It's Your Game…Keep It Real in South Carolina: A Group Randomized Trial Evaluating the Replication of an Evidence-Based Adolescent Pregnancy and Sexually Transmitted Infection Prevention Program.

Objectives: To evaluate the effectiveness of an evidence-based HIV/sexually transmitted infection (STI)/pregnancy prevention program for middle schools implemented by school staff in South Carolina.

Methods: Twenty-four schools, representing 3143 youths, participated in a randomized trial from 2011 to 2014. Students completed surveys before programming (fall of seventh grade), after completing the 2-year It's Your Game…Keep It Real program (spring of eighth grade), and 1-year postprogram (spring of ninth grade).

Results: There was no statistically significant effect on initiation of vaginal sex between baseline and eighth grade. Significantly fewer students in the comparison condition reported initiating sex at ninth grade, relative to the intervention condition. No group differences existed on other behavioral outcomes that addressed sexual activity in the past 3 months at ninth grade. Seven of 26 psychosocial outcomes (3 knowledge, 1 attitude, 1 self-efficacy, 2 personal limits) were positively affected at eighth grade; 4 remained significant at ninth grade.

Conclusions: The original studies' behavioral effects were not replicated in this population, possibly as a result of this being an effectiveness trial instead of an efficacy trial, counterfactual exposure design issues, or postprogram exposure to evidence-based programming.