title: Mobile phones support adherence and retention of indigenous participants in a randomised controlled trial: strategies and lessons learnt.
abstract: BACKGROUND
  Ensuring adherence to treatment and retention is important in clinical trials, particularly in remote areas and minority groups. We describe a novel approach to improve adherence, retention and clinical review rates of Indigenous children.
  
  
  METHODS
  This descriptive study was nested within a placebo-controlled, randomised trial (RCT) on weekly azithromycin (or placebo) for 3-weeks. Indigenous children aged ≤24-months hospitalised with acute bronchiolitis were recruited from two tertiary hospitals in northern Australia (Darwin and Townsville). Using mobile phones embedded within a culturally-sensitive approach and framework, we report our strategies used and results obtained. Our main outcome measure was rates of adherence to medications, retention in the RCT and self-presentation (with child) to clinic for a clinical review on day-21.
  
  
  RESULTS
  Of 301 eligible children, 76 (21%) families declined participation and 39 (13%) did not have access to a mobile phone. 186 Indigenous children were randomised and received dose one under supervision in hospital. Subsequently, 182 (99%) children received dose two (day-7), 169 (93%) dose three (day-14) and 180 (97%) attended their clinical review (day-21). A median of 2 calls (IQR 1-3) were needed to verify adherence. Importantly, over 97% of children remained in the RCT until their clinical endpoint at day-21.
  
  
  CONCLUSIONS
  In our setting, the use of mobile phones within an Indigenous-appropriate framework has been an effective strategy to support a clinical trial involving Australian Indigenous children in urban and remote Australia. Further research is required to explore other applications of this approach, including the impact on clinical outcomes.
  
  
  BACKGROUND
  ACTRN12608000150347 (RCT component).
authors.affiliation: Child Health Division, Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia. gabrielle.mccallum@menzies.edu.au.
authors.forename: Gabrielle B
authors.initials: GB
authors.lastname: McCallum
authors.forename: Lesley A
authors.initials: LA
authors.lastname: Versteegh
authors.forename: Peter S
authors.initials: PS
authors.lastname: Morris
authors.forename: Clare C
authors.initials: CC
authors.lastname: Mckay
authors.forename: Nerida J
authors.initials: NJ
authors.lastname: Jacobsen
authors.forename: Andrew V
authors.initials: AV
authors.lastname: White
authors.forename: Heather A
authors.initials: HA
authors.lastname: D'Antoine
authors.forename: Anne B
authors.initials: AB
authors.lastname: Chang
mesh_terms: D000208:Acute Disease; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D017963:Azithromycin / Q000627:therapeutic use*; D001988:Bronchiolitis / Q000188:drug therapy*; D040421:Cell Phone; D005260:Female; D006303:Health Services, Indigenous; D006801:Humans; D007223:Infant; D008297:Male; D015876:Northern Territory; D017010:Reminder Systems; D000095283:Australian Aboriginal and Torres Strait Islander Peoples; D016903:Drug Monitoring
chemical_list: D000900:Anti-Bacterial Agents; D017963:Azithromycin