Multicentre double-blind randomised placebo-controlled trial evaluating the efficacy of the meningococcal B vaccine, 4CMenB (Bexsero), against Neisseria gonorrhoeae infection in men who have sex with men: the GoGoVax study protocol.

INTRODUCTION: Gonorrhoea, the sexually transmissible infection caused by Neisseria gonorrhoeae, has a substantial impact on sexual and reproductive health globally with an estimated 82 million new infections each year worldwide. N. gonorrhoeae antimicrobial resistance continues to escalate, and disease control is largely reliant on effective therapy as there is no proven effective gonococcal vaccine available. However, there is increasing evidence from observational cohort studies that the serogroup B meningococcal vaccine four-component meningitis B vaccine (4CMenB) (Bexsero), licensed to prevent invasive disease caused by Neisseria meningitidis, may provide cross-protection against the closely related bacterium N. gonorrhoeae. This study will evaluate the efficacy of 4CMenB against N. gonorrhoeae infection in men (cis and trans), transwomen and non-binary people who have sex with men (hereafter referred to as GBM+). METHODS AND ANALYSIS: This is a double-blind, randomised placebo-controlled trial in GBM+, either HIV-negative on pre-exposure prophylaxis against HIV or living with HIV (CD4 count >350 cells/mm3), who have had a diagnosis of gonorrhoea or infectious syphilis in the last 18 months (a key characteristic associated with a high risk of N. gonorrhoeae infection). Participants are randomised 1:1 to receive two doses of 4CMenB or placebo 3 months apart. Participants have 3-monthly visits over 24 months, which include testing for N. gonorrhoeae and other sexually transmissible infections, collection of demographics, sexual behaviour risks and antibiotic use, and collection of research samples for analysis of N. gonorrhoeae-specific systemic and mucosal immune responses. The primary outcome is the incidence of the first episode of N. gonorrhoeae infection, as determined by nucleic acid amplification tests, post month 4. Additional outcomes consider the incidence of symptomatic or asymptomatic N. gonorrhoeae infection at different anatomical sites (ie, urogenital, anorectum or oropharynx), incidence by N. gonorrhoeae genotype and antimicrobial resistance phenotype, and level and functional activity of N. gonorrhoeae-specific antibodies. ETHICS AND DISSEMINATION: Ethical approval was obtained from the St Vincent's Hospital Human Research Ethics Committee, St Vincent's Hospital Sydney, NSW, Australia (ref: 2020/ETH01084). Results will be disseminated in peer-reviewed journals and via presentation at national and international conferences. TRIAL REGISTRATION NUMBER: NCT04415424.

A proposal for a simplified measure of HIV preexposure prophylaxis prevention-effective adherence in self-report questionnaires.

Evaluating HIV preexposure prophylaxis (PrEP) use and HIV risk events concurrently remains challenging. We developed a single question method for measuring prevention-effective adherence with PrEP in self-report questionnaires. In a questionnaire completed by 409 gay and bisexual men, 46% reported condomless anal sex that was not covered by their own PrEP use, and this was more common among younger, lower-income participants. Refining this questionnaire item could improve measurement of prevention-effective adherence.

Sexual pleasure and HIV-related worry in female sex workers on oral pre-exposure prophylaxis in south-western Uganda.

BACKGROUND: Female sex workers (FSWs) contribute disproportionately to HIV transmission in Uganda, and pre-exposure prophylaxis (PrEP) is effective in preventing HIV among cisgender women. Psychological factors are important for PrEP uptake, but few studies have examined psychosocial changes due to PrEP use in Uganda. METHODS: In 2021, we recruited 524 FSWs in three Trans-African Highway towns and four fishing communities in south-western Uganda. We conducted structured interviews among women who were attending routine PrEP follow-up visits in six health units. Bivariable and multivariable modified regression using a robust covariance matrix estimator were used to identify factors associated with experiencing increased sexual pleasure and less worry about HIV because of PrEP. RESULTS: Overall, 80.9% participants reported that sex was more pleasurable because of taking PrEP. There were statistical trends for sex being more pleasurable when taking PrEP or when having condomless sex with casual paying partners (aPR=1.19, 95% CI=1.07-1.32, P =0.001). Almost three-quarters of the participants (76.3%) were less worried about getting HIV because of PrEP. Condomless sex with casual paying partners (aPR=1.17, 95% CI=1.05-1.31, P =0.032, P =0.003) and being On PrEP for the past 1-2years (aPR=1.18, 95% CI=1.00-1.38, P =0.032) was significantly associated with HIV-related worry (aPR=1.17, 95% CI=1.05-1.31, P =0.032, P =0.003) Conclusions : We found a positive impact of PrEP in Ugandan FSWs on two key psychosocial dimensions: (1) more pleasurable sex; and (2) less worry about acquiring HIV. Interventions aiming to increase PrEP uptake may find it useful to focus on psychosocial dimensions.

Human papillomavirus and p16INK4a in oropharyngeal squamous cell carcinomas: A systematic review and meta-analysis.

We intended to update human papillomavirus (HPV) prevalence and p16INK4a positivity in oropharyngeal squamous cell carcinomars (SCC), and calculate HPV attributable fraction (AF) for oropharyngeal SCC by geographic region. We searched Medline, Embase, and the Cochrane Library to identify published studies of HPV prevalence and p16INK4a positivity alone or together in oropharyngeal SCC before December 28, 2021. Studies that reported type-specific HPV DNA prevalence using broad-spectrum PCR-based testing methods were included. We estimated pooled HPV prevalence, type-specific HPV prevalence, and p16INK4a positivity. AF of HPV was calculated by geographic region. One hundred and thirty-four studies including 12 139 cases were included in our analysis. The pooled HPV prevalence estimate for oropharyngeal SCC was 48.1% (95% confidence interval [CI] 43.2-53.0). HPV prevalence varied significantly by geographic region, and the highest HPV prevalence in oropharyngeal SCC was noted in North America (72.6%, 95% CI 63.8-80.6). Among HPV positive cases, HPV 16 was the most common type with a prevalence of 40.2% (95% CI 35.7-44.7). The pooled p16INK4a positivity in HPV positive and HPV16 positive oropharyngeal SCC cases was 87.2% (95% CI 81.6-91.2) and 91.7% (84.3-97.2). The highest AFs of HPV and HPV16 were noted in North America at 69.6% (95% CI 53.0-91.5) and 63.0% (48.0-82.7). [Correction added on 31 October 2023, after first online publication: the percentage symbol (%) was missing and has been added to 63.0% (48.0-82.7) in the Abstract and Conclusion.] A significant proportion of oropharyngeal SCC was attributable to HPV. HPV16 accounts for the majority of HPV positive oropharyngeal SCC cases. These findings highlight the importance of HPV vaccination in the prevention of a substantial proportion of oropharyngeal SCC cases.

Trends in Testing and Self-Reported Diagnoses of Sexually Transmitted Infections in Gay and Bisexual Men in Australia, 2017 to 2021: Analysis of National Behavioral Surveillance Surveys.

BACKGROUND: Gay, bisexual, and other men who have sex with men (GBM) are overrepresented in diagnoses of sexually transmitted infections (STIs) relative to their population size. This study assessed trends in STI testing and diagnoses among GBM in Australia. METHODS: The Gay Community Periodic Surveys are repeated cross-sectional behavioral surveillance surveys of GBM. Participants reported the number of anal swabs, throat swabs, urine samples, and blood tests for syphilis they undertook in the last year. "Frequent comprehensive testing" was defined as ≥3 of each test in the previous year. Participants reported STI diagnoses of chlamydia, gonorrhea, syphilis, and other STIs in the last year. Trends in testing and diagnoses from 2017 to 2020 and 2020 to 2021 were assessed with logistic regression models. RESULTS: We analyzed 24,488 survey responses from participants reporting casual sex in the last 6 months. Between 2017 and 2020, frequent comprehensive STI testing decreased among HIV-negative GBM on preexposure prophylaxis (PrEP) from 71.7% to 68.9% and declined further to 58.6% in 2021. Frequent comprehensive STI testing was stable during 2017-2020 among HIV-negative/untested GBM not on PrEP (17.4%-14.6%) and HIV-positive GBM (30.4%-35.1%) but declined in 2021 to 7.5% among non-PrEP-users and 25.7% among HIV-positive participants. There were minimal changes in STI diagnoses during 2017-2020, but diagnoses declined in 2021. CONCLUSIONS: Many GBM do not meet Australian STI testing guidelines that recommend quarterly testing. Further evaluation of whether this recommendation is realistic or necessary to reduce STIs among GBM is recommended.

HIV treatment-as-prevention and its effect on incidence of HIV among cisgender gay, bisexual, and other men who have sex with men in Australia: a 10-year longitudinal cohort study.

BACKGROUND: Although HIV treatment-as-prevention reduces individual-level HIV transmission, population-level effects are unclear. We aimed to investigate whether treatment-as-prevention could achieve population-level reductions in HIV incidence among gay, bisexual, and other men who have sex with men (GBM) in Australia's most populous states, New South Wales and Victoria. METHODS: TAIPAN was a longitudinal cohort study using routine health record data extracted from 69 health services that provide HIV diagnosis and care to GBM in New South Wales and Victoria, Australia. Data from Jan 1, 2010, to Dec 31, 2019, were linked within and between services and over time. TAIPAN collected data from all cisgender GBM who attended participating services, resided in New South Wales or Victoria, and were 16 years or older. Two cohorts were established: one included HIV-positive patients, and the other included HIV-negative patients. Population prevalence of viral suppression (plasma HIV viral load <200 RNA copies per µL) was calculated by combining direct measures of viral load among the HIV-positive cohort with estimates for undiagnosed GBM. The primary outcome of HIV incidence was measured directly via repeat testing in the HIV-negative cohort. Poisson regression analyses with generalised estimating equations assessed temporal associations between population prevalence of viral suppression and HIV incidence among the subsample of HIV-negative GBM with multiple instances of HIV testing. FINDINGS: At baseline, the final sample (n=101 772) included 90 304 HIV-negative and 11 468 HIV-positive GBM. 59 234 patients in the HIV-negative cohort had two or more instances of HIV testing and were included in the primary analysis. Over the study period, population prevalence of viral suppression increased from 69·27% (95% CI 66·41-71·96) to 88·31% (86·37-90·35), while HIV incidence decreased from 0·64 per 100 person-years (95% CI 0·55-0·76) to 0·22 per 100 person-years (0·17-0·28). Adjusting for sociodemographic characteristics and HIV pre-exposure prophylaxis (PrEP) use, treatment-as-prevention achieved significant population-level reductions in HIV incidence among GBM: a 1% increase in population prevalence of viral suppression corresponded with a 6% decrease in HIV incidence (incidence rate ratio [IRR] 0·94, 95% CI 0·93-0·96; p<0·0001). PrEP was introduced in 2016 with 17·60% uptake among GBM that year, which increased to 36·38% in 2019. The relationship between population prevalence of viral suppression and HIV incidence was observed before the availability of PrEP (IRR 0·98, 95% CI 0·96-0·99; p<0·0001) and was even stronger after the introduction of PrEP (0·80, 0·70-0·93; p=0·0030). INTERPRETATION: Our results suggest that further investment in HIV treatment, especially alongside PrEP, can improve public health by reducing HIV incidence among GBM. FUNDING: National Health and Medical Research Council of Australia.

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.

Second Primary Cancers in People With HIV/AIDS: A National Data Linkage Study of Incidence and Risk Factors.

BACKGROUND: Evidence regarding the characteristics of second primary cancer (SPC) in people living with HIV (PLWHIV) is limited. SETTING: We performed a national population-based data linkage study to determine the incidence and risk factors of SPC in PLWHIV in Australia between 1982 and 2012. METHODS: We conducted a probabilistic data linkage study to compare the incidence of SPC over time, defined using HIV treatment eras, for SPCs related to oncogenic viral infection in comparison with non-infection-related SPCs. Risk factors considered included age at diagnosis of cancer, sex, HIV exposure modality, and CD4 + count. RESULTS: Of 29,383 individuals diagnosed with HIV, 3123 individuals who developed a first primary cancer were included in the analysis. Among them, 229 cases of SPC were identified across 27,398 person-years of follow-up. The most common SPCs were non-Hodgkin lymphomas (n = 71, 31%). The incidence of SPC overall did not change over time; however, there was an increase in individuals diagnosed with HIV in later eras ( P trend =0.001). The incidence of non-infection-related SPC increased over time and was associated with older age ( P trend = 0.005) and the acquisition of HIV in later eras ( P trend <0.001). Conversely, the incidence of infection-related SPC decreased ( P trend <0.001), but this was no longer significant after adjustment for age ( P trend = 0.14). CONCLUSIONS: The risk of SPC in PLWHIV in Australia remains high, with a temporal increase observed in non-infection-related cancer, likely due to aging of the population. Optimal screening and prevention strategies for SPC in PLWHIV are increasingly important.

Identifying Patterns of Discontinuing and Recommencing Pre-exposure Prophylaxis in the Context of Sexual Behavior Among Gay and Bisexual Men in Australia.

We mapped gay and bisexual men's (GBM) patterns of using pre-exposure prophylaxis (PrEP) over time and explored sexual behavior as PrEP use changed. We conducted semi-structured interviews between June 2020 and February 2021 with 40 GBM living in Australia who had changed their PrEP use since initiating. There was considerable diversity in patterns of discontinuation, suspension, and recommencement of PrEP. Reasons for changing PrEP use mostly centered on accurate perceived changes to HIV risk. Twelve participants reported condomless anal intercourse with casual or fuckbuddy partners after discontinuing PrEP. These sex events were unanticipated, condoms were not a preferred option, and other risk reduction strategies were applied inconsistently. Service delivery and health promotion can support safer sex among GBM when PrEP use fluctuates by promoting event-driven PrEP and/or non-condom-based risk reduction methods during periods off daily PrEP, and guiding GBM to better recognize changing circumstances of risk and when to recommence PrEP.

Performance of Human Papillomavirus Attribution Algorithms to Predict Causative Genotypes in Anal High-Grade Lesions.

BACKGROUND: Gay and bisexual men (GBM) are at increased risk of human papillomavirus (HPV)-associated anal high-grade squamous intraepithelial lesions (HSILs). Understanding the fractions of HSILs attributable to HPV genotypes is important to inform potential impacts of screening and vaccination strategies. However, multiple infections are common, making attribution of causative types difficult. Algorithms developed for predicting HSIL-causative genotype fractions have never been compared with a reference standard in GBM. METHOD: Samples were from the Study of the Prevention of Anal Cancer. Baseline HPV genotypes detected in anal swab samples (160 participants) were compared with HPV genotypes in anal HSILs (222 lesions) determined by laser capture microdissection (LCM). Five algorithms were compared: proportional, hierarchical, maximum, minimum, and maximum likelihood estimation. RESULTS: All algorithms predicted HPV-16 as the most common HSIL-causative genotype, and proportions differed from LCM detection (37.8%) by algorithm (with differences of -6.1%, +20.9%, -20.4%, +2.9%, and +2.2% respectively). Fractions predicted using the proportional method showed a strong positive correlation with LCM, overall (R = 0.73 and P = .002), and by human immunodeficiency virus (HIV) status (HIV positive, R = 0.74 and P = .001; HIV-negative, R = 0.68 and P = .005). CONCLUSIONS: Algorithms produced a range of inaccurate estimates of HSIL attribution, with the proportional algorithm performing best. The high occurrence of multiple HPV infections means that these algorithms may be of limited use in GBM.

Discontinuation of government subsidized HIV pre-exposure prophylaxis in Australia: a whole-of-population analysis of dispensing records.

INTRODUCTION: HIV pre-exposure prophylaxis (PrEP) has been government subsidized in Australia since April 2018 and while uptake is high among men who have sex with men, rates of discontinuation are also high. The aims of this study were to examine the impact of discontinuation on overall PrEP usage, the proportion of PrEP users who discontinue and the predictors of discontinuation. METHODS: We used linked de-identified dispensing records of all government subsidized PrEP in Australia between April 2018 and September 2021: a whole-of-population data set. Defining discontinuation as 180 days or more without PrEP after the final dispensed supply, we calculated the number of people who discontinued at each 6-month interval during the study period, the proportion who had discontinued 2 years after the first supply and, using Cox regression, predictors of discontinuation. RESULTS: Of 49,164 people dispensed PrEP (98.5% male, median age 34 years), 40.3% (19,815) had discontinued by September 2021. Within 2 years of their first supply, 11,150 (37.7%) of 29,549 PrEP users had discontinued, including 10.0% after a single dispensed supply. Large variations were observed, particularly according to prescriber characteristics: discontinuation was higher among people prescribed PrEP by low caseload (≤10 patients) prescribers (61.2%) than by high caseload (>100 patients) prescribers (31.1%, p<0.001), and by prescribers practising in areas with low estimated prevalence (<1.0%) of gay men (64.1%) than high (>5%) prevalence (36.7%, p<0.001). Women and younger people were more likely to discontinue, while patients receiving a higher level of government subsidy were less likely. The independent predictors of discontinuation with the greatest effect size were female sex (adjusted hazards ratio [aHR] 2.99, p<0.001), low estimated gay prevalence of prescriber location (aHR 1.98, p<0.001) and low prescriber PrEP caseload (aHR 1.79, p<0.001). CONCLUSIONS: There are high rates of PrEP discontinuation in Australia and some populations are at increased risk of discontinuation. Strategies are needed to support persistence on PrEP and the re-starting of PrEP during periods of risk.

Characteristics of Human Immunodeficiency Virus (HIV) Seroconversions in a Large Prospective Implementation Cohort Study of Oral HIV Preexposure Prophylaxis in Men Who Have Sex with Men (EPIC-NSW).

BACKGROUND: Most human immunodeficiency virus (HIV) seroconversions in people who have initiated preexposure prophylaxis (PrEP) occur in the context of insufficient adherence. We describe participants who seroconverted after being dispensed PrEP in a large PrEP implementation study in Australia. METHODS: Expanded PrEP Implementation in Communities in New South Wales was an implementation study of daily oral PrEP in individuals aged ≥18 years at high risk for acquiring HIV. HIV seroconversions were defined as a positive HIV test by either antigen, antibody, or detectable HIV viral load after enrollment. Insufficient adherence, measured by dispensing logs or participant self-report, was defined as <4 PrEP doses per week. RESULTS: A total of 9596 participants were enrolled and dispensed PrEP between 1 March 2016 and 30 April 2018; 30 were diagnosed with HIV by 31 March 2019. The median (interquartile range [IQR]) age was 31 (25-38) years, all identified as male, 29 (97%) identified as gay or homosexual, and 20 (69%) lived in a postcode with a low concentration of gay male residents. The median (IQR) days from first PrEP dispensing to diagnosis was 409 (347-656). There was no evidence that participants who seroconverted had been sufficiently adherent to PrEP. Nineteen (63%) participants who seroconverted were diagnosed with chlamydia, gonorrhoea, syphilis, or new hepatitis C infection. One participant had resistance to emtricitabine (M184V mutation) at diagnosis. CONCLUSIONS: Participants who seroconverted were insufficiently adherent to PrEP despite being at high risk for acquiring HIV. Understanding the reasons for poor PrEP adherence in individuals who subsequently acquire HIV is critical to improving PrEP effectiveness.

Self-reported and pill count measures of adherence to oral HIV PrEP among female sex workers living in South-Western Uganda.

BACKGROUND: Female sex workers (FSWs) in Uganda are at high risk of HIV infection. Scaling up oral pre-exposure prophylaxis (PrEP) will reduce HIV incidence if high levels of adherence are maintained. This study evaluates PrEP adherence using clinic-based pill counts and self-reported measures, and factors associated with protective levels of adherence. METHODS: Participants were sex workers who had been taking PrEP for at least 5 months and were attending routine follow-up visits for PrEP care in fishing communities and along the Trans-African Highway. Participants who had a pill count showing at least 85% use since their last clinic visit and those who reported taking their PrEP every day in the last 5 months were categorised as having 'protective adherence'. Spearman's correlation and weighted kappa assessed the relationship between pill count and self-reported measures. Bivariate and multivariate logistic regression was used to determine factors associated with protective adherence as measured by pill count. RESULTS: We recruited 524 FSWs, with a median age of 29 years (IQR 23-35). Participants were recruited from fishing communities and Trans-African Highway towns (n = 297, 56.7%, and n = 227, 43.0%). Nearly three quarters (n = 372, 71.0%) of women were estimated to have protective adherence based on pill count (i.e., a pill count of >85%) and 50.4% by self-report in last 3 months. There was a strong positive association between self-reported measures and pill count measures (rest = 0.6453, 95% CI = 0.5924-0.6927) and a moderate agreement between self-reported measures and pill count measures, κ = 0.544 (95%CI = 0.4869-0.6011, p < 0.001). Factors associated with protective adherence included being aged 35 years or older (aOR = 2.40, 95% CI = 1.17-4.86), living in a fishing community (aOR = 1.45, 95% CI = 0.62-3.38), and having an STI in last 3 months (aOR = 1.64, 95% CI = 1.07-2.49). CONCLUSION: Our findings indicate that PrEP-experienced FSWs attending clinical follow-up visits reported high protective levels of oral pre-exposure prophylaxis, as measured by both pill count and self-reported measures, and a moderate agreement between pill count and self-reported measures.

Experiences of recently HIV-diagnosed gay and bisexual migrants in Australia: Implications for sexual health programmes and health promotion.

Gay and bisexual migrants from low- and middle-income countries living in high-income countries are disproportionately diagnosed with HIV. Most research focuses on preventing HIV acquisition among HIV-negative migrant gay and bisexual men (GBM). This study is uniquely positioned to report on migrant GBM's experiences and needs at and after an HIV diagnosis. Semi-structured interviews were conducted with 24 migrant GBM diagnosed at sexual health clinics in Australia from 2017 onwards. Interviews were analysed using a codebook thematic analysis. Due to the stigma of HIV and homosexuality in their countries of origin, about half of participants had poor HIV knowledge prior to diagnosis. Absorbing diagnosis information was consequently difficult, and feelings of shame, hopelessness, lost sexual opportunities and infectiousness were common. However, many were thankful for the comprehensive clinical support they received and believed that over time life would 'normalise' with sustained undetectable viral load. None reported that their clinician stigmatised them, but the anticipation of stigma nonetheless infused their experiences after diagnosis. Many were selective about HIV disclosure, and some mentioned that clinic systems posed a risk to confidentiality. Non-permanent residents were concerned about the impacts of HIV status on future visa applications. We recommend that newly HIV-diagnosed migrant GBM receive referral to legal and culturally appropriate migration services to help absorb what a diagnosis might mean for their health and visa status. We also recommend sexual health clinics continue to assess confidentiality in their systems. Health promotion initiatives should highlight to migrant GBM that high-HIV caseload sexual health clinicians provide confidential and comprehensive care.

Increased awareness of event-driven PrEP and knowledge of how to use it: results from a cross-sectional survey of gay and bisexual men in Australia.

BACKGROUND: Recent changes to Australian PrEP prescribing guidelines support the use of event-driven pre-exposure prophylaxis (ED-PrEP) to prevent HIV among gay and bisexual men (GBM). Social marketing campaigns to increase awareness of ED-PrEP were conducted in early 2021. This study aimed to assess the awareness and knowledge of this method after these campaigns. METHODS: We conducted a national cross-sectional online survey about PrEP knowledge and attitudes from March to May 2021. Participants were asked if they had heard of ED-PrEP. Among aware participants, questions about the '2-1-1' method were asked to assess knowledge. Bivariate and multivariate logistic regression analyses were conducted to assess the characteristics of those who were aware of ED-PrEP, and those who had correct knowledge of ED-PrEP. Analysis was restricted to non-HIV-positive cis-GBM who were aware of PrEP. RESULTS: Among the 419 participants eligible for this analysis, 286 (68.3%) had heard of ED-PrEP. Awareness was associated with living in a postcode with ≥10% gay men, PrEP experience, and belief ED-PrEP is effective. Of these 286 participants, 125 (43.7%) correctly answered questions about how to take ED-PrEP. Correct knowledge was associated with PrEP experience and belief ED-PrEP is effective. CONCLUSIONS: A growing proportion of GBM are aware of ED-PrEP, but many still do not know how to take it as per clinical guidelines. More work is needed to increase knowledge among GBM to promote effective use of this method.

Sustaining sexual and reproductive health through COVID-19 pandemic restrictions: qualitative interviews with Australian clinicians.

BACKGROUND: The sexual and reproductive health care of people with HIV and those at risk of HIV has largely been delivered face-to-face in Australia. These services adapted to the coronavirus disease 2019 (COVID-19) pandemic with a commitment to continued care despite major impacts on existing models and processes. Limited attention has been paid to understanding the perspectives of the sexual and reproductive health care workforce in the research on COVID-19 adaptations. METHODS: Semi-structured interviews were conducted between June and September 2021 with 15 key informants representing a diverse range of service settings and professional roles in the Australian sexual and reproductive health sector. Inductive themes were generated through a process of reflexive thematic analysis, informed by our deductive interest in clinical adaptations. RESULTS: The major adaptations were: triage (rapidly adapting service models to protect the most essential forms of care); teamwork (working together to overcome ongoing threats to service quality and staff wellbeing), and the intwined themes of telehealth and trust (remaining connected to marginalised communities through remote care). Despite impacts on care models and client relationships, there were sustained benefits from the scaleup of remote care, and attention to service safety, teamwork and communication. CONCLUSIONS: Attending to the experiences of those who worked at the frontline of the COVID-19 response provides essential insights to inform sustained, meaningful system reform over time. The coming years will provide important evidence of longer-term impacts of COVID-19 interruptions on both the users and providers of sexual and reproductive health services.

The acceptability and usability of two HIV self-test kits among men who have sex with men: a randomised crossover trial.

OBJECTIVES: To compare the usability and acceptability of oral fluid- and blood-based HIV self-test kits among men who have sex with men in Australia. DESIGN: Randomised crossover trial. SETTING, PARTICIPANTS: Gay, bisexual, and other men aged 18 years or older who have sex with men, who attended two metropolitan sexual health clinics in Sydney and Melbourne, 7 January - 10 December 2019. MAIN OUTCOME MEASURES: Ease of use of HIV self-test kits; preferred HIV self-test type; difficulties encountered during HIV self-testing. RESULTS: 170 men were recruited (median age, 34 years; interquartile range, 29-43 years); 144 identified as gay (85%), 96 were born outside Australia (57%). Participants were more likely to report the oral fluid HIV self-test was easy to use than the blood-based self-test (oral fluid, 99%; blood, 86%; odds ratio [OR], 3.0; 95% confidence interval [CI], 1.4-6.6). The oral fluid test was preferred by 98 participants (58%; 95% CI, 50-65%), the blood-based test by 69 (41%; 95% CI, 33-48%). Difficulties with the oral fluid test kit identified by observing nurses included problems placing the buffer solution into the stand (40 of 170 participants, 24%) and not swabbing both gums (23 of 169, 14%); difficulties with the blood-based test kit included problems filling the device test channel (69 of 170, 41%) and squeezing the finger firmly enough to generate a blood drop (42 of 170, 25%). No participant received an invalid result with the oral fluid self-test; two of 162 participants (1%) received invalid results with the blood self-test. After adjusting for age, education level, and ethnic background, characteristics associated with higher odds of using HIV self-testing in the future were overseas birth (adjusted OR, 3.07; 95% CI, 1.42-6.64), and self-evaluated ease of use and confidence in using the kits. CONCLUSION: It is important to provide options for obtaining both oral fluid- and blood-based HIV self-tests. The usability and acceptability of both kits were high, but the ease of use and perceived accuracy influenced test kit preference.

Comparison of four assays for human papillomavirus detection in the anal canal.

OBJECTIVE: Anal cancer is preceded by high-risk human papillomavirus (HRHPV) infection, predominantly HPV16. No HPV assay is licenced for use in anal screening. We aimed to determine the sensitivity and specificity of four anal canal swab HPV assays to predict high-grade squamous epithelial lesions (HSIL). METHODS: In a cohort of Australian HIV-positive and negative gay and bisexual men, we compared the sensitivity and specificity of detection of 13 anal HRHPV genotypes by Linear Array (LA), Cobas 4800, EuroArray, and Anyplex II HPV28 (+ and ++ cut offs), compared their ability to predict prevalent anal HSIL, and compared anal canal HRHPV detection with HRHPV isolated from HSIL using laser capture microdissection (LCM). RESULTS: A total of 475 participants had baseline results available for all four assays (166, 35.0% HIV positive), and 169 participants had a diagnosis of cytological and/or histological HSIL. The HPV16 and any HRHPV detection were highest with Anyplex II HPV28 (+) (156, 32.8% 95% CI 28.6-37.2 and 359, 75.6%, 95% CI 71.5-79.4, respectively). For detection of concurrent HSIL and HPV16, the assay sensitivity was similar, ranging from 49.1%, 95% CI 41.4-56.9 (Anyplex II HPV28 ++) to 55.0%, 95% CI 47.2-62.7 (Anyplex II HPV28 +). For concurrent HSIL and any HRHPV detection, EuroArray was more specific than Anyplex II HPV28 (+) (45.9% 95% CI 40.2-51.7 vs 36.7%, 95% CI 31.3-42.4, p = 0.021) and had comparable specificity with Anyplex II HPV28 (++) (45.9% vs 47.2%, 95% CI 41.5-53.0, p = 0.75). All assays had high sensitivities for predicting HPV16 detected on LCM (92.5-97.5%). Anyplex II HPV28 and EuroArray were significantly more sensitive than LA for lesions caused by non-HPV16 HRHPV types on LCM. DISCUSSION: Anyplex II HPV28 and EuroArray detected more non-16 HRHPV genotypes than LA. Increasing the Anyplex II HPV28 cutoff improved specificity without compromising sensitivity for detection of concurrent HSIL.

Scaling up preexposure prophylaxis to maximize HIV prevention impact.

PURPOSE OF REVIEW: Ten years since the first regulatory approval of oral HIV preexposure prophylaxis (PrEP), this review summarizes PrEP uptake, the role of ambitious PrEP targets, emerging evidence of impact on the HIV epidemic and innovative approaches to increasing PrEP uptake. RECENT FINDINGS: PrEP uptake among people at risk of HIV has been slow, but has accelerated in recent years, particularly in gay and bisexual men in a limited number of high-income settings and recently in heterosexuals at risk of HIV in sub-Saharan Africa. However, UNAIDS 2020 PrEP targets and HIV prevention targets were missed by large margins. Although UNAIDS testing and treatment targets have galvanised public health action, in contras, PrEP targets have been lower profile and insufficiently ambitious. Parts of the USA, Australia and the UK with high PrEP coverage have demonstrated striking reductions in HIV infection at the population level, as PrEP is introduced at scale. Scaling up PrEP uptake will require innovations in PrEP promotion, simplified models of care, improved adherence interventions, improved choice in the form of longer-acting PrEP and interventions to ensure that all those who can benefit from PrEP can access it. SUMMARY: PrEP is a revolutionary HIV prevention tool, which if ambitiously scaled up could drive HIV transmission towards elimination. Highly publicized and ambitious PrEP targets could help drive this.