The DACRIN data project: A process for harmonising data collection for clinical research in alcohol and other drugs services in New South Wales.

INTRODUCTION: Standardised data collection processes allow for harmonisation and comparison of data across different studies and services. This project aimed to develop a 'core dataset' to serve as the default collection when designing future studies and evaluations, building upon data routinely collected in clinical alcohol and other drugs (AOD) settings in NSW, Australia. METHODS: A working group was established, comprising clinicians, researchers, data managers and consumers from public sector and non-government organisation AOD services in the NSW Drug and Alcohol Clinical Research and Improvement Network. A series of Delphi meetings occurred to reach consensus on the data items to be included in the core dataset for three domains: demographics, treatment activity and substance use variables. RESULTS: There were 20-40 attendees at each meeting. An initial consensus criterion of having received >70% of the vote was established. Given the difficulty in reaching consensus for most items, subsequently, this was changed to eliminate items that received <5 votes, after which the item receiving the most votes would be selected. DISCUSSIONS AND CONCLUSIONS: This important process received considerable interest and buy-in across the NSW AOD sector. Ample opportunity for discussion and voting was provided for the three domains of interest, allowing participants to contribute their expertise and experience to inform decisions. As such, we believe the core dataset includes the best options currently available to collect data for these domains in the NSW AOD context, and potentially more broadly. This foundational study may inform other attempts to harmonise data across AOD services.

Development of immunity following financial incentives for hepatitis B vaccination among people who inject drugs: A randomized controlled trial.

BACKGROUND: People who inject drugs (PWID) are at risk of hepatitis B virus (HBV) but have low rates of vaccination completion. The provision of modest financial incentives increases vaccination schedule completion, but their association with serological protection has yet to be determined. OBJECTIVE: To investigate factors associated with vaccine-induced immunity among a sample of PWID randomly allocated to receive AUD$30 cash following receipt of doses two and three ('incentive condition') or standard care ('control condition') using an accelerated 3-dose (0,7,21 days) HBV vaccination schedule. STUDY DESIGN: A randomised controlled trial among PWID attending two inner-city health services and a field site in Sydney, Australia, assessing vaccine-induced immunity measured by hepatitis B surface antibodies (HBsAb ≥ 10 mIU/ml) at 12 weeks. The cost of the financial incentives and the provision of the vaccine program are also reported. RESULTS: Just over three-quarters of participants - 107/139 (77%)--completed the vaccination schedule and 79/139 (57%) were HBsAb ≥ 10 mIU/ml at 12 weeks. Vaccine series completion was the only variable significantly associated with vaccine-induced immunity in univariate analysis (62% vs 41%, p<0.035) but was not significant in multivariate analysis. There was no statistically discernible association between group allocation and series completion (62% vs 53%). The mean costs were AUD$150.5, (95% confidence interval [CI]: 142.7-158.3) and AUD$76.9 (95% CI: 72.6-81.3) for the intervention and control groups respectively. CONCLUSION: Despite increasing HBV vaccination completion, provision of financial incentives was not associated with enhanced serological protection. Further research into factors which affect response rates and the optimal vaccination regimen and incentive schemes for this population are needed.

A prospective study of hepatitis C incidence in Australian prisoners.

AIMS: To document the relationships between injecting drug use, imprisonment and hepatitis C virus (HCV) infection. DESIGN: Prospective cohort study. SETTING: Multiple prisons in New South Wales, Australia. PARTICIPANTS: HCV seronegative prisoners with a life-time history of injecting drug use (IDU) were enrolled and followed prospectively (n = 210) by interview and HCV antibody and RNA testing 6-12-monthly for up to 4 years when in prison. MEASUREMENTS: HCV incidence was calculated using the person-years method. Cox regression was used to identify predictors of incident infection using time-dependent covariates. RESULTS: Almost half the cohort reported IDU during follow-up (103 subjects; 49.1%) and 65 (31%) also reported sharing of the injecting apparatus. There were 38 HCV incident cases in 269.94 person-years (py) of follow-up with an estimated incidence of 14.08 per 100 py [confidence interval (CI) = 9.96-19.32]. Incident infection was associated independently with Indigenous background, injecting daily or more and injecting heroin. Three subjects were RNA-positive and antibody-negative at the incident time-point, indicating early infection, which provided a second incidence estimate of 9.4%. Analysis of continuously incarcerated subjects (n = 114) followed over 126.73 py, identified 13 new HCV infections (10.26 per 100 py, CI = 5.46-17.54), one of which was an early infection case. Bleach-cleansing of injecting equipment and opioid substitution treatment were not associated with a significant reduction in incidence. CONCLUSIONS: In New South Wales, Australia, imprisonment is associated with high rates of hepatitis C virus transmission. More effective harm reduction interventions are needed to control HCV in prison settings.

Extremely low and sustained HIV incidence among people who inject drugs in a setting of harm reduction.

This study created a retrospective cohort by linking repeat respondents in a large, national, annual cross-sectional sero-survey to estimate HIV incidence among people who inject drugs (PWID) in Australia. The results indicate extremely low and sustained rates of HIV incidence (0.11 per 100 person-years) over almost two decades (1995-2012). The findings demonstrate that sustained prevention of HIV transmission among PWID is possible and suggest that the early establishment and rapid scale-up of needle and syringe programmes, at a time when background prevalence was low, likely contributed to the prevention of an HIV epidemic among Australian PWID.

Sexually transmitted infections, sexual risk behaviours and perceived barriers to safe sex among drug users.

OBJECTIVE: Drug users are at elevated risk of HIV and other sexually transmitted infections (STIs). This study examines prevalence of STIs and perceived barriers to safe sex among drug users accessing low-threshold primary healthcare in inner-city Sydney. METHODS: Data were extracted manually from clients' medical records and analysed using STATA. RESULTS: Prevalence of HIV, syphilis, chlamydia and gonorrhoea were low (<2%), whereas hepatitis C (62%), hepatitis A (30%), and previous exposure to hepatitis B (25%) were more common. Recent unprotected vaginal and anal intercourse were reported by 85% and 26% of clients, respectively. Younger clients and those with a history of sex work or recent anal intercourse were more likely to report multiple recent unprotected sex partners. Having a regular sex partner was the most prevalent barrier to condom use (37%), and was more likely to be identified by clients who were older, of Indigenous descent, and/or heterosexual. Drug intoxication was a second important barrier (20%), and was more commonly identified by excessive alcohol users. CONCLUSIONS: Targeted programs might increase awareness regarding the benefits of condom use and potential sexual risk associated with regular partners. Periodic assessments of alcohol use, and brief interventions for drug users who report problematic use, should also be considered.

Reduction in HCV incidence among injection drug users attending needle and syringe programs in Australia: a linkage study.

OBJECTIVES: We examined trends in HCV incident infection among injection drug users (IDUs) attending needle and syringe programs (NSPs) in Australia in 1995 to 2010. METHODS: We created a passive retrospective cohort of 724 IDUs who tested negative for HCV antibodies by a simple deterministic method linking partial identifiers to find repeat respondents in annual cross-sectional serosurveillance. RESULTS: We identified 180 HCV seroconversions over the study period, for a pooled incidence density of 17.0 per 100 person-years (95% confidence interval [CI] = 14.68, 19.66). Incidence density declined, from a high of 30.8 per 100 person-years (95% CI = 21.3, 44.6) in 2003 to a low of 4.0 (95% CI = 1.3, 12.3) in 2009. CONCLUSIONS: A decline in HCV incidence among Australian IDUs attending NSPs coincided with considerable expansion of harm reduction programs and a likely reduction in the number of IDUs, associated with significant changes in drug markets. Our results demonstrate the capacity of repeat cross-sectional serosurveillance to monitor trends in HCV incidence and provide a platform from which to assess the impact of prevention and treatment interventions.

A randomised controlled trial of financial incentives to increase hepatitis B vaccination completion among people who inject drugs in Australia.

OBJECTIVE: This study aimed to investigate the efficacy of modest financial incentives in increasing completion of an accelerated 3-dose hepatitis B virus (HBV) vaccination schedule (0, 7, 21days) among people who inject drugs (PWID). METHODS: Randomised controlled trial. Participants were randomly allocated to receive $30 Australian Dollars cash following receipt of vaccine doses two and three ('incentive condition'), or standard care ('control condition'). Serologically confirmed HBV-susceptible PWID. Two inner-city health services and a field study site in Sydney, Australia. The primary outcome was completion of the vaccination series. Additional assessments included self-reported demographic, drug use and treatment, and risk-taking histories. RESULTS: Compared to the control condition, significantly more participants in the incentive condition received all three vaccine doses, under intention-to-treat analyses (n=139; 87% versus 66%; p=.004); and within the specified window periods under per protocol analyses (n=107 received three vaccine doses; 92% versus 67%; p=.001). Multivariate analysis indicated that the incentive condition and longer injecting histories significantly increased the likelihood of series completion. Aboriginal/Torres Strait Islanders were significantly less likely to complete the series. CONCLUSIONS: Modest financial incentives, per-dose, increased adherence to the accelerated HBV vaccination schedule among PWID. Results have implications for increasing HBV and, potentially, other vaccine-preventable infections, among PWID.

Healthcare utilisation and disclosure of injecting drug use among clients of Australia's needle and syringe programs.

BACKGROUND: People who inject drugs (PWID) report limited access to healthcare, and may avoid disclosing drug use. Health service utilisation was examined among participants in the Australian Needle and Syringe Program Survey (ANSPS), an annual cross-sectional sero-survey of needle syringe program (NSP) attendees. METHODS: An anonymous questionnaire was self-completed by 2,395 NSP clients throughout Australia. Multivariable logistic regressions identified variables independently associated with (i) disclosure of injecting to the most recent healthcare provider; and (ii) recent presentation to emergency departments. RESULTS: Seventy-eight percent of participants reported accessing healthcare in the preceding 12 months. Reasons for presentation included general health issues (46%); medication seeking (17%); and both (37%). Participants who recently accessed healthcare or had previously visited their most recent provider were more likely to disclose injecting drug use. Participants presenting to a GP or medical centre were less likely than others to disclose injecting. Those accessing emergency departments were more likely to report recent imprisonment. CONCLUSIONS: Despite Australia's universal healthcare system and harm reduction policies, NSP-participants remain reluctant to disclose injecting, potentially hindering appropriate care and highlighting the need for multiple entry points to the healthcare system, including NSPs and opioid substitution therapy clinics.

Self-perceived problem with alcohol use among opioid substitution treatment clients.

BACKGROUND AND AIM: Excessive alcohol use increases mortality and morbidity among opioid substitution therapy (OST) clients. Regular attendance for OST dosing presents key opportunities for screening and treatment. However, individuals' perception of their alcohol consumption as problematic or otherwise may impact their willingness to change. This study examines patterns of alcohol consumption among OST clients, perceptions of their own use and correlates of excess consumption. METHODS: Confidential, structured interviews were conducted with 264 clients of two Sydney OST clinics. Alcohol consumption was assessed using the Alcohol Use Disorders Identification Test (AUDIT); and illicit drug dependence with the Severity of Dependence Scale. RESULTS: Forty-one percent of the participants scored ≥8 on the AUDIT ('AUDIT-positive'), indicating excessive alcohol use. The higher a participant's AUDIT score, the more likely they were to demonstrate insight into the potential problems associated with their drinking (linear trend, p<0.01). However, only half of AUDIT-positive participants believed they drank too much and/or had a problem with alcohol. One-third had discussed their drinking with OST staff, and a similar proportion reported a history of alcohol treatment. AUDIT-positive participants were more likely than others to be classified as dependent on an illicit drug in the last six months (AOR=1.76, 95% CI:1.00-3.09), report a history of alcohol treatment (AOR=5.70, 95% CI:2.83-11.48) and believe it is safe to drink 4+ standard drinks in one session (AOR=5.30, 95% CI:2.79-10.06). CONCLUSIONS: OST clients with AUDIT scores ≥8 appear to underestimate the risks associated with their alcohol consumption. Regular assessments of alcohol use and targeted brief alcohol interventions may improve health outcomes among OST clients.

Are primary health care centres that target injecting drug users attracting and serving the clients they are designed for? A case study from Sydney, Australia.

BACKGROUND: Low-threshold primary healthcare (PHC) centres targeting injecting drug users (IDUs) are increasingly being created to offer preventative and opportunistic services. However, no data are available on the characteristics of clients who utilise such services, or the effectiveness of these services in facilitating prevention or treatment. METHOD: A retrospective clinical record audit examined the characteristics, service utilisation patterns and referral uptake of 384 clients presenting to a low-threshold PHC service in Sydney, Australia. RESULTS: Of the 384 clients, 85% were IDUs. Sixty-two percent reported also having access to a general medical practitioner (GP), with this group more likely to report taking benzodiazepines or other psychoactive medication. Despite this relatively high level of GP access, only 50% were fully vaccinated against hepatitis B virus (HBV). Testing for blood-borne viral and sexually transmitted infections were the most common reasons for presentation to the PHC. Most (82%) clients made at least one return visit, with an average of 3.5 presentations per client. All clients were offered HBV vaccination where indicated (n = 145); and more than half (55%) of referrals to external services were attended. Clients accessing this PHC were younger, more likely to be male and born outside Australia than IDUs attending needle syringe programs (NSPs) in Australia's most populous state, New South Wales. CONCLUSION: Results suggest that this low-threshold PHC service was underutilised and its role as a low-threshold healthcare outlet remains limited. Further research is needed to more clearly delineate the health and economic benefits of this model.

Opioid substitution therapy clients' preferences for targeted versus general primary health-care outlets.

INTRODUCTION AND AIMS: Opioid substitution therapy (OST) ideally constitutes a window of opportunity for the provision of essential primary health care (PHC) for OST clients. In the absence of such opportunities, however, OST clients access PHC from existing outlets, either general services or those targeted to specific groups. This study examined OST clients' current main source and preferred future outlets of PHC services and correlates of preferences. DESIGN AND METHODS: Anonymous interviews conducted with n = 257 clients of two public OST clinics in Sydney's inner-west. RESULTS: Overall, 61% (n = 158) of participants reported currently accessing PHC primarily from general outlets (general practitioners or medical centres: 51%, hospital/emergence departments: 10%) and the remainder (39%, n = 99) from outlets that target specific groups (e.g. Aboriginal Medical Services, OST prescriber/clinics, drug user-targeted PHCs). Twenty-two percent reported discomfort disclosing drug use to their current PHC providers. However, the majority were satisfied with the care they received and reported a preference to remain with their current PHC providers for a range of reasons, most commonly familiarity with and trust in staff (56%) and not feeling judged about their drug use (49%). Nevertheless, 28% reported that they would access PHC through their OST clinic if it were available. DISCUSSION AND CONCLUSIONS: PHC outlets that target specific groups appear to have an ongoing and important role in providing accessible health care to OST clients.

Housing instability among people who inject drugs: results from the Australian needle and syringe program survey.

High rates of substance dependence are consistently documented among homeless people, and are associated with a broad range of negative outcomes among this population. Investigations of homelessness among drug users are less readily available. This study examined the prevalence and correlates of housing instability among clients of needle syringe programs (NSPs) via the Australian NSP Survey, annual cross-sectional seroprevalence studies among NSP attendees. Following self-completion of a brief, anonymous survey and provision of a capillary blood sample by 2,396 NSP clients, multivariate logistic regressions identified the variables independently associated with housing instability. Nineteen percent of ANSPS participants reported current unstable housing, with primary ('sleeping rough'; 5 %), secondary (staying with friends/relatives or in specialist homelessness services; 8 %), and tertiary (residential arrangements involving neither secure lease nor private facilities; 6 %) homelessness all evident. Extensive histories of housing instability were apparent among the sample: 66 % reported at least one period of sleeping rough, while 77 % had shifted between friends/relatives (73 %) and/or resided in crisis accommodation (52 %). Participants with a history of homelessness had cycled in and out of homelessness over an average of 10 years; and one third reported first being homeless before age 15. Compared to their stably housed counterparts, unstably housed participants were younger, more likely to be male, of Indigenous Australian descent, and to report previous incarceration; they also reported higher rates of key risk behaviors including public injecting and receptive sharing of injecting equipment. The high prevalence of both historical and current housing instability among this group, particularly when considered in the light of other research documenting the many adverse outcomes associated with this particular form of disadvantage, highlights the need for increased supply of secure, affordable public housing in locations removed from established drug markets and serviced by health, social, and welfare support agencies.

The cost of providing primary health-care services from a needle and syringe program: a case study.

INTRODUCTION AND AIMS: Targeted primary health-care services for injecting drug users have been established in several countries to reduce barriers to health care, subsequent poor health outcomes and the considerable costs of emergency treatment. The long-term sustainability of such services depends on the resources required and the coverage provided. This study assesses the additional cost required to operate a nurse-led primary health care in an existing needle syringe program setting, estimates the costs per occasion of service and identifies key factors influencing improved service utilisation. DESIGN AND METHODS: Using standard costing methods and the funder perspective, this study estimates costs using the 'ingredients' approach where the costs of inputs are based on quantities and unit prices (the ingredients). RESULTS: During the 2009-2010 fiscal year, the primary health-care clinic provided 1252 occasions of service to 220 individuals, who each made an average of 3.9 presentations. A total cost of AU$250,626 was incurred, 69% of which was for personnel and 22% for pathology. During the study period the average cost per occasion of service was AU$199.96, which could be as low as AU$93.32 if the clinic reached its full utilisation level. DISCUSSION AND CONCLUSIONS: Although the average number of presentations per client was satisfactory, the clinic was underutilised during the study period. Proactive engagement of clients at the needle syringe program shopfront and an increased range of services offered by the clinic may help to attract more clients.

Relative efficacy of cash versus vouchers in engaging opioid substitution treatment clients in survey-based research.

Concerns that cash payments to people who inject drugs (PWID) to reimburse research participation will facilitate illicit drug purchases have led some ethical authorities to mandate department store/supermarket vouchers as research reimbursement. To examine the relative efficacy of the two forms of reimbursement in engaging PWID in research, clients of two public opioid substitution therapy clinics were invited to participate in a 20-30 min, anonymous and confidential interview about alcohol consumption on two separate occasions, 4 months apart. Under the crossover design, at Time 1, clients of Clinic 1 were offered $A20 cash as reimbursement, while clients of Clinic 2 were offered an $A20 voucher; at Time 2, the form of reimbursement was reversed. Using clinic records to determine the denominator (number of clients dosed), we found that compared with clients offered a voucher, a significantly higher proportion of clients who were offered cash participated in the survey (58% (139/241) vs 74% (186/252); χ(2)=14.27; p=0.0002). At first participation, respondents most commonly reported planning to purchase food/drinks/groceries (68%), cigarettes (21%) and transport/fuel (11%) with their payments, with those reimbursed in cash more likely to report planning to fund transport/fuel (19% vs 1%; p<.01) and less likely to report planning to purchase food/drinks/groceries (62% vs 76%; p=0.02). Just three out of 155 cash participants reported planning to purchase illicit drugs with their payment. Results demonstrate that modest cash payments enhanced recruitment of this group, an important consideration given the challenges of delineating the parameters of a population defined by illegal activity, seemingly without promoting excessive additional drug use.

Linkage into specialist hepatitis C treatment services of injecting drug users attending a needle syringe program-based primary healthcare centre.

Injecting drug users (IDUs), the key risk population for hepatitis C virus (HCV) infection, constitute just a small proportion of HCV treatment clients. This study describes an HCV treatment assessment model developed by an inner-city IDU-targeted primary healthcare (PHC) facility and, using a retrospective clinical audit, documents predictors of successful referrals to a tertiary liver clinic. Between July 2006-December 2010, 479 clients attended the PHC, of whom 353 (74%) were screened for HCV antibody. Sixty percent (212/353) tested positive, of whom 93% (197/212) were screened for HCV-RNA with 73% (143/197) positive. Referrals to a tertiary liver clinic were provided to 96 clients, of whom 68 (71%) attended. Eleven clients commenced antiviral therapy (AVT), with seven achieving sustained virological responses by December 2010. Clients who had not recently injected drugs and those with elevated ALT levels were more likely to attend the referrals, while those not prescribed psychiatric medications were more likely to commence AVT. The relatively high uptake of referrals, the number of individuals commencing AVT and final treatment outcomes are reasonably encouraging, highlighting the potential of targeted PHC services to facilitate reductions in liver disease burden among IDUs.

Correlates of susceptibility to hepatitis B among people who inject drugs in Sydney, Australia.

Despite a safe, effective vaccine, hepatitis B virus (HBV) vaccination coverage remains low among people who inject drugs (PWID). Characteristics of participants screened for a trial investigating the efficacy of financial incentives in increasing vaccination completion among PWID were examined to inform targeting of vaccination programs. Recruitment occurred at two health services in inner-city Sydney that target PWID. HBV status was confirmed via serological testing, and questionnaires elicited demographic, drug use, and HBV risk data. Multinomial logistic regression was utilized to determine variables independently associated with HBV status. Of 172 participants, 64% were susceptible, 17% exposed (HBV core antibody-positive), and 19% demonstrated evidence of prior vaccination (HBV surface antibody ≥ 10 mIU/ml). Compared with exposed participants, susceptible participants were significantly more likely to be aged less than 35 years and significantly less likely to be receiving current opioid substitution therapy (OST) and to test hepatitis C antibody-positive. In comparison to vaccinated participants, susceptible participants were significantly more likely to be male and significantly less likely to report daily or more frequent injecting, current OST, and prior awareness of HBV vaccine. HBV vaccination uptake could potentially be increased by targeting younger, less frequent injectors, particularly young men. In addition to expanding vaccination through OST, targeting "at risk" youth who are likely to have missed adolescent catch-up programs may be an important strategy to increase coverage. The lack of an association between incarceration and vaccination also suggests increasing vaccination uptake and completion in adult and juvenile correctional facilities may also be important.

The reliability of sensitive information provided by injecting drug users in a clinical setting: clinician-administered versus audio computer-assisted self-interviewing (ACASI).

Research with injecting drug users (IDUs) suggests greater willingness to report sensitive and stigmatised behaviour via audio computer-assisted self-interviewing (ACASI) methods than during face-to-face interviews (FFIs); however, previous studies were limited in verifying this within the same individuals at the same time point. This study examines the relative willingness of IDUs to report sensitive information via ACASI and during a face-to-face clinical assessment administered in health services for IDUs. During recruitment for a randomised controlled trial undertaken at two IDU-targeted health services, assessments were undertaken as per clinical protocols, followed by referral of eligible clients to the trial, in which baseline self-report data were collected via ACASI. Five questions about sensitive injecting and sexual risk behaviours were administered to participants during both clinical interviews and baseline research data collection. "Percentage agreement" determined the magnitude of concordance/discordance in responses across interview methods, while tests appropriate to data format assessed the statistical significance of this variation. Results for all five variables suggest that, relative to ACASI, FFI elicited responses that may be perceived as more socially desirable. Discordance was statistically significant for four of the five variables examined. Participants who reported a history of sex work were more likely to provide discordant responses to at least one socially sensitive item. In health services for IDUs, information collection via ACASI may elicit more reliable and valid responses than FFI. Adoption of a universal precautionary approach to complement individually tailored assessment of and advice regarding health risk behaviours for IDUs may address this issue.