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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, unwanted pregnancy, reported sexual practices, depression, and substance misuse.Results There was no evidence that Stepping Stones lowered the incidence of HIV (adjusted incidence rate ratio 0.95, 95% confidence interval 0.67 to 1.35). The programme was associated with a reduction of about 33% in the incidence of HSV-2 (0.67, 0.46 to 0.97; P=0.036)-that is, Stepping Stones reduced the number of new HSV-2 infections over a two year period by 34.9 (1.6 to 68.2) per 1000 people exposed. Stepping Stones significantly improved a number of reported risk behaviours in men, with a lower proportion of men reporting perpetration of intimate partner violence across two years of follow-up and less transactional sex and problem drinking at 12 months. In women desired behaviour changes were not reported and those in the Stepping Stones programme reported more transactional sex at 12 months.

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