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The past 5 years has been a time of increasing optimism in HIV treatment and HIV prevention. In 2015, two of the key chinks in the armour of biomedical prevention [...]

PrELUDE study evaluated daily pre-exposure prophylaxis (PrEP) in high-risk individuals in Australia. This open-label, single-arm study tested participants for HIV/STI and collected behavioural information three-monthly. We report trends over 18 months in medication adherence, side-effects, HIV/STI incidence and behaviour. 320 gay/bisexual men (GBM), 4 women and 3 transgender participants, followed on average 461 days, reported taking seven pills/week on 1,591 (88.5%) occasions and 4-6 pills/week on 153 (8.5%) occasions. No HIV infections were observed. STI incidence was high and stable, while gonorrhoea infections declined from 100.0 to 25.8/100 person-years between 6 and 15 months (p < 0.001). The number of HIV-positive and unknown-status sex partners, and condomless anal intercourse, significantly increased. In this high-risk cohort of mainly GBM, increases in risk behaviours and high STI incidence were not accompanied by HIV infections due to high adherence to daily PrEP. The study informed policy and further PrEP implementation among Australian GBM. [ABSTRACT FROM AUTHOR]

The number of gay and bisexual men (GBM) taking HIV pre-exposure prophylaxis (PrEP) to prevent HIV has rapidly increased since 2010, but limited information about barriers and facilitators to adherence has been reported outside of formal trial settings. We conducted semistructured in-depth interviews with 24 Australian cis- and transgender GBM with a history of PrEP use to gather data on adherence to PrEP. The majority of participants were able to access PrEP at no cost through implementation studies. Three key domains were explored—how individuals took PrEP, factors that aided PrEP adherence, and barriers to PrEP use. All participants recognized the importance of regular dosing to ensure protection from HIV, with some participants taking the initiative to pre-empt possible adherence obstacles and plan around these. Multiple strategies were used to aid adherence, including using tools such as a phone alarm and support and tips from other PrEP users, friends, or clinicians. Barriers to PrEP adherence included stigma, concerns about side effects, and difficulties in accessing PrEP. Although most participants encountered at least one barrier to PrEP use, they were resourceful and utilized a variety of approaches to ensure good adherence to PrEP was maintained. These narratives highlight a commitment to finding ways to make PrEP work in the daily lives of this cohort of Australian GBM, demonstrated by their active investigation of different routines to determine the most suitable dosing strategy, and creation of contingency plans if they were unable to access PrEP in their usual or preferred manner. [ABSTRACT FROM AUTHOR]

Pre-exposure prophylaxis (PrEP) with antiretrovirals could prevent millions of infections, yet effective strategies to get PrEP delivered are just being defined. This editorial introduces a series of 17 articles which form a special issue of Sexual Health focused on the opportunities and challenges for health service providers engaged in PrEP prescribing. All pieces presented here share useful lessons from PrEP pioneers; more than that, they should serve as catalysts to accelerate PrEP implementation around the world. [ABSTRACT FROM AUTHOR]

We estimated the size of the population of gay-identified men who have sex with men (gay men) eligible for PrEP in Australia under the current national PrEP guidelines. Using input indicators from the Australian Bureau of Statistics, the national representative survey Second Australian Study of Health and Relationships, and national HIV- behavioural surveillance, we calculated the size of the population of sexually active gay men and estimated a range for the number eligible for PrEP using different scenarios based on the guidelines. In 2015, an estimated 108,850 sexually-active 16-69-year-old gay men were classified as at risk of acquiring HIV in Australia. Of these men, 10,558 to 30,913 (9.7%-28.4%) were classified as being at high risk and therefore eligible for PrEP, most commonly due to recent receptive condomless intercourse with casual partners (6.1% to 15.5%), STI infections (5.4% to 10.6%) or the use of crystal methamphetamine (1.4% to 9.4%). The higher estimates included men who may have been at HIV risk for shorter time periods or with fewer partners. Australian PrEP guidelines recommend targeting PrEP to people at high HIV risk. Our estimation of potential PrEP users informed PrEP implementation in Australia. The choice of PrEP eligibility criteria, and interpretation of the guidelines, strongly affects the population estimates. In the future, higher numbers of gay men may become eligible for PrEP, because the estimates are largely defined by and follow trends in condomless anal intercourse. Our estimation methods can be adapted to other settings. [ABSTRACT FROM AUTHOR]

Background Regular sexual partnerships among gay and bisexual men (GBM) who practice condomless anal intercourse (CLAI) have not been well characterised in terms of partnership type, HIV seroconcordance and risk of HIV transmission. Primarily sexual regular partnerships, although commonly reported by gay men, have largely been ignored in research and HIV prevention. Among regular partners reporting CLAI with each other, we determined factors differentiating romantic or committed relationships from partnerships organised primarily around sex ('fuckbuddies') and estimated the proportion of CLAI presenting risk for HIV transmission.Methods: An online, cross-sectional survey of Australian GBM was conducted. Univariate and multivariate generalised estimating equations were used to determine statistical associations.Results: Men reported on 2250 regular sexual partnerships. Over half the partnerships were romantic or committed relationships. Over half the partnerships were HIV-negative seroconcordant (54.9%), 3.1% were HIV-positive seroconcordant, 5.2% were serodiscordant and 36.8% were of unknown seroconcordance. Potential risks presented by CLAI were sometimes mitigated by protective factors, such as having a clear spoken agreement about sex with outside partners, having fewer outside partners, openly discussing HIV risk and having an agreement to reduce risk from outside partners. These protective factors were more often found in romantic or committed relationships than among primarily sexual partnerships, and were less often found in partnerships of unknown seroconcordance.Conclusion: CLAI is more common among regular sexual partnerships considered to be of a romantic, committed nature. However, factors associated with such romantic or committed partnerships can also protect against HIV transmission risk. Unknown seroconcordance, particularly lack of communication about HIV status among primarily sexual partnerships, is a key risk factor that needs to be addressed by HIV education. [ABSTRACT FROM AUTHOR]

Background: In Australia, pre-exposure prophylaxis (PrEP) is targeted to individuals at high risk for HIV infection. We describe the HIV risk profile and characteristics of PRELUDE participants, and evaluate the population validity of the sample in representing high-risk gay and bisexual men (GBM) eligible for PrEP. Methods: PRELUDE is an on-going, open-label, single-arm observational study. Participants were identified in clinics and screened for eligibility using a paper-based risk assessment tool which followed the New South Wales (NSW) PrEP guidelines. Selection was validated using an independent online behavioural survey, completed by study participants upon enrolment. Demographic information was analysed using descriptive statistics, and kappa tests were used to determine agreement between reporting of high-risk practices in the risk assessment and behavioural survey. Results: During 2014–15, 471 individuals were targeted for enrolment; 341 were assessed for PrEP eligibility and 313 were enrolled. Of these, 303 (97%) identified as GBM. Overall, 85% of GBM met at least one high-risk criterion; 68% reported receptive intercourse with an HIV-positive or unknown status casual male partner, and 37% reported methamphetamine use in the three months preceding enrolment. The remaining 15% were enrolled based on medium-risk behaviours, or at the clinicians’ discretion. We found an 82% total agreement between self-reported high-risk behaviour and clinicians’ categorisation of GBM as being at high risk for HIV based on PrEP eligibility criteria. Conclusions: Behavioural eligibility criteria used by clinicians successfully identified individuals at high risk for HIV infection. This targeted approach ensures that the greatest public health and HIV prevention benefits can be derived in a setting without universal access to PrEP. [ABSTRACT FROM AUTHOR]

Rapid developments in the field of HIV pre-exposure prophylaxis (PrEP) with antiretrovirals offer a promise to bring HIV transmission among gay and other men who have sex with men (MSM) to zero by 2030. This review evaluates studies, which modelled the impact of PrEP on HIV diagnoses, and discusses the progress towards PrEP implementation. Studies in English, conducted after 2010 among MSM in countries of the Organization for Economic Cooperation and Development (OECD) were reviewed. Six modelling studies were included, three of which had been conducted outside the US. None of the published models showed that PrEP alone can reduce HIV diagnoses to zero and eliminate HIV transmission by 2030. However, PrEP in combination with other biomedical interventions can reduce HIV diagnoses on the population level by ~95%. Other upcoming biomedical prevention strategies may strengthen combination prevention. Access to PrEP remains limited, even in the OECD countries. Modelling studies can assist governments with decision-making about PrEP implementation and add urgency to the implementation of PrEP. More work is needed on modelling of the impact of PrEP on HIV diagnoses trends outside the US where PrEP implementation is in its early stages. [ABSTRACT FROM AUTHOR]

HIV ‘treatment as prevention’ (TasP) is highly effective in reducing HIV transmission in serodiscordant couples. There has been little examination of gay and bisexual men’s attitudes towards TasP, particularly regarding men’s willingness to act on beliefs about TasP. We conducted an online cross-sectional survey of Australian men in late 2012 to investigate knowledge and beliefs about new developments in HIV prevention. Amongst 839 men (mean age 39.5 years), men tended to disagree that TasP was sufficiently effective to justify reduced condom use, although HIV-positive men had more favourable attitudes. Only a minority of men were aware of any evidence for TasP; and one-quarter incorrectly believed that evidence for the effectiveness of TasP already existed for the homosexual population. One-fifth (20.5%) of men reported that they would be willing to have condomless anal intercourse with an opposite-status sexual partner when the HIV-positive partner was taking HIV treatments. Factors independently associated with such willingness were: HIV-positive serostatus, reporting any serodiscordant or serononconcordant condomless anal intercourse with a regular male partner in the previous six months, reporting any condomless anal intercourse with a casual male partner in the previous six months, and having greater beliefs in the effectiveness of TasP. This indicated that the men most willing to rely on TasP to prevent transmission were already engaging in higher risk practices. Biomedical HIV prevention represents a rapidly changing environment with new research as well as community and policy responses emerging at a fast pace. For men with serodiscordant sexual partners to successfully apply TasP to reducing transmission risk, more support and education is needed to enable better utilisation of TasP in specific relational and sexual contexts. [ABSTRACT FROM AUTHOR]

Background: Behavioural surveillance and research among gay and other men who have sex with men (GMSM) commonly relies on non-random recruitment approaches. Methodological challenges limit their ability to accurately represent the population of adult GMSM. We compared the social and behavioural profiles of GMSM recruited via venue-based, online, and respondent-driven sampling (RDS) and discussed their utility for behavioural surveillance. Methods: Data from four studies were selected to reflect each recruitment method. We compared demographic characteristics and the prevalence of key indicators including sexual and HIV testing practices obtained from samples recruited through different methods, and population estimates from respondent-driven sampling partition analysis. Results: Overall, the socio-demographic profile of GMSM was similar across samples, with some differences observed in age and sexual identification. Men recruited through time-location sampling appeared more connected to the gay community, reported a greater number of sexual partners, but engaged in less unprotected anal intercourse with regular (UAIR) or casual partners (UAIC). The RDS sample overestimated the proportion of HIV-positive men and appeared to recruit men with an overall higher number of sexual partners. A single-website survey recruited a sample with characteristics which differed considerably from the population estimates with regards to age, ethnically diversity and behaviour. Data acquired through time-location sampling underestimated the rates of UAIR and UAIC, while RDS and online sampling both generated samples that underestimated UAIR. Simulated composite samples combining recruits from time-location and multi-website online sampling may produce characteristics more consistent with the population estimates, particularly with regards to sexual practices. Conclusion: Respondent-driven sampling produced the sample that was most consistent to population estimates, but this methodology is complex and logistically demanding. Time-location and online recruitment are more cost-effective and easier to implement; using these approaches in combination may offer the potential to recruit a more representative sample of GMSM. [ABSTRACT FROM AUTHOR]

This editorial to the special issue of Sexual Health on antiretroviral-based prevention of HIV infection is dedicated to showcasing research and practice in this area. It aims to promote debate regarding the potential of new antiretroviral-based prevention approaches and the challenges encountered in moving prevention innovations into the community. This special issue covers the breadth of innovative HIV prevention research, including that undertaken in the fields of epidemiology, clinical research, social and behavioural science, public health and policy analysis, and with special emphasis on Asia and the Pacific region. Most importantly, it provides an indication of how the region is progressing towards embracing new prevention approaches to combat HIV epidemics across the region. [ABSTRACT FROM AUTHOR]

We aimed to describe the current use of antiretrovirals (ARVs) before unprotected anal intercourse (UAI) among Australian gay men, which may represent informal HIV preexposure prophylaxis (PrEP).Using data from Australian Gay Community Periodic Surveys conducted in 2011, we assessed the preventive use of ARVs before UAI and its association with sociodemographic characteristics, sexual practices, and drug use in the preceding 6 months. Associations were assessed using multivariate logistic regression analysis.Of 3677 sexually active non-HIV-positive men, 2.5% reported taking ARVs before UAI. The likelihood of ARV use before UAI was significantly higher if any of the following behaviors were also reported: >1 sex partner; UAI with casual partners, irrespective of reporting UAI with regular partners [adjusted odds ratio (AOR) = 2.36; 95% confidence interval (CI): 1.24 to 4.48] or not (AOR = 2.71; 95% CI: 1.44 to 5.07); injecting drugs at least monthly (AOR = 2.56; 95% CI: 1.03 to 6.36); using “party” drugs, occasionally (AOR = 2.23; 95% CI: 1.33 to 3.73) or regularly (AOR = 5.34; 95% CI: 2.99 to 9.56); and group sex while using party drugs, occasionally (AOR = 2.42; 95% CI: 1.29 to 4.53) or regularly (AOR = 5.31; 95% CI: 2.62 to 10.76). Among non-HIV-positive men in regular relationships with HIV-positive partners or partners of unknown HIV status, 1.7% and 4.7%, respectively, reported preventive ARV use before UAI.Our findings illustrate sporadic use of ARVs before UAI among gay men in Australia, which was associated with high-risk casual sex and party drug use. These initial data contribute to a much needed understanding of the informal use of ARVs for HIV prevention. [ABSTRACT FROM AUTHOR]

Gay men who request nonoccupational postexposure prophylaxis (PEP) may seek preexposure prophylaxis (PrEP) should this become available. We explored trends and predictors of PEP use among Australian gay men to inform future biomedical prevention programs.We used 2001-2010 data from Gay Community Periodic Surveys in 3 Eastern Australian states and assessed PEP awareness and use in the 6 months before each survey, and among HIV-uninfected men in all surveys predictors of PEP use. Analytical methods included chi-square test for trend and multivariate log-binomial estimation of associations.The awareness of PEP significantly increased from 23% in 2001 to 64% in 2010. PEP use also increased from 2.3% to 3.9%, respectively. PEP use was significantly associated with being in a regular relationship with an HIV-serodiscordant partner, higher number of sex partners, engaging in anal intercourse with casual partners, and regularly testing for HIV/sexually transmitted infections. However, fewer than 8% of men who engaged in these practices reported PEP use.Our findings highlight the profiles of current PEP users: men in HIV-serodiscordant relationships, and men having high numbers of casual partners and unprotected anal intercourse with them. These men are in need of effective HIV prevention strategies and may be receptive to preexposure prophylaxis in the future. Presently, targeted HIV education to improve risk assessment skills may prevent some seroconversions through the appropriate use of PEP. [ABSTRACT FROM AUTHOR]

Introduction: The effectiveness of daily pre-exposure prophylaxis (PrEP) is well established. However, there has been increasing interest in non-daily dosing schedules among gay and bisexual men (GBM). This paper explores preferences for PrEP dosing schedules among GBM at baseline in the PRELUDE demonstration project., Materials and Methods: Individuals at high-risk of HIV were enrolled in a free PrEP demonstration project in New South Wales, Australia, between November 2014 and April 2016. At baseline, they completed an online survey containing detailed behavioural, demographic, and attitudinal questions, including their ideal way to take PrEP: daily (one pill taken every day), event-driven (pills taken only around specific risk events), or periodic (daily dosing during periods of increased risk)., Results: Overall, 315 GBM (98% of study sample) provided a preferred PrEP dosing schedule at baseline. One-third of GBM expressed a preference for non-daily PrEP dosing: 20% for event-driven PrEP, and 14% for periodic PrEP. Individuals with a trade/vocational qualification were more likely to prefer periodic to daily PrEP [adjusted odds ratio (aOR) = 4.58, 95% confidence intervals (95% CI): (1.68, 12.49)], compared to individuals whose highest level of education was high school. Having an HIV-positive main regular partner was associated with strong preference for daily, compared to event-driven PrEP [aOR = 0.20, 95% CI: (0.04, 0.87)]. Participants who rated themselves better at taking medications were more likely to prefer daily over periodic PrEP [aOR = 0.39, 95% CI: (0.20, 0.76)]., Discussion: Individuals' preferences for PrEP schedules are associated with demographic and behavioural factors that may impact on their ability to access health services and information about PrEP and patterns of HIV risk. At the time of data collection, there were limited data available about the efficacy of non-daily PrEP schedules, and clinicians only recommended daily PrEP to study participants. Further research investigating how behaviours and PrEP preferences change correspondingly over time is needed., Trial Registration: ClinicalTrials.gov NCT02206555. Registered 28 July 2014.

Background: Prevalence of anxiety and mood disorders (AMDs) in HIV-infected individuals has varied widely because of the variety of measurements used and differences in risk factor profiles between different populations. We aimed to examine the relationship between HIV status and hospitalization for AMDs in gay and bisexual men (GBM)., Design and Methods: HIV-infected (n = 557) and HIV-uninfected (n = 1325) GBM recruited in Sydney, Australia were probabilistically linked to their hospital admissions and death notifications (2000-2012). Random-effects Poisson models were used to assess HIV risk factors for hospitalization. Cox regression methods were used to assess risk factors for mortality., Results: We observed 300 hospitalizations for AMDs in 15.3% of HIV-infected and 181 in 5.4% of HIV-uninfected participants. Being infected with HIV was associated with a 2.5-fold increase in risk of hospitalization for AMDs in GBM. Other risk factors in the HIV-infected cohort included previous hospitalization for HIV-related dementia, a more recent HIV diagnosis, and a CD4 T-cell count above 350 cells per cubic millimeter. Being hospitalized for an AMD was associated with a 5.5-fold increased risk of mortality; this association did not differ by HIV status. An association between substance use and mortality was observed in individuals hospitalized for AMDs., Conclusions: There is a need to provide more effective strategies to identify and treat AMDs in HIV-infected GBM. This research highlights the importance of further examination of the effects of substance use, neurocognitive decline, and AMDs on the health of HIV-infected individuals., Competing Interests: The authors have no financial, consultant, institutional or other relationships that might lead to bias or conflict of interest for this manuscript.

We explored seroguessing (serosorting based on the assumption of HIV seroconcordance) and casual unprotected anal intercourse (UAIC) associated with seroguessing. The ongoing Positive Health and Health in Men cohorts, Australia, provided data for trends in seroconcordant UAIC and HIV disclosure to sex partners. In event-level analyses, we used log-binomial regression adjusted for within-individual correlation and estimated prevalence rate ratios (PRRs) and 95% confidence intervals (95% CIs) for the association between the knowledge of a casual partner's seroconcordance and UAIC. UAIC and HIV disclosure significantly increased during 2001-2006. HIV-positive men knew partners were seroconcordant in 54% and assumed it in 13% of sex encounters (42 and 17% among HIV-negative men). Among HIV-positive men, the likelihood of UAIC was higher when a partner's status was known (Adjusted PRR = 5.17, 95% CI: 3.82-7.01) and assumed seroconcordant because of seroguessing (Adjusted PRR = 3.70, 95% CI: 2.56-5.35) compared with unknown. Among HIV-negative men, the likelihood of UAIC was also higher when a partner's status was known (Adjusted PRR = 1.88, 95% CI: 1.58-2.24) and assumed seroconcordant (Adjusted PRR = 2.12, 95% CI: 1.72-2.62) compared with unknown. As levels of UAIC remain high, seroguessing increasingly exposes gay men to the risk of HIV infection. Because both HIV-positive and HIV-negative men often seroguess, education and prevention programs should address the fact that HIV-negative men who engage in UAI due to this practice may be at high risk of HIV infection. HIV prevention should take into account these contemporary changes in behaviors, especially among HIV-negative gay men.

Objectives: We examined whether trends in HIV testing in community-based samples of homosexual men may account for the convergence in HIV notification rates in homosexual men across the eastern states of Australia., Methods: We examined data on self-reported HIV testing from annual cross-sectional, self-completed anonymous surveys of homosexual men conducted between 1998 and 2006 in Sydney, Melbourne and Brisbane. Men were recruited at gay community venues and events. Comparisons of HIV testing between the three cities and across time were carried out. We also compared reported rates of HIV testing across states in Private Lives, the 2005 online survey of health and wellbeing among non-heterosexual people., Results: Men recruited from clinics had a much higher prevalence of HIV testing and were excluded from further analyses. Among the 48 263 completed questionnaires obtained in non-clinic sites, there was a marked decline in the proportion of men who had never been tested for HIV in Sydney (from 8.1 to 5.1%, P trend < 0.001) and Brisbane (from 11.8 to 7.9%, P trend = 0.002) but no change in Melbourne. This proportion of men who had never been tested was lower in Sydney than in either Melbourne or Brisbane (P < 0.001). There were increases in the proportion of non-HIV-positive men who had been tested for HIV in the previous year across all three cities, although the proportion in Melbourne was lower than in the other two cities., Conclusion: These data suggest that changes in HIV testing rates among homosexual men are insufficient to account for the recent differences in trends in HIV notifications in eastern Australia.

Background: In Australia, the HIV epidemic is concentrated among gay men. In recent years, the number of new diagnoses stabilised in New South Wales (NSW), but increased in other states. We reviewed the trends in sexual behaviours to explain this difference., Methods: We used the Gay Community Periodic Surveys in NSW, Victoria and Queensland during 1998-2006 and restricted analyses to the 30-49 year olds who contribute most of the HIV cases. We used the chi(2)-test for trends in unprotected anal intercourse with casual partners (UAIC) and regular partners, number of partners, type of relationships, knowledge of HIV serostatus and its disclosure. We compared behaviours of HIV-positive and -negative men and men across states using logistic regression adjusted for the year of report., Results: Trends in behaviours differed across the states: following a period of increase, UAIC prevalence declined in NSW since 2001, but continued to increase in Victoria and Queensland. There were other changes in NSW that were not observed in Victoria and Queensland: a decline in factors increasing HIV risk (the proportions of men with multiple sex partners and men engaging in UAIC and not knowing or not disclosing HIV serostatus) and an increase in behaviours reducing it (the proportions of men in monogamous relationships and men disclosing HIV serostatus while having UAIC)., Conclusion: There were patterns of declining HIV risk behaviours in NSW, and increasing risk behaviours elsewhere, that mirrored recent changes in HIV case notifications in Australia. These data suggest that behavioural surveillance can predict changes in HIV epidemiology.