Rationale and design of a randomized controlled trial testing the efficacy of Safe South Africa, an intervention to prevent HIV risk behavior and sexual violence among adolescent boys.

backgroundRates of HIV acquisition and sexual violence perpetration are pressing public health issues for adolescents in South Africa. The evidence base around interventions that concomitantly address both HIV risk and prevention of sexual violence perpetration needs development. This protocol describes the design and procedures for a randomized controlled trial that investigates the efficacy of a behavioral intervention to address HIV and sexual violence called Safe South Africa.

methodsSafe South Africa is a behavioral intervention. The intervention takes an integrated approach for preventing or reducing risk behavior related to the acquisition of human immunodeficiency virus (HIV) and sexually transmitted infections (STIs) and the perpetration of sexual violence among adolescents in South Africa. The behavioral intervention is gender and developmentally tailored for adolescent boys aged 15-17 years and delivered in the school setting. The trial will compare the experimental intervention-Safe South Africa-with control of practice as usual. In South Africa, the practice as usual consists of no intervention, as there are currently no existing interventions that have been proven to be efficacious for reducing the risk for HIV and perpetration of sexual violence concurrently with adolescent boys in this setting. The study is based on the hypothesis that the behavioral intervention-Safe South Africa-will result in adolescent boys randomized to the intervention showing (a) a lower incidence of any STI (including HIV) and (b) reductions in sexual violence perpetration frequency and decreased endorsement of intimate partner violence supportive attitudes as compared to the control. N = 836 participants will be randomly assigned to either the intervention group or the control group with an allocation ratio of 1:1. Eligible participants include the following: (1) identification as boys; (2) ages 15-17 years; (3) enrolled at public high schools in South Africa situated in communities with high rates of HIV and violence. Participants must provide informed written assent (following parental consent). We will compare primary outcomes between the two study arms at 4 and 12 months versus baseline to quantify the intervention's short- and long-term effects using generalized estimating equations to account for repeated measures. DISCUSSION: Study findings will allow us to contribute to the evidence base of integrated HIV-violence prevention interventions that meet the needs of adolescents in school settings.

trial registrationThis study has been registered at ClinicalTrials.gov under protocol ID NCT03231358. Registered on December 27, 2024.