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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]

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]

Background : Rapid HIV testing was introduced at 12 clinics in New South Wales (NSW) for routine testing and promoted with social marketing. The effect of the availability of rapid HIV testing on testing frequency among gay and bisexual men (GBM) was evaluated. Methods : An observational design using patient data from 12 clinics was used. The primary outcome was the mean number of HIV tests in 12 months. The intervention group comprised GBM who had one or more rapid tests from October 2013 to September 2014 and this was compared with two control groups; a concurrent group (no rapid test in the same period) and a historical group (attended between July 2011 and June 2012). Independent sample t -tests were conducted to compare mean number of tests among men in the intervention, concurrent and historical groups. Multivariate logistic regression was used to assess the association between rapid HIV testing and testing frequency. Results : Men in the intervention group (n = 3934) had a mean of 1.8 HIV tests in 12 months, compared with 1.4 in the concurrent group (n = 5063; P 0.001) and 1.4 in the historical group (n = 5904; P 0.001); testing frequency was higher among men at increased risk of HIV in the intervention group compared with the other two groups (mean 2.2, 1.6 and 1.5 respectively; P 0.001). Membership of the intervention group was associated with increased odds of having two or more HIV tests in 12 months (AOR = 2.5, 95%CI 2.2–2.8; P 0.001) compared with the concurrent group, after controlling for demographic and behavioural factors. Conclusion : Introducing and promoting rapid HIV testing in clinics in NSW was associated with increased HIV testing frequency among GBM. [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.