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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]

After publication of the article [1], it has been brought to our attention that one of the members of the EPIC-NSW study group has had their name spelt incorrectly in the acknowledgements. The article mentions "Muhammad Hammoud" when in fact the correct spelling is "Mohamed Hammoud". [ABSTRACT FROM AUTHOR]