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Objective To assess the impact of Stepping Stones, a HIV prevention programme, on incidence of HIV and herpes simplex type 2 (HSV-2) and sexual behaviour.

Design Cluster randomised controlled trial.

Setting 70 villages (clusters) in the Eastern Cape province of South Africa.

Participants 1360 men and 1416 women aged 15-26 years, who were mostly attending schools.

Intervention Stepping Stones, a 50 hour programme, aims to improve sexual health by using participatory learning approaches to build knowledge, risk awareness, and communication skills and to stimulate critical reflection. Villages were randomised to receive either this or a three hour intervention on HIV and safer sex. Interviewers administered questionnaires at baseline and 12 and 24 months and blood was tested for HIV and HSV-2.

Main outcome measures Primary outcome measure: incidence of HIV. Other outcomes: incidence of HSV-2 …