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The Cedar Project WelTel mHealth intervention for HIV prevention in young Indigenous people who use illicit… Jongbloed, Kate; Friedman, Anton J; Pearce, Margo E; Van Der Kop, Mia L; Thomas, Vicky; Demerais, Lou; Pooyak, Sherri; Schechter, Martin T; Lester, Richard T; Spittal, Patricia M Mar 9, 2016

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STUDY PROTOCOL Open AccessThe Cedar Project WelTel mHealthintervention for HIV prevention in youngIndigenous people who use illicit drugs:study protocol for a randomized controlledtrialKate Jongbloed1, Anton J. Friedman2, Margo E. Pearce2, Mia L. Van Der Kop3,4, Vicky Thomas2, Lou Demerais5,Sherri Pooyak6, Martin T. Schechter1, Richard T. Lester7, Patricia M. Spittal1* and The Cedar Project PartnershipAbstractBackground: Despite successes in preventing and treating HIV, Indigenous people in Canada continue to facedisproportionately high rates of HIV infection. Programs that support healing from lifetime trauma, supportconnection to culture, and reduce drug-related harms are critical to preventing HIV among young Indigenouspeople who use drugs. The Cedar Project WelTel mHealth intervention proposed here is a structured mobile-phoneinitiative to connect young Indigenous people who use drugs with Cedar Case Managers in a community-basedsetting. The intervention consists of a package of supports, including a mobile phone and cellular plan, weeklytwo-way text messaging, and support from Cedar Case Managers.Methods: The Cedar Project WelTel mHealth study is a multi-site Zelen pre-randomized trial to measure the effectof a two-way supportive text-message intervention to reduce HIV vulnerability among young Indigenous peoplewho use illicit drugs in two Canadian cities. The trial is nested within the Cedar Project, an ongoing cohort studyaddressing HIV and hepatitis C vulnerability among young Indigenous people who use drugs in Vancouver andPrince George, British Columbia. The Cedar Project Partnership, an independent body of Indigenous Elders, leaders,and health/social service experts, governs all aspects of the study. Two hundred participants will be followed over a16-month period, with HIV propensity score at 6 months as the primary outcome. Secondary outcomes include HIVpropensity at 1 year, HIV risk, resilience, psychological distress, access to drug-related services, and connection toculture measured at 6 months and 1 year. Primary analysis is by intention to treat.Discussion: Culturally safe interventions that address barriers to HIV prevention while supporting the strength ofyoung Indigenous people who use drugs are urgently needed. Despite presenting a tremendous opportunity toconnect young, highly transient Indigenous people who use drugs to prevention services, supportive two-waymHealth programs have yet to be tested for HIV prevention in a community-based setting with this population.Trial registration: ClinicalTrials.gov NCT02437123 https://clinicaltrials.gov/show/NCT02437123 (registered 4 May 2015).Protocol version: 24 July 2015.Keywords: mHealth, Indigenous, HIV prevention, Substance use* Correspondence: spittal@sm.hivnet.ubc.ca1School of Population and Public Health, Faculty of Medicine, University ofBritish Columbia, 2206 East Mall, Vancouver, BC V6T 1Z3, CanadaFull list of author information is available at the end of the article© 2016 Jongbloed et al. Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, andreproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link tothe Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.Jongbloed et al. Trials  (2016) 17:128 DOI 10.1186/s13063-016-1250-3BackgroundIndigenous scholars suggest that understanding substanceuse and HIV vulnerability among young Indigenouspeople must begin with consideration of the ongoing im-pact of colonization and intergenerational trauma whilealso acknowledging strength and survival in the face of in-credible hardships [1–5]. Indigenous scholars have de-scribed intergenerational trauma as a collective emotionaland psychological “soul wound” that continues to affectthe youngest generations of Indigenous people [6, 7]. InCanada, well over 150,000 Indigenous children were for-cibly removed from their homes and placed in residentialschools between 1883 and 1996 [8]. The persistent devalu-ation of Indigenous cultural identity and widespreadphysical, sexual, and emotional abuse that occurred atresidential schools has had far-reaching consequences forthe health of Indigenous people [9]. Many Indigenousscholars and advocates argue that cultural oppressionthrough the removal of children from their families andcommunities has continued through the child welfare sys-tem [10]. In fact, estimates indicate that three times asmany Indigenous children are currently in care of the statecompared with during the peak of the residential schoolsystem in the 1940s [10]. In a study of young Indigenouspeople who use drugs in British Columbia (BC), 65 % hadbeen removed from their biological parents and placedinto care [11]. Those who had been in care were 2.1 timesmore likely to have a parent who attended residentialschool and 2.6 times more likely to have been sexuallyabused. The residential school and child welfare systemsin Canada disrupted ways of life that had sustained Indi-genous families and communities over generations, andintroduced cycles of multi-generational grief, trauma, anddisplacement [10]. Acknowledging the profound effect ofintergenerational and lifetime trauma, and subsequent re-liance on the powerful numbing effect of drugs, is criticalto understanding HIV vulnerability among young Indigen-ous people who use drugs [4, 7, 12–15].Indigenous leaders in Canada are justifiably concernedabout alarming rates of HIV infection among their youngpeople who continue to be vastly over-represented in theHIV epidemic [16]. Although Indigenous people comprisejust 3.8 % of Canada’s total population, Indigenous peoplein 2013 represented 16 % of positive HIV tests in thecountry [17]. Injection drug use remains the primary ex-posure among Indigenous people, accounting for 64 % ofHIV infections, compared with 11 % among non-Indigenous people [16]. In addition, one third of new in-fections were among young Indigenous people under30 years of age, compared with only 20 % among youngnon-Indigenous people [16]. There is a continuing crisisof HIV infection among young Indigenous people whouse injection and non-injection drugs in BC; HIV preva-lence reached 9 % overall and 17 % among those whoinject drugs [12]. In addition, HIV incidence among youngIndigenous people who use injection drugs in BC is esti-mated to be three times higher than among non-indigenous young people [18].Significant and multi-layered barriers to HIV preventionservices, including health care, harm reduction, addictiontreatment, and safer sex work environments, have beenidentified among young Indigenous people who use drugs[2, 3, 12, 13]. Young Indigenous people who use drugshave described frequent encounters with systemic andinterpersonal racism, stigma and judgement within harmreduction and health services [1, 19–23]. Furthermore,despite compelling evidence that harm reduction pro-grams, including supervised drug consumption facilities[24] and opioid substitution therapy [25], are effective atpreventing HIV infection, studies indicate that young Indi-genous people are failing to engage with these services[12, 18, 26, 27]. Finally, safety in sex work, as well as sup-ports to leave sex work if desired, remains elusive in acountry where young Indigenous women in sex work rou-tinely face extreme violence and death in the course oftheir work [28, 29].Addressing barriers to HIV prevention among youngIndigenous people who use drugs—while also acknow-ledging resilience despite adversity—is urgently required.In New Zealand, Maori nurses have emphasized theneed for health care that is “culturally safe” in order toovercome power imbalances that shape interactions be-tween health-care providers and Indigenous clients [30].Culturally safe care simultaneously privileges Indigenousworldviews and acknowledges the impact of structuralviolence experienced by colonized peoples in health-caresettings [31]. Indigenous experts also recognize theimportance of “culture as intervention” to support resili-ence and resistance to HIV infection as well as trauma-informed counseling as a response to the harmful effectsof historical and lifetime trauma [1]. Others have notedthe critical role of interconnectedness with family andcommunity to support health and healing among Indi-genous individuals [32]. Further research has highlightedthe importance of non-medical, supplementary supportfor young Indigenous people in order to break throughlayers of marginalization experienced in their everydaylives [33].Mobile health (mHealth), the provision of health carevia mobile phones, has been identified as potential toolto support young drug-using Indigenous people to over-come barriers to HIV prevention. Recent trials in sub-Saharan Africa have provided evidence that supportivetext-message interventions can improve HIV treatmentadherence and viral suppression among people livingwith HIV [34, 35]. Others have begun to investigate theimpact of mHealth for HIV care and treatment amongpeople living with HIV who use drugs [36–38]. However,Jongbloed et al. Trials  (2016) 17:128 Page 2 of 12much of the existing evidence on mHealth interventionsfor HIV prevention has focused on improving HIVknowledge by delivering HIV prevention messages to di-verse at-risk groups [39]. To our knowledge, no studieshave investigated the potential for a two-way supportivetext-message program to reach out to young drug-usingIndigenous people to reduce vulnerability to HIVinfection.This protocol outlines a multi-site Zelen pre-randomizedtrial to measure the effect of a culturally safe, two-way sup-portive text-message intervention to reduce HIV vulnerabil-ity among young Indigenous people who use illicit drugs.This work will build on findings from recent studies imple-menting mHealth interventions in HIV clinics in Nairobi,Kenya and Vancouver, Canada [34, 40]. Outcomes includeHIV propensity score, HIV risk, resilience, psychologicaldistress, access to drug-related services, and connec-tion to culture. We hypothesize that the Cedar ProjectWelTel mHealth intervention will result in improved up-take and access to HIV prevention services, includinghealth-care, harm reduction and addictions services, cul-tural supports, housing, and counseling. We believe that,together with the supportive element that “someonecares” enough to check in each week, improved access toservices will help strengthen participants’ resilience andreduce vulnerability to HIV infection.Methods and designStudy designThe Cedar Project WelTel mHealth study is a two-site,two-arm, parallel group, open, stratified Zelen pre-randomized controlled trial to measure the effect of a cul-turally safe, two-way supportive text-message interventionto reduce HIV vulnerability among young Indigenouspeople who use illicit drugs in a community-based setting(ClinicalTrials.gov identifier NCT02437123). Participantswill be pre-randomized to two groups—either the mHealthintervention or standard care—at a 1:1 allocation ratio.Study settingThis trial is a sub-study nested within the Cedar Project,a cohort study of young Indigenous people who use in-jection and non-injection drugs and reside in Vancouverand Prince George, BC, Canada. Initial recruitment intothe Cedar Project occurred between 2003 and 2007 andwas re-opened in 2011. To date, 738 participants haveenrolled in the main Cedar Project cohort in Vancouverand Prince George. Eligibility criteria included being be-tween the ages of 14 to 30 at enrollment, provision of in-formed consent, self identification as having Indigenousancestry, and smoking or injecting drugs—includingcrystal methamphetamine, opiates, crack or cocaine—atenrollment. Cedar Project participants complete an en-rollment visit as well as follow-up visits every 6 months.At each study visit, participants complete detailed ques-tionnaires eliciting demographic, behavioural and healthinformation, administered by trained Indigenous inter-viewers. Participants also provide a venous blood samplefor HIV and hepatitis C virus antibody testing. In grati-tude for participants’ time, honoraria are provided ateach follow-up visit. The Cedar Project has been ap-proved by the University of British Columbia ProvidenceHealth Care Research Ethics Board (H02-50304).The Cedar Project study storefront research offices arelocated in Vancouver’s downtown eastside and in thedowntown core of Prince George. Vancouver is a large cityin southern BC and is located on the traditional territoryof the Coast Salish peoples. Prince George is a forestryand mining town in the province’s northern interior, lo-cated on the traditional territory of the Lheidli T’ennehpeople. Cedar Project participants represent many of thediverse First Nations, Inuit and Métis communities acrossCanada and are often living far away from their homecommunities. Participants are highly transient, movingfrequently between cities and reserves, making continuityof care a tremendous challenge [41]. Indigenous inter-viewers and nurses support both sites and are encouragedto provide referrals to cultural supports, health care, sub-stance use services, food programs, housing, and counsel-ing for participants who seek them.The Cedar Project Partnership modelSince its inception, the Cedar Project has beencommunity-driven, interdisciplinary research that re-sponds to the continuing crisis of HIV infection and con-tributes to the health and healing of young Indigenouspeople who use drugs. The Cedar Project Partnership, anindependent body of Indigenous Elders, health and socialservice experts, researchers, and elected leaders, governsthe entire research process. The Cedar Project Partnershiprecognizes that conducting culturally safe research withyoung, vulnerable Indigenous people requires creating safespaces where their identities, voices and stories are heardand respected [30]. A critical component of the CedarProject is to ensure that our site offices are safe, welcom-ing settings without judgement of drug use, where policeare not allowed, and cultural identity is honoured. Part ofbuilding cultural safety into the Cedar Project includessupporting access to traditional foods and ceremonies,such as through annual feasts, memorials, and a recentLearning Potlatch to honour our partners and participantsheld in Prince George. Overall, our paradigm is to ac-knowledge grief and historical trauma while building onyoung Indigenous peoples’ strengths.ParticipantsA stratified random sample of participants in the CedarProject cohort will be selected for participation in theJongbloed et al. Trials  (2016) 17:128 Page 3 of 12Cedar Project WelTel mHealth study (Fig. 1). A sam-pling frame of eligible Cedar Project participants will becreated on the basis of the following eligibility criteria:(1) Currently enrolled in the Cedar Project(2) Completed main Cedar Project baselinequestionnaire and attended at least one follow-upvisit since 2009(3) Had not tested positive for HIV(4) Joined study in Vancouver or Prince George(5) Alive at initiation of the Cedar Project WelTelmHealth study.Participants who do not meet the eligibility criteria orwho decline to participate will be excluded. Stratifiedrandomization in a 1:1 ratio will be used to ensure a bal-ance of key factors, including study site (Prince Georgeand Vancouver) and reporting injection drug use at thelast visit (yes versus no). Sampled participants will berandomly assigned to receive the intervention or beAssessed for eligibility(n = 738)Excluded as did not meet inclusion criteria (n = 388)Randomized (n = 240)Allocated for invitation into intervention(n = 140)Will receive intervention (n = 100)Zelen randomizationSampling frameCohort controls(n = 100)Baseline assessmentHIV propensity scoreHIV riskResiliencePsychological distressAccess to drug-related servicesConnection to cultureFollow upSampling frame (n = 350)HIV propensity scoreHIV riskResiliencePsychological distressAccess to drug-related servicesConnection to culture6 and 12 monthsHIV propensity scoreHIV riskResiliencePsychological distressAccess to drug-related servicesConnection to culture6 and 12 monthsHIV propensity scoreHIV riskResiliencePsychological distressAccess to drug-related servicesConnection to cultureFig. 1 Cedar Project mHealth Study for HIV prevention CONSORT diagram of study designJongbloed et al. Trials  (2016) 17:128 Page 4 of 12included in the comparison group through computer-generated codes developed by a statistician at the Centrefor Evaluation and Outcome Sciences at St. Paul’s Hospital.A list of participants to be invited into the intervention armwill be distributed to each study site. Informed consent willbe sought from each participant invited to receive the inter-vention who agreed to participate. Those assigned to thecomparison group will continue in the usual Cedar Projectcohort study under its existing informed consent with nochange whatsoever to their participation in the overallstudy. Target enrollment is set at 200 participants.Intervention groupTo ensure that we reach our target sample, initialrandomization will be slightly unbalanced to accommo-date refusals to participate or difficulty locating partici-pants. A total of 140 participants (70 from each site) willbe randomly allocated to receive the invitation to partici-pate in the intervention arm of the mHealth study. Thiswill allow for an estimated 20 participants per site whocannot be reached or who decline to participate. Cedarstaff will invite and enroll participants from this list tojoin the study until enrollment reaches 50 at each studysite. Three attempts will be made to invite participantsin the intervention arm into the study, including duringregular visits to the research offices, phone, email, wordof mouth, and street outreach.Comparison groupOne hundred Cedar Project participants who meet theeligibility criteria will be allocated to serve as the cohortcomparison group, stratified on the same variables usedto select the intervention group. Participants randomlyassigned to the control group will continue as CedarProject participants under usual circumstances. Thisgroup of cohort controls will not be required to provideany additional data to the study beyond that which theyprovide in semi-annual follow-up interviews as partici-pants in the main Cedar Project study.The interventionThe Cedar Project WelTel mHealth intervention beingevaluated is a structured mobile-phone initiative to connectyoung Indigenous people who use drugs with Cedar CaseManagers in a community-based setting. The interventionconsists of a package of supports, including a mobile phoneand cellular plan, weekly two-way text messaging, and sup-port from Cedar Case Managers. The intervention will beimplemented over a 16-month period, and all participantswill receive the intervention for a minimum of 6 months.Cedar Case Managers include Indigenous and non-Indigenous nurses and Cedar Project staff members whohave extensive frontline outreach experience with youngIndigenous people who use drugs in Prince George andVancouver. Cedar Case Managers follow a “culturallysafe” approach that acknowledges both trauma andstrengths and includes an explicit focus on the criticalroles of cultural assets and safe relationships with careproviders in HIV risk reduction [31].Participants allocated to receive the intervention willbe provided with a cellular phone at the start of thestudy. Each phone is pre-programmed with severalphone numbers for emergency and health-related ser-vices relevant to the study site. During the study period,participants will receive a monthly cellular plan that in-cludes unlimited calling and texting within Canada, butno data. We made an explicit decision to include long-distance calling and texting to provide the opportunityfor participants to connect with family and loved onesliving in home communities and elsewhere in Canada. Ifphones are lost or stolen, participants will be eligible toreceive one replacement. If two phones are lost, the par-ticipant may bring their own sim card-enabled cellularhandset to use with the study monthly cellular plan.The supportive text-message component of the study isbased on the intervention tested in the WelTel Kenya1trial (Fig. 2) [34]. Each Monday at noon, a text messagesaying, “How’s it going?” is automatically sent to interven-tion arm participants through the WelTel mHealth soft-ware platform. Cedar Case Managers will login within 24to 48 hours to triage the incoming text messages. Theywill respond to all participants and follow up with partici-pants who replied with a specific problem or need. OnWednesday, participants who have not replied will receivean additional text saying, “Haven’t heard from you, areyou OK?” On Thursday or Friday, staff will attemptto call all remaining participants who have nottext message at start of the weekResponds that they are okayResponds that they have a problemNo response by end of the weekParticipant doing okayCedar Case Manager follows up with a phone call Cedar Case Managerprovides support or referralFig. 2 The Cedar Project WelTel mHealth interventionJongbloed et al. Trials  (2016) 17:128 Page 5 of 12responded by text message. Throughout, study staffwill keep a log of all responses and actions takenthrough the WelTel platform.BlindingWe recognize that blinding in a trial such as ours ischallenging. Care providers (Cedar Case Managers) andintervention arm participants cannot be blinded, as themHealth intervention requires overt participation andan “invite list” is provided upfront. However, participantsin both the intervention and control groups will beblinded to specific study hypotheses. Primary and sec-ondary outcomes will be drawn from routine data collec-tion that occurs as part of participation in the overallcohort; it is unlikely that participants will identify thespecific questions used to generate outcomes from ourextensive questionnaires. The data analyst will also beblinded to group allocation.ObjectivesThe study’s primary objective is to test whether theCedar Project mHealth intervention reduces vulnerabil-ity to HIV among young Indigenous people who usedrugs, measured by using an HIV propensity score de-scribed below. Our secondary objectives are to test thespecific ways the mHealth intervention may reduce vul-nerability to HIV by exploring HIV risk behaviours, re-silience, psychological distress, access to drug-relatedservices, and connection to culture among participantsover the course of the study.We hypothesize that participants receiving the inter-vention will seek help from Cedar Case Managers tonavigate barriers to drug-related services, housing, cul-tural supports, and health care. Also, we hypothesizethat participants will use the phones as tools to connectwith other supports and sources of strength in theirlives, including family, work, culture, and services. Thus,we hypothesize that the intervention will help youngpeople to work towards goals related to their own healthand well-being, supporting them to reduce HIV risk.Outcome measuresPrimary outcomesThe primary outcome (Table 1) is HIV risk, measuredby an HIV propensity score assessed at the 6-monthtime point. Previous analyses of Cedar Project data withrespect to HIV infection have identified several factorsas associated with HIV infection, including recent injec-tion drug use, high-frequency drug use, needle sharing,and participation in sex work [12]. Logistic regression ofrisk factors for prevalent HIV infection at study recruit-ment will provide coefficients to combine these four riskvariables into a single primary outcome measuring pro-pensity for HIV infection. Mean change in HIV propensityscore from baseline to 6 months will be used to determinethe impact of the intervention on HIV vulnerability.Secondary outcomesThe potential benefits of the supportive mHealth inter-vention are broad. As a result, multiple secondary out-comes are of interest. These were selected throughconsultation with academic and community partnersand are part of routine Cedar Project data collection.They fall under five categories: HIV risk, resilience, psy-chological distress, access to drug-related services, andconnection to culture. For all secondary outcomes, theeffect of the mHealth intervention will be measured aschange in the outcome from baseline to 6 months. Par-ticipants with sufficient follow-up time will contribute toanalyses of all outcomes at the 1-year time point to de-termine longer-term effects of the intervention.HIV propensity (12 months) Participants who receivedthe intervention for a sufficient length of time will con-tribute to a secondary analysis of change in HIV propen-sity at 1 year to determine longer-term effects of theCedar Project WelTel mHealth intervention. The HIVpropensity variable will be generated by using the sameapproach used for the primary outcome.HIV vulnerability Although the effect of the interventionon HIV risk will be assessed in the primary analysis, wewill also analyze the effect of the intervention on specificbehaviours. Several self-reported binary measures will beused to determine the effect of the intervention on HIVvulnerability in the previous 6-month period, including in-jection drug use in the past 6 months, high-frequency(daily or more) drug use, needle sharing, and participationin sex work. These measures will be ascertained fromCedar Project questionnaires collected every 6 months aspart of the main Cedar Project cohort. HIV vulnerabilitywill be assessed at baseline, 6 months, and 1 year.Resilience Resilience, or the ability to cope with adver-sity, will be characterized by using the Connor-DavidsonResilience Scale (CD-RISC). The creators of the scalebroadly define resilience as “personal qualities that en-able one to thrive in the face of adversity” [42]. The CD-RISC scale measures resilience via 25 items on a five-point scale with scores ranging between 0 and 100, withhigher scores indicating greater resilience. Resilience willbe assessed at baseline, 6 months, and 1 year.Psychological distress The Symptom Checklist-90-R(SCL-90-R) is a 90-item self-reported symptom inventorythat measures the severity of nine dimensions of psycho-logical distress in the past 3 months scored on a five-pointLikert scale (from ‘not at all’ to ‘extremely’). Participants’Jongbloed et al. Trials  (2016) 17:128 Page 6 of 12SCL-90-R scores will be transformed into an averageGlobal Severity Index, providing a single average measurethat profiles overall degree of psychological distress [43].Psychological distress will be assessed at baseline,6 months, and 1 year.Access to drug-related services Self-reported access todrug-related services, including opioid substitution ther-apy, needle exchange, safe injection facility, and drugtreatment, in the previous 6-month period, will be ascer-tained from the main Cedar Project questionnaire. Pro-portions of participants reporting access to theseservices will be compared in the intervention and con-trol groups. We will also determine whether there aredifferences among treated and control groups in termsof proportion of people who tried to quit in the previous6-month period. Access to drug-related services will beassessed at baseline, 6 months, and 1 year.Connection to culture Connection to Indigenous cul-ture has been hypothesized as a key protective factor foryoung Indigenous people who use drugs. It will beassessed by using two dichotomous variables that meas-ure cultural activity in the prior 6-month period: (1)self-reported participation in traditional ceremonies (in-cluding potlatch, feast, fast, burning ceremony, washingceremony, naming ceremony, big/smoke house, rites ofpassage, smudge, dances, or any other traditional Indi-genous ceremony) and (2) frequency living by traditionalculture (never/rarely versus often/always). These vari-ables were defined by Earl Henderson (Cree, Métis) andViolet Bozoki (Lheidli T’enneh) who are IndigenousElders, traditional knowledge keepers, and members ofthe Cedar Project Partnership.Sample sizeConsidering current follow-up rates, we are likely able toreach and recruit at least 200 participants for participationin both arms of the Cedar Project WelTel mHealth study.As mentioned previously, the primary objective is HIVrisk, measured by using an HIV propensity score evalu-ated at 6 months. On the basis of a 1:1 allocation ratio, aTable 1 Outcome measuresOutcome measure Specific variable Analysis metric Hypothesis(intervention > control)Type AnalysisPrimaryHIV propensity(6 months)HIV propensity score Mean change - HIV propensity score Decrease in HIV risk Continuous T testSecondaryHIV propensity(12 months)HIV propensity score Mean change - HIV propensity score Decrease in HIV risk Continuous T testHIV vulnerability Injection drug use Mean change - proportion injection Decrease in injection Binary χ2 testHigh-frequency injection Mean change - proportion frequentinjectionDecrease in injectionfrequencyBinary χ2 testNeedle sharing Mean change - proportion needle sharing Decrease in needlesharingBinary χ2 testParticipation in sex work Mean change - proportion sex work Decrease in sex work Binary χ2 testResilience Connor-Davidson ResilienceScale (CD-RISC)Mean change - CD-RISC score Increase in resilience Continuous T testPsychological distress Symptom Checklist-90-R(SCL-90-R)Mean change - SCL-90-R score Decrease inpsychological distressContinuous T testAccess to drug-related servicesOpioid substitution therapy(OST)Mean change - proportion accessed OST Increase in access OST Binary χ2 testNeedle exchange (NX) Mean change - proportion attended NX Increase in access NX Binary χ2 testSafe injection facility (SIF) Mean change - proportion visited SIF Increase in access SIF Binary χ2 testDrug treatment Mean change - proportion seekingtreatmentIncrease in seekingtreatmentBinary χ2 testTried to quit using drugs Mean change - proportion trying to quit Increase in trying toquitBinary χ2 testConnection tocultureParticipation in traditionalceremoniesMean change - proportion participated intraditional ceremonyIncrease in access toceremonyBinary χ2 testFrequently living by traditionalcultureMean change - proportion lived bytraditional cultureIncrease in traditionalcultureBinary χ2 testAll variables refer to behaviour in the 6-month period preceding the interview. All variables are measured as mean change in proportion or score from baselineJongbloed et al. Trials  (2016) 17:128 Page 7 of 12significance level of 0.05 (one-sided) and 80 % power, it isestimated that we require 78 participants in each studyarm. This computation assumes a standardized mean ef-fect size (using Cohen’s d) of 0.40. Assuming attritionrates of approximately 20 %, we intend to over-enroll,resulting in a target of 200 participants overall (100 ineach arm). Sample size was calculated by using the pwrpackage in R, software version 3.2.1.Statistical analysisThe analysis and reporting of the results will follow theCONSORT (Consolidated Standards of Reporting Trials)guidelines [44]. Descriptive statistics of socio-demographic,historical/lifetime trauma, sex- and drug-related HIV vul-nerabilities, and health-related variables will be presentedto assess comparability of the intervention and controlgroups. Mean (standard deviation) or median (quartiles)will be used for continuous variables and count (percent-age) for categorical variables. Our primary analysis to evalu-ate the effect of the mHealth intervention on HIVprevention will be by intention to treat (ITT) for primaryand secondary outcomes among all randomly assigned par-ticipants according to the study group to which they wereoriginally allocated. Student’s t tests and chi-squared testswill be used to determine differences in the mean change inproportions or scores from baseline at 6 months or 1 yearbetween the two study arms. If baseline characteristics arefound to be substantially different between the two studyarms, we will adjust for these factors by using regressionmodels. In addition, we will conduct a secondary analysisby using a modified ITT approach including only partici-pants who agreed to participate in the intervention makingup the intervention group (excluding over-sampled partici-pants who did not receive the intervention). To minimizethe risk of bias introduced in our modified ITT analysis, wepropose to use complier average causal effect (CACE) ana-lysis [45]. This approach will allow us to retain the initialrandom assignment by taking into account two subgroupswithin the group pre-randomized to receive the interven-tion (those who did and did not actually receive the inter-vention) and then helping us to identify a similar subgroupof control participants who could have been expected to re-ceive the intervention had it been offered [45]. By compar-ing expected and observed outcomes in these subgroups,we will obtain a less biased estimate of effect of the inter-vention [45]. Missing data will be approached by using mul-tiple imputation. An up-to-date version of R statisticalsoftware will be used to conduct all analyses [46]. All testswill be two-sided; P values of less than 0.10 will be consid-ered significant. We plan to conduct four predeterminedexploratory subgroup analyses that may help to tailor theintervention for specific high-need populations, includingcomparisons by gender, city, injection drug use, and urbanversus rural. Statistical methods similar to those describedabove for whole-group analyses will be conducted for pri-mary and secondary outcomes. All subgroup results will bereported, regardless of significance. Inferences will behypothesis-generating, given concerns related to multiplecomparisons and lower power to detect an effect insubgroups.Nested studiesStudy implementationAs this study is the first of its kind in a community-based setting among young Indigenous people who usedrugs, it is critical that the implementation of the inter-vention be described in detail. Daily mHealth memosprepared by each study site, combined with proceduraldocuments, will inform a description of how a support-ive two-way text-message program looks and functionsin practice. Descriptive statistics generated from themHealth baseline questionnaire will provide additionalinsight into the feasibility of applying this program insimilar settings. The survey asks about ownership anduse of mobile phones, how often participants text mes-sage, and perceived helpfulness or concerns about re-ceiving text messages related to health.Types of support requestedExamining the types of support requested by Cedar Pro-ject WelTel mHealth participants via text will help toidentify current challenges accessing prevention servicesand support among young Indigenous people who usedrugs. A comparative content analysis of text-messageinteractions captured on the WelTel platform over thestudy period will be used for this purpose. This descrip-tive analysis will help inform scale-up of this program,including the human resource requirements for futureimplementation in similar settings.Participant perceptionsParticipant perceptions of the mHealth intervention willbe evaluated via the mHealth follow-up questionnaire.All intervention arm participants will be invited tocomplete an administered questionnaire to assess satis-faction with the care and support they received via theintervention. Evaluation of patient perceptions will in-clude thematic analysis of narrative responses and basicdescriptive statistics.EthicsThe Cedar Project follows the guidelines provided in theTri-Council Policy Statement on Ethical Conduct for Re-search Involving Humans – Chapter Nine: Research involv-ing the First Nations Inuit and Métis Peoples of Canada[47]. In addition, the study will adhere to the principles ofOwnership, Control, Access and Possession in relation toresearch with Indigenous people [48]. Through the CedarJongbloed et al. Trials  (2016) 17:128 Page 8 of 12Project Partnership, Indigenous collaborators will continueto be involved in the conception, design and interpretationof the results of the Cedar Project WelTel mHealth study.The Cedar Project Partnership will serve as the data andsafety monitoring board for this study. They have also ap-proved this manuscript for publication. The Cedar ProjectWelTel mHealth study has been approved by the Universityof British Columbia Providence Health Care ResearchEthics Board (H13-02718), and we will be accountable tothem for approval and monitoring.All participants have provided informed consent aspart of the main Cedar Project cohort study. Participantsrandomly assigned to receive an invitation to participatein the Cedar Project WelTel mHealth intervention willundergo an additional consent process. After the studyparticipant is invited to participate in the Cedar ProjectWelTel mHealth study, a trained Cedar Project staffmember will describe the study. If the person would liketo enroll, the research staff will review the consent formand answer any questions. Participants who give consentare provided with a copy of the study introduction letterand consent form.HarmsAdverse events will be documented in writing and re-ported to investigators. Study staff at both sites have beentrained in recognizing and reporting of adverse events, in-cluding those directly attributable to the intervention (e.g.,accidental disclosure of illicit drug use) and those resultingfrom trial participation. Because the study takes place in acommunity-based (not clinical) setting, staff will make re-ferrals to care where appropriate. Potential harms will beoutlined to participants during the informed consentprocess. All unanticipated risks to human participants orothers will be reported to the Cedar Project Partnershipand the University of British Columbia/Providence HealthCare Research Ethics Board where appropriate.DisseminationKnowledge translation is a hallmark of the Cedar Projectand will be a key component of the Cedar Project WelTelmHealth study. Integrated knowledge translation isplanned throughout the study, and updates will be pro-vided to the Cedar Project Partnership at quarterly meet-ings. Findings will be shared through ceremony withIndigenous partners; peer-reviewed publications and pre-sentations; and consultations with policy makers and ser-vice delivery organizations to support uptake of results.DiscussionInnovative, culturally safe interventions that address thebarriers to HIV prevention while supporting the strengthof young Indigenous people who use drugs are urgentlyneeded. This study, due to report its findings in 2017,tests the effectiveness of a two-way supportive text-message program delivered in a community-based settingto support HIV prevention among young Indigenouspeople who use drugs. Despite presenting a tremendousopportunity to connect young, highly transient Indigenouspeople who use drugs to prevention services and support,supportive two-way mHealth programs have yet to betested for HIV prevention in a community-based settingwith young Indigenous people who use drugs [34, 49–51].Other researchers have used two-way supportive messa-ging interventions to engage people living with HIV incare and to improve adherence [34, 36, 40, 52, 53]. Recentrandomized controlled trials in Kenya indicated that intro-ducing mobile-phone technology into HIV case manage-ment improved HIV treatment adherence and HIV-related clinical outcomes, despite high levels of poverty,remote and rural living, transience, stigma, and discrimin-ation [34, 50, 54]. These studies have demonstrated theimportance of text-message programs that are both sup-portive and interactive [35, 55–57], as passive mHealthprograms that seek to monitor, remind or educate havehad limited success [58–60]. It is important to note thatwe have deliberately chosen an open-ended weekly textmessage to allow participants to set their own prioritiesaround their health and well-being, as well as to avoidpossible disclosure of drug use and other sensitive issues.We have chosen a cohort-embedded Zelen pre-randomized controlled trial design [61–63]. Our ongoingCedar Project cohort study provides the opportunity tosupport recruitment into the embedded trial and also al-lows us to use routinely measured outcomes collected lon-gitudinally among the whole cohort. All participantsentering the cohort have consented to providing observa-tional data. Consent to “try” the intervention is beingsought only from those who have been pre-randomized toreceive the intervention [63]. Study outcomes amongrandomly selected participants will be compared with thoseof the cohort members not randomly selected to receivethe intervention. Another advantage of this design is tominimize false hopes, resentment, and contaminationamong controls had they learned they were not receiving apotentially valued intervention through trial consent andrandomization [61, 62]. In our instance, as it is not possibleto completely separate intervention participants from therest of the cohort, it is likely that some members of the co-hort will come to know about the intervention. However,even if control participants have or obtain a phone and cel-lular plan, full crossover of participants from control tointervention is not possible, owing to the nature of theintervention. As noted above, neither group will be awareof the hypotheses under study. A limitation of this design isthat a significant number of participants allocated to theintervention arm may refuse to receive it whereas controlsubjects do not have this option. Including the formerJongbloed et al. Trials  (2016) 17:128 Page 9 of 12group in an ITT analysis may dilute the treatment effect,whereas excluding them could lead to a biased comparison.In our case, we believe that the intervention is likely to behighly valued among invitees and there will be few who re-fuse. Nevertheless, this will be monitored closely, and asnoted earlier, we will also use a modified ITTapproach.A key component of the Cedar Project WelTel mHealthstudy is relational accountability [64]. We honour our rela-tionships with study participants who have continued toshare their stories with us since joining the Cedar Project.Testing this intervention is a way for us to respond to theclear message from Cedar Project participants about theimportance of having support to navigate barriers to careand services that they face in their daily lives. An additionalcomponent of our relational accountability is through thegoverning leadership of the Cedar Project Partnership, whowork to ensure that this research is relevant to the commu-nities they represent and is conducted in a good way.LimitationsOur decision to over-sample in the intervention arm toadjust for refusals to participate or difficulty locatingparticipants may result in a dilution of the effect of theintervention in ITT analysis. As a result, we have pro-posed a parallel, modified ITT analysis, which may be af-fected by selection bias. Diversity of HIV risk amongparticipants (non-homogeneity) may also dilute the de-tected effect of the intervention. Representativeness ofthe sample is dependent on representativeness of theCedar Project cohort study sample overall; however, wehave made a considerable attempt to ensure that thesample represents the population under study [12]. Asthis study involves a package of support that includesmobile phones, two-way text messaging, and support, itis difficult to determine the relative contribution of com-ponents of the package to any effect the interventionmay have. The qualitative nested studies will help in thisregard. Furthermore, we cannot rule out that simultan-eous co-interventions could impact our results. As BC’sHIV incidence has been stable for several years and manypublic health initiatives (including needle exchanges andsafe injection sites) are already in place, we feel it is un-likely that new transformative co-interventions will takeeffect over the study period. However, we will monitor po-tential co-interventions that could impact study outcomesthrough our main cohort questionnaires, as well as trackmajor policy and programmatic changes in the Province.Blinding in this study is not possible as assessors havestrong relationships with participants. In addition, loss tofollow-up may be higher in the comparison group thanthe intervention group. Cedar Project participants arehighly transient and often difficult to track down [41].Having a mobile phone and consistent airtime will likelymake it easier to reach participants receiving theintervention for follow-up visits. Active follow-up with allparticipants through phone, email, and outreach will helpensure retention and interview appointment attendance.In addition, our measures may not adequately capturecomplex concepts such as connection to culture and re-silience. Finally, the intervention under study is complexand multifaceted. It may be that our proposed outcomesdo not adequately capture the impact of the interventionon the lives of participants involved.Trial statusEnrollment in the trial has begun but has not yetreached full enrollment.AbbreviationsBC: British Columbia; CD-RISC: Connor-Davidson resilience scale; ITT: Intention totreat; mHealth: Health care delivered via mobile phone; NX: Needle exchange;OST: Opioid substitution therapy; SIF: Safe injection facility; SCL-90-R: Symptomchecklist 90-R.Competing interestsRTL is the co-founder and executive director of the WelTel International mHealthSociety and has an interest in WelTel, the company that provides the SMSsoftware platform. The other authors declare that they have no competinginterests.Authors’ contributionsKJ helped to conceive of the study, develop the study design, secure thefunding, develop study procedures, initiate study implementation, write thestudy protocol and is a grant holder. LD helped to conceive of the study,develop the study design and provide input on Indigenous research methodsand cultural safety in study protocols and procedures. RTL helped to conceiveof the study and develop the study design. PMS helped to conceive of thestudy, develop the study design, secure the funding, develop study procedures,initiate study implementation and is a grant holder. MTS helped to conceive ofthe study, develop the study design, secure the funding and is a grant holder.MEP helped to secure the funding and write the study protocol. AJF helped tosecure the funding, develop study procedures, initiate study implementation,and write the study protocol. VT helped to develop study procedures, initiatestudy implementation and provide input on Indigenous research methods andcultural safety in study protocols and procedures. MLVDK helped to write thestudy protocol and gave input on study design, measures and statisticalanalyses. SP provided input on Indigenous research methods and cultural safetyin study protocols and procedures. The Cedar Project Partnership helped toconceive of the study, develop the study design, secure the funding andprovided governance and leadership. All authors contributed critical intellectualinput to refinement of the study protocol and approved the final manuscript.AcknowledgementsThe authors would like to thank the Cedar Project participants who continueto share their voices with us. We remain grateful to the Cedar ProjectPartners, including Elders Violet Bozoki (Lheidli T’enneh) and Earl Henderson(Cree, Métis); Prince George Native Friendship Centre; Carrier Sekani Child& Family Services; Splatsin Secwepmc Nation; Adams Lake Indian Band;Neskonlith Indian Band; Positive Living North; Red Road Aboriginal AIDSNetwork; Canadian Aboriginal AIDS Network; Vancouver Native HealthSociety; Central Interior Native Health; and All Nations Hope Network, whoguide and govern this study. Thanks to the Cedar Project staff (includingVicky Thomas, Amanda Wood, Sharon Springer, Matt Quenneville, JillFikowski and Shawna Morrison) for their invaluable contributions. Thank youalso to the Oak Tree and WelTel staff who provided mentoring and sharedbest practices as we initiated the Cedar Project WelTel mHealth study. Wewould like to acknowledge the support of TELUS for providing mobilephones and subsidized monthly cellular plans and of WelTel for contributingtheir mHealth patient engagement software.Jongbloed et al. Trials  (2016) 17:128 Page 10 of 12FundingThe Cedar Project WelTel mHealth study is supported by a Canadian Institutesfor Health Research (CIHR) operating grant (RN 156 278–272441) with additionalfunding from the St. Paul’s Hospital Foundation Enhanced Patient Care Fund.The funding sources had no role in the design of the study and will not haveany role in its execution, analyses, interpretation, or decision to submit results.KJ is supported by a CIHR Doctoral Award (May 2013).Author details1School of Population and Public Health, Faculty of Medicine, University ofBritish Columbia, 2206 East Mall, Vancouver, BC V6T 1Z3, Canada. 2The CedarProject, Centre for Health Evaluation and Outcome Sciences, St. Paul’sHospital, 588-1081 Burrard Street, Vancouver, BC V6Z 1Y6, Canada.3Department of Public Health Sciences, Karolinska Institutet,Tomtebodavägen 18a, Campus Solna, Stockholm 171 77, Sweden. 4Divisionof Infectious Diseases, Faculty of Medicine, University of British Columbia,566-828 West 10th Avenue, Vancouver, BC V5Z 1L8, Canada. 5VancouverNative Health Society, 455 Hastings Street E, Vancouver, BC V6A 1P5, Canada.6Canadian Aboriginal AIDS Network, 6520 Salish Drive, Vancouver, BC V6N2C7, Canada. 7Neglected Global Diseases Initiative, Faculty of Medicine,University of British Columbia, 564-828 West 10th Avenue, Vancouver, BC V5Z1L8, Canada.Received: 29 July 2015 Accepted: 23 February 2016References1. 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Te IraTangata: A Zelen randomised controlled trial of a treatment packageincluding problem solving therapy compared to treatment as usual inMaori who present to hospital after self harm. Trials. 2011;12:117.63. Relton C, Torgerson D, O’Cathain A, Nicholl J. Rethinking pragmaticrandomised controlled trials: introducing the “cohort multiple randomisedcontrolled trial” design. BMJ. 2010;340:963–7.64. Wilson S. Research is ceremony: Indigenous research methods. Winnipeg:Fernwood Publishing; 2008.•  We accept pre-submission inquiries •  Our selector tool helps you to find the most relevant journal•  We provide round the clock customer support •  Convenient online submission•  Thorough peer review•  Inclusion in PubMed and all major indexing services •  Maximum visibility for your researchSubmit your manuscript atwww.biomedcentral.com/submitSubmit your next manuscript to BioMed Central and we will help you at every step:Jongbloed et al. Trials  (2016) 17:128 Page 12 of 12


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