Hiding in plain sight: highlighting the research gap on access to HIV and other sexual health services for underrepresented gay men in developed Western countries - insights from a scoping review with a focus on Arab men.

BACKGROUND: Strategies pertaining to HIV and sexual health for gay, bisexual, and other men who have sex with men (GBMSM) have shifted focus towards underrepresented subgroups within some developed Western countries. Although emerging research exists on some subgroups, limited attention has been given to the needs of Arab GBMSM in these contexts. Considering they are part of a large diaspora, understanding their access to services is crucial. This paper focuses on Arab GBMSM as a case study within a scoping review, highlighting their hidden status within the broader landscape of HIV and sexual health research for GBMSM in the West. METHODS: A multi-method search strategy was employed, including searching four electronic databases using several terms within each of the following search topics: Arab, GBMSM, HIV and other sexual health services, and developed Western countries. RESULTS: Of the 384 articles found, only one addressed the research question and met the inclusion criteria, revealing a stark scarcity of research on access to HIV and sexual health services for this population. CONCLUSIONS: This review highlights a paucity of research on access to HIV and sexual health services for underrepresented GBMSM populations in developed Western countries. The literature indicates that, for Arab men, this may be due to a difficulty in participant recruitment and poor data collection efforts. By focusing on one hidden population, we aim to advocate for inclusive policies and interventions that promote equitable sexual health access for all. Addressing this research gap aligns with broader local and global HIV strategies to reduce disparities among underrepresented GBMSM populations.

Perceived risk of HIV transmission by blood transfusion among gay, bisexual, and other men who have sex with men (gbMSM) in Australia.

BACKGROUND: In Australia, men who have sex with men (MSM) are deferred from blood donation for 3 months from last sexual contact. Internationally, deferral policies for MSM are evolving in the direction of expanded inclusivity in response to community expectations. To inform future policy options, we assessed perceptions of the risk of HIV transmission from blood transfusion among Australian MSM. STUDY DESIGN AND METHODS: Flux is an online prospective cohort of Australian gay and bisexual men (cis or trans, regardless of their sexual history) and other men who have had sex with men (gbMSM). We included questions on blood donation rules, window period (WP) duration, infectivity of blood from people with HIV on treatment and attitudes to more detailed questioning of sexual practices in the regular survey of Flux participants and conducted a descriptive analysis of responses. RESULTS: Of 716 Flux participants in 2019, 703 responded to the blood donation questions. The mean age was 43.7 years (SD 13.6 years). Overall, 74% were willing to confidentially respond to specific sexual behavior questions, such as the last time they had sex and the type of sex they had, in order to be considered eligible to donate blood. The majority (92%) of participants correctly assessed the duration of the WP as less than 1 month. When asked whether transfusion of blood from a donor with HIV and an undetectable viral load could transmit HIV, just under half (48%) correctly said yes. CONCLUSION: Our study suggests Australian gbMSM are generally comfortable with answering more detailed questions regarding sexual activity during the assessment to donate, indicating they would do so honestly. gbMSM are knowledgeable about the WP duration, important for their ability to correctly self-assess their HIV risk. However, half of participants incorrectly assessed the transmissibility by blood transfusion from an HIV positive person with an undetectable viral load, suggesting the need for a targeted education campaign.

COVID-19 Testing in a Weekly Cohort Study of Gay and Bisexual Men: The Impact of Health-Seeking Behaviors and Social Connection.

Gay, bisexual, and other men who have sex with men (GBM) have developed community norms for regular HIV/STI testing. We investigated factors associated with self-reported COVID-19 testing in response to reported COVID-19 cases and public health restrictions. Participants responded to weekly cohort surveys between 10th May 2021 and 27th September 2021. We used the Andersen-Gill extensions to the Cox proportional hazards model for multivariable survival data to predict factors influencing COVID-19 testing. Mean age of the 942 study participants was 45.6 years (SD: 13.9). In multivariable analysis, GBM were more likely to report testing during periods of high COVID-19 caseload in their state of residence; if they were younger; university educated; close contact of someone with COVID-19; or reported coping with COVID-19 poorly. COVID-19 testing was higher among men who: were more socially engaged with other GBM; had a higher proportion of friends willing to vaccinate against COVID-19; and were willing to contact sexual partners for contact tracing. Social connection with other gay men was associated with COVID-19 testing, similar to what has been observed throughout the HIV epidemic, making community networks a potential focus for the promotion of COVID-19 safe practices.

Mpox (monkeypox) knowledge, concern, willingness to change behaviour, and seek vaccination: results of a national cross-sectional survey.

BACKGROUND: In mid-2022, a global mpox (formerly 'monkeypox') outbreak affecting predominantly gay and bisexual men emerged in non-endemic countries. Australia had never previously recorded mpox cases and there was no prior research on knowledge or attitudes to mpox among gay and bisexual men across Australia. METHODS: We conducted a national, online cross-sectional survey between August 2022 and September 2022. Participants were recruited through community organisation promotions, online advertising, and direct email invitations. Eligible participants were gay, bisexual or queer; identified as male (cisgender or transgender) or non-binary; aged 16years or older; and lived in Australia. The main outcome measures were: knowledge and concern about mpox; recognition of mpox symptoms and transmission routes; vaccination history; acceptability of behavioural changes to reduce mpox risk, and willingness to be vaccinated. RESULTS: Of 2287 participants, most participants were male (2189/2287; 95.7%) and gay (1894/2287; 82.8%). Nearly all had heard about mpox (2255/2287; 98.6%), and the majority were concerned about acquiring it (1461/2287; 64.4%). Most of the 2268 participants not previously diagnosed with mpox correctly identified skin lesions (2087; 92%), rash (1977; 87.2%), and fever (1647; 72.6%) as potential symptoms, and prolonged and brief skin-to-skin contact as potential ways to acquire mpox (2124, 93.7%; and 1860, 82%, respectively). The most acceptable behavioural changes were reducing or avoiding attendance at sex parties (1494; 65.9%) and sex-on-premises venues (1503; 66.4%), and having fewer sexual partners (1466; 64.6%). Most unvaccinated and undiagnosed participants were willing to be vaccinated (1457/1733; 84.1%). CONCLUSIONS: People at risk of mpox should be supported to adopt acceptable risk reduction strategies during outbreaks and to seek vaccination.

Reasons for not Using HIV Pre-Exposure Prophylaxis (PrEP) among Gay and Bisexual Men in Australia: Mixed-Methods Analyses from a National, Online, Observational Study.

Although approximately 31,000 Australian gay and bisexual men (GBM) are eligible for HIV pre-exposure prophylaxis (PrEP), only 18,500 people currently use it, indicating a need to investigate why GBM do not use it. This article uses data from a national, online, observational study. It adopts a mixed-methods analysis to responses to survey questions asking about reasons Australian GBM were not using PrEP in 2018, according to their level of HIV risk as delineated by the Australian PrEP prescribing guidelines at the time. Participants responded to check-box questions and had the option to respond to a qualitative free-text question. Results showed that just over one-fifth of men were at higher risk of HIV acquisition. Compared to lower-risk men, higher-risk men were more likely to indicate PrEP was too expensive and more likely to cite embarrassment asking for it. Reasons for not using PrEP included a lack of personal relevance, poor accessibility or knowledge, concerns about PrEP's inability to protect against STIs, potential side effects, and a preference for condoms. We conclude that health promotion more effectively targeting GBM who may benefit the most from PrEP may be valuable.

Increase in Depression and Anxiety Among Australian Gay and Bisexual Men During COVID-19 Restrictions: Findings from a Prospective Online Cohort Study.

We examined depression and anxiety prior to and during COVID-19 restrictions in Australian gay and bisexual men (GBM). In an online cohort, a COVID-19-focused survey was conducted in April 2020. During 2019 and in April 2020, 664 GBM completed the Patient Health Questionnaire (PHQ-9, measuring depression) and Generalized Anxiety Disorder Assessment (GAD-7, measuring anxiety). Increased depression and anxiety were defined as a ≥ 5 point increase on the respective scales. Mean PHQ-9 and GAD-7 scores increased between 2019 and 2020 (PHQ-9: from 5.11 in 2019 to 6.55 in 2020; GAD-7: from 3.80 in 2019 to 4.95 in 2020). The proportion of participants with moderate-severe depression (PHQ-9 ≥ 10) increased from 18.8% (n = 125) to 25.5% (n = 169), while the proportion of participants with moderate-severe anxiety (GAD-7 ≥ 10) increased from 12.7% (n = 84) to 17.3% (n = 115). Almost one-quarter of participants (n = 158, 23.8%) had increased depression; in these men, mean PHQ-9 increased from 2.49 in 2019 to 11.65 in 2020 (p < 0.001). One-in-five (20.6%) participants (n = 137) had increased anxiety; among these men, mean GAD-7 increased from 2.05 in 2019 to 10.22 in 2020 (p < 0.001). Increases were associated with concerns about job security, reduction in social and sexual connections and opportunities, and being personally concerned about COVID-19 itself. COVID-19 appeared to have a sudden and pronounced impact on depression and anxiety in Australian GBM, with a significant minority showing sharp increases. Ongoing monitoring is required to determine longer-term impacts and GBM need access to appropriate and sensitive supports both during and after the COVID-19 pandemic.

Changes in Sexual Behaviour Following PrEP Initiation Among Australian Gay and Bisexual Men in Relationships: Results from a Prospective Observational Study.

Few studies have examined changes in sexual behaviour following HIV pre-exposure prophylaxis (PrEP) initiation among gay, bisexual and other men who have sex with men (GBM) in relationships. In a national, online, prospective study of GBM in Australia, we compared sexual behaviours prior to and after PrEP initiation among HIV-negative and unknown-HIV-status men (recruited 2014-2017) not taking PrEP at baseline and who completed at least one six-monthly follow-up by July 2018. Among men in relationships who did not initiate PrEP (n = 339), we compared their most recent survey to their prior one, while among men in relationships who initiated PrEP (n = 81), we compared follow-ups before and after PrEP initiation. Among the 81 PrEP-initiators who were in a relationship both before and after initiation, the proportion reporting their regular partner was on PrEP increased from 8.3 to 44.4% (p < 0.001) and the proportion reporting receptive CLAIC increased from 27.2 to 44.4% (p = 0.009). Overall, men who initiated PrEP were more likely to be in a relationship with a partner on PrEP, and it appeared they started PrEP around the same time. Receptive CLAIC also became more common.

Qualitative Findings on the Impact of COVID-19 Restrictions on Australian Gay and Bisexual Men: Community Belonging and Mental Well-being.

COVID-19 may threaten the already poor mental health outcomes of Australian gay and bisexual men and cut ties to important social/sexual networks and community. Qualitative research into the experiences of gay and bisexual men during COVID-19 regulations is currently sparse. We report on 489 responses to a qualitative free-text question asking Australian gay and bisexual men about the impacts of COVID-19 during April 2020. Issues pertinent to gay and bisexual men include lost ties to gay and bisexual social/sexual communities, spaces, and activities, which can reduce a sense of belonging to important sexual identity spaces, as well as significant mental well-being vulnerabilities. Reminiscing the collective response to HIV/AIDS, findings reinforce the value of gay and bisexual community organizations, spaces, and networks as supports for gay and bisexual men and emphasize the need for delivering mental health services.

Attitudes and willingness to donate blood among gay and bisexual men in Australia.

BACKGROUND: Men who have sex with men in Australia are currently ineligible to donate blood (are "deferred") for 12 months since last oral or anal sexual contact with another man. In Australia and overseas, there has been limited research on attitudes and perceptions related to blood donation in this population. STUDY DESIGN AND METHODS: Questions on blood donation histories and attitudes toward the deferral policy were included in the questionnaire of an online prospective cohort of gay and bisexual men (GBM) living in Australia. RESULTS: In 2018, 1595 GBM responded to the survey. In this sample, 28.7% reported previously donating blood. Among the remaining men who had never donated blood, 64.5% expressed an interest in doing so. Nearly all men indicated they were not willing to abstain from sex with another man for 12 months in order to donate, and the vast majority believed the rule was unfair, too strict, and homophobic. Three-quarters (77.7%) said that if the policy changed, they would likely donate blood. Age and openness about one's sexuality were independently associated with one's willingness to donate blood in the absence of the deferral. CONCLUSION: There was a high level of willingness and desire to donate blood among GBM. However, rather than abstaining from sex in order to donate, many men comply with the deferral policy and do not donate. A less conservative deferral policy may increase donations from GBM.

Correction to: Gay and Bisexual Men's Perceptions of Pre-exposure Prophylaxis (PrEP) in a Context of High Accessibility: An Australian Qualitative Study.

The original version of this article unfortunately contained an error. The authors would like to correct the error with this erratum.

Biomedical HIV Protection Among Gay and Bisexual Men Who Use Crystal Methamphetamine.

Use of crystal methamphetamine (crystal) among gay and bisexual men (GBM) has been associated with condomless anal intercourse with casual partners (CLAIC) and HIV infection. Pre-exposure prophylaxis (PrEP) and undetectable viral load (UVL) are important biomedical HIV prevention strategies. We investigate the relationship between crystal use and HIV sexual risk behaviours in the context of PrEP and UVL. In 2018, 1367 GBM provided details about crystal use and HIV prevention strategies. Binary logistic regression was used to estimate associations between crystal use and behaviour. Recent crystal use was independently associated with greater social engagement with gay men and having more sexual partners. Crystal use was also independently associated with use of PrEP and UVL among GBM who engaged in CLAIC. Although GBM who used crystal were more likely to have engaged in CLAIC, they were also more likely to use biomedical HIV prevention which mitigates against the risks of HIV infection.

Off-Label Use of Phosphodiesterase Type 5 Inhibitor Erectile Dysfunction Medication to Enhance Sex Among Gay and Bisexual Men in Australia: Results From the FLUX Study.

BACKGROUND: Gay and bisexual men (GBM) use oral erectile dysfunction medications (EDMs) often with little evidence of medical indication necessitating their use. AIM: To investigate the prevalence, contexts, and motivations for oral EDM use and its relation to sexual risk behavior. METHODS: A total of 2,250 Australian GBM completed an online survey of licit and illicit drug use and their associated behaviors. Multivariate logistic regression analysis identified factors associated with use of EDMs in the previous 6 months and, for those who had used EDMs, factors associated with use on a weekly basis. OUTCOMES: Any EDM use and at least weekly use in the previous 6 months. RESULTS: The median age of the sample was 33.0 years (range = 16-81). Two thirds (67.7%) reported no lifetime history of EDM use. Approximately 1 in 10 participants (11.1%) had last used an EDM more than 6 months previously. In the previous 6 months, 11.5% reported using EDMs less than monthly, 5.3% reported using EDMs approximately monthly, and 4.5% reported using EDMs at least weekly. Of men who had used EDMs in the previous 6 months, common reasons cited for its use were to maintain an erection for longer (73.3%), to make it easier to "get hard" (67.3%), and difficulty in attaining or maintain an erection (53.5%). Use of EDMs in the previous 6 months was associated with illicit drug use and higher rates of sexual risk behavior. Weekly users were more likely to have severe anxiety than less frequent users. CLINICAL TRANSLATION: The use of EDMs in the context of intensive sex partying, with the associated potential for increased risk of HIV transmission and illicit drug use, indicates a need to consider the use of EDMs among GBM in HIV prevention and minimizing harm. STRENGTHS AND LIMITATIONS: This large-scale study of drug use among GBMs includes comprehensive detailed data on their history of use and rationales for use. Our online methodology potentially decreases social desirability bias in reporting illegal or stigmatized behaviors. This volunteer online convenience sample might not be representative of all GBMs in Australia. CONCLUSION: GBMs who used an oral EDM in the previous 6 months often used it for recreational purposes, but many of those who used it on a weekly basis also might have used it for therapeutic reasons. GBMs often use EDMs to enhance their sexual experiences often in the context of intensive sex partying (which can include risky sexual behavior). Hammoud MA, Jin F, Lea T, et al. Off-Label Use of Phosphodiesterase Type 5 Inhibitor Erectile Dysfunction Medication to Enhance Sex Among Gay and Bisexual Men in Australia: Results From the FLUX Study. J Sex Med 2017;14:774-784.

Gay and bisexual men's interest in marriage: an Australian perspective.

Same-sex marriage is a widely debated issue, including in Australia. This study used an online anonymous survey, with free-text responses, to investigate romantic and sexual relationships among Australian gay and bisexual men. We sought to identify what proportion of such men intended to marry their primary regular partner if marriage was made legally available to same-sex couples in Australia, as well as factors associated with intention or non-intention to marry. Most men in the sample did not intend to marry their primary regular partner. Even among men who considered themselves to be in a 'relationship' with their primary regular partner, less than half intended to marry him. However, many men who would not marry their current primary regular partner agreed that same-sex marriage should be available for gay and bisexual men in Australia. Reasons for intention to marry included a desire for social and legal equality, and ideas about marriage as a rite of passage, an expression of love and the most valued form of relationship in Australia. Those who did not intend to marry their primary regular partner offered a number of reasons, including that the nature of their relationship was incompatible with marriage, and reported a critical position towards marriage as a heteronormative institution.

Relationship Between Sexual Behaviors with Non-committed Relationship Partners and COVID-19 Restrictions and Notification Rates: Results from a Longitudinal Study of Gay and Bisexual Men in Australia.

Introduction: COVID-19 related lockdowns have impacted the sexual activity of gay and bisexual men (GBM). We investigated trends in sexual behaviors and the COVID-19 context in which they occurred (COVID-notification rates and jurisdictional restrictions) to understand changes in the duration and severity of periods of lockdown on the sexual behavior of Australian GBM. Methods: In an online, prospective observational study of 831 GBM from May 2020 to May 2021, we investigated associations between changes in sexual behavior among Australian GBM, lockdowns, and COVID-19 notification rates through weekly surveys from May 2020 to May 2021. Results: The mean age was 45.71 years (SD: 13.93). Most identified as gay (89.0%) and 10.2% were living with HIV. There was an overall increase in the mean weekly number of non-committed relationship partners (0.53-0.90, p < 0.001). The state of Victoria experienced a significant extended COVID-19 outbreak, accompanied by severe lockdown restrictions. In response, Victorian men's partner numbers shifted three times, while elsewhere there was an overall gradually increasing trend. Conclusions: Less severe outbreaks with shorter lockdown periods, involving fewer and geographically contained, COVID-19 notifications were accompanied by non-significant changes in sex with non-relationship partners than more severe outbreaks over extended periods and larger geographical areas. Supplementary Information: The online version contains supplementary material available at 10.1007/s13178-022-00733-8.

Optimisation of treatments for oral Neisseria gonorrhoeae infection: Pharmacokinetics Study (STI-PK project) - study protocol for non-randomised clinical trial.

INTRODUCTION: Neisseria gonorrhoeae infections are common and incidence increasing. Oropharyngeal infections are associated with greater treatment failure compared with other sites and drive transmission to anogenital sites through saliva. Gonococcal resistance is increasing and new treatments are scarce, therefore, clinicians must optimise currently available and emerging treatments in order to have efficacious therapeutic options. This requires pharmacokinetic data from the oral cavity/oropharynx, however, availability of such information is currently limited. METHODS AND ANALYSIS: Healthy male volunteers (participants) recruited into the study will receive single doses of either ceftriaxone 1 g, cefixime 400 mg or ceftriaxone 500 mg plus 2 g azithromycin. Participants will provide samples at 6-8 time points (treatment regimen dependent) from four oral sites, two oral fluids, one anorectal swab and blood. Participants will complete online questionnaires about their medical history, sexual practices and any side effects experienced up to days 5-7. Saliva/oral mucosal pH and oral microbiome analysis will be undertaken. Bioanalysis will be conducted by liquid chromatography-mass spectrometry. Drug concentrations over time will be used to develop mathematical models for optimisation of drug dosing regimens and to estimate pharmacodynamic targets of efficacy. ETHICS AND DISSEMINATION: This study was approved by Royal Melbourne Hospital Human Research Ethics Committee (60370/MH-2021). The study results will be submitted for publication in peer-reviewed journals and reported at conferences. Summary results will be sent to participants requesting them. All data relevant to the study will be included in the article or uploaded as supplementary information. TRIAL REGISTRATION NUMBER: ACTRN12621000339853.

Substantial Decline in Use of HIV Preexposure Prophylaxis Following Introduction of COVID-19 Physical Distancing Restrictions in Australia: Results From a Prospective Observational Study of Gay and Bisexual Men.

BACKGROUND: In response to the novel coronavirus disease (COVID-19) pandemic, Australia introduced public health and physical distancing restrictions in late March 2020. We investigated the impact of these restrictions on HIV preexposure prophylaxis (PrEP) use among Australian gay and bisexual men (GBM). METHODS: Participants in an ongoing online cohort study previously reported PrEP use from 2014 to 2019. In April 2020, 847 HIV-negative and untested participants completed questionnaires assessing changes in PrEP use as a result of COVID-19 public health measures. Binary logistic multiple regression was used to estimate adjusted odds ratios (aOR) and 95% confidence intervals (95% CI) to compare changes in PrEP use behaviors. RESULTS: Among 847 men, mean age was 44.1 years (SD: 12.7). PrEP use rose from 4.9% in 2015 to 47.2% in 2020. Among those, 41.8% (n = 167) discontinued PrEP use during COVID-19 restrictions. Discontinuing PrEP during COVID-19 restrictions was independently associated with being less likely to have recently tested for HIV (aOR: 0.17; 95% CI: 0.09 to 0.34; P < 0.001) and less likely to report sex with casual partners (aOR: 0.28; 95% CI: 0.14 to 0.54; P < 0.001). CONCLUSIONS: By April 2020, following the introduction of COVID-19 restrictions, GBM dramatically reduced PrEP use, coinciding with a reduction in sexual activity. Longer-term impacts of COVID-19 restrictions on sexual behaviors among GBM need to be monitored because they may foreshadow fluctuations in prevention coverage and risk of HIV infection. Our findings indicate a potential need for clear, targeted information about resumption of PrEP and on-demand optimal dosing regimens in response to ongoing changes in restrictions.

High Levels of Prevention-Effective Adherence to HIV PrEP: An Analysis of Substudy Data From the EPIC-NSW Trial.

BACKGROUND: Preexposure prophylaxis (PrEP) prevents HIV infection but relies on good adherence at times of risk, termed "prevention-effective adherence." Most studies assess adherence without reference to sexual behaviur, making it challenging to determine if poor adherence coincides with HIV risk. SETTING: We examined data from a behavioral substudy of a large-scale PrEP implementation trial in New South Wales, Australia. METHODS: Trial participants completed optional brief quarterly surveys, reporting the number of pills taken and sexual behavior with male partners for each day of the "last full week" before each survey. Condomless sex (CLS) was defined as "higher risk" for HIV when with HIV-positive men with detectable/unknown viral loads or unknown HIV status men. Adequate PrEP protection was defined as ≥4 pills for participants assigned male sex at birth and ≥6 pills for participants assigned female sex at birth (including transgender men). RESULTS: Of 9596 participants dispensed PrEP, 4401 completed baseline and ≥1 follow-up survey. Participants reported on 12,399 "last full weeks": 7485 weeks (60.4%) involved CLS and 2521 weeks (33.7% of CLS-weeks) involved higher risk CLS. There were 103 weeks in which participants did not have adequate PrEP protection and had higher risk CLS: 4.1% of higher-risk CLS weeks (n = 103/2521), 1.4% of all CLS weeks (n = 103/7485), and 0.8% of all observed weeks (n = 103/12,399). CONCLUSIONS: In a large PrEP trial, prevention-effective adherence to PrEP was very high at 99%. Our findings illustrate the importance of measuring pill-taking and sexual behavior in the same period so that prevention-effective adherence can be better estimated.

Long-term protection from HIV infection with oral HIV pre-exposure prophylaxis in gay and bisexual men: findings from the expanded and extended EPIC-NSW prospective implementation study.

BACKGROUND: Daily pre-exposure prophylaxis (PrEP) is effective in preventing HIV, but few long-term data are available on effectiveness and adherence in real-world settings. Here, we report trends in HIV incidence over 3 years in individuals at high risk who were prescribed PrEP in New South Wales (NSW), as well as adherence before the transition to subsidised PrEP. METHODS: Expanded PrEP Implementation in Communities-New South Wales (EPIC-NSW) was a pragmatic, prospective, single-arm, implementation study of daily, oral PrEP in 31 sites (sexual health clinics, general practices, and a hospital) in NSW, Australia. Eligible participants were HIV-negative adults (aged ≥18 years) who were at high risk of HIV infection as defined in local PrEP guidelines. Participants were prescribed coformulated (once-daily, oral tablet) tenofovir disoproxil fumarate (300 mg) and emtricitabine (200 mg) as HIV PrEP and were followed up with HIV testing, sexually transmitted infection testing, and PrEP dispensing. Originally planned for 3700 participants followed for 1 year, the study was expanded so that all eligible participants in the state could obtain PrEP and extended until publicly subsidised PrEP became available in Australia. The primary outcome was new HIV infection among all participants who were dispensed PrEP at least once and had at least one follow-up HIV test result. Adherence was estimated by medication possession ratio (MPR), defined as the proportion of PrEP pills dispensed in 90 days, assuming daily dosing. This study is registered with ClinicalTrials.gov, NCT02870790. FINDINGS: Between March 1, 2016, and April 30, 2018, we enrolled 9709 participants. 9596 participants were dispensed PrEP, of whom 9448 (98·3%) were gay or bisexual men. Participants were followed up until March 31, 2019, with at least one follow-up HIV test available in 9520 (99·2%) participants. Mean MPR declined from 0·93 to 0·64 from the first to the ninth quarter. There were 30 HIV seroconversions over 18 628 person-years, an incidence of 1·61 per 1000 person-years (95% CI 1·13-2·30). Being younger, living in a postcode with fewer gay men, reporting more risk behaviours at baseline, and having an MPR of less than 0·6 were each univariately associated with increased HIV incidence. In the final year of follow-up, when PrEP was mostly purchased rather than provided free by the study, HIV incidence remained low at 2·24 per 1000 person-years (1·46-3·44). INTERPRETATION: HIV incidence remained low over up to 3 years of follow-up, including during a transition from study-provided to publicly subsidised PrEP. In a setting of affordable PrEP and associated health-care services, very low HIV incidence of 1 to 2 per 1000 person-years can be maintained in gay and bisexual men who were previously at high risk. FUNDING: New South Wales Ministry of Health, Australian Capital Territory Health Directorate, Gilead Sciences.

Characteristics of gay and bisexual men who rarely use HIV risk reduction strategies during condomless anal intercourse: Results from the FLUX national online cohort study.

PURPOSE: To understand the characteristics of a minority of Australian gay and bisexual men (GBM) who, despite an increase in the number and availability of HIV risk reduction strategies, do not consistently use a strategy to protect themselves from HIV. METHODS: This analysis is based on data from 2,920 participants in a national, online, prospective observational cohort study. GBM who never or rarely used HIV risk reduction strategies (NRR) were compared with two groups using multivariate logistic regression: i) GBM using pre-exposure prophylaxis (PrEP) and ii) GBM frequently using risk reduction strategies (FRR) other than PrEP. RESULTS: Compared to PrEP users, NRR men were younger (p<0.0001), less socially engaged with gay men (p<0.0001) and less likely to have completed a postgraduate (p<0.05) or undergraduate degree (p<0.05). They were also less likely to have recently used amyl nitrite (p<0.05), erectile dysfunction medication (p<0.05) and cocaine (p<0.05) in the previous 6 months. Compared with FRR men, NRR men were less likely to have completed a postgraduate (p<0.0001) or undergraduate degree (p<0.05), scored higher on the sexual sensation-seeking scale (p<0.0001) and were more likely to identify as versatile (p<0.05), a bottom (p<0.05) or very much a bottom (p<0.05) during anal sex. CONCLUSIONS: NRR men were largely similar to other Australian GBM. However, our analysis suggests it may be appropriate to focus HIV prevention interventions on younger, less socially engaged and less educated GBM, as well as men who prefer receptive anal intercourse to promote the use of effective HIV risk reduction strategies.

Sustained, Low Prevalence of Undiagnosed HIV Among Gay and Bisexual Men in Sydney, Australia Coincident With Increased Testing and Pre-exposure Prophylaxis Use: Results From Repeated, Bio-Behavioral Studies 2014-2018.

BACKGROUND: Gay and bisexual men with undiagnosed HIV contribute disproportionately to HIV transmission in Australia. METHODS: In 2014 and 2018, we recruited men at gay venues and events in Sydney. Participants self-completed surveys and provided oral fluid samples for HIV testing. We calculated the prevalence of HIV and undiagnosed infection, and assessed changes in behavior, HIV testing, and the use of pre-exposure prophylaxis. We weighted the samples to adjust for differences in where participants were recruited between rounds. Two-sample tests of proportion were used to compare prevalence estimates and χ tests to assess differences between the samples. RESULTS: In 2014, 944 men were recruited, and 890 men were recruited in 2018. In 2014, the weighted estimate of HIV prevalence was 6.1% [95% confidence intervals (CI): 4.6 to 7.6], of which 13.8% (95% CI: 5.0 to 22.7) was undiagnosed. In 2018, weighted HIV prevalence was 6.4% (95% CI: 4.8 to 8.0), of which 5.3% (95% CI: 0.5 to 11.1) was undiagnosed. Between 2014 and 2018 among all participants, men reporting at least 10 recent casual partners increased from 22.3% to 27.7% (P = 0.008), condomless anal intercourse with casual partners in the previous 6 months increased from 23.9% to 37.3% (P < 0.001), and sexually transmitted infection diagnoses in the previous year increased from 14.4% to 27.5% (P < 0.001). HIV testing and the use of pre-exposure prophylaxis in the previous 6 months increased from 49.6% to 56.3% (P = 0.004) and 2.0%-21.0% (P < 0.001), respectively. CONCLUSIONS: Repeated, bio-behavioral surveillance suggests the prevalence of undiagnosed HIV remains low in Sydney, despite gay and bisexual men reporting more casual sex partners, condomless sex, and sexually transmitted infections.