Rosalind Foster

Positivity at test of cure following first-line treatment for genital Mycoplasma genitalium: follow-up of a clinical cohort

Objectives To describe antibiotic use for treatment of Mycoplasma genitalium (MG) at an urban sexual health centre in Australia. To describe MG positivity rates in those returning for 1u2005month test of cure (TOC) following first-line antibiotic treatment for MG. Methods Retrospective cross-sectional case-note review for all patients diagnosed with MG at Sydney Sexual Health Centre from 2009 to 2013. Results Two hundred and eighteen MG cases were identified; 66% were male and 90% were symptomatic at presentation. Four people did not return for treatment. Azithromycin containing regimens were prescribed as first-line treatment in 88% of cases; azithromycin 1u2005g stat in 75% of cases and a course of extended azithromycin 1u2005g stat plus 500u2005mg daily for 4u2005days in 14% of cases. TOC was performed in 53% (95% CI 46% to 60%) of cases and 28% (95% CI 20% to 38%) of these cases were MG-positive at TOC. Of those having a MG-positive result at TOC, 26% received azithromycin 1u2005g stat and 33% received extended azithromycin. Accounting for cases lost to follow-up in azithromycin containing regimens, the positive MG TOC rate was estimated to be between 15% and 61%. Conclusions High rates of MG positivity were found in those attending TOC following first-line treatment of MG with azithromycin containing regimens.

Single-Tablet Emtricitabine-Rilpivirine-Tenofovir as HIV Postexposure Prophylaxis in Men Who Have Sex With Men

BACKGROUNDnCompletion rates for human immunodeficiency virus (HIV) postexposure prophylaxis (PEP) are low. We investigated the adherence and safety of coformulated emtricitabine (FTC), rilpivirine (RPV), and tenofovir disoproxil fumarate (TDF) as a 3-drug, single-tablet regimen for PEP in men who have sex with men (MSM).nnnMETHODSnIn an open-label, single-arm study at 2 public sexual health clinics and 2 hospital emergency departments in urban Australia, 100 HIV-uninfected MSM requiring 3-drug PEP received single-tablet FTC-RPV-TDF once daily for 28 days. The primary endpoint was premature PEP cessation or primary HIV infection through week 12. Additional endpoints were adherence (by self-report of doses missed or not ingested with a meal, by pill count, and by plasma concentrations of tenofovir and FTC at week 4); and safety (clinical and laboratory adverse events [AEs]).nnnRESULTSnPEP completion was 92% (95% confidence interval, 85%-96%); premature cessation resulted from loss to follow-up (6%), AEs (1%), or study burden (1%). No participant was found to acquire HIV through week 12. Adherence was 98.6% (standard deviation [SD], 2.4) by pill count and 98.5% (SD, 2.7) by self-report; 86% reported taking all doses with food, and 88% of the subset tested had plasma tenofovir levels suggesting full adherence (>40 ng/mL). Eighty-eight participants experienced at least 1 clinical AE; 4 had grade 3 AEs or higher, possibly attributable to study drug. Fifty-six participants experienced at least 1 laboratory AE; 4 had AEs of grade 3 or higher, possibly attributable to study drug.nnnCONCLUSIONSnA single-tablet regimen of FTC-RPV-TDF was well tolerated as once-daily PEP, with high levels of adherence and completion.nnnCLINICAL TRIALS REGISTRATIONnNCT01715636.

Reactive arthritis at the Sydney Sexual Health Centre 1992–2012: declining despite increasing chlamydia diagnoses:

Summary Reactive arthritis is an under-studied complication of genital Chlamydia trachomatis infection (chlamydia). We assessed trends and risk factors for reactive arthritis in a large urban sexual health clinic. Using a case-control design, data on reactive arthritis cases and controls at the Sydney Sexual Health Centre over the period 1992–2012 were extracted and multivariate analyses were performed. Trend analyses were performed on reactive arthritis diagnoses. Over the 1992–2012 study period, 85 reactive arthritis cases were diagnosed at Sydney Sexual Health Centre. The rate of reactive arthritis diagnoses decreased over time (23 in 1992–1996 to one in 2007–2011 and none in 2012), while chlamydia diagnoses increased (770 in 1992–1996 to 2257 in 2007–2011). In multivariate analysis, factors independently associated with a reactive arthritis diagnosis were: being male (adjusted odds ratio [aOR] 3.27; 95% confidence interval [CI] 1.04–10.32; pu2009=u20090.043) or born overseas (aOR 2.69; 95% CI 1.27–5.70; pu2009=u20090.010), while a past sexually transmitted infection other than chlamydia or non-gonococcal urethritis was protective (aOR 0.21; 95% CI 0.10–0.45; pu2009<u20090.001). Reactive arthritis was not associated with current or recent chlamydia infection (pu2009=u20090.184) but was marginally associated with past non-gonococcal urethritis (pu2009=u20090.080). This study found a decline in reactive arthritis diagnoses despite an increase in chlamydia diagnoses.

Validation of participant eligibility for pre-exposure prophylaxis: Baseline data from the PRELUDE demonstration project

Background In Australia, pre-exposure prophylaxis (PrEP) is targeted to individuals at high risk for HIV infection. We describe the HIV risk profile and characteristics of PRELUDE participants, and evaluate the population validity of the sample in representing high-risk gay and bisexual men (GBM) eligible for PrEP. Methods PRELUDE is an on-going, open-label, single-arm observational study. Participants were identified in clinics and screened for eligibility using a paper-based risk assessment tool which followed the New South Wales (NSW) PrEP guidelines. Selection was validated using an independent online behavioural survey, completed by study participants upon enrolment. Demographic information was analysed using descriptive statistics, and kappa tests were used to determine agreement between reporting of high-risk practices in the risk assessment and behavioural survey. Results During 2014–15, 471 individuals were targeted for enrolment; 341 were assessed for PrEP eligibility and 313 were enrolled. Of these, 303 (97%) identified as GBM. Overall, 85% of GBM met at least one high-risk criterion; 68% reported receptive intercourse with an HIV-positive or unknown status casual male partner, and 37% reported methamphetamine use in the three months preceding enrolment. The remaining 15% were enrolled based on medium-risk behaviours, or at the clinicians’ discretion. We found an 82% total agreement between self-reported high-risk behaviour and clinicians’ categorisation of GBM as being at high risk for HIV based on PrEP eligibility criteria. Conclusions Behavioural eligibility criteria used by clinicians successfully identified individuals at high risk for HIV infection. This targeted approach ensures that the greatest public health and HIV prevention benefits can be derived in a setting without universal access to PrEP.

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 15xa0months (pu2009<u20090.001). 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.

Baseline Preferences for Daily, Event-Driven, or Periodic HIV Pre-Exposure Prophylaxis among Gay and Bisexual Men in the PRELUDE Demonstration Project

Introduction The effectiveness of daily pre-exposure prophylaxis (PrEP) is well established. However, there has been increasing interest in non-daily dosing schedules among gay and bisexual men (GBM). This paper explores preferences for PrEP dosing schedules among GBM at baseline in the PRELUDE demonstration project. Materials and methods Individuals at high-risk of HIV were enrolled in a free PrEP demonstration project in New South Wales, Australia, between November 2014 and April 2016. At baseline, they completed an online survey containing detailed behavioural, demographic, and attitudinal questions, including their ideal way to take PrEP: daily (one pill taken every day), event-driven (pills taken only around specific risk events), or periodic (daily dosing during periods of increased risk). Results Overall, 315 GBM (98% of study sample) provided a preferred PrEP dosing schedule at baseline. One-third of GBM expressed a preference for non-daily PrEP dosing: 20% for event-driven PrEP, and 14% for periodic PrEP. Individuals with a trade/vocational qualification were more likely to prefer periodic to daily PrEP [adjusted odds ratio (aOR)u2009=u20094.58, 95% confidence intervals (95% CI): (1.68, 12.49)], compared to individuals whose highest level of education was high school. Having an HIV-positive main regular partner was associated with strong preference for daily, compared to event-driven PrEP [aORu2009=u20090.20, 95% CI: (0.04, 0.87)]. Participants who rated themselves better at taking medications were more likely to prefer daily over periodic PrEP [aORu2009=u20090.39, 95% CI: (0.20, 0.76)]. Discussion Individuals’ preferences for PrEP schedules are associated with demographic and behavioural factors that may impact on their ability to access health services and information about PrEP and patterns of HIV risk. At the time of data collection, there were limited data available about the efficacy of non-daily PrEP schedules, and clinicians only recommended daily PrEP to study participants. Further research investigating how behaviours and PrEP preferences change correspondingly over time is needed. Trial registration ClinicalTrials.gov NCT02206555. Registered 28 July 2014.

Dolutegravir with tenofovir disoproxil fumarate-emtricitabine as HIV postexposure prophylaxis in gay and bisexual men.

Objectives: Completion rates for HIV postexposure prophylaxis (PEP) are often low. We investigated the adherence and safety of dolutegravir (DTG; 50u200amg daily) with tenofovir disoproxil fumarate–emtricitabine (TDF–FTC; 300/200u200amg, respectively) as three-drug PEP in gay and bisexual men. Design: Open-label, single-arm study at three sexual health clinics and two emergency departments in Australia. Methods: In total, 100 HIV-uninfected gay and bisexual men requiring PEP received DTG and TDF–FTC for 28 days. The primary end point was PEP failure (premature PEP cessation or primary HIV infection through week 12). Additional end points were adherence by self-report (nu200a=u200a98) and pill count (nu200a=u200a55), safety, and plasma drug levels at day 28. Results: PEP completion was 90% (95% confidence interval 84–96%). Failures (occurring at a median 9 days, interquartile range 3–16) comprised loss to follow-up (9%) and adverse event resulting in study drug discontinuation (headache, 1%). No participant was found to acquire HIV through week 12. Adherence to PEP was 98% by self-report and in the 55 participants with corresponding pill count data. The most common clinical adverse events were fatigue (26%), nausea (25%), diarrhoea (21%), and headache (10%). There were only four grade 3–4 subjective adverse events. The most common laboratory adverse event was raised alanine aminotransferase (22%), but there was no case of clinical hepatitis. At day 28, the mean estimated glomerular filtration rate decrease was 14u200aml/min/1.73m2 (SD 17, Pu200a=u200a0.001); an estimated glomerular filtration rate of less than 60u200aml/min/1.73m2 occurred in 3%. Conclusions: DTG with TDF–FTC is a well tolerated option for once-daily PEP.

Does Living Outside of a Major City Impact on the Timeliness of Chlamydia Treatment? A Multicenter Cross-Sectional Analysis.

Background Timely treatment of Chlamydia trachomatis infection reduces complications and onward transmission. We assessed client, process, and clinic factors associated with treatment delays at sexual health clinics in New South Wales, Australia. Methods A retrospective review of 450 consecutive clients with positive chlamydia results (not treated at the time of the consultation) was undertaken at 6 clinics (1 urban, 3 regional, and 2 remote) from October 2013. Mean and median times to treatment were calculated, overall and stratified by process steps and clinic location. Results Nearly all clients (446, 99%) were treated, with 398 (88%) treated in ⩽14 days and 277 (62%) in ⩽7 days. The mean time-to-treatment was 22 days at remote clinics, 13 days at regional and 8 days at the urban clinic (P < 0.001). Mean time between the laboratory receipt of specimen and reporting of result was 4.9 in the remote clinics, 4.1 in the regional, and 2.7 days in the urban clinic (P < 0.001); and the mean time between the clinician receiving the result until client treatment was15, 5, and 3 days (P < 0.01), respectively. Conclusions At participating clinics, treatment uptake was high, however treatment delays were greater with increasing remoteness. Strategies to reduce the time-to-treatment should be explored such as point-of-care testing, faster specimen processing, dedicated clinical time to follow up recalls, SMS results to clients, and taking treatment out to clients.

Reactive arthritis following a Microsporidia infection.

Reactive arthritis may be caused by both sexually transmissible and enteric organisms, though Microsporidia is not currently recognised as a causative agent. This case report describes the development of reactive arthritis following Microsporidia infection in an immunocompetent man.

Risk factors associated with incident sexually transmitted infections in HIV-positive patients in the Australian HIV Observational Database: a prospective cohort study.

We established a subcohort of HIV‐positive individuals from 10 sexual health clinics within the Australian HIV Observational Database (AHOD). The aim of this study was to assess demographic and other factors that might be associated with an incident sexually transmitted infection (STI).