Publications by authors named "Christopher K Fairley"

558 Publications

Sexual health service adaptations to the coronavirus disease 2019 (COVID-19) pandemic in Australia: a nationwide online survey.

Aust N Z J Public Health 2021 Sep 2. Epub 2021 Sep 2.

Central Clinical School, Monash University, Melbourne, Victoria.

Objective: Examine the changes in service delivery Australian public sexual health clinics made to remain open during lockdown.

Methods: A cross-sectional survey designed and delivered on Qualtrics was emailed to 21 directors of public sexual health clinics across Australia from July-August 2020 and asked about a variety of changes to service delivery. Descriptive statistics were calculated.

Results: Twenty clinics participated, all remained open and reported service changes, including suspension of walk-in services in eight clinics. Some clinics stopped offering asymptomatic screening for varying patient populations. Most clinics transitioned to a mix of telehealth and face-to-face consultations. Nineteen clinics reported delays in testing and 13 reported limitations in testing. Most clinics changed to phone consultations for HIV medication refills (n=15) and eleven clinics prescribed longer repeat prescriptions. Fourteen clinics had staff redeployed to assist the COVID-19 response.

Conclusion: Public sexual health clinics pivoted service delivery to reduce risk of COVID-19 transmission in clinical settings, managed staffing reductions and delays in molecular testing, and maintained a focus on urgent and symptomatic STI presentations and those at higher risk of HIV/STI acquisition. Implications for public health: Further research is warranted to understand what impact reduced asymptomatic screening may have had on community STI transmission.
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http://dx.doi.org/10.1111/1753-6405.13158DOI Listing
September 2021

Effect on genital warts in Australian female and heterosexual male individuals after introduction of the national human papillomavirus gender-neutral vaccination programme: an analysis of national sentinel surveillance data from 2004-18.

Lancet Infect Dis 2021 Jul 30. Epub 2021 Jul 30.

The Kirby Institute, University of New South Wales Sydney, Sydney, NSW, Australia; Sydney Sexual Health Centre, Sydney Hospital, Sydney, NSW, Australia.

Background: In Australia, the government-funded human papillomavirus (HPV) vaccination programme was introduced in April, 2007, for girls and young women, and in February, 2013, for boys. As of Dec 31, 2018, all Australian-born female individuals younger than 38 years and male individuals younger than 21 years have been eligible for the free quadrivalent or nonavalent HPV vaccine. We aimed to examine the trends in genital wart diagnoses among Australian-born female and heterosexual male individuals who attended sexual health clinics throughout Australia before and after the introduction of the gender-neutral HPV vaccination programme in February, 2013.

Methods: We did a serial cross-sectional analysis of genital wart diagnoses among Australian-born female and heterosexual male individuals attending a national surveillance network of 35 clinics between Jan 1, 2004, and Dec 31, 2018. We calculated prevalence ratios of genital warts, using log-binomial regression models, for the female-only vaccination period (July 1, 2007, to Feb 28, 2013), gender-neutral vaccination period (March 1, 2013, to Dec 31, 2018), and the whole vaccination period (July 1, 2007, to Dec 31, 2018) compared with the pre-vaccination period (Jan 1, 2004, to June 30, 2007).

Findings: We included 121 038 men and 116 341 women in the analysis. Overall, we observed a 58% reduction (prevalence ratio 0·42, 95% CI 0·40-0·44) in genital wart diagnoses in female individuals and a 45% reduction (0·55, 0·53-0·57) in genital wart diagnoses in heterosexual male individuals after the introduction of the vaccination programme in 2007. The largest reduction in genital warts was observed in younger individuals, and there was a decreasing magnitude of reduction with increasing age (80%, 72%, 61%, 41%, and 16% reductions in female individuals aged 15-20 years, 21-25 years, 26-30 years, 31-35 years, and ≥36 years, respectively; 70%, 61%, 49%, 37%, and 29% reductions in male individuals aged 15-20 years, 21-25 years, 26-30 years, 31-35 years, and ≥36 years, respectively). Significant reductions observed in female individuals (0·32, 0·28-0·36) and male individuals (0·51, 0·43-0·61) aged 15-20 years in the female-only vaccination period were followed by a more substantial reduction in female individuals (0·07, 0·06-0·09) and male individuals (0·11, 0·08-0·15) aged 15-20 years in the gender-neutral vaccination period.

Interpretation: The national gender-neutral HPV vaccination programme has led to substantial and ongoing reduction in genital warts among Australian female and heterosexual male individuals, with a marked reduction in young individuals who received the vaccine at school.

Funding: Seqirus Australia and the Australian Government Department of Health.
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http://dx.doi.org/10.1016/S1473-3099(21)00071-2DOI Listing
July 2021

Associations Between Methods of Meeting Sexual Partners and Sexual Practices Among Heterosexuals: Cross-sectional Study in Melbourne, Australia.

JMIR Form Res 2021 Jul 20;5(7):e26202. Epub 2021 Jul 20.

Central Clinical School, Monash University, Clayton, Australia.

Background: The association between meeting partners on the web and sexual practices has been understudied in heterosexuals.

Objective: This study aims to examine the associations between the methods of meeting partners and sexual practices and HIV and sexually transmitted infections (STIs) in heterosexuals.

Methods: We conducted a survey among heterosexuals attending the Melbourne Sexual Health Centre in 2019. This survey asked about the methods through which the participants engaged in meeting their sexual partners, sexual practices, and intravenous drug use (IVDU) over the past 3 months. The participants' HIV and STI (chlamydia, gonorrhea, and syphilis) status was obtained from clinical testing. Multivariable logistic regression was used to examine the association between each method of meeting and the participants' sexual practices, IVDU, and STI status.

Results: A total of 698 participants (325 men and 373 women) were included in the study. Most of the participants reported using only one method to meet partners (222/325, 68.3% men; 245/373, 65.7% women; P=.05). The men met partners most commonly at social venues (eg, bar, pub, or party; 126/325, 38.8%), whereas the women met partners most commonly through friends or family (178/373, 47.7%). Paying for sex was associated with men meeting partners at sex venues (adjusted odds ratio [AOR] 145.34, 95% CI 26.13-808.51) and on the internet (AOR 10.00, 95% CI 3.61-27.55). There was no association between IVDU and methods of meeting. Social venues were associated with condomless vaginal sex among men (AOR 3.31, 95% CI 1.94-5.71) and women (AOR 2.58, 95% CI 1.61-4.13) and testing positive for STI among men (AOR 3.04, 95% CI 1.24-7.48) and women (AOR 3.75, 95% CI 1.58-8.89).

Conclusions: Heterosexuals who met partners at social venues had a more than threefold risk of testing positive for STIs, indicating that heterosexuals may benefit from health promotion campaigns that are delivered through a public setting.
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http://dx.doi.org/10.2196/26202DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8335617PMC
July 2021

Human papillomavirus prevalence and risk factors among Australian women 9-12 years after vaccine program introduction.

Vaccine 2021 08 17;39(34):4856-4863. Epub 2021 Jul 17.

Centre for Women's Infectious Diseases, The Royal Women's Hospital, Melbourne, Australia; Melbourne School of Population and Global Health, University of Melbourne, Victoria, Australia; The Kirby Institute for Infection and Immunity in Society, University of New South Wales, Sydney, Australia. Electronic address:

Background: In Australia, high and widespread uptake of the quadrivalent human papillomavirus (HPV) vaccine has led to substantial population-level reductions in the prevalence of quadrivalent vaccine targeted HPV genotypes 6/11/16/18 in women aged ≤ 35 years. We assessed risk factors for HPV detection among 18-35 year old women, 9-12 years after vaccine program introduction.

Methods: Women attending health services between 2015 and 2018 provided a self-collected vaginal specimen for HPV genotyping (Roche Linear Array) and completed a questionnaire. HPV vaccination status was validated against the National Register. Adjusted odds ratios (aORs) and 95% confidence intervals (CI) were calculated for factors associated with HPV detection.

Results: Among 1564 women (median age 24 years; IQR 21-27 years), Register-confirmed ≥ 1-dose vaccine coverage was highest at 69.3% and 68.1% among women aged 18-21 and 22-24 years respectively, decreasing to 42.9% among those aged 30-35 years. Overall prevalence of quadrivalent vaccine-targeted HPV types was very low (2.0%; 95% CI: 1.4-2.8%) and influenced only by vaccination status (5.5% among unvaccinated compared with 0.7% among vaccinated women; aOR = 0.13 (95% CI: 0.05-0.30)). Prevalence of remaining HPV types, at 40.4% (95% CI: 38.0-42.9%), was influenced by established risk factors for HPV infection; younger age-group (p-trend < 0.001), more recent (p < 0.001) and lifetime sexual partners (p-trend < 0.001), but not vaccination status. Prevalence of HPV31/33/45, which shared risk factors with that of non-vaccine targeted HPV types, was also lower among vaccinated (4%) compared with unvaccinated (7%) women (aOR = 0.51; 95% CI: 0.29-0.89), indicative of cross-protection.

Conclusion: Vaccination has changed the epidemiology of HPV infection in Australian women, having markedly reduced the prevalence of vaccine-targeted types, including amongst women with known risk factors for infection. Vaccinated women appear to be benefiting from modest cross-protection against types 31/33/45 afforded by the quadrivalent HPV vaccine. These results reinforce the importance of HPV vaccination.
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http://dx.doi.org/10.1016/j.vaccine.2021.07.005DOI Listing
August 2021

A comparison of cotton-tipped and nylon flocked swabs for culture of Neisseria gonorrhoeae from oropharyngeal samples.

Diagn Microbiol Infect Dis 2021 Jun 18;101(3):115455. Epub 2021 Jun 18.

Melbourne Sexual Health Centre, Alfred Health, Melbourne, Victoria, Australia; Central Clinical School, Monash University, Melbourne, Victoria, Australia; Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, Victoria, Australia. Electronic address:

Our aim was to determine if there was a difference in culture positivity for oropharyngeal gonorrhoea when sampling using a nylon-flocked versus cotton-tipped swab. We collected FLOQSwabs and cotton-tipped swabs from individuals aged ≥ 18 years who had untreated oropharyngeal gonorrhoea detected by NAAT between November 2019-June 2020.Of 78 participants, 32 (41.0%) were culture-positive for N. gonorrhoeae from either swab. Of these 32, 29 (90.6%, 95%CI: 75.0%-98.0%) were positive on both swabs, one (3.1%, 95%CI: 0.0%-16.2%) tested positive on FLOQSwab only and two (6.2%, 95%CI: 0.1%-20.8%) tested positive on cotton-tipped swabs only. There was moderate agreement between the swabs in the amount of bacterial growth (Cohen's Kappa (k)=0.745; 95%CI: 0.622-0.868, p<0.001). Our results showed that the proportion of positive results was comparable using the FLOQSwabs versus the cotton-tipped swabs for oropharyngeal gonorrhoea culture.
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http://dx.doi.org/10.1016/j.diagmicrobio.2021.115455DOI Listing
June 2021

The clinical indications for testing women for .

Sex Transm Infect 2021 Jul 1. Epub 2021 Jul 1.

Melbourne Sexual Health Centre, Alfred Health, Melbourne, Victoria, Australia.

Background: While the contribution of (MG) to symptoms in men is well described, less is known about its association with common genital symptoms in women. We aimed to determine the prevalence of MG and macrolide resistance, and its association with common genital symptoms in women attending a sexual health service, to inform indications for testing and clinical practice.

Methods: We undertook a cross-sectional study of symptomatic and asymptomatic women attending Melbourne Sexual Health Centre (MSHC), between April 2017 and April 2019. Women were tested for MG and macrolide resistance, (CT), , , bacterial vaginosis and vulvovaginal candidiasis. Women completed a questionnaire on symptoms, and symptomatic women underwent examination. The prevalence of MG (and macrolide resistance) and other genital infections was calculated with 95% CIs, and associations between these outcomes and specific genital symptoms were examined using logistic regression.

Results: Of 1318 women, 83 (6%, 95% CI: 5% to 8%) had MG, of which 39 (48%, 95% CI: 36% to 59%) had macrolide-resistant MG; 103 (8%, 95% CI: 6% to 9%) women had CT. MG prevalence was similar in asymptomatic (10 of 195; 5%) and symptomatic (73 of 1108; 7%) women, p=0.506. MG was associated with mucopurulent cervicitis on examination (adjusted OR=4.38, 95% CI: 1.69 to 11.33, p=0.002), but was not associated with other specific genital symptoms or signs.

Conclusions: MG was as common as CT among women attending MSHC. MG was not associated with genital symptoms, but like CT, was significantly associated with cervicitis. These data provide evidence that routine testing for MG in women with common genital symptoms is not indicated. The presence of macrolide resistance in 48% of women supports use of resistance-guided therapy.
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http://dx.doi.org/10.1136/sextrans-2020-054818DOI Listing
July 2021

What do young people in high-income countries want from STI testing services? A systematic review.

Sex Transm Infect 2021 Jun 30. Epub 2021 Jun 30.

Central Clinical School, Monash University, Carlton, Victoria, Australia.

Background: There are upward trends of STI rates among young people in most high-income countries. We reviewed the literature to provide a summary of information to support health services with the aim of increasing testing of STIs among young people living in high-income countries.

Methods: We conducted a systematic review (Prospero: CRD42020179720) using PubMed, Embase, PsychINFO and CINAHL. The search was performed on 10 January 2020 for studies between January 2000 and 10 January 2020. Two reviewers independently screened articles, and any discrepancies were resolved by a third reviewer. Studies were included if they were performed in high-income countries and contained data on both young people (<26 years) and STI testing preferences. Data regarding the characteristics of STI testing services that young people preferred was extracted. We categorised these characteristics using the framework of a social-ecological model.

Results: We identified 1440 studies, and 63 studies were included in the final review. We found 32 studies that addressed individual factors, 62 studies that addressed service factors and 17 studies that addressed societal factors. At an individual level, we identified eight attributes including the need for improved sexual health education. At a service level, 14 attributes were identified including preferences from different subgroups of young people (such as sexual and ethnic minorities) for the types of services. At a societal level, we identified two attributes including the need to address stigma associated with STIs.

Conclusion: We provide an overview of the growing body of literature capturing the preferences of young people for STI testing services. To optimise the uptake of STI testing among young people, factors from all socioecological levels should be considered. In addition, understanding and accounting for distinct preferences from subgroups of young people could increase demand for STI testing services for those at greatest need.
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http://dx.doi.org/10.1136/sextrans-2021-055044DOI Listing
June 2021

The Presence or Absence of Symptoms Among Cases of Urethral Gonorrhoea Occurring in a Cohort of Men Taking Human Immunodeficiency Virus Pre-exposure Prophylaxis in the PrEPX Study.

Open Forum Infect Dis 2021 Jun 23;8(6):ofab263. Epub 2021 May 23.

Melbourne Sexual Health Centre, Alfred Health, Melbourne, Victoria, Australia.

We aimed to estimate how often urethral gonorrhoea is symptomatic among men in the Pre-Exposure Prophylaxis Expanded Victoria study. Eighty-seven percent of 213 cases of urethral gonorrhoea were symptomatic. Ensuring men with urethral gonorrhoea both recognize and present early for treatment is critical to reduce transmission.
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http://dx.doi.org/10.1093/ofid/ofab263DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8231363PMC
June 2021

Azithromycin or Doxycycline for Asymptomatic Rectal .

N Engl J Med 2021 06;384(25):2418-2427

From the University of Melbourne (A.L., F.Y.S.K., S.P., E.P.F.C., N.C., J.S.H.), the Melbourne Sexual Health Centre (C.K.F., M.Y.C., C.S.B., E.P.F.C., J.S.H.), and Monash University (C.K.F., M.Y.C., C.S.B., E.P.F.C.), Melbourne, VIC, Macquarie University, Macquarie, NSW (J.A.), Central Clinical School, Faculty of Medicine and Health, University of Sydney (D.J.T.), Sydney Sexual Health Centre (A.M., B.D.), and the School of Population Health (A.M.) and the Kirby Institute (D.J.T., M.L., B.D., D.G.R., J.K., J.A.), University of New South Wales, Sydney, the Department of Sexual Health Medicine and Sexual Assault Medicine, Sydney Local Health District, Camperdown, NSW (D.J.T.), Western Sydney Sexual Health Centre, Parramatta, NSW, and Westmead Clinical School, University of Sydney, Westmead, NSW (D.A.L.), the Adelaide Sexual Health Centre (C.K., M.R.) and the University of Adelaide (M.A.B.), Adelaide, SA, and the University of the Sunshine Coast, Sippy Downs, QLD (P.T.) - all in Australia.

Background: Rectal chlamydia is a common bacterial sexually transmissible infection among men who have sex with men. Data from randomized, controlled trials are needed to guide treatment.

Methods: In this double-blind trial conducted at five sexual health clinics in Australia, we randomly assigned men who have sex with men and who had asymptomatic rectal chlamydia to receive doxycycline (100 mg twice daily for 7 days) or azithromycin (1-g single dose). Asymptomatic chlamydia was selected as the trial focus because more than 85% of men with rectal chlamydia infection are asymptomatic, and clinical guidelines recommend a longer treatment course for symptomatic infection. The primary outcome was a negative nucleic acid amplification test for rectal chlamydia (microbiologic cure) at 4 weeks.

Results: From August 2016 through August 2019, we enrolled 625 men (314 in the doxycycline group and 311 in the azithromycin group). Primary outcome data were available for 290 men (92.4%) in the doxycycline group and 297 (95.5%) in the azithromycin group. In the modified intention-to-treat population, a microbiologic cure occurred in 281 of 290 men (96.9%; 95% confidence interval [CI], 94.9 to 98.9) in the doxycycline group and in 227 of 297 (76.4%; 95% CI, 73.8 to 79.1) in the azithromycin group, for an adjusted risk difference of 19.9 percentage points (95% CI, 14.6 to 25.3; P<0.001). Adverse events that included nausea, diarrhea, and vomiting were reported in 98 men (33.8%) in the doxycycline group and in 134 (45.1%) in the azithromycin group (risk difference, -11.3 percentage points; 95% CI, -19.5 to -3.2).

Conclusions: A 7-day course of doxycycline was superior to single-dose azithromycin in the treatment of rectal chlamydia infection among men who have sex with men. (Funded by the National Health and Medical Research Council; RTS Australian New Zealand Clinical Trials Registry number, ACTRN12614001125617.).
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http://dx.doi.org/10.1056/NEJMoa2031631DOI Listing
June 2021

Azithromycin or Doxycycline for Asymptomatic Rectal .

N Engl J Med 2021 06;384(25):2418-2427

From the University of Melbourne (A.L., F.Y.S.K., S.P., E.P.F.C., N.C., J.S.H.), the Melbourne Sexual Health Centre (C.K.F., M.Y.C., C.S.B., E.P.F.C., J.S.H.), and Monash University (C.K.F., M.Y.C., C.S.B., E.P.F.C.), Melbourne, VIC, Macquarie University, Macquarie, NSW (J.A.), Central Clinical School, Faculty of Medicine and Health, University of Sydney (D.J.T.), Sydney Sexual Health Centre (A.M., B.D.), and the School of Population Health (A.M.) and the Kirby Institute (D.J.T., M.L., B.D., D.G.R., J.K., J.A.), University of New South Wales, Sydney, the Department of Sexual Health Medicine and Sexual Assault Medicine, Sydney Local Health District, Camperdown, NSW (D.J.T.), Western Sydney Sexual Health Centre, Parramatta, NSW, and Westmead Clinical School, University of Sydney, Westmead, NSW (D.A.L.), the Adelaide Sexual Health Centre (C.K., M.R.) and the University of Adelaide (M.A.B.), Adelaide, SA, and the University of the Sunshine Coast, Sippy Downs, QLD (P.T.) - all in Australia.

Background: Rectal chlamydia is a common bacterial sexually transmissible infection among men who have sex with men. Data from randomized, controlled trials are needed to guide treatment.

Methods: In this double-blind trial conducted at five sexual health clinics in Australia, we randomly assigned men who have sex with men and who had asymptomatic rectal chlamydia to receive doxycycline (100 mg twice daily for 7 days) or azithromycin (1-g single dose). Asymptomatic chlamydia was selected as the trial focus because more than 85% of men with rectal chlamydia infection are asymptomatic, and clinical guidelines recommend a longer treatment course for symptomatic infection. The primary outcome was a negative nucleic acid amplification test for rectal chlamydia (microbiologic cure) at 4 weeks.

Results: From August 2016 through August 2019, we enrolled 625 men (314 in the doxycycline group and 311 in the azithromycin group). Primary outcome data were available for 290 men (92.4%) in the doxycycline group and 297 (95.5%) in the azithromycin group. In the modified intention-to-treat population, a microbiologic cure occurred in 281 of 290 men (96.9%; 95% confidence interval [CI], 94.9 to 98.9) in the doxycycline group and in 227 of 297 (76.4%; 95% CI, 73.8 to 79.1) in the azithromycin group, for an adjusted risk difference of 19.9 percentage points (95% CI, 14.6 to 25.3; P<0.001). Adverse events that included nausea, diarrhea, and vomiting were reported in 98 men (33.8%) in the doxycycline group and in 134 (45.1%) in the azithromycin group (risk difference, -11.3 percentage points; 95% CI, -19.5 to -3.2).

Conclusions: A 7-day course of doxycycline was superior to single-dose azithromycin in the treatment of rectal chlamydia infection among men who have sex with men. (Funded by the National Health and Medical Research Council; RTS Australian New Zealand Clinical Trials Registry number, ACTRN12614001125617.).
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http://dx.doi.org/10.1056/NEJMoa2031631DOI Listing
June 2021

Is it the end of mouthwash as an intervention for gonorrhoea?

Lancet Infect Dis 2021 06;21(6):763-764

Melbourne Sexual Health Centre, Alfred Health, Melbourne, VIC 3053, Australia; Central Clinical School, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, VIC, Australia.

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http://dx.doi.org/10.1016/S1473-3099(21)00195-XDOI Listing
June 2021

Modelling the multiple anatomical site transmission of Mycoplasma genitalium among men who have sex with men in Australia.

Sci Rep 2021 May 27;11(1):11087. Epub 2021 May 27.

China Australia Joint Research Center for Infectious Diseases, School of Public Health, Xi'an Jiaotong University Health Science Centre, Xi'an, 710061, Shaanxi, People's Republic of China.

Mycoplasma genitalium (M. genitalium) is a recently recognised and important sexually transmitted infection among men who have sex with men (MSM). The role of oral sex, rimming, and kissing on M. genitalium transmission in MSM is unclear. We created four deterministic susceptible-infectious-susceptible epidemic models to examine the role that different sexual behaviours play in transmitting M. genitalium at the oropharynx, urethra anorectum among men who have sex with men in Australia. Our results suggest that oral and anal sex without other sexual practices (model 1) replicate well single site infection at the oropharynx, urethra and anorectum and also multi-site infection. If kissing or rimming are added to model 1 (i.e., model 2-4) no substantial improvements in the calibration of the models occur. Model 1 estimates that 3.4% of infections occur at the oropharynx, 34.8% at the urethra and 61.8% at the anorectum. Model 1 also estimates that the proportion of incident M. genitalium transmitted by anal sex was 82.4%, and by oral sex was about 17.6%. Our findings could provide an enhanced understanding of M. genitalium transmission in MSM, thus providing insights into what sexual practices contribute most to transmission.
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http://dx.doi.org/10.1038/s41598-021-90627-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8160207PMC
May 2021

Prevalence of human papillomavirus in young men who have sex with men after the implementation of gender-neutral HPV vaccination: a repeated cross-sectional study.

Lancet Infect Dis 2021 May 24. Epub 2021 May 24.

Melbourne Sexual Health Centre, Alfred Health, Melbourne, VIC, Australia; Central Clinical School, Monash University, Melbourne, VIC, Australia.

Background: Anal infection with high-risk human papillomavirus (HPV) genotypes 16 and 18 and anal cancer are overrepresented in men who have sex with men (MSM). This study investigated HPV prevalence in young MSM before and after the implementation of a school-based quadrivalent HPV (genotypes 6, 11, 16, and 18) vaccination programme for boys in Australia in 2013.

Methods: In this repeated cross-sectional study, MSM aged 16-20 years were recruited from two successive birth cohorts via sexual health clinics and the community in Melbourne, Australia. The first cohort was before the implementation of gender-neutral vaccination (HYPER1 study, done in 2010-12, NCT01422356), and the second was the post-vaccination cohort (HYPER2 study, done in 2017-18, NCT03000933). Men who self-identified as being same-sex attracted were enrolled, and those recruited via the HYPER2 study had to be resident in Australia since 2013 to ensure eligibility. Study procedures were done in the Melbourne Sexual Health Centre. A clinician-collected anal swab and self-collected penile swab and oral rinse were tested for 28 HPV genotypes, and data on demographics and sexual health practices were collected via questionnaires. Only assessable samples were included in the analyses. We compared anatomical site-specific prevalence of HPV genotypes between cohorts by calculating the prevalence ratio, adjusting for age, circumcision, and sex with women. Herd protection was also assessed, by calculating the adjusted prevalence ratios by vaccination status.

Findings: 400 MSM, 200 per cohort, were included in the study. In both cohorts, the median number of lifetime male partners was ten (IQR 5-25). The prevalence of any anal quadrivalent vaccine-preventable HPV genotype was higher in the pre-vaccination cohort (54 [28%] of 193) than in the post-vaccination cohort (14 [7%] of 193; adjusted prevalence ratio [PR] 0·24, 95% CI 0·14-0·42), largely driven by decreases in HPV6, followed by HPV11, 16, and 18. Nevertheless, there was also a significant reduction in anal HPV16 and 18 in the post-vaccination cohort from the pre-vaccination cohort (0·31, 0·14-0·68). The prevalence of any penile quadrivalent vaccine-preventable HPV genotype was also higher in the pre-vaccination cohort (21 [12%] of 177) than in the post-vaccination cohort (11 [6%] of 179; 0·48, 0·24-0·97), driven by decreases in HPV 6 and 11, but not by 16 and 18. The prevalence of any oral quadrivalent vaccine-preventable HPV genotype was higher in the pre-vaccination cohort (seven [4%] of 200) than in the post-vaccination cohort (one [1%] of 199; 0·10, 0·01-0·97); there were no cases of oral HPV6 or 11 detected in HYPER2. Comparing the pre-vaccinated cohort with the 149 confirmed vaccinated men from HYPER2 showed a reduction in any quadrivalent vaccine-preventable HPV genotype for anal (0·09, 0·03-0·25) and penile (0·18, 0·05-0·59) infection but not for oral infection (0·17, 0·03-1·08).

Interpretation: A reduction in anal, penile, and oral quadrivalent vaccine-targeted genotypes occurred in young MSM following the implementation of a school-based gender-neutral HPV vaccination programme. The fall in anal HPV16 and 18 may lead to a reduction in the incidence of anal cancer.

Funding: Merck and the Australian Government Department of Health.
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http://dx.doi.org/10.1016/S1473-3099(20)30687-3DOI Listing
May 2021

Prevalence of human papillomavirus in young men who have sex with men after the implementation of gender-neutral HPV vaccination: a repeated cross-sectional study.

Lancet Infect Dis 2021 May 24. Epub 2021 May 24.

Melbourne Sexual Health Centre, Alfred Health, Melbourne, VIC, Australia; Central Clinical School, Monash University, Melbourne, VIC, Australia.

Background: Anal infection with high-risk human papillomavirus (HPV) genotypes 16 and 18 and anal cancer are overrepresented in men who have sex with men (MSM). This study investigated HPV prevalence in young MSM before and after the implementation of a school-based quadrivalent HPV (genotypes 6, 11, 16, and 18) vaccination programme for boys in Australia in 2013.

Methods: In this repeated cross-sectional study, MSM aged 16-20 years were recruited from two successive birth cohorts via sexual health clinics and the community in Melbourne, Australia. The first cohort was before the implementation of gender-neutral vaccination (HYPER1 study, done in 2010-12, NCT01422356), and the second was the post-vaccination cohort (HYPER2 study, done in 2017-18, NCT03000933). Men who self-identified as being same-sex attracted were enrolled, and those recruited via the HYPER2 study had to be resident in Australia since 2013 to ensure eligibility. Study procedures were done in the Melbourne Sexual Health Centre. A clinician-collected anal swab and self-collected penile swab and oral rinse were tested for 28 HPV genotypes, and data on demographics and sexual health practices were collected via questionnaires. Only assessable samples were included in the analyses. We compared anatomical site-specific prevalence of HPV genotypes between cohorts by calculating the prevalence ratio, adjusting for age, circumcision, and sex with women. Herd protection was also assessed, by calculating the adjusted prevalence ratios by vaccination status.

Findings: 400 MSM, 200 per cohort, were included in the study. In both cohorts, the median number of lifetime male partners was ten (IQR 5-25). The prevalence of any anal quadrivalent vaccine-preventable HPV genotype was higher in the pre-vaccination cohort (54 [28%] of 193) than in the post-vaccination cohort (14 [7%] of 193; adjusted prevalence ratio [PR] 0·24, 95% CI 0·14-0·42), largely driven by decreases in HPV6, followed by HPV11, 16, and 18. Nevertheless, there was also a significant reduction in anal HPV16 and 18 in the post-vaccination cohort from the pre-vaccination cohort (0·31, 0·14-0·68). The prevalence of any penile quadrivalent vaccine-preventable HPV genotype was also higher in the pre-vaccination cohort (21 [12%] of 177) than in the post-vaccination cohort (11 [6%] of 179; 0·48, 0·24-0·97), driven by decreases in HPV 6 and 11, but not by 16 and 18. The prevalence of any oral quadrivalent vaccine-preventable HPV genotype was higher in the pre-vaccination cohort (seven [4%] of 200) than in the post-vaccination cohort (one [1%] of 199; 0·10, 0·01-0·97); there were no cases of oral HPV6 or 11 detected in HYPER2. Comparing the pre-vaccinated cohort with the 149 confirmed vaccinated men from HYPER2 showed a reduction in any quadrivalent vaccine-preventable HPV genotype for anal (0·09, 0·03-0·25) and penile (0·18, 0·05-0·59) infection but not for oral infection (0·17, 0·03-1·08).

Interpretation: A reduction in anal, penile, and oral quadrivalent vaccine-targeted genotypes occurred in young MSM following the implementation of a school-based gender-neutral HPV vaccination programme. The fall in anal HPV16 and 18 may lead to a reduction in the incidence of anal cancer.

Funding: Merck and the Australian Government Department of Health.
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http://dx.doi.org/10.1016/S1473-3099(20)30687-3DOI Listing
May 2021

Treponema pallidum detection in lesion and non-lesion sites in men who have sex with men with early syphilis: a prospective, cross-sectional study.

Lancet Infect Dis 2021 09 22;21(9):1324-1331. Epub 2021 Apr 22.

Melbourne Sexual Health Centre, Alfred Health, Melbourne, VIC, Australia; Central Clinical School, Faculty of Nursing, Medicine and Health Sciences, Monash University, Melbourne, VIC, Australia.

Background: Syphilis transmission is increasing, and precisely how Treponema pallidum is transmitted sexually from person to person is unclear. We aimed to determine the frequency of T pallidum shedding from potentially asymptomatic sites and the stage of infection at which shedding is most frequent in men who have sex with men (MSM), who have been disproportionately affected by syphilis.

Methods: We did a prospective, cross-sectional study in MSM recruited from Melbourne Sexual Health Centre (Melbourne, VIC, Australia). Men were eligible if they were aged 18 years or older, reported sex with men during the past 12 months, and had laboratory confirmed primary, secondary, or early latent syphilis, consistent with Australian definitions. Primary and secondary syphilis lesions were swabbed and non-lesion samples were collected via oral rinse, oral cavity swab, anal canal swab, urine, and semen. Samples were tested for T pallidum using PCR assays targeting polA (lesion and non-lesion samples) and 47 kDa (non-lesion samples only) gene targets. The primary outcome was the proportion of men with T pallidum detected from potentially asymptomatic sites-namely, the mouth, anus, urethra, and semen.

Findings: Between Nov 30, 2015, and May 23, 2019, 246 MSM were screened for inclusion, of whom 200 had serologically confirmed early syphilis and were included in the study: 54 (27%) of 200 had primary syphilis, 93 (47%) had secondary syphilis, and 53 (27%) had early latent syphilis. T pallidum DNA was detected in 48 (24%; 95% CI 18·3-30·5) of 200 men by oral rinse or oral lesion swab, or both, of whom 24 had no oral lesions. Oral T pallidum detection was most frequent in those with secondary syphilis compared with those at other stages of disease (41 [44%] of 93 vs seven [7%] of 107; p<0·0001), and in men with rapid plasma reagin titres of 1/64 or higher compared with those with lower titres (37 [32%] of 117 vs 11 [13%] of 83; p=0·0026). T pallidum was detected by anal canal swab or anal lesion swab, or both, in 45 (23·0%; 95% CI 17·3-29·5) of 196 men with available samples, of whom ten had no anal lesion. Furthermore, T pallidum was detected in urine samples of 12 (6·1%, 3·2-10·3) of 198 men and in semen samples from six (12·0%, 4·5-24·3) of 50 men who provided samples. Among the 93 men with secondary syphilis, 69 (74%) had T pallidum detected at any site, and 24 (26%) had detection at two or more separate sites. Among the 54 men with primary syphilis, 49 (91%) had T pallidum detected at any site, and 11 (20%) had detection at two or more separate sites. Among the 53 men with early latent syphilis, four (8%) had T pallidum detected at any site and none had T pallidum detected at two or more separate sites.

Interpretation: Unrecognised oral and anal shedding of T pallidum occurs in MSM with early syphilis, most frequently in those with secondary syphilis, suggesting secondary syphilis is the most infectious stage and that earlier detection and treatment of syphilis to prevent progression to the secondary stage might improve syphilis control. Future research is needed to ascertain the contribution of shedding of T pallidum from non-lesion sites to transmission of syphilis.

Funding: Australian National Health and Medical Research Council.
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http://dx.doi.org/10.1016/S1473-3099(20)30838-0DOI Listing
September 2021

Spatial and temporal epidemiology of infectious syphilis in Victoria, Australia, 2015-2018.

Sex Transm Dis 2021 Apr 14. Epub 2021 Apr 14.

Melbourne Sexual Health Centre, Alfred Health, Melbourne, Victoria, Australia Central Clinical School, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Victoria, Australia Department of Health, Melbourne, Victoria, Australia Microbiological Diagnostic Unit Public Health Laboratory, Department of Microbiology and Immunology, The University of Melbourne at The Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia Centre for Excellence in Rural Sexual Health, Melbourne Medical School, The University of Melbourne, Melbourne, Victoria, Australia Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, Victoria, Australia.

Abstract: This analysis of notified syphilis cases in Victoria, Australia between 2015 and 2018 shows the syphilis epidemic in Victoria has become more generalised, with increases among heterosexual men and women residing in outer Melbourne suburbs - areas that differ from those of gay men.
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http://dx.doi.org/10.1097/OLQ.0000000000001438DOI Listing
April 2021

Oropharyngeal gonorrhoea infections among heterosexual women and heterosexual men with urogenital gonorrhoea attending a sexual health clinic in Melbourne, Australia.

Clin Microbiol Infect 2021 May 6. Epub 2021 May 6.

Central Clinical School, Monash University, Melbourne, Victoria, Australia; Melbourne Sexual Health Centre, Alfred Health, Melbourne, Victoria, Australia; Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, Victoria, Australia. Electronic address:

Objectives: There is limited evidence about the transmission and prevalence of oropharyngeal gonorrhoea in heterosexuals. From August 2017, Melbourne Sexual Health Centre (MSHC) began testing for oropharyngeal gonorrhoea among heterosexuals with untreated urogenital gonorrhoea. This study aims to determine the positivity of oropharyngeal gonorrhoea among heterosexuals diagnosed with urogenital gonorrhoea at MSHC between August 2017 and May 2020.

Methods: We included individuals who had oropharyngeal gonorrhoea testing within 30 days of initial testing. We reported the number and proportion of oropharyngeal gonorrhoea positivity, stratified by gender and contact of gonorrhoea. The χ test was performed to compare the oropharyngeal gonorrhoea positivity between groups.

Results: Of 617 individuals with untreated urogenital gonorrhoea, 424 (68.7%) were tested for oropharyngeal gonorrhoea. Oropharyngeal gonorrhoea positivity was 38.9% (95%CI 34.2-43.7%, 165/424), and was higher in women than in men (115/252, 45.6% versus 50/172, 29.1%, p = 0.001). Furthermore, oropharyngeal gonorrhoea positivity was higher among individuals who were contacts of gonorrhoea cases compared to those who were not (29/44, 65.9% versus 136/380, 35.8%, p < 0.001). There was also no significant difference between women who were sex workers and those who were not (30/78, 38.5% versus 85/174, 48.9%, p = 0.126).

Conclusions: Our data suggest that oropharyngeal gonorrhoea infection is common among heterosexual women and heterosexual men with untreated urogenital gonorrhoea. Testing heterosexual women and heterosexual men for oropharyngeal gonorrhoea will identify a significant proportion with unrecognized oropharyngeal infections whose recommended treatment is different in some countries.
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http://dx.doi.org/10.1016/j.cmi.2021.03.033DOI Listing
May 2021

Timing of primary syphilis treatment and impact on the development of treponemal antibodies: a cross-sectional clinic-based study.

Sex Transm Infect 2021 Mar 29. Epub 2021 Mar 29.

Melbourne Sexual Health Centre, Alfred Health, Carlton, Victoria, Australia.

Background: Serology is negative in a proportion of primary syphilis cases where PCR testing is positive. We aimed to identify discordant, PCR-positive, serology-negative primary syphilis cases and any clinical or laboratory factors associated with failure to subsequently seroconvert.

Methods: Serodiscordant primary syphilis cases that were PCR-positive and serology-negative (including rapid plasma reagin, particle agglutination, enzyme immunoassay or chemiluminescence assay) were identified from the Melbourne Sexual Health Centre electronic records between April 2011 and December 2019. Clinical and laboratory associations were examined.

Results: There were 814 primary syphilis cases in the study period and 38 (4.7%) were serodiscordant, 35 in men who have sex with men. Thirty-two had follow-up serology performed a median of 24 days later, of which 16 (50%) seroconverted, mostly (81%) within 6 weeks. Failure to seroconvert was significantly associated with treatment on day 1. Of the 12 cases treated on day 1, 10 (83%) failed to seroconvert compared with 6 of 20 (30%) among those who were treated after day 1.

Discussion: Earlier treatment of primary syphilis can prevent the development of serological markers. PCR can identify primary syphilis lesions before the development of serological markers and improve diagnosis of early primary syphilis lesions. Serology alone will miss a proportion of primary syphilis infections and should be repeated if a diagnosis of syphilis is being considered.
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http://dx.doi.org/10.1136/sextrans-2020-054739DOI Listing
March 2021

Projected COVID-19 epidemic in the United States in the context of the effectiveness of a potential vaccine and implications for social distancing and face mask use.

Vaccine 2021 04 27;39(16):2295-2302. Epub 2021 Feb 27.

China-Australia Joint Research Center for Infectious Diseases, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, Shaanxi, China; Melbourne Sexual Health Centre, Alfred Health, Melbourne, Australia; Central Clinical School, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia; Department of Epidemiology and Biostatistics, College of Public Health, Zhengzhou University, Zhengzhou, Henan, China. Electronic address:

Background: Multiple candidates of COVID-19 vaccines have entered Phase III clinical trials in the United States (US). There is growing optimism that social distancing restrictions and face mask requirements could be eased with widespread vaccine adoption soon.

Methods: We developed a dynamic compartmental model of COVID-19 transmission for the four most severely affected states (New York, Texas, Florida, and California). We evaluated the vaccine effectiveness and coverage required to suppress the COVID-19 epidemic in scenarios when social contact was to return to pre-pandemic levels and face mask use was reduced. Daily and cumulative COVID-19 infection and death cases from 26th January to 15th September 2020 were obtained from the Johns Hopkins University Coronavirus resource center and used for model calibration.

Results: Without a vaccine (scenario 1), the spread of COVID-19 could be suppressed in these states by maintaining strict social distancing measures and face mask use levels. But relaxing social distancing restrictions to the pre-pandemic level without changing the current face mask use would lead to a new COVID-19 outbreak, resulting in 0.8-4 million infections and 15,000-240,000 deaths across these four states over the next 12 months. Under this circumstance, introducing a vaccine (scenario 2) would partially offset this negative impact even if the vaccine effectiveness and coverage are relatively low. However, if face mask use is reduced by 50% (scenario 3), a vaccine that is only 50% effective (weak vaccine) would require coverage of 55-94% to suppress the epidemic in these states. A vaccine that is 80% effective (moderate vaccine) would only require 32-57% coverage to suppress the epidemic. In contrast, if face mask usage stops completely (scenario 4), a weak vaccine would not suppress the epidemic, and further major outbreaks would occur. A moderate vaccine with coverage of 48-78% or a strong vaccine (100% effective) with coverage of 33-58% would be required to suppress the epidemic. Delaying vaccination rollout for 1-2 months would not substantially alter the epidemic trend if the current non-pharmaceutical interventions are maintained.

Conclusions: The degree to which the US population can relax social distancing restrictions and face mask use will depend greatly on the effectiveness and coverage of a potential COVID-19 vaccine if future epidemics are to be prevented. Only a highly effective vaccine will enable the US population to return to life as it was before the pandemic.
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http://dx.doi.org/10.1016/j.vaccine.2021.02.056DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7914016PMC
April 2021

Brief Report: Low Incidence of Hepatitis C Among a Cohort of HIV-Negative Gay and Bisexual Men Using HIV Pre-exposure Prophylaxis (PrEP) in Melbourne, Australia, and the Contribution of Sexual Transmission.

J Acquir Immune Defic Syndr 2021 08;87(4):1011-1015

Department of Infectious Diseases, the Alfred Hospital, Melbourne, Australia.

Background: PrEPX was an Australian HIV pre-exposure prophylaxis (PrEP) study conducted between 2016 and 2018. This analysis aimed to estimate hepatitis C (HCV) incidence and explore likely modes of transmission.

Setting: Cohort study of PrEP users in Victoria, Australia.

Methods: HCV tests were conducted at enrollment and every 12 months thereafter. HCV incident cases were identified from laboratory data. Likely modes of transmission were inferred from computer-assisted self-interviews, medical records, and interviews.

Results: Among 3202 PrEPX participants tested for HCV at baseline, HCV RNA-positive prevalence was 0.22% (95% confidence interval: 0.09 to 0.45). Among participants testing HCV antibody-negative or RNA-negative at baseline, 2058 had at least one follow-up HCV test. Eight incident HCV cases were identified during 2111 person-years of follow-up (incidence 0.38/100 person-years); all were primary infections in men who had sex with men. Clinical, laboratory, and computer-assisted self-interviews data were available for all, and 6 cases were interviewed. Three cases were attributable to injecting drug use (IDU). A fourth case reported IDU, but his HCV was attributable to sexual transmission. Four other cases reported no IDU and probably acquired HCV sexually. Most cases reported anal trauma in the context of condomless receptive anal intercourse during group sex at sex-on-premises venues.

Conclusions: In PrEPX, HCV incidence was low compared to international PrEP studies, and most cases were transmitted sexually. Our findings highlight the need for HCV prevention messaging by clinicians, in sex-on-premises venues, and on digital platforms used to arrange group sex; and the need for HCV screening among some PrEP-using men who have sex with men.
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http://dx.doi.org/10.1097/QAI.0000000000002685DOI Listing
August 2021

Global estimates for the lifetime cost of managing HIV.

AIDS 2021 07;35(8):1273-1281

Central Clinical School, Monash University.

Objective: There are an estimated 38 million people with HIV (PWH), with significant economic consequences. We aimed to collate global lifetime costs for managing HIV.

Design: We conducted a systematic review (PROSPERO: CRD42020184490) using five databases from 1999 to 2019.

Methods: Studies were included if they reported primary data on lifetime costs for PWH. Two reviewers independently assessed the titles and abstracts, and data were extracted from full texts: lifetime cost, year of currency, country of currency, discount rate, time horizon, perspective, method used to estimate cost and cost items included. Descriptive statistics were used to summarize the discounted lifetime costs [2019 United States dollars (USD)].

Results: Of the 505 studies found, 260 full texts were examined and 75 included. Fifty (67%) studies were from high-income, 22 (29%) from middle-income and three (4%) from low-income countries. Of the 65 studies, which reported study perspective, 45 (69%) were healthcare provider and the remainder were societal. The median lifetime costs for managing HIV differed according to: country income level: $5221 [interquartile range (IQR)]: 2978-11 177) for low-income to $377 820 (IQR: 260 176-541 430) for high-income; study perspective: $189 230 (IQR: 14 794-424 069) for healthcare provider, to $508 804 (IQR: 174 781-812 418) for societal; and decision model: $190 255 (IQR: 13 588-429 772) for Markov cohort, to $283 905 (IQR: 10 558-453 779) for microsimulation models.

Conclusion: Estimating the lifetime costs of managing HIV is useful for budgetary planning and to ensure HIV management is affordable for all. Furthermore, HIV prevention strategies need to be strengthened to avert these high costs of managing HIV.
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http://dx.doi.org/10.1097/QAD.0000000000002887DOI Listing
July 2021

Sexual behaviours associated with incident high-risk anal human papillomavirus among gay and bisexual men.

Sex Transm Infect 2021 Mar 16. Epub 2021 Mar 16.

The Kirby Insitute, UNSW Sydney, Sydney, New South Wales, Australia.

Objective: High-risk human papillomavirus (HRHPV) causes anal cancer, which disproportionately affects gay and bisexual men (GBM). We examined sexual behaviours associated with incident anal HRHPV in an observational cohort study of GBM in Sydney, Australia.

Methods: GBM aged 35 years and above were enrolled in the Study of the Prevention of Anal Cancer. Detailed information on sexual practices in the last 6 months, including receptive anal intercourse (RAI) and non-intercourse receptive anal practices, was collected. Anal human papillomavirus (HPV) testing was performed at the baseline and three annual follow-up visits. Risk factors for incident HRHPV were determined by Cox regression using the Wei-Lin-Weissfeld method.

Results: Between 2010 and 2015, 617 men were recruited and 525 who had valid HPV results at baseline and at least one follow-up visit were included in the analysis. The median age was 49 years (IQR 43-56) and 188 (35.8%) were HIV-positive. On univariable analysis, incident anal HRHPV was associated with being HIV-positive (p<0.001), having a higher number of recent RAI partners regardless of condom use (p<0.001 for both), preference for the receptive position during anal intercourse (p=0.014) and other non-intercourse receptive anal sexual practices, including rimming, fingering and receptive use of sex toys (p<0.05 for all). In multivariable analyses, being HIV-positive (HR 1.46, 95% CI 1.09 to 1.85, p=0.009) and reporting condom-protected RAI with a higher number of sexual partners (p<0.001) remained significantly associated with incident HRHPV. When stratified by recent RAI, non-intercourse receptive anal practices were not associated with incident HRHPV in men who reported no recent RAI.

Conclusion: GBM living with HIV and those who reported RAI were at increased of incident anal HRHPV. Given the substantial risk of anal cancer and the difficulty in mitigating the risk of acquiring anal HRHPV, HPV vaccination should be considered among sexually active older GBM.

Trial Registration Number: ANZCTR365383.
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http://dx.doi.org/10.1136/sextrans-2020-054851DOI Listing
March 2021

Antiseptic mouthwash for gonorrhoea prevention (OMEGA): a randomised, double-blind, parallel-group, multicentre trial.

Lancet Infect Dis 2021 05 4;21(5):647-656. Epub 2021 Mar 4.

Melbourne Sexual Health Centre, Alfred Health, Melbourne, VIC, Australia; Central Clinical School, Monash University, Melbourne, VIC, Australia; China-Australia Joint Research Centre for Infectious Diseases, School of Public Health, Xi'an Jiaotong University, Xi'an, China.

Background: To address the increasing incidence of gonorrhoea and antimicrobial resistance, we compared the efficacy of Listerine and Biotène mouthwashes for preventing gonorrhoea among men who have sex with men (MSM).

Methods: The OMEGA trial was a multicentre, parallel-group, double-blind randomised controlled trial among MSM, done at three urban sexual health clinics and one general practice clinic in Australia. Men were eligible if they were diagnosed with oropharyngeal gonorrhoea by nucleic acid amplification test (NAAT) in the previous 30 days or were aged 16-24 years. They were randomly assigned to receive Listerine (intervention) or Biotène (control) via a computer-generated sequence (1:1 ratio, block size of four). Participants, clinicians, data collectors, data analysts, and outcome adjudicators were masked to the interventions after assignment. Participants were instructed to rinse and gargle with 20 mL of mouthwash for 60 s at least once daily for 12 weeks. Oropharyngeal swabs were collected by research nurses every 6 weeks, and participants provided saliva samples every 3 weeks, to be tested for Neisseria gonorrhoeae with NAAT and quantitative PCR. The primary outcome was proportion of MSM diagnosed with oropharyngeal N gonorrhoeae infection at any point over the 12-week period, defined as a positive result for either oropharyngeal swabs or saliva samples by NAAT, and the cumulative incidence of oropharyngeal gonorrhoea at the week 12 visit. A modified intention-to-treat analysis for the primary outcome was done that included men who provided at least one follow-up specimen over the 12-week study period. The trial was registered on the Australian and New Zealand Clinical Trials Registry (ACTRN12616000247471).

Findings: Between March 30, 2016, and Oct 26, 2018, 786 MSM were screened and 256 were excluded. 264 MSM were randomly assigned to the Biotène group and 266 to the Listerine group. The analysis population included 227 (86%) men in the Biotène group and 219 (82%) in the Listerine group. Oropharyngeal gonorrhoea was detected in ten (4%) of 227 of MSM in the Biotène group and in 15 (7%) of 219 in the Listerine group (adjusted risk difference 2·5%, 95% CI -1·8 to 6·8). The cumulative incidence of oropharyngeal gonorrhoea at the week 12 visit did not differ between the two mouthwash groups (adjusted risk difference 3·1%, 95% CI -1·4 to 7·7).

Interpretation: Listerine did not reduce the incidence of oropharyngeal gonorrhoea compared with Biotène. However, previous research suggests that mouthwash might reduce the infectivity of oropharyngeal gonorrhoea; therefore, further studies of mouthwash examining its inhibitory effect on N gonorrhoeae are warranted to determine if it has a potential role for the prevention of transmission.

Funding: Australian National Health and Medical Research Council.
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http://dx.doi.org/10.1016/S1473-3099(20)30704-0DOI Listing
May 2021

Reflex Detection of Ciprofloxacin Resistance in Neisseria gonorrhoeae by Use of the SpeeDx ResistancePlus GC Assay.

J Clin Microbiol 2021 04 20;59(5). Epub 2021 Apr 20.

Department of Microbiology and Immunology, The Peter Doherty Institute for Infection and Immunity, The University of Melbourne, Melbourne, Victoria, Australia

Resistance-guided therapy (RGT) for gonorrhea may reduce unnecessary use of broad-spectrum antibiotics. When reflexed from the Aptima Combo 2 assay, the ResistancePlus GC assay demonstrated 94.8% sensitivity and 100.0% specificity for detection. Of the 379 concordant -positive samples, 86.8% were found to possess the S91F mutation, which was highly predictive for ciprofloxacin resistance and stable across 3,144 publicly available genomes. Our work supports the feasibility of implementing RGT for gonorrhea into routine molecular workflows.
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http://dx.doi.org/10.1128/JCM.00089-21DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8091848PMC
April 2021

Effects of New York's Executive Order on Face Mask Use on COVID-19 Infections and Mortality: A Modeling Study.

J Urban Health 2021 04 1;98(2):197-204. Epub 2021 Mar 1.

China-Australia Joint Research Center for Infectious Diseases, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, Shaanxi, China.

There is growing evidence on the effect of face mask use in controlling the spread of COVID-19. However, few studies have examined the effect of local face mask policies on the pandemic. In this study, we developed a dynamic compartmental model of COVID-19 transmission in New York City (NYC), which was the epicenter of the COVID-19 pandemic in the USA. We used data on daily and cumulative COVID-19 infections and deaths from the NYC Department of Health and Mental Hygiene to calibrate and validate our model. We then used the model to assess the effect of the executive order on face mask use on infections and deaths due to COVID-19 in NYC. Our results showed that the executive order on face mask use was estimated to avert 99,517 (95% CIs 72,723-126,312) COVID-19 infections and 7978 (5692-10,265) deaths in NYC. If the executive order was implemented 1 week earlier (on April 10), the averted infections and deaths would be 111,475 (81,593-141,356) and 9017 (6446-11,589), respectively. If the executive order was implemented 2 weeks earlier (on April 3 when the Centers for Disease Control and Prevention recommended face mask use), the averted infections and deaths would be 128,598 (94,373-162,824) and 10,515 (7540-13,489), respectively. Our study provides public health practitioners and policymakers with evidence on the importance of implementing face mask policies in local areas as early as possible to control the spread of COVID-19 and reduce mortality.
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http://dx.doi.org/10.1007/s11524-021-00517-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7919630PMC
April 2021

Elevated glucose level leads to rapid COVID-19 progression and high fatality.

BMC Pulm Med 2021 Feb 24;21(1):64. Epub 2021 Feb 24.

Key Laboratory of Ministry of Industry and Information Technology of Biomedical Engineering and Translational Medicine, Chinese PLA General Hospital, Beijing, 100853, People's Republic of China.

Objectives: We aimed to identify high-risk factors for disease progression and fatality for coronavirus disease 2019 (COVID-19) patients.

Methods: We enrolled 2433 COVID-19 patients and used LASSO regression and multivariable cause-specific Cox proportional hazard models to identify the risk factors for disease progression and fatality.

Results: The median time for progression from mild-to-moderate, moderate-to-severe, severe-to-critical, and critical-to-death were 3.0 (interquartile range: 1.8-5.5), 3.0 (1.0-7.0), 3.0 (1.0-8.0), and 6.5 (4.0-16.3) days, respectively. Among 1,758 mild or moderate patients at admission, 474 (27.0%) progressed to a severe or critical stage. Age above 60 years, elevated levels of blood glucose, respiratory rate, fever, chest tightness, c-reaction protein, lactate dehydrogenase, direct bilirubin, and low albumin and lymphocyte count were significant risk factors for progression. Of 675 severe or critical patients at admission, 41 (6.1%) died. Age above 74 years, elevated levels of blood glucose, fibrinogen and creatine kinase-MB, and low plateleta count were significant risk factors for fatality. Patients with elevated blood glucose level were 58% more likely to progress and 3.22 times more likely to die of COVID-19.

Conclusions: Older age, elevated glucose level, and clinical indicators related to systemic inflammatory responses and multiple organ failures, predict both the disease progression and the fatality of COVID-19 patients.
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http://dx.doi.org/10.1186/s12890-021-01413-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7903375PMC
February 2021

Lactic acid-containing products for bacterial vaginosis and their impact on the vaginal microbiota: A systematic review.

PLoS One 2021 11;16(2):e0246953. Epub 2021 Feb 11.

Central Clinical School, Monash University, Melbourne, Victoria, Australia.

Objective: The vaginal microbiota in bacterial vaginosis (BV) typically has low abundance of lactic acid producing lactobacilli. Lactic acid has properties that may make it effective for treating BV and/or restoring an optimal lactobacillus-dominated vaginal microbiota. We conducted a systematic review to describe the effect of intravaginal lactic acid-containing products on BV cure, and their impact on vaginal microbiota composition (PROSPERO registration: CRD42018115982).

Methods: PubMed, Embase and OVID were searched from inception to November 2019 to identify eligible studies. Included studies evaluated an intravaginal lactic acid-containing product and reported BV cure using established diagnostic methods, and/or vaginal microbiota composition using molecular methods. Studies were independently screened and assessed, and the proportion of women cured post-treatment was calculated. Study results were described in a qualitative manner.

Results: We identified 1,883 articles and assessed 57 full-texts for eligibility. Seven different lactic acid-containing products were evaluated and differed with respect to excipients, lactic acid concentration and pH. Most studies had medium or high risk of bias. Three trials compared the efficacy of a lactic acid-containing product to metronidazole for BV cure. One study found lactic acid to be equivalent to metronidazole and two studies found lactic acid to be significantly inferior to metronidazole. Two studies included a control group receiving a placebo or no treatment. One reported lactic acid to be superior than no treatment and the other reported lactic acid to be equivalent to placebo. Lactic acid-containing products did not significantly impact the vaginal microbiota composition.

Conclusion: There is a lack of high-quality evidence to support the use of lactic acid-containing products for BV cure or vaginal microbiota modulation. However, adequately powered and rigorous randomised trials with accompanying vaginal microbiota data are needed to evaluate the efficacy of lactic acid as a BV treatment strategy.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0246953PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7877752PMC
September 2021

Paying for Sex Among Males and Females: A Cross-Sectional Survey in Melbourne, Australia.

Sex Transm Dis 2021 03;48(3):195-199

From the Melbourne Sexual Health Centre, Alfred Health.

Background: Most research focuses on individual selling sex but very few on paying for sex. This study aimed to determine the proportion of males and females who paid for sex and associated factors.

Methods: We conducted a short survey at the Melbourne Sexual Health Centre between March and April 2019, which included a question on whether they had paid for sex in the past 3 months. The proportion of individuals who had paid for sex was calculated by sex and sexual orientation. Univariable and multivariable logistic regression models were conducted to identify individual's factors (e.g., demographics, sexual orientation, and HIV/sexually transmitted infection [STI] positivity) associated with paying for sex in the past 3 months.

Results: The proportion who reported paying for sex in the past 3 months was 12.2% (42/345) among heterosexual males, followed by 6.4% (23/357) among men who have sex with men (MSM) and 0.2% (1/430) among females. HIV status, preexposure prophylaxis use, and sexual orientation were not associated with paying for sex among MSM. No MSM living with HIV reported paying for sex in the past 3 months. There was a significant association between paying for sex and gonorrhea (odds ratio, 2.84; 95% confidence interval, 1.05-7.71; P = 0.041) but not HIV, syphilis, and chlamydia among MSM. HIV/STI was not associated with paying for sex among heterosexual males.

Conclusions: Paying for sex was more commonly reported among heterosexual males, followed by MSM. Females were very unlikely to pay for sex. There was a limited association between HIV/STI diagnosis and paying for sex among males.
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http://dx.doi.org/10.1097/OLQ.0000000000001307DOI Listing
March 2021

A New Method for Estimating the Incidence of Infectious Diseases.

Am J Epidemiol 2021 07;190(7):1386-1395

Ambitious World Health Organization targets for disease elimination require monitoring of epidemics using routine health data in settings of decreasing and low incidence. We evaluated 2 methods commonly applied to routine testing results to estimate incidence rates that assume a uniform probability of infection between consecutive negative and positive tests based on 1) the midpoint of this interval and 2) a randomly selected point in this interval. We compared these with an approximation of the Poisson binomial distribution, which assigns partial incidence to time periods based on the uniform probability of occurrence in these intervals. We assessed bias, variance, and convergence of estimates using simulations of Weibull-distributed failure times with systematically varied baseline incidence and varying trend. We considered results for quarterly, half-yearly, and yearly incidence estimation frequencies. We applied the methods to assess human immunodeficiency virus (HIV) incidence in HIV-negative patients from the Treatment With Antiretrovirals and Their Impact on Positive and Negative Men (TAIPAN) Study, an Australian study of HIV incidence in men who have sex with men, between 2012 and 2018. The Poisson binomial method had reduced bias and variance at low levels of incidence and for increased estimation frequency, with increased consistency of estimation. Application of methods to real-world assessment of HIV incidence found decreased variance in Poisson binomial model estimates, with observed incidence declining to levels where simulation results had indicated bias in midpoint and random-point methods.
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http://dx.doi.org/10.1093/aje/kwab014DOI Listing
July 2021
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