title: Planning for a group-randomized trial with American Indian youth.
abstract: OBJECTIVE
  To describe lessons learned working with tribal communities in the Northern Plains to plan and implement a group randomized trial of multimedia Circle of Life (mCOL), a sexual risk reduction program designed for American Indian (AI) youth.
  
  
  METHODS
  Project records including emails, travel reports, and meeting minutes were reviewed and synthesized to describe participatory development of the project.
  
  
  RESULTS
  Several challenges were identified including: discussing sexual health interventions for preteens with communities; developing a culturally appropriate research design; managing costs of conducting research in remote and culturally distinct tribal communities; and building research infrastructure of partner organizations. Opportunities for strengthening research partnerships included transparency, openness to bi-directional learning, planning for change, flexibility, and strategic use of technology.
  
  
  CONCLUSIONS
  Findings suggest that meaningful AI community participation in research trials is achievable and a critical step towards generating evidence for interventions in settings where they are most needed. Substantial investments in time, resources, and relationship-building are necessary.
authors.affiliation: Centers for American Indian and Alaska Native Health, University of Colorado-Anschutz Medical Campus, Aurora, Colorado. Electronic address: carol.kaufman@ucdenver.edu.
authors.forename: Carol E
authors.initials: CE
authors.lastname: Kaufman
authors.affiliation: Centers for American Indian and Alaska Native Health, University of Colorado-Anschutz Medical Campus, Aurora, Colorado.
authors.forename: Kirsten
authors.initials: K
authors.lastname: Black
authors.affiliation: Centers for American Indian and Alaska Native Health, University of Colorado-Anschutz Medical Campus, Aurora, Colorado.
authors.forename: Ellen M
authors.initials: EM
authors.lastname: Keane
authors.affiliation: Northern Plains Regional Field Office, Pine Ridge, South Dakota, Centers for American Indian and Alaska Native Health, University of Colorado-Anschutz Medical Campus, Aurora, Colorado.
authors.forename: Cecelia K
authors.initials: CK
authors.lastname: Big Crow
authors.affiliation: Northern Plains Regional Field Office, Pine Ridge, South Dakota, Centers for American Indian and Alaska Native Health, University of Colorado-Anschutz Medical Campus, Aurora, Colorado.
authors.forename: Carly
authors.initials: C
authors.lastname: Shangreau
authors.affiliation: Centers for American Indian and Alaska Native Health, University of Colorado-Anschutz Medical Campus, Aurora, Colorado.
authors.forename: Ruth
authors.initials: R
authors.lastname: Arthur-Asmah
authors.affiliation: Northern Plains Regional Field Office, Pine Ridge, South Dakota, Centers for American Indian and Alaska Native Health, University of Colorado-Anschutz Medical Campus, Aurora, Colorado.
authors.forename: Colette
authors.initials: C
authors.lastname: Keith
authors.affiliation: Centers for American Indian and Alaska Native Health, University of Colorado-Anschutz Medical Campus, Aurora, Colorado.
authors.forename: Bradley
authors.initials: B
authors.lastname: Morse
authors.affiliation: Centers for American Indian and Alaska Native Health, University of Colorado-Anschutz Medical Campus, Aurora, Colorado.
authors.forename: Greg
authors.initials: G
authors.lastname: Schaffer
authors.affiliation: Centers for American Indian and Alaska Native Health, University of Colorado-Anschutz Medical Campus, Aurora, Colorado; Center for Public Health Practice, Colorado School of Public Health, University of Colorado-Anschutz Medical Campus, Aurora, Colorado.
authors.forename: Nicole
authors.initials: N
authors.lastname: Tuitt
mesh_terms: D000293:Adolescent; D002648:Child; D055812:Community-Based Participatory Research; D054521:Cultural Competency; D005260:Female; D006801:Humans; D007198:Indians, North American; D008297:Male; D011247:Pregnancy; D011253:Pregnancy in Adolescence / Q000208:ethnology / Q000517:prevention & control*; D016730:Program Development / Q000379:methods; D016032:Randomized Controlled Trials as Topic / Q000379:methods / Q000592:standards; D040242:Risk Reduction Behavior; D012725:Sexual Behavior / Q000208:ethnology*; D012749:Sexually Transmitted Diseases / Q000208:ethnology / Q000517:prevention & control*; D014481:United States / Q000453:epidemiology
keywords: American Indian; Community-based participatory research; Randomized trial; Sexual risk; Youth