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),whenadjusted for baseline prevalences, compared with health-promotion control participants. Conclusion: This is the first large-scale, community-level, randomized intervention trial toshowsignificant effectson the HIV/STD sexual risk behavior of South African adolescents in the earliest stages of entry into sexual activity. ©2010 American Medical Association. All rights reserved.