Emerging evidence suggests that risk of bacterial sexually transmitted infections (STIs) increases among gay and bisexual men following initiation of HIV preexposure prophylaxis (PrEP). OBJECTIVE To describe STI incidence and behavioral risk factors among a cohort of predominantly gay and bisexual men who use PrEP, and to explore changes in STI incidence following PrEP commencement. DESIGN, SETTING, AND PARTICIPANTS The Pre-exposure Prophylaxis Expanded (PrEPX) Study, a multisite, open-label intervention study, was nested within the Australian Collaboration for Coordinated Enhanced Sentinel Surveillance (ACCESS) clinic network. A total of 4275 participants were enrolled (July 26, 2016-April 1, 2018) in Victoria, Australia. Of these, 2981 enrolled at 5 ACCESS clinics (3 primary care, 1 sexual health, and 1 community-based HIV rapid testing service), had at least 1 follow-up visit, and were monitored until April 30, 2018. EXPOSURES Upon enrollment, participants received daily oral tenofovir disoproxil fumurate and emtricitabine for HIV PrEP, quarterly HIV and STI testing, and clinical monitoring. MAIN OUTCOMES AND MEASURES The primary outcome was incidence of chlamydia, gonorrhea, or syphilis. Incidence rates and hazard ratios describing behavioral risk factors of STI diagnosis were calculated. Incidence rate ratios (IRRs), adjusted for change in testing frequency, described changes in STI incidence from 1-year preenrollment to study follow-up among participants with preenrollment testing data (n = 1378). RESULTS Among the 2981 individuals (median age, 34 years [interquartile range, 28-42]), 98.5% identified as gay or bisexual males, 29% used PrEP prior to enrollment, 89 (3%) withdrew and were censored at date of withdrawal, leaving 2892 (97.0%) enrolled at final follow-up. During a mean follow-up of 1.1 years (3185.0 person-years), 2928 STIs were diagnosed among 1427 (48%) participants (1434 chlamydia, 1242 gonorrhea, 252 syphilis). STI incidence was 91.9 per 100 person-years, with 736 participants (25%) accounting for 2237 (76%) of all STIs. Among 2058 participants with complete data for multivariable analysis, younger age, greater partner number, and group sex were associated with greater STI risk, but condom use was not. Among 1378 participants with preenrollment testing data, STI incidence increased from 69.5 per 100 person-years prior to enrollment to 98.4 per 100 person-years during follow-up (IRR, 1.41 [95% CI, 1.29-1.56]). After adjusting for testing frequency, the increase in incidence from 1 year preenrollment to follow-up was significant for any STI (adjusted IRR, 1.12 [95% CI, 1.02-1.23]) and for chlamydia (adjusted IRR, 1.17 [95% CI, 1.04-1.33]). CONCLUSIONS AND RELEVANCE Among gay and bisexual men using PrEP, STIs were highly concentrated among a subset, and receipt of PrEP after study enrollment was associated with an increased incidence of STIs compared with preenrollment. These findings highlight the importance of frequent STI testing among gay and bisexual men using PrEP.

Background: Over the last 10 years, increases in demand for transgender health care has occurred worldwide. There are few data on clinical characteristics of Australian adult transgender individuals. Understanding gender identity patterns, sociodemographic characteristics, gender-affirming treatments, as well as medical and psychiatric morbidities, including neurobehavioral conditions affecting transgender and gender-diverse adults will help to inform optimal health service provision.Purpose: In an Australian adult transgender cohort, we aimed to first, assess referral numbers and describe the sociodemographic and clinical characteristics, and second, to specifically assess the prevalence of autism spectrum disorder (ASD) and attention-deficit/hyperactivity disorder (ADHD).Methods: We performed a retrospective audit of deidentified electronic medical records in a primary care and a secondary care gender clinic in Melbourne, Australia. Annual referral rates, sociodemographic data, and prevalence of medical and psychiatric conditions were obtained.Results: Data for 540 transgender individuals were available. Rapid rises were observed in referrals for transgender health services, more than 10 times the number in 2016 compared with 2011. Median age at initial presentation was 27 years (interquartile range (22, 36), range 16–74). Around 21.3% were unemployed and 23.8% had experienced homelessness despite high levels of education. Around 44.1% identified as trans male, 36.3% as trans female, and 18.3% as gender nonbinary. Medical morbidities were rare but mental illness was very common. The prevalence of depression was 55.7%, anxiety in 40.4%, ADHD in 4.3%, and ASD in 4.8%, all higher than reported age-matched general Australian population prevalence.Conclusions: Rising demand for transgender care, socioeconomic disadvantage, and high burden of mental health conditions warrants a comprehensive multidisciplinary approach to provide optimal care for transgender individuals. Given that ASD and ADHD are prevalent, in addition to gender-affirming treatments, psychosocial interventions may assist individuals in navigating health care needs and to support social aspects of gender transition. Further studies are required to understand links between ASD, ADHD, and gender identity and to evaluate optimal models of health service provision for transgender individuals.

Background Oestradiol with or without an anti-androgen (cyproterone acetate or spironolactone) is commonly prescribed in transfeminine individuals who have not had orchidectomy; however, there is no evidence to guide optimal treatment choice. Objective We aimed to compare add-on cyproterone acetate versus spironolactone in lowering endogenous testosterone concentrations in transfeminine individuals. Design Retrospective cross-sectional study. Methods We analysed 114 transfeminine individuals who had been on oestradiol therapy for >6 months in two gender clinics in Melbourne, Australia. Total testosterone concentrations were compared between three groups; oestradiol alone (n = 21), oestradiol plus cyproterone acetate (n = 21) and oestradiol plus spironolactone (n = 38). Secondary outcomes included serum oestradiol concentration, oestradiol valerate dose, blood pressure, serum potassium, urea and creatinine. Results Median age was 27.0 years (22.5–45.1) and median duration of hormone therapy was 1.5 years (0.9–2.6), which was not different between groups. On univariate analysis, the cyproterone group had significantly lower total testosterone concentrations (0.8 nmol/L (0.6–1.20)) compared with the spironolactone group (2.0 nmol/L (0.9–9.4), P = 0.037) and oestradiol alone group (10.5 nmol/L (4.9–17.2), P < 0.001), which remained significant (P = 0.005) after adjustments for oestradiol concentration, dose and age. Serum urea was higher in the spironolactone group compared with the cyproterone group. No differences were observed in total daily oestradiol dose, blood pressure, serum oestradiol, potassium or creatinine. Conclusions The cyproterone group achieved serum total testosterone concentrations in the female reference range. As spironolactone may cause feminisation without inhibition of steroidogenesis, it is unclear which anti-androgen is more effective at feminisation. Further prospective studies are required.

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Background: There are 2 common approaches to assess an individual before commencing of gender-affirming hormone therapy (GAHT); a mental health practitioner assessment and approval or an informed consent model undertaken with a primary care general practitioner (GP). Aim: In a primary care clinic practising an Informed Consent Model of care to initiate GAHT, we aimed to firstly describe the proportion and characteristics of patients referred for secondary consultation to a mental health practitioner (MH referred) and secondly, we aimed to measure patient satisfaction. Methods: A retrospective audit of all new patients with a transgender or gender diverse identity presenting to a primary care clinic in Melbourne, Australia was performed between March 2017 and March 2019. In those newly seeking GAHT, de-identified data were obtained including presence of secondary mental health practitioner referral, time to GAHT commencement and co-occurring mental health conditions. A separate survey assessed patient satisfaction. Outcomes: Mental health conditions and overall patient satisfaction in those referred for secondary mental health consultation (MH referred) were compared with those who were not (GP assessed). Results: Of 590 new consultations, 309 were newly seeking GAHT. Referrals for secondary mental health assessment before GAHT occurred in 8%. The GP-assessed group commenced GAHT at median 0.9 months (0.5e1.8) after initial consultation compared with 3.1 months (1.3e4.0), P < .001 in the MH-referred group. The MH-referred group was more likely to have post-traumatic stress disorder (adjusted P ¼ .036) and schizophrenia (adjusted P ¼ .011). Of 43 respondents to the survey, a higher proportion in the GP-assessed group was extremely satisfied with their overall care compared with the MH-referred group (P < .01). Notably, 80% in the GP-assessed group chose to seek mental health professional support. Clinical Implications: Initiation of GAHT can be performed in primary care by GPs using an informed consent model and is associated with high patient satisfaction. Mental health professionals remain a key source of support. Strengths & Limitations: This retrospective audit did not randomize patients to pathways to initiate GAHT. Follow-up duration was short. Responder bias to survey with low response rates may overestimate patient satisfaction. This is one of the first studies to evaluate an informed consent model of care. Conclusion: More widespread uptake of an informed consent model of care to initiate GAHT by primary care physicians has the potential for high patient satisfaction and may be a practical solution to reduce waiting lists in gender clinics.