Hepatitis C incidence among patients attending primary care health services that specialise in the care of people who inject drugs, Victoria, Australia, 2009 to 2020.

BACKGROUND: Monitoring trends in hepatitis C virus (HCV) incidence is critical for evaluating strategies aimed at eliminating HCV as a public health threat. We estimate HCV incidence and assess trends in incidence over time among primary care patients. METHODS: Data were routinely extracted, linked electronic medical records from 12 primary care health services. Patients included were aged ≥16 years, tested HCV antibody negative on their first test recorded and had at least one subsequent HCV antibody or RNA test (January 2009-December 2020). HCV incident infections were defined as a positive HCV antibody or RNA test. A generalised linear model assessed the association between HCV incidence and calendar year. RESULTS: In total, 6711 patients contributed 17,098 HCV test records, 210 incident HCV infections and 19,566 person-years; incidence was 1.1 per 100 person-years (95% confidence interval (CI): 0.9 to 1.2). Among 559 (8.2%) patients ever prescribed opioid-related pharmacotherapy (ORP) during the observation period, 135 infections occurred during 2,082 person-years (incidence rate of 6.5 per 100 person-years (95% CI: 5.4 to 7.7)). HCV incidence declined 2009-2020 overall (incidence rate ratio per calendar year 0.8 (95% CI: 0.8 to 0.9) and among patients ever prescribed ORT (incidence rate ratio per calendar year 0.9, 95% CI: 0.75 to 1.0). CONCLUSION: HCV incidence declined among patients at primary care health services including among patients ever prescribed ORP and during the period following increased access to DAA therapy.

The impact of removing financial incentives and/or audit and feedback on chlamydia testing in general practice: A cluster randomised controlled trial (ACCEPt-able).

BACKGROUND: Financial incentives and audit/feedback are widely used in primary care to influence clinician behaviour and increase quality of care. While observational data suggest a decline in quality when these interventions are stopped, their removal has not been evaluated in a randomised controlled trial (RCT), to our knowledge. This trial aimed to determine whether chlamydia testing in general practice is sustained when financial incentives and/or audit/feedback are removed. METHODS AND FINDINGS: We undertook a 2 × 2 factorial cluster RCT in 60 general practices in 4 Australian states targeting 49,525 patients aged 16-29 years for annual chlamydia testing. Clinics were recruited between July 2014 and September 2015 and were followed for up to 2 years or until 31 December 2016. Clinics were eligible if they were in the intervention group of a previous cluster RCT where general practitioners (GPs) received financial incentives (AU$5-AU$8) for each chlamydia test and quarterly audit/feedback reports of their chlamydia testing rates. Clinics were randomised into 1 of 4 groups: incentives removed but audit/feedback retained (group A), audit/feedback removed but incentives retained (group B), both removed (group C), or both retained (group D). The primary outcome was the annual chlamydia testing rate among 16- to 29-year-old patients, where the numerator was the number who had at least 1 chlamydia test within 12 months and the denominator was the number who had at least 1 consultation during the same 12 months. We undertook a factorial analysis in which we investigated the effects of removal versus retention of incentives (groups A + C versus groups B + D) and the effects of removal versus retention of audit/feedback (group B + C versus groups A + D) separately. Of 60 clinics, 59 were randomised and 55 (91.7%) provided data (group A: 15 clinics, 11,196 patients; group B: 14, 11,944; group C: 13, 11,566; group D: 13, 14,819). Annual testing decreased from 20.2% to 11.7% (difference -8.8%; 95% CI -10.5% to -7.0%) in clinics with incentives removed and decreased from 20.6% to 14.3% (difference -7.1%; 95% CI -9.6% to -4.7%) where incentives were retained. The adjusted absolute difference in treatment effect was -0.9% (95% CI -3.5% to 1.7%; p = 0.2267). Annual testing decreased from 21.0% to 11.6% (difference -9.5%; 95% CI -11.7% to -7.4%) in clinics where audit/feedback was removed and decreased from 19.9% to 14.5% (difference -6.4%; 95% CI -8.6% to -4.2%) where audit/feedback was retained. The adjusted absolute difference in treatment effect was -2.6% (95% CI -5.4% to -0.1%; p = 0.0336). Study limitations included an unexpected reduction in testing across all groups impacting statistical power, loss of 4 clinics after randomisation, and inclusion of rural clinics only. CONCLUSIONS: Audit/feedback is more effective than financial incentives of AU$5-AU$8 per chlamydia test at sustaining GP chlamydia testing practices over time in Australian general practice. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12614000595617.

The sexual behaviours of adolescents aged between 14 and 17 years involved with the juvenile justice system in Australia: A community-based survey.

OBJECTIVES: To overcome key knowledge gaps in relation to justice involved and vulnerable young people and their sexual health and to compare this group with their peers from other youth health surveys in Australia to determine the extent of the issues. METHODS: Young people, aged between 14 and 17 years, who had ever been or were currently involved with the criminal justice system were purposively sampled. The survey was anonymous and delivered using Computer Assisted Telephone Interview (CATI). RESULTS: A total of 465 justice involved MeH-JOSH young people, aged between 14 and 17 years, participated in the study: 44% Aboriginal and/or Torres Strait Islander (Indigenous) and 37% not attending school. Of the total valid responses, 76% (n = 348) reported having ever had sex, with sexual initiation at a median age of 14 years. We compared these data with their peers in other Australian surveys and found that young people in our study had a higher engagement in sex and start having sex at a younger age, reporting more sexual partners at all ages. CONCLUSIONS: The sexual behaviours of young people involved in the justice system in this study suggest they may be at a greater risk for sexually transmissible infections than their age-matched peers in the general population. Policymakers should elevate them to a priority population for targeting sexual health services and health promotion.

Incomplete recording of Indigenous identification status under-estimates the prevalence of Indigenous population attending Australian general practices: a cross sectional study.

BACKGROUND: Australian Aboriginal and Torres Strait Islander (Indigenous) peoples face major health disadvantage across many conditions. Recording of patients' Indigenous status in general practice records supports equitable delivery of effective clinical services. National policy and accreditation standards mandate recording of Indigenous status in patient records, however for a large proportion of general practice patient records it remains incomplete. We assessed the completeness of Indigenous status in general practice patient records, and compared the patient self-reported Indigenous status to general practice medical records. METHODS: A cross sectional analysis of Indigenous status recorded at 95 Australian general practices, participating in the Australian Chlamydia Control Effectiveness Pilot (ACCEPt) in 2011. Demographic data were collected from medical records and patient surveys from 16 to 29 year old patients at general practices, and population composition from the 2011 Australian census. General practitioners (GPs) at the same practices were also surveyed. Completeness of Indigenous status in general practice patient records was measured with a 75% benchmark used in accreditation standards. Indigenous population composition from a patient self-reported survey was compared to Indigenous population composition in general practice records, and Australian census data. RESULTS: Indigenous status was complete in 56% (median 60%, IQR 7-81%) of general practice records for 109,970 patients aged 16-29 years, and Indigenous status was complete for 92.5% of the 3355 patients aged 16-29 years who completed the survey at the same clinics. The median proportion per clinic of patients identified as Indigenous was 0.9%, lower than the 1.8% from the patient surveys and the 1.7% in clinic postcodes (ABS). Correlations between the proportion of Indigenous people self-reporting in the patient survey (5.2%) compared to status recorded in all patient records (2.1%) showed a fair association (r = 0.6468; p < 0.01). After excluding unknown /missing data, correlations weakened. CONCLUSIONS: Incomplete Indigenous status records may under-estimate the true proportion of Indigenous people attending clinics but have higher association with self-reported status than estimates which exclude missing/unknown data. The reasons for incomplete Indigenous status recording in general practice should be explored so efforts to improve recording can be targeted and strengthened. TRIAL REGISTRATION: ACTRN12610000297022 . Registered 13th April 2010.

ADOPTing a new method of partner management for genital chlamydia in New South Wales: findings from a pilot implementation program of patient-delivered partner therapy.

Background Patient-delivered partner therapy (PDPT) for chlamydia is an effective and safe additional partner management strategy. Some Australian regulatory changes have been made to support PDPT, but implementation guidance is lacking. This paper describes a pilot implementation program of PDPT in New South Wales (NSW), the Australian Development and Operationalisation of Partner Therapy (ADOPT). METHODS: ADOPT involved: (1) clarification of the NSW PDPT legal and policy framework; (2) development and implementation of PDPT service models, resources and data collection tools for select publicly funded sexual health services (PFSHS) and Family Planning (FP) NSW clinics; and (3) evaluation of PDPT uptake. RESULTS: PDPT can be undertaken in NSW if accompanied by adequate provider, patient and partner information. Regulatory amendments enabled medication prescribing. The pilot implementation took place in four PFSHS and five FPNSW clinics from January to December 2016. In PFSHS, 30% of eligible patients were offered PDPT and 89% accepted the offer. In FPNSW clinics, 42% of eligible patients were offered PDPT and 63% accepted the offer. Most partners for whom PDPT was accepted were regular partners. CONCLUSIONS: A close collaboration of researchers, policy makers and clinicians allowed successful implementation of a PDPT model for chlamydia in heterosexual patients at select PFSHS and FPNSW clinics, providing guidance on its use as standard of care. However, for the full public health benefits of PDPT to be realised, it must be implemented in general practice, where most chlamydia is diagnosed. Further work is recommended to explore feasibility, develop guidelines and promote the integration of PDPT into general practice.

HIV incidence in Indigenous and non-Indigenous populations in Australia: a population-level observational study.

BACKGROUND: Australia has set a national target of ending HIV by 2020, achieving this will require the inclusion of priority populations (eg, Indigenous Australians) in strategies to reach elimination. To assist in evaluating the target of elimination, we analysed HIV notification data for Indigenous and non-Indigenous Australians. METHODS: Using the National HIV Registry at The Kirby Institute at UNSW, Sydney, NSW, Australia, we collated and analysed annual HIV notification data for 1996-2015. Patients who were not born in Australia were excluded. We calculated the rates of HIV diagnoses with annual trends in notification rates for Indigenous versus non-Indigenous Australians by demographic characteristics, exposure categories, and stage of HIV at diagnosis. For missing data, assumptions were made and verified through sensitivity analyses. Annual rate ratio (RR) and 4 year summary rate ratio (SRR) trends were calculated to determine patterns of HIV diagnosis in the two populations. FINDINGS: Between Jan 1, 1996, and Dec 31, 2015, 11 492 people born in Australia were reported with a diagnosis of HIV, of whom 461 (4%) were recorded as Indigenous Australians and we classified the remaining 11 031 (96%) as non-Indigenous Australians. For exposure to HIV, among Indigenous Australians a higher proportion of diagnoses occurred among women, and through injecting drug use and heterosexual sex than among non-Indigenous Australians (p<0·0001). Among Indigenous Australians, we found a significantly higher SRR of HIV diagnoses among men in the period 2012-15 than in previous periods (SRR 1·53, 95% CI 1·28-1·83; p<0·0001), and significantly higher diagnosis among Indigenous women (4·92, 4·02-6·02; p<0·0001) for the entire study period than among non-Indigenous women. Concurrently, a decrease in HIV diagnoses of 1% per annum (RR 0·99, 95% CI 0·98-0·99; p<0·0001) across the study period was seen among non-Indigenous people. Indigenous Australians were more likely to be diagnosed at an advanced stage of HIV infection than non-Indigenous Australians (20·8% vs 15·1%; p=0·0088). INTERPRETATION: Greater efforts should be made to include Indigenous people in prevention strategies, particularly newer biomedical interventions, such as scale up of pre-exposure prophylaxis and treatment as prevention initiatives in Australia. More involvement of Indigenous Australians in these approaches is also required to prevent widening of the gap in HIV diagnosis rates between non-Indigenous and Indigenous Australians. FUNDING: None.

Hepatitis C testing and re-testing among people attending sexual health services in Australia, and hepatitis C incidence among people with human immunodeficiency virus: analysis of national sentinel surveillance data.

BACKGROUND: Direct acting antivirals are expected to drastically reduce the burden of hepatitis C virus (HCV) in people living with Human Immunodeficiency Virus (HIV). However, rates of HCV testing, re-testing and incident infection in this group remain uncertain in Australia. We assessed trends in HCV testing, re-testing and incident infection among HIV-positive individuals, and evaluated factors associated with HCV re-testing and incident infection. METHODS: The study population consisted of HIV-positive individuals who visited a sexual health service involved in the Australian Collaboration for Coordinated Enhanced Sentinel Surveillance (ACCESS) between 2007 and 2015. Poisson regression was used to assess trends and to evaluate factors associated with HCV re-testing and incident HCV infection. RESULTS: There were 9227 HIV-positive individuals included in our testing rate analysis. Of 3799 HIV-positive/HCV-negative people that attended an ACCESS sexual health service more than once, 2079 (54.7%) were re-tested for HCV and were therefore eligible for our incidence analysis. The rate of HCV testing increased from 17.1 to 51.4 tests per 100 patient years between 2007 and 2015 (p for trend <0.01). Over the same period, HCV re-testing rates increased from 23.9 to 79.7 tests per 100 person years (p for trend <0.01). A clear increase in testing and re-testing began after 2011. Patients who identified as men who have sex with men and those with a history of injecting drug use experienced high rates of HCV re-testing over the course of the study period. Among those who re-tested, 157 incident HCV infections occurred at a rate of 2.5 events per 100 person years. Between 2007 and 2009, 2010-2011, 2012-2013 and 2014-2015, rates of incident HCV were 0.8, 1.5, 3.9 and 2.7 events per 100 person years, respectively (p for trend <0.01). Incident HCV was strongly associated with a history of injecting drug use. CONCLUSIONS: High rates of HCV testing and re-testing among HIV-positive individuals in Australia will assist strategies to achieve HCV elimination through rapid treatment scale up. Continued monitoring of HCV incidence in this population is essential for guiding both HCV prevention and treatment strategies.

Can preventive care activities in general practice be sustained when financial incentives and external audit plus feedback are removed? ACCEPt-able: a cluster randomised controlled trial protocol.

BACKGROUND: Financial incentives and audit plus feedback on performance are two strategies commonly used by governments to motivate general practitioners (GP) to undertake specific healthcare activities. However, in recent years, governments have reduced or removed incentive payments without evidence of the potential impact on GP behaviour and patient outcomes. This trial (known as ACCEPt-able) aims to determine whether preventive care activities in general practice are sustained when financial incentives and/or external audit plus feedback on preventive care activities are removed. The activity investigated is annual chlamydia testing for 16- to 29-year-old adults, a key preventive health strategy within this age group. METHODS/DESIGN: ACCEPt-able builds on a large cluster randomised controlled trial (RCT) that evaluated a 3-year chlamydia testing intervention in general practice. GPs were provided with a support package to facilitate annual chlamydia testing of all sexually active 16- to 29-year-old patients. This package included financial incentive payments to the GP for each chlamydia test conducted and external audit plus feedback on each GP's chlamydia testing rates. ACCEPt-able is a factorial cluster RCT in which general practices are randomised to one of four groups: (i) removal of audit plus feedback-continue to receive financial incentive payments for each chlamydia test; (ii) removal of financial incentive payments-continue to receive audit plus feedback; (iii) removal of financial incentive payments and audit plus feedback; and (iv) continue financial incentive payments and audit plus feedback. The primary outcome is chlamydia testing rate measured as the proportion of sexually active 16- to 29-year-olds who have a GP consultation within a 12-month period and at least one chlamydia test. DISCUSSION: This will be the first RCT to examine the impact of removal of financial incentive payments and audit plus feedback on the chlamydia testing behaviour of GPs. This trial is particularly timely and will increase our understanding about the impact of financial incentives and audit plus feedback on GP behaviour when governments are looking for opportunities to control healthcare budgets and maximise clinical outcomes for money spent. The results of this trial will have implications for supporting preventive health measures beyond the content area of chlamydia. TRIAL REGISTRATION: The trial has been registered on the Australian and New Zealand Clinical Trials Registry ( ACTRN12614000595617 ).

Was an epidemic of gonorrhoea among heterosexuals attending an Adelaide sexual health services associated with variations in sex work policing policy?

BACKGROUND: A review of historical trends in gonococcal diagnoses made at the Adelaide Sexual Health Clinic (ASHC), South Australia, identified a substantial rise in diagnoses among heterosexuals between 2006 and 2010. Sex work is illegal in South Australia, regulated in Victoria and legal in New South Wales. This and other factors that could have influenced the epidemic were explored in this analysis. METHODS: Retrospective analyses of gonorrhoea diagnoses made by sexual health services between 1990 and 2012 in three Australian state capitals, Melbourne (Victoria) and Sydney (New South Wales) were undertaken. RESULTS: At the ASHC the proportion of gonorrhoea diagnoses was higher between 2006 and 2010 among heterosexual men (5.34% vs 0.84%, p<0.001), non-sex worker women (0.64% vs 0.28%, p<0.001) and female sex workers (FSWs) (1.75% vs 0.24%, p<0.001) compared with other years. This relationship was not seen at the Melbourne Sexual Health Clinic and corresponding data from the Sydney Sexual Health Centre showed that FSWs were less likely to have gonorrhoea between 2006 and 2010 than the other groups (p=0.746, p=0.522, p=0.024, respectively). At ASHC FSWs were significantly more likely to be diagnosed between 2006 and 2010 (OR 2.8, 95% CI 1.48 to 5.27, p=0.002). Charges against sex workers peaked in 2007/2008. CONCLUSIONS: A substantial, self-limiting rise in diagnoses of heterosexual gonorrhoea was seen in Adelaide FSWs between 2006 and 2010. Removing barriers to condom use is vital to the prevention of HIV and STI transmission.

Methods of a national survey of young Aboriginal and Torres Strait Islander people regarding sexually transmissible infections and bloodborne viruses.

OBJECTIVE: To describe the methods and basic demographics of participants in a national survey of Aboriginal and Torres Strait Islander (Aboriginal) people specific to sexually transmissible infections and bloodborne viruses. METHODS: A national cross-sectional survey of Aboriginal people aged 16-29 years in all Australian jurisdictions between 2011 and 2013 conducted at Aboriginal community events. Questions comprised demographic information, knowledge, risk behaviours and health service utilisation. Questionnaires were completed on personal digital assistants (PDAs). RESULTS: A total of 2,877 people at 21 unique community events completed the questionnaire. A total of 59% of participants were female, median age was 21 years and more than 60% were single at the time of the survey. Just over half the participants were resident in an urban area (53%) and 38% were from a regional area. Aboriginal health organisations played an important role in implementing the research. PDAs were found to be an acceptable method for collecting health information. CONCLUSION: This survey has recruited a large representative sample of Aboriginal people aged 16-29 years using a methodology that is feasible, acceptable and repeatable. IMPLICATIONS: The methodology provides a model for ongoing monitoring of this population as programs and policies are implemented to address young Aboriginal people's STI and BBV risks.

Population-level impact and herd effects following human papillomavirus vaccination programmes: a systematic review and meta-analysis.

BACKGROUND: Human papillomavirus (HPV) vaccination programmes were first implemented in several countries worldwide in 2007. We did a systematic review and meta-analysis to assess the population-level consequences and herd effects after female HPV vaccination programmes, to verify whether or not the high efficacy reported in randomised controlled clinical trials are materialising in real-world situations. METHODS: We searched the Medline and Embase databases (between Jan 1, 2007 and Feb 28, 2014) and conference abstracts for time-trend studies that analysed changes, between the pre-vaccination and post-vaccination periods, in the incidence or prevalence of at least one HPV-related endpoint: HPV infection, anogenital warts, and high-grade cervical lesions. We used random-effects models to derive pooled relative risk (RR) estimates. We stratified all analyses by age and sex. We did subgroup analyses by comparing studies according to vaccine type, vaccination coverage, and years since implementation of the vaccination programme. We assessed heterogeneity across studies using I(2) and χ(2) statistics and we did trends analysis to examine the dose-response association between HPV vaccination coverage and each study effect measure. FINDINGS: We identified 20 eligible studies, which were all undertaken in nine high-income countries and represent more than 140 million person-years of follow-up. In countries with female vaccination coverage of at least 50%, HPV type 16 and 18 infections decreased significantly between the pre-vaccination and post-vaccination periods by 68% (RR 0·32, 95% CI 0·19-0·52) and anogenital warts decreased significantly by 61% (0·39, 0·22-0·71) in girls 13-19 years of age. Significant reductions were also recorded in HPV types 31, 33, and 45 in this age group of girls (RR 0·72, 95% CI 0·54-0·96), which suggests cross-protection. Additionally, significant reductions in anogenital warts were also reported in boys younger than 20 years of age (0·66 [95% CI 0·47-0·91]) and in women 20-39 years of age (0·68 [95% CI 0·51-0·89]), which suggests herd effects. In countries with female vaccination coverage lower than 50%, significant reductions in HPV types 16 and 18 infection (RR 0·50, 95% CI 0·34-0·74]) and in anogenital warts (0·86 [95% CI 0·79-0·94]) occurred in girls younger than 20 years of age, with no indication of cross-protection or herd effects. INTERPRETATION: Our results are promising for the long-term population-level effects of HPV vaccination programmes. However, continued monitoring is essential to identify any signals of potential waning efficacy or type-replacement. FUNDING: The Canadian Institutes of Health Research.

Rationale and design of REACT: a randomised controlled trial assessing the effectiveness of home-collection to increase chlamydia retesting and detect repeat positive tests.

BACKGROUND: Repeat infection with Chlamydia trachomatis is common and increases the risk of sequelae in women and HIV seroconversion in men who have sex with men (MSM). Despite guidelines recommending chlamydia retesting three months after treatment, retesting rates are low. We are conducting the first randomised controlled trial to assess the effectiveness of home collection combined with short message service (SMS) reminders on chlamydia retesting and reinfection rates in three risk groups. METHODS/DESIGN: The REACT (retest after Chlamydia trachomatis) trial involves 600 patients diagnosed with chlamydia: 200 MSM, 200 women and 200 heterosexual men recruited from two Australian sexual health clinics where SMS reminders for retesting are routine practice. Participants will be randomised to the home group (3-month SMS reminder and home-collection) or the clinic group (3-month SMS reminder to return to the clinic). Participants in the home group will be given the choice of attending the clinic if they prefer. The mailed home-collection kit includes a self-collected vaginal swab (women), UriSWAB (Copan) for urine collection (heterosexual men), and UriSWAB plus rectal swab (MSM). The primary outcome is the retest rate at 1-4 months after a chlamydia diagnosis, and the secondary outcomes are: the repeat positive test rate; the reinfection rate; the acceptability of home testing with SMS reminders; and the cost effectiveness of home testing. Sexual behaviour data collected via an online survey at 4-5 months, and genotyping of repeat infections, will be used to discriminate reinfections from treatment failures. The trial will be conducted over two years. An intention to treat analysis will be conducted. DISCUSSION: This study will provide evidence about the effectiveness of home-collection combined with SMS reminders on chlamydia retesting, repeat infection and reinfection rates in three risk groups. The trial will determine client acceptability and cost effectiveness of this strategy. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry ACTRN12611000968976.

Increasing access by priority populations to Australian sexual health clinics.

Data from a network of 35 Australian sexual health clinics, in geographically diverse locations, showed that the number and proportion of patients from priority populations (ie, young people, men who have sex with men, indigenous people, and female sex workers) increased significantly between 2004 and 2011.

A randomised trial of point-of-care tests for chlamydia and gonorrhoea infections in remote Aboriginal communities: Test, Treat ANd GO- the "TTANGO" trial protocol.

BACKGROUND: High prevalence rates of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) have been reported in Aboriginal people in remote and regional areas of Australia for well over two decades, and repeat positivity rates are high. To interrupt disease transmission and reduce the risk of complications, early diagnosis and treatment is important. However in many remote and regional areas there are long delays between testing for these curable sexually transmissible infections and providing treatment, due to both physical distance from laboratories and difficulties when recalling patients for subsequent management once results are available. Point-of-care (POC) tests have the potential to provide more timely diagnosis, to increase treatment and contact tracing, and in turn reduce CT and NG infection rates. METHODS/DESIGN: TTANGO (Test, Treat, ANd GO) is a cross-over cluster randomised controlled trial in 12 regional or remote Australian health services, which predominantly provide clinical services to Aboriginal people. The overall aim of TTANGO is to measure the clinical effectiveness, cost-effectiveness and cultural and operational acceptability of molecular POC testing for CT and NG infection. The primary outcome is repeat positivity at three months after treatment of an initial CT or NG infection. Participating health services will undertake the clinical management of CT and NG under two different modalities for one year each. In the first year, six health services will be randomly assigned to manage these infections under current diagnostic guidelines. The other six will supplement current diagnostic guidelines with POC testing, whereby diagnosis is made and subsequent treatment for those with positive POC tests is offered at the initial consultation. In the second year, the health services will cross over to the opposite management modality. TTANGO will be conducted over four years; 1.5 years of trial initiation and community consultation, 2 years of trial conditions and evaluation, and 6 months of data analysis and feedback. DISCUSSION: TTANGO is the first cluster randomised trial of POC testing for CT and NG internationally. The results of this trial will provide crucial information to guide sexual health clinical practice in remote Aboriginal communities and other high prevalence settings. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry ACTRN12613000808741.

Tracking type specific prevalence of human papillomavirus in cervical pre-cancer: a novel sampling strategy.

BACKGROUND: Surveillance designed to detect changes in the type-specific distribution of HPV in cervical intraepithelial neoplasia grade 3 (CIN-3) is necessary to evaluate the effectiveness of the Australian vaccination programme on cancer causing HPV types. This paper develops a protocol that eliminates the need to calculate required sample size; sample size is difficult to calculate in advance because HPV's true type-specific prevalence is imperfectly known. METHOD: A truncated sequential sampling plan that collects a variable sample size was designed to detect changes in the type-specific distribution of HPV in CIN-3. Computer simulation to evaluate the accuracy of the plan at classifying the prevalence of an HPV type as low (< 5%), moderate (5-15%), or high (> 15%) and the average sample size collected was conducted and used to assess its appropriateness as a surveillance tool. RESULTS: The plan classified the proportion of CIN-3 lesions positive for an HPV type very accurately, with >90% of simulations correctly classifying a simulated data-set with known prevalence. Misclassifying an HPV type of high prevalence as being of low prevalence, arguably the most serious kind of potential error, occurred < 0.05 times per 100 simulations. A much lower sample size (21-22 versus 40-48) was required to classify samples of high rather than low or moderate prevalence. CONCLUSIONS: Truncated sequential sampling enables the proportion of CIN-3 due to an HPV type to be accurately classified using small sample sizes. Truncated sequential sampling should be used for type-specific HPV surveillance in the vaccination era.

High annual syphilis testing rates among gay men in Australia, but insufficient retesting.

INTRODUCTION: Since 2000, infectious syphilis notifications have increased substantially among Australian gay men. We describe testing at a frequency lower than guidelines recommend. METHODS: We examined data from a cross-sectional survey of gay men in 5 Australian cities in 2010. We used logistic regression to identify correlates of no lifetime syphilis test among HIV-uninfected men and <2 tests per year in HIV-infected men and higher-risk HIV-uninfected men. RESULTS: Of 6329 HIV-uninfected men, 65% reported a syphilis test in the past year, and 86% in their lifetime, and factors associated with no lifetime syphilis test were lower social engagement with gay men, older age, fewer sexual partners, no anal sex with casual partners, and not being aware syphilis could be asymptomatic. Among higher-risk HIV-uninfected men (>10 partners in the past 6 months), factors associated with <2 syphilis tests in the past year were nonmetropolitan residence, older age, no anal sex or unprotected anal intercourse with casual partners, not aware syphilis could be acquired through oral sex, and testing at a nonregular general practitioner. Of the 580 HIV-infected, 87% reported a syphilis test in the past year, and 96% in their lifetime, and factors associated with <2 syphilis tests in the past year were unprotected anal intercourse with HIV-uninfected casual partner and recruitment from social or sex-on-premises venues. CONCLUSIONS: Our analysis showed high lifetime and annual syphilis testing rates in Australian gay men, but low retesting rates. We identified factors associated with less frequent syphilis testing rates among Australian gay men to assist in developing targeted screening strategies.

Economic evaluation of monitoring virologic responses to antiretroviral therapy in HIV-infected children in resource-limited settings.

OBJECTIVE: Antiretroviral therapy (ART) management for HIV-infected children is critical in many resource-constrained countries. We investigated the cost-effectiveness and cost-utility of different frequencies of monitoring plasma viral load among HIV-positive children initiating ART in a resource-limited setting. DESIGN/METHODS: A stochastic agent-based simulation model was built and directly informed by a cohort of 304 HIV-infected children starting ART in Thailand between 2001 and 2009. The model simulated the expected costs and clinical outcomes over time according to different viral load monitoring frequencies and initiation of second-line therapies when appropriate. RESULTS: The optimal frequency of viral load monitoring was found to be annual, after a single screening at 6 months. Associated costs of viral load monitoring and appropriate ART would approximately triple current treatment costs. Compared with current conditions, a single screening during the first year of ART led to a 58.4% reduction in the total person-years of virological failure with annual monitoring leading to a 76.6% reduction. The incremental cost per quality adjusted life year gained from the optimal monitoring frequency was estimated as US$ 68,084 when including costs of ART and US$ 7224 without ART costs. The estimated cost attributed to preventing 1 year of virological failure was US$ 3393 with ART costs and US$ 359 without ART costs. CONCLUSION: Even infrequent viral load monitoring is likely to provide substantial clinical benefit to HIV-infected children on ART. Viral load monitoring can be considered cost-effective in many resource-limited settings. However, the costs associated with second-line therapies could be a barrier to its economic feasibility.