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Long-acting injectable PrEP, particularly cabotegravir (CAB-LA), has the potential to enhance HIV prevention in Asia, and was the topic of a roundtable held in Singapore in June 2023. Despite proven efficacy, CAB-LA's impact in Asia is hindered by regulatory, manufacturing, and cost barriers. There is an urgent need to address these challenges to expedite CAB-LA's introduction and scale-up, including collaborative research, streamlined regulatory processes, and increased manufacturing capacity. We call for better preparedness in long-acting PrEP in research and implementation science, product licensing and accessibility, and capacity readiness for scale-up, to meet the significant demand among key populations in Asia.

Using repeated behavioural surveillance data collected from gay and bisexual men (GBM) across Australia, we assessed trends in HIV prevention coverage (the level of 'safe sex' achieved in the population by the use of effective prevention methods, including condoms, pre-exposure prophylaxis [PrEP] and having an undetectable viral load). We stratified these trends by age, country of birth/recency of arrival, sexual identity, and the proportion of gay residents in the participant's suburb. Among 25,865 participants with casual male partners, HIV prevention coverage increased from 69.8% in 2017 to 75.2% in 2021, lower than the UNAIDS target of 95%. Higher levels of coverage were achieved among older GBM (≥ 45 years), non-recently-arrived migrants, and in suburbs with ≥ 10% gay residents. The lowest levels of prevention coverage (and highest levels of HIV risk) were recorded among younger GBM (< 25 years) and bisexual and other-identified participants. Younger, recently-arrived, and bisexual GBM were the most likely to use condoms, while PrEP use was concentrated among gay men, 25-44-year-olds, and in suburbs with more gay residents. The use of undetectable viral load was most common among participants aged ≥ 45 years. Our analysis shows that high HIV prevention coverage can be achieved through a mixture of condom use, PrEP use, and undetectable viral load, or by emphasising PrEP use. In the Australian context, younger, bisexual and other-identified GBM should be prioritised for enhanced access to effective HIV prevention methods. We encourage other jurisdictions to assess the level of coverage achieved by combination prevention, and variations in uptake., (© 2023. The Author(s).)

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/mm 3 ), 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., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Evaluating HIV preexposure prophylaxis (PrEP) use and HIV risk events concurrently remains challenging. We developed a single question method for measuring prevention-effective adherence with PrEP in self-report questionnaires. In a questionnaire completed by 409 gay and bisexual men, 46% reported condomless anal sex that was not covered by their own PrEP use, and this was more common among younger, lower-income participants. Refining this questionnaire item could improve measurement of prevention-effective adherence., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Competing Interests: NJD has received research funding from Gilead Sciences for an unrelated project. BRB has received research funding, honoraria, and travel expenses from Gilead Sciences and ViiV Healthcare for unrelated projects.

Introduction: Investigating drug trends among Australian gay and bisexual men (GBM) is crucial for understanding levels of use and the potential for harm, including HIV transmission risk., Method: Using repeated, national, cross-sectional survey data collected between 2012 and 2021 (69,567 surveys), trends of recent (previous 6 months) and frequent (weekly) drug use were analysed, using logistic regression models. The last round of data from each jurisdiction (6709 surveys) was used to compare GBM who reported no use, infrequent (less than weekly) use and frequent (at least weekly) use of party drugs to investigate the association between party drug use and HIV transmission risk, using multinomial logistic regression models., Results: There was a significant upward trend in any recent drug use (from 58.4% in 2012 to 64.1% in 2021; p < 0.001). Frequent party drug use remained a minority practice over the period (consistently less than 3%). In cross-sectional analysis, frequent party drug users were more likely to report behaviours with HIV transmission risks, such as condomless anal intercourse without biomedical prevention strategies (30.0% vs. 13.1%; adjusted relative risk ratio [aRRR], 2.08; 95% CI, 1.24-3.47), weekly group sex (16.3% vs. 0.6%; aRRR, 12.36; 95% CI, 5.75-26.56) and more than 20 recent sexual partners (42.5% vs. 5.0%; aRRR, 21.44; 95% CI, 5.82-78.89), compared with GBM who did not use party drugs., Discussion and Conclusion: Our findings suggest that the frequent use of party drugs remains a marker of HIV transmission risk among Australian GBM, despite the increased adoption of biomedical HIV prevention strategies over the past few years., (© 2023 The Authors. Drug and Alcohol Review published by John Wiley & Sons Australia, Ltd on behalf of Australasian Professional Society on Alcohol and other Drugs.)

Introduction: Overseas-born gay and bisexual men (GBM) are overrepresented in HIV diagnoses in Australia. We assessed social and sexual behaviours, and the use of HIV prevention and testing, by region of birth and length of residence in Australia. We sought to identify similarities and differences between recently arrived and non-recently arrived GBM from non-English-speaking countries to improve targeting and engagement with HIV testing and prevention., Methods: Data were collected in national repeated, behavioural surveillance surveys conducted across Australia during 2019-2021. Logistic regression was used to identify factors that differentiated between recently arrived (<2 years) and non-recently arrived (≥2 years in Australia) GBM from non-English-speaking countries., Results: Among 24,707 participants in 2019-21, 2811 (11.4%) were from high-income English-speaking countries, 714 (2.9%) were recently arrived overseas-born GBM and 3833 (15.5%) were non-recently arrived migrants. Recently arrived GBM were most likely to be born in Asia (36.1%) and Europe (21.1%). Compared with non-recently arrived GBM, recently arrived GBM from non-English-speaking countries were younger (aOR = 0.95, 95% CI = 0.94-0.96, p<0.001), more likely to be students (aOR = 1.43, 95% CI = 1.11-1.85, p = 0.005), less likely to be in full-time employment (aOR = 0.56, 95% CI = 0.46-0.69, p <0.001), more likely to report consistent condom use (aOR = 1.30, 95% CI = 1.01-1.66, p = 0.039), but had lower awareness (aOR = 0.62, 95% CI = 0.48-0.80, p<0.001) and use of pre-exposure prophylaxis (PrEP) (22.8%, vs. 32.3%, χ 2 (1, 4185) = 23.78, p<0.001), and similar levels of casual sex with a risk of HIV acquisition or transmission (aOR = 1.29, 95% CI = 0.98-1.69, p = 0.066). Recently arrived GBM reported similar levels of lifetime HIV testing (aOR = 0.97, 95% CI = 0.54-1.74, p = 0.915) and recent HIV testing (OR = 1.03, 95% CI = 0.86-1.22, p = 0.779), but were much less likely to have tested at general practitioners (aOR = 0.53, 95% CI = 0.41-0.68, p<0.001) and more likely to report testing at hospitals (aOR = 3.35, 95% CI = 2.53-4.43, p<0.001), at home (aOR = 2.85, 95% CI = 1.63-4.99, p<0.001), or community-based services (aOR = 1.36, 95% CI = 1.01-1.84, p = 0.043)., Conclusions: Recently arrived GBM from non-English-speaking countries reported similar levels of risk of HIV acquisition to longer-term residents in Australia, but lower levels of PrEP awareness and use, and more reliance on HIV testing services which are free or low cost. It is necessary to enhance access to HIV testing and prevention among recently arrived GBM in Australia., (© 2024 The Authors. Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of International AIDS Society.)

Background: Female sex workers (FSWs) contribute disproportionately to HIV transmission in Uganda, and pre-exposure prophylaxis (PrEP) is effective in preventing HIV among cisgender women. Psychological factors are important for PrEP uptake, but few studies have examined psychosocial changes due to PrEP use in Uganda., Methods: In 2021, we recruited 524 FSWs in three Trans-African Highway towns and four fishing communities in south-western Uganda. We conducted structured interviews among women who were attending routine PrEP follow-up visits in six health units. Bivariable and multivariable modified regression using a robust covariance matrix estimator were used to identify factors associated with experiencing increased sexual pleasure and less worry about HIV because of PrEP., Results: Overall, 80.9% participants reported that sex was more pleasurable because of taking PrEP. There were statistical trends for sex being more pleasurable when taking PrEP or when having condomless sex with casual paying partners (aPR=1.19, 95% CI=1.07-1.32, P =0.001). Almost three-quarters of the participants (76.3%) were less worried about getting HIV because of PrEP. Condomless sex with casual paying partners (aPR=1.17, 95% CI=1.05-1.31, P =0.032, P =0.003) and being On PrEP for the past 1-2years (aPR=1.18, 95% CI=1.00-1.38, P =0.032) was significantly associated with HIV-related worry (aPR=1.17, 95% CI=1.05-1.31, P =0.032, P =0.003) Conclusions : We found a positive impact of PrEP in Ugandan FSWs on two key psychosocial dimensions: (1) more pleasurable sex; and (2) less worry about acquiring HIV. Interventions aiming to increase PrEP uptake may find it useful to focus on psychosocial dimensions.

Background: Asian gay, bisexual, and other men who have sex with men (GBMSM) are overrepresented in new HIV diagnoses in Australia. Social engagement with other GBMSM has been associated with HIV testing and pre-exposure prophylaxis (PrEP) uptake. Asian GBMSM may be socially disconnected from LGBTQ+ people, which may increase their HIV risk. This analysis assessed the contribution of social connection on HIV risk among Asian GBMSM., Methods: Using an online cross-sectional survey of Asian GBMSM in Australia, we measured condomless anal intercourse (CLAI) in the last 6months without PrEP or an undetectable viral load (UVL), i.e. CLAI with a risk of HIV transmission. Bivariable and multivariable logistic regression models were performed to compare demographic characteristics and social engagement of participants who had CLAI without PrEP or UVL to those who had not. Analyses were restricted to participants who reported sex with casual partners in the last 6months., Results: Among 509 participants who had casual partners in the last 6months, 151 (29.7%) reported CLAI without PrEP or UVL. CLAI without PrEP or UVL was negatively associated with full-time employment, and recently being tested for HIV and was positively associated with experiencing discrimination based on sexual orientation. Social engagement with LGBTQ+ people was not associated with CLAI without PrEP or UVL., Conclusions: CLAI without PrEP or UVL was not related to social connections with LGBTQ+ people but was more likely among Asian men who had experienced sexuality-related discrimination, suggesting that mitigating homophobia and biphobia may assist in improving HIV prevention among Asian GBMSM who live in Australia.

Background: Gay, bisexual, and other men who have sex with men (GBM) are overrepresented in diagnoses of sexually transmitted infections (STIs) relative to their population size. This study assessed trends in STI testing and diagnoses among GBM in Australia., Methods: The Gay Community Periodic Surveys are repeated cross-sectional behavioral surveillance surveys of GBM. Participants reported the number of anal swabs, throat swabs, urine samples, and blood tests for syphilis they undertook in the last year. "Frequent comprehensive testing" was defined as ≥3 of each test in the previous year. Participants reported STI diagnoses of chlamydia, gonorrhea, syphilis, and other STIs in the last year. Trends in testing and diagnoses from 2017 to 2020 and 2020 to 2021 were assessed with logistic regression models., Results: We analyzed 24,488 survey responses from participants reporting casual sex in the last 6 months. Between 2017 and 2020, frequent comprehensive STI testing decreased among HIV-negative GBM on preexposure prophylaxis (PrEP) from 71.7% to 68.9% and declined further to 58.6% in 2021. Frequent comprehensive STI testing was stable during 2017-2020 among HIV-negative/untested GBM not on PrEP (17.4%-14.6%) and HIV-positive GBM (30.4%-35.1%) but declined in 2021 to 7.5% among non-PrEP-users and 25.7% among HIV-positive participants. There were minimal changes in STI diagnoses during 2017-2020, but diagnoses declined in 2021., Conclusions: Many GBM do not meet Australian STI testing guidelines that recommend quarterly testing. Further evaluation of whether this recommendation is realistic or necessary to reduce STIs among GBM is recommended., Competing Interests: Conflict of Interest and Sources of Funding: No conflicts of interests to declare. The Gay Community Periodic Surveys are supported by funds from state and territory health departments. The Centre for Social Research in Health and the Kirby Institute are supported by funding from the Australian Government Department of Health. This research was supported by an Australian Government Research Training Program Scholarship., (Copyright © 2023 American Sexually Transmitted Diseases Association. All rights reserved.)

HIV self-testing allows people to collect samples and test themselves at home, addressing known barriers to facility-based testing. We aimed to measure the uptake of home HIV testing among Australian gay and bisexual men (GBM). Using national cross-sectional data from the Australian Gay Community Periodic Surveys, we assessed trends in home HIV testing among non-HIV positive GBM between 2018 and 2020. Overall, the use of home HIV testing was low, but slightly increased during 2018-2020 (from 0.3 to 0.8%, RR = 1.54, 95%CI = 1.23-1.92, p-trend < 0.001). Testing at home was more likely among non-HIV-positive GBM who were born overseas and recently arrived in Australia, at higher risk of HIV, and infrequent HIV testers. Given the greater use of home testing by men at higher risk of HIV, recent migrants and infrequent testers, all priority groups in Australia's HIV epidemic, we recommend increasing access to HIV self-testing to enhance uptake in these and other groups of GBM., (© 2023. The Author(s).)

We mapped gay and bisexual men's (GBM) patterns of using pre-exposure prophylaxis (PrEP) over time and explored sexual behavior as PrEP use changed. We conducted semi-structured interviews between June 2020 and February 2021 with 40 GBM living in Australia who had changed their PrEP use since initiating. There was considerable diversity in patterns of discontinuation, suspension, and recommencement of PrEP. Reasons for changing PrEP use mostly centered on accurate perceived changes to HIV risk. Twelve participants reported condomless anal intercourse with casual or fuckbuddy partners after discontinuing PrEP. These sex events were unanticipated, condoms were not a preferred option, and other risk reduction strategies were applied inconsistently. Service delivery and health promotion can support safer sex among GBM when PrEP use fluctuates by promoting event-driven PrEP and/or non-condom-based risk reduction methods during periods off daily PrEP, and guiding GBM to better recognize changing circumstances of risk and when to recommence PrEP., (© 2023. The Author(s).)

The introduction of HIV pre-exposure prophylaxis (PrEP) has the potential to impact the attitudes gay and bisexual men (GBM) who consequently choose to take PrEP have towards treatment as prevention (TasP), and the extent to which they are willing to have condomless anal intercourse (CLAI) with an HIV-positive sexual partner who has an undetectable viral load (UVL). Using a cross-sectional sample from an observational cohort study conducted from August 2018 to March 2020, we examined the extent to which PrEP-experienced GBM are willing to have CLAI with a partner who has a UVL. Simple and multiple logistic regression models were used to identify associated variables. Of the 1386 participants included in the analyses, 79.0% believed in the effectiveness of TasP, and 55.3% were willing to have CLAI with a partner who has a UVL. Wiling participants were less worried about getting HIV when taking PrEP and more likely to believe in TasP. Further research is needed to better understand the gap between belief in TasP and willingness to have CLAI with a partner who has a UVL among PrEP-experienced GBM., (© 2023. The Author(s).)

Objective: To assess changes in personal and relationship characteristics among HIV-positive Australian gay and bisexual men (GBM) as rates of antiretroviral therapy and knowledge and confidence regarding the effectiveness of viral suppression in preventing HIV transmission have increased., Design: Repeated behavioral surveillance of GBM recruited from venues, events, and online in 7 Australian states and territories., Methods: HIV-positive participants were included. Trends in demographics, HIV treatment, and relationship characteristics were assessed with binary and multivariable logistic regression., Results: A total of 3643 survey responses (2016-2020) were included. Over time, HIV-positive GBM became less likely to identify as gay or report an Anglo-Australian ethnicity. The average length of time since HIV diagnosis increased and the frequency of attending HIV-related clinical appointments decreased. There were no changes in the reported number of recent sex partners or proportion reporting regular male partners over time. Among HIV-positive GBM in relationships, the proportion reporting HIV-positive partners decreased and the proportion reporting HIV-negative partners increased. Levels of condomless sex with regular partners increased over time; however, this was concentrated among HIV-positive GBM in serodiscordant relationships., Conclusion: Findings suggest that increased accessibility and trust in biomedical prevention strategies have contributed to broader relationship and sexual opportunities for HIV-positive GBM in Australia. Our findings suggest that future health promotion activities could highlight the social and relationship benefits of treatment as prevention to further increase trust in it as an HIV prevention strategy among GBM., Competing Interests: The authors have no funding or conflicts of interest to disclose., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Pre-exposure prophylaxis (PrEP) is recommended for people susceptible to HIV acquisition, and the scale-up of PrEP programmes has contributed to new HIV case reductions at a population level. However, international migrants continue to be disproportionately affected by HIV. Understanding barriers and facilitators to PrEP implementation among international migrants can optimise PrEP use among this population and ultimately reduce HIV incidence worldwide. We reviewed the evidence regarding factors influencing PrEP implementation among international migrants; 19 studies were included. The barriers and facilitators at the individual level were related to knowledge and risk perception of HIV. Cost, provider discriminations, and health system navigation influenced PrEP use at the service level. Positive or negative perception towards LGBT+ identities, HIV, and PrEP users affected PrEP use at the societal level. Most existing PrEP campaigns do not target international migrants; therefore, culturally tailored approaches for people from different backgrounds are warranted. Potentially migration-related and HIV-related discriminatory policies must be reviewed to increase access to HIV prevention services to end HIV transmission at a population level., Competing Interests: Declaration of interests JJO has received funding from Gilead Sciences (Getting to 0 Grant to improve awareness and uptake of PrEP among overseas-born men who have sex with men in Australia). EPFC has received speaker's honoraria from MSD, CSL Seqirus, Roche, and Gilead Sciences, and investigator-initiated grants from MSD, outside the submitted work. BRB has received honoraria and research grants from Gilead Sciences and ViiV Healthcare, outside of the submitted work. AG received payments to his institution from ViiV Healthcare (grant and travel funding) and received fundings from GSK (for the gonorrhoea project), outside of the submitted work. All other authors declare no competing interests., (Copyright © 2023 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Background: The Undetectable=Untransmittable (U=U) message has been promoted since it was demonstrated that viral suppression through HIV treatment prevents sexual transmission between serodiscordant partners (HIV treatment as prevention). Our study assessed familiarity with, perceived accuracy of, and willingness to rely on U=U in a national sample of gay and bisexual men in Australia., Methods: We conducted a national, online cross-sectional survey in April-June 2021. Eligible participants were gay, bisexual and queer men and non-binary people who lived in Australia. Logistic regression was used to identify factors associated with familiarity, perceived accuracy and willingness to rely on U=U (by having condomless sex with a partner with HIV who has an undetectable viral load)., Results: Of 1280 participants, most were familiar with U=U (1006/1280; 78.6%), the majority of whom believed U=U was accurate (677/1006; 67.3%). Both familiarity and perceived accuracy were higher among participants living with HIV, followed by pre-exposure prophylaxis (PrEP) users, HIV-negative participants not taking PrEP, and untested/unknown status participants. Knowing at least one person living with HIV, among other factors, was associated with familiarity and perceived accuracy of U=U; and familiarity was associated with perceived accuracy. Among participants familiar with U=U, less than half were willing to rely on U=U (473/1006; 47.0%). Familiarity with U=U and knowing at least one person living with HIV were associated with willingness to rely on U=U, among other factors., Conclusions: We found familiarity with U=U was associated with perceived accuracy and willingness to rely upon it. There is an ongoing need to educate gay and bisexual men (particularly HIV-negative men) about U=U and its benefits.

The HIV epidemic in Australia is changing with higher risk for HIV among newly-arrived Asian-born men who have sex with men (MSM) compared to Australian-born MSM. We evaluated the preferences for HIV prevention strategies among 286 Asian-born MSM living in Australia for <5 years. A latent class analysis uncovered three classes of respondents who were defined by their preferences: "PrEP" (52%), "Consistent condoms" (31%), and "No strategy" (17%). Compared to the "No strategy" class, men in the "PrEP" class were less likely to be a student or ask their partner for their HIV status. Men in the "Consistent condoms" class were more likely to get information about HIV from online, and less likely to ask their partner for their HIV status. Overall, PrEP was the preferred HIV prevention strategy for newly arrived migrants. Removing structural barriers to access PrEP can accelerate progress toward ending HIV transmission., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Ung, Martin, Terris-Prestholt, Quaife, Tieosapjaroen, Phillips, Lee, Chow, Medland, Bavinton, Pan, Mao and Ong.)

Background: Gay and bisexual men (GBM) who use HIV preexposure prophylaxis (HIV-PrEP) have high rates of bacterial sexually transmitted infections (STIs). The use of daily antibiotics as STI preexposure prophylaxis (STI-PrEP) may be appealing to GBM who are using or have previously used HIV-PrEP (HIV-PrEP-experienced) for the prevention of bacterial STIs., Methods: We examined willingness to use daily STI-PrEP among a cross-sectional sample of HIV-PrEP-experienced GBM in Australia who participated in an observational online cohort study from August 2018 to March 2020. Factors associated with willingness to use daily STI-PrEP were determined using bivariate and multivariate logistic regression., Results: Of the 1347 participants, half (54.3%) were willing to use daily STI-PrEP. Factors independently associated with greater willingness to use daily STI-PrEP included having >10 sexual partners in the last 6 months, using methamphetamine in the last 6 months, being more conscious about avoiding STIs, having a greater number of STIs since commencing HIV-PrEP, being willing to take HIV-PrEP for as long as they were at risk of acquiring HIV, and only using condoms when a sexual partner requested them. Conversely, factors associated with less willingness to use daily STI-PrEP included being university educated, using nondaily dosing regimens of HIV-PrEP, preferring event-driven HIV-PrEP, and being concerned about long-term HIV-PrEP adverse effects., Conclusions: Sexually transmitted infection PrEP is likely to be appealing to many HIV-PrEP-experienced GBM, especially those who engage in activities associated with a higher risk of STI transmission. However, they are less likely to be willing to use STI-PrEP unless it aligns with their HIV-PrEP dosing regimen, suggesting that research into the safety and efficacy of alternative STI prophylaxis dosing options should be prioritized., Competing Interests: Conflict of Interest and Sources of Funding: A.E.G. has received an honorarium from MSD (2021) and research support from Glaxo Smith Kline (2021–2023) and ViiV Healthcare (2022–2023). A.E.H. has received honoraria from MSD (2022) and Pfizer (2021). B.R.B. has received honoraria from Gilead Sciences (2020) and ViiV Healthcare (2022), and is currently receiving unrestricted research grants from Gilead Sciences (2021–2022) and ViiV Healthcare (2022–2023). For the remaining authors, none were declared., (Copyright © 2022 American Sexually Transmitted Diseases Association. All rights reserved.)

Relationship agreements are important for HIV prevention among gay and bisexual men (GBM) in relationships, with research earlier in the HIV epidemic often finding that agreements specified monogamy or condom use with casual partners. There is evidence that HIV pre-exposure prophylaxis (PrEP) has shifted sexual practices among some men in relationships, such as allowing condomless sex with casual partners, but there has been little attention paid to relationship agreements among GBM who use PrEP. In this paper, we analyzed national, Australian, cross-sectional data from an online survey completed by non-HIV-positive GBM in 2021 (N = 1,185). Using logistic regression, we identified demographic characteristics, sexual practices and the types of relationship agreement that were associated with PrEP use among GBM in relationships. Using Pearson's chi-squared tests, we explored whether PrEP users in relationships reported similar sexual practices to PrEP users not in relationships. PrEP use among GBM in relationships was independently associated with older age, identifying as gay, being in a non-monogamous relationship, having a spoken (explicit) relationship agreement, having a primary HIV-negative partner taking PrEP or a primary partner living with HIV, reporting recent condomless casual sex, reporting an STI diagnosis in the past year, and knowing at least one other PrEP user. We found that PrEP users in relationships had similar sexual practices to PrEP users not in relationships. GBM in relationships who have casual sex and who meet PrEP suitability criteria may be good candidates for PrEP. Our findings suggest that explicit relationship agreements remain important for HIV prevention, and they support PrEP use among GBM in relationships., (© 2022. The Author(s).)

COVID-19 has disrupted sexual behaviour and access to health systems. We adapted regular HIV behavioural surveillance of gay and bisexual men (GBM) in Australia in response to COVID-19, assessed the impact on the profile of the sample, the participants' HIV-related behaviour, and whether COVID-19 may have accentuated existing disparities in the Australian HIV epidemic. Data collected from five states during July 2017-June 2021 were included (N = 31,460). The emphasis on online recruitment after COVID-19 led to smaller sample sizes, greater geographic reach, and a higher proportion of bisexual-identifying participants. Most participants (88.1%) reported physical distancing and 52.1% had fewer sex partners due to COVID-19. In the COVID-19-affected rounds (July 2020-June 2021), the number of male partners, recent HIV testing and pre-exposure prophylaxis (PrEP) use all fell, and HIV risk among the smaller group of participants who reported casual sex increased. COVID-related changes were generally more pronounced among GBM aged under 25 years, participants from suburbs with fewer gay residents, and bisexual men. These groups should be prioritised when encouraging GBM to reengage with HIV testing services and effective prevention methods, like condoms and PrEP., (© 2022. The Author(s).)

Objectives: Gay, bisexual and other men who have sex with men (GBMSM) and trans and gender diverse (TGD) people are disproportionately affected by poorer sexual health outcomes compared to heterosexual populations. We aimed to explore the preferences of GBMSM and TGD for using eHealth for sexual health (eSexualHealth)., Methods: We distributed an anonymous online survey from April to August 2021among the lesbian, gay, bisexual, transgender, intersex, queer and other people of diverse sexuality or gender (LGBTIQA+) community in Australia. The survey collected data on sociodemographic characteristics and sexual behaviors, their preferences for app/website functions and preferred HIV and sexually transmitted infection (STI) testing reminders. We used descriptive statistics to summarize the characteristics of the study population. Free-text responses were thematically analyzed., Results: Of 466 participants included, most identified as cisgender males (92.7%). The median age was 48 [interquartile range (IQR): 37-56]. For accessing sexual health-related information, 160 (34.6%) would use either a website or an app, 165 (32.7%) would prefer a website, 119 (25.8%) would prefer an app, and 33 (7.1%) would not use either platform. There was no significant difference between GBMSM and TGD people. Participants were most interested in information about STI clinics, HIV/STI hotspots, and sexual health education. Participants stressed the need for privacy and anonymity when using eHealth. Regarding reminders to test for HIV/STIs, receiving regular SMS was most popular (112/293, 38.2%), followed by regular emails (55/293 18.8%) and a reminder function on their phone (48/293, 16.4%)., Conclusion: Our study suggests a promising future for eHealth among GBMSM and TGD people. Sexual health is still a stigmatized area, and eHealth may circumvent barriers this population faces., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Abraham, Chow, Fairley, Lee, Kong, Mao, Goller, Medland, Bavinton, Sudarto, Joksic, Wong, Phillips and Ong.)

Introduction: HIV pre-exposure prophylaxis (PrEP) has been government subsidized in Australia since April 2018 and while uptake is high among men who have sex with men, rates of discontinuation are also high. The aims of this study were to examine the impact of discontinuation on overall PrEP usage, the proportion of PrEP users who discontinue and the predictors of discontinuation., Methods: We used linked de-identified dispensing records of all government subsidized PrEP in Australia between April 2018 and September 2021: a whole-of-population data set. Defining discontinuation as 180 days or more without PrEP after the final dispensed supply, we calculated the number of people who discontinued at each 6-month interval during the study period, the proportion who had discontinued 2 years after the first supply and, using Cox regression, predictors of discontinuation., Results: Of 49,164 people dispensed PrEP (98.5% male, median age 34 years), 40.3% (19,815) had discontinued by September 2021. Within 2 years of their first supply, 11,150 (37.7%) of 29,549 PrEP users had discontinued, including 10.0% after a single dispensed supply. Large variations were observed, particularly according to prescriber characteristics: discontinuation was higher among people prescribed PrEP by low caseload (≤10 patients) prescribers (61.2%) than by high caseload (>100 patients) prescribers (31.1%, p<0.001), and by prescribers practising in areas with low estimated prevalence (<1.0%) of gay men (64.1%) than high (>5%) prevalence (36.7%, p<0.001). Women and younger people were more likely to discontinue, while patients receiving a higher level of government subsidy were less likely. The independent predictors of discontinuation with the greatest effect size were female sex (adjusted hazards ratio [aHR] 2.99, p<0.001), low estimated gay prevalence of prescriber location (aHR 1.98, p<0.001) and low prescriber PrEP caseload (aHR 1.79, p<0.001)., Conclusions: There are high rates of PrEP discontinuation in Australia and some populations are at increased risk of discontinuation. Strategies are needed to support persistence on PrEP and the re-starting of PrEP during periods of risk., (© 2023 The Authors. Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of the International AIDS Society.)

Condoms have been the primary form of HIV prevention for gay and bisexual men (GBM) for most of the HIV epidemic. The introduction of biomedical HIV prevention may have changed attitudes towards condoms. Data from repeated national online surveys of GBM in Australia were used to examine how attitudes towards condoms and confidence discussing condoms with partners changed in the period 2011-2019. The proportion of all participants who reported a positive experience in using condoms remained low and unchanged (9.6% in 2011 to 6.0% in 2019). Confidence in discussing condoms with partners decreased over time (from 72.2% in 2011 to 56.6% in 2019). Confidence in discussing condoms was associated with concern about sexually transmitted infections, and more consistent condom use. Sustaining confidence in using condoms may be more challenging as biomedical prevention methods become more commonly used.

Background: The sexual and reproductive health care of people with HIV and those at risk of HIV has largely been delivered face-to-face in Australia. These services adapted to the coronavirus disease 2019 (COVID-19) pandemic with a commitment to continued care despite major impacts on existing models and processes. Limited attention has been paid to understanding the perspectives of the sexual and reproductive health care workforce in the research on COVID-19 adaptations., Methods: Semi-structured interviews were conducted between June and September 2021 with 15 key informants representing a diverse range of service settings and professional roles in the Australian sexual and reproductive health sector. Inductive themes were generated through a process of reflexive thematic analysis, informed by our deductive interest in clinical adaptations., Results: The major adaptations were: triage (rapidly adapting service models to protect the most essential forms of care); teamwork (working together to overcome ongoing threats to service quality and staff wellbeing), and the intwined themes of telehealth and trust (remaining connected to marginalised communities through remote care). Despite impacts on care models and client relationships, there were sustained benefits from the scaleup of remote care, and attention to service safety, teamwork and communication., Conclusions: Attending to the experiences of those who worked at the frontline of the COVID-19 response provides essential insights to inform sustained, meaningful system reform over time. The coming years will provide important evidence of longer-term impacts of COVID-19 interruptions on both the users and providers of sexual and reproductive health services.

Background: Female sex workers (FSWs) in Uganda are at high risk of HIV infection. Scaling up oral pre-exposure prophylaxis (PrEP) will reduce HIV incidence if high levels of adherence are maintained. This study evaluates PrEP adherence using clinic-based pill counts and self-reported measures, and factors associated with protective levels of adherence., Methods: Participants were sex workers who had been taking PrEP for at least 5 months and were attending routine follow-up visits for PrEP care in fishing communities and along the Trans-African Highway. Participants who had a pill count showing at least 85% use since their last clinic visit and those who reported taking their PrEP every day in the last 5 months were categorised as having 'protective adherence'. Spearman's correlation and weighted kappa assessed the relationship between pill count and self-reported measures. Bivariate and multivariate logistic regression was used to determine factors associated with protective adherence as measured by pill count., Results: We recruited 524 FSWs, with a median age of 29 years (IQR 23-35). Participants were recruited from fishing communities and Trans-African Highway towns (n = 297, 56.7%, and n = 227, 43.0%). Nearly three quarters (n = 372, 71.0%) of women were estimated to have protective adherence based on pill count (i.e., a pill count of &gt;85%) and 50.4% by self-report in last 3 months. There was a strong positive association between self-reported measures and pill count measures (rest = 0.6453, 95% CI = 0.5924-0.6927) and a moderate agreement between self-reported measures and pill count measures, κ = 0.544 (95%CI = 0.4869-0.6011, p &lt; 0.001). Factors associated with protective adherence included being aged 35 years or older (aOR = 2.40, 95% CI = 1.17-4.86), living in a fishing community (aOR = 1.45, 95% CI = 0.62-3.38), and having an STI in last 3 months (aOR = 1.64, 95% CI = 1.07-2.49)., Conclusion: Our findings indicate that PrEP-experienced FSWs attending clinical follow-up visits reported high protective levels of oral pre-exposure prophylaxis, as measured by both pill count and self-reported measures, and a moderate agreement between pill count and self-reported measures., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2022 Nakiganda et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Gay and bisexual migrants from low- and middle-income countries living in high-income countries are disproportionately diagnosed with HIV. Most research focuses on preventing HIV acquisition among HIV-negative migrant gay and bisexual men (GBM). This study is uniquely positioned to report on migrant GBM's experiences and needs at and after an HIV diagnosis. Semi-structured interviews were conducted with 24 migrant GBM diagnosed at sexual health clinics in Australia from 2017 onwards. Interviews were analysed using a codebook thematic analysis. Due to the stigma of HIV and homosexuality in their countries of origin, about half of participants had poor HIV knowledge prior to diagnosis. Absorbing diagnosis information was consequently difficult, and feelings of shame, hopelessness, lost sexual opportunities and infectiousness were common. However, many were thankful for the comprehensive clinical support they received and believed that over time life would 'normalise' with sustained undetectable viral load. None reported that their clinician stigmatised them, but the anticipation of stigma nonetheless infused their experiences after diagnosis. Many were selective about HIV disclosure, and some mentioned that clinic systems posed a risk to confidentiality. Non-permanent residents were concerned about the impacts of HIV status on future visa applications. We recommend that newly HIV-diagnosed migrant GBM receive referral to legal and culturally appropriate migration services to help absorb what a diagnosis might mean for their health and visa status. We also recommend sexual health clinics continue to assess confidentiality in their systems. Health promotion initiatives should highlight to migrant GBM that high-HIV caseload sexual health clinicians provide confidential and comprehensive care., (© 2022 The Authors. Health and Social Care in the Community published by John Wiley & Sons Ltd.)

Changes to how gay, bisexual, and other men who have sex with men (GBM) connect with each other and with their communities have implications for HIV prevention. Social engagement with gay men (defined as having friends who are gay men and spending time with them) has been associated with HIV related outcomes over time among Australian GBM. Using data collected in national, repeated, cross-sectional surveys of GBM between 1998 and 2020 (N = 161,117), analyses of trends in the prevalence of gay social engagement (GSE) in Australia were conducted using linear regression. To assess changing associations with GSE at different time points in the HIV epidemic, three cross-sectional analyses were conducted on factors associated with high and low GSE in 1999/2000, 2009/2010, and 2019/2020 using bivariate and multivariable logistic regression. GSE (scored from 0 to 7) declined among all participants from 4.76 in 1998 to 4.04 in 2020 (p < 0.001) with a steeper decline among GBM aged under 25 years from 4.63 in 1998 to 3.40 in 2020 (p < 0.001). In all timepoints, high GSE was associated with older age, being university educated, full time employment, identifying as gay, recent HIV testing, and PrEP uptake. While mostly associated with protective behaviors, high GSE was also associated with some practices that may put GBM at risk of HIV infection such as drug-enhanced sex and group sex in the most recent timepoint. Changing levels of GSE have implications for health promotion among GBM, particularly how to engage GBM less connected to gay social networks., (© 2022. The Author(s).)

Purpose of Review: Ten years since the first regulatory approval of oral HIV preexposure prophylaxis (PrEP), this review summarizes PrEP uptake, the role of ambitious PrEP targets, emerging evidence of impact on the HIV epidemic and innovative approaches to increasing PrEP uptake., Recent Findings: PrEP uptake among people at risk of HIV has been slow, but has accelerated in recent years, particularly in gay and bisexual men in a limited number of high-income settings and recently in heterosexuals at risk of HIV in sub-Saharan Africa. However, UNAIDS 2020 PrEP targets and HIV prevention targets were missed by large margins. Although UNAIDS testing and treatment targets have galvanised public health action, in contras, PrEP targets have been lower profile and insufficiently ambitious. Parts of the USA, Australia and the UK with high PrEP coverage have demonstrated striking reductions in HIV infection at the population level, as PrEP is introduced at scale. Scaling up PrEP uptake will require innovations in PrEP promotion, simplified models of care, improved adherence interventions, improved choice in the form of longer-acting PrEP and interventions to ensure that all those who can benefit from PrEP can access it., Summary: PrEP is a revolutionary HIV prevention tool, which if ambitiously scaled up could drive HIV transmission towards elimination. Highly publicized and ambitious PrEP targets could help drive this., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Event-driven pre-exposure prophylaxis (ED-PrEP), when taken according to the "2-1-1" dosing method, is highly effective at preventing HIV acquisition for gay, bisexual, and other men who have sex with men (GBM). Any missed doses when using ED-PrEP drastically reduce its effectiveness, so it is vital that people using this method know how to take it correctly. This study investigated Australian GBM's awareness of ED-PrEP and their knowledge of how to take it correctly., Method: We conducted a survey of 1471 PrEP-experienced GBM in Australia, between October 2019 and March 2020. The survey assessed awareness and knowledge of the 3 components of the "2-1-1" ED-PrEP dosing regimen (number of pills for loading dose, timing of loading dose, and number of days after sex to take PrEP pills) among GBM. Characteristics associated with ED-PrEP awareness and correct knowledge of how to take ED-PrEP were assessed with multivariate logistic regression., Results: Two-thirds (n = 1004, 68.4%) had heard of ED-PrEP, of whom only one-eighth (n = 125, 12.5%) knew the correct details of the "2-1-1" ED-PrEP method; one-third (n = 339, 33.8%) did not know any of the 3 key components. Awareness of ED-PrEP and correct knowledge was associated with greater belief in PrEP efficacy, university education, and intention to take a nondaily PrEP regimen in the next 6 months., Conclusions: Although ED-PrEP awareness was considerable, most participants did not know how to use ED-PrEP correctly. Further work is needed to increase awareness and knowledge of ED-PrEP among GBM., Competing Interests: The authors have no conflicts of interest to disclose., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Men who have sex with men in Uganda are a heterogenous, discriminated population, experiencing high HIV burden, limited access to HIV testing, and low treatment adherence. We contribute to the lack of information about men who have sex with men in rural Uganda by using socio-ecological analyses to examine the social influences shaping their engagement with HIV services. Based on in-depth interviews with 16 men, our findings reveal the inhibitive influence of interpersonal relationships with sexual partners, peers and families, and institutional influences within health service and non-governmental organizational settings. Yet men take action to strategize and seek support to enhance engagement with HIV care in heavily criminalized and stigmatized settings. Future HIV prevention, testing, treatment, and care responses could draw on what affected individuals and communities are already doing to enhance access to HIV services and the effective support strategies of some non-governmental organizations and healthcare workers.

Background: Discrimination and stigmatization at the institutional and sociocultural level (conceptualized as "structural stigma") has been associated with adverse health outcomes among sexual and gender minorities. However, few studies explore whether structural stigma is associated with sexual health outcomes. Addressing this gap, here, we explore this relationship among Australian gay, bisexual, and other men who have sex with men (GBM)-a population disproportionately affected by HIV., Setting and Methods: Using responses from the 2017 Australian Marriage Law Postal Survey, we operationalized structural stigma related to sexual minority status as the regional percentage of votes against legalizing same-sex marriage. These responses were then linked to national HIV behavioral surveillance data from Australian GBM (43,811 responses between 2015 and 2019). Controlling for a rich set of individual and regional level confounders, regression analyses were used to estimate the extent to which structural stigma was associated with testing for, and diagnoses of, HIV and sexually transmitted infections (STIs), and awareness and use of HIV prevention and treatment interventions (pre-exposure and postexposure prophylaxis, combination therapy, and HIV-related clinical care)., Results: Australian GBM living in regions with higher levels of structural stigma were less likely to undergo HIV/STI testing, receive HIV/STI diagnoses, and be taking, or aware of, biomedical prevention strategies. Among GBM living with HIV, structural stigma was associated with a reduced likelihood of being on combination therapy and fewer HIV-related clinical visits., Conclusions: Altogether, these results suggest that structural stigma may undermine HIV prevention strategies as well as adequate management of HIV infection among GBM., Competing Interests: The authors have no conflicts of interest to disclose., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

Alternatives to daily dosing of HIV pre-exposure prophylaxis (PrEP) are continuing to emerge. From October 2019 to March 2020, we conducted an online survey of PrEP-experienced gay and bisexual men in Australia about interest in and preference for four different PrEP modalities: daily dosing, event-driven dosing, long-acting injectable (LAI)-PrEP and subdermal PrEP implants. Using data from 1477 participants, we measured interest and preference of different modalities using multivariate logistic regression. High proportions of participants were interested in LAI-PrEP (59.7%), daily PrEP (52.0%), PrEP implants (45.3%) and event-driven PrEP (42.8%). LAI-PrEP was the most frequently selected preference (30.5%), followed by PrEP implants (26.3%), daily PrEP (21.4%) and event-driven PrEP (21.2%). Higher interest and preference for non-daily PrEP modalities were associated with being concerned about side effects and perceived difficulties with daily adherence. As novel modalities emerge, attitudes to them should be considered in public health messaging to facilitate informed decision-making., (© 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background Overseas-born people who are ineligible for government-subsidised health care experience barriers to accessing HIV pre-exposure prophylaxis (PrEP) in Australia. This study aimed to assess a program providing free PrEP to overseas-born adults at risk of acquiring HIV. Methods Medicare-Ineligible Expanded Implementation in Communities (MI-EPIC) was a single-arm, open-label trial of daily tenofovir disoproxil fumarate/emtricitabine as PrEP. Six clinics recruited Medicare-ineligible adults who met HIV risk criteria in New South Wales, Australia. We recorded data on HIV and sexually transmitted infection (STI) diagnoses, and PrEP dispensing from July 2019 to June 2020. PrEP adherence as a medication possession ratio (MPR) was calculated as pills dispensed divided by days. We administered an optional survey on behaviours and attitudes to PrEP and sexual health. Results The 221 participants (206 men; 93.2%) had a median age of 29years (IQR 26-34). Participants were mostly born in Asia (53.4%), Latin America or the Caribbean (25.3%), or Europe (10.9%). Adherence was high; 190 participants (86.0%) had an MPR of >60%. Of 121 survey participants, 42 (34.7%) completed the survey in a language other than English. Of participants who had not used PrEP in the 6months before enrolment (n=45, 37.2%), the most common reasons were cost (n=22, 48.9%), and lack of knowledge about accessing PrEP (n=20, 44.4%). Conclusions Medicare-ineligible people at risk of HIV demonstrate high adherence when given access to free PrEP and translated information. Increasing PrEP awareness and reducing barriers to accessing PrEP in this high-risk population should be priorities in HIV prevention.

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., (© 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Social capital has been positively associated with reduced HIV risk. However, few studies have investigated if associations vary between men who have sex with men (MSM) or heterosexual alters (possessors of actual resources embedded within social capital networks) and HIV risk-taking behaviors. In a cross-sectional survey of 1564 MSM in Greater Tokyo, we investigated whether social capital ascertained from MSM or heterosexual alters influenced HIV risk-taking behaviors (i.e., consistent condom use and lifetime HIV testing). Multiple logistic regression revealed that MSM with high levels of social capital from heterosexual networks were twice as likely to report consistent condom use with casual male partners, while MSM who reported high levels of social capital from MSM networks were over twice as likely to have tested for HIV yet were half as likely to use condoms consistently with regular male partners. Associations between MSM, social capital, and HIV testing indicate the potential for integrating social capital enhancement programs into current HIV interventions., (© 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background: HIV-1 infections occur following viral exposure at anogenital mucosal surfaces in the presence of semen. Semen contains immunosuppressive and pro-inflammatory factors. Semen from HIV-1-infected donors contains anti-HIV-1 antibodies. We assessed if passively infused anti-HIV-1 neutralizing antibody conferred protection from rectal SHIV SF162P3 challenge at semen exposed mucosae., Methods: We pooled seminal plasma from HIV-1-infected donors. The pool was screened by ELISA for antibodies against HIV-1 SF162 gp140. The ability of seminal plasma to inhibit macaque NK cells from responding to direct and antibody-dependent stimulation was assessed. The ability of seminal plasma to inhibit macaque granulocytes from mediating oxidative burst was also assessed. To demonstrate viral infectivity in the presence of seminal plasma, macaques (n = 4) were rectally challenged with SHIV SF162P3 following exposure to 2.5 mL of seminal plasma. To evaluate if anti-HIV-1 neutralizing antibody confers protection against rectal SHIV challenge at semen exposed mucosae, eight macaques were intravenously infused with PGT121, either wild type (n = 4) or the Fc receptor binding deficient LALA variant (n = 4), and rectally challenged with SHIV SF162P3 following exposure to 2.5 mL of seminal plasma., Findings: Anti-HIV-1 SF162 gp140 antibodies were detected in seminal plasma. Seminal plasma inhibited direct and antibody-dependent NK cell activation and granulocyte oxidative burst in vitro. Rectal SHIV SF162P3 challenge of control macaques following seminal plasma exposure resulted in infection of all animals. All macaques infused with wild type or LALA PGT121 and challenged with SHIV SF162P3 following seminal plasma exposure were protected., Interpretation: PGT121 conferred protection against rectal SHIV SF162P3 challenge at semen exposed mucosae. Future research should investigate if semen alters protection conferred by antibodies more dependent on non-neutralizing functions., Funding: This work was supported by a grant from the Australian National Health and Medical Research Council (APP1124680)., Competing Interests: Declaration of Competing Interest None., (Copyright © 2021 The Authors. Published by Elsevier B.V. All rights reserved.)

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., Competing Interests: Declaration of interests AEG received a grant from the NSW Ministry of Health and the ACT Health Directorate, and non-financial support from Gilead Sciences, enabling the conduct of the reported study. AEG also receives personal fees from Viiv Healthcare and a grant from Seqirus Australia, outside the submitted work. AC reports grants, personal fees, and non-financial support from Gilead Sciences, grants and personal fees from ViiV Healthcare, and grants and personal fees from MSD, outside the submitted work. BY reports travel and accommodation support from Mylan Australia to present at the HIV Clinical Care meeting in the ACT in 2019, unrelated to the submitted work. BRB reports personal fees from Gilead Sciences, outside the submitted work. CTMS reports support from Gilead Sciences to attend a workshop and accommodation. DAB reports grants from ViiV Healthcare, Gilead Sciences, and MSD, during the conduct of the study. MB reports grants from NSW State Government during the conduct of the study; grants and personal fees from Gilead Sciences, ViiV Healthcare, and AbbVie, personal fees from Janssen, and grants from MSD and GSK, outside the submitted work. NJD reports grants from Gilead Sciences unrelated to the submitted work. PR reports institutional research funding and speaking honoraria received from Gilead Sciences unrelated to this manuscript. SM reports grants from ACT Health Directorate and ACT Government, during the conduct of the study. All other authors report no competing interests., (Copyright © 2021 Elsevier Ltd. All rights reserved.)

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., Competing Interests: The authors have no conflict of interest to disclose., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Same-sex sexual relations are criminalised in Uganda, and men who have sex with men (MSM) experience a high burden of HIV infection. In Uganda, health promotion policies focus on equity in healthcare and creating enabling environments. At present there is limited evidence upon which to enhance engagement of MSM in rural settings into effective HIV prevention. To fill this gap, our study explored MSM's understandings of HIV risk and strategies used to reduce HIV risk in their sexual lives., Methods: In-depth interviews were conducted with sixteen MSM in rural communities in Southwestern Uganda. Inductive thematic analysis examined men's perceptions of HIV risk and strategies of reducing their own HIV risks., Results: Understandings of HIV risk and risk practices were framed by lack of access to condoms, challenges negotiating condom and pre-exposure prophylaxis (PrEP) use, and condomless sex being reported as more pleasurable than sex with condoms. Strategies men perceived as enabling them to manage HIV risk included: PrEP use; condom use; knowing partners' HIV status; avoiding partners associated with HIV risk; oral sex; withdrawal before ejaculation and washing one's penis after sex. There were several misconceptions arising from poor HIV prevention knowledge. Strategies reliant on communication and negotiation with sexual partners were inhibited by gendered powered imbalances., Conclusions: Our findings illustrate that MSM in rural settings in Uganda are making concerted efforts to implement strategies that might reduce risk of HIV transmission and infection within their sexual relationships. Key HIV health promotion and service-related strategies to support MSM with these efforts include an effective condom and lubricant supply chain; a PrEP program in trusted local health units, implemented via discreet community-outreach mechanisms; and same-sex specific HIV-related health promotion.

More than a decade after the first efficacy evidence for oral HIV pre-exposure prophylaxis (PrEP) was reported, PrEP uptake globally has been inadequate and global HIV prevention targets have been missed. Access to PrEP is still highly concentrated in a fairly small number of countries and, even within countries with widespread PrEP access, inequalities have emerged. More ambitious, high-priority global targets for PrEP uptake are required and could accelerate the HIV prevention response in a similar way to the success of the 90-90-90 testing and treatment targets. Health systems must be PrEP-friendly and allow PrEP to be prescribed in settings already attended by large numbers of HIV-negative individuals who are at risk. Several models have been advanced for the greater demedicalisation of PrEP. Individual-level barriers to PrEP uptake and persistence have been characterised, such as low awareness, low willingness to use PrEP, and the gap between self-perceived and actual HIV risk. Overcoming these barriers will require further efforts to understand and address them first. New PrEP modalities are emerging; as more options become available, we need to develop a greater understanding of the long-term patterns of PrEP use in different populations and to develop models of such use that can accommodate people alternating through periods of use and non-use, as well as switching between dosing regimens or modalities as they become available. Scaling up PrEP is crucial to achieving the UNAIDS prevention targets for 2030. Simply getting more people onto PrEP cannot be the only goal: the big-picture definition of success for PrEP programmes must be their impact on the HIV epidemic., Competing Interests: Declaration of interests BRB reports grants and personal fees from Gilead Sciences, outside the submitted work. AEG reports grants from the New South Wales Ministry of Health and non-financial support from Gilead Sciences during the conduct of the study, and personal fees from Merck, Sharpe & Dohme and ViiV Healthcare, and grants from Sequirus, outside the submitted work., (Copyright © 2021 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Objectives: To assess trends in HIV prevention strategies among Australian gay and bisexual men (GBM) since the introduction of preexposure prophylaxis (PrEP), the level of net prevention coverage (the use of safe strategies), and the characteristics of HIV-negative and untested GBM who remain at risk of HIV., Design: Repeated behavioural surveillance of GBM recruited from venues, events and online in seven Australian states and territories., Methods: Participants with casual male partners were included. Trends in sexual practices, prevention strategies, net prevention coverage and the characteristics of 'at risk' participants were assessed with binary and multivariate logistic regression., Results: A total of 32 048 survey responses (2014-2019) were included. The proportion of participants who reported consistent condom use declined (44.6-23.2%). The proportion who reported any condomless anal intercourse with casual partners increased (37.4-62.0%) but net prevention coverage also increased (68.1-74.9%), with higher levels of undetectable viral load among HIV-positive participants and rapidly increasing PrEP use by HIV-negative participants. PrEP became the most commonly reported prevention strategy in 2019 (31.1%). The analysis of 'at risk' participants showed that they became more likely to report frequent condomless anal intercourse with casual partners but had fewer partners and more partners with undetectable viral load or on PrEP. 'At risk' participants became more likely to identify as bisexual and to be born overseas., Conclusion: There has been a rapid, historic shift in HIV prevention among GBM in Australia. Net prevention coverage has increased among GBM and 'at risk' GBM have become less at risk of HIV, facilitating reductions in HIV transmission., (Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved.)

Introduction: The human immunodeficiency virus 1 (HIV-1) pandemic is characterized by numerous distinct sub-epidemics (clusters) that continually fuel local transmission. The aims of this study were to identify active growing clusters, to understand which factors most influence the transmission dynamics, how these vary between different subtypes and how this information might contribute to effective public health responses., Methods: We used HIV-1 genomic sequence data linked to demographic factors that accounted for approximately 70% of all new HIV-1 notifications in New South Wales (NSW). We assessed differences in transmission cluster dynamics between subtype B and circulating recombinant form 01&#95;AE (CRF01&#95;AE). Separate phylogenetic trees were estimated using 2919 subtype B and 473 CRF01&#95;AE sequences sampled between 2004 and 2018 in combination with global sequence data and NSW-specific clades were classified as clusters, pairs or singletons. Significant differences in demographics between subtypes were assessed with Chi-Square statistics., Results: We identified 104 subtype B and 11 CRF01&#95;AE growing clusters containing a maximum of 29 and 11 sequences for subtype B and CRF01&#95;AE respectively. We observed a > 2-fold increase in the number of NSW-specific CRF01&#95;AE clades over time. Subtype B clusters were associated with individuals reporting men who have sex with men (MSM) as their transmission risk factor, being born in Australia, and being diagnosed during the early stage of infection (p < 0.01). CRF01&#95;AE infections clusters were associated with infections among individuals diagnosed during the early stage of infection (p < 0.05) and CRF01&#95;AE singletons were more likely to be from infections among individuals reporting heterosexual transmission (p < 0.05). We found six subtype B clusters with an above-average growth rate (>1.5 sequences / 6-months) and which consisted of a majority of infections among MSM. We also found four active growing CRF01&#95;AE clusters containing only infections among MSM. Finally, we found 47 subtype B and seven CRF01&#95;AE clusters that contained a large gap in time (>1 year) between infections and may be indicative of intermediate transmissions via undiagnosed individuals., Conclusions: The large number of active and growing clusters among MSM are the driving force of the ongoing epidemic in NSW for subtype B and CRF01&#95;AE., (© 2021 The Authors. Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of the International AIDS Society.)

Changes over time in HIV-1 subtype diversity within a population reflect changes in factors influencing the development of local epidemics. Here we report on the genetic diversity of 2364 reverse transcriptase sequences from people living with HIV-1 in New South Wales (NSW) notified between 2004 and 2018. These data represent >70% of all new HIV-1 notifications in the state over this period. Phylogenetic analysis was performed to identify subtype-specific transmission clusters. Subtype B and non-B infections differed across all demographics analysed ( p < 0.001). We found a strong positive association for infections among females, individuals not born in Australia or reporting heterosexual transmission being of non-B origin. Further, we found an overall increase in non-B infections among men who have sex with men from 50 to 79% in the last 10 years. However, we also found differences between non-B subtypes; heterosexual transmission was positively associated with subtype C only. In addition, the majority of subtype B infections were associated with clusters, while the majority of non-B infections were singletons. However, we found seven non-B clusters (≥5 sequences) indicative of local ongoing transmission. In conclusion, we present how the HIV-1 epidemic has changed over time in NSW, becoming more heterogeneous with distinct subtype-specific demographic associations.

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.

Serodiscordant couples are often understood through a discourse of HIV-risk or researched in terms of the psychological stressors they face. However, due to antiretroviral treatments people living with HIV can achieve undetectable viral loads, which not only make them non-infectious to partners, but allow them to think of their lives and relationships as safe and viable. These realisations mean that serodiscordant couples often embrace an HIV 'normalisation' discourse. In this article, we argue that this discourse of HIV 'normalisation' can overlook the more nuanced complexity of issues still faced by couples today, which reveal how their experiences of 'normal' are sometimes challenged and are not necessarily 'normal'. Utilising semi-structured interviews with 21 gay men in serodiscordant relationships in Sydney, Australia, we draw on the concept of 'home' life to explore how men engage with discourses of normalisation to describe and enact their relationships. We argue that although HIV is managed well enough to be insignificant in the context of home life, experiences or anticipation of stigma in public often remind couples that they are yet to be considered 'normal' socially., (© 2020 Foundation for the Sociology of Health & Illness.)

Increasing HIV testing frequency in gay and bisexual men (GBM) is critical to reducing the time between HIV infection and diagnosis. Using anonymous national behavioural surveillance data (2013-2018) from 43,753 surveys of Australian GBM, we examined HIV testing frequency trends and factors differentiating PrEP-users, non-PrEP-users reporting two or more tests in the previous year, and non-PrEP-users reporting less frequent testing. The proportion tested at least annually increased from 64.4% in 2013 to 70.8% in 2018 (p-trend < 0.001), and from 73.9% to 84.6% among the 51.6% of men classified as higher-risk. Among higher-risk men, having two or more tests in the previous year increased from 48.0% to 69.3% (p-trend < 0.001). Among higher-risk non-PrEP-users, it increased from 47.2% to 54.8% (p-trend < 0.001), however, there was a decrease since 2016 (p-trend < 0.001). Among PrEP-users, it increased from 82.1% in 2013 to 97.3% in 2018 (p-trend < 0.001). Non-PrEP-using higher-risk men having less frequent tests reported lower risk than PrEP-users and non-PrEP-using men reporting two or more tests in the previous year. However, recent risk behaviour was not uncommon: nearly half reported condomless sex; one-fifth reported receptive condomless sex with ejaculation; over half reported group sex; one-quarter used drugs for the purposes of sex; and one-fifth had more than ten sex partners. Efforts are needed to encourage frequent testing and PrEP use among non-PrEP-users who are at higher-risk.

Competing Interests: Competing interests: None declared.

Gay and bisexual men engage in a variety of sexual partnerships, but the most common distinction made in HIV research and behavioral surveillance is a binary between "regular" and "casual" partners. The "regular partner" category is often perceived as pertaining to ongoing coupled "boyfriend" relationships, with the literature to date rarely troubling what actually constitutes a "regular partner." Some emerging literature has identified "fuckbuddy" partnerships as a type of regular partnership requiring attention, but it is relatively new and not well understood. Currently, assumptions of the regular partner category do not capture how men perceive and conduct commitment in different sexual partnerships that could also be considered "regular," and the implications this has for HIV prevention. Drawing on in-depth interviews with a sample of 61 Australian gay-identified men, we explore a diversity of partnership types that represent unique ways of enacting commitment. We identify three sexual partnerships: "fuckbuddies," dating, and serial monogamy, each with specific issues for HIV risk and prevention. These partnerships suggest important differences in the way men conceive of and practice intimacy and sex.