Rigorous evaluation of a pregnancy prevention program for American Indian youth and adolescents: study protocol for a randomized controlled trial

BACKGROUND: 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. METHODS: 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. DISCUSSION: 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. TRIAL REGISTRATION: Clinicaltrials.gov, NCT02904629. Retrospectively registered on 23 September 2016. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-017-1842-6) contains supplementary material, which is available to authorized users.