bluuebunny/crossref_metadata_2025_split huggingface dataset:
O3-S2.04 Cervical ectopy is not associated with acquisition of HPV infection
Authors: Hwang L Y , Lieberman J , Ma Y , Moscicki A B 
Published: July 2011

BackgroundHPV infection and cervical cancer are often found at the cervical transformation zone. High rates of HPV in adolescents have been attributed to their greater extent of “cervical ectopy”, defined as areas of columnar and metaplastic epithelium visible on the ectocervix. The study aim was to examine associations between the extent of cervical ectopy and incident HPV infection in healthy adolescents.MethodsSexually active young women were enrolled as part of a prospective HPV Natural History Study. Women were eligible if they were 13–21 years old, sexually active (5 years maximum), and had no history of cervical intraepithelial neoplasia, cervical procedures, or immunosuppression. At 4-month interval visits, we performed colpophotography to document the epithelium, HPV testing for 37 types by Roche Reverse Line Blot assay, and interviews to assess behaviours. This study selected women (N=147) who had negative HPV results at the first two consecutive visits. Epithelial areas of interest were measured in the digitised colpophotographs by using computerised planimetry to produce pixel counts. The extent of ectopy was measured as a percentage of the total cervical face. Cox proportional hazards models examined ectopy as a predictor for incident HPV, defined as the first positive HPV result following the initial two negative results, adjusted for the number of new sexual partners. Outcomes included incidence of any HPV type; α-9 HPV types (defined as 16, 31, 33, 35, 52, 58, 67); and a-3/15 HPV types (defined as 61, 71, 72, 81, 83, 84, 89).ResultsThe 147 women attended a total of 545 visits. The mean age at baseline was 17.2 years, mean age of menarche was 12.8 years, and mean age of first sex was 15.4 years. Self-reported race/ethnicity was 35 (24%) Asian, 14 (10%) African-American, 43 (29%) Caucasian, 52 (35%) Latina, and 3 (2%) Other. The median ectopy measurement from the 545 visits was 14% (interquartile range 6–32%) of the total cervical face. Incident HPV of any type was found in 42 (29%) women. The extent of ectopy was not significantly associated with incidence of any HPV type (HR 1.004, p=0.63); α-9 HPV types (HR 0.99, p=0.43); or α-3/15 HPV types (HR 1.02, p=0.18). Results were unchanged when adjusted for new sexual partners in the past 8 months (HR 1.9, p<0.01).ConclusionsWhen measured quantitatively, the extent of cervical ectopy is not a risk factor for the acquisition of HPV infection in healthy adolescent women.
O3-S2.05 Prevalence ofTrichomonas vaginalisand co-infection withChlamydia trachomatisandNeisseria gonorrhoeain the USA as determined by the APTIMATrichomonas vaginalisnucleic acid amplification assay
Authors: Ginocchio C C , Chapin K , Smith J S , Aslanzadeh J , Snook J , Hill C S , Gaydos C A 
Published: July 2011

BackgroundTrichomonas vaginalis(TV) is the most common curable sexually transmitted infection worldwide. True prevalence of TV infection is not well characterised as previous studies mainly used methods with relatively poor sensitivity compared to nucleic acid amplification methods. Our aim was to determine TV prevalence using the APTIMA TV Assay (ATV, Gen-Probe Incorporated) and the frequency of co-infections withChlamydia trachomatis(CT) andNeisseria gonorrhoea(NG) in the USA among women being screened.MethodsSamples from 7593 women aged 18–89 years undergoing routine CT and NG screening at obstetrics/gynaecology, emergency room, hospital in-patient, family practice, family planning, internal medicine, jail, and STD clinic populations in 21 states were collected. Consecutive samples previously tested for CT and NG by the APTIMA COMBO 2 Assay (Gen-Probe Incorporated) were retrospectively tested with the ATV assay. Endocervical, urine, vaginal swab and PreservCyt liquid Pap samples (Hologic Inc.) diluted into APTIMA specimen transport buffer were tested.ResultsOverall prevalences of TV, CT and NG in surveyed women were 8.7%, 6.7%, and 1.7%, respectively. TV prevalence ranged from 7.5 to 8.6% in women age 18 to 39 yr, and increased to 9.8% in women age 40–44 yr. Highest observed TV prevalences were in women ages 45–49 yr (13.4%) and over 50 yr (13.0%). CT and NG prevalences were less than 2% in the 40+ age group and highest in women less than 30 years of age ranging from 5.2% to 14.3% for CT and 1.3%–3.3% for NG. TV was the more prevalent STD than either CT or NG in all age groups, except the 18-19 yr group (CT: 14.3%; TV: 8.5%). TV prevalence differed by race/ethnicity (20.2% blacks; 5.7% whites; 5.0% Hispanics; 3.8% Asians). TV prevalence was 14.4% in the Southeast, 9.5% in the Southwest and Midwest, and 4.3% in the Northeast and ranged from 5.4% in Family Planning clinics to 22.3% in jails. Co-infections in most age groups were <1%, and were highest in the 18–19 yr group (TV/CT: 2.1%; TV/NG: 0.88%).ConclusionsTV prevalence was highest in women over 40 years of age, in contrast to CT and NG prevalences which were highest in women under 30 years of age. Co-infection of TV with CT or NG was relatively low. The high TV prevalence in all age groups suggests that all women being screened for CT/NG should also be screened for TV. Routine TV screening should also be considered for at-risk sexually active women of any age.
O3-S3.01 Comparison of a new APTIMA specimen collection and transportation kit to L-Pap for detection ofC trachomatis,N gonorrhoeaeandT vaginalisin cervical and vaginal specimens
Authors: Chernesky M 
Published: July 2011

BackgroundControl of sexually transmitted infections in women has focused on screening using cervical, vaginal or urine samples. The objective was to compare a new specimen collection and transportation (SCT) kit to PreservCyt (PC) and SurePath (SP) liquid-based Pap (L-Pap) for cervical sampling and self- and physician-collected vaginal samples.MethodsWomen (n=562) attending a gynaecology clinic (GYC) (n=435) or a youth health clinic (YHC) (n=127) signed consent for a physician to collect two L-Pap samples with a Cervex broom, cervical (CSCT) and vaginal (VSCT) samples and a self-collected VSCT. All specimens were tested for Chlamydia trachomatis (CT) andNeisseria gonorrhoeae(NG) by APTIMA Combo 2 (AC2) andTrichomonas vaginalis(TV) by APTIMA TV on a TIGRIS instrument. Each patient was asked on a scale of one to five to express strength of agreement or disagreement with ease or comfort of the 6 step self collection process for the VSCT.ResultsThere were a total of 22 CT, 19 TV and 2 NG infections with dual infections in 6 people (one CT and NG, one NG and TV and four CT and TV). Prevalences were as follows: CT 3.9% (GYC 1.3% and YHC 12.6%); NG 0.3% (2.0% in YHC); TV 3.4% (GYC 0.4% and YHC 13.4%). Sensitivity for CT infections were CSCT 100%, PC 100%, SP 81.8%; VSCT-self 100%, VSCT-physician 95.4%: for TV infections CSCT 89.4%, PC 84.2%, SP 63.2%; both VSCT 100%: for NG all collections 100%. There were no false positives (% specificity 100). Results of the survey revealed that the majority of patients found opening the package, self sampling, insertion of the SCT swab into preservation media and uncapping and recapping the tube were relatively easy to perform. Eighty two per cent experienced no discomfort using the SCT kit for collection.ConclusionsAPTIMA testing on the TIGRIS showed that the cervical and vaginal SCT and PC L-Pap samples were 100% sensitive in detecting CT and NG infections. VSCT samples detected all TV infections but cervical SCT and PC L-Pap were less sensitive. SP L-Pap samples showed reduced sensitivity for CT and TV. Overall, patients were in strong agreement with the ease of use of the VSCT and most found the process comfortable.
O3-S3.03 DifferingNeisseria gonorrhoeaebacterial loads in the pharynx and rectum: implications for gonococcal detection, transmission and control
Authors: Bissessor M , Tabrizi S , Fairley C , Danielewski J , Whitton B , Bird S , Garland S , Chen M 
Published: July 2011

BackgroundTo help improve our understanding of the potential transmissibility of gonococcal infections from the pharynx and rectum we measured gonococcal bacterial loads at these sites and examined clinical and laboratory determinants of these loads.MethodsMen who had sex with men were tested for pharyngeal and rectal gonorrhoea by culture using modified Thayer Martin medium and by two real-time quantitative qPCRs targetting opa gene, and porA pseudogene.Results1011 rectal and 1076 pharyngeal specimens were obtained from 1076 MSM. Forty three (3.9%) pharyngeal specimens were PCR positive of which 17 were culture positive (sensitivity 39%, 95% CI: 25% to 54%). Forty seven (4.6%) rectal specimens were PCR positive of which 25 were also culture positive (sensitivity 58%, 95% CI 44% to 71%). The median bacterial load among PCR positive rectal infections (18 960 copies per swab) was significantly higher than that for PCR positive pharyngeal infections (2,100 copies per swab) (p=0.001). The median bacterial load among men with symptomatic rectal infection was higher (278 800 copies per swab) than with asymptomatic men, PCR positive rectal infections (13,980 copies per swab, p<0.001). The median bacterial load of gonorrhoea was significantly higher in culture positive than culture negative specimens. This applied for both rectal (p<0.001) as well as pharyngeal infections (p=0.03).ConclusionHigher bacterial loads of gonorrhoea were observed in rectal infections, particularly with symptomatic rectal infections. This has implications for gonococcal transmission and control.
O3-S4.01 The new superbugNeisseria gonorrhoeaemakes gonorrhoea untreatable?—first high-level ceftriaxone resistance worldwide and public health importance
Authors: Ohnishi M , Unemo M , Golparian D , Shimuta K , Saika T , Hoshina S , Iwasaku K , Nakayama S I , Kitawaki J 
Published: July 2011

BackgroundThe firstNeisseria gonorrhoeaestrain (H041) worldwide that is highly resistant to the extended-spectrum cephalosporin (ESC) ceftriaxone, which is the last remaining option for empirical treatment of gonorrhoea, has now been identified! This is a large public health problem and the era of untreatable gonorrhoea may now have been initiated. The present study completely characterised H041, phenotypically and genetically, to confirm the finding, comprehensively examine its antimicrobial resistance (AMR) and in detail elucidate the resistance mechanisms. Finally, public health actions for preventing and/or detaining global spread of ceftriaxone-resistant and untreatable gonorrhoea will be discussed.MethodsH041 was examined using seven species-confirmatory tests, antibiograms (30 antimicrobials) with Etest and agar dilution (only for ESCs), porB sequencing,N gonorrhoeaemulti-antigen sequence typing (NG-MAST), multilocus sequence typing (MLST) and sequencing of ESC resistance determinants (penA, mtrR, penB, ponA and pilQ). Transformation, using appropriate recipient strains, was performed to confirm the ESC resistance determinants.ResultsH041 was assigned serovar Bpyust, MLST ST7363 and the new NG-MAST ST4220. H041 proved highly resistant to ceftriaxone (2–4 mg/l, which is 4-8-fold higher than any previously described isolate) and all other cephalosporins, as well as most other antimicrobials tested. A new penA mosaic allele, containing only four not previously described amino acid alterations, caused the ceftriaxone resistance, which was all proven using several transformation experiments.ConclusionsThe new superbugN gonorrhoeaehas now developed also ceftriaxone resistance and an era of untreatable gonorrhoea may have been initiated. A reduction in global gonorrhoea burden by enhanced disease control activities combined with wider strategies for general AMR control and enhanced understanding of mechanisms of emergence and spread of AMR, which need to be monitored globally, is crucial. Furthermore, a public health response plan (including sustainable clinical, microbiological and epidemiological components) for a global perspective is essential. Ultimately, new drugs are essential to develop for efficacious gonorrhoea treatment.
O3-S4.03 Safety and efficacy of WC2031 vs vibramycin for the treatment of uncomplicated urogenitalChlamydia trachomatisinfection
Authors: Geisler W M , Mena L , Taylor S N , Batteiger B E , Thurman A , Hook E W , Koltun W D , Abdelsayed N , Vaughn T A , Annett M P ,   WC2031 Investigator Team
Published: July 2011

BackgroundRecent studies report that treatment failure rates for single-dose azithromycin for urogenital chlamydia in females may be as high as 8%. There has been sparse research investigating new antibiotics for chlamydia, especially those that may reduce adherence difficulties with the CDC recommended doxycycline regimen (100 mg orally twice daily for 7 days).MethodsThe safety and efficacy of WC2031 (doxycycline hyclate delayed-release 200 mg tablet) orally once daily for 7 days vs Vibramycin (doxycycline hyclate capsule) 100 mg orally twice daily for 7 days for the treatment of uncomplicated urogenital chlamydia was evaluated in a randomised, double-blind, double-dummy, active-controlled, multicenter study. Males and nonpregnant females ages 19–45 with a confirmed diagnosis of urogenital chlamydia <14 days prior to enrolment or with a sexual partner with chlamydia were eligible. The study consisted of three visits: baseline, day 8 (end-of-treatment), and day 28 (test-of-cure [TOC]). The primary outcome was microbiological cure at TOC, defined as a negative result for Chlamydia trachomatis by the Gen-Probe (GP) Aptima Combo (AC) 2 assay (on urine in males and vaginal swab in females). The mITT population consisted of treated subjects with a GP AC2 positive forC trachomatisat baseline. Non-inferiority of WC2031 was inferred if the lower limit of the 95% CI of the difference in cure rates was >-10%. Safety was studied through clinical evaluation and laboratory tests.Results495 subjects were randomised at 41 study sites. The mITT population with evaluable efficacy consisted of 323 (65%) subjects (156 in the WC 2031 group and 167 in the Vibramycin group). Baseline characteristics did not differ by group: median age 23, 61% female, 58% African American vs 36% Caucasian vs 7% other race, and 21% Hispanic ethnicity. The microbiological cure rate (95% CI) for the WC2031 group was 95.5 % (92.3 to 98.8) vs 95.2% (92.0 to 98.4) for the Vibramycin group; the 95% CI for the difference in cure rates between treatments was (−4.3% to 4.9%). Types of adverse events were comparable between treatment groups. The WC 2031 group had less nausea and vomiting (13% vs 21% and 8% vs 12%).ConclusionsWC2031 was non-inferior to Vibramycin for treatment of uncomplicated urogenital chlamydia, was better tolerated, and demonstrated comparable safety. The once daily dosing of WC2031 may improve treatment adherence compared with twice daily doxycycline.
O3-S4.05 Treatment of students infected with chlamydia and gonorrhoea in a school-wide screening program
Authors: Taylor S N , Brennan C , Longfellow L , Martin D H , Nsuami M J 
Published: July 2011

BackgroundProviding treatment to individuals screened for a health condition is a key component of any health screening program. School-based screenings for sexually transmitted diseases (STD) offer the possibility of efficiently and promptly treating participants because students can be easily located after they have been tested. We describe treatment rates and time to treatment for students with Chlamydia trachomatis (CT) orNeisseria gonorrhoeae(NG) infection in a school-wide screening program.MethodsBetween 1995 and 2005, 20 224 high school students were tested for CT and NG during annual screenings using urine specimens and commercial nucleic acid amplification tests. Test results were available approximately five working days after specimen collection. Students who tested positive were located at school during regular class hours for counselling and treatment by a school nurse, a clinic nurse, a public health nurse, or a physician. Treatment was with a single 1 gram oral dose of azithromycin for CT and 500 mg oral ciprofloxacin for NG, administered under direct observation. Before its removal from the market, cefixime 400 mg in single oral dose was used to treat NG. The names of infected students who could not be located in school were forwarded to a public health Disease Intervention Specialist (DIS) for follow-up. The DIS provided the program with an update on the follow-up status of each name referred.ResultsDuring the 10-year period, 3422 infections (CT: 2746; NG: 304; CT and NG: 372) were identified. Treatment was documented for 2844 infections (83.1%). There were no significant differences in rates of treatment (p>0.37) by gender or by infection. The rates of treatment varied by school year from a low of 64.8% in 1996–1997 to a high of 94.9% in 1997–1998 (p<0.0001). For 2692 infections with documented dates of treatment, the median time from specimen collection to treatment was 21 days (75th percentile: 33 days).ConclusionsThis high school STD screening and treatment program achieved high treatment rates for both CT and NG, although the treatment effort required strong commitments of various individuals from the screening program, the administrations in participating schools, and the local health services. Differences in treatment rates per school year reflected the dynamic interplay of these various individuals and organisations as well as the commonly high absentee, truancy, and dropout rates among students in the school district.
O3-S5.05 RPR titre variation following early syphilis therapy: a potential confounder of treatment outcome assessment
Authors: Holman K , Wolff M , Seña A , Martin D , Behets F , Van Damme K , Leone P , McNeil L , Winestone J , Hook E 
Published: July 2011

ObjectiveSerologic tests for syphilis (STS) results at the time of diagnosis are the basis for evaluating response to syphilis therapy. Following treatment, however, STS titres may continue to increase for several weeks. In a recent study comparing azithromycin to penicillin or doxycycline for early syphilis treatment, patients had RPR titres measured initially, at 7 and at 14 days following treatment. We evaluated variation in RPR titres over the 14 days following therapy, hypothesising that RPR titre changes would vary with stage and initial titre.MethodsProspectively identified HIV-seronegative participants at five North American and three Madagascar sites with primary, secondary or early latent syphilis were randomly assigned to penicillin, doxycycline (in the case of penicillin allergy) or azithromycin treatment. Blood for RPR analysis was drawn at days 0, 7, and 14 post-treatment. All RPR titres were determined simultaneously at a central laboratory. Analysis was done using SAS 9.2.Results465 patients had data available for at least 2 of 3 RPR measurements. Median RPR at diagnosis by stage was Primary 1:16, Secondary 1:64, Early Latent 1:32. Overall, 20% of patients showed a titre increase of at least one dilution in the 14 days following therapy. Of this group, 88.2% demonstrated an increase of 1 dilution, while 11.8% demonstrated an increase of ≥2 dilutions. The greatest proportion of titre increases following therapy was seen in patients with primary syphilis.ConclusionsGiven the reliance upon changes in RPR titres for evaluating response to therapy, these changes in titre following therapy could affect whether a response is classified as treatment success/failure or serofast status. Further analyses will evaluate factors associated with increasing RPR titres following therapy, as well as the effect of these changes in titre on evaluation of response to therapy.Abstract O3-S5.05 Table 1StageNMedian RPR at diagnosis% With increased titres within 14 days following treatment (95% CI)% With titres increased by one dilution following therapy (95% CI)% With titres increased by ≥2 dilutions following therapy (95% CI)Primary1151:1630.4 (22.2 to 39.7)80.0 (63.1 to 91.6)20.0 (8.4 to 36.9)Secondary2181:6417.0 (12.2 to 22.6)97.3 (85.8 to 99.9)2.70 (0.1 to 14.2)Early latent1321:3215.9 (10.1 to 23.3)85.7 (63.7 to 97.0)14.3 (3.0 to 36.3)Total4651:6420.0 (16.5 to 23.9)88.2 (79.8 to 93.9)11.8 (6.1 to 20.2)
O3-S5.06 Double-blind randomised placebo controlled trial of oral metronidazole in combination with either vaginal clindamycin or an oestrogen-containing vaginal probiotic for the treatment of bacterial vaginosis
Authors: Bradshaw C , Pirotta M , Hocking J , Garland S , de Guigand D , Fehler G , Morrow A , Walker S , Vodstrcil L , Fairley C 
Published: July 2011

BackgroundTo determine if addition of vaginal clindamycin or an oestrogen-containing vaginal probiotic, to current recommended therapy for bacterial vaginosis (BV), oral metronidazole for 7 days, reduces 6 month recurrence rates.MethodsThree arm randomised double-blind placebo controlled trial of 450 women (150 per arm): [MetPlac] oral metronidazole (7 days)/vaginal placebo (12 days), [MProb] oral metronidazole (7 days)/vaginal probiotic(12 days) and [MetClin] oral metronidazole (7 days)/vaginal clindamycin (1 g 2% nocte,7 days). Symptomatic 18–50-year-old females with BV on vaginal swab by the Nugent method were enrolled at Melbourne Sexual Health Centre, Australia. Participants underwent initial examination & STI screen and completed a detailed behavioural questionnaire at 0, 1, 2, 3 & 6 months. At each interval participants were posted a kit containing swabs and a slide for self-collection and a questionnaire. Principle study outcome: Nugent score of 7–10. Cumulative BV recurrence rates were calculated and compared using χ2and survival analyses using SPSS and STATA.Results450 women with BV were recruited from December 2007 to May 2010. Median age was 27 years (range 18–49), 210 (48%) reported a past history of BV; there were no significant differences in participant demographic or behavioural characteristics between arms. Adherence to study medication did not differ between arms: 382 (91%) took all or most oral metronidazole and 330 (80%) all or most vaginal therapy. Retention rates were high, with 77 (17%) lost to follow-up over 6 months, and did not differ between arms. Participants contributed 153.7 person years of follow-up to analyses. On exit survey 88% of participants did not know or correctly guess the vaginal therapy they had received. Six month cumulative BV recurrence rates did not differ between study arms by per protocol analysis: MetPlac (32%, 95% CI 24% to 41%) MetProb (33%, 25% to 42%) and MetClin (34%, 26% to 42%), p>0.05 (Abstract O3-S5.06 figure 1), or intention-to-treat analysis (noncompleter=recurrence) [recurrence range 44-9%].Abstract O3-S5.06 Figure 1ConclusionsThe addition of vaginal clindamycin or a vaginal probiotic to oral metronidazole does not improve 6 month BV recurrence rates. This is the first RCT to evaluate the efficacy of combination clindamycin/metronidazole for BV treatment, and has important implications for clinical practice. Combination therapy is often used in patients with recurrent BV, but evidence to support this practice has not been available.