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.

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.

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.

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.

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.

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.

Concomitant medication polypharmacy, interactions and imperfect adherence are common in Australian adults on suppressive antiretroviral therapy.

OBJECTIVES: We quantified concomitant medication polypharmacy, pharmacokinetic and pharmacodynamic interactions, adverse effects and adherence in Australian adults on effective antiretroviral therapy. DESIGN: Cross-sectional. METHODS: Patients recruited into a nationwide cohort and assessed for prevalence and type of concomitant medication (including polypharmacy, defined as ≥5 concomitant medications), pharmacokinetic or pharmacodynamic interactions, potential concomitant medication adverse effects and concomitant medication adherence. Factors associated with concomitant medication polypharmacy and with imperfect adherence were identified using multivariable logistic regression. RESULTS: Of 522 participants, 392 (75%) took a concomitant medication (mostly cardiovascular, nonprescription or antidepressant). Overall, 280 participants (54%) had polypharmacy of concomitant medications and/or a drug interaction or contraindication. Polypharmacy was present in 122 (23%) and independently associated with clinical trial participation, renal impairment, major comorbidity, hospital/general practice-based HIV care (versus sexual health clinic) and benzodiazepine use. Seventeen participants (3%) took at least one concomitant medication contraindicated with their antiretroviral therapy, and 237 (45%) had at least one pharmacokinetic/pharmacodynamic interaction. Concomitant medication use was significantly associated with sleep disturbance and myalgia, and polypharmacy of concomitant medications with diarrhoea, fatigue, myalgia and peripheral neuropathy. Sixty participants (12%) reported imperfect concomitant medication adherence, independently associated with requiring financial support, foregoing necessities for financial reasons, good/very good self-reported general health and at least 1 bed day for illness in the previous 12 months. CONCLUSION: In a resource-rich setting with universal healthcare access, the majority of this sample took a concomitant medication. Over half had at least one of concomitant medication polypharmacy, pharmacokinetic or pharmacodynamic interaction. Concomitant medication use was associated with several adverse clinical outcomes.

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.

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.

Cervical screening uptake and abnormalities among women attending sexual health clinics for HIV care.

The aim of this study was to describe cervical screening uptake and assess correlates of screen-detected abnormalities in women attending sexual health services for HIV care. Of 156 women, 115 had documentation of a Pap test at least once in 3 years and 9.6% had an annual Pap test performed. Pap abnormalities were associated with younger age, being born in Sub-Saharan Africa, more recent arrival in Australia, lower CD4 count, detectable viral load, shorter time on antiretroviral therapy and more recent HIV diagnosis. Women accessing sexual health services for HIV care, especially those from culturally and linguistically diverse backgrounds, appear to be substantially under-screened and efforts to optimise screening are needed.

Vulval Crohn's disease.

We report a case of vulval Crohn's disease, the diagnosis of which was complicated by the presence of sexually transmissible infections.

The sexually transmitted infection 'check up'.

BACKGROUND: Many sexually transmitted infections (STIs) and blood borne viruses (BBV) such as HIV are asymptomatic. Early detection is important for minimising associated risks. With appropriate treatment and management (including contact tracing) it is possible to substantially reduce morbidity as well as transmission to sexual partners and the neonate. OBJECTIVE: This paper outlines which tests should be administered to otherwise 'well' individuals. It also examines the questions of when, why and how to respond to requests for an STI 'screen' or 'check up'. DISCUSSION: Testing and screening for asymptomatic STIs and BBV are important, especially in situations where proven interventions can decrease morbidity and transmission. Screening for STIs also provides the opportunity in a one-on-one consultation for health promotion. Sexually transmitted infection testing can also initiate a conversation about 'safer sex' and may help address other concerns patients may have.