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1.  Risk factors for elevated HIV incidence among Aboriginal injection drug users in Vancouver 
Background
Because of established links between entrenched poverty and risk of HIV infection, there have long been warnings that HIV/AIDS will disproportionately affect Aboriginal people in Canada. We compared HIV incidence rates among Aboriginal and non-Aboriginal injection drug users (IDUs) in Vancouver and studied factors associated with HIV seroconversion among Aboriginal participants.
Methods
This analysis was based on 941 participants (230 Aboriginal people) recruited between May 1996 and December 2000 who were seronegative at enrolment and had completed at least one follow-up visit. Incidence rates were calculated using the Kaplan–Meier method. The Cox proportional hazards regression model was used to identify independent predictors of time to HIV seroconversion among female and male Aboriginal IDUs.
Results
As of May 31, 2001, seroconversion had occurred in 112 (11.9%) of the participants, yielding a cumulative incidence of HIV infection at 42 months of 12.7% (95% confidence interval [CI] 10.3%–15.1%). The cumulative incidence at 42 months was significantly higher among the Aboriginal participants than among the non-Aboriginal participants (21.1% v. 10.7%, p < 0.001). This elevation in risk was present in both female and male Aboriginal IDUs. Among the female Aboriginal IDUs, frequent speedball (combined cocaine and heroin) injection (adjusted relative risk [RR] 3.1; 95% CI 1.4–7.1) and going on binges of injection drug use (adjusted RR 2.3; 95% CI 1.0–5.2) were found to be independent predictors of HIV seroconversion. Among the male Aboriginal IDUs, the independent predictors of seroconversion were frequent speedball injection (adjusted RR 2.9; 95% CI 1.0–8.5) and frequent cocaine injection (adjusted RR 2.5; 95% CI 1.0–6.5).
Interpretation
In Vancouver, Aboriginal IDUs are becoming HIV positive at twice the rate of non-Aboriginal IDUs. Our findings emphasize the urgent need for an appropriate and effective public health strategy — planned and implemented in partnership with Aboriginal AIDS service organizations and the Aboriginal community — to reduce the harms of injection drug use in this population.
PMCID: PMC139313  PMID: 12515780
2.  Effectiveness and Cost Effectiveness of Expanding Harm Reduction and Antiretroviral Therapy in a Mixed HIV Epidemic: A Modeling Analysis for Ukraine 
PLoS Medicine  2011;8(3):e1000423.
A cost-effectiveness study by Sabina Alistar and colleagues evaluates the effectiveness and cost effectiveness of different levels of investment in methadone, ART, or both, in the mixed HIV epidemic in Ukraine.
Background
Injection drug use (IDU) and heterosexual virus transmission both contribute to the growing mixed HIV epidemics in Eastern Europe and Central Asia. In Ukraine—chosen in this study as a representative country—IDU-related risk behaviors cause half of new infections, but few injection drug users (IDUs) receive methadone substitution therapy. Only 10% of eligible individuals receive antiretroviral therapy (ART). The appropriate resource allocation between these programs has not been studied. We estimated the effectiveness and cost-effectiveness of strategies for expanding methadone substitution therapy programs and ART in mixed HIV epidemics, using Ukraine as a case study.
Methods and Findings
We developed a dynamic compartmental model of the HIV epidemic in a population of non-IDUs, IDUs using opiates, and IDUs on methadone substitution therapy, stratified by HIV status, and populated it with data from the Ukraine. We considered interventions expanding methadone substitution therapy, increasing access to ART, or both. We measured health care costs, quality-adjusted life years (QALYs), HIV prevalence, infections averted, and incremental cost-effectiveness. Without incremental interventions, HIV prevalence reached 67.2% (IDUs) and 0.88% (non-IDUs) after 20 years. Offering methadone substitution therapy to 25% of IDUs reduced prevalence most effectively (to 53.1% IDUs, 0.80% non-IDUs), and was most cost-effective, averting 4,700 infections and adding 76,000 QALYs compared with no intervention at US$530/QALY gained. Expanding both ART (80% coverage of those eligible for ART according to WHO criteria) and methadone substitution therapy (25% coverage) was the next most cost-effective strategy, adding 105,000 QALYs at US$1,120/QALY gained versus the methadone substitution therapy-only strategy and averting 8,300 infections versus no intervention. Expanding only ART (80% coverage) added 38,000 QALYs at US$2,240/QALY gained versus the methadone substitution therapy-only strategy, and averted 4,080 infections versus no intervention. Offering ART to 80% of non-IDUs eligible for treatment by WHO criteria, but only 10% of IDUs, averted only 1,800 infections versus no intervention and was not cost effective.
Conclusions
Methadone substitution therapy is a highly cost-effective option for the growing mixed HIV epidemic in Ukraine. A strategy that expands both methadone substitution therapy and ART to high levels is the most effective intervention, and is very cost effective by WHO criteria. When expanding ART, access to methadone substitution therapy provides additional benefit in infections averted. Our findings are potentially relevant to other settings with mixed HIV epidemics.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
HIV epidemics in Eastern Europe and Central Asia are mainly driven by increasing use of injection drugs combined with heterosexual transmission. In the Ukraine, in 2007, there were 82,000 officially registered people living with HIV—three times the number registered in 1999—and an estimated 395,000 HIV infected adults. The epidemic in Ukraine, like other countries in the region, is concentrated in at-risk populations, particularly people who inject drugs: in 2007, an estimated 390,000 Ukrainians were injecting drugs, an increase in drug use over the previous decade, not only in Ukraine, but in other former USSR states, owing to the easy availability of precursors for injection drugs in a climate of economic collapse.
The common practices of people who inject drugs in Ukraine and in other countries in the region, such as social injecting, syringe sharing, and using common containers, increase the risk of transmitting HIV. Public health interventions such as needle exchange can limit these risk factors and have been gradually implemented in these countries. In 2007, Ukraine approved the use of methadone substitution therapy and the current target is for 11,000 people who inject drugs to be enrolled in substitution therapy by 2011. Furthermore, since treatment for HIV-infected individuals is also necessary, national HIV control plans included a target of 90% antiretroviral therapy (ART) coverage by 2010 but in 2007 less than 10% of the 91,000 eligible people received treatment. Although the number of people who inject drugs and who receive ART is unknown, physicians are often reluctant to treat people who inject drugs using ART owing to alleged poor compliance.
Why Was This Study Done?
As resources for HIV interventions in the region are limited, it is important to investigate the appropriate balance between investments in methadone substitution therapy and ART in order to maximize benefits to public health. Several studies have analyzed the cost effectiveness of methadone substitution therapy in similar settings but have not considered tradeoffs between ART and methadone substitution therapy. Therefore, to provide insights into the appropriate public health investment in methadone substitution therapy and ART in Ukraine, the researchers evaluated the public health effectiveness and cost effectiveness of different strategies for scaling up methadone substitution therapy and/or expanding ART.
What Did the Researchers Do and Find?
The researchers developed a model to accommodate different population groups: people who inject drugs on substitution therapy with methadone; people who inject opiates and do not take any substitution therapy; and people who do not inject any drugs, hence do not need substitution therapy. The researchers inputted Ukraine country-level data into this model and used current HIV trends in Ukraine to make rational assumptions on possible future trends and scenarios. They considered scenarios expanding methadone substitution therapy availability, increasing acces to ART, or both. Then, the researchers measured health care costs, quality-adjusted life years (QALYs), HIV prevalence, infections averted, and incremental cost effectiveness for the different scenarios. They found that after 20 years, HIV prevalence reached 67.2% in people who inject drugs and 0.88% in people who do not inject drugs without further interventions. Offering methadone substitution therapy to 25% of people who inject drugs was the most effective strategy in reducing prevalence of HIV and was also the most cost effective, averting 4,700 infections and adding 75,700 QALYs versus the status quo at $530/QALY gained. Expanding both methadone substitution therapy and ART was also a highly cost effective option, adding 105,000 QALYs at US$1,120/QALY gained versus the methadone substitution therapy-only strategy. Offering ART to 80% of eligible people who did not inject drugs, and 10% of people who injected drugs averted only 1,800 infections, and added 76,400 QALYs at $1,330/QALY gained.
What Do These Findings Mean?
The results show that methadone substitution-focused therapeutic scenarios are the most cost effective, and that benefits increase with the scale of the project, even among people who do not inject drugs. This makes a methadone substitution strategy a highly cost-effective option for addressing the growing HIV epidemic in Ukraine. Therefore, if it is not feasible to invest in large-scale methadone substitution programs for any reason, political circumstances for example, providing as much methadone substitution as is acceptable is still desirable. While substitution therapy appears to avert the most HIV infections, expanded ART provides the largest total increase in QALYs. Thus, methadone substitution therapy and ART offer complementary benefits. Because the HIV epidemic in Ukraine is representative of the HIV epidemic in Eastern Europe and Central Asia, the cost-effective strategies that the researchers have identified may help inform all decision makers faced with a mixed HIV epidemic.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1000423.
Alliance provides information on its work supporting community action on AIDS in Ukraine
USAID provides an HIV/AIDS Health Profile for Ukraine
UNICEF provides information about its activities to help Ukraine fight rising HIV/AIDS infection rates
International Harm Reduction Association provides information about the status of harm reduction interventions such as methadone substitution therapy around the world
doi:10.1371/journal.pmed.1000423
PMCID: PMC3046988  PMID: 21390264
3.  Elevated rates of HIV infection among young Aboriginal injection drug users in a Canadian setting 
Objectives
Recent reports have suggested that Aboriginal and American Indian people are at elevated risk of HIV infection. We undertook the present study to compare socio-demographic and risk variables between Aboriginal and non-Aboriginal young (aged 13 – 24 years) injection drug users (IDUs) and characterize the burden of HIV infection among young Aboriginal IDUs.
Methods
We compared socio-demographic and risk variables between Aboriginal and non-Aboriginal young IDUs. Data were collected through the Vancouver Injection Drug Users Study (VIDUS). Semi-annually, participants have completed an interviewer-administered questionnaire and have undergone serologic testing for HIV and Hepatitis C (HCV).
Results
To date over 1500 Vancouver IDU have been enrolled and followed, among whom 291 were aged 24 years and younger. Of the 291 young injectors, 80 (27%) were Aboriginal. In comparison to non-Aboriginal youth, Aboriginal youth were more likely to test seropositive for either HIV (20% vs 7%, p=< 0.001) or Hepatitis C virus (HCV) (66% vs 38%, p =< 0.001), be involved in sex work and live in the city's IDU epi-centre at baseline. After 48 months of follow-up, Aboriginal youth experienced significantly higher HIV seroconversion rates than non-Aboriginal youth, 27.8 per ppy (95% CI: 13.4–42.2) vs. 7.0 per ppy (95% CI: 2.3–11.8) respectively (log-rank p = 0.005) and the incidence density over the entire follow-up period was 12.6 per 100 pyrs (CI: 6.49–21.96) and 3.9 per 100 pyrs (CI: 1.8–7.3) respectively.
Interpretation
These findings demonstrate that culturally relevant, evidence based prevention programs are urgently required to prevent HIV infection among Aboriginal youth.
doi:10.1186/1477-7517-3-9
PMCID: PMC1431516  PMID: 16524484
4.  Factors relating to participation in follow-up to the 45 and up study in Aboriginal and non-Aboriginal individuals 
Background
This study aimed to characterise the factors relating to participation in a postal follow-up study in Aboriginal and non-Aboriginal individuals, given the need to quantify potential biases from loss to follow-up and the lack of evidence regarding postal surveys among Aboriginal people.
Methods
The first 100,000 participants from the Sax Institute’s 45 and Up Study, a large scale cohort study, were posted a follow-up questionnaire gathering general demographic, health and risk factor data, emphasising Social, Economic and Environmental Factors (“The SEEF Study”). For each variable of interest, percentages of those invited who went on to participate in follow-up were tabulated separately for Aboriginal and non-Aboriginal participants and age- and sex-adjusted participation rate ratios (aPRR) were calculated.
Results
Of the 692 Aboriginal and 97,178 non-Aboriginal invitees to the study, 314 Aboriginal (45 %) and 59,175 non-Aboriginal (61 %) individuals responded. While Aboriginal people were less likely to respond than non-Aboriginal people (aPRR 0.72, 95 % CI 0.66–0.78), factors related to response were similar. Follow-up study participants were more likely than non-participants to have university versus no educational qualifications (1.6, 1.3–2.0 [Aboriginal]; 1.5, 1.5–1.5 [non-Aboriginal]) and an annual income of ≥70,000 versus < $20,000 (1.6, 1.3–2.0; 1.2, 1.2–1.3 [χ2 = 7.7; p = 0.001]). Current smokers (0.55, 0.42–0.72; 0.76, 0.74–0.77 [χ2 = 7.14; p = 0.03]), those reporting poor self-rated health (0.68, 0.47–0.99; 0.65, 0.61–0.69), poor quality of life (0.63, 0.41–0.97; 0.61, 0.57–0.66) and very high psychological distress (0.71, 0.68–0.75 [non-Aboriginal]) were less likely than other cohort members to respond.
Conclusions
Relatively large numbers of Aboriginal and non-Aboriginal individuals participated in the first 45 and Up Study follow-up suggesting that postal surveys can be used to follow Aboriginal participants in cohort studies. Despite somewhat greater loss to follow-up in Aboriginal people (after considering socio-demographic and health characteristics), factors related to follow-up participation were similar in both groups: greater loss was observed in those experiencing disadvantage, ill-health and health risk, with implications for interpretation of future findings. Aboriginal low income earners and current regular smokers had a particularly elevated likelihood of non-participation compared to non-Aboriginal people. These findings highlight the importance of identifying and addressing barriers to participation among hard-to-reach population groups.
Electronic supplementary material
The online version of this article (doi:10.1186/s12874-016-0155-x) contains supplementary material, which is available to authorized users.
doi:10.1186/s12874-016-0155-x
PMCID: PMC4865025  PMID: 27169779
Aboriginal people; Cohort study; Loss-to-follow up; Participation rates; Socio-demographic factors; Health behaviours
5.  Prevalence of Hepatitis C Among Australian Aboriginal and Torres Strait Islander people: A Systematic Review and Meta-Analysis 
Hepatitis Monthly  2016;16(7):e38640.
Context
Aboriginal and Torres Strait Islanders (Aboriginal) account for approximately 3% of the Australian population. They have the poorest health, economic and social outcomes. Higher notification rates of hepatitis C antibodies (anti-HCV) have been reported among Aboriginal compared with non-Aboriginal people. The identification of Aboriginal people in national surveillance has some weaknesses, with only four of the eight jurisdictions included in national reporting. To address some of these limitations, we aim to estimate the pooled prevalence of anti-HCV among Aboriginal people in Australia.
Evidence Acquisition
We searched the databases: Pubmed, Web of Science and Informit, and the New South Wales and Northern Territory Public Health Bulletins. A study was included if it reported the number of Aboriginal people testing positive for anti-HCV and the number tested for anti-HCV. A meta-analysis by population-group was conducted if three or more studies reported a prevalence estimate. Variables included: author, year of publication, study design, study period, gender (female, male), age, population group (Aboriginal people in prison, Aboriginal people who inject drugs), number testing anti-HCV positive, number tested for anti-HCV and prevalence (%). Due to a long time period, we separated the studies estimating the prevalence anti-HCV among Aboriginal people in prison into two time periods, 1994 - 2004 and 2005 - 2012.
Results
Overall, 15 studies met our inclusion criteria. Among Aboriginal people in prison, the pooled prevalence of anti-HCV was 18.1% (95%CI: 6.6 - 29.7). The pooled prevalence among Aboriginal people in prison was 25.7% (95%CI: 4.1-47.3) in studies published between 1994 - 2004 and 14.5% (95%CI: 1.7 - 27.3) in studies published from 2005 - 2012. The pooled prevalence of anti-HCV was 58.7% (95%CI: 53.9 - 63.5) among Aboriginal people who inject drugs and 2.9% (95%CI: 0.30 - 6.1) among Aboriginal people who did not inject drugs, however there was significant heterogeneity (I2 > 90.0%, P < 0.01). There was significant selection bias in the studies as most included individuals who inject drugs.
Conclusions
Our analysis shows that the overall prevalence of anti-HCV was significantly biased towards people who inject drugs; resulting in an over-estimation of anti-HCV prevalence among Aboriginal people. Our review highlights that unsafe injecting is the main transmission route for HCV infection among Aboriginal people in Australia.
doi:10.5812/hepatmon.38640
PMCID: PMC5020402  PMID: 27651805
HCV; Indigenous
6.  Changes in HIV Incidence among People Who Inject Drugs in Taiwan following Introduction of a Harm Reduction Program: A Study of Two Cohorts 
PLoS Medicine  2014;11(4):e1001625.
Kenrad Nelson and colleagues report on the association between HIV incidence and exposure to a national harm-reduction program among people who inject drugs in Taiwan.
Please see later in the article for the Editors' Summary
Background
Harm reduction strategies for combating HIV epidemics among people who inject drugs (PWID) have been implemented in several countries. However, large-scale studies using sensitive measurements of HIV incidence and intervention exposures in defined cohorts are rare. The aim of this study was to determine the association between harm reduction programs and HIV incidence among PWID.
Methods and Findings
The study included two populations. For 3,851 PWID who entered prison between 2004 and 2010 and tested HIV positive upon incarceration, we tested their sera using a BED HIV-1 capture enzyme immunoassay to estimate HIV incidence. Also, we enrolled in a prospective study a cohort of 4,357 individuals who were released from prison via an amnesty on July 16, 2007. We followed them with interviews at intervals of 6–12 mo and by linking several databases. A total of 2,473 participants who were HIV negative in January 2006 had interviews between then and 2010 to evaluate the association between use of harm reduction programs and HIV incidence. We used survival methods with attendance at methadone clinics as a time-varying covariate to measure the association with HIV incidence. We used a Poisson regression model and calculated the HIV incidence rate to evaluate the association between needle/syringe program use and HIV incidence. Among the population of PWID who were imprisoned, the implementation of comprehensive harm reduction programs and a lower mean community HIV viral load were associated with a reduced HIV incidence among PWID. The HIV incidence in this population of PWID decreased from 18.2% in 2005 to 0.3% in 2010. In an individual-level analysis of the amnesty cohort, attendance at methadone clinics was associated with a significantly lower HIV incidence (adjusted hazard ratio: 0.20, 95% CI: 0.06–0.67), and frequent users of needle/syringe program services had lower HIV incidence (0% in high NSP users, 0.5% in non NSP users). In addition, no HIV seroconversions were detected among prison inmates.
Conclusions
Although our data are affected by participation bias, they strongly suggest that comprehensive harm- reduction services and free treatment were associated with reversal of a rapidly emerging epidemic of HIV among PWID.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
About 35 million people worldwide are currently infected with HIV, the virus that causes AIDS, and about 2.3 million people become newly infected every year. HIV is mainly transmitted through unprotected sex with an infected partner. However, people who inject drugs (PWID) have a particularly high risk of HIV infection because blood transfer through needle and syringe sharing can transmit the virus. It is estimated that 5%–10% of all people living with HIV are PWID. Indeed, in some regions of the world the primary route of HIV transmission is through shared drug injection equipment and the prevalence (the proportion of a population that has a specific disease) of HIV infection among PWID is very high. In Asia, for example, more than a quarter of PWID are HIV positive. Because the high prevalence of HIV among PWID poses a global health challenge, bodies such as the Joint United Nations Programme on HIV/AIDS endorse harm reduction strategies to prevent risky injection behaviors among PWID. These strategies include the provision of clean needles and syringes, opioid substitution therapy such as methadone maintenance treatment, and antiretroviral treatment for HIV-positive PWID.
Why Was This Study Done?
Although harm reduction strategies for combating HIV epidemics among PWID have been implemented in several countries, few large-scale studies have examined the association between HIV incidence (the proportion of new cases of HIV in a population per year) and exposure to harm reduction programs among PWID. In this cohort study (an investigation that determines the characteristics of a group of people and then follows them over time), the researchers determine the association between harm reduction programs and HIV incidence among PWID in Taiwan. HIV infections used to be rare among the 60,000 PWID living in Taiwan, but after the introduction of a new HIV strain into the country in 2003, an HIV epidemic spread rapidly. In response, the Taiwanese government introduced a pilot program of harm reduction that included the provision of clean needles and syringes and health education in July 2005. The program was expanded to include methadone maintenance treatment in early 2006 and implemented nationwide in June 2006.
What Did the Researchers Do and Find?
The researchers enrolled two study populations. The first cohort comprised 3,851 PWID who were incarcerated for illicit drug use between 2004 and 2010 and who tested positive for HIV upon admission into prison. By using the BED assay, which indicates whether an HIV infection is recent, the researchers were able to determine the HIV incidence among the prisoners. In 2004, the estimated HIV incidence among prisoners with a history of drug injection was 6.44%. The incidence peaked in 2005 at 18.2%, but fell to 0.3% in 2010.
The second study population comprised 2,473 individuals who were HIV negative on January 1, 2006, and who had been incarcerated for drug use crimes but were released on July 16, 2007, during an amnesty. The researchers regularly interviewed these participants between their release and 2010 about their use of harm reduction interventions, and obtained other data about them (for example, diagnosis of HIV infection) from official databases. Analysis of all these data indicated that, in this cohort, attendance at methadone maintenance treatment clinics and frequent use of needle and syringe services were both associated with a significantly lower HIV incidence.
What Do These Findings Mean?
These findings suggest that the introduction of a comprehensive harm reduction program in Taiwan was associated with a significant reduction in the HIV incidence rate among PWID. These findings must be interpreted with caution, however. First, because the participants in the study were selected from PWID with histories of incarceration, the findings may not be representative of all PWID in Taiwan or of PWID in other countries. Second, PWID who chose to use needle and syringe services or methadone maintenance treatment clinics might have shared other unknown characteristics that affected their risk of HIV infection. Finally, some of the reduction in HIV incidence seen during the study is likely to be associated with the availability of free treatment, which has been offered to all HIV-positive individuals in Taiwan since 1997. Despite these limitations, these findings suggest that countries with a high prevalence and incidence of HIV among PWID should provide comprehensive harm reduction services to their populations to reduce risky drug injection behaviors.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001625.
Information is available from the US National Institute of Allergy and Infectious diseases on HIV infection and AIDS
NAM/aidsmap provides basic information about HIV/AIDS, and summaries of recent research findings on HIV care and treatment
Information is available from Avert, an international AIDS charity, on many aspects of HIV/AIDS, including information on injecting drug users and HIV/AIDS and on harm reduction and HIV prevention (in English and Spanish)
The US National Institute on Drug Abuse also provides information about drug abuse and HIV/AIDS (in English and Spanish)
The 2013 UNAIDS World AIDS Day report provides up-to-date information about the AIDS epidemic and efforts to halt it
Personal stories about living with HIV/AIDS are available through Avert, Nam/aidsmap, and Healthtalkonline
doi:10.1371/journal.pmed.1001625
PMCID: PMC3979649  PMID: 24714449
7.  Impact of blended treatment literacy and psychoeducation on methadone maintenance treatment outcomes in Yunnan, China 
Background
Outcomes of methadone maintenance treatment (MMT) in the management of opioid dependency can be impaired by poor adherence and retention, concomitant drug use, poor adjustment of methadone dosage, and low levels of awareness regarding methadone among drug users, among other factors. This study investigated the effects of intensive blended treatment literacy and psychoeducation on treatment compliance, methadone dose, and heroin use among MMT clients in China.
Methods
A total of 492 MMT clients who tested positive for urine morphine at least once during a 12-week intervention period preceding the study were recruited from 16 MMT clinics. Employing a client-centred approach, a blended treatment literacy and psychoeducation intervention was then implemented between March and June 2014, comprising (1) intensified methadone treatment literacy sessions; (2) participatory goal setting; (3) continuous adherence monitoring and support; and (4) engagement of both peers and doctors in delivering psychoeducation. Wilcoxon signed-rank test was used to compare urine morphine positive rates, daily methadone dosage, and the number of days that clients successfully accessed methadone before and during the intervention.
Results
During the intervention, urine morphine positive rates reduced to 27 % from 49.3 % previously; p < 0.001. In response to client needs, methadone dosages increased among 74 % of participants, remained unchanged among 12.0 %, and reduced among 13.4 % during the intervention. In addition, the average daily methadone dose increased from 63.0 to 72.6 mg; p < 0.001, while the average number of days that clients successfully accessed methadone increased from 69.4 to 73.9 over a period of 12 weeks; p < 0.001.
Conclusions
Blended treatment literacy and psychoeducation delivered by a combination of peers and doctors was associated with reduced heroin use, improved treatment adherence, and higher methadone doses among our sample of MMT clients.
doi:10.1186/s12954-016-0097-y
PMCID: PMC4768342  PMID: 26915361
Methadone; Psychoeducation; Harm reduction; Injecting drug use; China
8.  IMPACT OF INCARCERATION ON RATES OF METHADONE USE IN A COMMUNITY RECRUITED COHORT OF INJECTION DRUG USERS 
Addictive behaviors  2015;46:1-4.
Background
Despite barriers to its use in many settings, opioid agonist therapy with methadone has become the standard of care for treating opioid (e.g. heroin) use disorder. Since people with opioid use disorders have an increased incidence of incarceration, we undertook the present study to evaluate the association between incarceration and methadone maintenance therapy among a cohort of injection drug users in a Canadian setting.
Methods
A cohort of people who inject drugs were prospectively followed between May 1996 and May 2013 in Vancouver, Canada. We investigated the relationship between recent incarceration and methadone use using multivariate generalized estimating equations (GEE) logistic regression analysis.
Results
Overall, 2758 individuals were recruited during the study period and followed for a median of 64 (interquartile range: 23 – 106) months. After adjusting for various potential confounders in the multivariate GEE model, being incarcerated remained independently associated with a lower likelihood of having received methadone treatment (Adjusted Odds Ratio: 0.87, 95% confidence interval: 0.81 – 0.93).
Conclusions
Our study demonstrates that incarceration was independently associated with a significantly lower likelihood of being on methadone. Given the role of methadone in reducing the harms of heroin use, including drug acquisitive crime and recidivism, these data suggest a need to scale-up methadone provision for incarcerated injection drug users.
doi:10.1016/j.addbeh.2015.01.038
PMCID: PMC4395538  PMID: 25746159
Methadone maintenance therapy; Injection drug use; Incarceration
9.  Prevalence and incidence of hepatitis C virus infection among Aboriginal young people who use drugs: results from the Cedar Project 
Open Medicine  2009;3(4):e220-e227.
Background
We sought to estimate the prevalence and incidence of hepatitis C virus (HCV) infection among Aboriginal young people who use drugs and to identify risk factors associated with HCV infection in this population.
Methods
The Cedar Project is a longitudinal study involving Aboriginal young people living in Vancouver and Prince George, British Columbia. Eligibility criteria include age from 14 to 30 years and self-reported use (smoking or injection) of illicit drugs (e.g., crystal methamphetamine, crack cocaine, heroin or other opiates, and cocaine) at least once in the month before enrolment. At each visit, participants completed a detailed questionnaire administered by an Aboriginal interviewer. For this analysis, we included information for 512 participants who were recruited between September 2003 and April 2005.
Results
Among the 512 participants, the prevalence of HCV infection was 34.8% (95% confidence interval [CI] 30.6%–38.9%); the rates were similar in Prince George and Vancouver (34.5% and 35.0% respectively, p = 0.37). Among those who reported the use of injection drugs at baseline (n = 286), the prevalence of HCV infection was 59.4% (95% CI 53.8%–65.1%); the rate in this group was slightly higher in Prince George than in Vancouver (62.4% v. 57.1% respectively, p = 0.37). The prevalence was 3.5% among participants who reported smoking drugs (n = 226). In the multivariate logistic regression analysis, factors significantly associated with HCV infection among participants who used injection drugs included daily injection of opiates (adjusted odds ratio [OR] 2.7, 95% CI 1.0–7.4), reuse of syringes (adjusted OR 2.4, 95% CI 1.3–4.4), having at least 1 parent who attended residential school (adjusted OR 1.9, 95% CI 1.1–3.4), female sex (adjusted OR 1.9, 95% CI 1.1–3.4) and duration of injection drug use (per year) (adjusted OR 1.4, 95% CI 1.3–1.5). The crude incidence rate of HCV infection was 10.6% and the incidence density estimate was 9.9 per 100 person-years in this cohort.
Interpretation
The prevalence of HCV infection was elevated among Aboriginal young people living in Prince George and Vancouver who use drugs. Culturally based prevention, treatment and harm-reduction programs are urgently needed in this population.
PMCID: PMC3090112  PMID: 21688759
10.  Factors associated with pretreatment and treatment dropouts: comparisons between Aboriginal and non-Aboriginal clients admitted to medical withdrawal management 
Background
Addiction treatment faces high pretreatment and treatment dropout rates, especially among Aboriginals. In this study we examined characteristic differences between Aboriginal and non-Aboriginal clients accessing an inpatient medical withdrawal management program, and identified risk factors associated with the probabilities of pretreatment and treatment dropouts, respectively.
Methods
2231 unique clients (Aboriginal = 451; 20%) referred to Vancouver Detox over a two-year period were assessed. For both Aboriginal and non-Aboriginal groups, multivariate logistic regression analyses were conducted with pretreatment dropout and treatment dropout as dependent variables, respectively.
Results
Aboriginal clients had higher pretreatment and treatment dropout rates compared to non-Aboriginal clients (41.0% vs. 32.7% and 25.9% vs. 20.0%, respectively). For Aboriginal people, no fixed address (NFA) was the only predictor of pretreatment dropout. For treatment dropout, significant predictors were: being female, having HCV infection, and being discharged on welfare check issue days or weekends. For non-Aboriginal clients, being male, NFA, alcohol as a preferred substance, and being on methadone maintenance treatment (MMT) at referral were associated with pretreatment dropout. Significant risk factors for treatment dropout were: being younger, having a preferred substance other than alcohol, having opiates as a preferred substance, and being discharged on weekends.
Conclusions
Our results highlight the importance of social factors for the Aboriginal population compared to substance-specific factors for the non-Aboriginal population. These findings should help clinicians and decision-makers to recognize the importance of social supports especially housing and initiate appropriate services to improve treatment intake and subsequent retention, physical and mental health outcomes and the cost-effectiveness of treatment.
doi:10.1186/1477-7517-10-38
PMCID: PMC3878858  PMID: 24325629
Aboriginal; Housing; Pretreatment dropout rate; Treatment dropout rate; Withdrawal management; Substance use disorders; Detoxification
11.  Participation dynamics of a cohort of drug users in a low-threshold methadone treatment programme 
Background
The low-threshold methadone maintenance treatment (MMT) programme in Hong Kong has been in place for about 40 years. Assessment of the participation pattern of methadone users may inform future programme development to achieve effective harm reduction.
Methods
Longitudinal clinical data of methadone users who first registered for MMT in the year 2008 in Hong Kong were retrieved after ethical and institutional approval. Participation pattern of this cohort was evaluated by examining users’ frequency of attendance and then the overall retention rate. A subgroup of consistent users who remained on treatment in 2012 and/or 2013 was analysed. Comparison was made between high- and low-frequency users, and among high/moderate and low consistency users, to test their correlations with socio-demographics and social connectivity.
Results
The cohort of methadone users registering in the year 2008 was composed of 351 persons, 77 % of whom were ethnic Chinese, with a median age of 34 and the duration of heroin dependency of 6 years. The participation pattern of methadone users was highly variable, with a 6-year retention rate of 38 %. Discontinuations or 'breaks' of >28 days had occurred in 212 (60 %) methadone users. About one third (n = 117) were high-frequency users who had attended more than twice a week for at least 90 % of their treatment periods. The dosages received by high-frequency users were generally higher. Of those continuing on treatment in the fifth and/or sixth year (n = 185), 30 (16 %), 29 (16 %) and 126 (68 %) gave a high, moderate and low level of consistency as defined by the lengths of breaks. High/moderate consistency users had a longer history of heroin use and a higher degree of connectivity with other users by social network analysis.
Conclusions
Despite the variability of frequency and consistency of attendance of drug users enrolling in the low-threshold MMT programme in Hong Kong, a consistent pattern could be seen in the proportional distribution of dosage and participation efforts. Whereas an adequate dosage was a potential predictor of optimal frequency of attendance, demographics and connectivity had varied between continued users with different levels of consistency.
doi:10.1186/s12954-015-0072-z
PMCID: PMC4608158  PMID: 26470863
Low threshold; Methadone maintenance treatment; Injecting drug users; Social connectivity
12.  Dialysis and transplantation among Aboriginal children with kidney failure 
Background:
Relatively little is known about the management and outcomes of Aboriginal children with renal failure in Canada. We evaluated differences in dialysis modality, time spent on dialysis, rates of kidney transplantation, and patient and allograft survival between Aboriginal children and non-Aboriginal children.
Methods:
For this population-based cohort study, we used data from a national pediatric end-stage renal disease database. Patients less than 18 years old who started renal replacement treatment (dialysis or kidney transplantation) in nine Canadian provinces (Quebec data were not available) and all three territories between 1992 and 2007 were followed until death, loss to follow-up or end of the study period. We compared initial modality of dialysis and time to first kidney transplant between Aboriginal children, white children and children of other ethnicity. We examined the association between ethnicity and likelihood of kidney transplantation using adjusted Cox proportional hazard models for Aboriginal and white children (data for the children of other ethnicity did not meet the assumptions of proportional hazards).
Results:
Among 843 pediatric patients included in the study, 104 (12.3%) were Aboriginal, 521 (61.8%) were white, and 218 (25.9%) were from other ethnic minorities. Hemodialysis was the initial modality of dialysis for 48.0% of the Aboriginal patients, 42.7% of the white patients and 62.6% of those of other ethnicity (p < 0.001). The time from start of dialysis to first kidney transplant was longer among the Aboriginal children (median 1.75 years, interquartile range 0.69–2.81) than among the children in the other two groups (p < 0.001). After adjustment for confounders, Aboriginal children were less likely than white children to receive a transplant from a living donor (hazard ratio [HR] 0.36, 95% confidence interval [CI] 0.21–0.61) or a transplant from any donor (HR 0.54, 95% CI 0.40–0.74) during the study period.
Interpretation:
The time from start of dialysis to first kidney transplant was longer among Aboriginal children than among white children. Further evaluation is needed to determine barriers to transplantation among Aboriginal children.
doi:10.1503/cmaj.101840
PMCID: PMC3134757  PMID: 21609989
13.  Recent epidemiologic trends of diabetes mellitus among status Aboriginal adults 
Background:
Little is known about longitudinal trends in diabetes mellitus among Aboriginal people in Canada. We compared the incidence and prevalence of diabetes, and its impact on mortality, among status Aboriginal adults and adults in the general population between 1995 and 2007.
Methods:
We examined de-identified data from Alberta Health and Wellness administrative databases for status Aboriginal people (First Nations and Inuit people with treaty status) and members of the general public aged 20 years and older who received a diagnosis of diabetes mellitus from Apr. 1, 1995, to Mar. 31, 2007. We calculated the incidence and prevalence of diabetes and mortality rate ratios by sex and ethnicity in 2007. We examined the average relative changes per year for longitudinal trends.
Results:
The average relative change per year in the prevalence of diabetes showed a smaller increase over time in the Aboriginal population than in the general population (2.39 v. 4.09, p < 0.001). A similar finding was observed for the incidence of diabetes. In the Aboriginal population, we found that the increase in the average relative change per year was greater among men than among women (3.13 v. 1.88 for prevalence, p < 0.001; 2.60 v. 0.02 for incidence, p = 0.001). Mortality among people with diabetes decreased over time to a similar extent in both populations. Among people without diabetes, mortality decreased in the general population but was unchanged in the Aboriginal population (−1.92 v. 0.11, p = 0.04). Overall, mortality was higher in the Aboriginal population than in the general population regardless of diabetes status.
Interpretation:
The increases in the incidence and prevalence of diabetes over the study period appeared to be slower in the status Aboriginal population than in the general population in Alberta, although the overall rates were higher in the Aboriginal population. Mortality decreased among people with diabetes in both populations but was higher overall in the Aboriginal population regardless of diabetes status.
doi:10.1503/cmaj.101882
PMCID: PMC3168663  PMID: 21788417
14.  The Cedar Project: high incidence of HCV infections in a longitudinal study of young Aboriginal people who use drugs in two Canadian cities 
BMC Public Health  2012;12:632.
Background
Factors associated with HCV incidence among young Aboriginal people in Canada are still not well understood. We sought to estimate time to HCV infection and the relative hazard of risk factors associated HCV infection among young Aboriginal people who use injection drugs in two Canadian cities.
Methods
The Cedar Project is a prospective cohort study involving young Aboriginal people in Vancouver and Prince George, British Columbia, who use illicit drugs. Participants’ venous blood samples were drawn and tested for HCV antibodies. Analysis was restricted to participants who use used injection drugs at enrolment or any of follow up visit. Cox proportional hazards regression was used to identify independent predictors of time to HCV seroconversion.
Results
In total, 45 out of 148 participants seroconverted over the study period. Incidence of HCV infection was 26.3 per 100 person-years (95% Confidence Interval [CI]: 16.3, 46.1) among participants who reported using injection drugs for two years or less, 14.4 per 100 person-years (95% CI: 7.7, 28.9) among participants who had been using injection drugs for between two and five years, and 5.1 per 100 person-years (95% CI: 2.6,10.9) among participants who had been using injection drugs for over five years. Independent associations with HCV seroconversion were involvement in sex work in the last six months (Adjusted Hazard Ratio (AHR): 1.59; 95% CI: 1.05, 2.42) compared to no involvement, having been using injection drugs for less than two years (AHR: 4.14; 95% CI: 1.91, 8.94) and for between two and five years (AHR: 2.12; 95%CI: 0.94, 4.77) compared to over five years, daily cocaine injection in the last six months (AHR: 2.47; 95% CI: 1.51, 4.05) compared to less than daily, and sharing intravenous needles in the last six months (AHR: 2.56; 95% CI: 1.47, 4.49) compared to not sharing.
Conclusions
This study contributes to the limited body of research addressing HCV infection among Aboriginal people in Canada. The HCV incidence rate among Cedar Project participants who were new initiates of injection drug use underscores an urgent need for HCV and injection prevention and safety strategies aimed at supporting young people surviving injection drug use and sex work in both cities. Young people must be afforded the opportunity to provide leadership and input in the development of prevention programming.
doi:10.1186/1471-2458-12-632
PMCID: PMC3490797  PMID: 22877418
15.  Methadone continuation versus forced withdrawal on incarceration in a combined US prison and jail: a randomised, open-label trial 
Lancet (London, England)  2015;386(9991):350-359.
Summary
Background
Methadone is an effective treatment for opioid dependence. When people who are receiving methadone maintenance treatment for opioid dependence are incarcerated in prison or jail, most US correctional facilities discontinue their methadone treatment, either gradually, or more often, abruptly. This discontinuation can cause uncomfortable symptoms of withdrawal and renders prisoners susceptible to relapse and overdose on release. We aimed to study the effect of forced withdrawal from methadone upon incarceration on individuals’ risk behaviours and engagement with post-release treatment programmes.
Methods
In this randomised, open-label trial, we randomly assigned (1:1) inmates of the Rhode Island Department of Corrections (RI, USA) who were enrolled in a methadone maintenance-treatment programme in the community at the time of arrest and wanted to remain on methadone treatment during incarceration and on release, to either continuation of their methadone treatment or to usual care—forced tapered withdrawal from methadone. Participants could be included in the study only if their incarceration would be more than 1 week but less than 6 months. We did the random assignments with a computer-generated random permutation, and urn randomisation procedures to stratify participants by sex and race. Participants in the continued-methadone group were maintained on their methadone dose at the time of their incarceration (with dose adjustments as clinically indicated). Patients in the forced-withdrawal group followed the institution’s standard withdrawal protocol of receiving methadone for 1 week at the dose at the time of their incarceration, then a tapered withdrawal regimen (for those on a starting dose >100 mg, the dose was reduced by 5 mg per day to 100 mg, then reduced by 3 mg per day to 0 mg; for those on a starting dose ≤100 mg, the dose was reduced by 3 mg per day to 0 mg). The main outcomes were engagement with a methadone maintenance-treatment clinic after release from incarceration and time to engagement with methadone maintenance treatment, by intention-to-treat and as-treated analyses, which we established in a follow-up interview with the participants at 1 month after their release from incarceration. Our study paid for 10 weeks of methadone treatment after release if participants needed financial help. This trial is registered with ClinicalTrials.gov, number NCT01874964.
Findings
Between June 14, 2011, and April 3, 2013, we randomly assigned 283 prisoners to our study, 142 to continued methadone treatment, and 141 to forced withdrawal from methadone. Of these, 60 were excluded because they did not fit the eligibility criteria, leaving 114 in the continued-methadone group and 109 in the forced-withdrawal group (usual care). Participants assigned to continued methadone were more than twice as likely than forced-withdrawal participants to return to a community methadone clinic within 1 month of release (106 [96%] of 110 in the continued-methadone group compared with 68 [78%] of 87 in the forced-withdrawal group; adjusted hazard ratio [HR] 2·04, 95% CI 1·48–2·80). We noted no differences in serious adverse events between groups. For the continued-methadone and forced-withdrawal groups, the number of deaths were one and zero, non-fatal overdoses were one and two, admissions to hospital were one and four; and emergency-room visits were 11 and 16, respectively.
Interpretation
Although our study had several limitations—eg, it only included participants incarcerated for fewer than 6 months, we showed that forced withdrawal from methadone on incarceration reduced the likelihood of prisoners re-engaging in methadone maintenance after their release. Continuation of methadone maintenance during incarceration could contribute to greater treatment engagement after release, which could in turn reduce the risk of death from overdose and risk behaviours.
doi:10.1016/S0140-6736(14)62338-2
PMCID: PMC4522212  PMID: 26028120
16.  Diacetylmorphine versus Methadone for the Treatment of Opioid Addiction 
The New England journal of medicine  2009;361(8):777-786.
BACKGROUND
Studies in Europe have suggested that injectable diacetylmorphine, the active ingredient in heroin, can be an effective adjunctive treatment for chronic, relapsing opioid dependence.
METHODS
In an open-label, phase 3, randomized, controlled trial in Canada, we compared injectable diacetylmorphine with oral methadone maintenance therapy in patients with opioid dependence that was refractory to treatment. Long-term users of injectable heroin who had not benefited from at least two previous attempts at treatment for addiction (including at least one methadone treatment) were randomly assigned to receive methadone (111 patients) or diacetylmorphine (115 patients). The primary outcomes, assessed at 12 months, were retention in addiction treatment or drug-free status and a reduction in illicit-drug use or other illegal activity according to the European Addiction Severity Index.
RESULTS
The primary outcomes were determined in 95.2% of the participants. On the basis of an intention-to-treat analysis, the rate of retention in addiction treatment in the diacetylmorphine group was 87.8%, as compared with 54.1% in the methadone group (rate ratio for retention, 1.62; 95% confidence interval [CI], 1.35 to 1.95; P<0.001). The reduction in rates of illicit-drug use or other illegal activity was 67.0% in the diacetylmorphine group and 47.7% in the methadone group (rate ratio, 1.40; 95% CI, 1.11 to 1.77; P=0.004). The most common serious adverse events associated with diacetylmorphine injections were overdoses (in 10 patients) and seizures (in 6 patients).
CONCLUSIONS
Injectable diacetylmorphine was more effective than oral methadone. Because of a risk of overdoses and seizures, diacetylmorphine maintenance therapy should be delivered in settings where prompt medical intervention is available. (ClinicalTrials.gov number, NCT00175357.)
doi:10.1056/NEJMoa0810635
PMCID: PMC5127701  PMID: 19692689 CAMSID: cams373
17.  Methadone Maintenance for HIV Positive and HIV Negative Patients in Kyiv: Acceptability and Treatment Response 
Drug and alcohol dependence  2014;137:62-67.
Background
With up to 40% of opioid injectors infected with HIV, Ukraine has one of the most concentrated HIV epidemics in the world, mainly due to unsterile injection practices and a historical absence of effective prevention services. Harm reduction programs, including syringe exchange and a small buprenorphine treatment program, were introduced in 2004 and methadone maintenance was allowed in 2007. Despite an initial expansion, by 2009, only 3221 injectors were receiving methadone treatment. A growing body of research on methadone maintenance has found high retention rates with reduction in opioid use and HIV risk behaviors. We report on the acceptability and initial outcome of methadone treatment as a function of HIV status, an issue that has not yet been reported for injectors in Ukraine.
Methods
Longitudinal observational study of a 12-week course of methadone treatment in 25 HIV+ and 25 HIV− opioid addicted individuals recruited from a harm reduction program and the city AIDS Center. Drug use and HIV risk were assessed at baseline and weeks 4, 8, 12 and 20; all patients were offered continued methadone maintenance in the Kyiv city program at the end of 12 weeks.
Results
Fifty-four individuals were asked if they were interested in the study and 50, demographically similar to other samples of opioid addicted Ukrainians, agreed to participate. Two died of non-study related causes; the other 48 completed assessments at weeks 4, 8 and 12, and 47 completed followups at week 20. Significant reductions were seen in use of heroin (p<. 0001), other opiates/analgesics (p< 0.0001), and HIV risk behaviors (drug, sex, total; all p <0.0001). All 48 patients chose to continue methadone after the 12-weeks of study medication ended. Unlike most opioid treatment studies, sexual risk was somewhat higher than injecting risk at study intake.
Conclusions
Methadone maintenance was well accepted by HIV+ and HIV− opioid dependent individuals and has the potential for significant public health impact if made more widely available with sustained access and support.
doi:10.1016/j.drugalcdep.2014.01.008
PMCID: PMC3985084  PMID: 24548802
Methadone maintenance; HIV risk; Ukraine; PWID
18.  Optimum Methadone Compliance Testing 
Executive Summary
Objective
The objective of this analysis was to determine the diagnostic utility of oral fluid testing collected with the Intercept oral fluid collection device.
Clinical Need: Target Population and Condition
Opioids (opiates or narcotics) are a class of drugs derived from the opium poppy plant that typically relieve pain and produce a euphoric feeling. Methadone is a long-acting synthetic opioid used to treat opioid dependence and chronic pain. It prevents symptoms of opioid withdrawal, reduces opioid cravings and blocks the euphoric effects of short-acting opioids such as heroin and morphine. Opioid dependence is associated with harms including an increased risk of exposure to Human Immunodeficiency Virus and Hepatitis C as well as other health, social and psychological crises. The goal of methadone treatment is harm reduction. Treatment with methadone for opioid dependence is often a long-term therapy. The Ontario College of Physicians and Surgeons estimates that there are currently 250 physicians qualified to prescribe methadone, and 15,500 people in methadone maintenance programs across Ontario.
Drug testing is a clinical tool whose purpose is to provide objective meaningful information, which will reinforce positive behavioral changes in patients and guide further treatment needs. Such information includes knowledge of whether the patient is taking their methadone as prescribed and reducing or abstaining from using opioid and other drugs of abuse use. The results of drug testing can be used with behavior modification techniques (contingency management techniques) where positive reinforcements such as increased methadone take-home privileges, sustained employment or parole are granted for drug screens negative for opioid use, and negative reinforcement including loss of these privileges for drug screens positive for opioid used.
Body fluids including blood, oral fluid, often referred to as saliva, and urine may contain metabolites and the parent drug of both methadone and drugs of abuse and provide a means for drug testing. Compared with blood which has a widow of detection of several hours, urine has a wider window of detection, approximately 1 to 3 days, and is therefore considered more useful than blood for drug testing. Because of this, and the fact that obtaining a urine specimen is relatively easy, urine drug screening is considered the criterion measure (gold standard) for methadone maintenance monitoring. However, 2 main concerns exist with urine specimens: the possibility of sample tampering by the patient and the necessity for observed urine collection. Urine specimens may be tampered with in 3 ways: dilution, adulteration (contamination) with chemicals, and substitution (patient submits another persons urine specimen). To circumvent sample tampering the supervised collection of urine specimens is a common and recommended practice. However, it has been suggested that this practice may have negative effects including humiliation experienced by patient and staff, and may discourage patients from staying in treatment. Supervised urine specimen collection may also present an operational problem as staff must be available to provide same-sex supervision. Oral fluid testing has been proposed as a replacement for urine because it can be collected easily under direct supervision without infringement of privacy and reduces the likelihood of sample tampering. Generally, the results of oral fluid drug testing are similar to urine drug testing but there are some differences, such as lower concentrations of substances in oral fluid than urine, and some drugs remain detectable for longer periods of time in urine than oral fluid.
The Technology Being Reviewed
The Intercept Oral Specimen Collection Device (Ora-Sure Technologies, Bethlehem, PA) consists of an absorbent pad mounted on a plastic stick. The pad is coated with common salts. The absorbent pad is inserted into the mouth and placed between the cheek and gums for 3 minutes on average. The pad absorbs the oral fluid. After 3 minutes (range 2min-5 min) the collection device is removed from the mouth and the absorbent pad is placed in a small vial which contains 0.8mL of pH-balanced preservative, for transportation to a laboratory for analysis. It is recommended that the person undergoing oral fluid drug testing have nothing to eat or drink for a 10- minute period before the oral fluid specimen is collected. This will remove opportunity for adulteration. Likewise, it is recommended that the person be observed for the duration of the collection period to prevent adulteration of the specimen. An average of 0.4 mL of saliva can be collected. The specimen may be stored at 4C to 37C and tested within 21 days of collection (or within 6 weeks if frozen).
The oral fluid specimen must be analyzed in a laboratory setting. There is no point-of-care (POC) oral fluid test kit for drugs of abuse (other than for alcohol). In the laboratory the oral fluid is extracted from the vial after centrifugation and a screening test is completed to eliminate negative specimens. Similar to urinalysis, oral fluid specimens are analyzed first by enzyme immunoassay with positive specimens sent for confirmatory testing. Comparable cut-off values to urinalysis by enzyme immunoassay have been developed for oral fluids
Review Strategy
 
Research Question
What is the diagnostic utility of the Intercept oral specimen device?
Inclusion criteria:
Studies evaluating paired urine and oral fluid specimens from the same individual with the Intercept oral fluid collection device.
The population studied includes drug users.
Exclusion criteria:
Studies testing for marijuana (THC) only.
Outcomes:
Sensitivity and Specificity of oral fluid testing compared to urinalysis for methadone (methadone metabolite), opiates, cocaine, benzodiazepines, and alcohol.
Quality of the Body of Evidence
The Grading of Recommendations Assessment, Development and Evaluation (GRADE) system was used to evaluate the overall quality of the body of evidence (defined as 1 or more studies) supporting the research questions explored in this systematic review. A description of the GRADE system is reported in Appendix 1.
Summary of Findings
A total of 854 potential citations were retrieved. After reviewing titles and abstracts, 2 met the inclusion and exclusion criteria. Two other relevant studies were found after corresponding with the author of the 2 studies retrieved from the literature search. Therefore a total of 4 published studies are included in this analysis. All 4 studies carried out by the same investigator meet the definition of Medical Advisory Secretariat level III (not a-randomized controlled trial with contemporaneous controls) study design. In each of the studies, paired urine and oral fluid specimens where obtained from drug users. Urine collection was not observed in the studies however, laboratory tests for pH and creatinine were used to determine the reliability of the specimen. Urine specimens thought to be diluted and unreliable were removed from the evaluation. Urinalysis was used as the criterion measurement for which to determine the sensitivity and specificity of oral fluid testing by the Intercept oral fluid device for opiates, benzodiazepines, cocaine and marijuana. Alcohol was not tested in any of the 4 studies. From these 4 studies, the following conclusions were drawn:
The evidence indicates that oral fluid testing with the Intercept oral fluid device has better specificity than sensitivity for opiates, benzodiazepines, cocaine and marijuana.
The sensitivity of oral fluids testing with the Intercept oral fluid device seems to be from best to worst: cocaine > benzodiazepines >opiates> marijuana.
The sensitivity and specificity for opiates of the Intercept oral fluid device ranges from 75 to 90% and 97- 100% respectively.
The consequences of opiate false-negatives by oral fluid testing with the Intercept oral fluid device need to be weighed against the disadvantages of urine testing, including invasion of privacy issues and adulteration and substitution of the urine specimen.
The window of detection is narrower for oral fluid drug testing than urinalysis and because of this oral fluid testing may best be applied in situations where there is suspected frequent drug use. When drug use is thought to be less frequent or remote, urinalysis may offer a wider (24-48 hours more than oral fluids) window of detection.
The narrow window of detection for oral fluid testing may mean more frequent testing is needed compared to urinalysis. This may increase the expense for drug testing in general.
POC oral fluid testing is not yet available and may limit the practical utility of this drug testing methodology. POC urinalysis by immunoassay is available.
The possible applications of oral fluid testing may include:
Because of its narrow window of detection compared to urinalysis oral fluid testing may best be used during periods of suspected frequent or recent drug use (within 24 hours of drug testing). This is not to say that oral fluid testing is superior to urinalysis during these time periods.
In situations where an observed urine specimen is difficult to obtain. This may include persons with “shy bladder syndrome” or with other urinary conditions limiting their ability to provide an observed urine specimen.
When the health of the patient would make urine testing unreliable (e,g., renal disease)
As an alternative drug testing method when urine specimen tampering practices are suspected to be affecting the reliability of the urinalysis test.
Possible limiting Factors to Diffusion of Oral Fluid Technology
No oral fluid POC test equivalent to onsite urine dips or POC analyzer reducing immediacy of results for patient care.
Currently, physicians get reimbursed directly for POC urinalysis. Oral fluid must be analyzed in a lab setting removing physician reimbursement, which is a source of program funding for many methadone clinics.
Small amount of oral fluid specimen obtained; repeat testing on same sample will be difficult.
Reliability of positive oral fluid methadone (parent drug) results may decrease because of possible contamination of oral cavity after ingestion of dose. Therefore high methadone levels may not be indicative of compliance with treatment. Oral fluid does not as yet test for methadone metabolite.
There currently is no licensed provincial laboratory that analyses oral fluid specimens.
Abbreviations
2-ethylidene- 1,5-dimethyl-3,3-diphenylpyrrolidine
enzyme immunoassay
Enzyme Linked Immunosorbent Assay (ELISA),
Enzyme Multiplied Immunoassay Test (EMIT)
Gas chromatography
gas chromatography/mass spectrometry
High-performance liquid chromatography
Limit of Detection
Mass spectrometry
Methadone Maintenance Treatment
Oral fluid testing
Phencyclidine
Point of Care Testing
tetrahydrocannabinol
11-nor-delta-9-tetrhydrocannabinol-9-carboxylic acid
urine drug testing
PMCID: PMC3379523  PMID: 23074492
19.  Aboriginal users of Canadian quitlines: an exploratory analysis 
Tobacco Control  2007;16(Suppl 1):i60-i64.
Objectives
To conduct an exploratory, comparative study of the utilisation and effectiveness of tobacco cessation quitlines among aboriginal and non‐aboriginal Canadian smokers.
Setting
Population based quitlines that provide free cessation information, advice and counselling to Canadian smokers.
Subjects
First time quitline callers, age 18 years of age and over, who called the quitline between August 2001 and December 2005 and who completed the evaluation and provided data on their ethnic status (n = 7082).
Main measures
Demographic characteristics and tobacco behaviours of participants at intake and follow‐up; reasons for calling; actions taken toward quitting, and 6‐month follow‐up quit rates.
Results
7% of evaluation participants in the time period reported aboriginal origins. Aboriginal participants were younger than non‐aboriginals but had similar smoking status and level of addiction at intake. Concern about future health and current health problems were the most common reasons aboriginal participants called. Six months after intake aboriginals and non‐aboriginals had taken similar actions with 57% making a 24‐hour quit attempt. Quit rates were higher for aboriginals than non‐aboriginals, particularly for men. The 6‐month prolonged abstinence rate for aboriginal men was 16.7% compared with 7.2% for aboriginal women and 9.4% and 8.3% for non‐aboriginal men and women, respectively.
Conclusions
This exploratory analysis showed that even without targeted promotion, aboriginal smokers do call Canadian quitlines, primarily for health related reasons. We also showed that the quitlines are effective at helping them to quit. As a population focused intervention, quitlines can reach a large proportion of smokers in a cost efficient manner. In aboriginal communities where smoking rates exceed 50% and multiple health risks and chronic diseases already exist, eliminating non‐ceremonial tobacco use must be a priority. Our results, although exploratory, suggest quitlines can be an effective addition to aboriginal tobacco cessation strategies.
doi:10.1136/tc.2007.020115
PMCID: PMC2598513  PMID: 18048634
smoking cessation; quitlines; aboriginal
20.  Survivors of sexual abuse: clinical, lifestyle and reproductive consequences 
BACKGROUND: In recent years, an increase in the prevalence of sexual abuse of women has been reported in Canada and elsewhere. However, there are few empirical data on the extent of the problem in Canadian aboriginal populations. The authors investigated the presence of a reported history of sexual abuse and other health determinants in a sample of women attending a community health centre with a substantial aboriginal population. This allowed determination of whether reported sexual abuse and its associated demographic and health-related effects were different for aboriginal and non-aboriginal women. METHODS: A sample of 1696 women was selected from women attending a community health centre in a predominantly low-income inner-city area of Winnipeg for a cross-sectional survey designed to study the association between sexual behavior and cervical infections. The survey was conducted between November 1992 and March 1995 and involved a clinical examination, laboratory tests and an interviewer-administered questionnaire. A substudy was conducted among 1003 women who were asked 2 questions about sexual abuse. RESULTS: The overall response rate for the main study was 87%. Of the 1003 women who were asked the questions about sexual abuse, 843 (84.0%) responded. Among the respondents, 368 (43.6%) were aboriginal. Overall, 308 (36.5%) of the respondents reported having been sexually abused, 74.0% of the incidents having occurred during childhood. The prevalence was higher among aboriginal women than among non-aboriginal women (44.8% v. 30.1%, p < 0.001). Women who had been sexually abused were younger when they first had sexual intercourse, they had multiple partners, and they had a history of sexually transmitted diseases. In addition, non-aboriginal women who had been sexually abused were more likely than those who had not been abused to have been separated or divorced, unemployed and multiparous and to have used an intrauterine device rather than oral contraceptives. Aboriginal women who had been sexually abused were more likely than those who had not been abused to have been separated or divorced, unemployed and multiparous and to have used an intrauterine device rather than oral contraceptives. Aboriginal women who had been sexually abused were more likely than those who had not been abused to have had abnormal Papanicolaou smears. The proportion of smokers was higher among the abused women than among the non-abused women in both ethnic groups. INTERPRETATION: A history of sexual abuse was associated with other clinical, lifestyle and reproductive factors. This suggests that sexual abuse may be associated with subsequent health behaviors, beyond specific physical and psychosocial disorders. Aboriginal and non-aboriginal women who have suffered sexual abuse showed substantial differences in their subsequent health and health-related behaviours.
PMCID: PMC1229591  PMID: 9732710
21.  Factors Associated with Illicit Methadone Injecting in a Canadian Setting 
Background and Objectives
While methadone is well established as an evidence-based treatment for opioid use disorder, safety concerns persist regarding its diversion. We examine the prevalence of and risk factors associated with injection of methadone in an urban population.
Methods
Between December 2005 and November 2013, data were derived from two open prospective studies of persons who inject drugs (PWID) in Vancouver, Canada. Generalized estimating equations (GEE) logistic regression was used to determine factors independently associated with illicit methadone injecting.
Results
During the study, 1911 individuals (34% women) were recruited; 134 (7%) participants reported methadone injecting at least once. In multivariable analysis, Caucasian ethnicity [adjusted odds ratio (AOR) = 1.90, 95% confidence interval (CI) = 1.20 – 3.00]; homelessness (AOR = 1.46, 95% CI = 1.09 – 1.95); drug dealing (AOR = 2.10, 95% CI = 1.50 – 2.93); ≥ daily heroin injection (AOR = 1.57, 95% CI = 1.08 – 2.26); ≥ daily crack smoking (AOR = 2.06, 95% CI = 1.44 – 2.95); being a victim of violence (AOR = 1.48, 95% CI = 1.04 – 2.12); and non-fatal overdose (AOR = 1.67, 95% CI = 1.67 (1.00 – 2.79) were independently and positively associated with methadone injection; female gender (AOR = 0.47, 95% CI = 0.30 – 0.75) was negatively associated.
Discussion and Conclusion
The diversion of methadone for illicit injection in this urban setting was associated with several markers of addiction severity and other health and social vulnerabilities.
Scientific Significance
These findings underscore the need to ensure methadone accessibility while limiting diversion-related risk.
doi:10.1111/ajad.12257
PMCID: PMC4576827  PMID: 26282339
methadone; opioids; prescription drug abuse
22.  Illicit use of methadone and buprenorphine among adolescents and young adults in Sweden 
Background
Illicit use of methadone and buprenorphine has been described as a growing problem in Sweden in recent years, and has been associated with an increased drug-related mortality. Critics claim that the substances have become popular among adolescents and that they function as a gateway to heroin use. The aim of this study is to investigate, firstly, the extent to which illicit use of methadone and buprenorphine occurs among adolescents and young adults in Sweden, and secondly, at what stage in a user’s drug career these substances tend to appear.
Methods
The study is based on surveys and structured interviews on drug use among various populations of young people, in addition to qualitative interviews with 86 informants who, in their professional capacity, encounter adolescents or young adults who are using illicit drugs.
Results
Illicit use of methadone and buprenorphine is rare among young people in Sweden. According to high school surveys, less than 0.1% have tried these substances. Among young drug users in general, few have tried the substances, and there is nothing to indicate that they act as gateway drugs. Among adolescents and young adults with severe drug problems, however, the illicit use of methadone and buprenorphine is more common (54% in a compulsory care sample). These substances normally enter the drug career late, and few use them as their main drug of choice. Other prescription drugs, like benzodiazepines and tramadol, are used by adolescents to a far greater extent. Diversion and illicit use of methadone and buprenorphine is not seen as a serious problem by the professionals interviewed. A general view is that the substances are mainly used by people with a heroin or polydrug addiction, often for “self-medication” purposes. However, several informants express concern that methadone and buprenorphine may cause fatalities among young drug users without an opioid tolerance.
Conclusions
Illicit use of methadone and buprenorphine among young drug users is not a widespread problem in Sweden. Harm-reduction measures should target drug users with more severe problems, among whom illicit use of methadone and buprenorphine is more common and pose a medical risk. Illicit use of other prescription drugs, which are less controlled and more widely used by young people, is an important issue for further research.
doi:10.1186/1477-7517-10-27
PMCID: PMC3853648  PMID: 24139199
Methadone; Buprenorphine; Illicit use; Adolescents; Young adults; Drug career; Diversion
23.  High prevalence of HIV infection among homeless and street-involved Aboriginal youth in a Canadian setting 
Aboriginal people experience a disproportionate burden of HIV infection among the adult population in Canada; however, less is known regarding the prevalence and characteristics of HIV positivity among drug-using and street-involved Aboriginal youth. We examined HIV seroprevalence and risk factors among a cohort of 529 street-involved youth in Vancouver, Canada. At baseline, 15 (2.8%) were HIV positive, of whom 7 (46.7%) were Aboriginal. Aboriginal ethnicity was a significant correlate of HIV infection (odds ratio = 2.87, 95%CI: 1.02 – 8.09). Of the HIV positive participants, 2 (28.6%) Aboriginals and 6 (75.0%) non-Aboriginals reported injection drug use; furthermore, hepatitis C co-infection was significantly less common among Aboriginal participants (p = 0.041). These findings suggest that factors other than injection drug use may promote HIV transmission among street-involved Aboriginal youth, and provide further evidence that culturally appropriate and evidence-based interventions for HIV prevention among Aboriginal young people are urgently required.
doi:10.1186/1477-7517-5-35
PMCID: PMC2607257  PMID: 19019253
24.  GENDER DIFFERENCES IN ACCESS TO METHADONE MAINTENANCE THERAPY IN A CANADIAN SETTING 
Drug and alcohol review  2015;10.1111/dar.12251.
Introduction and Aims
Methadone maintenance therapy (MMT) is an evidence-based treatment for opioid addiction. While gender differences in MMT pharmacokinetics, drug use patterns and clinical profiles have been previously described, few studies have compared rates of MMT use among community-recruited samples of persons who inject drugs (IDU).
Design and Methods
The present study used prospective cohorts of IDU followed between May 1996 and May 2013 in Vancouver, British Columbia, Canada. We investigated potential factors associated with time to methadone initiation using Cox proportional hazards modeling. Stratified analyses were used to examine for gender differences in rates of MMT enrolment.
Results
Overall, 1848 baseline methadone naïve IDU were included in the study, among whom 595 (32%) were female. In an adjusted model, male gender was independently associated with increased time to MMT initiation and an overall lower rate of enrolment (adjusted relative hazard (ARH) = 0.74 [95% confidence interval [CI]: 0.65-0.85]). Among both female and male IDU, Caucasian ethnicity and daily injection heroin use were associated with decreased time to methadone initiation, while in females pregnancy was also associated with more rapid initiation.
Discussion and Conclusions
These data highlight gender differences in methadone use among a population of community-recruited IDU. While factors associated with methadone use were similar between genders, rates of use were lower among male IDU, highlighting the need to consider gender when designing strategies to improve recruitment into MMT.
doi:10.1111/dar.12251
PMCID: PMC4573369  PMID: 25735544
methadone; gender; intravenous drug abuse; MMT
25.  Methadone induction in primary care (ANRS-Methaville): a phase III randomized intervention trial 
BMC Public Health  2012;12:488.
Background
In France, the rapid scale-up of buprenorphine, an opioid maintenance treatment (OMT), in primary care for drug users has led to an impressive reduction in HIV prevalence among injecting drug users (IDU) but has had no major effect on Hepatitis C incidence. To date, patients willing to start methadone can only do so in a methadone clinic (a medical centre for drug and alcohol dependence (CSAPA) or a hospital setting) and are referred to primary care physicians after dose stabilization. This study aims to assess the effectiveness of methadone in patients who initiated treatment in primary care compared with those who initiated it in a CSAPA, by measuring abstinence from street opioid use after one year of treatment.
Methods/Design
The ANRS-Methaville study is a randomized multicenter non-inferiority control trial comparing methadone induction (lasting approximately 2 weeks) in primary care and in CSAPA. The model of care chosen for methadone induction in primary care was based on study-specific pre-training of all physicians, exclusion criteria and daily supervision of methadone during the initiation phase. Between January 2009 and January 2011, 10 sites each having one CSAPA and several primary care physicians, were identified to recruit patients to be randomized into two groups, one starting methadone in primary care (n = 147), the other in CSAPA (n = 48). The primary outcome of the study is the proportion of participants abstinent from street opioids after 1 year of treatment i.e. non-inferiority of primary care model in terms of the proportion of patients not using street opioids compared with the proportion observed in those starting methadone in a CSAPA.
Discussion
The ANRS-Methaville study is the first in France to use an interventional trial to improve access to OMT for drug users. Once the non-inferiority results become available, the Ministry of Health and agency for the safety of health products may change the the New Drug Application (NDA) of methadone and make methadone induction by trained primary care physicians possible.
The trial is registered with the French Agency of Pharmaceutical Products (AFSSAPS) under the number 2008-A0277-48, the European Union Drug Regulating Authorities Clinical Trials.
Number Eudract 2008-001338-28, the ClinicalTrials.gov Identifier: NCT00657397 and the International Standard Randomised Controlled Trial Number Register ISRCTN31125511.
doi:10.1186/1471-2458-12-488
PMCID: PMC3528472  PMID: 22741944
Methadone; Primary care; Initiation; Overdose; Opioid use; Opioid maintenance treatment

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