Economic evaluation alongside a clinical trial of near-to-patient testing for sexually transmitted infections.

BACKGROUND: Current clinical care for common bacterial STIs (Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG) and Mycoplasma genitalium (MG)) involves empiric antimicrobial therapy when clients are symptomatic, or if asymptomatic, waiting for laboratory testing and recall if indicated. Near-to-patient testing (NPT) can improve pathogen-specific prescribing and reduce unnecessary or inappropriate antibiotic use in treating sexually transmitted infections (STI) by providing same-day delivery of results and treatment. METHODS: We compared the economic cost of NPT to current clinic practice for managing clients with suspected proctitis, non-gonococcal urethritis (NGU), or as an STI contact, from a health provider's perspective. With a microsimulation of 1000 clients, we calculated the cost per client tested and per STI- and pathogen- detected for each testing strategy. Sensitivity analyses were conducted to assess the robustness of the main outcomes. Costs are reported as Australian dollars (2023). RESULTS: In the standard care arm, cost per client tested for proctitis, NGU in men who have sex with men (MSM) and heterosexual men were the highest at $247.96 (95% Prediction Interval (PI): 246.77-249.15), $204.23 (95% PI: 202.70-205.75) and $195.01 (95% PI: 193.81-196.21) respectively. Comparatively, in the NPT arm, it costs $162.36 (95% PI: 161.43-163.28), $158.39 (95% PI: 157.62-159.15) and $149.17 (95% PI: 148.62-149.73), respectively. Using NPT resulted in cost savings of 34.52%, 22.45% and 23.51%, respectively. Among all the testing strategies, substantial difference in cost per client tested between the standard care arm and the NPT arm was observed for contacts of CT or NG, varying from 27.37% to 35.28%. CONCLUSION: We found that NPT is cost-saving compared with standard clinical care for individuals with STI symptoms and sexual contacts of CT, NG, and MG.

Accuracy of Self-reported Human Papillomavirus Vaccination Status Among Gay and Bisexual Adolescent Males: Cross-sectional Study.

BACKGROUND: Men who have sex with men are a risk group for anal human papillomavirus (HPV) and anal cancer. Australia introduced a universal school-based HPV vaccination program in 2013. Self-reported HPV vaccination status has been widely used in clinical and research settings, but its accuracy is understudied. OBJECTIVE: We aimed to examine the accuracy of self-reported HPV vaccination status among gay and bisexual adolescent males. METHODS: We included 192 gay and bisexual males aged 16-20 years from the Human Papillomavirus in Young People Epidemiological Research 2 (HYPER2) study in Melbourne, Australia. All participants had been eligible for the universal school-based HPV vaccination program implemented in 2013 and were asked to self-report their HPV vaccination status. Written informed consent was obtained to verify their HPV vaccination status using records at the National HPV Vaccination Program Register and the Australian Immunisation Register. We calculated the sensitivity, specificity, positive predictive value, and negative predictive value of self-reported HPV vaccination status. RESULTS: The median age of the 192 males was 19 (IQR 18-20) years. There were 128 males (67%) who had HPV vaccination records documented on either registry. Self-reported HPV vaccination had a sensitivity of 47.7% (95% CI 38.8%-56.7%; 61/128), a specificity of 85.9% (95% CI 75.0%-93.4%; 55/64), a positive predictive value of 87.1% (95% CI 77.0%-93.9%; 61/70), and a negative predictive value of 45.1% (95% CI 36.1%-54.3%; 55/122). CONCLUSIONS: Self-reported HPV vaccination status among Australian gay and bisexual adolescent males underestimates actual vaccination and may be inaccurate for clinical and research purposes.

Epidemiology of anal human papillomavirus infection and high-grade squamous intraepithelial lesions in 29 900 men according to HIV status, sexuality, and age: a collaborative pooled analysis of 64 studies.

BACKGROUND: Robust age-specific estimates of anal human papillomavirus (HPV) and high-grade squamous intraepithelial lesions (HSIL) in men can inform anal cancer prevention efforts. We aimed to evaluate the age-specific prevalence of anal HPV, HSIL, and their combination, in men, stratified by HIV status and sexuality. METHODS: We did a systematic review for studies on anal HPV infection in men and a pooled analysis of individual-level data from eligible studies across four groups: HIV-positive men who have sex with men (MSM), HIV-negative MSM, HIV-positive men who have sex with women (MSW), and HIV-negative MSW. Studies were required to inform on type-specific HPV infection (at least HPV16), detected by use of a PCR-based test from anal swabs, HIV status, sexuality (MSM, including those who have sex with men only or also with women, or MSW), and age. Authors of eligible studies with a sample size of 200 participants or more were invited to share deidentified individual-level data on the above four variables. Authors of studies including 40 or more HIV-positive MSW or 40 or more men from Africa (irrespective of HIV status and sexuality) were also invited to share these data. Pooled estimates of anal high-risk HPV (HR-HPV, including HPV16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68), and HSIL or worse (HSIL+), were compared by use of adjusted prevalence ratios (aPRs) from generalised linear models. FINDINGS: The systematic review identified 93 eligible studies, of which 64 contributed data on 29 900 men to the pooled analysis. Among HIV-negative MSW anal HPV16 prevalence was 1·8% (91 of 5190) and HR-HPV prevalence was 6·9% (345 of 5003); among HIV-positive MSW the prevalences were 8·7% (59 of 682) and 26·9% (179 of 666); among HIV-negative MSM they were 13·7% (1455 of 10 617) and 41·2% (3798 of 9215), and among HIV-positive MSM 28·5% (3819 of 13 411) and 74·3% (8765 of 11 803). In HIV-positive MSM, HPV16 prevalence was 5·6% (two of 36) among those age 15-18 years and 28·8% (141 of 490) among those age 23-24 years (ptrend=0·0091); prevalence was 31·7% (1057 of 3337) among those age 25-34 years and 22·8% (451 of 1979) among those age 55 and older (ptrend<0·0001). HPV16 prevalence in HIV-negative MSM was 6·7% (15 of 223) among those age 15-18 and 13·9% (166 of 1192) among those age 23-24 years (ptrend=0·0076); the prevalence plateaued thereafter (ptrend=0·72). Similar age-specific patterns were observed for HR-HPV. No significant differences for HPV16 or HR-HPV were found by age for either HIV-positive or HIV-negative MSW. HSIL+ detection ranged from 7·5% (12 of 160) to 54·5% (61 of 112) in HIV-positive MSM; after adjustment for heterogeneity, HIV was a significant predictor of HSIL+ (aPR 1·54, 95% CI 1·36-1·73), HPV16-positive HSIL+ (1·66, 1·36-2·03), and HSIL+ in HPV16-positive MSM (1·19, 1·04-1·37). Among HPV16-positive MSM, HSIL+ prevalence increased with age. INTERPRETATION: High anal HPV prevalence among young HIV-positive and HIV-negative MSM highlights the benefits of gender-neutral HPV vaccination before sexual activity over catch-up vaccination. HIV-positive MSM are a priority for anal cancer screening research and initiatives targeting HPV16-positive HSIL+. FUNDING: International Agency for Research on Cancer.

Prevalence of genital and oropharyngeal chlamydia and gonorrhoea among female sex workers in Melbourne, Australia, 2015-2017: need for oropharyngeal testing.

OBJECTIVE: The Victorian legislation requires sex workers to have quarterly screening for genital chlamydia and gonorrhoea, but screening for oropharyngeal infection is not mandatory in Victoria, Australia. In 2017, oropharyngeal screening for gonorrhoea and chlamydia was added as part of the routine quarterly screening for sex workers attending the Melbourne Sexual Health Centre (MSHC). The aim of this study was to examine the prevalence of oropharyngeal gonorrhoea and chlamydia among female sex workers (FSW). METHODS: We included females who (1) self-identified as sex workers or were attended MSHC for a sex work certificate and (2) had tested for any STI or HIV, between March 2015 and December 2017. The prevalence of HIV, syphilis, chlamydia and gonorrhoea was calculated. RESULTS: There were 8538 FSW consultations among 2780 individuals during the study period. There was a twofold increase in genital gonorrhoea (from 0.5% (95% CI 0.3% to 0.9%) to 1.1% (95% CI 0.8% to 1.5%); ptrend=0.047) and a 1.5-fold increase in genital chlamydia (from 2.2% (95% CI 1.6% to 2.8%) to 3.2% (95% CI 2.6% to 3.8%); ptrend=0.031) during the period. Overall, the prevalence of HIV (0.2% (95% CI 0.1% to 0.3%)) and syphilis (0.1% (95% CI 0.0% to 0.2%)) remained low and did not change over time. In 2017, the prevalence of oropharyngeal gonorrhoea was 2.0% (95% CI 1.6% to 2.6%) and oropharyngeal chlamydia was 2.1% (95% CI 1.6% to 2.7%). Among FSW who were tested positive for gonorrhoea and chlamydia, 55% (n=41) and 34% (n=45) only tested positive in the oropharynx but not genital for gonorrhoea and chlamydia, respectively. CONCLUSION: The prevalence of oropharyngeal gonorrhoea and chlamydia is similar to the prevalence at genital sites and is often independent of genital infection. It is important to test the oropharynx and genital site for chlamydia and gonorrhoea among FSW.

Incidence of renal Fanconi syndrome in patients taking antiretroviral therapy including tenofovir disoproxil fumarate.

The objective of this study was to determine the incidence and predictors of Fanconi Syndrome (FS) in a cohort of patients taking tenofovir disoproxil fumarate (TDF). Clinical records and laboratory investigations from patients receiving TDF between 2002 and 2016 were extracted. FS was defined as normoglycaemic glycosuria and proteinuria and at least one other marker of renal dysfunction. Regression analysis was performed with time to development of FS and the following covariates: ritonavir co-administration, age, gender, co-morbidities (hypertension, hyperlipidaemia, diabetes, viral hepatitis), CD4 cell count nadir and baseline eGFR. One thousand and forty-four patients received TDF without ritonavir and 398 patients with ritonavir. Thirteen cases of FS were identified with a mean duration of exposure of 55 months. The incidence of FS was 1.09/1000PY (0.54-1.63) of TDF exposure (without ritonavir) and 5.50/1000PY (3.66-7.33) of TDF-ritonavir co-administration (p=0.0057). The adjusted hazards ratio for ritonavir co-administration was 4.71 (1.37-16.14, p=0.014). Known risk factors for chronic kidney disease were not associated with development of FS. Ritonavir co-administration, but not other factors, is associated with a greater risk of FS. FS developed late. Known risk factors for chronic kidney disease and length of treatment are not useful for identifying patients most at risk of developing FS in patients taking TDF.

Sexually Transmitted Infections in Melbourne, Australia from 1918 to 2016: nearly a century of data.

INTRODUCTION: Our aim was to describe trends in the number of bacterial sexually transmitted infections (STIs) diagnosed at Melbourne's sexual health clinic over a century. METHODS: A retrospective analysis of STI diagnoses (gonorrhoea, infectious syphilis and chancroid) among individuals attending Melbourne's sexual health service over 99 years between 1918 and 2016. RESULTS: Substantial increases in STI rates coincided with World War II, the 'Sexual Revolution of the 1960s and 1970s', and the last 10 years. Substantial declines coincided with the advent of antibiotics and the HIV/AIDS pandemic. There were also key differences between STIs. Chancroid virtually disappeared after 1950. Syphilis fell to very low levels in women after about 1950 and has only rebounded in men. The declines in gonorrhoea were less marked. A substantial peak in gonorrhoea occurred in women in the early 1970s and rates are currently rising in women, albeit much less than in men. CONCLUSIONS: Both antibiotics and changing sexual behaviour have had a powerful effect on STI rates. These data suggest gonorrhoea is more difficult to control than syphilis or chancroid. Indeed, the past rates suggest substantial endemic gonorrhoea transmission in heterosexuals occurred in the third quarter of last century before the appearance of the HIV pandemic. Worryingly, there is a suggestion that endemic heterosexual gonorrhoea may be returning. The data also suggest that future control of gonorrhoea and syphilis in men who have sex with men is going to be challenging.

Provision of HIV test results by telephone is both safe and efficient for men who have sex with men.

The aim of this study was to assess the impact of delivering HIV test results by telephone on HIV testing and subsequent risk behaviour of men, as well as saving on clinic consultation time. It was conducted at the Melbourne Sexual Health Centre, the main public sexual health clinic servicing Victoria, Australia. In 2013, a policy change was introduced so men could obtain their HIV test result via telephone. We compared the proportion of men testing for HIV and receiving results in the 24 months before (2011-2012) and the 24 months after (2013-2014) the policy change. There was a modest increase in the proportion of men having a HIV test of 3.2% ( p < 0.001) after the policy change. The provision of HIV results by telephone more than halved the number of men re-attending (74.4% vs. 33.1%) which freed up 516 hours of clinic time and had no adverse outcome on subsequent risk behaviour, nor changed the proportion of men who obtained their HIV results ( p = 0.058), or the period of time between testing and obtaining results for HIV-negative ( p = 0.007) and HIV-positive results ( p = 0.198). Telephone notification of HIV test results is a useful option given the potential beneficial effects shown.

Finger counting method is more accurate than age-based weight estimation formulae in estimating the weight of Hong Kong children presenting to the emergency department.

OBJECTIVE: The aim of the present study was to evaluate the finger counting method and compare its performance with four commonly used age-based weight estimation formulae in children aged 1-9 years presenting to the ED in Hong Kong. METHODS: A cross-sectional, observational study of children aged 1-9 years who presented to the ED of a tertiary referral hospital in Hong Kong over a 6 month period was conducted. Actual weight was compared with estimated weight using the finger counting method and four commonly used age-based weight estimation formulae. Bland-Altman analysis was performed to evaluate the degree of agreement in which the mean percentage difference (MPD) and 95% limits of agreement (LOA) were calculated. Root mean squared error (RMSE) and proportions of weight estimates within 10%, 15% and 20% of actual weight were determined. RESULTS: A total of 4178 children were included. The finger counting method was the most accurate method (MPD 0.1%; 95% LOA -34.0% to 34.2%). The original Advanced Paediatric Life Support (APLS) formula (MPD -7.0%; 95% LOA -38.4% to 24.3%) and the updated APLS formula (MPD -0.4%; 95% LOA -38.5% to 37.8%) underestimated weight whereas the Luscombe formula (MPD 7.2%; 95% LOA -31.8% to 46.2%) and the Best Guess formula (MPD 10.6%; 95% LOA -27.3% to 48.4%) overestimated weight. The finger counting method had smallest RMSE of 4.06 kg and estimated the largest proportion of children within 10%, 15% and 20% of actual weight. CONCLUSION: The finger counting method outperforms the commonly used age-based weight estimation formulae in children aged 1-9 years presenting to the ED in Hong Kong.

Characteristics of adenovirus urethritis among heterosexual men and men who have sex with men: a review of clinical cases.

BACKGROUND: The aim of this study was to characterise the clinical features of adenovirus urethritis in men and to compare the frequency of these between heterosexual men and men who have sex with men (MSM). METHODS: This was a review of the clinical and laboratory information from men diagnosed with PCR-confirmed adenovirus urethritis at the Melbourne Sexual Health Centre between January 2006 and April 2014. RESULTS: 102 adenovirus urethritis cases were reported, among which 61 were heterosexual men and 41 MSM. Eighty-nine per cent (n=91) had signs of meatitis or conjunctivitis: 51% had meatitis only; 32% meatitis together with conjunctivitis and 6% with conjunctivitis only. The distribution of symptoms and signs was similar among heterosexual men and MSM (p values >0.1). Adenovirus was the sole pathogen found in 93% of cases, excluding gonorrhoea, chlamydia, Mycoplasma genitalium and herpes simplex virus. Only 37% had ≥5 polymorphs per high-power field from a urethral smear. Where samples were still available for adenoviral sequencing (n=20), all were subgroup D. CONCLUSIONS: The clinical features of adenovirus urethritis in men can be distinctive and aid diagnosis, distinguishing it from other treatable causes of male urethritis.