Community-based provision of direct-acting antiviral therapy for hepatitis C: study protocol and challenges of a randomized controlled trial.

BACKGROUND: To achieve the World Health Organization hepatitis C virus (HCV) elimination targets, it is essential to increase access to treatment. Direct-acting antiviral (DAA) treatment can be provided in primary healthcare services (PHCS), improving accessibility, and, potentially, retention in care. Here, we describe our protocol for assessing the effectiveness of providing DAAs in PHCS, and the impact on the HCV care cascade. In addition, we reflect on the challenges of conducting a model of care study during a period of unprecedented change in HCV care and treatment. METHODS: Consenting patients with HCV infection attending 13 PHCS in Australia or New Zealand are randomized to receive DAA treatment at the local tertiary institution (standard care arm), or their PHCS (intervention arm). The primary endpoint is the proportion commenced on DAAs and cured. Treatment providers at the PHCS include: hepatology nurses, primary care practitioners, or, in two sites, a specialist physician. All PHCS offer opioid substitution therapy. DISCUSSION: The Prime Study is the first real-world, randomized, model of care study exploring the impact of community provision of DAA therapy on HCV-treatment uptake and cure. Although the study has faced challenges unique to this period of time characterized by changing treatment and service delivery, the data gained will be of critical importance in shaping health service policy that enables the elimination of HCV. TRIAL REGISTRATION: ClinicalTrials.gov , ID: NCT02555475 . Registered on 15 September 2015.

Repeat participation in annual cross-sectional surveys of drug users and its implications for analysis.

OBJECTIVE: We sought to establish the extent of repeat participation in a large annual cross-sectional survey of people who inject drugs and assess its implications for analysis. RESULTS: We used "porn star names" (the name of each participant's first pet followed by the name of the first street in which they lived) to identify repeat participation in three Australian Illicit Drug Reporting System surveys. Over 2013-2015, 2468 porn star names (96.2%) appeared only once, 88 (3.4%) twice, and nine (0.4%) in all 3 years. We measured design effects, based on the between-cluster variability for selected estimates, of 1.01-1.07 for seven key variables. These values indicate that the complex sample is (e.g.) 7% less efficient in estimating prevalence of heroin use (ever) than a simple random sample, and 1% less efficient in estimating number of heroin overdoses (ever). Porn star names are a useful means of tracking research participants longitudinally while maintaining their anonymity. Repeat participation in the Australian Illicit Drug Reporting System is low (less than 5% per annum), meaning point-prevalence and effect estimation without correction for the lack of independence in observations is unlikely to seriously affect population inference.

Anorectal swabs as a marker of male-to-male sexual exposure in STI surveillance systems.

Identification of priority populations such as men who have sex with men (MSM) is important in surveillance systems to monitor trends of sexually transmitted infections (STIs). We explored using routinely collected non-behavioural data as a means to establish MSM status in surveillance by assessing anorectal swab as a marker of male-to-male sexual exposure. We used chlamydia testing data from a sexual health clinic, 2007-2012. Men reporting any male sexual partner(s) in the previous 12 months were considered MSM. The dataset was split into development and validation samples to develop a univariate predictive model and assess the model fit. The dataset included 30 358 individual men and 48 554 episodes of STI testing; 45% were among reported MSM and an anorectal swab was performed in 40% of testing episodes. Anorectal swabbing had good diagnostic performance as a marker for MSM status (sensitivity = 87%, specificity = 99%, positive predictive value = 98·6%, negative predictive value = 90·3%). The model showed good fit against the internal validation sample (area under the curve = 0·93). Anorectal swabs are a valid marker of MSM behaviour in surveillance data from sexual health clinics, and they are likely to be particularly useful for monitoring STI trends among MSM with higher risk behaviour.

The effects of needle-sharing and opioid substitution therapy on incidence of hepatitis C virus infection and reinfection in people who inject drugs.

Although high hepatitis C virus (HCV) prevalence has been observed in people who inject drugs (PWID) for decades, research suggests incidence is falling. We examined whether PWIDs' use of opioid substitution therapy (OST) and their needle-and-syringe sharing behaviour explained HCV incidence. We assessed HCV incidence in 235 PWID in Melbourne, Australia, and performed discrete-time survival with needle-sharing and OST status as independent variables. HCV infection, reinfection and combined infection/reinfection incidences were 7·6 [95% confidence interval (CI) 4·8-11·9], 12·4 (95% CI 9·1-17·0) and 9·7 (95% CI 7·4-12·6) per 100 person-years, respectively. Needle-sharing was significantly associated with higher incidence of naive HCV infection [hazard ratio (HR) 4·9, 95% CI 1·3-17·7] but not reinfection (HR 1·85, 95% CI 0·79-4·32); however, a cross-model test suggested this difference was sample specific. Past month use of OST had non-significant protective effects against naive HCV infection and reinfection. Our data confirm previous evidence of greatly reduced HCV incidence in PWID, but not the significant protective effect of OST on HCV incidence detected in recent studies. Our findings reinforce the need for greater access to HCV testing and prevention services to accelerate the decline in incidence, and HCV treatment, management and support to limit reinfection.

Resumption of injecting drug use following release from prison in Australia.

INTRODUCTION: Ex-prisoners with a history of injecting drug use (IDU) experience disproportionate drug-related harm. Rapid resumption of substance use following prison release is common and evidenced in high rates of overdose mortality. However, few studies have documented the rate of IDU resumption following prison release or identified risk factors for relapse. METHODS: Structured interviews were conducted with 533 adults with a history of IDU in Queensland, Australia prior to release from prison and approximately 1, 3 and 6 months post-release. Incidence of self-reported IDU resumption was calculated overall and for each follow-up interval. Risk factors associated with time to resumption of IDU were estimated using discrete-time survival analysis. RESULTS: IDU resumption was reported by 41% of participants during a median of 98days of follow-up (IQR=94-121), an overall crude incidence of 1.06 per person-year. The highest rate was observed in the first month (23%; crude incidence 2.24 per person-year). In adjusted discrete-time survival analyses, being unemployed at the previous interview (AHR=1.59; 95%CI:1.10-2.30), shorter incarceration (≤90days vs. >365days; AHR=2.20; 95%CI:1.33-3.65), and IDU during the index incarceration (AHR=2.80; 95%CI:1.92-4.09) were significantly associated with time to IDU resumption; parole was protective (AHR=0.66; 95%CI:0.47-0.92). CONCLUSIONS: Evidence-based efforts to prevent IDU in prison and IDU resumption after release are important for both prisoner and public health. Enhancing opportunities for employment and capitalising on the short-term benefits of parole for ex-prisoners may delay resumption of IDU after release from prison. These strategies should complement rather than replace harm reduction efforts for this high-risk population.

Factors predictive of patient outcome following total wrist arthrodesis.

AIMS: Total wrist arthrodesis (TWA) produces a spectrum of outcomes. We investigated this by reviewing 77 consecutive TWA performed for inflammatory and post-traumatic arthropathies, wrist instability and as a salvage procedure. PATIENTS AND METHODS: All operations were performed by a single surgeon using a specifically designed pre-contoured dorsally applied non-locking wrist arthrodesis plate at a single centre. RESULTS: Median post-operative Buck-Gramcko Lohman (BGL), Disabilities of the Arm, Shoulder and Hand and Patient Rated Wrist Evaluation scores at six years (interquartile range (IQR) 3 to 11) were 9 (IQR = 6 to 10), 19 (IQR = 7 to 45) and 13 (IQR = 1 to 31) respectively. Polyarticular inflammatory arthritis and female gender were associated with poorer patient-reported outcomes, although the effect of gender was partly explained by higher rates of inflammatory disease among women. Return to work was negatively influenced by workers' compensation and non-inflammatory wrist pathology. There was no difference in complication rates for inflammatory and non-inflammatory indications. TAKE HOME MESSAGE: Polyarticular inflammatory arthritis is a risk factor for adverse patient-reported outcomes in TWA. Furthermore, when compared with patients without inflammatory arthritis, dorsally applied pre-contoured plates can be used for wrist arthrodesis in patients with inflammatory arthritis without an increased risk of complications. Cite this article: Bone Joint J 2016;98-B:647-53.

Performance of diagnosis-based risk adjustment measures in a population of sick Australians.

OBJECTIVE: Australia is beginning to explore 'managed competition' as an organising framework for the health care system. This requires setting fair capitation rates, i.e. rates that adjust for the risk profile of covered lives. This paper tests two US-developed risk adjustment approaches using Australian data. METHODS: Data from the 'co-ordinated care' dataset (which incorporates all service costs of 16,538 participants in a large health service research project conducted in 1996-99) were grouped into homogenous risk categories using risk adjustment 'grouper software'. The grouper products yielded three sets of homogenous categories: Diagnostic Groups and Diagnostic cost Groups. A two-stage analysis of predictive power was used: probability of any service use in the concurrent year, next year and the year after (logistic regression) and, for service users, a regression of logged cost of service use. The independent variables were diagnosis gender, a SES variable and the RESULTS: Age, gender and diagnosis-based risk adjustment measures explain around 40-45% of variation in costs of service use in the current year for untrimmed data (compared with around 15% for age and gender alone). Prediction of subsequent use is much poorer (around 20%). Using more information to assign people to risk categories generally improves prediction. CONCLUSIONS: Predictive power of diagnosis-base risk adjusters on this Australian dataset is similar to that found in IMPLICATIONS: Low predictive power carries policy risks of cream skimming rather than managing population health and care. Competitive funding models with risk adjustment on prior year experience could reduce system efficiency if implemented with current risk adjustment technology.