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Adequate adherence to pre-exposure prophylaxis (PrEP) is critical to prevent HIV infection, but accurately measuring adherence remains challenging. We compared two biological [blood drug concentrations in plasma and peripheral blood mononuclear cells (PBMC)] and two self-reported measures (facilitated recall to clinicians and self-report in online surveys) and identified predictors of daily PrEP adherence among gay and bisexual men (GBM) in their first 12 months on PRELUDE, an open-label, single-arm PrEP demonstration project in New South Wales, Australia. 327 participants were enrolled; 263 GBM attended their 12-month follow-up visit (81% retention). Overall, 91% of blood samples had plasma drug concentrations indicative of taking 7 pills/week, and 99% had protective drug concentrations (≥ 4 pills/week). Facilitated recall to clinicians identified 99% of participants with protective adherence as measured by PBMC drug concentrations. Daily adherence measured by facilitated recall was associated with behavioural practices including group sex (aOR 1.33, 95% CI 1.15–1.53, p < 0.001). Retained participants maintained high adherence to daily PrEP over 12 months, confirmed by four different measures. Facilitated recall to clinicians is a suitable measure for assessing PrEP adherence in populations engaged in care where there is established trust and rapport with patients. Trial registration: ClinicalTrials.gov NCT02206555. [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]

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 and Aims: Gay, bisexual and other men who have sex with men (GBM) use alkyl nitrites ('poppers') at higher rates than other populations to functionally enhance sexual experiences. Their use has been associated with HIV sexual risk behaviours including receptive anal sex. We investigate the prevalence, frequency, and motivations for poppers use and their relationship with HIV risk. We also discuss the implications of the recent scheduling changes to poppers by the Australian Therapeutic Goods Administration.Methods: Data were drawn from the Following Lives Undergoing Change (Flux) study, a prospective observational study of licit and illicit drug use among GBM. Between 2014 and 2018, 3273 GBM enrolled in the study. In 2018, 1745 GBM provided data relating to frequency of and motivations for poppers use and were included in this analysis.Results: Median age was 33 years (IQR 25-46) and 801 GBM (45.9%) had used poppers in the previous six months ('recent use'). Among these men, 195 (24.3%) had used them weekly or more frequently. Most recent users (77.4%) reported using poppers for a 'buzz' during sex or to facilitate receptive anal intercourse (60.8%). The majority (57.7%) of HIV-negative men reporting recent poppers use were concurrently taking HIV pre-exposure prophylaxis. Recent poppers use was independently associated with receptive anal intercourse with casual partners (aOR 1.71; 95%CI 1.35-2.16) and chemsex (aOR 4.32; 95%CI 3.15-5.94). Poppers use was not associated with anxiety, depression, or drug-related harms. Only 15.4% of current users indicated they would stop using poppers if they were criminalised; 65.0% said they would 'find other ways' to obtain them.Conclusions: Poppers are commonly used by Australian GBM to functionally enhance sexual experiences, particularly to facilitate receptive anal intercourse. Few men experienced drug-related harms from poppers use. Regulatory changes must ensure potential harms from popper use are minimised without increasing barriers to access or perpetuating stigma. [ABSTRACT FROM AUTHOR]