title: Complex realities: community engagement for a paediatric randomized controlled malaria vaccine trial in Kilifi, Kenya.
abstract: BACKGROUND
  Community engagement (CE) is increasingly promoted for biomedical research conducted in resource poor settings for both intrinsic and instrumental purposes. Given the potential importance of CE, but also complexities and possibility of unexpected negative outcomes, there is need for more documentation of CE processes in practice. We share experiences of formal CE for a paediatric randomized controlled malaria vaccine trial conducted in three sites within Kilifi County, Kenya.
  
  
  METHODS
  Social scientists independent of the trial held in-depth individual interviews with trial researchers (n=5), community leaders (n=8) and parents (15 with enrolled children and 4 without); and group discussions with fieldworkers (n=6) and facility staff (n=2). We conducted a survey of participating households (n=200) and observed over 150 CE activities.
  
  
  RESULTS
  The overall CE plan was similar across the three study sites, although less community-based information in site C. Majority perceived CE activities to clear pre-existing concerns and misconceptions; increase visibility, awareness of and trust in trial staff. Challenges included: some community leaders attempting to exert pressure on people to enrol; local wording in information sheets and consent forms feeding into serious anxieties about the trial; and concerns about reduced CE over time. Negative effects of these challenges were mitigated through changes to on-going CE activities, and final information sharing and consent being conducted individually by trained clinical staff. One year after enrolment, 31% (n = 62) of participants' parents reported malaria prevention as the main aim of the activities their children were involved in, and 93% wanted their children to remain involved.
  
  
  CONCLUSIONS
  The trial teams' goals for CE were relatively clear from the outset. Other actors' hopes and expectations (like higher allowances and future employment) were not openly discussed, but emerged over the course of engagements. Encouraging open discussion of all actors' intentions and goals from the outset takes time, risks raising expectations that cannot be met, and is complex. However, doing so in future similar trials may allow successes here to be built upon, and some challenges minimized or avoided.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT00866619 (registration 19-Mar-2009).
authors.forename: Vibian
authors.initials: V
authors.lastname: Angwenyi
authors.forename: Dorcas
authors.initials: D
authors.lastname: Kamuya
authors.forename: Dorothy
authors.initials: D
authors.lastname: Mwachiro
authors.forename: Betty
authors.initials: B
authors.lastname: Kalama
authors.forename: Vicki
authors.initials: V
authors.lastname: Marsh
authors.forename: Patricia
authors.initials: P
authors.lastname: Njuguna
authors.affiliation: The Kenya Medical Research Institute (KEMRI)/Wellcome Trust Research Programme, P,O, Box, 230-80108, Kilifi, Kenya. SMolyneux@kemri-wellcome.org.
authors.forename: Sassy
authors.initials: S
authors.lastname: Molyneux
mesh_terms: D000293:Adolescent; D000328:Adult; D000367:Age Factors; D001291:Attitude of Health Personnel; D044383:Black People / Q000523:psychology*; D003153:Community Health Services; D003159:Community-Institutional Relations; D032882:Comprehension; D003299:Cooperative Behavior; D003466:Cultural Characteristics; D003906:Developing Countries; D005260:Female; D007722:Health Knowledge, Attitudes, Practice / Q000208:ethnology; D006801:Humans; D007223:Infant; D007258:Informed Consent; D033183:Interdisciplinary Communication; D007630:Kenya / Q000453:epidemiology; D008288:Malaria / Q000208:ethnology / Q000276:immunology / Q000517:prevention & control*; D017780:Malaria Vaccines / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010290:Parents / Q000523:psychology*; D018579:Patient Selection; D019035:Rural Health Services; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D017780:Malaria Vaccines