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Methodology for evaluating Insite: Canada's first medically supervised safer injection facility for injection… Wood, Evan; Kerr, Thomas; Lloyd-Smith, Elisa; Buchner, Chris; Marsh, David C; Montaner, Julio S; Tyndall, Mark W Nov 9, 2004

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ralssBioMed CentHarm Reduction JournalOpen AcceMethodologyMethodology for evaluating Insite: Canada's first medically supervised safer injection facility for injection drug usersEvan Wood*1,2, Thomas Kerr1,3, Elisa Lloyd-Smith1, Chris Buchner4, David C Marsh1,4, Julio SG Montaner1,2 and Mark W Tyndall1,2Address: 1British Columbia Centre for Excellence in HIV/AIDS, St. Paul's Hospital; Vancouver, BC, Canada, 2Department of Medicine; Faculty of Medicine; University of British Columbia; Vancouver, BC, Canada, 3Canadian HIV/AIDS Legal Network; Canada and 4Vancouver Coastal Health; Vancouver, BC, CanadaEmail: Evan Wood* - ewood@cfenet.ubc.ca; Thomas Kerr - tkerr@cfenet.ubc.ca; Elisa Lloyd-Smith - elloydsm@interchange.ubc.ca; Chris Buchner - chris.buchner@vch.ca; David C Marsh - david.marsh@vch.ca; Julio SG Montaner - jmontaner@hivnet.ubc.ca; Mark W Tyndall - mtyndall@cfenet.ubc.ca* Corresponding author    AbstractMany Canadian cities are experiencing ongoing infectious disease and overdose epidemics amonginjection drug users (IDUs). In particular, Human Immunodeficiency Virus (HIV) and hepatitis CVirus (HCV) have become endemic in many settings and bacterial and viral infections, such asendocarditis and cellulitis, have become extremely common among this population. In an effort toreduce these public health concerns and the public order problems associated with public injectiondrug use, in September 2003, Vancouver, Canada opened a pilot medically supervised safer injectingfacility (SIF), where IDUs can inject pre-obtained illicit drugs under the supervision of medical staff.The SIF was granted a legal exemption to operate on the condition that its impacts be rigorouslyevaluated. In order to ensure that the evaluation is appropriately open to scrutiny among the publichealth community, the present article was prepared to outline the methodology for evaluating theSIF and report on some preliminary observations. The evaluation is primarily structured around aprospective cohort of SIF users, that will examine risk behavior, blood-borne infectiontransmission, overdose, and health service use. These analyses will be augmented with process datafrom within the SIF, as well as survey's of local residents and qualitative interviews with users, staff,and key stakeholders, and standardised evaluations of public order changes. Preliminaryobservations suggest that the site has been successful in attracting IDUs into its programs and inturn helped to reduce public drug use. However, each of the indicators described above is thesubject of a rigorous scientific evaluation that is attempting to quantify the overall impacts of thesite and identify both benefits and potentially harmful consequences and it will take several yearsbefore the SIF's impacts can be appropriately examined.IntroductionMany Canadian cities are currently experiencing Human[1,2]. Other costly infectious diseases that can be easilyacquired from non-hygenic injection practices, such asPublished: 09 November 2004Harm Reduction Journal 2004, 1:9 doi:10.1186/1477-7517-1-9Received: 24 June 2004Accepted: 09 November 2004This article is available from: http://www.harmreductionjournal.com/content/1/1/9© 2004 Wood et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.Page 1 of 5(page number not for citation purposes)Immunodeficiency Virus (HIV) and hepatitis C virus(HCV) epidemics as a result of illicit injection drug useendocarditis and cellulitis, are also common [3]. Thehealth of injection drug users (IDUs) is further compro-Harm Reduction Journal 2004, 1:9 http://www.harmreductionjournal.com/content/1/1/9mised by avoidance and erratic use of primary care serv-ices, costly emergency room visits, and acute carehospitalizations [3-6]. Public drug use also occurs inmany inner city neighborhoods, and public drug use andthe unsafe disposal of syringes is a major community con-cern [7,8].In over two dozen European cities and more recently inSydney, Australia, safer injection facilities (SIFs), whereinjection drug users can inject pre-obtained illicit drugs,have been implemented in an effort to reduce the com-munity and public health impacts of illicit drug use [9].SIF typically have several primary objectives including: thereduction of public drug use, fatal and non-fatal overdose,and infectious disease risk; improving contact between ahighly marginalized 'at-risk' population and the health-care system; and enhancing recruitment into medical careand addiction treatment [9-11]. Within SIFs, IDUs areprovided with clean injecting equipment, medical atten-tion in the event of overdose, as well as access to or referralto primary healthcare and other services including addic-tion treatment.While it must be stressed that limited quantitative data arepresently available, various reports have credited SIFs witha number of public health and community benefitsincluding: improving the health and social functioning oftheir clients [11], while reducing overdose deaths [12],risk behaviors known to transmit infectious diseases [13],improperly discarded syringes [14], and public drug use[15]. In addition, improved access to medical care anddrug treatment has been attributed to SIF attendance[10,16]. A limitation of these earlier analyses is that, in anumber of settings, there has not been a commitment onthe part of health agencies to fund comprehensive evalua-tions, and in many instances there have not existed pro-spective cohorts to inform examinations of SIF's impacts[17].On September 22, 2003 Vancouver, Canada openedNorth America's first government sanctioned SIF pilotstudy [18]. Federal government approval for the three-year pilot study was granted on the condition that thehealth and social impacts of the SIF be the subject of a rig-orous scientific evaluation. More recently, several Cana-dian cities have begun to consider their own SIFevaluations, including Montreal and Victoria [19,20].Since several years were devoted to the development ofthe Vancouver SIF evaluation methodology, and since theinvestigators wished to be as open with methodology aspossible [21], the present article was prepared to describethe framework of the evaluation and to report on prelim-inary observations. The publication of these observationsClient AnonymityPrior to the opening of the SIF, a major concern with theevaluation related to willingness of the target communityto use the injection facility [18]. In order to attract the tar-get population without raising fears about confidentiality,and to make the service as low threshold as possible, allclients of the SIF can remain anonymous. Since fearsregarding reduced willingness to use SIF, if client registra-tion was required, were observed in feasibility studies con-ducted prior to Insite's opening [18], the SIF operated as acompletely low threshold service in the first 6 months ofoperation and maximizing access to the SIF was the toppriority. During this time only paper records were main-tained. After 6 months of operation, and after trust wasdeveloped between the SIF operators and the target com-munity, service use was tracked at an individual levelusing a database that tracks all client service use and out-comes within Insite. The phasing in of a digital trackingsystem was successful, although service uptake was so sub-stantial and immediate after the site opened, it is notknown if this was necessary. A further challenge was theethical dilemma posed by providing a health service thatmust also be rigorously evaluated [22]. Specifically, it wasapparent to the investigators that it would be unethical tolimit use of the SIF to those who agreed to participate inresearch. Instead, equipoise was reached by allowing par-ticipation in surveys and other aspects of the research tobe optional to SIF users.Aims of InsiteIn brief, the aims of Insite are to reduce public injectiondrug use and the unsafe disposal of syringes in publicspaces, the reduction of overdoses and infectious diseaserisk, and improve access to healthcare services amongIDUs. The methodology for evaluating these aims isdescribed below and involves both a prospective cohortdesign and additional data sources including evaluationof community impacts.Evaluation MethodologyData SourcesThe framework for the Vancouver SIF evaluation wasdesigned prior to the SIF's opening and involved anumber of methodological approaches. In light of thelack of existing quantitative efficacy data [17], the exist-ence of ethical concerns [22], and an awareness that anon-randomized studies may be vulnerable to substantialselection biases [23], the Vancouver SIF evaluation is pri-marily structured around a prospective cohort design thatinvolves the longitudinal measurement of a number ofoutcomes including blood-borne infection and overdoseincidence, risk behavior, drug use practices, such as publicdrug use, and health services use.Page 2 of 5(page number not for citation purposes)may also be useful for other Canadian considering initiat-ing SIF trials [19,20].Harm Reduction Journal 2004, 1:9 http://www.harmreductionjournal.com/content/1/1/9The Vancouver SIF evaluation is somewhat uniquebecause of the availability of a number of pre-existing datasources. These data sources include the community healthand safety evaluation (CHASE) cohort, which is a com-munity recruited virtual cohort of Downtown Eastside res-idents that prospectively and retrospectively examineshealth service use in the community by linking to admin-istrative health record databases. In addition, the Vancou-ver Injection Drug Users Study (VIDUS) is an ongoingprospective cohort study of injection drug users thatinvolves semi-annual serology of HIV and HCV as well asa semi-annual questionnaire [24]. VIDUS and CHASEallow for the description of IDUs in the community whoare using Insite and a comparison between those that areand are not using the service.In addition, in order to augment these data sources and toallow for close examination of the characteristics of Insiteclients over time, a prospective cohort of Insite users hasalso been established. The Scientific Evaluation of Super-vised Injecting (SEOSI) cohort is based on a representativesample of Insite users. The sample is derived through ran-dom recruitment of Insite users who are offered aninformed consent to enroll into the study. Randomrecruitment involves attending the SIF at times of the daythat are randomly selected using a random number gener-ation program in SPSS, and inviting all users who use theSIF at this time to enroll in the study. As with VIDUS, par-ticipants provide a blood sample and conduct an inter-viewer-administered questionnaire. The SEOSIquestionnaire deals with items that are particularly rele-vant to Insite, such as risk behaviours, public drug use, sat-isfaction with Insite, and access to medical care andaddiction treatment services. All SEOSI participants pro-vide informed consent to link to the Insite database sothat SIF use can be tracked, as well as informed consent toaccess administrative health record databases in the com-munity. As of September 1, 2004 over 900 Insite usershave been enrolled into SEOSI and comparisons of socio-demographic variables (age, gender, etc) has shown thatthe SEOSI cohort is statistically similar to the overallcohort of insight users (all p > 0.05).Client SatisfactionMeasures of client satisfaction are compiled as part of theSEOSI questionnaire. Through ratings of service quality interms of the 5 SERVQUAL dimensions: Tangibles (e.g., theappearance of the physical facilities); Reliability (e.g., theability of staff to perform the service dependably);Responsiveness (e.g., the willingness of staff to help cli-ents and provide prompt service); Assurance (e.g., secu-rity, credibility and courtesy); and Empathy (e.g., ease ofaccess, approachability and effort taken to understand cli-service are measured among IDUs in VIDUS who have notused Insite.Additional Data SourcesThese above prospective cohort data will be augmented bya number of other data sources including: process indica-tors, measures of community satisfaction and perceivedimpact, standardized measures of public order, and qual-itative and quantitative measures of the health of the tar-get population. The collection of each of these datasources is described below.Process MeasuresIn order to track service use in the database at an individ-ual level, while allowing for participant anonymity, eachclient must select a unique client 'handle' or nickname.The SIF database has a search function that allows forrapid searches based on demographic information, suchas birth date, if an individual forgets their handle. Similaranonymous tracking of individual clients is commonlyused at needle exchanges and other services for illicitinjection drug users [25].A primary purpose of the evaluation is to measure processindicators related to service uptake within the SIF, and thisis enabled through the Insite database. The databasetracks what drugs participants are consuming (heroin,cocaine, etc) and what services, such as nursing care andcounseling services, are accessed by each client. Forinstance, in the month of May 2004, over 1300 uniquevisits were logged into the database.Community and Staff SatisfactionCommunity satisfaction and the perceived impact of theSIF on business persons are measured through a commu-nity survey that is performed in person among streetrecruited residents and at street-level businesses. The sur-vey is similar to surveys being used in the Sydney SIF trial,and examines perceived changes in the neighborhoodafter the SIF's opening. In addition, staff satisfaction withthe operation of the facility is measured through focusgroups and qualitative interviews with staff persons. Theseinterviews focus on how service delivery can be improvedand on what measures can be taken to ensure staff safetyand satisfaction.Public OrderStandardized measures of public order were undertakento examine the impact of the SIF on several indicators ofpublic injection drug use. In brief, the survey protocolinvolves measuring specified public order indicatorswithin an a priori defined geographical area in the neigh-borhood and at a priori defined times of the week. DataPage 3 of 5(page number not for citation purposes)ents' requirements). Similarly, reasons for avoiding the collection times are spread evenly throughout the weekand involved walking through the study zone in the sameHarm Reduction Journal 2004, 1:9 http://www.harmreductionjournal.com/content/1/1/9pattern. Measures of discarded syringes, injection-relatedlitter, and public injection drug use are all measured pro-spectively. An evaluation of these indicators has recentlybeen described in detail [26].Preliminary observationsFollowing the opening of the SIF in September 2003,there was widespread support among the target popula-tion with a steady increase in uptake during the first fewweeks. The site reached virtual capacity within twomonths and currently an approximate average of 500injections take place each day in the site. The busiest timesof the day are mid-afternoon and early evening at whichtimes demand often exceeds capacity and waiting times toget into the 12 seat injection room can result in partici-pants obtaining syringes and injecting elsewhere. Whetherthe wait times are disproportionately affecting specificpopulations is presently being investigated. Utilizationalso fluctuates daily, peaking on the days leading up to,and following welfare day. Exit surveys of IDU clientshave been widely supportive of the service and high levelsof satisfaction with the service among Insite staff havebeen reported. Contrary to the suggestion that cocaineusers would be unwilling to use the SIF [9], approximatelyhalf of all injections include cocaine.Despite the chaotic behaviours often associated withinjection drug use, overall staff safety has been high andthe instances of verbal or physical abuse by clients aremanaged efficiently as per the service's protocols. In out-standing circumstances, Vancouver Police Departmenthas been called to remove disruptive clients, and supportand assistance from the police in this regard has been verypositive. Overall the staff remains very committed to theactivities at Insite and staff satisfaction has been high.Overdoses, from a range of illicit drugs, are commonlyobserved in the SIF. The severity of these overdoses rangefrom lowered respiration rate to severe emergency situa-tions that have required the administration of naloxoneand ambulance responses. Given the high levels of illness(for instance HIV and hepatitis C co-infection) and drugusing behaviours (unknown substances of unknownpurity) of the target population, it is not inconceivablethat a fatality could occur in the SIF despite staff supervi-sion and emergency response.There have been no instances where used syringe borrow-ing has been seen within Insite. These behaviours arecommon among street based injectors and it is well recog-nized that these activities promote the spread of blood-borne infections. It is also noteworthy that alcohol swabsto clean the injection site, and clean water and cookers arealcohol swabs are rarely used, and that non-hygenic watersources, such as puddle water, are commonly used. It isalso noteworthy that within the SIF, safer hygenic injec-tion practices are taught by the nursing staff to IDUs whohave never been shown how to inject safely.In addition to supervising injections, teaching safer inject-ing practices, and responding to overdoses, there has beensubstantial health intervention within Insite. In particu-lar, referrals to medical care at St Paul's Hospital are com-mon as well as referrals to community health centres.Early intervention for primary medical care concerns, suchas abscesses, is commonly provided by the Insite nursingteam, and coverage with public health interventions, suchas flu shots, has been provided to Insite users. In addition,addictions counseling occurs on site and there have beenmany referrals to detoxification programs and methadonemaintenance therapy.SummaryOverall, Insite has attracted the target population and pre-liminary evidence suggests that the experiences withinInsite as well as the community impact have been consist-ent with the experience of over two dozen European set-tings where SIF exist, and more recently Sydney, Australia.The examination of early changes in public order has beencompleted and there is strong evidence of improvementin several indicators including public drug use [26].However, each of the indicators described above is thesubject of a rigorous scientific evaluation that is attempt-ing to quantify the overall impacts of the site and identifyboth benefits and potentially harmful consequences overa multi-year period. This evaluation is primarily struc-tured around a prospective cohort design that will involvethe longitudinal measurement of health and communityindicators over the next several years. As such, it will besome time before the overall impact of Insite on a numberof outcomes, such as blood-borne infections and IDUsbehavior, can be adequately quantified.AcknowledgmentsThe authors wish to thank the staff of the Insite SIF and Vancouver Coastal Health (Heather Hay). Evan Wood is supported through a New Investiga-tor Award from the Canadian Institutes of Health Research. We also thank Bonnie Devlin, Evelyn King, Aaron Eddie, Peter Vann, Dave Isham, Steve Gaspar, Carl Bognar, Steve Kain, and Suzy Coulter for their administrative assistance and suggestions. The SIF evaluation has been made possible through a financial contribution from Health Canada, though the views expressed herein do not represent the official policies of Health Canada.References1. Strathdee SA, Galai N, Safaeian M, Celentano DD, Vlahov D, LisetteJ, Nelson K: Sex Differences in Risk Factors for HIV Serocon-version amon Injection Drug Users: A Ten Year Perspective.Page 4 of 5(page number not for citation purposes)all provided to optimize hygenic injection procedures.Research of street-based IDU in Vancouver has shown thatArchives of Internal Medicine 2001, 161:1281-1288.2. Craib KJ, Spittal PM, Wood E, Laliberte N, Hogg RS, Li K, Heath K,Tyndall MW, O'Shaughnessy MV, Schechter MT: Risk factors forPublish with BioMed Central   and  every scientist can read your work free of charge"BioMed Central will be the most significant development for disseminating the results of biomedical research in our lifetime."Sir Paul Nurse, Cancer Research UKYour research papers will be:available free of charge to the entire biomedical communitypeer reviewed and published immediately upon acceptancecited in PubMed and archived on PubMed Central Harm Reduction Journal 2004, 1:9 http://www.harmreductionjournal.com/content/1/1/9elevated HIV incidence among Aboriginal injection drugusers in Vancouver. CMAJ 2003, 168:19-24.3. Palepu A, Tyndall MW, Leon H, Muller J, O'Shaughnessy MV, Schech-ter MT, Anis AH: Hospital utilization and costs in a cohort ofinjection drug users. CMAJ 2001, 165:415-420.4. Anis AH, Sun H, Guh DP, Palepu A, Schechter MT, O'ShaughnessyMV: Leaving hospital against medical advice among HIV-pos-itive patients. CMAJ 2002, 167:633-637.5. Palepu A, Strathdee SA, Hogg RS, Anis AH, Rae S, Cornelisse PG,Patrick DM, O'Shaughnessy MV, Schechter MT: The social deter-minants of emergency department and hospital use by injec-tion drug users in Canada. Journal of Urban Health 1999,76:409-418.6. Wood E, Montaner JS, Schechter MT, Tyndall MW, O'ShaughnessyMV, Hogg RS: Prevalence and correlates of untreated HIV-1infection in the era of modern antiretroviral therapy. Journalof Infectious Diseases 2003, 188:1164-1170.7. Doherty MC, Garfein RS, Vlahov D, Junge B, Rathouz PJ, Galai N,Anthony JC, Beilenson P: Discarded needles do not increasesoon after the opening of a needle exchange program. Am JEpidemiol 1997, 145:730-737.8. Doherty MC, Junge B, Rathouz P, Garfein RS, Riley E, Vlahov D: Theeffect of a needle exchange program on numbers of dis-carded needles: a 2-year follow-up. Am J Public Health 2000,90:936-939.9. Wood E, Kerr T, Spittal PM, Li K, Small W, Tyndall MW, Hogg RS,O'Shaughnessy MV, Schechter MT: The potential public healthand community impacts of safer injecting facilities: evidencefrom a cohort of injection drug users. J Acquir Immune Defic Syndr2003, 32:2-8.10. Broadhead RS, Kerr TH, J.P. G, Altice FL: Safer Injection Facilitiesin North America: Their Place in Public Policy and HealthInitiatives. Journal of Drug Issues 2002, 32:329-355.11. Dolan K, Kimber J, Fry C, Fitzgerald J, McDonald D, Frautmann F:Drug Consumption Facilities in Europe and the Establish-ment of Supervised Injecting Centres in Australia. Drug andAlcohol Review 2000, 19:337-346.12. de Jong W, Wever U: The professional acceptance of drug use:a closer look at drug consumption rooms in the Netherlands,Gemany, and Switzerland. International J Drug Policy 1999,10:99-108.13. Ronco C, Spuhler G, Coda P, Schopfer R: Evaluation for alley-rooms I, II, and III in Basel. Soc Prev Med 1996, 41:S58-68.14. Kemmesies U: Final Report: The open drug scene and the safeinjection room offers in Frankfurt am Main. 1999.15. van Beek I, Gilmour S: Preference to have used a medicallysupervised injecting centre among injecting drug users inKings Cross, Sydney. Aust N Z J Public Health 2000, 24:540-542.16. Van Beek I, Dakin A, Kimber J: Drug overdoses in a supervisedinjecting room setting. 14th Int Conf on Reduction of DrugRelated Harm.  Chiang Mai, Thailand; April 6-10, 2003. .17. Wood E, Kerr T, Montaner JS, Strathdee SA, Wodak A, Hankins CA,Schechter MT, Tyndall MW: Rationale for evaluating NorthAmerica's first medically supervised safer injecting facility.Lancet Infect Dis 2004, 4:301-306.18. Kerr T, Wood E, Small D, Palepu A, Tyndall M: Potential use ofsafer injecting facilities among injection drug users in Van-couver's Downtown Eastside. CMAJ 2003, 169:759-763.19. Times Colonist.  Health officer endorses safe drug site forVictoria. March 27, 2004. .20. Online: http://www.montrealmirror.com/ARCHIVES/2002/121202/front.html. .21. Des Jarlais DC, Lyles C, Crepaz N: Improving the reporting qual-ity of nonrandomized evaluations of behavioral and publichealth interventions: the TREND statement. Am J Public Health2004, 94:361-366.22. Christie T, Wood E, Schechter MT, O'Shaughnessy MV: A compar-ison of the new Federal Guidelines regulating supervisedinjection site research in Canada and the Tri-Council PolicyStatement on Ethical Conduct for Research InvolvingHuman Subjects. Int J Drug Pol 2003, (In Press):.23. Schechter MT, Strathdee SA, Cornelisse PG, Currie S, Patrick DM,Rekart ML, O'Shaughnessy MV: Do needle exchange pro-grammes increase the spread of HIV among injection drug24. Strathdee SA, Patrick DM, Currie SL, Cornelisse PG, Rekart ML,Montaner JS, Schechter MT, O'Shaughnessy MV: Needle exchangeis not enough: lessons from the Vancouver injecting drug usestudy. AIDS 1997, 11:F59-65.25. Bardsley J, Turvey J, Blatherwick J: Vancouver's needle exchangeprogram. Can J Public Health 1990, 81:39-45.26. Wood E, Kerr T, Small W, Li K, Marsh D, Montaner JS, Tyndall MW:Changes in public order after the opening of a medicallly supervised safer injecting facility for illicit injection drugusers. CMAJ 2004, 171(731):734.yours — you keep the copyrightSubmit your manuscript here:http://www.biomedcentral.com/info/publishing_adv.aspBioMedcentralPage 5 of 5(page number not for citation purposes)users?: an investigation of the Vancouver outbreak. AIDS 1999,13:F45-51.

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