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Background: Although risk factors of recurrent and persistent bacterial vaginosis (BV) have been explored in the literature, the longitudinal incidence patterns of BV remain elusive., Methods: We conducted a secondary analysis of longitudinal data from a randomized clinical trial of metronidazole treatment for asymptomatic BV. Repeated-measures latent class analysis was used to identify distinct longitudinal patterns of incident BV cases. Multinomial regression analysis was used to determine the predictors of class membership. The multivariable model included age, last BV treatment, douching frequency, birth control, sexual risk behavior, and assignment to treatment arm., Results: A total of 858 African American women who were asymptomatic for BV were included in the analysis. Three emergent patterns of BV for 12 months were identified by repeated-measures latent class analysis: persistent (55.9%), recurrent (30.5%), and clearance (13.5%). Participants who had douched at least once had significantly lower odds to be in the recurrent class versus the clearance class (adjusted odds ratio [adjOR], 0.55; 95% confidence interval [CI], 0.18-0.63). Women who had sex with women had significantly lower odds of belonging to the persistent class versus the clearance class (adjOR, 0.38; 95% CI, 0.22-0.68) and the recurrent class (adjOR, 0.43; 95% CI, 0.23-0.81). Those who were assigned to the treatment arm had significantly increased odds of being in the recurrent class versus the clearance class (adjOR, 1.92; 95% CI, 1.22-3.03). Women older than 21 years were significantly more likely to be in the recurrent class (adjOR, 1.88; 95% CI, 1.17-3.00) than in the clearance class., Conclusions: Assessment of BV cases revealed distinct patterns of recurrence and persistence of BV, which were significantly associated with douching, being in the treatment arm, and being a woman who had sex with women.

Background: Little is known about the natural history of Mycoplasma genitalium (MG) infection in women. We retrospectively tested archived vaginal fluid samples to assess MG prevalence, incidence, persistence, recurrence and antimicrobial resistance markers among women participating in the Preventing Vaginal Infections trial, a randomized trial of monthly presumptive treatment to reduce vaginal infections., Methods: High-risk, nonpregnant, HIV-negative women aged 18 to 45 years from Kenya and the United States were randomized to receive metronidazole 750 mg + miconazole 200 mg intravaginal suppositories or placebo for 5 consecutive nights each month for 12 months. Clinician-collected swabs containing cervicovaginal fluid were tested for MG using Hologic nucleic acid amplification testing at enrollment and every other month thereafter. Specimens that were MG+ underwent additional testing for macrolide resistance-mediating mutations by DNA sequencing., Results: Of 234 women enrolled, 221 had available specimens and 25 (11.3%) had MG at enrollment. Among 196 women without MG at enrollment, there were 52 incident MG infections (incidence, 33.4 per 100 person-years). Smoking was independently associated with incident MG infection (adjusted hazard ratio, 3.02; 95% confidence interval, 1.32-6.93), and age less than 25 years trended toward an association (adjusted hazard ratio, 1.70; 95% confidence interval, 0.95-3.06). Median time to clearance of incident MG infections was 1.5 months (interquartile range, 1.4-3.0 months). Of the 120 MG+ specimens, 16 specimens from 15 different women were macrolide resistance-mediating mutation positive (13.3%), with no difference by country., Conclusions: M. genitalium infection is common among sexually active women in Kenya and the Southern United States. Given associations between MG and adverse reproductive health outcomes, this high burden of MG in reproductive-aged women could contribute to substantial morbidity.

Men and women attending family planning and sexually transmitted disease clinics for sexually transmitted infection screening in 2012 to 2013 were tested for Trichomonas vaginalis (TV) using a sensitive nucleic acid amplification test. T. vaginalis prevalence in urogenital samples was 11.3% in 77,740 women and 6.1% in 12,604 men, and increased with age in both sexes.

Background: Three recent prospective studies have suggested that the 1-g dose of azithromycin for Chlamydia trachomatis (Ct) was less effective than expected, reporting a wide range of treatment failure rates (5.8%-22.6%). Reasons for the disparate results could be attributed to geographic or methodological differences. The purpose of this study was to reexamine the studies and attempt to harmonize methodologies to reduce misclassification as a result of false positives from early test-of-cure (TOC) or reinfection as a result of sexual exposure rather than treatment failure., Methods: Men who had sex with women, who received 1-g azithromycin under directly observed therapy for presumptive treatment of nongonococcal urethritis with confirmed Ct were included. Baseline screening was performed on urethral swabs or urine, and TOC screening was performed on urine using nucleic acid amplification tests. Posttreatment vaginal sexual exposure was elicited at TOC. Data from the 3 studies were obtained and reanalyzed. Rates of Ct retest positive were examined for all cases, and a sensitivity analysis was conducted to either reclassify potential false positives/reinfections as negative or remove them from the analysis., Results: The crude treatment failure rate was 12.8% (31/242). The rate when potential false positives/reinfections were reclassified as negative was 6.2% (15/242) or when these were excluded from analysis was 10.9% (15/138)., Conclusions: In these samples of men who have sex with women with Ct-related nongonococcal urethritis, azithromycin treatment failure was between 6.2% and 12.8%. This range of failure is lower than previously published but higher than the desired World Health Organization's target chlamydia treatment failure rate of < 5%.

Background: The AmpliVue Trichomonas Assay (Quidel) is a new Federal Drug Administration-cleared rapid test for qualitative detection of Trichomonas vaginalis (TV) DNA in female vaginal specimens. The assay is based on BioHelix's helicase-dependent amplification isothermal technology in conjunction with a disposable lateral-flow detection device, with a total turnaround time of approximately 45 minutes., Objective: The objective of this study was to compare the performance of this new assay to wet preparation and culture as well as to another Federal Drug Administration-cleared nucleic acid amplification assay., Methods: Four clinician collected vaginal swabs were obtained from women attending sexually transmitted disease, family planning, and OB/GYN clinics and tested by AmpliVue Trichomonas Assay and comparator tests: saline microscopy, TV culture (InPouch), and Aptima TV. AmpliVue Trichomonas Assay results were compared with a composite positive comparator (CPC) as determined by the results from culture and/or wet mount microscopic examination. At least one of either the wet preparation or culture reference test results was required to be positive to establish CPC., Results: A total of 992 patients, 342 symptomatic and 650 asymptomatic patients, were included in the study. Results for AmpliVue for all women combined compared with saline microscopy and culture as a CPC yielded a sensitivity of 100%. Specificity for all women was 98.2%. Overall percent agreement versus Aptima TV was 97.8%. Sensitivity for AmpliVue compared with Aptima was 90.7% %, whereas specificity was 98.9%., Conclusions: The rapid AmpliVue Trichomonas Assay performed as well as microscopy and culture, and had comparable sensitivity and specificity to another nucleic acid amplification test for the detection of TV. This study provided evidence of new diagnostic options and indicated very good performance of amplified testing for detection of TV in symptomatic and asymptomatic women.

Background: Mucopurulent cervicitis (MPC) is a clinical syndrome characterized by mucopurulent discharge from the cervix and other signs of inflammation. This was a phase III, multicenter study designed to evaluate the effectiveness of placebo versus empiric antibiotic treatment for clinical cure of MPC of unknown etiology at 2-month follow-up. Unfortunately, enrollment was terminated because of low accrual of women with cervicitis of unknown etiology, but important prevalence and outcome data were obtained., Methods: Five hundred seventy-seven women were screened for MPC. Women with MPC were randomized to the treatment or placebo arm of the study, and the 2 arms were evaluated based on the etiology, clinical cure rates, adverse events (AEs), and rates of pelvic inflammatory disease., Results: One hundred thirty-one (23% [131/577]) screened women were found to have MPC. Eighty-seven were enrolled and randomized. After excluding women with sexually transmitted infections and other exclusions, 61% (53/87) had cervicitis of unknown etiology. The overall clinical failure rate was 30% (10/33), and the clinical cure rate was only 24% (8/33). Rates were not significantly different between the arms. There were 24 gastrointestinal AEs in the treatment arm compared with 1 AE in the placebo arm., Conclusions: More than half of the cases of MPC were of unknown etiology. Clinical cure rates for the placebo and treatment arms were extremely low, with most women concluding the study with a partial response. Gastrointestinal AEs were higher in the treatment arm.

Objective: Although testing for Chlamydia trachomatis is encouraged and increasingly practiced at sexually transmitted disease (STD) and family planning clinics, patterns of testing and follow-up in other settings are not well described. To begin to address these issues, we performed a chart review of patients with a positive laboratory test for C. trachomatis at a major university medical center., Methods: Chart review of medical records for all patients with positive laboratory tests for C. trachomatis during calendar year 1996., Results: Of 326 patients with positive tests, 95% were female and 5% were male. Median age was 22 for females and 25 for males. Most positive C. trachomatis test results were from the emergency room (ER)/walk-in clinic (55%) or patients receiving obstetric/gynecologic (OB/GYN) care (31%). While most C. trachomatis tests performed were on patients who had symptoms, patterns of treatment varied between sites. Fifty-seven percent of ER/walk-in patients received empiric antibiotics at the initial visit versus 36% of patients under OB/GYN care. Among patients with positive screening tests seen in the ER/walk-in clinic, 32% of patients had no treatment documented versus 14% of OB/GYN patients. Four percent of women with positive tests who did not receive therapy at the time of their initial evaluation developed pelvic inflammatory disease in the interval between testing and return to the medical center., Conclusions: Of the patients with positive chlamydial screening tests, the proportion not treated was similar to that found in studies performed in STD clinics.

Background and Objectives: A cross-sectional survey of sexually transmitted disease (STD) patients assessed sexual activity and condom use during the time between STD symptom onset and clinic attendance., Study Design: Patients were asked to report sexual activity and condom use while STD symptoms were present. Medical records were abstracted for diagnoses., Results: The study population (n = 3025) was predominately African American (75.3%) and male (63.5%), with a mean age of 28.1 years. Sexual activity while experiencing STD symptoms was reported by 39.7% of 2,508 symptomatic patients, 17.2% of whom reported always using a condom. Logistic regression models identified the significant independent determinants of sexual intercourse while symptomatic were duration of symptoms before clinic visit [0-7 days versus 8 or more days, OR = 5.9]; race [African American versus other races (primarily Hispanics), OR = 2.1]; and gender [men versus women, OR = 1.5]. Older age [> or = 30 years versus 18-29 years, OR = 1.5] and higher education attainment [> or = high school versus > high school, OR = 1.5] were the significant factors associated with reporting always using a condom., Conclusion: These data suggest patient groups with behaviors likely to enhance STD transmission could be targeted for educational messages.

Background and Objectives: The ability to study daily changes in the vaginal flora may provide insight into the pathogenesis of bacterial vaginosis. Because culture of the vaginal fluid is tedious and expensive, the utility of self-obtained vaginal smears for documenting changes in the flora was evaluated., Goals: To validate the adequacy of self-collected vaginal fluid Gram stains and use them to monitor vaginal flora., Study Design: Ten asymptomatic premenopausal women collected daily vaginal smears for 30 days. The smears were Gram stained and interpreted using a standardized scoring system (Nugent criteria). In addition, results from self- and clinician-obtained vaginal smears from 18 women were compared to validate the adequacy of self-obtained smears., Results: Two women had asymptomatic bacterial vaginosis. One woman, who was postpartum, had intermediate flora that toward the end of the collection period changed to Lactobacillus predominant. The remaining seven women exhibited two patterns. One was Lactobacillus morphotypes only; the second consisted of Lactobacillus-predominant days interspersed with days with moderate to high numbers of Gardnerella/Bacteroides morphotypes. There was a significant correlation of the point of change in the flora of this group with menses., Conclusions: The adequacy of self-collected vaginal fluid Gram's stains was validated. Changes in vaginal flora were demonstrated over a 30-day period by use of this methodology.

Background and Objectives: Patients attending sexually transmitted diseases (STD) clinics may be at high risk for tuberculosis (TB) infection. The authors conducted a pilot study of TB screening in this setting to determine the prevalence of TB infection and compliance of the population with a screening program., Goals: To determine the prevalence of positive skin test results indicating TB among patients attending an STD clinic and to test a simple incentive designed to enhance compliance with return visits for skin test interpretation., Study Design: Skin tests for TB were offered to clients attending an STD clinic. Testing was accompanied by self-assessment questionnaires designed to assess risk for TB. After 2 months, a simple incentive package was initiated to enhance compliance with skin test interpretation., Results: The prevalence of positive skin test results was 34%. Compliance with return visits was doubled by use of the simple incentive package., Conclusions: Patients attending STD clinics are at high risk for TB and can be motivated toward increased compliance by the use of simple incentives.

Background: Obstetric and gynecologic complications associated with bacterial vaginosis and trichomoniasis have heightened awareness of these conditions, and thus metronidazole's role in obstetric and gynecologic practice continues to increase., Goal of This Study: To review the clinical indications for metronidazole in the obstetric and gynecologic setting, as well as the pharmacokinetics and potential adverse effects of the drug., Study Design: Review of the current literature concerning metronidazole., Results and Conclusions: Metronidazole remains a valuable agent for the treatment of anaerobic and protozoal infections with little evidence of resistance. Although issues of mutagenicity and carcinogenicity remain theoretical concerns, current data do not support the existence of these risks in humans.