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Objective. Interventions to reduce high-risk behaviors such as sex and substance use among youths have focused mainly on promoting abstinence, refusal skills, and negotiation skills, yet the frequency of high-risk behaviors among youths may also be influenced by opportunity, particularly the amount of time during which they are not supervised by adults. In this study, we examined when and where youths have sex and whether there is a relationship between unsupervised time and sex, sexually transmitted diseases (STDs), and substance use. Methods. A cross-sectional survey was conducted in 6 public high schools in an urban school district. Participants were 1065 boys and 969 girls from a school-based STD screening program. Ninety-eight percent of students were black, and 79% were in the free or reduced lunch program. Most students reported living with 1 parent only, primarily the mother (52%); only 27% lived in 2-parent families. Sexual activity, substance use, and the prevalence of gonorrhea or chlamydia as determined by a ligase-chain reaction test on a urine sample were measured. Results. Fifty-six percent reported being home without an adult present 4 or more hours per day after school. There was no difference in the number of unsupervised after-school hours between children in 1- and 2-parent families. Fifty-five percent of boys and 41% of girls were participating in or planned to participate in after-school activities during the school year. Boys were more likely than girls to report having had sex for the first time before age 14 (42% vs 9%) and had a greater number of lifetime sex partners (mean: 4.2 vs 2.4 partners). Among the respondents who had had intercourse, 91% said that the last time had been in a home setting, including their own home (37%), their partner's home (43%), and a friend's home (12%), usually after school. Boys were more likely than girls to report having had sex in their own homes (43% vs 28%) and less likely than girls to report having had sex in their partner's homes (30% vs 59%). Fifty-six percent of youths who had had intercourse reported that the last time was on a weekday: 18% before 3:00 PM, 17% between 3:00 and 6:00 PM, and 21% after 6:00 PM. There were no gender differences in the day of the week or time of day during which students reported having had intercourse. Youths who were unsupervised for 30 or more hours per week were more likely to be sexually active compared with those who were unsupervised for 5 hours a week or less (80% vs 68%). In addition, for boys, the greater the amount of unsupervised time, the higher the number of lifetime sex partners. Among girls but not among boys, sexual activity was associated with nonparticipation in after-school programs; 71% of those who were not participating in an after-school activity were sexually active compared with 59% of those who were participating. Tobacco and alcohol use were associated with unsupervised time among boys but not among girls. Boys who were unsupervised >5 hours per week after school were twice as likely to have gonorrhea or chlamydial infection as boys who were unsupervised for 5 hours or less. Conclusions. We found that substantial numbers of youths currently spend long periods of time without adult supervision and have limited opportunities to participate in after-school activities. More than half of sexually active youths reported that they had sex at home after school, and, particularly for boys, sexual-and drug-elated risks increased as the amount of unsupervised time increased. As youths come of age, parents probably believe that it is appropriate to leave them increasingly on their own, and, accordingly, prevention approaches have concentrated on providing information and motivation for abstinence or safer sex. However, given the independent association between the amount of unsupervised time and sexual behaviors (with STD rates suggestive of particularly risky sexual behaviors) and substance use behaviors, it is worth considering increasing youth supervision, if not by parents, then by programs organized at school or other community settings. Parents and community members should consider increasing opportunities for supervised activities to determine whether this will reduce risk-taking among youths. Pediatrics 2002;110(6). URL: http://www.pediatrics.org/ cgi/content/full/110/6/e66; sex, adult supervision, sexually transmitted diseases, high-risk behaviors.

WC2031, a delayed-release doxycycline administered once daily, was noninferior to Vibramycin administered twice daily when given orally for 7 days for treatment of uncomplicated urogenital chlamydia in men and women. WC2031 appeared to be better tolerated and demonstrated a favorable safety profile.Background. Recent studies have raised concern about efficacy of azithromycin for Chlamydia trachomatis infection. Research investigating new antibiotic regimens for chlamydia has been sparse, especially regimens that may reduce adherence difficulties with the recommended twice-daily doxycycline regimen.Methods. We conducted a randomized, double-blind, double-dummy, active-controlled, multicenter trial with the objective of evaluating the safety and efficacy of WC2031 (doxycycline hyclate delayed-release 200-mg tablet) orally once daily for 7 days versus Vibramycin (doxycycline hyclate capsule) 100 mg orally twice daily for 7 days for treatment of uncomplicated urogenital chlamydia. Men and nonpregnant women aged 19–45 years with a urogenital chlamydial diagnosis or a sexual partner with chlamydia were eligible. The primary outcome was microbial cure by nucleic acid amplification testing at day 28. Noninferiority of WC2031 was inferred if the lower limit of the 95% confidence interval (CI) of the difference in cure rates was >−10%.Results. A total of 495 subjects were randomized. The modified intent-to-treat (mITT) population with evaluable efficacy consisted of 323 subjects. Baseline patient characteristics did not differ between the mITT groups. Microbial cure rates for WC2031 were 95.5% (95% CI, 92.3–98.8) versus 95.2% (95% CI, 92.0–98.4) for Vibramycin (95% CI for the difference in cure rates, −4.3% to 4.9%). Types of adverse events were comparable. Nausea and vomiting occurred less frequently with WC2031 than with Vibramycin (13% vs 21% and 8% vs 12%, respectively).Conclusions. WC2031 was noninferior to Vibramycin for uncomplicated urogenital chlamydia treatment, better tolerated, and demonstrated comparable safety. WC2031 could improve treatment adherence over twice-daily Vibramycin.Clinical Trials Registration. NCT01113931. [ABSTRACT FROM AUTHOR]

The article presents a study which evaluates the performance of the BD ProbeTec chlamydia trachomatis Q (CTQ) amplified DNA assay on BD Viper System. It outlines the method of the study which uses 1538 men and women attending sexually transmitted disease, family planning, and obstetrics clinics. The study indicates that the performance of CTQ assay are comparable with other commercially available nucleic acid-based tests such as Aptima Combo 2 and BD Probtec.

The author focuses on trichomonas vaginalis (TV), a sexually transmitted disease. Topics discussed include lack of medical screening, surveillance or control programs for people having TV, sexually transmitted disease (STD) guidelines of the U.S. Centers for Disease Control & Prevention (CDC) suggesting TV screening for the infected women having vaginal discharge, and TV infection rates in older patients higher than those suffering from Neisseria gonorrhoeae and Chlamydia trachomatis.

Molecular-based assays demonstrate excellent sensitivity for the detection of vaginitis causes. Here, the high-throughput BD Vaginal Panel for BD COR System (VP-COR) performance was compared to that of the predicate, BD MAX Vaginal Panel for BD MAX System (VP-MAX). Clinical or contrived samples were used to determine the agreement between VP-COR and VP-MAX. Acceptance criteria for VP-COR agreement were as follows: bacterial vaginosis (BV) required a positive percent agreement (PPA) point estimate of ≥95% and a negative percent agreement (NPA) point estimate of ≥98%; Candida group, Candida glabrata , Candida krusei , and Trichomonas vaginalis (TV) required a PPA and NPA point estimate of ≥95% [with lower bound of 95% confidence interval (95% CI) ≥90%]. PPA was 99.5% (95% CI: 97.5-100) and 97.9% (95% CI: 96.5-98.8) for BV contrived ( n = 516) and BV clinical ( n = 1,050) specimens, respectively. For the Candida group (clinical; n = 724), C. glabrata (contrived; n = 544), C. krusei (contrived; n = 522), and TV (clinical; n = 702), PPA was 99.4% (95% CI: 98.0-99.9), 100% (95% CI: 97.9-100), 100% (95% CI: 97.6-100), and 99.7% (95% CI: 98.3-100), respectively; the lowest lower bound CI value was 97.6%. NPA was >95% for BV contrived and BV clinical specimens. For the Candida group, C. glabrata , C. krusei , and TV, NPA was ≥98.9%; the lowest lower bound CI value was 97.3%. These results demonstrate the equivalent performance of the VP-COR assay when compared to VP-MAX.IMPORTANCEVaginitis is common among women of reproductive age, resulting in around 10 million office visits a year. Diagnosis is often difficult due to its multiple causes-including bacterial vaginosis, vulvovaginal candidiasis, and trichomoniasis-as well as variation in symptom presentation. Typically, cases are identified with a combination of symptomology, medical history, physical examination, and office- or laboratory-based testing. These traditional techniques involve subjective elements and demonstrate varying sensitivity and specificity. Inaccurate or delayed diagnosis leads to continued symptoms, repeat visits, inappropriate treatment, and unnecessary costs. Alternatively, the use of molecular-based assays increases sensitivity for the detection of vaginitis causes. With the validation of the vaginal panel molecular assay on COR (a high-throughput platform), a workflow can be streamlined in high-demand laboratories while providing high sensitivity for vaginitis detection., Competing Interests: E.S. and E.L. are employees of the study sponsor, Becton, Dickinson and Company, BD Life Sciences–Diagnostic Solutions. W.G. and S.N.T. received research funding as part of this study.

Objectives: Infections due to Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) are among the most common bacterial sexually transmitted infections worldwide, most of which are asymptomatic. Detection of infection using a variety of specimen types in symptomatic and asymptomatic subjects is important to effectively combat CT/NG infections. The performance of the cobas CT/NG v2.0 test was assessed for urogenital swabs, urine and cervical cytology samples collected in PreservCyt Solution from 5266 symptomatic and asymptomatic women (including 202 who were pregnant), and urine from 738 men., Methods: Sensitivity and specificity were estimated compared with a patient infected status determined using two US Food and Drug Administration-cleared nucleic acid amplification tests., Results: Among 6004 participants, 487 CT (8.1%) and 159 NG (2.6%) infections were identified. Sensitivity estimates for CT for women ranged from 91.2% to 97.6% depending on specimen type, and the estimate for male urine specimens was 98.4%. Specificity for CT ranged from 99.2% to 99.7%. Sensitivity estimates for NG ranged from 95.6% to 100.0% for women, and the estimate for men was 100.0%. Specificity for NG ranged from 99.3% to 100.0%., Conclusions: The cobas CT/NG v2.0 test performs well using urogenital swabs, urine and cervical samples collected in PreservCyt solution., Competing Interests: Competing interests: BVDP discloses consulting honoraria or research funding received from Atlas Genetics, BD Diagnostics, Beckman Coulter, Cepheid, Rheonix and Roche Molecular Systems. EWH III has received research support from Roche Molecular Systems, BD Diagnostics, Hologic Gen-Probe Inc., Siemens and Cepheid. SNT discloses research support from Roche Molecular Systems, BD Diagnostics, Hologic Gen-Probe Inc. and Cepheid. BAB discloses being former employee and officer of Laboratory Corporation, Holdings (LabCorp) and advisory board service and contracts for laboratory work for Roche Diagnostics for which LabCorp was compensated and advisory board service for Roche Molecular Systems for which LabCorp was compensated. She has current consulting contracts with LabCorp, Qiagen, Inc. and Meridian Biosciences, Inc. JO, ML and OL are employees of Roche Molecular Diagnostics. No other authors disclose conflicts of interest., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: In this phase 2 study, we evaluated the efficacy and safety of oral gepotidacin, a novel triazaacenaphthylene bacterial type II topoisomerase inhibitor, for the treatment of uncomplicated urogenital gonorrhea., Methods: Adult participants with suspected urogenital gonorrhea were enrolled and completed baseline (day 1) and test-of-cure (days 4-8) visits. Pretreatment and posttreatment urogenital swabs were collected for Neisseria gonorrhoeae (NG) culture and susceptibility testing. Pharyngeal and rectal swab specimens were collected if there were known exposures. Participants were stratified by gender and randomized 1:1 to receive a 1500-mg or 3000-mg single oral dose of gepotidacin., Results: The microbiologically evaluable population consisted of 69 participants, with NG isolated from 69 (100%) urogenital, 2 (3%) pharyngeal, and 3 (4%) rectal specimens. Microbiological eradication of NG was achieved by 97%, 95%, and 96% of participants (lower 1-sided exact 95% confidence interval bound, 85.1%, 84.7%, and 89.1%, respectively) for the 1500-mg, 3000-mg, and combined dose groups, respectively. Microbiological cure was achieved in 66/69 (96%) urogenital infections. All 3 failures were NG isolates that demonstrated the highest observed gepotidacin minimum inhibitory concentration of 1 µg/mL and a common gene mutation. At the pharyngeal and rectal sites, 1/2 and 3/3 NG isolates, respectively, demonstrated microbiological cure. There were no treatment-limiting adverse events for either dose., Conclusions: This study demonstrated that single, oral doses of gepotidacin were ≥95% effective for bacterial eradication of NG in adult participants with uncomplicated urogenital gonorrhea., Clinical Trials Registration: NCT02294682.

Trichomonas vaginalis is the most prevalent nonviral sexually transmitted infection worldwide, and improved diagnostic methods are critical for controlling this pathogen. Diagnostic assays that can be used in conjunction with routine chlamydia/gonorrhea nucleic acid-based screening are likely to have the most impact on disease control. Here we describe the performance of the new BD T. vaginalis Qx (TVQ) amplified DNA assay, which can be performed on the automated BD Viper system. We focus on data from vaginal swab samples, since this is the specimen type routinely used for traditional trichomonas testing and the recommended specimen type for chlamydia/gonorrhea screening. Vaginal swabs were obtained from women attending sexually transmitted disease or family planning clinics at 7 sites. Patient-collected vaginal swabs were tested by the TVQ assay, and the Aptima T. vaginalis (ATV) assay was performed using clinician-collected vaginal swabs. Additional clinician-collected vaginal swabs were used for the wet mount and culture methods. Analyses included comparisons versus the patient infection status (PIS) defined by positive results with the wet mount method or culture, direct comparisons assessed with κ scores, and latent class analysis (LCA) as an unbiased estimator of test accuracy. Data from 838 women, 116 of whom were infected with T. vaginalis, were analyzed. The TVQ assay sensitivity and specificity estimates based on the PIS were 98.3% and 99.0%, respectively. The TVQ assay was similar to the ATV assay (κ=0.938) in direct analysis. LCA estimated the TVQ sensitivity and specificity as 98.3 and 99.6%, respectively. The TVQ assay performed well using self-collected vaginal swabs, the optimal sample type, as recommended by the CDC for chlamydia/gonorrhea screening among women.