ABSTRACT

Jewkes, R., Mzikazi Nduna, J. Levin, N. Jama, K. Dunkle, N. Khuzwayo, M. Koss, A. Puren, Kate Wood, and N. Duvvury. 2006. "A cluster randomized-controlled trial to determine the effectiveness of Stepping Stones in preventing HIV infections and promoting safer sexual behaviour amongst youth in the rural Eastern Cape, South Africa: Trial design, methods and baseline findings," Tropical Medicine and International Health 11(1): 3–16. 

Objective
To describe the study design, methods, and baseline findings of a behavioral intervention trial aimed at reducing HIV incidence.

Method
A cluster randomized-controlled trial (RCT) conducted in 70 villages in rural South Africa. A behavioral intervention, Stepping Stones, was implemented in 35 communities in two workshops of 20 men and 20 women in each community who met for 17 sessions (50 hours) over a period of 3–12 weeks. Individuals in the control arm communities attended a single session of about three hours on HIV and safer sex. Impact assessment was conducted through two questionnaire and serological surveys at 12-month intervals. The primary outcome was HIV incidence and secondary measures included changes in knowledge, attitude, and sexual behaviors. Qualitative research was also undertaken with ten men and ten women from two sites receiving the intervention (one rural and one urban) and five men and five women from one village in the control arm. They were interviewed individually three times prior to the workshops and then 9–12 months later.

Results
A total of 2,776 participants (1,409 intervention and 1,367 control) were enrolled at baseline and had an interview, and HIV serostatus was established. HIV baseline prevalence rates in women were 9.8 percent in the intervention arm and 12.8 percent in the control arm. In men the prevalence was 1.7 percent in the intervention arm and 2.1 percent in the control arm. Demographic and behavioral characteristics were similar in the two arms. In the intervention groups 59.9 percent of participants attended more than 75 percent of the sessions. In the control group 66.3 percent attended the control session.

Conclusion
This is the third RCT to be conducted in sub-Saharan Africa evaluating a behavioral intervention using HIV incidence as a primary outcome. It is of particular interest as the intervention in question is used in many developing countries. There is good baseline comparability between the study arms and the process data on the workshops suggested that the interventions were feasible and adequately implemented.

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