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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. [ABSTRACT FROM AUTHOR]

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]

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]

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]

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 : 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]