bluuebunny/crossref_metadata_2025 huggingface dataset:
P3-S1.43 Women friendly gonorrhoea culture by self taken vaginal swabs for the purpose of surveillance of gonorrhoea resistance
Authors: Götz H M , Luijendijk A , Nuradini B , van Westreenen M
Published: July 2011

Background

Surveillance of Gonorrhoea resistance is a public health priority. At the Rotterdam STI clinic diagnostic tests for gonorrhoea are done by NAAT techniques from urine in men, and (self taken) vaginal swabs in women. For the purpose of resistance monitoring confirmation by culture is performed from urethra in men and cervix in women. In this study we evaluated whether culture is possible from vaginal swab, and whether women could perform this by self taken vaginal swabs.

Methods

Gonorrhoea diagnostic is performed by SDA technique (BD-USA). For Culture swabs are put on GC-lect agar plates and incubated overnight at 30°C in CO2atmosphere. The next day transport to the laboratory is done in CO2jars. Cultures are examined for a maximum of 72 h. (Presumed) Positive cultures are identified by AccuProbe (BioMerieux-France). In phase 1 culture in female patients was performed by a health care provider by cervical swabs, in phase 2 by cervical and vaginal swab, in phase 3 a vaginal swab by the patient was added.

Results

In Phase 1, 8/26 (31%) cervical cultures showed growth of gonorrhoea, 18 were negative. Mean time between PCR and culture was 18 days in positive and negative cases. In Phase 2, 21 women were cultured cervically and vaginally; 6/21 (29%) showed growth of gonorrhoea without discrepancies between the sites. In 17 women only vaginal swabs were taken, of whom 29% positive in culture. Mean time between PCR and culture was 20 days in positive and negative cases. In phase 3, seven women were cultured three times. 2/7 cultures (29%) were positive cervically and vaginally (professional and patient swab). The five other cases were all negative.

Conclusions

Confirmation of vaginal gonorrhoea infection by culture was only achieved in 30% despite optimal laboratory methods. Gonococci can be grown from vaginal swabs, and no discrepancy was found between health care provider and patient taken swabs. Cultures taken for surveillance of resistance can be taken by women themselves without having to undergo physical examination.
P3-S1.44 Comparison of self-taken vulvo-vaginal swabs and clinician-taken endocervical swabs using the Gen-Probe Aptima Combo 2 assay vs clinician-taken urethral and endocervical swabs for culture of gonorrhoea
Authors: Wilson J , Stewart C , Schoeman S , Booth R , Smith S , Wilcox M
Published: July 2011

Background

The role of non-invasive testing for gonorrhoea (GC) in women has not yet been fully established in the UK. Validation of NAATs in low prevalence populations has been recommended. Our study is the first to compare gonorrhoea detection on self-taken VVSs by AC2 assay with gold-standard culture of clinician-taken urethral and endocervical (endocx) samples. As it is unclear whether a VVS or endocx swab is better for the detection of chlamydia (CT) by AC2 assay in women needing an examination we also compared the sensitivities of these samples for CT detection.

Methods

Women aged 16+ requesting STI testing consenting to perform a self-taken VVS prior to routine examination were included. Clinicians took urethral and endocx samples for gonorrhoea culture and an endocx swab for AC2 assay. AC2 positives were confirmed with Aptima GC and Aptima CT assays.

Results

3973 women included, 100 (2.5%) were infected with GC. Overall sensitivities were culture 82%; clinician taken endocx AC2 96%; self-taken VVS AC2 99% (p=0.0002). The specificity of all the AC2 tests was 100%. In women with symptoms the sensitivities were culture 84%; clinician taken endocx AC2 100% and VVS AC2 100% (p=0.003). In women with no symptoms 1.9% had GC. The sensitivities were culture 79%; clinician taken endocx AC2 91% and self-taken VVS AC2 97.5% (p=0.015). The endocx AC2 performed less well in women without symptoms, 91% vs 100% (p=0.031); the VVS AC2 assay performed equally well, 97.5% vs 100% (p=0.41). Overall sensitivities for CT were clinician taken endocx AC2 89%; self-taken VVS AC2 97% (p=0.0001). In women with symptoms the sensitivities were clinician taken endocx AC2 88%; self-taken VVS AC2 97% (p=0.001). In women with no symptoms the sensitivities were clinician taken endocx AC2 89%; self-taken VVS AC2 98% (p=0.002).

Conclusion

AC2 assay of self-taken VVSs was significantly more sensitive for the detection of GC than culture of urethral and endocx samples and equivalent to detection by AC2 assay from clinician-taken endocx swabs. The specificity and PPV of the AC2 assay was very high in this low prevalence population. AC2 assay of self-taken VVSs was significantly more sensitive for the detection of CT than AC2 assay of clinician-taken endocx samples. On the basis of these findings a self-taken VVS is the sample of choice in women who do not need an examination. In those who are being examined either a self-taken or clinician-taken VVS is the sample of choice giving better detection rates of GC and CT than an endocx swab.
P3-S2.02 Variations in testing and treatment received by infants with possible neonatal herpes
Authors: Meites E , Xu F , Hutchins K , Ackerson B , Gee J , Eriksen E , Naleway A , Markowitz L , Zangwill K
Published: July 2011

Background

Data are scarce on clinical care of infants with possible neonatal herpes simplex virus (HSV) infection, a rare and serious condition that should be treated with systemic acyclovir for 14–21 days. We reviewed HSV testing and treatment in a large cohort of US infants in order to assess clinical care received.

Methods

We investigated >270 000 infants born from 1997 to 2002 at three managed care organizations participating in the US Vaccine Safety Datalink. Medical records were abstracted if an infant had a discharge ICD-9 code compatible with HSV infection, a positive laboratory test for HSV, or neonatal death. Abstracted data included symptoms, testing, and treatment. Two physicians reviewed likely HSV infections. We identified confirmed cases (compatible symptoms and positive laboratory test), probable cases (compatible symptoms only), and others (with an alternate diagnosis). Descriptive frequencies were calculated.

Results

We abstracted records from 770 infants, identifying 35 cases (24 confirmed and 11 probable) and 735 others. HSV infection manifested as skin, eye, and mucosal (SEM) disease in 20 cases, central nervous system (CNS) disease in 8 cases, and disseminated disease in seven cases. Among 35 cases, all 35 (100%) had symptoms compatible with HSV infection; these included vesicular lesions in 20 (57%) and seizure in 7 (20%). Overall, 35 (100%) were ever tested for HSV. At least 34 (97%) received some acyclovir; median time to treatment, available for 32 cases, was 3 days (range 0–35 days). Only 8 (23%) received systemic acyclovir for the recommended 14–21 days, while 18 (51%) received <14 days and 8 (23%) received more than 21 days. Among 735 others, 701 (95%) had symptoms compatible with HSV infection; these included vesicular lesions in 10 (1%) and seizure in 244 (33%). Overall, 172 (23%) were ever tested for HSV, including 7/10 (70%) with vesicular lesions and 69/244 (28%) with seizure. At least 98 (13%) received some acyclovir, including 2/10 (20%) with vesicular lesions and 18/244 (7%) with seizure. Of these, 32 (4%) infants received acyclovir for ≥7 days.

Conclusions

Our results reveal variations in clinical care of infants with possible neonatal HSV infection. Among cases, duration of antiviral therapy rarely followed treatment recommendations. Among symptomatic infants, most with vesicular lesions but few with seizures were ever tested for HSV. These variations suggest opportunities for clinical quality improvements.
P3-S2.04 Clinical evaluation of the BD HSV2 Qx assay for the direct qualitative testing of HSV2 as compared to viral culture and a laboratory-based PCR assay using male and female external anogenital lesions
Authors: Hires L , Van Der Pol B , Williams J , Corey L , Hook E W , Nye M , Taylor S , Martens M , Mena L , Warren T
Published: July 2011

Background

To compare the performance characteristics of the BD ProbeTecTM HSV2 Qx Assay* on the BD ViperTM System in Extracted Mode to viral culture and a well-characterised molecular assay for the detection of HSV2. External anogenital lesions were sampled with two different collection devices: a universal viral transport (UVT) kit and a BD Qx swab (QS) kit*.

Methods

Eleven geographically diverse clinical centers participated in the study, with nine of the sites enrolling participants. The UVT was collected first followed by the QS specimen. A portion of each UVT specimen was transferred to a Qx Diluent Tube (diluted UVT) and a cryovial. The remainder of the UVT in the original tube was frozen at −70°C and sent to one of two sites for HSV viral culture using the ELVIS®HSV ID and D3 Typing Test System (Diagnostic Hybrids, Inc). The diluted UVT and QS specimens were shipped to one of three sites for HSV testing on the BD Viper. The UVT aliquot in the cryovial was stored at −70°C and shipped to the University of Washington for PCR testing for HSV.

Results

Subjects (n=508) were enrolled between February and August of 2010 with 501 UVT and 498 QS samples available for comparison to ELVIS culture, and 506 and 503 samples, respectively, for comparison to the PCR assay. The sensitivity and specificity of the BD HSV2 Qx Assay were compared to ELVIS culture and the positive (PPA) and negative (NPA) per cent agreement of the assay was compared to the HSV PCR assays for both specimen types. Of the BD HSV2 Qx Assay positive, culture negative samples, 46/51 (90.2%) of the UVT and 49/60 (81.7%) of the QS were positive by HSV2 PCR see Abstract P3-S2.04 table 1.

Abstract P3-S2.04 Table 1

HSV2

Specimen typeHSV2 Qxassay performanceCompared to ELVIS HSV2 cultureCompared to HSV2 PCR assaySensitivitySpecificityPPANPADiluted UVT98.4% (186/189)83.7% (261/312)97.5% (237/243)98.1% (258/263)QxSwab (QS)98.4% (186/189)80.6% (249/309)98.8% (240/243)95.8% (249/260)

Conclusions

The BD HSV2 Qx Assay on the BD Viper had excellent agreement with the lab developed PCR assay for diagnosis of HSV2, which is currently recognised as one of the best available tests for the detection of HSV. A commercially available molecular-based assay for the detection of HSV would not only improve detection and reduce turn-around time on results, but may also obviate the need for stringent transport conditions required for HSV culture. *Product not for sale, for investigational use only in the USA.
P1-S1.45 Neisseria gonorrhoeaeantimicrobial susceptibility in Latin America and the Caribbean (2000–2009) - a contribution to the treatment guidelines revision
Authors: Starnino S , Liao M , Ruben M , Storey A , Dillon J A R ,   GASP-LAC Network
Published: July 2011

Background

Active surveillance of the antimicrobial susceptibility (AS) ofNeisseria gonorrhoeae(Ng) isolates was carried out by the Gonococcal Antimicrobial Surveillance Program (GASP) in Latin America and the Caribbean (LAC) during the 1990s. A retrospective analysis of surveillance activities undertaken during the 2000s was conducted to describe trends in Ng AS and to re-initiate the GASP network.

Methods

Ng isolates were collected and tested for AS to penicillin (Pen), tetracycline (Tet), ciprofloxacin (Cip), ceftriaxone (Cef), azithromycin (Azi) and spectinomycin (Spe) in 11 countries between 2000 and 2009. Agar dilution, disc diffusion and Etest methods were used as described by CLSI and previously established in the GASP-LAC network. Trends in AS were retrospectively analysed in each country and aggregated at the GASP-LAC Co-ordinating Centre.

Results

6 countries collected data over the entire study period and five countries tested for AS sporadically. In total, 9026 Ng isolates were tested. Cip resistance first appeared in 2000 with 2%, (19/784) and resistant per cent increased to 30% (297/975) in 2009. Cip resistance was observed in 10 countries. Azi resistance per cent increased from 6% (41/646) in 2000 to 27% (224/842) in 2009; one country reported no resistance. Pen resistance per cents ranged between 29% (299/1035) in 2000 and 33% (256/772) in 2006. Tet resistance percents declined from 61% (633/1041) in 2000 to 35% (323/931) in 2009. The majority of Ng isolates were susceptible to Cef and Spe. However, 7/110 isolates showed decreased susceptibility to Cef in one country in 2007 and 2/25 isolates showed intermediate susceptible to Spe in another country in 2009.

Conclusions

Cip for primary treatment of uncomplicated gonococcal infections is currently recommended in 10 of the 11 countries, 1 country recommended Cef in 2007. The emergence and spread of resistance to Cip and Azi, indicate that current treatment guidelines be reviewed using respective national antimicrobial surveillance data. The emergence of a few strains with reduced susceptibility to third-generation cephalosporins indicates that on-going GASP surveillance is warranted.
P3-S3.05 Cotrimoxazole resistant respiratory opportunistic pathogens in HIV and AIDS patients in Lagos, Nigeria
Authors: Idika N , Anidobe M , Onwujekwe D , Idigbe O
Published: July 2011

Introduction

Opportunistic infections, viral, bacterial, fungal and parasitic are the most common cause of morbidity and mortality in HIV patients. Of the different antibiotics used for bacterial respiratory tract infections, cotrimoxazole appears to be a drug of choice in most developing countries because of its very low cost. Studies in Ivory Coast showed that cotrimoxazole decreased hospitalisation in 50% of all HIV patients and decreased mortality by 50% when given to HIV positive TB patients. RecentlyStreptococus pneumoniae,Haemophilus influenzae,Moraxalla catarrhalishave become increasingly resistant to antibiotics and the rates vary between countries. Aware of the public health importance, the drug resistance patterns on bacterial respiratory opportunistic pathogens from HIV patients in Lagos were studied for better management of HIV in Nigeria.

Methods

310 sputum samples were collected from HIV patients presenting with respiratory complaints at ART clinics in Lagos after due informed consent from the patients and processed in the laboratory within 4 h using standard microbiological methods.

Results

57.1% patients were females, 70.5% of the samples grew bacterial pathogens mainlyMorascella catarrholis25.1%,Staphylococcus aureus9.2%,Streptococcus pneumoniae8.3%,Pseudomonas aeruginosa7.3%, coaggulase negative staphylococcus 5.3%. Some Enterobactereciae were isolated and 86.8% of isolates were susceptible to ofloxacin, 80.2% to ciprofloxacin and 12.8% to cotrimoxazole.

Conclusion

Pathogens isolated were susceptible to ofloxacin, ciprofloxacin but highly resistant to cotrimoxazole, an affordable and widely used drug in African countries. This poses a challenge to management of HIV in Nigeria.
P3-S3.09 New drugs targeting toxicities have highest hope of impacting patient prognosis
Authors: Smit M , Smit C , Cremin I , Hallett T , de Wolf F , Garnett G
Published: July 2011

Background

As more HIV drugs enter the market there is a need to evaluate the effect of various antiretroviral therapies (ART) on patient outcomes. We aim to quantify the impact of different first- and second-line ART strategies on patient outcome including TMC278, an investigative non-nucleoside reverse-transcriptase inhibitors, thought to have low toxicity rates.

Methods

A deterministic model was developed representing a cohort of 100 000 HIV-infected individuals. The model was parameterised using data from Athena; a cohort encompassing all patients infected with HIV-1 followed longitudinally since 1996 at 25 HIV treatment centres in the Netherlands. Clinical, biological and immunological data for HIV-infected patients are collected upon entry and at each follow-up visit. The model allows comparison of different ART strategies and of the impact of adverse outcomes: (I) toxicity; (II) general failure and (III) resistance on time on ART and life-years saved per person treated.

Results

One of the main reasons for switching treatment is toxicity; therefore, new drugs aimed at reducing toxicity will be valuable. The model shows that if TMC278 can reduce incidence of toxicity leading to discontinuation of first-line ART from 74 to 49 per 1000 patients per year (34%) compared with current treatment then this would equate to one additional life-year saved per patient (Abstract P3-S3.09 figure 1). In comparison, a reduction in general failure from 38 to 25 incidences per 1000 patients per year (34%) adds 6 months and a reduction in resistance from 13 to 1 incidence per 1000 patients per year (92%) adds only 5 months (Abstract P3-S3.09 figure 1). For second-line, reducing incidence of toxicity from 143 to 53 per 1000 patients per year (63%) will add one life-year to per patient. This compares favourably with empirical estimates of toxicity for TMC278 in clinical trials (70% reduction in toxicity leading to discontinuation of first-line ART compared with efavirenz). The model also shows that by reducing rates of toxicity for first-line ART, consequently improving patient prognosis, patients on average spend more time on first-line ART before switching. Decreasing toxicity by 34% equates to an additional 18 months on first-line ART and a 61% decrease in toxicity equates to about five additional years on first-line ART.

Abstract P3-S3.09 Figure 1

Increase in life-expectancy per person treated with reduced annual incidence of adverse outcomes per 1000 patients for first-line ART. The red markers indicate empirical data; the blue markers indicate simulated estimates.

Conclusions

New drugs which target a reduction in toxicities have the highest impact on patient prognosis, and such drugs are within reach of current candidate products.
P1-S1.46 Syphilis trends in Zambia - a 14-year observation
Authors: Makasa M , Fylkesnes K , Sandoy I
Published: July 2011

Background

Syphilis and other STIs are prevalent in sub-Saharan Africa, perhaps due to lack of effective curative services. Estimates among pregnant women and in the general population in Zambia range from 6% to 18%, with maternal syphilis contributing to a high number of mid-trimester abortions, still births, prematurity, and morbidity and mortality of the child. Existing evidence suggests that control of syphilis and other ulcerative and non-ulcerative STIs remains one of the key strategies for HIV control. There are no recent studies from Zambia comparing syphilis prevalence with HIV trends.

Objectives

To investigate trends in syphilis prevalence using Antenatal Clinic (ANC) sentinel surveillance data, and to validate the findings with population-based data.

Methods

The analyses are based on ANC data from 1994 to 2008 from 22 sites. Estimates are compared with data from Zambia Demographic and Health Surveys (ZDHS) 2001/2002 and 2007. Analyses were restricted to women aged 15–49 years and 15–24 years. ORs with 95% CIs were used to test whether the prevalence trends were significant.

Results

The overall syphilis prevalence dropped during the period 1994–2008 among both urban and rural women aged 15–49 years from 9.8% to 2.8% and 7.5% to 3.2%, respectively. Provincial variation was observed with a tendency towards a reduction. A sharper decline in syphilis prevalence was observed among women with more years in school than among those with fewer schooling years. A declining trend was also seen among young primi gravid women aged 15–19 years. A comparison of ZDHS 2001/2002 and 2007 findings also showed an overall reduction in syphilis prevalence in the general population.

Conclusions

There was an overall reduction in syphilis prevalence and this decline was sharper than the decline in HIV during the same period. In part this could be attributed to the revamping of STI services in the country. Reduction in both HIV and syphilis prevalence could also suggest a reduction in the disease incidence and is likely to partially reflect positive sexual behaviour changes. Provincial variations were striking and need to be further studied to better guide specific STI prevention and control programmes in different geographical settings.
P3-S3.12 Transmitted HIV drug resistance mutations in Ontario, Canada, 2002–2009
Authors: Burchell A , Bayoumi A , Major C , Gardner S , Taylor D , Rachlis A , Sandstrom P , Rourke S , Brooks J
Published: July 2011

Background

We estimated the prevalence of transmitted HIV drug resistance (TDR) among HIV-positive outpatients in Ontario, Canada who were diagnosed since 2002 when the provincial laboratories started testing for drug resistance among treatment-naïve patients.

Methods

We analysed data from the Ontario HIV Treatment Network Cohort Study, a multi-site open dynamic cohort of people living with HIV. Participants were recruited from specialised HIV clinics and primary care practices. Data were obtained from medical chart extractions, interviews and linked with data from the Ontario Public Health Laboratories, which performs almost all viral load and genotypic resistance testing (GRT). We analysed data from participants who received GRT testing while treatment-naïve, defined as (1) no record of antiretroviral use in their clinical chart and (2) detectable viral load. We used the Stanford University HIV Drug Resistance Database to identify TDR mutations in the viral sequences of the protease and reverse transcriptase genes. We used descriptive statistics to characterise the prevalence of TDR mutations and report results with 95% CI.

Results

Among 623 persons diagnosed in 2002–2009, 330 received GRT while treatment naïve. Among those tested, the mean age was 39 (SD 9.9); 12% were female, 65% men who have sex with men (MSM), and 66% white. The median baseline viral load count was 4.5 log10 copies/ml (IQR 3.9–5.0) and the median baseline CD4 count was 399 cells/mm3(IQR 240–540). Overall, 13.6% (CI 9.9 to 17.3%) had one or more drug resistance mutations, and 8.8% (CI 5.7 to 11.8%), 4.8% (CI 2.5 to 7.2%) and 2.7% (CI 1.0 to 4.5%) had mutations conferring resistance against nucleoside/tide reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), or protease inhibitors (PIs), respectively. TDR against two or more drug classes was observed in 2.7% (CI 1.0 to 4.5%). The most common mutations were T215 revertants, M41L, and K103N in the RT gene. The proportion with TDR was highest among IDU (30.4%), intermediate among MSM and heterosexuals (12.0% and 14.3%, respectively) and lowest among persons from HIV endemic regions (6.9%) (p=0.06). Participants diagnosed in 2008–2009 had a higher proportion of NRTI mutations (18.2% vs 5.9%, p=0.0009) and NNRTI mutations (11.7% vs 2.8%, p=0.004) than those diagnosed earlier; such increases were observed among MSM, heterosexuals and IDU. There was no evidence of a change in PI mutation frequency over time.

Conclusion

Our finding of a recent increase in NRTI and NNRTI mutations is concerning but requires confirmation, ideally in a random sample of specimens from newly diagnosed individuals. Although the actual dates of infection were unknown, the results suggest that drug-resistant strains are commonly circulating within the established HIV epidemics in Ontario.
P3-S4.02 High-risk human papillomavirus (HR-HPV) detection in men with and without the history ofChlamydia trachomatisinfection
Authors: Smelov V , Terekhov V , Ouburg S , Pleijster J , Gorelov A , Novikov A , Morre S
Published: July 2011

Introduction

HR-HPV andC trachomatis(CT) are among the most often diagnosed viral and bacterial STIs in the world, respectively. It has been speculated that both of them might be involved in urogenital carcinogenesis and, moreover, potentiate each other's impact and acquisition. The evidence points to a possible association between CT infection history and increased acquisition of HR-HPV infection was investigated among 173 urologist's office male attendees.

Material and Methods

Penile and urethral swabs, and expressed prostate secret were collected from 173 heterosexual men visiting an urologist's office to get routinely tested for STDs in the year of 2009 in St.

Petersburg

Only heterosexual men with no HIV, gonorrhoea, syphilis andT vaginaliswere enrolled in the study. CT infection was detected by in-house RT-PCR assay in St. Petersburg and confirmed in Amsterdam by a molecular test (TaqMan). The presence of HR-HPV DNA in the studied samples was investigated in Amsterdam by the validated worldwide used GP5+/6+ assay.

Results

The results are presented in the Abstract P3-S4.02 table 1. The overall CT and HPV prevalence in the study group was relatively high: 4.6% and 31.2%, respectively. No significant correlations have been found between HR-HPV findings and CT status (p=1.0).

Abstract P3-S4.02 Table 1

Detection of HR-HPV infection in 173 men with/without the history ofC trachomatisinfection

CT present, detected during the study (prevalence, %)CT in the past, history of being infected (prevalence, %)CT+CT−CT+CT−CT infection history8 (4.6%)16545 (35.2%)128173 men, in totalHR-HPV infection, detected in2 (25%)53 (32.1%)14 (31.3%)40 (31.3%)

Conclusions

Our study demonstrated: (1) CT and HPV prevalence among the Russian population can be high, (2) limited co-infection between HPV and CT infections: HR-HPV types were similarly often detected in both CT+ and CT men, also regardless on their CT acquisition in the past, (3) CT history seems not to increase the HR-HPV acquisition, however, the association between HPV andC trachomatisinfection still remains to be elucidated and follow-up studies especially among women or homosexuals. 4) All samples found RT-PCR CT+ in Russia were confirmed CT+ using molecular biological techniques in Amsterdam, showing the validity of CT detection in some settings in St. Petersburg. At the moment we additionally: (1) extent the study group, (2) investigate low-risk HPV detection and (3) perform immunogenetic analyses.
P3-S4.04 Topical 80% Trichloroacetic Acid (TCA) shows efficacy in the treatment of internal High-Grade Anal Intraepithelial Neoplasia (HGAIN)
Authors: Ho K , Elishaev E , Maciak D , Baker J , Parzynski C , Zhu C , Day R , Cranston R
Published: July 2011

Background

HIV positive men who have sex with men (MSM) are at 60–70 times increased risk of developing anal squamous cell carcinoma than the general population. HGAIN, the putative precursor to cancer, may be ablated by various methods in order to prevent neoplastic progression. While TCA has previously been used clinically to treat keratinised external anal warts, it may also be used to ablate internal HGAIN. Here we report on treatment efficacy and clinical predictors of success.

Methods

A retrospective chart review of all patients seen at the Anal Dysplasia Clinic at the Pittsburgh AIDS Center for Treatment was performed between 1 January 2008 and 30 June 2010. 41 HIV positive MSM had biopsy proven HGAIN (AIN1/2, AIN2, AIN 2/3, and AIN3) at high-resolution anoscopy. Treatment involved applying three sequential cotton swabs soaked in 80% TCA to the lesion. Patients were seen at an average of 6 months following treatment for follow-up. Clearance was defined as the absence of HGAIN epithelial markers at HRA (punctuation/mosaicism) or AIN 1/normal epithelium on biopsy. The impact of the following variables on lesion clearance were assessed using univariate logistic regression analysis: age, CD4 count, initial grade of dysplasia on biopsy, concomitant therapy with imiquimod, previous history of HGAIN treatment.

Results

The mean age of the study population was 52 years and the mean CD4 count was 565 cells/ml. Of the 43 HGAIN lesions treated in 41 patients, 22 (51%) demonstrated clearance of HGAIN epithelial markers. Repeat biopsy was performed on eight lesions and 4 (9%) lesions were AIN1, 3 (7%) lesions were AIN2, and one lesion was ungradable. By univariate logistic regression analysis, patients with a diagnosis of AIN1/2 (compared with those who had AIN2 or greater) demonstrated a non significant trend towards clearance of abnormal visual markers (OR 3.8 p=0.112). All other predictive variables did not achieve statistical significance.

Conclusions

On a per lesion basis, the success of a single visit triple topical application of TCA was 58% that is comparable with previously published treatment studies using techniques such as infrared coagulation. While larger prospective studies are called for, following exclusion of cancer by biopsy, HRA combined with TCA treatment may represent a low-cost, minimally invasive management strategy for this population with a high-incidence of HGAIN.
P3-S4.05 Missed opportunities for early detection of cervical cancer in an STD clinic
Authors: Arno J , Graffis R , Ferries-Rowe E , Hess L
Published: July 2011

Background

In 2009, more than 11 000 women were diagnosed with invasive cervical cancer and approximately 4000 died. Many of these women were never screened or not screened in the 5 years before their diagnosis. Because vaccine uptake has been low, it is critical to continue efforts at early detection. We examined how many women diagnosed with cervical cancer at a public hospital were seen at the public STD clinic up to 5 years before diagnosis to detect missed opportunities for early detection.

Methods

All cases with a diagnosis of cervical cancer from 1 January 1999 to 18 October 2010 were extracted from the electronic database of Wishard Hospital (Marion County Indiana's public hospital) using ICD-9 codes for severe squamous dysplasia (CIN3), adenocarcinoma in situ of the cervix and malignant neoplasm of cervix uteri. Results were validated using cytology and pathology records and women verified to have CIN3 or higher grade abnormalities were included. These were matched to patients in the electronic medical database of the Bell Flower Clinic (Marion County's public STD clinic) on the basis of first name, last name, date of birth, race and social security number when present. Missed opportunities were defined as those visits to Bell Flower within 5 years of a diagnosis of cervical cancer and no history of a PAP smear or HPV screening within 2 years at Wishard Hospital.

Results

We identified 1309 women with cervical cancer diagnosed or treated at Wishard Hospital during the study period. Of these, 202 women were found to have visited Bell Flower at some time during the study period whereas 73 were found to have made 147 visits to Bell Flower Clinic <5 years prior to their diagnosis of CIN3 or higher. Because a substantial number of these women had normal or low grade abnormal PAPs at Wishard <2 years prior to their diagnosis, only 48 patients (97 visits) had visits that qualified as missed opportunities.

Conclusions

Most women who developed cervical cancer diagnosed or treated at the public hospital had no record of a visit to the STD clinic. Of the 38 813 visits by women to Bell Flower during the study period, only 147 visits qualified as missed opportunities for detecting cervical cancer in 48 individuals. The number of women affected by missed opportunities was low, in part, because of accessible strong PAP smears at the public hospital.
P3-S5.01 Microbial diversity of genital ulcer disease in men enrolled in a randomised trial of male circumcision in Kisumu, Kenya
Authors: Mehta S , Maclain I , Baiely R , Moses S , Gillevet P , Spear G
Published: July 2011

Background

Medical male circumcision (MMC) reduces the risk of HIV acquisition by ∼60%, in part by reducing genital ulcer disease (GUD) and HSV-2. In the Ugandan and Kenyan trials, PCR did not find a sexually transmissible agent in 50–60% of GUD specimens, and MMC did not protect against HSV-2 in the Kenyan trial. We sought to better define the aetiology of GUD in the Kenyan trial and examine how MMC affects GUD aetiology.

Methods

We defined GUD of unknown aetiology as negative for HSV type 1 and type 2,T pallidum, andH ducreyiby PCR, and negative for HSV-2 andT pallidumby serology. In 59 GUD specimens from 59 men, 23 (39%) had unknown aetiology. We identified bacterial microbiota in all 59 specimens using multitag pyrosequencing of the 16S rRNA gene, and compared results by unknown vs STI aetiology. Statistical analysis employed exact methods.

Results

Overall, 83 distinct genera were detected. Prevotella spp. was most abundant, accounting for 18% of microbiota on average, and present in 75% of specimens. Bacterial diversity was greater in GUD of unknown aetiology than STI associated GUD (median number of genera 13 [range 7–20] vs 11 [range 3–20], p=0.06).Fusobacterium spp., Sneathia spp. and Anaerococcus spp.were more abundant in GUD of unknown aetiology (7.7%, 7.6%, and 7.3%, respectively) than in GUD of STI aetiology (4.6%, 5.0%, and 5.4%). Fusobacteriales (Fusobacterium spp.orSneathia spp.) [OR=4.7; 95% CI: 1.3 to 19.9] andAnaerococcus spp.[OR=4.6; 95% CI: 1.2 to 22.5] were more likely to be recovered in GUD of unknown aetiology than STI associated GUD. Fusobacteriales were more often recovered from uncircumcised men than circumcised men (62% vs 22%, p=0.04), and Anaerococcus spp. was present in 22% of circumcised vs 70% of uncircumcised men (p=0.010). Reported penile coital injuries were more common among men withAnaerococcus spp.(85% vs 57%, p=0.01), and condom use was less common (50% vs 71%, p=0.11). There was no difference in these bacteria by ulcer location.

Conclusions

Fusobacteriales andAnaerococcus spp.may colonise genital ulcers that develop from a mechanism related to circumcision status. Many such “ulcers” may be epithelial disruptions that are traumatic in origin. These bacteria have cytotoxic properties that may ulcerate or exacerbate pre-existing minor epithelial disruptions. MMC may reduce GUD through a reduction in these anaerobic bacteria.
P3-S5.03 Conflict of interest and point of care tests: an exploration of accuracy in Hepatitis C infection
Authors: Shivkumar S , Jafari Y , Lambert G , Claessens C , Klein M , Martinez-Cajas J , Peeling R , Joseph L , Pai N P
Published: July 2011

Background

The WHO estimates that 170 million people worldwide are infected with Hepatitis C. In the context of HIV co-infection, rapid point-of-care tests gain importance in both the developing and developed countries. Moreover, in the light of the Food and Drug Administration's approval of the Oraquick point-of-care test for Hepatitis C for use in the USA, the accuracy of these tests is relevant.

Objective

We conducted a systematic review and meta-analysis of the literature examining the sensitivity and specificity of all rapid point-of-care tests used to diagnose incident or prevalent Hepatitis C, with an attention to involvement of industry in reporting of results.

Methods

Two reviewers conducted independent searches of five databases between the years of 1995 and 2010. Bayesian meta-analysis was conducted accounting for the use of imperfect reference standards (sensitivity and specificity ranges of 90%–100% were assumed) in the assessment of index tests. The quality of all included full-text studies was assessed using the QUADAS and STARD checklists, with a focus on reporting of conflict of interest with industry.

Results

A total of seven studies were identified from the database searches, of which five were conducted in developing settings. Eight index tests were examined including Oraquick, HCV Tri-Dot, HCV Bidot, Therma Ricerca, SM-HCV, Onecheck, Goldspot and Accurate. Sensitivity of all index tests ranged from 45% to 100%, while specificity ranged from 93% to 100%. Oraquick reportedly had the highest accuracy, with sensitivity ranging from 99% to 100% and a specificity of 100%. However, the authors of the study reported a financial relationship with Orasure Technologies Inc., the makers of Oraquick. Although pooled sensitivity of all tests was high at 92.72% (95% CI 72.11% to 99.93%), when the Oraquick study was removed from analysis, the pooled sensitivity of all other tests dropped to 77.11% (95% CI 45.49% to 99.61%) see Abstract P3-S5.03 table 1. Pooled specificity remained high at almost 100% regardless of whether the Oraquick study was included or not.

Abstract P3-S5.03 Table 1

Results of bayesian meta-analysis: diagnostic accuracy of index tests used to detect Hepatitis C

Pooled resultsSensitivity (95% CI)Specificity (95% CI)Including oraquick study92.72% (72.11% to 99.93%)99.88% (99.56% to 100%)Excluding oraquick study77.11% (45.49% to 99.61%)99.99% (99.82% to 100%)

Conclusion

Although Oraquick appears to be the most promising test, authors' ties with industry make these results less credible. More independent testing is required to be able to make policy recommendations for the most accurate index test to detect Hepatitis C infection.
P3-S5.05 Rapid point of care testing for ten sexually transmitted diseases
Authors: Kriesel J , Bhatia A , Vaughn M , Gardner J , Barrus C , Crisp R
Published: July 2011

Background

Delays in the reporting of STD testing sometimes result in inappropriate patient care where a patient must be called back in for treatment. Some STDs may be missed because not all specimens are tested in a comprehensive manner. We are developing a multiplex point of care test to fill this clinical need. This fully automated system is capable of detecting ten PCR targets from a single specimen in <1 h.

Methods

A Sexually Transmitted Disease (STD) Panel was designed for the FilmArray device to detect the following organisms:Chlamydia trachomatis(CT),Neisseria gonorrhoeae(GC),Treponema pallidum,Trichomonas vaginalis, Mycoplasma genitalium, Ureaplasma urealyticum, Ureaplasma parvum, Haemophilus ducreyi, and herpes simplex viruses (HSV-1 and 2). Multiple PCR primers for each of these organisms were multiplexed and validated with the appropriate laboratory strains or plasmids.

Results

Three hundred twenty-four subjects have been enrolled from the Salt Lake Valley Health Department STD clinic patient population, providing 600+ specimens for analysis. Ninety-nine clinical specimens have been tested so far. The STD panel test results were compared to the standard CDC recommended clinical tests run in parallel on duplicate specimens. Standard testing included gram staining, CT/GC amplification, wet mount examination, viral culture, and serum syphilis IgG. Sample types included urine (44), vaginal/cervical swabs (7), urethral swabs (5), ulcer swabs (7), oral swabs (20), and rectal swabs (16). Concordance between the new STD panel and standard testing was:C trachomatis(79/81, 98%),N gonorrhoeae(81/81, 100%), HSV1 (6/6, 100%), HSV-2 (6/6, 100%), andT vaginalis(5/6, 83%). The STD Panel detectedT pallidumin four samples from patients who were subsequently diagnosed with syphilis by serology.Ureaplasma spp. were detected in 28 of 99 (28%) andM genitaliumin three of 99 (3%) specimens. In patients with chronic dysuria where standard clinical testing failed to reveal a cause, we were able to detect infectious agent in 8 of 14 specimens (two HSV-1, fiveUreaplasma spp., oneM genitalium) see Abstract P3-S5.05 table 1.

Abstract P3-S5.05 Table 1

Positive tests among the 99 specimens subjected to point of care multiplex PCR using the filmarray device

Specimen typeDetected organismUrine N=44Urethral N=5Cervical N=7Rectal N=16Oral N=20Ulcer N=7TotalNeisseria gonorrhoeae422210Chlamydia trachomatis72312Treponema pallidum11114Trichomonas vaginalis123HSV-122HSV-20Mycoplasma genitalium33Ureaplasma spp.171342128Haemophilus ducreyi0

Conclusions

Point of care STD testing based on the FilmArray platform is a robust clinical diagnostic tool that has the potential to improve public health by providing sensitive and rapid results. This may improve clinical care for persons suspected of infections with STD organisms.
P3-S5.06 Surgery in the treatment of severe dyspareunia caused by vulvar vestibulitis syndrome-a long-term follow-up study
Authors: Paavonen J , Päivi T , Unkila-Kallio L
Published: July 2011

Background

Vulvar vestibulitis syndrome (VVS) causes severe dyspareunia in young women, but is poorly recognised and managed. We wanted to evaluate safety and effectiveness of posterior vestibulec-tomy in the treatment of VVS.

Methods

A cohort study of consecutive patients with refractory VVS treated at the University Hospital Vulva Clinic. The study population consisted of 70 women treated by posterior vestibulectomy during 1995–2007. All operated women were invited to participate in a long-term follow-up study. Patient characteristics, baseline visual analogue scale (VAS) for dyspareunia, and data of the postoperative pe-riod were collected. Of the 70 women invited, 57 attended the follow-up, including face-to-face inter-view, gynaecologicalgynaecological examination with swab-touch test for vestibular tenderness, current VAS score for dyspareunia, and McCoy questionnaire for sexual problems. Main outcome measures were short-term and long term complication rates, dyspareunia by VAS score, vestibular tenderness on examination, sexual problem index, and overall patient satisfaction.

Results

Ninety-one per cent of the patients were satisfied with the outcome. VAS for dyspareunia de-creased from a median of 9 to a median of 3 (66.7% decrease) (p <0.001). Posterior vestibular tender-ness was absent in 34 patients (64.2%). Six (8.6%) patients developed postoperative bleeding and 11 (15.7%) patients developed mild wound infection, and 4 (5.7%) patients developed Bartholin's cysts.

Conclusion

Posterior vestibulectomy is effective in the treatment of severe VVS and provides long-term patient satisfaction.
P3-S5.07 Multidisciplinary clinic for the treatment of Hepatitis C: an useful tool for the management of the patients; review of the experience of a regional hospital
Authors: Dolcé P , Brin-Clément S , Bernatchez H , Jutras P , Tourangeau F
Published: July 2011

Background

CSSSRN is a regional hospital with 240 acute-care beds, with a multidisciplinary clinic for the treatment of hepatitis C. This study aimed to review the clinical data from treated cases of hepatitis C, including the evaluation of the multidisciplinary support needed.

Methods

All files from patients evaluated for hepatitis C at CSSSRN between January 2000 and March 2009 were reviewed for clinical and microbiological data. Also, the numbers of visits to the different clinics were recorded. The data were analysed with Epi Info 3.5.1.

Results

A total of 165 cases of hepatitis C were evaluated at our facility and 46 treatments were initiated in 42 patients (four patients had two treatments). The average age was 41 years old (range 22–58) and 78% were men. All, except one, were native from the province of Quebec. The acquisition of hepatitis C was: injection or inhalation drug use (74%), blood transfusion (19%) and other causes (7%). The majority of treated individuals were heterosexual (93%), 55% had a history of alcohol abuse, 30% have been in detention, 19% had attempted suicide and 5% had done prostitution. HIV coinfection was present in three patients and none had HBV coinfection. The genotypes observed were 1 (55%), 3 (29%), 2 (9%) and 4 (7%). Liver biopsy was performed in 26 patients, eight had cirrhosis and one developed liver carcinoma. The treatments received were standard interferon alfa-2b/ribavirine (seven cases, 2000–2002), peginterferon alfa-2b/ribavirine (22 cases, 2003–2006), and peginterferon alfa-2a/ribavirine (17 cases, 2005–2008). Treatment was completed in 78% of patients. Sustained virological response (SVR) was achieved in 53% of genotypes 1 and 4; and in 69% of genotypes 2 and 3. During treatment, an average of 30 visits per patient was recorded. The frequency and mean number of visits were: clinical nurses from the ambulatory care unit (100%, 14), infectious diseases (100%, 10), gastroenterology (100%, 5), psychiatry (35%) and dietetic (16%).

Conclusion

A SVR was achieved in 53% (genotypes 1 and 4) and 69% (genotypes 2 and 3) of patients. The treatment of hepatitis C involved an average of 30 visits, with many actors, which is eased by a multidisciplinary clinic.
P3-S6.01 Validation of a treponemic antibodies quimioluminiscence automated test for syphilis detection among inmates of Mexico City
Authors: Juárez-Figueroa L , Iracheta P , Conde-Glez C , Bautista-Arredondo S , González-Rodriguez A
Published: July 2011

Background

When surveying large groups at risk for STI, the search of antiT pallidumAb is a valuable tool both for assessing risks associated with syphilis acquisition and, if followed by VDRL test, also for syphilis cases detection. By the other hand testing first with VDRL a large number of samples followed by confirmation with anti TP specific test would be laborious and prone to errors while the data of past cured syphilis would be lost. On 2010 the HIV/AIDS Program of Mexico City and the National Institute of Public Health, Mexico initiated a health survey of around 40 000 inmates of the city for assessing syphilis and other STIs. Presently more than 18 000 inmates have been surveyed for HIV, HBV HVC and syphilis using the automated immunoquimioluminiscence analysis system Abbott Architect i2000. The accuracy of Abbott Architect Syphilis TP (ASTP) for detecting treated and untreated syphilis was reported before thus our study focused in validate ASTP as compared with an accepted treponemic test.

Methods

For evaluatig the sensitivity and specificity of ASTP in the context of our HIV clinic we compared ASTP with a test extensively used for syphilis confirmation, Treponema pallidum haemagglutination assay (TPHA). Samples were assayed with ASTP in pools of four sera and each positive pool developed and re-assayed with ASTP to find one or more individual positive samples which were further assayed with tittered VDRL. ASTP− pools were not re-assayed and individual samples were scored as negative for syphilis. We selected 218 ASTP+ and 1920 ASTP− individual consecutive samples to be tested with BioRad Syphilis TPHA.

Results

From 218 ASTP+ samples 212 were TPHA+ and all 1920 ASTP− were also TPHA−. ASTP and TPHA detected all 77 VDRL+ samples thus considered diagnostic of latent or active syphilis. Six ASTP+/TPHA− samples and 135 ASTP−/TPHA− were also VDRL− and considered as evidence of treated/cured syphilis. Using TPHA as gold standard ASTP Sensitivity was 100% and Specificity was 99.7%. In two ASTP- pools that showed more than 0.6 but <1 S/CO reading, a sample weakly positive by ASTP and TPHA but VDRL− was found when assayed individually.

Conclusions

Reverting the traditional algorithm of syphilis diagnosis by first determining TP specific antibodies with ASTP followed by tittered VDRL of positive samples is highly accurate even if done in pools of four sera. This approach allows also the identification of epidemiologically valuable data of cured syphilis.