title: The Cedar Project WelTel mHealth intervention for HIV prevention in young Indigenous people who use illicit drugs: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Despite successes in preventing and treating HIV, Indigenous people in Canada continue to face disproportionately high rates of HIV infection. Programs that support healing from lifetime trauma, support connection to culture, and reduce drug-related harms are critical to preventing HIV among young Indigenous people who use drugs. The Cedar Project WelTel mHealth intervention proposed here is a structured mobile-phone initiative to connect young Indigenous people who use drugs with Cedar Case Managers in a community-based setting. The intervention consists of a package of supports, including a mobile phone and cellular plan, weekly two-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 effect of a two-way supportive text-message intervention to reduce HIV vulnerability among young Indigenous people who use illicit drugs in two Canadian cities. The trial is nested within the Cedar Project, an ongoing cohort study addressing HIV and hepatitis C vulnerability among young Indigenous people who use drugs in Vancouver and Prince 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 a 16-month period, with HIV propensity score at 6 months as the primary outcome. Secondary outcomes include HIV propensity at 1 year, HIV risk, resilience, psychological distress, access to drug-related services, and connection to culture measured at 6 months and 1 year. Primary analysis is by intention to treat.
  
  
  CONCLUSIONS
  Culturally safe interventions that address barriers to HIV prevention while supporting the strength of young Indigenous people who use drugs are urgently needed. Despite presenting a tremendous opportunity to connect young, highly transient Indigenous people who use drugs to prevention services, supportive two-way mHealth programs have yet to be tested for HIV prevention in a community-based setting with this population.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT02437123 https://clinicaltrials.gov/show/NCT02437123 (registered 4 May 2015). Protocol version: 24 July 2015.
authors.affiliation: School of Population and Public Health, Faculty of Medicine, University of British Columbia, 2206 East Mall, Vancouver, BC, V6T 1Z3, Canada. katejongbloed@gmail.com.
authors.forename: Kate
authors.initials: K
authors.lastname: Jongbloed
authors.affiliation: The Cedar Project, Centre for Health Evaluation and Outcome Sciences, St. Paul's Hospital, 588-1081 Burrard Street, Vancouver, BC, V6Z 1Y6, Canada. afriedman@cheos.ubc.ca.
authors.forename: Anton J
authors.initials: AJ
authors.lastname: Friedman
authors.affiliation: The Cedar Project, Centre for Health Evaluation and Outcome Sciences, St. Paul's Hospital, 588-1081 Burrard Street, Vancouver, BC, V6Z 1Y6, Canada. margo.e.pearce@gmail.com.
authors.forename: Margo E
authors.initials: ME
authors.lastname: Pearce
authors.affiliation: Department of Public Health Sciences, Karolinska Institutet, Tomtebodavägen 18a, Campus Solna, Stockholm, 171 77, Sweden. miavanderkop@gmail.com.|Division of Infectious Diseases, Faculty of Medicine, University of British Columbia, 566-828 West 10th Avenue, Vancouver, BC, V5Z 1L8, Canada. miavanderkop@gmail.com.
authors.forename: Mia L
authors.initials: ML
authors.lastname: Van Der Kop
authors.affiliation: The Cedar Project, Centre for Health Evaluation and Outcome Sciences, St. Paul's Hospital, 588-1081 Burrard Street, Vancouver, BC, V6Z 1Y6, Canada. vthomas@cheos.ubc.ca.
authors.forename: Vicky
authors.initials: V
authors.lastname: Thomas
authors.affiliation: Vancouver Native Health Society, 455 Hastings Street E, Vancouver, BC, V6A 1P5, Canada. admin@vnhs.net.
authors.forename: Lou
authors.initials: L
authors.lastname: Demerais
authors.affiliation: Canadian Aboriginal AIDS Network, 6520 Salish Drive, Vancouver, BC, V6N 2C7, Canada. sherrip@caan.ca.
authors.forename: Sherri
authors.initials: S
authors.lastname: Pooyak
authors.affiliation: School of Population and Public Health, Faculty of Medicine, University of British Columbia, 2206 East Mall, Vancouver, BC, V6T 1Z3, Canada. martin.schechter@ubc.ca.
authors.forename: Martin T
authors.initials: MT
authors.lastname: Schechter
authors.affiliation: Neglected Global Diseases Initiative, Faculty of Medicine, University of British Columbia, 564-828 West 10th Avenue, Vancouver, BC, V5Z 1L8, Canada. rlester.id@gmail.com.
authors.forename: Richard T
authors.initials: RT
authors.lastname: Lester
authors.affiliation: School of Population and Public Health, Faculty of Medicine, University of British Columbia, 2206 East Mall, Vancouver, BC, V6T 1Z3, Canada. spittal@sm.hivnet.ubc.ca.
authors.forename: Patricia M
authors.initials: PM
authors.lastname: Spittal
mesh_terms: D000293:Adolescent; D000328:Adult; D000367:Age Factors; D001955:British Columbia / Q000453:epidemiology; D040421:Cell Phone; D003466:Cultural Characteristics; D054521:Cultural Competency; D003695:Delivery of Health Care; D005260:Female; D015658:HIV Infections / Q000208:ethnology / Q000517:prevention & control* / Q000523:psychology / Q000635:transmission; D006303:Health Services, Indigenous; D006801:Humans; D013287:Illicit Drugs; D007198:Indians, North American / Q000523:psychology; D057194:Intention to Treat Analysis; D008297:Male; D011314:Preventive Health Services / Q000379:methods*; D012307:Risk Factors; D019966:Substance-Related Disorders / Q000175:diagnosis / Q000208:ethnology* / Q000523:psychology; D017216:Telemedicine / Q000295:instrumentation / Q000379:methods*; D060145:Text Messaging; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D013287:Illicit Drugs