Multicentre double-blind randomised placebo-controlled trial evaluating the efficacy of the meningococcal B vaccine, 4CMenB (Bexsero), against Neisseria gonorrhoeae infection in men who have sex with men: the GoGoVax study protocol.

INTRODUCTION: Gonorrhoea, the sexually transmissible infection caused by Neisseria gonorrhoeae, has a substantial impact on sexual and reproductive health globally with an estimated 82 million new infections each year worldwide. N. gonorrhoeae antimicrobial resistance continues to escalate, and disease control is largely reliant on effective therapy as there is no proven effective gonococcal vaccine available. However, there is increasing evidence from observational cohort studies that the serogroup B meningococcal vaccine four-component meningitis B vaccine (4CMenB) (Bexsero), licensed to prevent invasive disease caused by Neisseria meningitidis, may provide cross-protection against the closely related bacterium N. gonorrhoeae. This study will evaluate the efficacy of 4CMenB against N. gonorrhoeae infection in men (cis and trans), transwomen and non-binary people who have sex with men (hereafter referred to as GBM+). METHODS AND ANALYSIS: This is a double-blind, randomised placebo-controlled trial in GBM+, either HIV-negative on pre-exposure prophylaxis against HIV or living with HIV (CD4 count >350 cells/mm3), who have had a diagnosis of gonorrhoea or infectious syphilis in the last 18 months (a key characteristic associated with a high risk of N. gonorrhoeae infection). Participants are randomised 1:1 to receive two doses of 4CMenB or placebo 3 months apart. Participants have 3-monthly visits over 24 months, which include testing for N. gonorrhoeae and other sexually transmissible infections, collection of demographics, sexual behaviour risks and antibiotic use, and collection of research samples for analysis of N. gonorrhoeae-specific systemic and mucosal immune responses. The primary outcome is the incidence of the first episode of N. gonorrhoeae infection, as determined by nucleic acid amplification tests, post month 4. Additional outcomes consider the incidence of symptomatic or asymptomatic N. gonorrhoeae infection at different anatomical sites (ie, urogenital, anorectum or oropharynx), incidence by N. gonorrhoeae genotype and antimicrobial resistance phenotype, and level and functional activity of N. gonorrhoeae-specific antibodies. ETHICS AND DISSEMINATION: Ethical approval was obtained from the St Vincent's Hospital Human Research Ethics Committee, St Vincent's Hospital Sydney, NSW, Australia (ref: 2020/ETH01084). Results will be disseminated in peer-reviewed journals and via presentation at national and international conferences. TRIAL REGISTRATION NUMBER: NCT04415424.

Physical Distancing Due to COVID-19 Disrupts Sexual Behaviors Among Gay and Bisexual Men in Australia: Implications for Trends in HIV and Other Sexually Transmissible Infections.

INTRODUCTION: In March 2020, Australian state and federal governments introduced physical distancing measures alongside widespread testing to combat COVID-19. These measures may decrease people's sexual contacts and thus reduce the transmission of HIV and other sexually transmissible infections (STIs). We investigated the impact of physical distancing measures due to COVID-19 on the sexual behavior of gay and bisexual men in Australia. METHODS: Between April 4, 2020, and April 29, 2020, 940 participants in an ongoing cohort study responded to questions to measure changes in sexual behaviors during the COVID-19 pandemic. Men reported the date they become concerned about COVID-19 and whether they engaged in sexual behavior with regular or casual partners or "fuckbuddies" in the 6 months before becoming concerned about COVID-19 (hereafter referred to as "before COVID-19"), and following the date, they become concerned about COVID-19 (hereafter referred to as "since COVID-19"). Before and since COVID-19 was based on individual participants' own perceived date of becoming concerned about COVID-19. RESULTS: The mean age of was 39.9 years (SD: 13.4). Most participants (88.3%) reported sex with other men during the 6 months before COVID-19. Of the 587 men (62.4%) who reported sex with casual partners before COVID-19, 93 (15.8%) continued to do so in the period since COVID-19, representing a relative reduction of 84.2%. CONCLUSION: Gay and bisexual men in Australia have dramatically reduced their sexual contacts with other men since COVID-19. These behavioral changes will likely result in short-term reductions in new HIV and STI diagnoses. If sexual health screenings are undertaken before resuming sexual activity, this could present a novel opportunity to interrupt chains of HIV and STI transmission.

High levels of engagement with testing for HIV and sexually transmissible infection among gay Asian men in Sydney and Melbourne: an observational study.

Background Gay and other men who have sex with men of Asian background (GAM) have been identified as a key population in efforts to eradicate HIV in New South Wales. The aims of the present study were to evaluate current levels of engagement with HIV and sexually transmissible infection (STI) testing services, assess knowledge of pre- and post-exposure prophylaxis and to identify factors associated with service engagement in this group. METHODS: A survey of 604 GAM residing in Sydney and Melbourne was undertaken. RESULTS: The data identified that a significant proportion of non-HIV-positive men (i.e. HIV-negative men and men whose HIV status was unknown) surveyed (n = 567; 93.9%) had engaged in frequent HIV testing and comprehensive STI testing in the 12 months prior to the survey (n = 180; 31.7%). There were significant differences (P < 0.05) in sexual practices at the bivariate level between those who reported frequent and comprehensive HIV/STI testing and those who did not. Those who tested regularly were substantially more sexually active, were more likely to have multiple partners (P = 0.001) and were more likely to engage in condomless anal intercourse with both casual (P < 0.001) and regular (P = 0.002) partners. Those who engaged with testing initiatives were more likely to discuss HIV status with both regular (P = 0.008) and casual (P < 0.001) partners, and identified more reasons to test than their counterparts (P < 0.001). The data also highlighted key service venues, with gay men most likely to have used public sexual health clinics (46.9%) as their most recent testing venue. CONCLUSIONS: The data demonstrate an association between high levels of male-to-male sexual activity and engagement in frequent and comprehensive HIV and STI testing. This likely derives from both self-perceived notions of risk and current reliance on established gay community organisations to convey information around testing. Increasing engagement with testing initiatives beyond GAM who self-identify as being at high HIV and STI risk will require the use of novel routes by which to disseminate this information.

Prevalence, frequency, and motivations for alkyl nitrite use among gay, bisexual and other men who have sex with men in Australia.

BACKGROUND AND AIMS: Gay, bisexual and other men who have sex with men (GBM) use alkyl nitrites ('poppers') at higher rates than other populations to functionally enhance sexual experiences. Their use has been associated with HIV sexual risk behaviours including receptive anal sex. We investigate the prevalence, frequency, and motivations for poppers use and their relationship with HIV risk. We also discuss the implications of the recent scheduling changes to poppers by the Australian Therapeutic Goods Administration. METHODS: Data were drawn from the Following Lives Undergoing Change (Flux) study, a prospective observational study of licit and illicit drug use among GBM. Between 2014 and 2018, 3273 GBM enrolled in the study. In 2018, 1745 GBM provided data relating to frequency of and motivations for poppers use and were included in this analysis. RESULTS: Median age was 33 years (IQR 25-46) and 801 GBM (45.9%) had used poppers in the previous six months ('recent use'). Among these men, 195 (24.3%) had used them weekly or more frequently. Most recent users (77.4%) reported using poppers for a 'buzz' during sex or to facilitate receptive anal intercourse (60.8%). The majority (57.7%) of HIV-negative men reporting recent poppers use were concurrently taking HIV pre-exposure prophylaxis. Recent poppers use was independently associated with receptive anal intercourse with casual partners (aOR 1.71; 95%CI 1.35-2.16) and chemsex (aOR 4.32; 95%CI 3.15-5.94). Poppers use was not associated with anxiety, depression, or drug-related harms. Only 15.4% of current users indicated they would stop using poppers if they were criminalised; 65.0% said they would 'find other ways' to obtain them. CONCLUSIONS: Poppers are commonly used by Australian GBM to functionally enhance sexual experiences, particularly to facilitate receptive anal intercourse. Few men experienced drug-related harms from poppers use. Regulatory changes must ensure potential harms from popper use are minimised without increasing barriers to access or perpetuating stigma.

Following Lives Undergoing Change (Flux) study: Implementation and baseline prevalence of drug use in an online cohort study of gay and bisexual men in Australia.

BACKGROUND: Drug use among gay and bisexual men (GBM) is higher than most populations. The use of crystal methamphetamine, erectile dysfunction medication (EDM), and amyl nitrite have been associated with sexual risk behaviour and HIV infection among gay and bisexual men (GBM). OBJECTIVE: This paper describes an online prospective observational study of licit and illicit drug use among GBM and explores baseline prevalence of drug use in this sample. Capturing these data poses challenges as participants are required to disclose potentially illegal behaviours in a geographically dispersed country. To address this issue, an entirely online and study specific methodology was chosen. METHODS: Men living in Australia, aged 16.5 years of age or older, who identified as homosexual or bisexual or had sex with at least one man in the preceding 12 months were eligible to enrol. RESULTS: Between September 2014 and July 2015, a total of 2250 participants completed the baseline questionnaire, of whom, 1710 (76.0%) consented to six-monthly follow-up. The majority (65.7%) were recruited through Facebook targeted advertising. At baseline, over half (50.5%) the men reported the use of any illicit drug in the previous six months, and 28.0% had used party drugs. In the six months prior to enrolment, 12.0% had used crystal methamphetamine, 21.8% had used EDM, and 32.1% had used amyl nitrite. Among the 1710 men enrolled into the cohort, 790 men had used none of these drugs. CONCLUSION: Ease of entry and minimal research burden on participants helped ensure successful recruitment into this online cohort study. Study outcomes will include the initiation and cessation of drug use, associated risk behaviours, and health consequences, over time. Results will provide insights into the role gay community plays in patterns of drug use among GBM.

Hepatitis C in Australia: impact of a mass media campaign.

BACKGROUND: Hepatitis C affects over 200,000 Australians. This study evaluated the impact of a public education campaign about this disease in New South Wales (NSW), Australia. DESIGN: Cohort and independent cross-sectional telephone surveys before and after the campaign. SETTING/PARTICIPANTS: Random population samples of adults in NSW. INTERVENTION: Television, radio and newsprint advertisements, posters and public display boards, public awareness events and media releases, and dissemination of information to healthcare professionals in April 2000. Data were analyzed in 2000 and 2005. MAIN OUTCOME MEASURES: Campaign recall, and knowledge and attitudes concerning hepatitis C. RESULTS: Recall of information about hepatitis C increased between baseline and follow-up, from 11.1% to 45.5% in the independent samples and 11.8% to 65.3% in the cohort. The proportion of people who knew that there was a low risk of disease transmission by kissing, sharing food utensils, or breastfeeding also increased significantly. In the cohort sample, a higher number of correct knowledge responses was associated with reporting exposure to information about hepatitis C after the campaign, postsecondary education, and a greater level of knowledge at baseline. Most people reported supportive attitudes toward people with hepatitis C and to prevention programs addressing this disease, and there was little apparent improvement in these. CONCLUSIONS: This campaign successfully increased public exposure to information about hepatitis C and improved knowledge about the means of transmission of this disease. There is room for further improvements in community understanding about hepatitis C. Mass media campaigns have a valuable role to play in this endeavor.

Impact of a mass media campaign upon calls to the New South Wales Hep C helpline.

ISSUE ADDRESSED: This study evaluated the impact of a mass media campaign upon calls to the New South Wales Hep C Helpline. METHODS: A time-series design was used to record the number and characteristics of calls to the helpline before, during and after the campaign. RESULTS: The incidence rate ratio of calls during the month of the campaign was 3.12 (95% CI 2.45-3.97) compared with the months before the campaign, and in this month more callers were < or =30 years or > or =60 years of age or non-English speaking while fewer were professionals or people directly affected by hepatitis C. Callers during the campaign were more likely to have heard about the helpline through the media and to want information about disease transmission, and less likely to want to discuss topics such as support and legal issues. CONCLUSIONS: The calls received by the Hep C Helpline indicate that the campaign was a useful way to generate public interest about hepatitis C. The findings indicate that telephone helplines are an information dissemination strategy that can be coupled effectively with mass media campaigns about this issue.