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.

Interim position statement on doxycycline post-exposure prophylaxis (Doxy-PEP) for the prevention of bacterial sexually transmissible infections in Australia and Aotearoa New Zealand - the Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine (ASHM).

Recent studies have provided evidence for the effectiveness of using doxycycline (Doxy-PEP) to prevent bacterial sexually transmissible infections (STI), namely chlamydia, gonorrhoea, and syphilis, among gay, bisexual, and other men who have sex with men who have experienced multiple STIs. However, there remain several unanswered questions around potential adverse outcomes from Doxy-PEP, including the possibility of inducing antimicrobial resistance in STIs and other organisms, and the possibility of disrupting the microbiome of people who choose to use Doxy-PEP. This interim position statement from the Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine aims to outline the current evidence for Doxy-PEP, and to highlight potential adverse outcomes, to enable clinicians to conduct evidence-based conversations with patients in Australia and Aotearoa New Zealand who intend to use Doxy-PEP.

Low Prior Exposure and Incidence of Hepatitis C in Human Immunodeficiency Virus-Negative Gay and Bisexual Men Taking Preexposure Prophylaxis (PrEP): Findings From the Expanded PrEP Implementation in Communities-New South Wales Prospective Implementation Study.

BACKGROUND: The use of preexposure prophylaxis (PrEP) for the prevention of human immunodeficiency virus (HIV) has raised concerns of increased sexual risk behaviors. These behaviors may be associated with increased incidence of sexually acquired hepatitis C virus (HCV) among gay and bisexual men. METHODS: The Expanded PrEP Implementation in Communities-New South Wales (EPIC-NSW) study was a cohort study of daily coformulated tenofovir disoproxil fumarate and emtricitabine for HIV prevention. We recruited 9596 people at high risk of HIV acquisition from 31 clinics across New South Wales and the Australia Capital Territory in Australia. We report prior exposure to HCV and incidence in this cohort between 2016 and 2019. RESULTS: At least 1 HCV test result was available for 8658 (90.2%) participants. These individuals had a median age of 34 years (interquartile range, 28-43), most of whom were male (8530, 98.5%), identified as gay (7944, 91.8%), and were born in Australia (51.8%). Prior exposure to HCV was detected among 81 participants at baseline (0.9%; 95% confidence interval [CI]: .71.2). Twenty of 8577 participants were diagnosed with incident infection (rate 0.2/100 person-years [95% CI: .1-.3/100 person-years]). They were significantly older (median age 41 years vs 34 years, P = .044), and more likely to report methamphetamine use at baseline (incidence rate ratio, 2.7 [95% CI: 1.00-7.2]) than those without incident infection. CONCLUSIONS: In this population of PrEP users, HCV prior exposure and incidence were low. With high levels of HCV and HIV testing and treatment, the dual goals of HIV and HCV elimination could be achieved in this population. Clinical Trials Registration: number NCT02870790.

Overcoming barriers to HIV pre-exposure prophylaxis (PrEP) coverage in Australia among Medicare-ineligible people at risk of HIV: results from the MI-EPIC clinical trial.

Background Overseas-born people who are ineligible for government-subsidised health care experience barriers to accessing HIV pre-exposure prophylaxis (PrEP) in Australia. This study aimed to assess a program providing free PrEP to overseas-born adults at risk of acquiring HIV. Methods Medicare-Ineligible Expanded Implementation in Communities (MI-EPIC) was a single-arm, open-label trial of daily tenofovir disoproxil fumarate/emtricitabine as PrEP. Six clinics recruited Medicare-ineligible adults who met HIV risk criteria in New South Wales, Australia. We recorded data on HIV and sexually transmitted infection (STI) diagnoses, and PrEP dispensing from July 2019 to June 2020. PrEP adherence as a medication possession ratio (MPR) was calculated as pills dispensed divided by days. We administered an optional survey on behaviours and attitudes to PrEP and sexual health. Results The 221 participants (206 men; 93.2%) had a median age of 29years (IQR 26-34). Participants were mostly born in Asia (53.4%), Latin America or the Caribbean (25.3%), or Europe (10.9%). Adherence was high; 190 participants (86.0%) had an MPR of >60%. Of 121 survey participants, 42 (34.7%) completed the survey in a language other than English. Of participants who had not used PrEP in the 6months before enrolment (n=45, 37.2%), the most common reasons were cost (n=22, 48.9%), and lack of knowledge about accessing PrEP (n=20, 44.4%). Conclusions Medicare-ineligible people at risk of HIV demonstrate high adherence when given access to free PrEP and translated information. Increasing PrEP awareness and reducing barriers to accessing PrEP in this high-risk population should be priorities in HIV prevention.

Cross-sectional study of sexual behaviour and health of gay and bisexual men in suburban Sydney, New South Wales, Australia: contrasts between sex venue and clinic attendees.

Background In Australia, men-who-have-sex-with-men (MSM) have higher rates of sexually transmissible infections (STIs) and HIV compared with heterosexual men. We compared demographics, behaviour and HIV/STI prevalence for MSM attending a sex-on-premises-venue (SOPV) or the local sexual health clinic (SHC) to determine key differences. METHODS: Men attending a SOPV during onsite HIV/STI screening from November 2015 for 12 months were compared with MSM attending a local SHC for screening. Each group completed a self-administered questionnaire and STI/HIV testing. Data analysis was performed using SPSS. RESULTS: Compared with SHC participants (n = 108), SOPV participants (n = 84) had a higher median age (47 years [range, 22-88] vs 33 years [range, 19-71]; P < 0.001) and less likely to report previous HIV testing (73% vs 89%; P < 0.01), STI testing (60% vs 90%; P < 0.001) or be vaccinated for hepatitis A (32% vs 65%; P < 0.001) or hepatitis B (35% vs 73%; P < 0.001). SOPV participants were more likely to be married, widowed or have a long-term female partner (39% vs 7%; P < 0.001) and have a higher prevalence of urethral and rectal chlamydia (7% vs 1%; P = 0.02 and 8% vs 2%; P = 0.03, respectively). There was no significant difference between the groups for detection of syphilis (4% vs 9%), gonorrhoea (5% vs 9%) or HIV (1% vs 0%). CONCLUSION: MSM attending the SOPV had higher anogenital chlamydial prevalence compared with those attending the SHC. They reported higher rates of sex with female partners, which may facilitate STI/HIV transmission to heterosexual populations. Our findings have implications for HIV/STI service provision, contact tracing and local health promotion initiatives.

Prevalence of sexually transmissible infections and HIV in men attending sex-on-premises venues in Australia: a systematic review and meta-analysis of observational studies.

Background In Australia, men who have sex with men (MSM) have high rates sexually transmissible infections (STIs) and sex-on-premises venue (SOPV) patrons are at risk. This paper assesses Neisseria gonorrhoeae (NG), Chlamydia trachomatis (CT), syphilis and HIV prevalence in men tested at Australian SOPVs and describes testing services. METHODS: EMBASE, Medline, PubMed and international conference proceedings were searched for articles reporting on-site SOPV testing between 1 January 2000 and 31 January 2017. Meta-analysis calculated pooled prevalence estimates of STIs by anatomical site. RESULTS: Twelve cross-sectional studies were identified. Most (8/12) were local sexual health clinics (SHC) outreach services. Participants' mean age was 41.1 years (95% confidence interval (CI) 37.0-43.3; range 17 to 84 years). Testing included CT and NG (9/12), HIV (8/12) and syphilis (5/12). CT and NG prevalence overall summary estimates were 3.4% (95% CI 1.9-5.2%, I2 = 88.7%, P < 0.01) and 1.3% (95% CI 0.7-2.2%, I2 = 75.5%, P < 0.01) respectively. CT and NG prevalence was highest in the ano-rectum and oro-pharynx respectively. The HIV and syphilis pooled estimates were 2.3% (95% CI 1.6-2.9%, I2 = 93.1%, P < 0.01) and 3.2% (95% CI 1.8-4.6%, I2 = 72.8%, P < 0.01) respectively. Participation rate varied. CONCLUSION: This review examines HIV and STI testing in Australian SOPVs before HIV pre-exposure prophylaxis (PrEP). Findings indicate a high prevalence of STIs. PrEP use and resultant condomless sex may influence STI prevalence. Further research is required to determine the effect of PrEP on the STI prevalence among SOPV patrons.

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.

ADOPTing a new method of partner management for genital chlamydia in New South Wales: findings from a pilot implementation program of patient-delivered partner therapy.

Background Patient-delivered partner therapy (PDPT) for chlamydia is an effective and safe additional partner management strategy. Some Australian regulatory changes have been made to support PDPT, but implementation guidance is lacking. This paper describes a pilot implementation program of PDPT in New South Wales (NSW), the Australian Development and Operationalisation of Partner Therapy (ADOPT). METHODS: ADOPT involved: (1) clarification of the NSW PDPT legal and policy framework; (2) development and implementation of PDPT service models, resources and data collection tools for select publicly funded sexual health services (PFSHS) and Family Planning (FP) NSW clinics; and (3) evaluation of PDPT uptake. RESULTS: PDPT can be undertaken in NSW if accompanied by adequate provider, patient and partner information. Regulatory amendments enabled medication prescribing. The pilot implementation took place in four PFSHS and five FPNSW clinics from January to December 2016. In PFSHS, 30% of eligible patients were offered PDPT and 89% accepted the offer. In FPNSW clinics, 42% of eligible patients were offered PDPT and 63% accepted the offer. Most partners for whom PDPT was accepted were regular partners. CONCLUSIONS: A close collaboration of researchers, policy makers and clinicians allowed successful implementation of a PDPT model for chlamydia in heterosexual patients at select PFSHS and FPNSW clinics, providing guidance on its use as standard of care. However, for the full public health benefits of PDPT to be realised, it must be implemented in general practice, where most chlamydia is diagnosed. Further work is recommended to explore feasibility, develop guidelines and promote the integration of PDPT into general practice.

A national study of the clinical management of HIV-positive women in Australia: what are the successes and where are the gaps?

Background Women comprise ~10% of people living with HIV in Australia, so are often underrepresented in research. METHODS: This study invited clinicians providing care to women living with HIV to complete an anonymous survey containing questions related to four key areas: HIV (including diagnosis, treatment and virological outcomes), reproductive health (including sexual activity, contraception, pregnancy and outcomes) and linkage and retention in care. RESULTS: In total, 484 surveys were received, with responses from all states and territories. Most women living with HIV in Australia are on treatment (>90%) and virologically suppressed (>90% have a viral load <50 copies mL-1). Almost 75% of women have had at least one switch in treatment (with toxicity almost as common as simplification as the indication). Treatment interruption is also relatively common, but is more likely the longer a woman has been diagnosed, if she is on benefits (P = 0.007) and is the primary carer of children without a partner (P = 0.001). In Australia, women living with HIV are a diverse heterogeneous group, with over 70 different countries of birth and almost half speaking a language other than English at home. Mental health diagnosis was the most common co-morbid condition identified. A total of 21% of women were post-menopausal, with 42% reporting symptoms to their healthcare provider, but only 17% were receiving treatment for symptoms attributed to menopause. CONCLUSIONS: As well as strategies to support women vulnerable to treatment interruption, important areas for future investment in research and clinical care include co-morbid mental health and menopause symptoms and treatment.

Evaluation of the Deadly Liver Mob program: insights for roll-out and scale-up of a pilot program to engage Aboriginal Australians in hepatitis C and sexual health education, screening, and care.

BACKGROUND: Deadly Liver Mob (DLM) is a peer-driven, incentivised health promotion program aimed at increasing understanding of hepatitis C, promoting harm reduction in relation to injecting drug use, and linking participants to screening for hepatitis C, other blood borne viruses and sexually transmissible infections among Aboriginal people in Western Sydney, NSW. This paper presents the evaluation of a pilot study examining the acceptability of the program as a first step of a scalability assessment. METHODS: Deadly Liver Mob operated in co-located needle and syringe programs and sexual health clinics in two sites: (Site 1: two and a half years for 2 days/week; Site 2: 1 year for 1 day per week). Comparisons were made of the proportion of Aboriginal clients (Site 1) and occasions of service provided to Aboriginal clients (Site 2) in the 12 months prior and post-introduction of DLM. Interviews were conducted with 13 staff involved in delivery of DLM and with 19 clients. RESULTS: A total of 655 and 55 Aboriginal clients, respectively, attended Site 1 and Site 2 for health education. The proportion of Aboriginal clients attending both sites was significantly higher during the DLM compared with prior to its implementation. Of those attending for health education, 79 and 73%, respectively, attended screening following education. DLM clients strongly endorsed the program. Some staff were concerned about workforce capacity to effectively engage Aboriginal clients with multiple and complex needs, managing the differing aims of the participating services involved, and about offering of incentives for attendance at health services. CONCLUSION: While acceptability was high among staff and clients and preliminary results show high engagement with Aboriginal communities, this evaluation of a pilot program raises some issues to consider in scale up of DLM to other sites. The initiation of additional DLM sites should address issues of alignment with governing strategies and workforce capacity.

A Case-Control Study in Primary Care Settings on the Roles of Dermatoscopy in Infectious Diseases Affecting the Skin, Part 1: Viral and Bacterial Infections.

We aimed to investigate roles of dermatoscopy in skin infections, with Part 1 of our report covering viral and bacterial infections. A case-control study was conducted on the medical records of all patients with skin infections who had had dermatoscopy performed over a period of 3 months. Our control participants were all patients with skin infections in two 3-month periods, and sex-pair-matched patients with the same infections, who had not undergone dermatoscopy. Records of 523 study subjects were analyzed. Our first new finding was that dermatoscopy brought forward the diagnosis of herpes zoster by 1.62 days (95% confidence interval [CI] 0.29 to 0.34 days; z-score -2.18). Second, dermatoscopy facilitated the diagnosis of genital (P<.01) and small extragenital risk ratio [RR] 1.28, 95% CI 1.03 to 1.59) viral warts. Third, patients with genital herpes and/or genital warts and/or genital molluscum contagiosum diagnosed by clinical examination and dermatoscopy were significantly more willing to pay US$300 to investigate for other sexually transmitted infections (STIs) (RR 2.52, 95% CI 1.32 to 3.18), and bring partners for investigation (RR 1.32, 95% CI 1.12 to 1.55), compared to patients diagnosed by clinical examination alone. We performed dermatoscope-guided laser ablation on viral warts, and dermatoscopy-guided excisional biopsy to confirm molluscum contagiosum. We conclude that dermatoscopy contributes to the diagnosis of some viral and bacterial infections. In addition, it may modify the help-seeking behaviour of patients with STIs.

Human Papillomavirus Prevalence in Unvaccinated Heterosexual Men After a National Female Vaccination Program.

Background: In Australia, high uptake of the quadrivalent human papillomavirus (4vHPV) vaccine has led to reductions in the prevalence of human papillomavirus (HPV) genotypes 6, 11, 16, and 18 in women and girls aged ≤25 years. We evaluated the impact of the program impact on HPV prevalence in unvaccinated male subjects. Methods: Sexually active heterosexual male subjects aged 16-35 years were recruited in 2014-2016. Participants provided a self-collected penile swab sample for HPV genotyping (Roche Linear Array) and completed a demographic and risk factor questionnaire. Results: The prevalence of 4vHPV genotypes among 511 unvaccinated male subjects was significantly lower in those aged ≤25 than in those aged >25 years: 3.1% (95% confidence interval, 1.5%-5.7%) versus 13.7% (8.9%-20.1%), respectively (P < .001); adjusted prevalence ratio, 0.22 (.09-.51; P < .001). By contrast, the prevalence of high-risk HPV genotypes other than 16 and 18 remained the same across age groups: 16.8% (95% confidence interval, 12.6%-21.9%) in men aged ≤25 years and 17.9% (12.4%-25.0%) in those aged >25 years (P = .76); adjusted prevalence ratio, 0.98, (.57-1.37; P = .58). Conclusions: A 78% lower prevalence of 4vHPV genotypes was observed among younger male subjects. These data suggest that unvaccinated men may have benefited from herd protection as much as women from a female-only HPV vaccination program with high coverage.

An express sexual health service: in and out in a jiffy.

Objectives The aims of the present study were to assess client satisfaction with existing services, gauge the interest in an express service option and to compare waiting times before and after the introduction of an express service. Methods A survey evaluating satisfaction with existing services, waiting times and interest in an express service was offered to all clients attending the Western Sydney Sexual Health Centre in May 2013. A pilot of the express service ran from May to December 2013, and a follow-up survey was conducted in December 2013. Results There was a high level of interest in the express service. Median waiting times and satisfaction with waiting times improved following introduction of the express clinic. A high level of satisfaction was reported in those who had used the express service. Conclusions The express service was well received by clients and has the potential to improve client waiting times, increase clinic capacity and improve the overall client journey through the clinic. What is known about the topic? Express service options for testing for sexually transmitted infections (STIs) are being introduced both in Australia and overseas. Express services have been shown to increase clinic capacity and can create cost savings. They appear to be acceptable to clients. What does this paper add? This paper demonstrates that an express service option can be successfully introduced in an at-risk multicultural population. What are the implications for practitioners? The present study helps show that new models can be successfully introduced into long-standing traditional service models. Such models can help improve efficiency, clinic capacity and may produce cost savings. An express clinic is an option for screening asymptomatic clients for STIs. Clients complete a self-collected history and take self-collected specimens, and clinician-collected blood tests and throat swabs are advised accordingly.

The rise of targeted HIV oral rapid testing in Australia.

OBJECTIVE: To assess the performance and acceptability of the OraQuick Advance Rapid HIV-1/2 Antibody Test (ORT) in Australia. DESIGN, PARTICIPANTS AND SETTING: Cross-sectional study of 1074 men who have sex with men (MSM) and individuals aged 18 years or older at high risk of acquiring HIV infection who attended five public HIV or sexual health services, two general practices and one community clinic in Sydney from 1 January to 31 December 2013. INTERVENTION: One ORT confirmed by fourth-generation HIV enzyme immunoassay (EIA). MAIN OUTCOME MEASURES: ORT sensitivity and specificity compared with EIA; acceptabiity of the ORT to participants. RESULTS: 83.5% of participants were MSM, 90.3% were aged under 50 years, and 9% had never been tested for HIV. There were 11 true-positive ORT results, two false-negative (non-reactive) results (both were early infections), and one false-positive (reactive) result (due to reader error). Sensitivity and specificity were 84.6% and 99.8%, respectively (compared with a sensitivity of 99.3% and specificity of 99.8% listed by the manufacturer). Three quarters of participants (74.0%; 730/987) found the ORT less stressful than venous sampling. Those who usually had tests at intervals of greater than 3 months deemed the ORT less stressful than those who had quarterly tests (77.5% v 64.8%; P<0.001). Nearly all participants (99.2%; 998/1006) would have an ORT again and 99.4% (994/1000) would recommend it to peers. Most participants (69.1%; 720/1042) felt ORT approval by Australia's Therapeutic Goods Administration (TGA) would encourage testing. CONCLUSION: ORT sensitivity is reduced in early HIV infection. The test is highly acceptable and less stressful than venous sampling. Participants are keen to be tested with the ORT in future, would recommend it to peers and would have tests more frequently if the ORT were licensed. TGA approval of this test might slow increasing HIV infection rates among MSM and others by facilitating diagnosis and treatment.

Updating the management of sexually transmitted infections.

The control of sexually transmitted infections relies on case-finding and treatment of sexual contacts to prevent further transmission. Screening for infections should be tailored to the demographic and sexual risk of the individual. For most sexually transmitted infections, screening is performed on self-collected, non-invasive samples using highly sensitive molecular assays. These are quick and inexpensive. Shorter courses of antivirals for genital herpes are now recommended. New chemoprophylactic strategies for preventing HIV transmission have emerged, including treatment to prevent transmission and the use of antiretrovirals for pre-exposure prophylaxis.

Engaging hard-to-reach men-who-have-sex-with-men with sexual health screening: Qualitative interviews in an Australian sex-on-premises-venue and sexual health service.

CONTEXT: Compared with the general population in Australia, men-who-have-sex-with-men (MSM) have higher rates of HIV and sexually transmissible infections (STIs). Despite widespread advice to test regularly, a minority of these men remain "hard to reach." We undertook qualitative interviews with a group of such men in Sydney to better understand their views and experiences in relation to sexual health screening. METHODS: We conducted semi-structured interviews with men engaging with HIV/STI screening services at a sex-on-premises-venue and the local Sexual Health Service in Greater Western Sydney. We analyzed these data for content and themes. RESULTS: Sexual behaviors and identities were diverse, often discordant and compartmentalized from everyday lives. Overall, reported HIV/STI knowledge was poor and men did not see themselves at risk of HIV/STIs regardless of sexual behavior. Men took calculated risks and balanced with pleasure and escapism. Reasons for avoidance of testing included fear, unwillingness to disclose behavior, privacy concerns, and perceived low risk. Men viewed sexual health care as distinct from general health care. Service delivery preferences varied by service venue. Participants highlighted convenience, confidentiality, and trust as critical factors for a testing service. CONCLUSION: A variety of testing options are needed to engage hard-to-reach MSM. Opportunities to enhance testing may include expanding health messaging, demystifying testing, and delinking sexual identity from sexual behavior and risk, thus promoting advantages of testing and establishing testing as standard of care.

Human papillomavirus prevalence and risk factors among Australian women 9-12 years after vaccine program introduction.

BACKGROUND: In Australia, high and widespread uptake of the quadrivalent human papillomavirus (HPV) vaccine has led to substantial population-level reductions in the prevalence of quadrivalent vaccine targeted HPV genotypes 6/11/16/18 in women aged ≤ 35 years. We assessed risk factors for HPV detection among 18-35 year old women, 9-12 years after vaccine program introduction. METHODS: Women attending health services between 2015 and 2018 provided a self-collected vaginal specimen for HPV genotyping (Roche Linear Array) and completed a questionnaire. HPV vaccination status was validated against the National Register. Adjusted odds ratios (aORs) and 95% confidence intervals (CI) were calculated for factors associated with HPV detection. RESULTS: Among 1564 women (median age 24 years; IQR 21-27 years), Register-confirmed ≥ 1-dose vaccine coverage was highest at 69.3% and 68.1% among women aged 18-21 and 22-24 years respectively, decreasing to 42.9% among those aged 30-35 years. Overall prevalence of quadrivalent vaccine-targeted HPV types was very low (2.0%; 95% CI: 1.4-2.8%) and influenced only by vaccination status (5.5% among unvaccinated compared with 0.7% among vaccinated women; aOR = 0.13 (95% CI: 0.05-0.30)). Prevalence of remaining HPV types, at 40.4% (95% CI: 38.0-42.9%), was influenced by established risk factors for HPV infection; younger age-group (p-trend < 0.001), more recent (p < 0.001) and lifetime sexual partners (p-trend < 0.001), but not vaccination status. Prevalence of HPV31/33/45, which shared risk factors with that of non-vaccine targeted HPV types, was also lower among vaccinated (4%) compared with unvaccinated (7%) women (aOR = 0.51; 95% CI: 0.29-0.89), indicative of cross-protection. CONCLUSION: Vaccination has changed the epidemiology of HPV infection in Australian women, having markedly reduced the prevalence of vaccine-targeted types, including amongst women with known risk factors for infection. Vaccinated women appear to be benefiting from modest cross-protection against types 31/33/45 afforded by the quadrivalent HPV vaccine. These results reinforce the importance of HPV vaccination.

Long-term protection from HIV infection with oral HIV pre-exposure prophylaxis in gay and bisexual men: findings from the expanded and extended EPIC-NSW prospective implementation study.

BACKGROUND: Daily pre-exposure prophylaxis (PrEP) is effective in preventing HIV, but few long-term data are available on effectiveness and adherence in real-world settings. Here, we report trends in HIV incidence over 3 years in individuals at high risk who were prescribed PrEP in New South Wales (NSW), as well as adherence before the transition to subsidised PrEP. METHODS: Expanded PrEP Implementation in Communities-New South Wales (EPIC-NSW) was a pragmatic, prospective, single-arm, implementation study of daily, oral PrEP in 31 sites (sexual health clinics, general practices, and a hospital) in NSW, Australia. Eligible participants were HIV-negative adults (aged ≥18 years) who were at high risk of HIV infection as defined in local PrEP guidelines. Participants were prescribed coformulated (once-daily, oral tablet) tenofovir disoproxil fumarate (300 mg) and emtricitabine (200 mg) as HIV PrEP and were followed up with HIV testing, sexually transmitted infection testing, and PrEP dispensing. Originally planned for 3700 participants followed for 1 year, the study was expanded so that all eligible participants in the state could obtain PrEP and extended until publicly subsidised PrEP became available in Australia. The primary outcome was new HIV infection among all participants who were dispensed PrEP at least once and had at least one follow-up HIV test result. Adherence was estimated by medication possession ratio (MPR), defined as the proportion of PrEP pills dispensed in 90 days, assuming daily dosing. This study is registered with ClinicalTrials.gov, NCT02870790. FINDINGS: Between March 1, 2016, and April 30, 2018, we enrolled 9709 participants. 9596 participants were dispensed PrEP, of whom 9448 (98·3%) were gay or bisexual men. Participants were followed up until March 31, 2019, with at least one follow-up HIV test available in 9520 (99·2%) participants. Mean MPR declined from 0·93 to 0·64 from the first to the ninth quarter. There were 30 HIV seroconversions over 18 628 person-years, an incidence of 1·61 per 1000 person-years (95% CI 1·13-2·30). Being younger, living in a postcode with fewer gay men, reporting more risk behaviours at baseline, and having an MPR of less than 0·6 were each univariately associated with increased HIV incidence. In the final year of follow-up, when PrEP was mostly purchased rather than provided free by the study, HIV incidence remained low at 2·24 per 1000 person-years (1·46-3·44). INTERPRETATION: HIV incidence remained low over up to 3 years of follow-up, including during a transition from study-provided to publicly subsidised PrEP. In a setting of affordable PrEP and associated health-care services, very low HIV incidence of 1 to 2 per 1000 person-years can be maintained in gay and bisexual men who were previously at high risk. FUNDING: New South Wales Ministry of Health, Australian Capital Territory Health Directorate, Gilead Sciences.