A trial protocol for the effectiveness of digital interventions for preventing depression in adolescents: The Future Proofing Study.

BACKGROUND: Depression frequently first emerges during adolescence, and one in five young people will experience an episode of depression by the age of 18 years. Despite advances in treatment, there has been limited progress in addressing the burden at a population level. Accordingly, there has been growing interest in prevention approaches as an additional pathway to address depression. Depression can be prevented using evidence-based psychological programmes. However, barriers to implementing and accessing these programmes remain, typically reflecting a requirement for delivery by clinical experts and high associated delivery costs. Digital technologies, specifically smartphones, are now considered a key strategy to overcome the barriers inhibiting access to mental health programmes. The Future Proofing Study is a large-scale school-based trial investigating whether cognitive behaviour therapies (CBT) delivered by smartphone application can prevent depression. METHODS: A randomised controlled trial targeting up to 10,000 Year 8 Australian secondary school students will be conducted. In Stage I, schools will be randomised at the cluster level either to receive the CBT intervention app (SPARX) or to a non-active control group comparator. The primary outcome will be symptoms of depression, and secondary outcomes include psychological distress, anxiety and insomnia. At the 12-month follow-up, participants in the intervention arm with elevated depressive symptoms will participate in an individual-level randomised controlled trial (Stage II) and be randomised to receive a second CBT app which targets sleep difficulties (Sleep Ninja) or a control condition. Assessments will occur post intervention (both trial stages) and at 6, 12, 24, 36, 48 and 60 months post baseline. Primary analyses will use an intention-to-treat approach and compare changes in symptoms from baseline to follow-up relative to the control group using mixed-effect models. DISCUSSION: This is the first trial testing the effectiveness of smartphone apps delivered to school students to prevent depression at scale. Results from this trial will provide much-needed insight into the feasibility of this approach. They stand to inform policy and commission decisions concerning if and how such programmes should be deployed in school-based settings in Australia and beyond. TRIAL REGISTRATION: Australian and New Zealand Clinical Trial Registry, ACTRN12619000855123. Registered on 31 May 2019. Clinical Trial Notification Scheme (CTN), CT-2019-CTN-02110-1-v1. Registered on 30 June 2019.

Effect of Intranasal vs Intramuscular Naloxone on Opioid Overdose: A Randomized Clinical Trial.

Importance: Previous unblinded clinical trials suggested that the intranasal route of naloxone hydrochloride was inferior to the widely used intramuscular route for the reversal of opioid overdose. Objective: To test whether a dose of naloxone administered intranasally is as effective as the same dose of intramuscularly administered naloxone in reversing opioid overdose. Design, Setting, and Participants: A double-blind, double-dummy randomized clinical trial was conducted at the Uniting Medically Supervised Injecting Centre in Sydney, Australia. Clients of the center were recruited to participate from February 1, 2012, to January 3, 2017. Eligible clients were aged 18 years or older with a history of injecting drug use (n = 197). Intention-to-treat analysis was performed for all participants who received both intranasal and intramuscular modes of treatment (active or placebo). Interventions: Clients were randomized to receive 1 of 2 treatments: (1) intranasal administration of naloxone hydrochloride 800 µg per 1 mL and intramuscular administration of placebo 1 mL or (2) intramuscular administration of naloxone hydrochloride 800 µg per 1 mL and intranasal administration of placebo 1 mL. Main Outcomes and Measures: The primary outcome measure was the need for a rescue dose of intramuscular naloxone hydrochloride (800 µg) 10 minutes after the initial treatment. Secondary outcome measures included time to adequate respiratory rate greater than or equal to 10 breaths per minute and time to Glasgow Coma Scale score greater than or equal to 13. Results: A total of 197 clients (173 [87.8%] male; mean [SD] age, 34.0 [7.82] years) completed the trial, of whom 93 (47.2%) were randomized to intramuscular naloxone dose and 104 (52.8%) to intranasal naloxone dose. Clients randomized to intramuscular naloxone administration were less likely to require a rescue dose of naloxone compared with clients randomized to intranasal naloxone administration (8 [8.6%] vs 24 [23.1%]; odds ratio, 0.35; 95% CI, 0.15-0.66; P = .002). A 65% increase in hazard (hazard ratio, 1.65; 95% CI, 1.21-2.25; P = .002) for time to respiratory rate of at least 10 and an 81% increase in hazard (hazard ratio, 1.81; 95% CI, 1.28-2.56; P = .001) for time to Glasgow Coma Scale score of at least 13 were observed for the group receiving intranasal naloxone compared with the group receiving intramuscular naloxone. No major adverse events were reported for either group. Conclusions and Relevance: This trial showed that intranasally administered naloxone in a supervised injecting facility can reverse opioid overdose but not as efficiently as intramuscularly administered naloxone can, findings that largely replicate those of previous unblinded clinical trials. These results suggest that determining the optimal dose and concentration of intranasal naloxone to respond to opioid overdose in real-world conditions is an international priority. Trial Registration: anzctr.org.au Identifier: ACTRN12611000852954.

"Beyond Safer Injecting"-Health and Social Needs and Acceptance of Support among Clients of a Supervised Injecting Facility.

Health and social issues in aging populations of people who inject drugs (PWID) tend to aggregate, despite risky injecting practices decreasing with age. Identifying needs and avenues of support is becoming increasingly important. We described the health and social situation among clients of a long-running supervised injecting facility (SIF) in Sydney, Australia. An interviewer-administered survey (n = 182) assessed current housing status, employment, physical and mental health, incarceration history, drug use, engagement in drug treatment, health service utilization, and willingness to accept support. Results were compared to the information provided at initial visit. Up to half of the participants transitioned between lower- and higher-risk health and social indicators over time. Willingness to accept support was greatest amongst those with higher self-perceived need. Support for mental health was a low priority, despite the high self-reporting of mental health issues. SIF clients are open to support for health and social issues, despite ongoing active drug use. Lower-threshold services such as SIFs are well-positioned to recognize and respond to deteriorating health and social issues for PWID. Facilitating care and treatment remains a challenge when the services to which people are being referred are higher-threshold with a more rigid approach.

Integrating Smoking Cessation Care into a Medically Supervised Injecting Facility Using an Organizational Change Intervention: A Qualitative Study of Staff and Client Views.

Background: Clients accessing supervised injecting facilities (SIFs) smoke at high rates. An SIF piloted an organizational change intervention to integrate smoking cessation care as routine treatment. This study aims to explore staff acceptability, perceived facilitators, and perceived barriers to implementing six core components of an organizational change intervention to integrate smoking cessation care in an SIF. Staff and client views on the acceptability, facilitators, and barriers to the provision of smoking cessation care were also examined. Methods: This paper presents findings from the qualitative component conducted post-intervention implementation. Face-to-face semi-structured staff interviews (n = 14) and two client focus groups (n = 5 and n = 4) were conducted between September and October 2016. Recruitment continued until data saturation was reached. Thematic analysis was employed to synthesise and combine respondent views and identify key themes. Results: Staff viewed the organizational change intervention as acceptable. Commitment from leadership, a designated champion, access to resources, and the congruence between the change and the facility's ethos were important facilitators of organizational change. Less engaged staff was the sole barrier to the intervention. Smoking cessation care was deemed suitable. Key facilitators of smoking cessation care included: Written protocols, ongoing training, and visually engaging information. Key barriers of smoking cessation care included: Lack of access to nicotine replacement therapy (NRT) outside of business hours, practical limitations of the database, and concerns about sustainability of NRT. Conclusion: This study develops our understanding of factors influencing the implementation of an organisational change intervention to promote sustainable provision of smoking cessation care in the SIF setting.

Perceptions of people who inject drugs towards HIV pre-exposure prophylaxis in Australia.

Background People who inject drugs (PWID) are a priority for HIV prevention. This study aimed to determine perceptions, potential eligibility and willingness to use PrEP among PWID in Sydney. METHODS: Clients completed a cross-sectional survey to collect data on demographics, perceived risk of HIV and willingness to use PrEP, which were then analysed. RESULTS: Twelve (7%) of 172 HIV-negative participants were eligible for PrEP under current guidelines for injecting reasons, of whom three would also be eligible for sexual risk, leaving nine (5%) eligible for injecting reasons alone. Half had heard of PrEP and, of these, 65% would consider taking it. Most (88%) thought they would continue using needle syringe program services. A minority (8%) indicated they may be likely to share needles and syringes or be less concerned about injecting partners' HIV status (26%). CONCLUSIONS: Although PrEP will benefit a small proportion of PWID, this may equate to a significant number nationally. Policy development around PrEP incorporating affected populations will best support the community of people currently injecting to keep rates of HIV low.

Drug consumption rooms: A systematic review of evaluation methodologies.

ISSUES: Drug consumptions rooms (DCR) and supervised injecting facilities (SIF) are expanding internationally. Previous reviews have not systematically addressed evaluation methodologies. APPROACH: Results from systematic searches of scientific databases in English until June 2017 were coded for paper type, country and year of publication. For evaluation papers, study outcome, methodology/study design and main indicators of DCR/SIF 'exposure' were recorded. KEY FINDINGS: Two hundred and nineteen eligible peer-reviewed papers were published since 1999: the majority from Canada (n = 117 papers), Europe (n = 36) and Australia (n = 32). Fifty-six papers reported evaluation outcomes. Ecological study designs (n = 10) were used to assess the impact on overdose, public nuisance and crime; modelling techniques (n = 6) estimated impact on blood-borne diseases, overdose deaths and costs. Papers using individual-level data included four prospective cohorts (n = 28), cross-sectional surveys (n = 7) and service records (n = 5). Individual-level data were used to assess safer injecting practice, uptake into health and social services and all the other above outcomes except for impact on crime and costs. Four different indicators of DCR/SIF attendance were used to measure service 'exposure'. IMPLICATIONS: Research around DCRs/SIFs has used ecological, modelling, cross-sectional and cohort study designs. Further research could involve systematic inclusion of a control group of people who are eligible but do not access SIFs, validation of self-reported proportion of injections at SIFs or a stepped-wedge or a cluster trial comparing localities. CONCLUSIONS: Methodologies appropriate for DCR/SIF evaluation have been established and can be readily replicated from the existing literature. Research on operational aspects, implementation and transferability is also warranted.

Overdose Risk and Client Characteristics Associated With the Injection of Buprenorphine at a Medically Supervised Injecting Center in Sydney, Australia.

Background: Buprenorphine and buprenorphine/naloxone (BNX) were developed to improve the safety profile of opioid substitution treatment (OST) and reduce diversion and injection, yet continue to be injected, despite the risk of harm. Previous studies examining injection of these substances have relied on self-reported injection and overdose. Using data from the Uniting Medically Supervised Injecting Center (MSIC) in Sydney, this study aimed to assess the overdose risk associated with the use of buprenorphine and BNX and identify factors associated with injecting. Methods: Client data routinely collected from MSIC, a drug consumption room where clients can legally inject drugs under supervision, was used. Odds ratios (OR) to assess the risk of overdose and their associated 95% confidence intervals (95%CI) were calculated and compared to other substances. Univariate analysis using χ-square and multivariate logistic regressions were used to determine characteristics associated with buprenorphine and BNX injection. Results: Data from 1,020,782 injections by 15,832 individuals were analyzed. Risk of overdose was low for buprenorphine compared to other substances (OR 0.16; 95%CI: 0.07-0.19) and no overdoses occurred when BNX was injected. Injection of both buprenorphine and BNX was associated with male gender, homelessness, no income/reliance upon government payments, and prior imprisonment. Conclusions: Buprenorphine and BNX continue to be injected, albeit in small numbers. This is the first study to report on injection and overdose risk using direct observation, and has confirmed the lower overdose risk. MSIC clients who inject buprenorphine and BNX tend to be marginalized and may benefit from targeted harm reduction measures.

Learning from the past, looking to the future - Is there a place for injectable opioid treatment among Australia's responses to opioid misuse?

In the 1990s, a trial of prescribing pharmaceutical heroin for people with opioid-dependence had support from Australian State Health Ministers. However, in 1997 the proposal was vetoed by the federal Prime Minister in face of a negative tabloid media campaign. The debate then shifted to abstinence-orientated treatments. Later on, reduced heroin availability took opioid-related harms away from public sight. In this commentary, we aimed to explore the current need and the options to implement such program, lately referred to as supervised injectable opioid treatment (SIOT), in Australia. We argue that with the aging populations of opioid-dependent people who have not benefited from existing treatment options, increased misuse of prescription opioids, rising overdose rates, and the risk of unfolding overdose crisis, it seems timely to pilot SIOT here. Since the 1990s, seven RCTs as summarised in two systematic literature reviews, demonstrated that SIOT is effective for treatment-resistant opioid dependence. A sustainable SIOT model should, however, respond to key concerns related to its delivery, such as the lack of a patient exit strategy and the high cost of indefinite treatment. Evidence from long-term studies seem to support the notion that SIOT could be provided as a medium duration treatment (as opposed to short-term or indefinite), with the clear aim to stabilise patients, gradually wean them off injectable medication and transfer to opioid assisted treatment (OAT). Also, SIOT could be integrated into the existing public OAT clinics in Australia. This would reduce costs, but also provide a more patient-centred response to opioid dependence and further improve the acceptability and efficiency of OAT. The controversy that developed in the past should be mitigated by advances in research since the first Australian enquiry, use of a registered medication (open-label hydromorphone) rather than pharmaceutical heroin, and setting up clear treatment aims.

Drug consumption rooms (DCRs) as a setting to address hepatitis C - findings from an international online survey.

BACKGROUND: Prevalence of Hepatitis C Virus (HCV) among people who inject drugs (PWID) is high. Risky injecting behaviours have been found to decrease in drug consumption rooms (DCRs) and supervised injecting facilities (SIFs), yet HCV prevention and treatment in these settings have not been extensively explored. METHODS: To determine the range and scope of HCV prevention and treatment options in these services, we assessed DCR/SIF operational features, their clients' characteristics and the HCV-related services they provide. A comprehensive online survey was sent to the managers of the 91 DCRs/SIFs that were operating globally as of September 2016. A descriptive cross-country analysis of the main DCR/SIF characteristics was conducted and bivariate logistic models were used to assess factors associated with enhanced HCV service provision. RESULTS: Forty-nine valid responses were retrieved from DCRs/SIFs in all countries where they were established at the time of the survey (Australia, Canada, Denmark, France, Germany, Luxembourg, Netherlands, Norway, Spain and Switzerland). Internationally, the operational capacities of DCRs/SIFs varied in terms of funding, location, size and staffing, but their clients all shared common features of vulnerability and marginalisation. Estimated HCV prevalence rates were around 60%. Among a range of health and social services and referrals to other programs, most DCRs/SIFs provided HCV testing onsite (65%) and/or offered liver monitoring or disease management (54%). HCV treatment onsite was offered or was planned to be offered by 21% of DCRs/SIFs. HCV testing onsite was associated with provision of other services addressing blood-borne diseases and HCV treatment was linked to the provision of OST. HCV disease management was associated with employing a nurse at a DCR/SIF and HCV treatment was associated with employing a medical doctor. CONCLUSIONS: DCRs/SIFs offer easy-to-access HCV-related services for PWID. The availability of onsite medical professionals and provision of support and education to non-medical staff are key to enhanced provision of HCV-related services in DCRs/SIFs. Funding and support for HCV treatment at the community level, via low-threshold services such as DCRs/SIFs, are worthy of action.

Integrating smoking cessation care into routine service delivery in a medically supervised injecting facility: An acceptability study.

BACKGROUND: Among people who inject drugs (PWIDs) the prevalence of tobacco smoking exceeds 80%; making smoking cessation intervention a priority for this population. This study aims to examine staff and client perspectives from a supervised injecting facility regarding: i) whether an organizational change intervention increased rates of smoking cessation care delivery (pre- to post-intervention); and ii) acceptability of the intervention. METHODS: A pre-and-post intervention pilot study in a supervised injecting facility was conducted in Sydney, Australia between July 2014-December 2015. The intervention employed an organizational change approach and included six components. Cross-sectional samples of staff (pre n = 27, post n = 22) and clients (pre n = 202, post n = 202) completed online surveys pre and post intervention. RESULTS: From pre to post-intervention staff reported smoking cessation practices significantly increased for the provision of verbal advice (30% to 82%; p < 0.001), offer of free or subsidized nicotine replacement therapy (30% to 91%; p < 0.001), referral to a general practitioner (19% to 64%; p = 0.001), and follow-up to check on quit smoking progress (18.5% to 64%; p = 0.001). Significantly more clients reported receiving all smoking cessation strategies post-intervention. Over 85% of staff agreed that it was acceptable to address client smoking as part of usual care and 95% of clients agreed that it was acceptable to be asked by staff about their tobacco smoking. CONCLUSIONS: Increasing the provision of smoking cessation care using an organizational change approach is both feasible for staff and acceptable to staff and clients of supervised injecting facilities.

'It's Fast, It's Quick, It Stops Me Being Sick': How to influence preparation of opioid tablets for injection.

INTRODUCTION AND AIMS: Injection of pharmaceutical opioids (PO) among people who inject drugs has increased in many countries. The common method for preparing PO tablets for injection uses heat, resulting in greater particulate matter and therefore increased risk of local infection risk and damage to veins and organs. A cold preparation process has fewer risks, but this preparation method is not commonly used. This study seeks to explore how people who inject PO learn to prepare injections and how health promotion efforts could influence practice. DESIGN AND METHODS: Between March and December 2013, qualitative interviews were undertaken with 33 clients of Sydney's Medically Supervised Injecting Centre who inject PO tablets regarding sources of knowledge and current preparation methods for injection of POs. RESULTS: Overwhelmingly, the most commonly reported source of knowledge around injection of tablets was others who inject. Most participants reported heating the solution as the quickest way to administer the drug. Attitudes to the use of wheel filters varied, with some participants reporting that they would use the filters if they were shown how, while others reported a number of barriers to using filters, including complexity of use. DISCUSSION AND CONCLUSIONS: Harnessing the power of social connections may provide avenues for education about safer injecting of tablets, including the use of wheel filters. Further work is required to debunk myths about the relative potencies of cold versus hot drug solution. Collaborations between harm reduction workers and peer workers would assist in knowledge dissemination regarding safer injecting practices.

Frequency and severity of non-fatal opioid overdoses among clients attending the Sydney Medically Supervised Injecting Centre.

BACKGROUND: Pharmaceutical opioid overdose rates have increased in recent years. The current study aimed to compare rates per 1000 injections of non-fatal overdose after heroin or oxycodone injection, and their comparative clinical severity. METHODS: Analysis of prospectively collected data from the Sydney Medically Supervised Injecting Centre (MSIC). Severity of overdose was measured using the Glasgow Coma Scale, oxygen saturation levels, and the administration of naloxone. RESULTS: Heroin overdoses occurred at three times the rate of oxycodone overdoses (12.7 v 4.1 per 1000 injections). Heroin overdoses appeared to be more severe than oxycodone overdoses, with higher levels of compromised consciousness (31 v 18%) and severe respiratory depression (67 v 48%), but there were no differences in naloxone doses (20 v 17%). Concurrent use of other depressants at the time of overdose was also associated with compromised consciousness, and the need for naloxone. CONCLUSIONS: Heroin overdoses occurred at a greater rate than oxycodone overdoses, and had more severe clinical indicators.

Mental health among clients of the Sydney Medically Supervised Injecting Centre (MSIC).

The Sydney Medically Supervised Injecting Centre (MSIC) is a supervised injecting facility (SIF) where people who inject drugs (PWID) can do so legally, under health professional supervision. The majority of clients have low levels of education and employment, high rates of incarceration and unstable housing and poor social networks, and 70 % do not access local health services. These factors increase the risk of poor mental health, and it has been documented that PWID have elevated rates of mood, anxiety, personality and psychotic disorders; post-traumatic stress disorder (PTSD); and higher rates of trauma exposure, suicidality and self-harm. The current study is the first to investigate the mental health among clients of a SIF. Validated instruments to examine clients' mental health, social networks and trauma histories were administered to 50 frequently attending clients by a mental health nurse. The majority of respondents were unemployed, homeless and had a history of incarceration, and 82 % report they had been diagnosed with a mental health problem, but only 24 % report they were receiving treatment. Respondents had poor social networks, had poorer mental health symptoms compared to US inpatients and had experienced multiple traumatic events, and a high number of respondents had scores indicative of PTSD. These results highlight the need for mental health clinicians to be employed in SIFs and other drug consumption rooms (DCRs) to assist clients to address their mental health and psychosocial needs, particularly in light of the fact that these services are often the only places these PWID engage with in an ongoing way.

Treatment outcomes for methamphetamine users receiving outpatient counselling from the Stimulant Treatment Program in Australia.

INTRODUCTION AND AIMS: The purpose of this study was to document treatment outcomes for methamphetamine users receiving outpatient counselling from the Stimulant Treatment Program (STP) in Australia. DESIGN AND METHODS: Clients attending the STP for methamphetamine use (n = 105) were assessed on entry to the service and at 3 (n = 86) and 6 months (n = 83) after starting treatment. At each interview methamphetamine use (days of use, severity of dependence), other drug use and health and social functioning (HIV risk behaviour, crime, disability, psychotic symptoms and hostility) were assessed for the past month. RESULTS: Participants received a median of six counselling sessions (interquartile range 1-11) over a period of 89 days (interquartile range 41-148 days). Past month methamphetamine use fell from 79% at treatment entry to 53% at the 3-month follow-up (P < 0.001) and 55% at the 6-month follow-up (P < 0.001). There were statistically significant reductions in psychotic symptoms, hostility and disability associated with poor mental health. There was no change in other drug use, crime or HIV risk behaviour. Reductions in methamphetamine were more common among younger participants, those who had no history of drug treatment and those without concurrent heroin use. DISCUSSION AND CONCLUSIONS: Methamphetamine users entering the STP showed reductions in methamphetamine use and improvements in their mental health after treatment. Improved treatment responses are needed to address polydrug use and other harms within in this population.

An evaluation of a pilot capacity building initiative for smoking cessation in social and community services: the Smoking Care project.

INTRODUCTION AND AIMS: New strategies are required to reach subpopulations with high smoking rates. This study reports on an evaluation of the Smoking Care intervention-a 2-year organisational capacity building strategy--for social and community service organisations (SCSOs) to provide smoking care to clients. DESIGN AND METHODS: The Smoking Care intervention consisted of: awareness raising seminars (half-day); smoking cessation training (1 day) and; nicotine replacement therapy grants (3 months). Baseline and 3-month follow-up data were collected within participating SCSOs and the primary outcomes measured were: changes in staff attitudes, confidence and practice of smoking cessation care. Changes in client self-reported smoking behaviours, quit attempts and interest in quitting were also measured. RESULTS: Of 600 staff who attended training, 306 (51%) returned pre- and post-intervention surveys. At 3-month follow-up staff reported statistically significant increases in positive attitudes to providing smoking cessation care, increased confidence in providing such care and increases in cessation practice. Of 400 client surveys distributed, 367 (92%) were returned at pre-intervention and 255 (64%) at post-intervention. Fewer clients reported daily smoking at post-intervention, while use of nicotine replacement therapy and group counselling increased significantly. Client interest in quitting and receiving quit support from case workers was high at both pre- and post-intervention. DISCUSSION AND CONCLUSIONS: The intervention had an impact on SCSO staff attitudes, confidence and provision of smoking care. Results show clients were receptive to this support. More rigorous testing of similar interventions in SCSOs is warranted.

What has fairness got to do with it? Tackling tobacco among Australia's disadvantaged.

ISSUE: While population wide smoking rates are falling steadily the rates remain high among the disadvantaged. The future we face is one where the differentials in smoking rates will continue to widen and will flow through to increased health inequalities. APPROACH: How best to reduce smoking rates among the disadvantaged? Alongside existing population level initiatives and social policy initiatives is an urgent need for a targeted, comprehensive approach that acknowledges the serious impact of smoking on the disadvantaged. In 2006 Cancer Council NSW embarked on a statewide, multi-component Tackling Tobacco Program to encourage and support non-government social and community services to address smoking among their clients. KEY FINDINGS: Tackling Tobacco Program results have shown that the 1600 staff from 400 organisations trained to provide smoking care can attain the knowledge and confidence to address tobacco and that clients are very receptive to receiving quit support from them. Improvements in quality of life for clients who do quit have been encouraging and the Tackling Tobacco Program has challenged assumptions and attitudes that disadvantaged people are uninterested and unable to quit. IMPLICATIONS: Alongside population and social policy approaches must be a serious investment in tackling smoking among the disadvantaged. CONCLUSIONS: Tackling Tobacco Program is an innovative example of how to engage disadvantaged smokers, de-normalise smoking and encourage and support quitting using familiar settings. Engaging Australia's large network of social and community services as allies in this work should be vigorously pursued.