation.

ObjectivesRecent outbreaks of anorectal lymphogranuloma venereum (LGV) among men who have sex with men (MSM) have been characterised by proctocolitis requiring extended antibiotic treatment compared with infections caused by other serovars of Chlamydia trachomatis (CT). We describe the prevalence and clinical features of LGV among Nigerian MSM diagnosed with anorectal CT.MethodsMSM were recruited for this observational cohort in Lagos, Nigeria, using respondent-driven sampling and screened for HIV and bacterial STIs every three months for up to 18 months. Nucleic acid amplification tests for CT were performed on rectal swab specimens. Prevalent and incident cases of anorectal CT underwent additional testing to identify LGV using novel real-time PCR assays specific for the L-serovars of CT.ResultsFrom April 2014 to July 2016, 420 MSM underwent testing for rectal STIs, of whom 66 (15.7%) had prevalent anorectal CT. Among those without prevalent disease, 68 developed incident infections during 208 person-years of follow-up. Of 134 prevalent and incident cases of anorectal CT, 7 (5.2%) were identified as LGV. None of the seven participants with LGV reported any symptoms. Two of the participants with LGV were simultaneously coinfected with rectal gonorrhoea. HIV coinfection was common among participants with both LGV (n=5, 71%) and non-LGV (n=98, 77%) serovars of CT (P=0.66).ConclusionsAnorectal LGV was uncommon but present among Nigerian MSM in this study. Consistent screening for L-serovars of CT, or presumptive treatment for LGV in cases with a high suspicion for this diagnosis, could potentially improve patient outcomes and decrease transmission.

We measured the microbial community structure of genital ulcers in women. Swabs from clinically detected ulcers were tested for HSV-2 and Treponema pallidum by polymerase chain reaction (PCR). HSV-2 and T. pallidum were detected by serum antibody testing. Microbial community structure was characterized by high-throughput 16 s rRNA gene amplicon sequencing. Multiple group testing and Elastic net and Lasso regressions identified taxa associated with differences in factors of interest. Among 49 ulcer specimens from 49 HSV-2 seropositive women, by PCR HSV-2 was recovered from 28 (57%) specimens and T. pallidum from none; one woman showed serologic evidence of syphilis. Overall, 63% of women were HIV-positive and 49% had an uncircumcised male sex partner. By both multiple group testing and regression, Porphyromonas (FDR p-value = 0.02), Prevotella (FDR p-value = 0.03), Anaerococcus (FDR p-value = 0.07), and Dialister (FDR p-value = 0.09) were detected at higher relative abundance in HSV-2 PCR-positive than negative ulcers. The presence of HSV-2 in a lesion was associated with presumed bacterial agents of Bacterial vaginosis. Differences in bacterial communities may contribute to HSV-2 ulcer pathogenesis, severity, or prolonged healing. If these results are confirmed, future studies may consider the influence of BV treatment on women’s GUD and HSV-2 incidence and recurrence.

Screening for sexually transmitted infections (STIs) outside of traditional health-care facilities is limited by the privacy needed for sample collection. We explored the acceptability of privacy shelters for the self-collection of genital swabs and tested the use of privacy shelters during mobile STI screening. Attendees ≥14 years old at two outdoor community events completed a questionnaire that assessed participant characteristics, health-care access, and rating of acceptability of self-collecting penile or vaginal swabs in a privacy shelter and four other private spaces: portable restroom, health van, home, and doctor’s office. A privacy shelter was used during mobile STI screening. The majority (65%) of the 95 participants reported that using a privacy shelter was somewhat or very acceptable. No participant characteristics or health-care access factors were associated with the acceptability of privacy shelters. Women rated a privacy shelter more acceptable than a portable restroom or health van. Men rated a privacy shelter more acceptable than a portable restroom. During mobile STI screening, all 13 men and women who requested STI testing used the privacy shelter for self-sampling. Rating of acceptability before and after privacy shelter use was the same. Privacy shelters may enable STI screening without using a building or vehicle for sample collection.

Background Mycoplasma genitalium is very difficult to grow in culture but has been more able to be studied for disease associations since the advent of research molecular amplification assays. Polymerase chain reaction (PCR) and other molecular assays have demonstrated an association with adverse disease outcomes, such as urethritis or nongonococcal urethritis in men and adverse reproductive sequelae in women-for example, cervicitis, endometritis, and pelvic inflammatory disease (PID), including an association with risk for human immunodeficiency virus. The lack of commercially available diagnostic assays has limited widespread routine testing. Increasing reports of high rates of resistance to azithromycin detected in research studies have heightened the need available commercial diagnostic assays as well as standardized methods for detecting resistance markers. This review covers available molecular methods for the diagnosis of M. genitalium and assays to predict the antibiotic susceptibility to azithromycin. Methods A PubMed (US National Library of Medicine and National Institutes of Health) search was conducted for literature published between 2000 and 2016, using the search terms Mycoplasma genitalium, M. genitalium, diagnosis, and detection. Results Early PCR diagnostic tests focused on the MPa adhesion gene and the 16S ribosomal RNA gene. Subsequently, a transcription-mediated amplification assay targeting ribosomes was developed and widely used to study the epidemiology of M. genitalium. Newer methods have proliferated and include quantitative PCR for organism load, AmpliSens PCR, PCR for the pdhD gene, a PCR-based microarray for multiple sexually transmitted infections, and multiplex PCRs. None yet are cleared by the Food and Drug Administration in the United States, although several assays are CE marked in Europe. As well, many research assays, including PCR, gene sequencing, and melt curve analysis, have been developed to detect the 23S ribosomal RNA gene mutations that confer resistance to azithromycin. One recently developed assay can test for both M. genitalium and azithromycin resistance mutations at the same time. Conclusions It is recommended that more commercial assays to both diagnose this organism and guide treatment choices should be developed and made available through regulatory approval. Research is needed to establish the cost-effectiveness of routine M. genitalium testing in symptomatic patients and screening in all individuals at high risk of acquiring and transmitting sexually transmitted infections.

Many health agencies now recommend routine HIV and syphilis testing for pregnant women and most-at-risk populations such as men who have sex with men. With the increased availability of highly sensitive, low cost rapid point-of-care tests, the ability to meet those recommendations has increased, granting wider access to quick and accurate diagnoses. Using blood specimens collected from a Baltimore City Health Department (BCHD) sexually transmitted infection clinic, we evaluated the SD Bioline HIV/Syphilis Duo, a rapid test that simultaneously detects antibodies to HIV and syphilis and has the potential to further benefit clinics and patients by reducing costs, testing complexity, and patient wait times. SD DUO HIV sensitivity and specificity, when compared to BCHD results, were 91.7 and 99.5%, respectively. SD DUO syphilis sensitivity and specificity, when compared to rapid plasma reagin, were 85.7 and 96.8%, respectively, and 69.7 and 99.7%, respectively, when compared to Treponema pallidum particle agglutination (TPPA). SD DUO syphilis sensitivity and specificity, when compared to a traditional screening algorithm, improved to 92.3 and 100%, respectively, and improved to 72.9 and 99.7%, respectively, when compared to a reverse screening algorithm. The HIV component of the SD DUO performed moderately well. However, results for the SD DUO syphilis component, when compared to TPPA, support the need for further testing and assessment.

BACKGROUND Urban adolescent and young adult women often require adult support throughout their transition to adulthood particularly regarding seeking healthcare. While confidentiality is crucial feature of care delivery, successful adherence to treatment can be multi-factorial. The purpose of this study is to determine factors associated with parental notification and engagement in self-care of young women diagnosed with Pelvic Inflammatory Disease (PID). METHODS This study utilizes data from 187 participants in the Technology Enhanced Community Health Nursing (TECH-N) study, a randomized controlled trial of an intervention to prevent recurrent STIs after a diagnosis of mild-moderate PID. Participants were recruited from pediatric ambulatory settings provided baseline demographic, reproductive history, and perceived social support using an audio computerized self-interview at baseline and parental notification collected during a two-week follow-up interview, served as the primary outcome. RESULTS Sixty-five percent of participants informed a parent of their PID diagnosis, 74% of whom reported receiving supportive care. Participants who reported a higher sense of responsibility to others were 17% less likely to inform a parent of their diagnosis. CONCLUSION Most urban young women with PID notify parents of their diagnosis and obtain support for self-management in the outpatient setting. While autonomy is a critical milestone for transition to young adulthood, these data suggest that proactive youth-managed parental engagement may be an underutilized resource for young women diagnosed with PID.

Self-collected specimens for infectious disease testing are becoming more commonplace. There are multiple published studies demonstrating that self-collected vaginal swabs for detection of sexually transmitted pathogens are as accurate as physician-collected endocervical swabs. Similarly, self-collected penile-meatal swabs are also acceptable for detecting sexually transmitted pathogens; however, unlike self-collected vaginal swabs, penile-meatal swabs are not considered an "on-label" specimen for U.S. FDA-cleared in vitro diagnostic products. Data on the accuracy of self-collected nasal specimens for respiratory tract infections are encouraging, but studies also show that patients do not always follow instructions when mailing samples back to the laboratory. Unfortunately, there are only a few reports of self-collected specimens for detecting enteric pathogens, such as Salmonella, Shigella, or Campylobacter . Microbiologists need to be proactive in making sure that training materials developed for self-collection (such as laminated cards, videos, and other resources) are accurate and easy to understand (which includes being available in multiple languages) and provide clear instructions on how to handle a specimen once it has been collected.

Although implementation of HIV testing in the emergency department has met with some success, one commonly cited challenge is the consent process. Kiosks offer one potential strategy to overcome this barrier. This pilot cross-sectional survey study examined patient comprehension of opt-in HIV testing consent and acceptability of using a kiosk to provide consent. Subjects were guided through a simulated consent process using a kiosk and then completed a survey of consent comprehension and acceptability of kiosk use. Subjects were 50.3% female, Black (74.4%), and had an education level of high school or less (61.3%). Subjects found the kiosk very easy or easy to use (83.9%) and reported they were very or mostly comfortable using the kiosk to consent to HIV testing (89.4%). Subjects understood the required aspects of consent: HIV testing was voluntary (93.0%, n = 185) and that refusal would not impact their care (98.5%, n = 196; 99.0%, n = 197). Following a simulated consent process, subjects demonstrated a high rate of comprehension about the vital components of HIV testing consent. Subjects reported they were comfortable using the kiosk, found the kiosk easy to use, and reported a positive experience using the kiosk to provide consent for HIV testing.

The 2014-15 influenza season saw the emergence of an antigenic drift variant of H3N2 which formed the 3C.2a HA clade. Nasopharyngeal swabs from patients with confirmed influenza A virus infection were used for whole viral genome sequencing to make HA clade calls and identify mutations in the NA (a new glycosylation site, NAg+) and PB1-F2 (H75P mutation). The mutations in NA and PB1-F2 that were present in a subset of clade 3C.2a viruses (NAg+F2P) which came to dominate in the subsequent influenza season. The NAg+F2P genotype viruses were associated with increased wheezing and shortness of breath in infected patients. The use of primary human nasal epithelial cell cultures allowed for more efficient isolation of H3N2 viruses and identified replication differences between H3N2 genotypes. The use of sequencing of clinical samples combined with in vitro analysis of virus replication provided a unique system for identifying and characterizing novel variants of influenza A virus. Conclusions In 2014-15, H3N2 antigenic drift variants of HA clade 3C.2a were the dominant influenza virus strain identified in the Johns Hopkins Center of Excellence in Influenza Research and Surveillance (JH CEIRS) network. H3N2 antigenic drift variants (HA clades) and additional mutations in other gene segments were determined by direct sequencing of human nasal swabs or washes. Virus isolation on hNECs was more efficient than isolation on MDCK cells. An NA mutation introducing a putative glycosylation site co-segregated with a PB1-F2 mutation (H75P). Viruses with the NAgly+ H75P genotype were associated with increased reporting of some clinical symptoms.

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.

Infectious vaginitis due to bacterial vaginosis (BV), vulvovaginal candidiasis (VVC), and Trichomonas vaginalis accounts for a significant proportion of all gynecologic visits in the United States. A prospective multicenter clinical study was conducted to validate the performance of two new in vitro diagnostic transcription-mediated amplification nucleic acid amplification tests (NAATs) for diagnosis of BV, VVC, and trichomoniasis., Infectious vaginitis due to bacterial vaginosis (BV), vulvovaginal candidiasis (VVC), and Trichomonas vaginalis accounts for a significant proportion of all gynecologic visits in the United States. A prospective multicenter clinical study was conducted to validate the performance of two new in vitro diagnostic transcription-mediated amplification nucleic acid amplification tests (NAATs) for diagnosis of BV, VVC, and trichomoniasis. Patient- and clinician-collected vaginal-swab samples obtained from women with symptoms of vaginitis were tested with the Aptima BV and Aptima Candida/Trichomonas vaginitis (CV/TV) assays. The results were compared to Nugent (plus Amsel for intermediate Nugent) scores for BV, Candida cultures and DNA sequencing for VVC, and a composite of NAAT and culture for T. vaginalis. The prevalences of infection were similar for clinician- and patient-collected samples: 49% for BV, 29% for VVC due to the Candida species group, 4% for VVC due to Candida glabrata, and 10% for T. vaginalis. Sensitivity and specificity estimates for the investigational tests in clinician-collected samples were 95.0% and 89.6%, respectively, for BV; 91.7% and 94.9% for the Candida species group; 84.7% and 99.1% for C. glabrata; and 96.5% and 95.1% for T. vaginalis. Sensitivities and specificities were similar in patient-collected samples. In a secondary analysis, clinicians’ diagnoses, in-clinic assessments, and investigational-assay results were compared to gold standard reference methods. Overall, the investigational assays had higher sensitivity and specificity than clinicians’ diagnoses and in-clinic assessments, indicating that the investigational assays were more predictive of infection than traditional diagnostic methods. These results provide clinical-efficacy evidence for two in vitro diagnostic NAATs that can detect the main causes of vaginitis.

BackgroundMen who have sex with men (MSM) and transgender women (TGW) are at risk for sexually transmitted infections (STIs), including those of the oropharynx. We estimated the prevalence and factors associated with oral sex practices and characterized oropharyngeal STIs among a cohort of MSM and TGW in Nigeria.MethodsFrom 2013 to 2018, TRUST/RV368 recruited MSM and TGW into HIV/STI diagnosis and treatment at community-based clinics in Nigeria. Participants who completed HIV testing and oral sex questions at enrollment were selected. Cross-sectional analyses with bivariate and multivariable logistic regression models estimated odds ratios (ORs) and 95% confidence intervals (CIs). Oropharyngeal swab testing for Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT) began in 2014 and for those with diagnostic results at enrollment, the unadjusted association of oral sex practices with oropharyngeal STIs was conducted.ResultsA total of 1342 participants had a median age of 25 years (interquartile range: 22-29), 58% were living with HIV, and 69% reported oral sex practices. Factors associated with increased odds of engaging in oral sex included living with HIV (adjusted [a]OR: 1.4, 95% CI: 1.1-1.8), self-identifying as a woman (aOR:1.8, 95% CI: 1.1-2.8), mobile phone ownership (aOR:2.3, 95% CI: 1.3-3.9), receptive anal sex (aOR:1.7, 95% CI:1.3-2.3) and multiple male sexual partners (2 to 4 vs. ≤1, aOR:1.5, 95% CI: 1.0-2.2; 5+ vs ≤1, aOR:2.9, 95% CI:1.9-4.3). Oropharyngeal STI prevalence was 7% (52/752) and higher among those who engaged in oral sex compared to those who did not (unadjusted OR: 2.5, 95% CI:1.2-5.3).ConclusionsOral sex was common and associated with an increased odds of oropharyngeal STIs among MSM and TGW from Nigeria. In the absence of screening and treatment guidelines, condoms continue to be the mainstay for oral STI prevention. A pre-exposure prophylaxis for bacterial STIs would complement current prevention strategies to curb transmission.

Background Knowledge of HIV risk factors and reduction strategies is essential for prevention in key populations such as men who have sex with men (MSM) and transgender women (TGW). We evaluated factors associated with HIV-related knowledge among MSM and TGW and the impact of engagement in care at trusted community health centers in Nigeria. Methods The TRUST/RV368 cohort recruited MSM and TGW in Lagos and Abuja, Nigeria via respondent driven sampling. During study visits every three months, participants underwent structured interviews to collect behavioral data, received HIV education, and were provided free condoms and condom compatible lubricants. Five HIV-related knowledge questions were asked at enrollment and repeated after 9 and 15 months. The mean number of correct responses was calculated for each visit with 95% confidence intervals (CIs). Multivariable Poisson regression was used to calculate adjusted risk ratios and CIs for factors associated with answering more knowledge questions correctly. Results From March 2013 to April 2018, 2122 persons assigned male sex at birth were enrolled, including 234 TGW (11.2%). The mean number of correct responses at enrollment was 2.36 (95% CI: 2.31–2.41) and increased to 2.95 (95% CI: 2.86–3.04) and 3.06 (95% CI: 2.97–3.16) after 9 and 15 months in the study, respectively. Among 534 participants who completed all three HIV-related knowledge assessments, mean number of correct responses rose from 2.70 (95% CI: 2.60–2.80) to 3.02 (95% CI: 2.93–3.13) and then 3.06 (95% CI: 2.96–3.16). Factors associated with increased overall HIV-related knowledge included longer duration of study participation, HIV seropositivity, higher education level, and more frequent internet use. Conclusions There was suboptimal HIV-related knowledge among Nigerian MSM and TGW at that improved modestly with engagement in care. These data demonstrate unmet HIV education needs among Nigerian MSM and TGW and provide insights into modalities that could be used to address these needs.

Clinical samples were evaluated with the Mobile Analysis Platform (MAP) to determine platform performance for detecting respiratory viruses in samples previously characterized using clinical reverse transcriptase polymerase chain reaction assays. The percent agreement between MAP and clinical results was 97% for influenza A (73/75), 100% (21/21) for influenza B, 100% (6/6) for respiratory syncytial virus (RSV), and 80% (4/5) for negative specimens. The approximate limit of detection of the MAP was 30 copies/assay for RSV and 1500 copies/assay for Middle East respiratory syndrome coronavirus.

ObjectiveResearch 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.MethodsAdolescent 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).Results483 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, PConclusionMG infection was common, associated with STI co-infection and often asymptomatic, and pregnancy status did not confer protection.

ObjectivesThough highly vulnerable to HIV and STIs, transgender female sex workers (TFSWs) are understudied in the US HIV and STI response. This study examined the correlates of laboratory-confirmed STIs among a cohort of 62 TFSWs followed over the course of 1 year and explored associations between specimen site and self-reported engagement in insertive and receptive anal intercourse.MethodsParticipants completed an interviewer-administered computer-assisted personal interview at baseline, 3-, 6-, 9- and 12-month visits where self-administered anal swabs and urine samples for gonorrhea, chlamydia and trichomoniasis were also collected. HIV testing was conducted at baseline, 6-month and 12-month visits.ResultsBaseline HIV prevalence was 40.3% with no HIV seroconversions over follow-up. Baseline prevalence of gonorrhea, chlamydia and trichomoniasis was 9.7%, 17.7% and 14.5%, respectively. In the multivariable regression modelling, recent arrest was significantly associated with testing positive for any STI (adjusted risk ratio (RR) 1.77; 95% CI: 1.10 to 2.84). Insertive anal sex with clients was associated with increased risk of testing positive for an STI via urine specimen (RR 3.48; 95% CI: 1.14 to 10.62), while receptive anal sex was not significantly associated with specimen site.ConclusionOur findings confirm a high prevalence of STIs among TFSWs and highlight the importance of addressing structural drivers such as criminal justice involvement as well as the need to ensure screening for STIs at all anatomical sites regardless of self-reported sites of potential exposure. More research is needed to better understand HIV and STI vulnerabilities and appropriate interventions for TFSWs in the USA.

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

We evaluated the results of an acceptability survey administered online to users of I Want the Kit, which offers Internet-requested kits for sexually transmitted infection screening. User satisfaction was high for I Want the Kit, with many users in our survey being repeat patients of this program. Both male and female respondents preferred genital self-collected swabs over urine collected specimens. Strong interest was expressed in home testing options for other sexually transmitted infections.

Background: Given the lack of new antimicrobials to treat Neisseria gonorrhoeae (NG) infections, reusing previously recommended antimicrobials has been proposed as a strategy to control the spread of multi-drug-resistant NG. We assessed ciprofloxacin susceptibility in a large sample set of NG isolates and identified correlates associated with ciprofloxacin-resistant NG infections. Methods: NG isolates collected in Baltimore, Maryland between 2014 and 2016 were evaluated by Gyrase A (gyrA) PCR and E-test for susceptibility to ciprofloxacin. Clinical characteristics and demographics were evaluated by multivariate regression analysis to identify correlates of ciprofloxacin-resistant NG infections. Results: 510 NG isolates from predominately African American (96.5%), heterosexual (85.7%), and HIV-negative (92.5%) male subjects were included in the study. The overall percentage of isolates with mutant gyrA sequences, indicative of ciprofloxacin resistance, was 32.4%, and significantly increased from 24.7% in 2014 to 45.2% in 2016 (p &lt, 0.001). Participants older than 35 years of age were 2.35 times more likely to have a gyrA mutant NG infection than younger participants (p &lt, 0.001). Race, sexual orientation, symptomology, or co-infection the HIV or syphilis were not associated with a particular NG gyrA genotype. Conclusions: Resistance to ciprofloxacin in Baltimore is lower than other regions and indicates that in this environment, use of ciprofloxacin may be appropriate for targeted treatment provided utilization of enhanced surveillance tools. The targeted use of ciprofloxacin may be more beneficial for individuals under 35 years of age. Point-of-care tests for NG diagnosis and susceptibility testing are urgently needed to identify individuals who can be treated with this targeted approach.

Importance Clinical studies have been inconclusive about the effectiveness of N95 respirators and medical masks in preventing health care personnel (HCP) from acquiring workplace viral respiratory infections. Objective To compare the effect of N95 respirators vs medical masks for prevention of influenza and other viral respiratory infections among HCP. Design, Setting, and Participants A cluster randomized pragmatic effectiveness study conducted at 137 outpatient study sites at 7 US medical centers between September 2011 and May 2015, with final follow-up in June 2016. Each year for 4 years, during the 12-week period of peak viral respiratory illness, pairs of outpatient sites (clusters) within each center were matched and randomly assigned to the N95 respirator or medical mask groups. Interventions Overall, 1993 participants in 189 clusters were randomly assigned to wear N95 respirators (2512 HCP-seasons of observation) and 2058 in 191 clusters were randomly assigned to wear medical masks (2668 HCP-seasons) when near patients with respiratory illness. Main Outcomes and Measures The primary outcome was the incidence of laboratory-confirmed influenza. Secondary outcomes included incidence of acute respiratory illness, laboratory-detected respiratory infections, laboratory-confirmed respiratory illness, and influenzalike illness. Adherence to interventions was assessed. Results Among 2862 randomized participants (mean [SD] age, 43 [11.5] years; 2369 [82.8%]) women), 2371 completed the study and accounted for 5180 HCP-seasons. There were 207 laboratory-confirmed influenza infection events (8.2% of HCP-seasons) in the N95 respirator group and 193 (7.2% of HCP-seasons) in the medical mask group (difference, 1.0%, [95% CI, −0.5% to 2.5%];P = .18) (adjusted odds ratio [OR], 1.18 [95% CI, 0.95-1.45]). There were 1556 acute respiratory illness events in the respirator group vs 1711 in the mask group (difference, −21.9 per 1000 HCP-seasons [95% CI, −48.2 to 4.4];P = .10); 679 laboratory-detected respiratory infections in the respirator group vs 745 in the mask group (difference, −8.9 per 1000 HCP-seasons, [95% CI, −33.3 to 15.4];P = .47); 371 laboratory-confirmed respiratory illness events in the respirator group vs 417 in the mask group (difference, −8.6 per 1000 HCP-seasons [95% CI, −28.2 to 10.9];P = .39); and 128 influenzalike illness events in the respirator group vs 166 in the mask group (difference, −11.3 per 1000 HCP-seasons [95% CI, −23.8 to 1.3];P = .08). In the respirator group, 89.4% of participants reported “always” or “sometimes” wearing their assigned devices vs 90.2% in the mask group. Conclusions and Relevance Among outpatient health care personnel, N95 respirators vs medical masks as worn by participants in this trial resulted in no significant difference in the incidence of laboratory-confirmed influenza. Trial Registration ClinicalTrials.gov Identifier:NCT01249625

The success of fecal microbiota transplant (FMT) in treating recurrent Clostridioides difficile infection has led to growing excitement about the potential of using transplanted human material as a therapy for a wide range of diseases and conditions related to microbial dysbiosis. We anticipate that the next frontier of microbiota transplantation will be vaginal microbiota transplant (VMT). The composition of the vaginal microbiota has broad impact on sexual and reproductive health. The vaginal microbiota in the “optimal” state are one of the simplest communities, dominated by one of only a few species of Lactobacillus. Diversity in the microbiota and the concomitant depletion of lactobacilli, a condition referred to as bacterial vaginosis (BV), is associated with a wide range of deleterious effects, including increased risk of acquiring sexually transmitted infections and increased likelihood of having a preterm birth. However, we have very few treatment options available, and none of them curative or restorative, for “resetting” the vaginal microbiota to a more protective state. In order to test the hypothesis that VMT may be a more effective treatment option, we must first determine how to screen donors to find those with minimal risk of pathogen transmission and “optimal” vaginal microbiota for transplant. Here, we describe a universal donor screening approach that was implemented in a small pilot study of 20 women. We further characterized key physicochemical properties of donor cervicovaginal secretions (CVS) and the corresponding composition of the vaginal microbiota to delineate criteria for inclusion/exclusion. We anticipate that the framework described here will help accelerate clinical studies of VMT.

Trachoma, caused by the bacteria Chlamydia trachomatis, is the world leading infectious cause of blindness. The disease is associated with poor living conditions, especially in developing countries. In these countries, diagnosis is usually based on clinical evaluation, although laboratory confirmation is necessary. Serological-based tests for trachoma laboratory confirmation are cheaper than molecular-based tests, but the later are more sensitive and specific. Among the available molecular tests, qPCR has the best cost-benefit. With this in mind, the present study developed a new duplex qPCR reaction, which concomitantly detects C. trachomatis cryptic plasmid and the human 18S rRNA gene, as an internal reaction control. The new qPCR was validated using 50 previously qPCR-characterized samples for trachoma infection, and showed 95% specificity and 100% sensitivity, with an estimated LOD95 of 600 ag/µL. Next, 50 samples from an endemic area (Marajó, Pará) and 12 from a non-endemic area (Curitiba, Paraná) were investigated using direct immunofluorescence assay (DFA) or the new duplex qPCR. Among the 50 endemic samples, three were positive by clinical evaluation (6%), 18 by DFA (36%) and 48 by qPCR (96%). All samples positive by the clinic evaluation were also positive by qPCR. From the 18 DFA-positives, qPCR identified 16 as positives as well. On the other hand, 32 samples that were DFA-negative due to the low number of elementary bodies (

Background Pelvic Inflammatory Disease (PID) is a polymicrobial infection currently treated using syndromic management with broad-spectrum antibiotics. There are limited data describing the vaginal microbiota among adolescent and young adult women with PID, and how the post-PID microbial state may predispose to subsequent infection due to ongoing infection and shifts in vaginal microbiota. The purpose of this pilot research is to examine the microbial environment among adolescent and young adult women with acute PID. Methods This analysis utilizes stored samples from 13–25-year-old patients (n=26) diagnosed with acute PID and enrolled in the Technology Enhanced Community Health Nursing (TECH-N) study, a large randomized controlled clinical trial designed to test a multi-faceted intervention for prevention of PID. Vaginal microbiota was characterized by 16S rRNA gene sequencing (V3-V4 regions) and clustered into community state types (CSTs). Results At baseline, the majority of patients with acute PID were in a low-Lactobacillus or L.iners dominated state (CST I (L. crispatus dominated (N=3, 11.54%), CST III L. iners-dominated (N=7, 26.9%), CST IV Low-Lactobacillus (N=15, 57.69%), CST V L. jensenii-dominated (N=1, 3.85%)). The single CST V case had a relatively low abundance (55%) of L. jensenii. Conclusion Preliminary vaginal microbiota testing among AYA with PID revealed over 1/2 of participants had a low abundance of Lactobacillus spp indicative of bacterial vaginosis and risk to STI. Over 1/4 had L. iners-dominated microbiotas, which are also often associated with BV. Lactobacillus spp and are thought to protect against pathogens; however, the level of protection may vary by strain. Additional research should examine these findings in larger samples, include PID-negative patients for comparison, and assess the changes in the vaginal microbiota associated with successful clearance of pathogens. Such work may improve understanding of the vaginal microenvironment during PID and elucidate a path to shift from syndromic management to precision treatment among affected patients. Disclosure No significant relationships.

Background Mycoplasma genitalium (MG) is an emerging sexually transmitted infection. It has been associated with cervicitis and PID in women and urethritis and persistent NGU in men. Methods We evaluated two MG qPCRs, 16S rRNA and pdhD. The limit of detection (LOD) for the 16S rRNA and pdhD assays were determined with 11 MG strains. Inclusivity/exclusivity testing was performed with 11 MG strains and 43 non-MG strains. Stability testing was performed with mock vaginal and urine samples stored at +4°C and 25°C at 1.5X, 4X, 10X and 20X LOD at 0, 7, 14, 21, 28 and 35 days. These assays were employed in an ongoing prospective study examining the prevalence of MG in symptomatic and asymptomatic men and women. Positives were sequenced to determine mutation rates in the 23S rRNA gene conferring macrolide resistance. Results The pdhD and 16S assays had LODs of 1324 and 1536 copies/ml, respectively. All inclusivity/exclusivity testing performed as expected. Detection in urine and vaginal matrix at 4°C was 100% for both assays. Detection in urine at 4°C was 100% for both assays while detection in urine at 25°C was 100% at 28 days, but was 90% at 35 days. For symptomatic men, the prevalence was 19% (4/21) and 14.3% (3/21) for the pdhD and 16S rRNA assays respectively, and was 7.14% (1/15) in symptomatic women for both assays. There were no MG detections in asymptomatic subjects. Of the positives, 100% (5/5) were determined to be 23S mutants. Conclusion Both assays had reasonable LODs and expected results for inclusivity/exclusivity testing. For stability testing, results were as expected up to 35 days, where a loss of positivity was observed for urine samples. We observed a high prevalence of MG in symptomatic men and women, as well as a high percentage of 23S mutants conferring macrolide resistance. Disclosure No significant relationships.

Background Many adolescent and young women (AYA) remain in relationships with their sexual partners at 3-months post-PID, but little is known about how those relationships continue to evolve and integrate risk reduction behaviors. The purpose of this study is to examine 12-month longitudinal sexual and reproductive health behaviors post-PID. Methods Participants in the Technology Enhanced Community Health Nursing Study (N=286), a large randomized controlled trial of an intervention to improve PID outcomes were enrolled in quarterly post-trial telephone follow-up interviews. This analysis presents data from participants who completed 12 months of follow-up (N=72). Participants were queried about interim symptoms, sexual and reproductive behaviors, and clinical outcomes such as recurrent STI, pregnancy, chronic abdominal pain) and relationship status. Data were analyzed using descriptive and logistic regression analyses. Results Of 72 participants who completed the 12-month post-trial follow-up, 33 were in the intervention group, and 39 were in the control group, and 42 (58%) reported new partners in the last 12 months. Participants with new partners were not more likely to report having an STI than women without new partners (estimated odds ratio 1.6, 95%CI 0.5, 4.6, p = 0.470) or to have used contraceptives in the past 12 months (OR = 4.5 95% CI 0.3, 244.5, p = 0.301), but are more likely to have had lower abdominal pain (OR 5.6 95% CI 1.8, 18.9, p=0.001). Most women (86%) reported condom use in the prior 12 months, but there were no differences in condom use over the last year based on new partner status. Conclusion Most AYA who experience PID acquire new partners during the year post-PID, but are not more likely to use condoms at 12 months. Given the increased association with lower abdominal pain, booster STI risk reduction strategies may be indicated to prevent associated sequelae among affected patients. Disclosure No significant relationships.

Background Transgender women (TGW) in the U.S. experience a disproportionate burden of HIV and STIs. National HIV/STI surveillance does not report statistics for TGW. We describe the baseline prevalence and characteristics of HIV and STI among a cohort of TGW enrolled across 6 cities in eastern and southern US to-date. Methods Adult TGW, regardless of HIV status, are recruited and enrolled in a baseline screening visit. Participants complete a socio-behavioral survey, oral HIV screening, urine and self-collected anal and vaginal specimens for Neisseria gonorrhoeae (GC) and Chlamydia trachomatis (CT) testing, and serum treponemal syphilis testing and rapid plasma reagin (RPR) testing with quantitative RPR titers. Participants with negative HIV antibody test results at baseline and HIV-related risk behaviors are enrolled into the cohort. Results Enrollment launched in March 2018. As of December 2018, 620 TGW completed baseline. Of these, 30% were identified with HIV at baseline and 63% enrolled into the HIV-uninfected cohort. Forty-percent reported a lifetime diagnosis of any STI. At baseline, 34% of HIV-infected participants and 12% of HIV-uninfected participants had ≥=1 laboratory-confirmed STI. Baseline prevalence among all participants included: 2% rectal GC, 0% urogenital GC, 5% rectal CT, 1% urogenital CT, and 13% active syphilis determined by RPR and treponemal results. None of the 38 participants with self-reported history of vaginoplasty had GC or CT at the neovaginal site. Active syphilis infection was associated with residence in a southern city (aOR: 3.8, 95%CI:1.7–8.6), identification as Black and/or Latinx (aOR: 3.7; 95%CI:1.1–12.7), concern about safety in transit to healthcare (aOR: 1.9; 95%CI:1.1–3.3), and positive baseline HIV antibody test (aOR: 3.1; 95%CI:1.7–5.7). Conclusion TGW in this 6-city baseline cohort have a high prevalence of HIV and STI. Study findings highlight demographic disparities, high HIV/syphilis co-infection, and barriers related to safety that may impede prompt diagnosis and treatment of STI and HIV in American TGW. Disclosure No significant relationships.

Background Chlamydia trachomatis (CT) is one of the most commonly diagnosed asymptomatic bacterial cause among sexually transmitted infection (STI) worldwide. We assessed the prevalence of CT in random STI patients to evaluate the presence of CT as either a single infection or in co-infection with other STI. Methods A total of 422 urogenital samples were collected from patients who attended the Diagnostic Centre in Saratov Region to be tested for specific DNA of CT and other STIs (Neisseria gonorrhoeae/Trichomonas vaginalis/Mycoplasma hominis/Mycoplasma genitalium/Human papillomavirus (HPV 16/18)/Cytomegalovirus/Herpes simplex virus (HSV 1/2)/Candida albicans/Gardnerella vaginalis/Ureaplasma species. Each clinical sample was carefully screened with the use of commercial kits, either as conventional PCR targeting CT plasmid, or real-time multiplex set (Vector-Best, Russia) validated further by additional confirmatory PCR for the CT-positive samples. Results CT was detected in 17/194 (4,02%) patients who were screened only for the presence of CT DNA (194/422, 45,97%). However, when all 422 patients were systematically screened for CT, along with all other STIs, CT infections were significantly higher (about 4-fold larger) in the patients with other STIs (70/422, 16.58%). Moreover, 56/70 (80%) CT DNA samples were successfully genotyped as CT genovars: E (50%), G (21,42%), D (17,85%), J (5,35%) and K (3,57%). Conclusion Chlamydial asymptomatic infection cases can be frequently masked by clinical symptoms of other STIs. Diagnostic testing for multiple STIs should provide a broader diagnostic coverage for asymptomatic CT patients in order to improve significantly CT early detection, prevention of transmission, and treatment strategies. Disclosure No significant relationships.

Background STIs including Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT) potentiate HIV acquisition and transmission especially among gay men and other men who have sex with men (MSM). We investigated the influence of sexual network composition on incident rectal NG and/or CT infections among Nigerian MSM. Methods TRUST/RV368 is a cohort of MSM recruited using respondent-driven sampling at trusted community centres in Abuja and Lagos, Nigeria. MSM respondents (egos) provided STI risk factors and demographic information for up to five of their most recent sexual partners (alters) within their sexual networks. Egos were tested for HIV, NG and CT every 3 months. Log-binomial regression was used to assess associations between alter characteristics and incident NG and/or CT. Results Between March 2013 and October 2015, 492 MSM were longitudinally screened for STIs, of which 28.0% (n=138) were positive for incident rectal STI (61 NG only, 42 CT only and 35 NG and CT). Among egos, condom use was associated with STIs (half of the time vs never (adjusted risk ratio (aRR) 0.5; 95% CI 0.3 to 0.8), always/almost always vs never (aRR 0.7; 95% CI 0.5 to 1.0)). Incident STIs were associated with having a younger alter ≤19 versus 30 years (aRR 0.6; 95% CI 0.4 to 1.0), HIV infection (aRR 1.5; 95% CI 1.1 to 2.0) and engaging in sex under the influence of alcohol (aRR 1.4 95% CI 1.1 to 1.7) among regular alters and age ≤19 versus 30 years (aRR 0.3; 95% CI 0.2 to 0.6), HIV infection (aRR 1.4; 95% CI 1.1 to 1.8) and engaging in sex under the influence of alcohol (aRR 1.2 95% CI 1.0 to 1.4) among casual alters. Conclusions Given the centrality of sexual partner characteristics as risks for incident STIs among Nigerian MSM, there is a need to move beyond individual interventions and syndromic surveillance and get ‘out there’ in the STI management.

Solana® (Quidel) is a new rapid (40 min.) point-of-care (POC) test for qualitative detection of Trichomonas vaginalis (TV) DNA. The assay has two steps: 1) specimen preparation, and 2) amplification and detection using isothermal Helicase-Dependent Amplification (HDA). The objective was to demonstrate the performance of Solana for vaginal swabs and female urines based on comparison to wet mount and TV culture. Performance was also compared to the Aptima-TV assay.Urine and four clinician-collected vaginal swabs were collected. The first two were used for FDA composite reference (wet mount; InPouch TV Culture). The third swab was used for Solana. Sensitivity/specificity were based on the reference method. A specimen was considered positive if either test was positive. The fourth swab was for Aptima-TV.Vaginal swabs and urines were obtained from 501 asymptomatic and 543 symptomatic women. Prevalence of TV by was 11.5%. For swabs, Solana® demonstrated high sensitivity and specificity from asymptomatic (100%/98.9%) and symptomatic (98.6%/98.5%) women, as well as for urines from asymptomatic (98.0%/98.4%) and symptomatic (92.9%/97.9%) women, compared to the reference method. Compared to Aptima-TV, the sensitivity/specificity was 89.7%/99.0% for swabs and 100%/98.9% for urines.The Solana® assay performed well compared to the reference assays.

Nucleic acid-based detection of gonorrhea infections typically require a two-step process involving isolation of the nucleic acid, followed by detection of the genomic target often involving polymerase chain reaction (PCR)-based approaches. In an effort to improve on current detection approaches, we have developed a unique two-step microwave-accelerated approach for rapid extraction and detection of Neisseria gonorrhoeae (gonorrhea, GC) DNA. Our approach is based on the use of highly focused microwave radiation to rapidly lyse bacterial cells, release, and subsequently fragment microbial DNA. The DNA target is then detected by a process known as microwave-accelerated metal-enhanced fluorescence (MAMEF), an ultra-sensitive direct DNA detection analytical technique. In the current study, we show that highly focused microwaves at 2.45 GHz, using 12.3-mm gold film equilateral triangles, are able to rapidly lyse both bacteria cells and fragment DNA in a time- and microwave power-dependent manner. Detection of the extracted DNA can be performed by MAMEF, without the need for DNA amplification, in less than 10 min total time or by other PCR-based approaches. Collectively, the use of a microwave-accelerated method for the release and detection of DNA represents a significant step forward toward the development of a point-of-care (POC) platform for detection of gonorrhea infections.

Ocular syphilis, a form of neurosyphilis, has been increasingly diagnosed in the United States. This case series summarizes the course of 6 patients recently diagnosed with ocular syphilis, emphasizing the varied sociodemographic factors and the wide range of symptoms and outcomes that are seen in patients with this disease.

For decades reproductive tract infections (RTIs) have been hypothesized to play a role in uterine fibroid development. The few previous studies conducted used self-reported history of RTIs and had inconsistent findings. We investigated this hypothesis further using serological analysis, an immunological measure of past exposure. We focused on herpes simplex virus type 2 (HSV-2) because prior published data have suggested a possible association with fibroids, and serology for HSV-2 is much more sensitive than self-report. We used cross-sectional enrollment data from African-American women enrolled in a prospective study of fibroid incidence and growth (recruited 2010–2012) in the Detroit, Michigan, area. The women were aged 23–34 years and were screened for fibroids using a standardized ultrasound examination at their enrollment. Age- and multivariable-adjusted logistic regression models were used to estimate odds ratios. Of 1,696 participants, 1,658 had blood samples and HSV-2 serology results; 22% of participants with serology results had fibroids. There was no significant association between HSV-2 seropositivity and the presence of fibroids (multivariable-adjusted odds ratio = 0.94, 95% confidence interval: 0.73, 1.20), nor were there any associations with size of the largest fibroid, number of fibroids, or total fibroid volume. Our data provide no evidence for an influence of HSV-2 exposure on fibroid risk in young African-American women. Further study of other serologically measured RTIs is warranted.

Highlights • The analytical sensitivities of seven SARS-CoV-2 molecular assays are compared. • A single positive clinical specimen quantified by droplet digital PCR was used for the comparison. • The Abbott, the Roche, and the Xpert Xpress assays appear more sensitive., The SARS-CoV-2 pandemic has challenged molecular microbiology laboratories to quickly implement and validate diagnostic assays and to expand testing capacity in a short timeframe. Multiple molecular diagnostic methods received FDA emergency use authorization (EUA) and were promptly validated for use nationwide. Several studies reported the analytical and/ or clinical evaluation of these molecular assays, however differences in the viral materials used for these evaluations complicated direct comparison of their analytical performance. In this study, we compared the analytical sensitivity (lower limit of detection, LOD) of seven commonly used qualitative SARS-CoV-2 molecular assays: the Abbott Molecular RealTime SARS-CoV-2 assay, the NeuMoDx™ SARS-CoV-2 assay, the Roche Cobas®SARS-CoV-2 assay, the BD SARS-CoV-2 reagents for BD MAX™ system, the Hologic Aptima® SARS-CoV-2 assay, the Xpert Xpress SARS-CoV-2 test, and the GenMark ePlex SARS-CoV-2 test. The comparison was performed utilizing a single positive clinical specimen that was serially diluted in viral transport media and quantified by the EUA approved SARS-CoV-2 droplet digital PCR (ddPCR) assay. Replicate samples were prepared and evaluated for reproducibility across different molecular assays with multiple replicates per assay. Our data demonstrated that the seven assays could detect 100 % of replicates at a nucleocapsid gene concentration of (N1 = 1,267 and N2 = 1,392) copies/mL. At a one log less concentration, the Abbott, the Roche, and the Xpert Xpress assays detected 100 % of the tested replicates.

Key Points Question How does a new point-of-care assay for detection of chlamydia and gonorrhea compare with commercially available laboratory-based molecular diagnostics? Findings This cross-sectional study including 1523 women and 922 men found that a new molecular point-of-care assay was associated with excellent performance compared with laboratory-based molecular diagnostics for vaginal swab samples and has been cleared for use by the US Food and Drug Administration. Male urine samples were associated with good performance in this assay and are undergoing continuing evaluation. Meaning Highly sensitive, rapid chlamydia and gonorrhea testing at the point of care is now a possibility that can support same-day testing and treatment strategies., 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., This cross-sectional study evaluates the clinical performance of a point-of-care molecular diagnostic assay for the detection of chlamydia and gonorrhea.

Point-of-care tests (POCTs) offer the opportunity for increased diagnostic capacity in resource-limited settings, where there is lack of electricity, technical capacity, reagents, and infrastructure. Understanding how POCTs are currently used and determining what health care workers (HCWs) need is key to development of appropriate tests. In 2016, we undertook an email survey of 7584 HCWs who had received training at the Infectious Diseases Institute, Uganda, in a wide variety of courses. HCWs were contacted up to three times and asked to complete the survey using Qualtrics software. Of 555 participants answering the survey (7.3% response rate), 62% completed. Ninety-one percent were from Uganda and 50.3% were male. The most commonly-used POCTs were pregnancy tests (74%), urine dipstick (71%), syphilis rapid test (66%), and Gram stain (41%). The majority (74%) practiced syndromic diagnosis for sexually transmitted infections/HIV. Lack of availability of POCTs, increased patient wait time, and lack of training were the leading barriers for POCT use. Increasing POCT availability and training could improve uptake of POCTs for sexually transmitted infections in Africa and decrease syndromic management. This could reduce overtreatment and slow the emergence of antibiotic resistance. This is the first published email survey of HCWs in Uganda; mechanisms to increase the response rate should be evaluated.

In 2016, the rate of USA gonorrhoea and chlamydia cases increased by 18.6% and 6.9% respectively. Most people infected are asymptomatic and are not treated immediately, which negatively affects sexually transmissible infection (STI)/HIV rates. Men and women were asked to provide self-collected oropharyngeal specimens for STI testing (n = 79). Over 75% reported the collection of the swab was ‘easy’ or ‘very easy’ to use; 90% were willing to test for STIs at home in the future. Self-collecting oropharyngeal swabs for STI testing is acceptable among men and women. Future research should test the effect of self-collecting pharyngeal swabs on STI testing behaviours and results.

© 2018 Elsevier Ltd Genital Chlamydia trachomatis infection is the most commonly diagnosed sexually transmitted infection. Trachoma is caused by ocular infection with C trachomatis and is the leading infectious cause of blindness worldwide. New serological assays for C trachomatis could facilitate improved understanding of C trachomatis epidemiology and prevention. C trachomatis serology offers a means of investigating the incidence of chlamydia infection and might be developed as a biomarker of scarring sequelae, such as pelvic inflammatory disease. Therefore, serological assays have potential as epidemiological tools to quantify unmet need, inform service planning, evaluate interventions including screening and treatment, and to assess new vaccine candidates. However, questions about the performance characteristics and interpretation of C trachomatis serological assays remain, which must be addressed to advance development within this field. In this Personal View, we explore the available information about C trachomatis serology and propose several priority actions. These actions involve development of target product profiles to guide assay selection and assessment across multiple applications and populations, establishment of a serum bank to facilitate assay development and evaluation, and development of technical and statistical methods for assay evaluation and analysis of serological findings. The field of C trachomatis serology will benefit from collaboration across the public health community to align technological developments with their potential applications.

OBJECTIVES: Antimicrobial resistance to gonorrhoea is a threat to global health security. There have been concerns expressed that countries with high rates of disease have poor surveillance. The objectives of the study were: to determine the antimicrobial resistance patterns of N. gonorrhoeae clinical isolates to antimicrobial agents in patients with HIV or high risk of HIV acquisition; to compare the concordance of disc diffusion and agar dilution as methods for determining antimicrobial resistance to N. gonorrhoeae, and to describe methodological challenges to carrying out AMR testing. METHODS: The study was conducted at an HIV outpatient service for at-risk populations and an outreach clinic for commercial sex workers in Kampala. Patients were offered a sexually transmitted infection screen using a PCR-based assay. Samples positive for gonorrhoea were cultured. Antimicrobial susceptibility testing was performed using disc diffusion and isolates were sent to a reference laboratory for agar dilution direct susceptibility testing. RESULTS: Five hundred and seventy five patients were screened. There were 33 (5.7%) patients with gonorrhoea by PCR. Of the 16 viable N. gonorrhoeae isolates, 100% were resistant to ciprofloxacin and tetracycline by disk diffusion; and 31% exhibited reduced susceptibility to ceftriaxone and cefixime. By agar dilution, 100% of isolates were resistant to ciprofloxacin and all isolates were susceptible to ceftriaxone and cefixime. CONCLUSIONS: One hundred percent resistance to ciprofloxacin was identified. There was concordance between disk diffusion and agar dilution for ciprofloxacin and tetracycline resistance and a significant discordance for third generation cephalosporins. More than half the women with gonorrhoea were asymptomatic, and represent a potential reservoir for ongoing transmission. Antimicrobial resistance testing of N.gonorrhoeae isolates is needed to ensure optimal treatment and prevention of antibiotic resistance progression.

Background Mycoplasma genitalium (MG) is a common sexually transmitted infection (STI), but there are limited strategies to identify individuals at risk of MG. Previously, a sex risk quiz was used to predict STIs including Chlamydia trachomatis, Neisseria gonorrhoeae, and/or Trichomonas vaginalis. The original quiz categorized individuals 25 years or younger as at risk of STIs, but the Centers for Disease Control and Prevention identifies females younger than 25 years as at risk of STIs. In this study, the quiz was changed to categorize females younger than 25 years as high risk. The objective was to determine if the age-modified risk quiz predicted MG infection. Methods A cross-sectional analysis of a prospective longitudinal study was performed including female adolescents and young adults (AYAs) evaluated in multiple outpatient clinics. Participants completed an age-modified risk quiz about sexual practices. Scores ranged from 0 to 10 and were categorized as low risk (0-3), medium risk (4-7), and high risk (8-10) based on the STI prevalence for each score. Vaginal and/or endocervical and/or urine specimens were tested for MG, T. vaginalis, C. trachomatis, and N. gonorrhoeae using the Aptima Gen-Probe nucleic amplification test. Results There were 693 participants. Most participants reported having 0 to 1 sexual partners in the last 90 days (91%) and inconsistent condom use (84%). Multivariable logistic regression analysis controlling for race, education, and symptom status demonstrated that a medium-risk score predicted MG infection among AYAs younger than 25 years (adjusted odds ratio, 2.56 [95% confidence interval, 1.06-6.18]). Conclusion A risk quiz may be useful during clinical encounters to identify AYA at risk of MG.

With a growing list of new platforms, end-user acceptability is an evolving topic in point-of-care (POC) test development. While technical reports of new experimental POC tests are common, it is rare to find reports which evaluate the end-user acceptability of such innovations. This work illustrates an example of bridging that gap by evaluating the end-user acceptability of an experimental POC test platform with novel technical features. A prototype smartphone-based STI tests was evaluated by ED technicians, followed by a survey of acceptability factors. Our findings suggest that the end-user acceptability of some design features implemented in the prototype.