title: Rigorous evaluation of a pregnancy prevention program for American Indian youth and adolescents: study protocol for a randomized controlled trial.
abstract: American Indian adolescents have one of the highest rates of teen pregnancy and repeat teen births in the US. Substance use is a significant risk factor for unprotected sex, and American Indian adolescents have the highest substance use-related morbidity and mortality of any US racial group. Despite these disparities, there are no existing, evidence-based programs for pregnancy prevention that have been rigorously evaluated among American Indian teens.
  
  
  
  The proposed study is a randomized controlled trial to test the efficacy of a comprehensive sexual and reproductive health program developed in partnership with an American Indian community. Participants will be American Indians ages 11-19 and their parent or trusted adult, randomized to receive the control condition or intervention called Respecting the Circle of Life: Mind, Body and Spirit. The intervention includes eight lessons delivered to self-selected peer groups during a summer basketball camp and one lesson delivered to the youth and parent/trusted adult together within 3 months after camp. All lessons are administered by trained community health workers from the participating American Indian community. Youth and parent/trusted adult participants will complete assessments at baseline, 3, 9, 12, 24 and 36 months post-intervention completion. The primary outcome variables are sexual/reproductive health knowledge, sexual initiation, condom use self-efficacy and intent to use a condom at next sex as changed from baseline to post-intervention between intervention and control participants. Selected primary outcomes are applicable to all study participants.
  
  
  
  Currently there are no sexual and reproductive health programs designed specifically for American Indian youth that have been rigorously evaluated and found to have an evidence base. Respecting the Circle of Life is highly innovative by incorporating lesson delivery into a summer basketball camp and involving parents or other trusted adults in curriculum administration. If found successful, it will be the first evidence-based program for teen pregnancy prevention for American Indian youth and adolescents.
  
  
  
  Clinicaltrials.gov, NCT02904629 . Retrospectively registered on 23 September 2016.
authors.affiliation: Johns Hopkins Center for American Indian Health, 415 N. Washington St, Baltimore, MD, 21231, USA. ltingey1@jhu.edu.
authors.forename: Lauren
authors.initials: L
authors.lastname: Tingey
authors.affiliation: Johns Hopkins Center for American Indian Health, 415 N. Washington St, Baltimore, MD, 21231, USA.
authors.forename: Rachel
authors.initials: R
authors.lastname: Chambers
authors.affiliation: Johns Hopkins Center for American Indian Health, 415 N. Washington St, Baltimore, MD, 21231, USA.|Johns Hopkins Center for American Indian Health, 308 Kuper St, Whiteriver, AZ, 85941, USA.
authors.forename: Novalene
authors.initials: N
authors.lastname: Goklish
authors.affiliation: Johns Hopkins Center for American Indian Health, 415 N. Washington St, Baltimore, MD, 21231, USA.|Johns Hopkins Center for American Indian Health, 308 Kuper St, Whiteriver, AZ, 85941, USA.
authors.forename: Francene
authors.initials: F
authors.lastname: Larzelere
authors.affiliation: Johns Hopkins Center for American Indian Health, 415 N. Washington St, Baltimore, MD, 21231, USA.|Johns Hopkins Center for American Indian Health, 308 Kuper St, Whiteriver, AZ, 85941, USA.
authors.forename: Angelita
authors.initials: A
authors.lastname: Lee
authors.affiliation: Johns Hopkins Center for American Indian Health, 415 N. Washington St, Baltimore, MD, 21231, USA.|Johns Hopkins Center for American Indian Health, 308 Kuper St, Whiteriver, AZ, 85941, USA.
authors.forename: Rosemarie
authors.initials: R
authors.lastname: Suttle
authors.affiliation: Johns Hopkins Center for American Indian Health, 415 N. Washington St, Baltimore, MD, 21231, USA.
authors.forename: Summer
authors.initials: S
authors.lastname: Rosenstock
authors.affiliation: Johns Hopkins Center for American Indian Health, 415 N. Washington St, Baltimore, MD, 21231, USA.
authors.forename: Kristin
authors.initials: K
authors.lastname: Lake
authors.affiliation: Johns Hopkins Center for American Indian Health, 415 N. Washington St, Baltimore, MD, 21231, USA.
authors.forename: Allison
authors.initials: A
authors.lastname: Barlow
mesh_terms: D000293:Adolescent; D000294:Adolescent Behavior / Q000208:ethnology*; D002648:Child; D017280:Condoms / Q000706:statistics & numerical data; D065246:Culturally Competent Care / Q000379:methods*; D005260:Female; D015438:Health Behavior / Q000208:ethnology*; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D007198:Indians, North American / Q000523:psychology*; D010287:Parent-Child Relations; D010379:Peer Group; D011247:Pregnancy; D011253:Pregnancy in Adolescence / Q000208:ethnology / Q000517:prevention & control* / Q000523:psychology; D015397:Program Evaluation; D012107:Research Design; D021841:Safe Sex; D020377:Self Efficacy; D012725:Sexual Behavior / Q000208:ethnology*; D012749:Sexually Transmitted Diseases / Q000208:ethnology / Q000517:prevention & control / Q000523:psychology; D019966:Substance-Related Disorders / Q000208:ethnology / Q000517:prevention & control / Q000523:psychology; D011795:Surveys and Questionnaires; D013997:Time Factors; D035502:Trust; D014481:United States; D055815:Young Adult
keywords: Adolescent; American Indian; HIV; Health behavior; Pregnancy and childbirth; Randomized controlled trials; Sexually transmitted infections