ESwab as an optional collection device for use with the Affirm VPIII microbial test system.

The ESwab collection device was compared to the collection swab provided as part of the Affirm VPIII microbial identification test kit for testing vaginal specimens with the Affirm test system. There was excellent agreement between the two sampling devices for Candida spp., Gardnerella vaginalis, and Trichomonas vaginalis.

Re-evaluating the treatment of nongonococcal urethritis: emphasizing emerging pathogens--a randomized clinical trial.

BACKGROUND: Nongonococcal urethritis (NGU) is a common chlamydia-associated syndrome in men; however, Trichomonas vaginalis and Mycoplasma genitalium are associated with its etiology and should be considered in approaches to therapy. We sought to determine whether the addition of tinidazole, an anti-trichomonal agent, to the treatment regimen would result in higher cure rates than those achieved with treatment with doxycycline or azithromycin alone. A secondary aim was to compare the efficacy of doxycycline therapy and with that of azithromycin therapy. METHODS: Randomized, controlled, double-blinded phase IIB trial of men with NGU. Participants were randomized to receive doxycycline plus or minus tinidazole or azithromycin plus or minus tinidazole and were observed for up to 45 days. RESULTS: The prevalences of Chlamydia trachomatis, M. genitalium, and T. vaginalis were 43%, 31%, and 13%, respectively. No pathogens were identified in 29% of participants. Clinical cure rates at the first follow-up visit were 74.5% (111 of 149 patients) for doxycycline-containing regimens and 68.6% (107 of 156 patients) for azithromycin-containing regimens. By the final visit, cure rates were 49% (73 of 149 patients) for doxycycline-containing regimens and 43.6% (68 of 156 patients) for azithromycin-containing regimens. There were no significant differences in clinical response rates among the treatment arms. However, the chlamydia clearance rate was 94.8% (55 of 58 patients) for the doxycycline arm and 77.4% (41 of 53 patients) for the azithromycin arm (P = .011), and the M. genitalium clearance rate was 30.8% (12 of 39 patients) for the doxycycline arm and 66.7% (30 of 45 patients) for the azithromycin arm (P = .002). CONCLUSIONS: Addition of tinidazole to the treatment regimen did not result in higher cure rates but effectively eradicated trichomonas. Clinical cure rates were not significantly different between patients treated with doxycycline and those treated with azithromycin; however, doxycycline had significantly better efficacy against Chlamydia, whereas azithromycin was superior to doxycycline for the treatment of M. genitalium.

Longitudinal assessment of nonavalent vaccine HPV types in a sample of sexually active African American women from ten U.S. Cities.

BACKGROUND: Chronic infection with high-risk human papillomavirus is a necessary cause for cervical carcinogenesis. This study examined prevalence of nonavalent vaccine preventable HPV types over four months among sexually active women in the United States. METHODS: This sub-study obtained meta-data for 80 of the 1,365 women (18-25 years), enrolled in the BRAVO study, a randomized, open-label trial of home screening and treatment of asymptomatic bacterial vaginosis at high-risk for sexually transmitted infections conducted between 2008 and 2013. Participants were randomized to treatment or standard-of-care, and followed every 2-months for 12 months. Stored vaginal swabs from the first three visits were tested for the nine vaccine preventable HPV types using quantitative PCR. Prevalence and associated 95% confidence intervals for the HPV types were assessed using R (version 3.6.1). RESULTS: The average age of the participants was 21.5 (SD ± 2.11) years, with 60% having ever been pregnant and all were African-American. Majority (71%) reported ≥ two sex partners in the prior year with 89% having unprotected vaginal sex and 45% having a new sex partner in the prior year. About 30% had ≥ one of the nine nonavalent vaccine HPV types at all three time points over a period of four months, 15% at two of any three visits, 19% at one of the three visits and 36% were negative for all nine vaccine HPV types at all time points. The most frequently detected HPV vaccine types were 52, 58, 16, and 18. The prevalence of any vaccine HPV types, and high-risk HPV types was 63.8% and 58.8%, respectively. CONCLUSIONS: Our findings suggest that HPV vaccination which is currently recommended for all unvaccinated persons through age 26 years, is likely to be more beneficial than previously thought as nonavalent HPV vaccine was not available during the time these data were collected.

Viability of Trichomonas vaginalis in Copan universal transport medium and eSwab transport medium.

We compared the use of universal transport medium and eSwab transport medium held at room temperature or 37 degrees C to bedside inoculation and immediate incubation of culture media for the detection of Trichomonas vaginalis. There were no significant culturable differences in the sensitivity of either of the transport media to that of bedside inoculation.

The polymicrobial hypothesis of bacterial vaginosis causation: a reassessment.

The cause of bacterial vaginosis remains controversial. The two leading hypotheses are that Gardnerella vaginalis is the specific aetiologic agent versus the polymicrobial hypothesis that G. vaginalis acts in concert with other bacteria, principally anaerobes, to produce the disease. Here we reassess the prevailing polymicrobial hypothesis, finding it conceptually problematical. No host initiating factors as postulated have been identified, nor is there conclusive evidence that G. vaginalis lacks diagnostic specificity for the disease. The polymicrobial hypothesis, presupposing a unique disruption of vaginal microecology, is inconsistent with the epidemiological profile of the syndrome, which is that of a sexually transmitted disease. The epidemiological and clinical similarities between bacterial vaginosis and trichomoniasis suggest a similar pathogenetic process; i.e., primary causation by a specific agent, with secondary anaerobic activation and resultant amine production.

A randomized trial of the duration of therapy with metronidazole plus or minus azithromycin for treatment of symptomatic bacterial vaginosis.

BACKGROUND: Bacterial vaginosis (BV) is the most common cause of vaginitis worldwide. Currently recommended treatments have poor efficacy and are associated with high rates of BV recurrence. We examined whether a longer duration of treatment with metronidazole or combination therapy with metronidazole and azithromycin would enhance the cure rates for BV. In addition, we examined factors other than drug therapy associated with cure. METHODS: Women with symptomatic BV (defined by a modified Amsel criteria) were enrolled in a 4-arm study that compared metronidazole for 7 days versus 14 days, plus or minus azithromycin on days 1 and 3. Data regarding interim behaviors were also obtained, as were vaginal specimens for Gram staining. RESULTS: At the first follow-up visit (7 days after the completion of therapy), there was a significant difference in cure rates among patients who received 7 days of metronidazole therapy, compared with those who received 14 days of therapy, combined across azithromycin therapy (P=.0003). There was no effect associated with azithromycin therapy. There were no differences in cure rates between any of the treatment groups at 21 days after completion of therapy. Abstinence or protected sex, refraining from douching, and a lower baseline Nugent score for the vaginal Gram stain were all significantly associated with cure. CONCLUSIONS: Cure rates for BV were significantly improved by 14 days of metronidazole treatment (compared with 7 days of treatment), but the effects were not sustained, suggesting that relapse or reinfection occurred. Combination therapy with the addition of azithromycin had no benefit. Lower baseline Nugent scores--presumably reflecting less complex vaginal flora--were significantly associated with cure, as was refraining from unprotected sex and from douching.

Clinical performance of the Solana® Point-of-Care Trichomonas Assay from clinician-collected vaginal swabs and urine specimens from symptomatic and asymptomatic women.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSION: The Solana® assay performed well compared to the reference assays.

Randomized trial of trovafloxacin and ofloxacin for single-dose therapy of gonorrhea. Trovafloxacin Gonorrhea Study Group.

PURPOSE: To compare trovafloxacin, a new quinolone antibiotic with enhanced activity against Neisseria gonorrhoeae, with ofloxacin as single-dose oral therapy for uncomplicated gonococcal urethritis or cervicitis. PATIENTS AND METHODS: In this multicenter, double-blind trial, 625 patients (270 men, 355 women) with uncomplicated gonococcal urethritis or cervicitis received one 100-mg tablet of trovafloxacin or two 200-mg capsules of ofloxacin as a single dose under direct supervision. RESULTS: Single-dose oral therapy with trovafloxacin was equivalent both bacteriologically and clinically to ofloxacin. Among evaluable patients, N gonorrhoeae was eradicated in 99% of trovafloxacin recipients and in 98% of ofloxacin recipients. Each treatment was well tolerated; vaginitis was the most frequently observed side effect (4% trovafloxacin, 7% ofloxacin). CONCLUSION: Based on the results presented here, trovafloxacin is a promising agent for single-dose therapy of uncomplicated gonorrhea.

An international study of the interobserver variation between interpretations of vaginal smear criteria of bacterial vaginosis.

An international workshop on vaginal smear-based diagnosis of bacterial vaginosis was organized where 13 investigators scoring 258 slides with smears from vaginal fluid. Interobserver reproducibility of interpretations of Nugent scores, Hay/Ison scores and wet smear scores for the diagnosis of bacterial vaginosis was shown to be high. Detailed analysis of individual scoring results however indicated that basic standards of quality control to ensure robust individual readings of slides must be adhered to.

Validity of the vaginal gram stain for the diagnosis of bacterial vaginosis.

OBJECTIVE: To determine the sensitivity and specificity of vaginal Gram stain as interpreted by the Nugent criteria for the diagnosis of bacterial vaginosis, and to consider the use of Gram stain as the criterion standard for the diagnosis of bacterial vaginosis. METHODS: A multicenter study was conducted of women attending gynecology or sexually transmitted disease clinics. Clinical data consisting of vaginal pH, "whiff test," clue cells, and appearance of the vaginal discharge (Amsel criteria) were compared with the vaginal fluid Gram stain (Nugent criteria) for the diagnosis of bacterial vaginosis. RESULTS: The sensitivity and specificity of the Gram stain compared with the Amsel criteria were 89 and 83%, respectively. There was significant variation in the specificity values by geographic site. If the Gram stain was considered the criterion standard for the diagnosis of bacterial vaginosis, the sensitivity and specificity of the Amsel criteria were 70 and 94%, respectively. CONCLUSION: The vaginal Gram stain (Nugent criteria) is a sensitive method for the diagnosis of bacterial vaginosis. The 83% specificity suggests that the currently used Amsel criteria may lead to the underdiagnosis of bacterial vaginosis.

Evaluation of Syva's enzyme immunoassay for the detection of Chlamydia trachomatis in urogenital specimens.

A newly developed microwell enzyme immunosorbent assay (EIA) system by Syva Company (Palo Alto, CA) can detect Chlamydia trachomatis in < 3 hr. It uses a polyclonal antibody to chlamydial lipopolysaccharide and end points are determined with a spectrophotometer. Three clinical trial sites (University of California Medical Center, San Francisco, CA; University of Washington, Seattle, WA; and Louisiana State University Medical Center, New Orleans, LA), compared this EIA with tissue culture (TC) for identifying Chlamydia in urogenital specimens. Overall prevalence by TC was 10.4% (136 of 1306). When tests were compared with TC (using vials or microtiter plates and a fluorescent antibody stain), we found an EIA sensitivity of 93.4% (127 of 136) and a specificity of 98.1% (1148 of 1170). This EIA has a performance profile that is, at the very least, comparable with other nonculture methods for diagnosing genital tract infections with C. trachomatis.

The validity of injecting drug users' self-reports about sexually transmitted diseases: a comparison of survey and serological data.

Researchers studying the validity of injecting drug users' self-reports have often reported a high degree of correspondence between self-reports and several types of criterion variables. In this study, injecting drug users' responses to questions about prior infection with four sexually transmitted diseases were compared with serological test data. For three of the four diseases studied, discrepancies between survey and serological results were quite large, especially when respondents said they had no previous history of infection. Limitations of serological testing, the questions asked, respondent knowledge and the more traditional concern with respondent veracity are discussed as possible explanations for the observed differences. Study data suggest that use of drug injectors' self-reports to measure infection with sexually transmitted diseases or to validate other measures is a questionable practice. Problems encountered in interpreting study results provide support for more frequent use of experimental or quasi-experimental designs and of multivariate analytic techniques when conducting research on response validity.

Sexually transmitted diseases in Ulaanbaatar, Mongolia.

Although human immunodeficiency virus (HIV) rates are increasing rapidly in Asia, a full understanding of the extent of other sexually transmitted diseases (STDs) in many of these areas is lacking. There have been anecdotes of rising rates of STDs in Mongolia, a country thus far relatively unaffected by HIV. To further the understanding of STDs, a prevalence study was conducted in the STD clinic in Ulaanbaatar, the capital and largest city in Mongolia. Among 260 patients, the prevalence of gonorrhoea, chlamydia and syphilis was 31.1%, 8.1% and 8.6% respectively for males and 10.3%, 9.9% and 6.0% for females. Sixty-seven per cent of females had trichomoniasis and 19.7% of males had non-gonococcal urethritis (NGU). Forty-two per cent of gonococcal isolates had plasmid mediated resistance to penicillin, and chromosomal resistance to penicillin, tetracycline, and ciprofloxacin was documented. No patients were infected with HIV. STDs are a significant problem in Mongolia. Improved control efforts are urgently needed to prevent the emergence of HIV.

PIP: Situated between Russia and China, two countries with growing rates of HIV prevalence, Mongolia is a country with a population of 2.3 million people. Although there is only 1 known case of HIV infection in Mongolia, HIV is spreading rapidly in Asia. The prevalence of sexually transmitted diseases (STDs) was assessed among 137 men and 123 women of mean ages 26 and 28 years, respectively, attending the public health STD clinic in Ulaanbaatar, the capital and largest city of Mongolia. Overall, study subjects were aged 15-62 years and mainly from urban areas. Only 1 man and 1 woman admitted to having sex with a same-sex partner. 7% of men and 10% of women consistently used condoms, and 45% of men and 33% of women reported ever having had STDs. 31.1%, 8.1%, and 8.6% of men and 10.3%, 9.9%, and 6.0% of women were infected with gonorrhea, chlamydia, and syphilis, respectively. 19.7% of men had nongonococcal urethritis and 67% of women had trichomoniasis. 42% of gonococcal isolates were plasmid-mediated resistant to penicillin, while chromosomal resistance to penicillin, tetracycline, and ciprofloxacin was observed. Even though no patient was infected with HIV, improved control efforts are urgently needed to prevent the spread of HIV in Mongolia given the existence and communication of STDs in the country.

Risk for HIV infection among health care workers. Nine questions physicians often ask.

Consideration is given to the risk from needlestick injury and other accidental exposure to blood and bodily fluids infected with HIV. Recommendations are made for postexposure prophylaxis with zidovudine: how soon to start administering the drug, optimal dosages, and subsequent monitoring of the person who has been exposed. Also discussed is the possibility of additional risks incurred by pregnant health care workers.

Gardnerella vaginalis: Still a Prime Suspect in the Pathogenesis of Bacterial Vaginosis.

Bacterial vaginosis (BV) is the most common cause of vaginal infection, yet its pathogenesis remains controversial. Although it has never been proven to be a sexually transmitted diseases the epidemiological evidence favoring this is quite robust. Although BV is characterized by its polymicrobial nature, it is highly likely that the inciting organism is Gardnerella vaginalis.

Update of trichomoniasis.

Trichomoniasis remains an extremely common infection despite the fact that rates of other treatable sexually transmitted diseases are declining. Newer diagnostic techniques such as polymerase chain reaction (PCR) are documenting higher rates of infection in heterosexual men than have been previously found with culture. Although data on the association of vaginal trichomoniasis with preterm birth are controversial, the association of trichomoniasis with HIV acquisition seems clear. Despite being a readily diagnosed and treated STD, trichomoniasis is not a reportable infection and control of the infection has received relatively little emphasis from public health STD control programmes. More recently, however, appreciation of high rates of disease and of associations of trichomoniasis in women with adverse outcomes of pregnancy and increased risk for HIV infection suggest a need for increased control efforts.