Factors Associated With Willingness to Use Daily Antibiotics as Sexually Transmitted Infection Prophylaxis Among HIV Preexposure Prophylaxis-Experienced Gay and Bisexual Men in Australia.

BACKGROUND: Gay and bisexual men (GBM) who use HIV preexposure prophylaxis (HIV-PrEP) have high rates of bacterial sexually transmitted infections (STIs). The use of daily antibiotics as STI preexposure prophylaxis (STI-PrEP) may be appealing to GBM who are using or have previously used HIV-PrEP (HIV-PrEP-experienced) for the prevention of bacterial STIs. METHODS: We examined willingness to use daily STI-PrEP among a cross-sectional sample of HIV-PrEP-experienced GBM in Australia who participated in an observational online cohort study from August 2018 to March 2020. Factors associated with willingness to use daily STI-PrEP were determined using bivariate and multivariate logistic regression. RESULTS: Of the 1347 participants, half (54.3%) were willing to use daily STI-PrEP. Factors independently associated with greater willingness to use daily STI-PrEP included having >10 sexual partners in the last 6 months, using methamphetamine in the last 6 months, being more conscious about avoiding STIs, having a greater number of STIs since commencing HIV-PrEP, being willing to take HIV-PrEP for as long as they were at risk of acquiring HIV, and only using condoms when a sexual partner requested them. Conversely, factors associated with less willingness to use daily STI-PrEP included being university educated, using nondaily dosing regimens of HIV-PrEP, preferring event-driven HIV-PrEP, and being concerned about long-term HIV-PrEP adverse effects. CONCLUSIONS: Sexually transmitted infection PrEP is likely to be appealing to many HIV-PrEP-experienced GBM, especially those who engage in activities associated with a higher risk of STI transmission. However, they are less likely to be willing to use STI-PrEP unless it aligns with their HIV-PrEP dosing regimen, suggesting that research into the safety and efficacy of alternative STI prophylaxis dosing options should be prioritized.

Predictors of Daily Adherence to HIV Pre-exposure Prophylaxis in Gay/Bisexual Men in the PRELUDE Demonstration Project.

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.

High Adherence to HIV Pre-exposure Prophylaxis and No HIV Seroconversions Despite High Levels of Risk Behaviour and STIs: The Australian Demonstration Study PrELUDE.

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.

Expanded HIV pre-exposure prophylaxis (PrEP) implementation in communities in New South Wales, Australia (EPIC-NSW): design of an open label, single arm implementation trial.

BACKGROUND: The New South Wales (NSW) HIV Strategy 2016-2020 aims for the virtual elimination of HIV transmission in NSW, Australia, by 2020. Despite high and increasing levels of HIV testing and treatment since 2012, the annual number of HIV diagnoses in NSW has remained generally unchanged. Pre-exposure prophylaxis (PrEP) is highly effective in preventing HIV infection among gay and bisexual men (GBM) when taken appropriately. However, there have been no population-level studies that evaluate the impact of rapid PrEP scale-up in high-risk GBM. Expanded PrEP Implementation in Communities in NSW (EPIC-NSW) is a population-level evaluation of the rapid, targeted roll-out of PrEP to high-risk individuals. METHODS: EPIC-NSW, is an open-label, single-arm, multi-centre prospective observational study of PrEP implementation and impact. Over 20 public and private clinics across urban and regional areas in NSW have participated in the rapid roll-out of PrEP, supported by strong community mobilization and PrEP promotion. The study began on 1 March 2016, aiming to enroll at least 3700 HIV negative people at high risk of HIV. This estimate took into consideration criteria for PrEP prescription in people at high risk for acquiring HIV as defined in the NSW PrEP guidelines. Study participants receive once daily co-formulated tenofovir disoproxil fumarate and emtricitabine (TDF/FTC) and are followed for up to 24 months. Follow-up includes: testing for HIV at 1 month, HIV and other sexually transmissible infections three-monthly, HCV annually and monitoring of renal function six-monthly. Optional online behavioural surveys are conducted quarterly. The co-primary endpoints are (i) HIV diagnoses and incidence in the cohort and (ii) HIV diagnoses in NSW. DISCUSSION: EPIC-NSW is a population-based PrEP implementation trial which targets the entire estimated population of GBM at high risk for HIV infection in NSW. It will provide a unique opportunity to evaluate the population impact of PrEP on a concentrated HIV epidemic. TRIAL REGISTRATION: https://clinicaltrials.gov/ (identifying number NCT02870790 ; registration date 14 August 2016), pre-results stage.

Correction: expanded HIV pre-exposure prophylaxis (PrEP) implementation in communities in new South Wales, Australia (EPIC-NSW): design of an open label, single arm implementation trial.

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".

Preexposure Prophylaxis of HIV Infection: the Role of Clinical Practices in Ending the HIV Epidemic.

PURPOSE OF REVIEW: The aim of this study is to summarise the recent evidence from high-income settings about providers' ability to deliver on the UNAIDS goal of at least three million people at substantial risk of HIV infection with PrEP by 2020, including awareness and knowledge about PrEP, willingness to prescribe PrEP, current levels of prescribing and service delivery models and issues. RECENT FINDINGS: Awareness about PrEP among health providers is growing, but at different pace depending on provider type. HIV and sexual health specialists are more likely to have knowledge about PrEP than generalists, and to be willing to prescribe it, mainly because of their closer contact with people at high risk for HIV and better risk assessment skills. There is still no consensus as to who should be responsible for providing PrEP, but clearly all hands on deck will be useful in delivering on the international target of three million people at substantial risk for HIV on PrEP by 2020. Only about 5% of the target has been reached so far. Local guidance and large-scale education and information programs for clinicians will be necessary to upskill health providers. High cost of PrEP is still a major barrier for its broad implementation, even in countries were PrEP roll-out has started. Health services are facing major structural challenges due to implementation of PrEP services to a substantial volume of patients. The early implementation experiences demonstrated that PrEP can be successfully delivered across a variety of settings, and a broad range of strategies and models of care can streamline PrEP delivery. Education of the providers and PrEP cost solutions will be essential for rapid roll-out of PrEP.

The Meaning of 'Regular Partner' in HIV Research Among Gay and Bisexual Men: Implications of an Australian Cross-Sectional Survey.

Estimates of the proportion of HIV infections coming from within regular sexual relationships among gay and bisexual men (GBM) vary widely. Research surveys use various partner type categories, but there is little understanding of how men classify their partners. We conducted an online cross-sectional survey of Australian GBM exploring sexual relationships, including 2057 men reporting on 2566 regular partnerships. Just over half of the partnerships were considered 'relationships', while the remainder were non-romantic 'fuckbuddy'-style arrangements. In multivariable analysis, factors associated with considering the partnership a 'relationship' were: using a 'romantic' descriptor, partnership length, monogamous agreements, any condomless anal sex with each other, love, and commitment. The category of 'regular partner' can mask diverse partnership types, which have different meanings to GBM, associated behaviours, and HIV risks. Certain HIV prevention techniques may be more suited to particular types of partnerships. 'Fuckbuddy' arrangements need to be more explicitly acknowledged in HIV prevention.

Patterns of Drug Use and Drug-related Hospital Admissions in HIV-Positive and -Negative Gay and Bisexual Men.

We aimed to compare rates of illicit drug-related hospitalisations in HIV-negative (HIV-ve) (n = 1325) and HIV-positive (HIV+ve) (n = 557) gay and bisexual men (GBM) with rates seen in the general male population and to examine the association between self-reported illicit drug use and drug-related hospitalisation. Participants were asked how often they used a range of illicit drugs in the previous 6 months at annual interviews. Drug-related hospital admissions were defined as hospital admissions for mental or behavioural disorders due to illicit drug use (ICD 10: F11-16, F18, F19), drug poisoning (T40-T45, T50) or toxic effect of gases (T53, T59, T65). Drug-related hospitalisations were 4.8 times higher in the HIV-ve cohort [SIR 4.75 (95 % CI 3.30-6.91)] and 3.5 times higher in the HIV+ve cohort [SIR 3.51 (1.92-5.88)] compared with the general population. Periods of weekly drug use [IRR 1.86 (1.01-3.46)], poly-drug use [IRR 2.17 (1.07-4.38)] and cannabis use [low use-IRR 1.95 (1.01-3.77), high use-IRR 2.58 (1.29-5.16)] were associated with drug-related hospitalisation in both cohorts, as was being a consistently high meth/amphetamine user throughout follow-up [IRR 3.24 (1.07-9.83)] and being an inconsistent or consistent injecting drug user throughout follow-up [IRR 3.94 (1.61-9.66), IRR 4.43(1.04-18.76), respectively]. Other risk factors for drug-related hospitalisation indicated the likelihood of comorbid drug and mental health issues in GBM hospitalised for drug use.

At home and away: gay men and high risk sexual practices.

We aimed to describe HIV risk practices of gay men who travel locally, regionally and overseas. We analysed data from the Sydney Gay Community Periodic Survey 2009 about high-risk sexual practices in four locations (locally, while travelling in NSW, Australia and overseas) and with partners of HIV positive, negative and unknown serostatus in each location. Analyses of associations used generalized log-binomial estimation procedures with Type I error of 5 %. Of 1,839 sexually active participants, 70.1 % reported having sex locally. 19.7 % elsewhere in NSW, 20.1 % interstate and 18 % overseas. Unprotected anal intercourse (UAI) was reported by 29.9, 28.6, 21.3 and 19.3 % of men in each location respectively. There was no difference in the levels of UAI locally and elsewhere in NSW, but UAI levels were lower in other Australian locations [adjusted prevalence rate ratio (APRR) = 0.76; 95 % confidence interval (95 % CI) 0.66-0.88] and overseas (APRR = 0.76; 95 % CI 0.65-0.89). UAI was more likely if partners were seroconcordant HIV positive (APRR = 1.67; 95 % CI 1.32-2.11) and less likely if partners were of different HIV serostatus (APRR = 0.39; 95 % CI 0.33-0.47) as compared to seroconcordant HIV negative partners. UAI was associated with group sex and use of party drugs. In this community sample, UAI levels were higher in the local context than in travel destinations, suggesting that familiarity between partners may play a role. High-risk sexual practices can nevertheless contribute to bridging different HIV epidemics and HIV transmission across borders. HIV prevention programs should develop effective approaches to target sexually adventurous gay men and HIV transmission associated with travel.

Understanding of norms regarding sexual practices among gay men: literature review.

Since there is little evidence about gay community norms across the world, we reviewed published literature in this area and discuss implications for prevention and research. Eight databases were searched for articles and 16 were considered suitable for analysis. All used quantitative methodology and seven were based on a published theoretical framework. The most common theory employed by four out of the seven papers was the Theory of Reasoned Action. All papers reviewed examined norms on condom use but norms on other risk reduction practices were not explored in these papers. Seven (44 %) studies found those men who perceived strong social support from their peers, were less likely to engage in unprotected anal intercourse. This finding suggests that social support from partners and community members plays a role in shaping safe sex norms. Better understanding of norms may help to redress HIV behaviour change programmes, particularly at the time when HIV diagnoses rates are increasing in most gay communities across the world.

Changes in gay men's participation in gay community life: implications for HIV surveillance and research.

Successful antiretroviral treatments, achievements in gay acceptance and human rights, and internet use have prompted changes in gay socialising which create potential challenges for engaging with gay men for HIV surveillance and research. We used data from the Australian behavioural surveillance and explored (i) the relationship between community engagement and HIV related practices, and (ii) time trends in gay men's engagement with the gay community. Analyses were conducted using log-binomial regression and chi-square test for trend. The proportion of men who socialized mainly with gay men declined and the Internet use to connect with sex partners increased over time. Gay social engagement was associated with HIV positive serostatus, unprotected anal intercourse with regular partners and a high frequency of HIV/STI testing. Our findings indicate a shift in how gay men socialise and find partners. We discuss the challenges for ongoing engagement with gay men for behavioural surveillance and HIV research.

Rates of condom and non-condom-based anal intercourse practices among homosexually active men in Australia: deliberate HIV risk reduction?

OBJECTIVE: Three decades into the HIV epidemic and with the advancement of HIV treatments, condom and non-condom-based anal intercourse among gay men in resource-rich countries needs to be re-assessed. METHODS: The proportions of men engaging in a range of anal intercourse practices were estimated from the ongoing cross-sectional Gay Community Periodic Surveys in six states in Australia from 2007 to 2009. Comparisons were made between HIV-negative men, HIV-positive men with an undetectable viral load and those with a detectable viral load. RESULTS: Condoms play a key role in gay men's anal intercourse practices: 33.8% of HIV-negative men, 25.1% of HIV-positive men with an undetectable viral load and 22.5% of those with a detectable viral load reported consistent condom use with all male partners in the 6 months before the survey. Among HIV-negative men, the second largest group were men who had unprotected anal intercourse (UAI) only in the context of HIV-negative seroconcordant regular relationships. Among HIV-positive men, the second largest group was men who had UAI in casual encounters preceded by HIV status disclosure to some, but not all, casual partners. CONCLUSIONS: A minority, yet sizeable proportion, of men consistently engaged in a number of UAI practices in specific contexts, suggesting they have adopted deliberate HIV risk-reduction strategies. While it is important that HIV behavioural prevention continues to reinforce condom use, it needs to address both the challenges and opportunities of the substantial uptake of non-condom-based risk-reduction strategies.

Casual sexual encounters among gay men: familiarity, trust and unprotected anal intercourse.

Familiarity with and a history of prior sex with casual partners is associated with unprotected anal intercourse and may increase the risk of HIV transmission among gay men. Using data from the Sydney Gay Community Periodic Survey 2007, we explored the relationship between familiarity and unprotected anal intercourse with the last casual partner (UAI-LC). 51% of the men knew their last casual partner and 49% had previously had sex with him. Men were more inclined to engage in UAI-LC if they had previously had sex with this partner. HIV-negative men were more likely to have UAI-LC with a more familiar partner independent of his serostatus. Familiarity with and a previous history of sex between casual partners may result in a false sense of trust and may increase the risk of HIV transmission. HIV prevention services should address this issue and develop programs to improve men's skills in negotiating safer sex.

Increases in unprotected anal intercourse with serodiscordant casual partners among HIV-negative gay men in Sydney.

Prevalence of unprotected anal intercourse between casual male partners (UAIC) has been increasing worldwide. We explored trends in serodiscordant UAIC and the associated factors among gay men in Sydney. Proportions of HIV-positive and negative men with serodiscordant casual partners increased during 2003-2006. Prevalence of serodiscordant UAIC increased among HIV-negative men. Age, number of partners, seeking partners online, drug use and esoteric practices were associated with serodiscordant UAIC. Increases in serodiscordant UAIC may be related to growing disclosure. These findings do not indicate a core group of high-risk men. More research is needed about the context in which serodiscordant UAIC happens.

Alcohol use, intimate partner violence, sexual coercion and HIV among women aged 15-24 in Rakai, Uganda.

Disinhibition due to alcohol may induce intimate partner violence and sexual coercion and increased risk of HIV infection. In a sample of 3,422 women aged 15-24 from the Rakai cohort, Uganda, we examined the association between self-reported alcohol use before sex, physical violence/sexual coercion in the past and prevalent HIV, using adjusted odds ratios (Adj OR) and 95% confidence intervals (95% CI). During the previous year, physical violence (26.9%) and sexual coercion (13.4%) were common, and alcohol use before sex was associated with a higher risk of physical violence/sexual coercion. HIV prevalence was significantly higher with alcohol consumption before sex (Adj OR = 1.45, 95% CI: 1.06-1.98) and especially when women reported both prior sexual coercion and alcohol use before sex (Adj OR = 1.79, 95% CI: 1.25-2.56). Alcohol use before sex was associated with physical violence and sexual coercion, and both are jointly associated with HIV infection risk in young women.

Gay men's current practice of HIV seroconcordant unprotected anal intercourse: serosorting or seroguessing?

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.

Getting pre-exposure prophylaxis (PrEP) to the people: opportunities, challenges and examples of successful health service models of PrEP implementation.

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.

The estimated number of potential PrEP users among gay-identifying men who have sex with men in Australia.

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.

Likely impact of pre-exposure prophylaxis on HIV epidemics among men who have sex with men.

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.

How partnership type and HIV seroconcordance affect HIV transmission risk in regular sexual partnerships: a cross-sectional survey of Australian gay and bisexual men.

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.