Effectiveness Evaluation of It's Your Game: Keep It Real, a Middle School HIV/Sexually Transmitted Infection/Pregnancy Prevention Program.

PURPOSE: This study assessed the effectiveness of the HIV/sexually transmitted infection/pregnancy prevention program, It's Your Game: Keep It Real (IYG). METHODS: IYG was implemented by classroom teachers in 24 urban middle schools from 2012 to 2015. Using a quasi-experimental design, each year we surveyed ninth-grade students in 10 high schools that were selected based on feeder patterns from project middle schools. We compared two groups of students (n = 4,562): (1) students whose middle school grade cohorts did not receive IYG ("No-IYG"), and (2) students whose middle school grade cohorts received IYG ("IYG"). Multilevel analyses examined differences between the two groups in the initiation of any type of sexual activity (oral, vaginal, or anal sex), presexual behaviors, and psychosocial mediators. RESULTS: Students in the IYG group were less likely to report initiation of sexual activity by ninth grade compared to students in the No-IYG group (odds ratio .77; 95% confidence interval .66-.90). The IYG group was significantly less likely to have engaged in presexual behaviors, including having been on a date, had a boyfriend/girlfriend, and touched or been touched on private body parts. The IYG group had better outcomes on 11 of 19 psychosocial variables, including knowledge; beliefs about abstinence, sex, friends' beliefs, norms, and behaviors; reasons for not having sex; personal limits; exposure to risky situations; self-efficacy; and quality of dating relationships. CONCLUSIONS: The results suggest that IYG, when implemented on a large scale by trained classroom teachers in urban public schools, had positive impacts on students' behaviors, beliefs, and knowledge.

Postlicensure safety surveillance of congenital anomaly and miscarriage among pregnancies exposed to quadrivalent human papillomavirus vaccine.

Limited safety data are available on inadvertent exposure to quadrivalent human papillomavirus vaccine (4vHPV) during pregnancy. We conducted a descriptive observational postlicensure safety surveillance study in Kaiser Permanente Southern California and Northern California to assess congenital anomaly and miscarriage among pregnancies exposed to 4vHPV. Using electronic medical records, we identified women who received a dose of 4vHPV between August 2006 and March 2008 within 30 days preconception or any time during a possible pregnancy. A broad algorithm was developed using diagnostic and procedure codes and laboratory tests to identify pregnancy, congenital anomalies, and miscarriages. Medical records of all potential congenital anomaly cases and a random sample of 100 potential miscarriage cases were reviewed to confirm pregnancy exposure and diagnosis. Results were reviewed by an independent Safety Review Committee (SRC). Among the population of 189,629 females who received at least one dose of 4vHPV during the study period, 2,678 females were identified as possibly having a 4vHPV-exposed pregnancy. Among 170 potential congenital anomalies identified, 44 (26%) were found to be both 4vHPV-exposed and confirmed congenital anomaly cases. Among the 633 potential miscarriages identified, the records of a random sample of 100 cases were reviewed, and 9 cases (9%) were confirmed as 4vHPV-exposed miscarriages. The SRC noted no safety signal for congenital anomaly or miscarriage associated with 4vHPV exposure during pregnancy. The rate of major congenital anomaly (3.6%) was in the range of background estimates from the literature. There was no apparent pattern of timing of 4vHPV exposure among 4vHPV-exposed miscarriages.