School-based randomized controlled trial of an HIV/STD risk-reduction intervention for South African adolescents.

OBJECTIVE To test the efficacy of a school-based human immunodeficiency virus/sexually transmitted disease (HIV/STD) risk-reduction intervention for South African adolescents. DESIGN A cluster-randomized, controlled design with assessments of self-reported sexual behavior collected before intervention and 3, 6, and 12 months after intervention. SETTING Primary schools in a large, black township and a neighboring rural settlement in Eastern Cape Province, South Africa. PARTICIPANTS Nine of 17 matched pairs of schools were randomly selected. Sixth-grade students with parent or guardian consent were eligible. INTERVENTIONS Two 6-session interventions based on behavior-change theories and qualitative research. The HIV/STD risk-reduction intervention targeted sexual risk behaviors; the attention-matched health promotion control intervention targeted health issues unrelated to sexual behavior. OUTCOME MEASURES The primary outcome was self report of unprotected vaginal intercourse in the previous 3 months averaged over the 3 follow-ups. Secondary outcomes were other sexual behaviors. RESULTS A total of 1057 (94.5%) of 1118 eligible students (mean age, 12.4 years) participated, with 96.7% retained at the 12-month follow-up. Generalized estimating equation analyses adjusted for clustering from 18 schools revealed that, averaged over the 3 follow-ups, a significantly smaller percentage of HIV/STD risk-reduction intervention participants reported having unprotected vaginal intercourse (odds ratio [OR], 0.51; 95% confidence interval [CI], 0.30-0.85), vaginal intercourse (OR, 0.62; 95% CI, 0.42-0.94), and multiple sexual partners (OR, 0.50; 95% CI, 0.28-0.89), when adjusted for baseline prevalences, compared with health-promotion control participants. CONCLUSION This is the first large-scale, community-level, randomized intervention trial to show significant effects on the HIV/STD sexual risk behavior of South African adolescents in the earliest stages of entry into sexual activity.