Identifying risk factors for developing obesity: a record linkage longitudinal study in metropolitan Sydney using the 45 and Up Study.

BACKGROUND: Primary care clinicians have key responsibilities in obesity prevention and weight management. AIMS: We aimed to identify risk factors for developing obesity among people aged ≥45 years. METHODS: We conducted a record linkage longitudinal study of residents of metropolitan Sydney, Australia using data from the: (1) 45 and Up Study at baseline (2005-2009) and first follow-up (2012-2015); (2) Medicare claims; (3) Pharmaceutical Benefits Scheme; and (4) deaths registry. We examined risk factors for developing obesity (body mass index [BMI]: 30-40) at follow-up, separately for people within the: (1) healthy weight range (BMI 18.5-<25) and (2) overweight range (BMI 25-<30) at baseline. Covariates included demographics, modifiable behaviours, health status, allied health use, and medication use. Crude and adjusted relative risks were estimated using Poisson regression modelling. RESULTS: At follow-up, 1.1% (180/16,205) of those in the healthy weight range group, and 12.7% (1,939/15,266) of those in the overweight range group developed obesity. In both groups, the following were associated with developing obesity: current smoking at baseline, physical functioning limitations, and allied health service use through team care planning, while any alcohol consumption and adequate physical activity were found to be associated with a lower risk of developing obesity. In the healthy weight group, high psychological distress and the use of antiepileptics were associated with developing obesity. In the overweight group, female sex and full-time work were associated with developing obesity, while older age was found to be associated with a lower risk of developing obesity. CONCLUSIONS: These findings may inform the targeting of preventive interventions for obesity in clinical practice and broader public health programs.

Early intervention to prevent weight gain requires a targeted multidisciplinary team-based approach to improve diet, increase physical activity, and change behaviour. However, the capacity to provide this within primary care is limited and there is little funding for consultations with allied health professionals. There is a need to identify priority at-risk groups to help primary care clinicians target interventions to those in most need. We have identified, using a longitudinal study of residents of metropolitan Sydney, key characteristics of older adults who are at risk of gaining weight and developing obesity, including risk behaviours (smoking and physical inactivity), and chronic conditions or their treatment (physical function, psychological distress, and use of anti-epileptic medications). These findings may help alert clinicians to the need for preventive interventions in selected cases, as well as informing the targeting of public health programs.

The acceptability and usability of two HIV self-test kits among men who have sex with men: a randomised crossover trial.

OBJECTIVES: To compare the usability and acceptability of oral fluid- and blood-based HIV self-test kits among men who have sex with men in Australia. DESIGN: Randomised crossover trial. SETTING, PARTICIPANTS: Gay, bisexual, and other men aged 18 years or older who have sex with men, who attended two metropolitan sexual health clinics in Sydney and Melbourne, 7 January - 10 December 2019. MAIN OUTCOME MEASURES: Ease of use of HIV self-test kits; preferred HIV self-test type; difficulties encountered during HIV self-testing. RESULTS: 170 men were recruited (median age, 34 years; interquartile range, 29-43 years); 144 identified as gay (85%), 96 were born outside Australia (57%). Participants were more likely to report the oral fluid HIV self-test was easy to use than the blood-based self-test (oral fluid, 99%; blood, 86%; odds ratio [OR], 3.0; 95% confidence interval [CI], 1.4-6.6). The oral fluid test was preferred by 98 participants (58%; 95% CI, 50-65%), the blood-based test by 69 (41%; 95% CI, 33-48%). Difficulties with the oral fluid test kit identified by observing nurses included problems placing the buffer solution into the stand (40 of 170 participants, 24%) and not swabbing both gums (23 of 169, 14%); difficulties with the blood-based test kit included problems filling the device test channel (69 of 170, 41%) and squeezing the finger firmly enough to generate a blood drop (42 of 170, 25%). No participant received an invalid result with the oral fluid self-test; two of 162 participants (1%) received invalid results with the blood self-test. After adjusting for age, education level, and ethnic background, characteristics associated with higher odds of using HIV self-testing in the future were overseas birth (adjusted OR, 3.07; 95% CI, 1.42-6.64), and self-evaluated ease of use and confidence in using the kits. CONCLUSION: It is important to provide options for obtaining both oral fluid- and blood-based HIV self-tests. The usability and acceptability of both kits were high, but the ease of use and perceived accuracy influenced test kit preference.

Sustaining success: a qualitative study of gay and bisexual men's experiences and perceptions of HIV self-testing in a randomized controlled trial.

BACKGROUND: HIV self-testing was proved as an effective tool for increasing testing frequency in gay and bisexual men at high risk of infection. Questions remain about understanding why HIVST encouraged testing and how such success can be translated to programmatic implementation. METHODS: We conducted a qualitative investigation of how FORTH participants experienced and perceived HIVST. Stratified sampling was used to recruit gay and bisexual men participating in the FORTH HIVST intervention to take part in interviews, focusing on infrequent testers and those who had received inaccurate HIVST results. RESULTS: Our analysis identified several prominent themes organized into two overarching domains from the 15 interviews: (i) aspects of HIVST contributing to HIV testing frequency, and (ii) sustaining HIVST into the future. Participants also believed that their use of HIVST in the future would depend on the test kit's reliability, particularly when compared with highly reliable clinic-based testing. CONCLUSION: HIVST increases the frequency of HIV testing among gay and bisexual men due, in part, to the practical, psychological, and social benefits it offers. To capitalize fully on these benefits, however, strategies to ensure the availability of highly reliable HIVST are required to sustain benefits beyond the confines of a structured research study.

Rapid HIV testing increases testing frequency among gay and bisexual men: a controlled before-after study.

Background Rapid HIV testing was introduced at 12 clinics in New South Wales (NSW) for routine testing and promoted with social marketing. The effect of the availability of rapid HIV testing on testing frequency among gay and bisexual men (GBM) was evaluated. METHODS: An observational design using patient data from 12 clinics was used. The primary outcome was the mean number of HIV tests in 12 months. The intervention group comprised GBM who had one or more rapid tests from October 2013 to September 2014 and this was compared with two control groups; a concurrent group (no rapid test in the same period) and a historical group (attended between July 2011 and June 2012). Independent sample t-tests were conducted to compare mean number of tests among men in the intervention, concurrent and historical groups. Multivariate logistic regression was used to assess the association between rapid HIV testing and testing frequency. RESULTS: Men in the intervention group (n = 3934) had a mean of 1.8 HIV tests in 12 months, compared with 1.4 in the concurrent group (n = 5063; P < 0.001) and 1.4 in the historical group (n = 5904; P < 0.001); testing frequency was higher among men at increased risk of HIV in the intervention group compared with the other two groups (mean 2.2, 1.6 and 1.5 respectively; P < 0.001). Membership of the intervention group was associated with increased odds of having two or more HIV tests in 12 months (AOR = 2.5, 95%CI 2.2-2.8; P < 0.001) compared with the concurrent group, after controlling for demographic and behavioural factors. CONCLUSION: Introducing and promoting rapid HIV testing in clinics in NSW was associated with increased HIV testing frequency among GBM.

An evaluation of a novel dual treponemal/nontreponemal point-of-care test for syphilis as a tool to distinguish active from past treated infection.

BACKGROUND: Most syphilis point-of-care (POC) tests detect treponemal antibodies, which persist after successful treatment. Subsequent POC tests are positive, despite no active infection, and can lead to unnecessary treatment. We evaluated a new POC test, incorporating a nontreponemal component, to distinguish active from past infection. METHODS: Sera stored at 2 Australian laboratories were tested with DPP Screen and Confirm Assay. Treponemal and nontreponemal test lines were compared to corresponding conventional treponemal and nontreponemal reference test results: immunoassays and rapid plasma reagin (RPR), respectively, with RPR quantification by endpoint titration. POC test outcome concordance with conventional test results was assessed according to serological and clinical categories. RESULTS: Among 1005 serum samples tested, DPP treponemal line sensitivity was 89.8% (95% confidence interval [CI], 87.3%-91.9%) and specificity was 99.3% (95% CI, 97.0%-99.9%). DPP nontreponemal line sensitivity was 94.2% (95% CI, 91.8%-96.0%) and specificity was 62.2% (95% CI, 57.5%-66.6%). DPP test outcome (pair of test lines) was concordant with both reference test results for 94.3% of 404 high-titer infections, 90.1% of 121 low-titer infections, 27.5% of 211 past/treated infections, and 78.1% of 242 infections classified as not syphilis. Among 211 past/treated infections, 49.8% were incorrectly identified as active infection and a further 22.8% as not syphilis. CONCLUSIONS: DPP test use would result in identification of >93% of active syphilis infections, whereas just over half of past infections would be diagnosed as past or not syphilis, avoiding unnecessary treatment compared with other POC tests. This may be at the expense of missing some active infections; thus, its potential benefits will depend on the prevalence of past vs active infection in a population.

Rationale and design of FORTH: a randomised controlled trial assessing the effectiveness of HIV self-testing in increasing HIV testing frequency among gay and bisexual men.

BACKGROUND: Gay and bisexual men (GBM) are a major risk group for HIV acquisition, yet the majority of higher-risk GBM test for HIV less often than recommended (3-6 monthly). HIV self-testing has the potential to increase testing frequency and improve awareness of personal HIV status. HIV self-tests have been approved in some countries, however there are concerns whether self-testing would increase HIV testing frequency enough to compensate for the reduced sensitivity of self-tests in early infection. We describe here a randomised controlled trial to assess the effectiveness of self-testing in increasing HIV testing frequency among higher-risk GBM, and its acceptability. METHODS/DESIGN: Participants are higher-risk HIV negative GBM (>5 partners or condomless anal intercourse in previous 3 months; n = 350), including 50 GBM who tested for HIV over two years ago or never tested before ('infrequent-testers'). Participants are recruited from sexual health clinics and community-based organisations, and randomised 1:1 to either self-testing or standard-care (routine clinic-based testing) arms. The trial employs a wait-list control design: participants in the standard-care arm switch to self-testing arm in the second year, and gain access to self-test kits. Participants in the self-testing arm receive four oral-fluid self-test kits at enrolment, with additional kits provided on request. Demographics, sexual behaviour and HIV testing preferences are collected at baseline, and the frequency and pattern of HIV and sexually transmissible infection (STI) testing is collected via online 3-monthly questionnaires. The acceptability of self-testing is assessed at 12 months via an online questionnaire and in-depth interviews. A 24-h telephone support is provided, with expedited follow-up of those with reactive self-test results. The primary outcome is HIV testing frequency (mean number of HIV tests per person) over 12 months, and the secondary outcomes are: mean number of STI tests (chlamydia, gonorrhoea, syphilis) per person; reasons for HIV testing; and acceptability of HIV self-testing. DISCUSSION: This is the first trial to evaluate the use of self-testing among GBM in Australia, and the first internationally among infrequent testers. The study will provide evidence on whether self-testing increases HIV testing frequency, and its acceptability among GBM. The findings will improve our understanding of self-testing patterns, and whether GBM supplement or replace their existing testing routine. TRIAL REGISTRATION: Australian and New Zealand Clinical Trial Registration number: ACTRN12613001236785 , registered on November 12, 2013.

Potential public health benefits of HIV testing occurring at home in Australia.

In many countries, including Australia, policies have recently changed to support HIV self-testing. The decision has created much debate about the public health benefits of the strategy versus the risks. Self-testing for HIV was approved in the US on the basis that it would facilitate greater HIV testing uptake, despite having a lower sensitivity than laboratory HIV immunoassays. We calculated the frequency of self-testing that would be required among Australian gay and bisexual men at high-risk for there to be a public health benefit (detection of HIV infections that would have otherwise remained undiagnosed). At a population level, if access to HIV self-testing led to men supplementing their usual sexual health check-ups (involving a laboratory HIV immunoassay) with one or more self-tests at home, or self-tests led to untested gay and bisexual men having an HIV test for the first time, there would be a public health benefit. If men replaced their average of one laboratory HIV immunoassay per year with self-testing at home, then three self-tests would be needed to counteract the lower sensitivity of the self-test (so zero infections would be missed). If four self-tests were undertaken then additional infections would be detected (ie, there would be a public health benefit). Additional public health benefits include a reduction in the period of undiagnosed infection, which is known to be a period of relatively high infectiousness.

Impact of multimorbidity and complex multimorbidity on healthcare utilisation in older Australian adults aged 45 years or more: a large population-based cross-sectional data linkage study.

OBJECTIVES: As life expectancy increases, older people are living longer with multimorbidity (MM, co-occurrence of ≥2 chronic health conditions) and complex multimorbidity (CMM, ≥3 chronic conditions affecting ≥3 different body systems). We assessed the impacts of MM and CMM on healthcare service use in Australia, as little was known about this. DESIGN: Population-based cross-sectional data linkage study. SETTING: New South Wales, Australia. PARTICIPANTS: 248 496 people aged ≥45 years who completed the Sax Institute's 45 and Up Study baseline questionnaire. PRIMARY OUTCOME: High average annual healthcare service use (≥2 hospital admissions, ≥11 general practice visits and ≥2 emergency department (ED) visits) during the 3-year baseline period (year before, year of and year after recruitment). METHODS: Baseline questionnaire data were linked with hospital, Medicare claims and ED datasets. Poisson regression models were used to estimate adjusted and unadjusted prevalence ratios for high service use with 95% CIs. Using a count of chronic conditions (disease count) as an alternative morbidity metric was requested during peer review. RESULTS: Prevalence of MM and CMM was 43.8% and 15.5%, respectively, and prevalence increased with age. Across three healthcare settings, MM was associated with a 2.02-fold to 2.26-fold, and CMM was associated with a 1.83-fold to 2.08-fold, increased risk of high service use. The association was higher in the youngest group (45-59 years) versus the oldest group (≥75 years), which was confirmed when disease count was used as the morbidity metric in sensitivity analysis.When comparing impact using three categories with no overlap (no MM/CMM, MM with no CMM, and CMM), CMM had greater impact than MM across all settings. CONCLUSION: Increased healthcare service use among older adults with MM and CMM impacts on the demand for primary care and hospital services. Which of MM or CMM has greater impact on risk of high healthcare service use depends on the analytic method used. Ageing populations living longer with increasing burdens of MM and CMM will require increased Medicare funding and provision of integrated care across the healthcare system to meet their complex needs.

New South Wales data linkage study reveals a shift in HCC mortality risk: Time for broader strategies.

BACKGROUND: This study aims to examine the impact of sociodemographic and clinical factors on hepatocellular carcinoma (HCC) mortality in New South Wales (NSW), Australia. METHODS: We conducted a 15-year retrospective study (2001-2015) using data linkage of health records and cancer registry databases, to identify all HCC cases and analyse HCC-related and all-cause mortality rates. Location-based socioeconomic status (SES) was determined using the Socioeconomic Indexes for Areas (SEIFA). Multivariable Cox regression analysis was used to determine the effect of key variables on mortality. RESULTS: 5564 cases of HCC were diagnosed during the study period. A study cohort of 5454 cases was analysed after excluding cases with key missing data. More than half of the chronic liver disease cases were due to non-viral causes. During the study period, 4033 deaths occurred, of which 2862 were HCC-related. The median survival time for HCC-related deaths was 547 days, and the 5-year survival rate was 31.3 %. Higher HCC-related mortality rates were observed in SEIFA quintiles 2, 3 and 4, when compared to 5 (where SEIFA 1 is most disadvantaged, and SEIFA 5 is most advantaged). Furthermore, significantly increased HCC-related mortality was observed for those aged ≥65, male gender, Australian-born, hospitalisation due to complications of alcohol use, having metastatic HCC at diagnosis, and not receiving surgery for HCC. CONCLUSIONS: There is higher prevalence of non-viral-related HCC than viral-related HCC in NSW, Australia, where HCC-related mortality risk is greatest among those Australian-born and lower to higher SES, when compared to highest SES. Identifying factors contributing to these emerging disparities is crucial for developing effective prevention programs and allocating research and health resources.

Which gay men would increase their frequency of HIV testing with home self-testing?

Many Australian gay men do not get tested for HIV at the recommended frequency. Barriers to HIV testing may be reduced by the availability of home HIV self-testing (HHST). An online cross-sectional questionnaire was conducted with 2,306 Australian gay men during 2009. Multivariate logistic regression identified factors associated with being likely to increase testing frequency if HHST was available, among previously-tested and never-tested men. Among 2,018 non-HIV-positive men, 83.9% had been tested. Two-thirds indicated they would test more often if HHST was available irrespective of previous testing history. In multivariate analysis, independent predictors of increased testing frequency with HHST included preferences for more convenient testing, not having to see a doctor when testing and wanting immediate results among all men, as well as not being from an Anglo-Australian background and recent unprotected anal sex with casual partners among previously-tested men only. The majority of gay men report that being able to test themselves at home would increase their frequency of HIV testing.

Impact of multimorbidity and complex multimorbidity on mortality among older Australians aged 45 years and over: a large population-based record linkage study.

OBJECTIVES: Multimorbidity (MM, co-occurrence of two or more chronic conditions) and complex multimorbidity (CMM, three or more chronic conditions affecting three or more different body systems) are used in the assessment of complex healthcare needs and their impact on health outcomes. However, little is known about the impacts of MM and CMM on mortality in Australia. DESIGN: Community-based prospective cohort study. SETTING: New South Wales, Australia. PARTICIPANTS: People aged 45 years and over who completed the baseline survey of the 45 and Up Study. MEASURES: Baseline survey data from the 45 and Up Study were linked with deaths registry data. Deaths that occurred within 8 years from the baseline survey date were the study outcome. Eleven self-reported chronic conditions (cancer, heart disease, diabetes, stroke, Parkinson's disease, depression/anxiety, asthma, allergic rhinitis, hypertension, thrombosis and musculoskeletal conditions) from the baseline survey were included in the MM and CMM classifications. Cox proportional hazard models were used to estimate adjusted and unadjusted 8-year mortality hazard ratios (HRs). RESULTS: Of 251 689 people (53% female and 54% aged ≥60 years) in the cohort, 111 084 (44.1%) were classified as having MM and 39 478 (15.7%) as having CMM. During the 8-year follow-up, there were 25 891 deaths. Cancer (34.7%) was the most prevalent chronic condition and the cardiovascular system (50.9%) was the body system most affected by a chronic condition. MM and CMM were associated with a 37% (adjusted HR 1.36, 95% CI 1.32 to 1.40) and a 22% (adjusted HR 1.22, 95% CI 1.18 to 1.25) increased risk of death, respectively. The relative impact of MM and CMM on mortality decreased as age increased. CONCLUSION: MM and CMM were common in older Australian adults; and MM was a better predictor of all-cause mortality risk than CMM. Higher mortality risk in those aged 45-59 years indicates tailored, person-centred integrated care interventions and better access to holistic healthcare are needed for this age group.

The longer-term effects of access to HIV self-tests on HIV testing frequency in high-risk gay and bisexual men: follow-up data from a randomised controlled trial.

BACKGROUND: A wait-list randomised controlled trial in Australia (FORTH) in high-risk gay and bisexual men (GBM) showed access to free HIV self-tests (HIVSTs) doubled the frequency of HIV testing in year 1 to reach guideline recommended levels of 4 tests per year, compared to two tests per year in the standard-care arm (facility-based testing). In year 2, men in both arms had access to HIVSTs. We assessed if the effect was maintained for a further 12 months. METHODS: Participants included GBM reporting condomless anal intercourse or > 5 male partners in the past 3 months. We included men who had completed at least one survey in both year 1 and 2 and calculated the mean tests per person, based on the validated self-report and clinic records. We used Poisson regression and random effects Poisson regression models to compare the overall testing frequency by study arm, year and testing modality (HIVST/facility-based test). FINDINGS: Overall, 362 men completed at least one survey in year 1 and 343 in year 2. Among men in the intervention arm (access to HIVSTs in both years), the mean number of HIV tests in year 2 (3⋅7 overall, 2⋅3 facility-based tests, 1⋅4 HIVSTs) was lower compared to year 1 (4⋅1 overall, 1⋅7 facility-based tests, 2⋅4 HIVSTs) (RR:0⋅84, 95% CI:0⋅75-0⋅95, p=0⋅002), but higher than the standard-care arm in year 1 (2⋅0 overall, RR:1⋅71, 95% CI:1⋅48-1.97, p<0⋅001). Findings were not different when stratified by sociodemographic characteristics or recent high risk sexual history. INTERPRETATION: In year 2, fewer HIVSTs were used on average compared to year 1, but access to free HIVSTs enabled more men to maintain higher HIV testing frequency, compared with facility-based testing only. HIV self-testing should be a key component of HIV testing and prevention strategies. FUNDING: This work was supported by grant 568971 from the National Health and Medical Research Council of Australia.

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.

HIV testing self-efficacy is associated with higher HIV testing frequency and perceived likelihood to self-test among gay and bisexual men.

Background Regular testing of individuals at higher-risk of HIV is central to current prevention strategies. The aim of the present study was to examine the extent to which confidence in one's perceived ability to undertake various aspects of HIV testing and self-testing (self-efficacy) affected HIV testing outcomes. We assessed factors, including self-efficacy, associated with HIV testing frequency and the likelihood to self-test among gay and bisexual men (GBM). METHODS: Participants were HIV-negative GBM at an increased risk of HIV (more than five partners or condomless anal intercourse in the previous 3 months) enrolled in a randomised controlled trial of HIV self-testing. The baseline questionnaire captured data regarding sociodemographic characteristics, HIV and/or sexually transmissible infection testing history, sexual behaviour, beliefs and attitudes towards HIV and eight items capturing confidence in HIV testing ability that were combined as a single broad measure of HIV testing self-efficacy (α=0.81). Factors associated with three or more HIV tests in the past year and the likelihood of self-testing in the future were determined using logistic regression. RESULTS: Of 354 GBM, 34% reported three or more HIV tests in the past year, and 64% reported being 'very likely' to self-test. Factors independently associated with three or more HIV tests in the past year were: higher self-efficacy (adjusted odds ratio (aOR) 1.08 per unit increase; 95% confidence interval (CI) 1.02-1.14; P=0.004); >10 male partners in the past 6 months (aOR 1.79; 95% CI 1.05-3.04; P=0.031) and higher optimism regarding the effects of HIV treatments on HIV transmission (aOR 1.14; 95% CI 1.00-1.29; P=0.044). Only higher self-efficacy was independently associated with reporting a greater likelihood to self-test in the future (aOR 1.10; 95% CI 1.05-1.15; P < 0.001). CONCLUSIONS: Improving self-efficacy by enhancing GBM's knowledge and experience may lead to higher testing frequency. The self-efficacy measure used in the present study could be useful in identifying GBM likely to face difficulties with HIV testing and self-testing.

Effect of availability of HIV self-testing on HIV testing frequency in gay and bisexual men at high risk of infection (FORTH): a waiting-list randomised controlled trial.

BACKGROUND: Frequent testing of individuals at high risk of HIV is central to current prevention strategies. We aimed to determine if HIV self-testing would increase frequency of testing in high-risk gay and bisexual men, with a particular focus on men who delayed testing or had never been tested before. METHODS: In this randomised trial, HIV-negative high-risk gay and bisexual men who reported condomless anal intercourse or more than five male sexual partners in the past 3 months were recruited at three clinical and two community-based sites in Australia. Enrolled participants were randomly assigned (1:1) to the intervention (free HIV self-testing plus facility-based testing) or standard care (facility-based testing only). Participants completed a brief online questionnaire every 3 months, which collected the number of self-tests used and the number and location of facility-based tests, and HIV testing was subsequently sourced from clinical records. The primary outcome of number of HIV tests over 12 months was assessed overall and in two strata: recent (last test ≤2 years ago) and non-recent (>2 years ago or never tested) testers. A statistician who was masked to group allocation analysed the data; analyses included all participants who completed at least one follow-up questionnaire. After the 12 month follow-up, men in the standard care group were offered free self-testing kits for a year. This trial is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12613001236785. FINDINGS: Between Dec 1, 2013, and Feb 5, 2015, 182 men were randomly assigned to self-testing, and 180 to standard care. The analysis population included 178 (98%) men in the self-testing group (174 person-years) and 165 (92%) in the standard care group (162 person-years). Overall, men in the self-testing group had 701 HIV tests (410 self-tests; mean 4·0 tests per year), and men in the standard care group had 313 HIV tests (mean 1·9 tests per year); rate ratio (RR) 2·08 (95% CI 1·82-2·38; p<0·0001). Among recent testers, men in the self-testing group had 627 tests (356 self-tests; mean 4·2 per year), and men in the standard care group had 297 tests (mean 2·1 per year); RR 1·99 (1·73-2·29; p<0·0001). Among non-recent testers, men in the self-testing group had 74 tests (54 self-tests; mean 2·8 per year), and men in the standard care group had 16 tests (mean 0·7 per year); RR 3·95 (2·30-6·78; p<0·0001). The mean number of facility-based HIV tests per year was similar in the self-testing and standard care groups (mean 1·7 vs 1·9 per year, respectively; RR 0·86, 0·74-1·01; p=0·074). No serious adverse events were reported during follow-up. INTERPRETATION: HIV self-testing resulted in a two times increase in frequency of testing in gay and bisexual men at high risk of infection, and a nearly four times increase in non-recent testers, compared with standard care, without reducing the frequency of facility-based HIV testing. HIV self-testing should be made more widely available to help increase testing and earlier diagnosis. FUNDING: The National Health and Medical Research Council, Australia.

Barriers to HIV testing and characteristics associated with never testing among gay and bisexual men attending sexual health clinics in Sydney.

INTRODUCTION: HIV diagnoses among gay and bisexual men have increased over the past decade in Australia. HIV point-of-care testing (POCT) was introduced in Australia in 2011 as a strategy to increase HIV testing by making the testing process more convenient. We surveyed gay and bisexual men undergoing POCT to assess barriers to HIV testing and characteristics associated with not having previously tested for HIV (never testing). METHODS: During 2011 and 2012, gay and bisexual men who were undergoing POCT at four Sydney sexual health clinics self-completed questionnaires assessing testing history and psychological and structural barriers to HIV testing. Bivariate and multivariate logistic regression was used to assess associations between patient characteristics and never testing. RESULTS: Of 1093 participants, 981 (89.9%) reported ever testing for HIV and 110 (10.1%) never testing. At least one barrier to testing was reported by 1046 men (95.7%), with only 47 men (4.3%) not reporting any barrier to testing. The most commonly reported barriers to testing were annoyance at having to return for results (30.2%), not having done anything risky (29.6%), stress in waiting for results (28.4%), being afraid of testing positive (27.5%) and having tested recently (23.2%). Never testing was independently associated with being non-gay-identified (adjusted odds ratio [AOR]: 1.9; 95% confidence interval [CI]: 1.1-3.2), being aged less than 25 years (AOR: 2.4; 95% CI: 1.6-3.8), living in a suburb with few gay couples (AOR: 1.9; 95% CI: 1.2-3.0), being afraid of testing HIV-positive (AOR: 1.6; 95% CI: 1.0-2.4), not knowing where to test (AOR: 3.8; 95% CI: 1.3-11.2) and reporting one or no sexual partners in the last six months (AOR: 2.7; 95% CI: 1.2-6.2). CONCLUSIONS: Barriers to HIV testing were commonly reported among the clinic-based gay and bisexual men in this study. Our findings suggest further health promotion and prevention strategies are needed to address the knowledge, attitudes and behavioural factors associated with never testing.

Rapid HIV Testing Is Highly Acceptable and Preferred among High-Risk Gay And Bisexual Men after Implementation in Sydney Sexual Health Clinics.

BACKGROUND: Rapid HIV testing (RHT) is well established in many countries, but it is new in Australia. We assessed the acceptability of RHT and its associations among gay, bisexual and other men who have sex with men (GBM) after implementation of RHT in Sydney sexual health clinics. METHODS: GBM were invited to complete an acceptability questionnaire before and after provision of the result of finger-prick blood RHT, comparing their experience of RHT with conventional HIV testing (CHT) involving venipuncture. Logistic regression was used to assess associations between patient characteristics and the preference for RHT over CHT next time they tested for HIV. RESULTS: Of 1061 GBM who received non-reactive RHT results, 59% found RHT less stressful than CHT and 34% reported no difference, and 61% found RHT more comfortable than CHT and 26% reported no difference. Nearly all men were satisfied with RHT result delivery (99%) and the RHT process overall (99%). Most men (79%) preferred RHT for their next HIV test and this preference was stronger in men who were aged 35-44 years (adjusted odds ratio [AOR] 2.49, p<0.01), reported they would test more often if RHT was available (AOR 1.66, p=0.01), found returning for results annoying (AOR 1.67, p=0.01), and found RHT less stressful (AOR 2.37, p<0.01) and more comfortable (AOR 1.62, p=0.02) than CHT. Men concerned about the reliability of RHT were less than half as likely to prefer RHT for their next HIV test (AOR 0.44, p<0.01). CONCLUSIONS: Most GBM preferred RHT to CHT next time and this preference was associated with finding RHT more convenient, more comfortable and less stressful than CHT. These findings suggest that in a clinic setting RHT should be considered to improve the patient experience and may potentially increase uptake and frequency of HIV testing.

Multi-centre evaluation of the Determine HIV Combo assay when used for point of care testing in a high risk clinic-based population.

BACKGROUND: Determine HIV Combo (DHC) is the first point of care assay designed to increase sensitivity in early infection by detecting both HIV antibody and antigen. We conducted a large multi-centre evaluation of DHC performance in Sydney sexual health clinics. METHODS: We compared DHC performance (overall, by test component and in early infection) with conventional laboratory HIV serology (fourth generation screening immunoassay, supplementary HIV antibody, p24 antigen and Western blot tests) when testing gay and bisexual men attending four clinic sites. Early infection was defined as either acute or recent HIV infection acquired within the last six months. RESULTS: Of 3,190 evaluation specimens, 39 were confirmed as HIV-positive (12 with early infection) and 3,133 were HIV-negative by reference testing. DHC sensitivity was 87.2% overall and 94.4% and 0% for the antibody and antigen components, respectively. Sensitivity in early infection was 66.7% (all DHC antibody reactive) and the DHC antigen component detected none of nine HIV p24 antigen positive specimens. Median HIV RNA was higher in false negative than true positive cases (238,025 vs. 37,591 copies/ml; p = 0.022). Specificity overall was 99.4% with the antigen component contributing to 33% of false positives. CONCLUSIONS: The DHC antibody component detected two thirds of those with early infection, while the DHC antigen component did not enhance performance during point of care HIV testing in a high risk clinic-based population.

A laboratory-based evaluation of four rapid point-of-care tests for syphilis.

BACKGROUND: Syphilis point-of-care tests may reduce morbidity and ongoing transmission by increasing the proportion of people rapidly treated. Syphilis stage and co-infection with HIV may influence test performance. We evaluated four commercially available syphilis point-of-care devices in a head-to-head comparison using sera from laboratories in Australia. METHODS: Point-of-care tests were evaluated using sera stored at Sydney and Melbourne laboratories. Sensitivity and specificity were calculated by standard methods, comparing point-of-care results to treponemal immunoassay (IA) reference test results. Additional analyses by clinical syphilis stage, HIV status, and non-treponemal antibody titre were performed. Non-overlapping 95% confidence intervals (CI) were considered statistically significant differences in estimates. RESULTS: In total 1203 specimens were tested (736 IA-reactive, 467 IA-nonreactive). Point-of-care test sensitivities were: Determine 97.3%(95%CI:95.8-98.3), Onsite 92.5%(90.3-94.3), DPP 89.8%(87.3-91.9) and Bioline 87.8%(85.1-90.0). Specificities were: Determine 96.4%(94.1-97.8), Onsite 92.5%(90.3-94.3), DPP 98.3%(96.5-99.2), and Bioline 98.5%(96.8-99.3). Sensitivity of the Determine test was 100% for primary and 100% for secondary syphilis. The three other tests had reduced sensitivity among primary (80.4-90.2%) compared to secondary syphilis (94.3-98.6%). No significant differences in sensitivity were observed by HIV status. Test sensitivities were significantly higher among high-RPR titre (RPR ≥ 8) (range: 94.6-99.5%) than RPR non-reactive infections (range: 76.3-92.9%). CONCLUSIONS: The Determine test had the highest sensitivity overall. All tests were most sensitive among high-RPR titre infections. Point-of-care tests have a role in syphilis control programs however in developed countries with established laboratory infrastructures, the lower sensitivities of some tests observed in primary syphilis suggest these would need to be supplemented with additional tests among populations where syphilis incidence is high to avoid missing early syphilis cases.